A Market Landscape

and Strategic Approach

to Increasing Access to
Prosthetic Devices and
Related Services in Low- and
Middle-Income Countries

PRODUCT NARRATIVE:

PROSTHESES

atscale2030.or
org
g

APRIL 2020
ACKNOWLEDGEMENTS

This report was delivered by the Clinton Health Access Initiative under the AT2030 programme in support
of the ATscale Strategy. The AT2030 programme is funded by UK aid from the UK government and led
by the Global Disability Innovation (GDI) Hub. The authors wish to acknowledge and thank prosthetics
sector experts, practitioners and users, and the partners from the AT2030 programme and Founding
Partners of ATscale, the Global Partnership for Assistive Technology, for their contributions. The Founding
Partners are: China Disabled Persons’ Federation, Clinton Health Access Initiative, GDI Hub, Government
of Kenya, International Disability Alliance, Norwegian Agency for Development Cooperation, Office of the
UN Secretary-General’s Envoy for Financing the Health Millennium Development Goals and for Malaria, UK
Department for International Development, UNICEF, United States Agency for International Development,
World Health Organization.
The views and opinions expressed within this report are those of the authors and do not necessarily
reflect the official policies or position of ATscale Founding Partners, partners of the AT2030 programme,
or funders.
Please use the following form: (https://forms.gle/kQdJTR9uXRj8g5aYA) to register any comments or
questions about the content of this document. Please direct any questions about ATscale, the Global
Partnership for Assistive Technology, to [email protected] or visit atscale2030.org. To learn more
about the AT2030 Programme, please visit at2030.org.
TABLE OF CONTENTS

Acknowledgements ii

Acronyms iv

Executive Summary 1

Introduction 3
1. Assistive Technology and Market Shaping 3
2. Product Narrative 4

Chapter 1: Market Landscape 5

3. Market Context 5
4. Market Assessment 15
5. Market Challenges 28

Chapter 2: Strategic Approach to Market Shaping 31

6. Strategic Approach to Market Shaping and Market Building 31
7. Next Steps 35

Annexes 36
Annex A: List of Consultations for Product Narrative Development 36
Annex B: Designations in Prosthetist/Orthotist professions according
to 2018 Education Standards (detailed) 39
Annex C: Global Component Supply Landscape 41
Annex D: Select prosthetic components developed for LMIC context 42
Annex E: Overview of prominent international organisations providing
prosthetic services 43
Annex F: Select regional NGO/FBOs 45
Annex G: Description of traditional socket fabrication and fitting process 47
Annex H: Overview of select novel socket fabrication technologies
with potential for adoption in LMICs 48
Annex I: Different component supply channels observed in LMICs 50

INCREASING ACCESS TO PROSTHESES AND RELATED SERVICES IN LOW AND MIDDLE INCOME COUNTRIES iii
 ACRONYMS

APDK Association of Physically Disabled Kenya

AT Assistive technology
BMVSS Bhagwan Mahaveer Viklang Sahayata Samiti
CBR Community-based rehabilitation
CE CE marking (compliance with EU legislation)
CEPO Centre of Excellence for Prosthetics and Orthotics
CHAI Clinton Health Access Initiative, Inc.
CSO Civil society organisation
CSPO The Cambodian School of Prosthetics and Orthotics
DPO Disabled persons’ organisation
EUR Euro (currency)
FBO Faith-based organisation
FDA US Food and Drug Administration
HI Humanity & Inclusion (formerly Handicap International)
HIC High-income country
HR Human Resources
ICRC International Committee of the Red Cross
ISPO International Society for Prosthetics and Orthotics
ISO International Organization for Standardization
LMIC Low- and middle-income country
NGO Non-governmental organisation
OADCPH Organisation Africaine pour le Développement des Centres pour Personnes Handicapées
OOP Out-of-pocket
P&O Prosthetics and orthotics
PPP Public-private partnership
SOL Scandinavian Orthopaedic Laboratory (Sweden)
SRA Stringent Regulatory Authority
TATCOT Tanzania Training Centre for Orthopaedic Technologists
TF Transfemoral (prosthesis)
TT Transtibial (prosthesis)
UK United Kingdom
US United States of America
USD United States Dollar
USAID United States Agency for International Development
WHO World Health Organization
3D Three-dimensional (printing)

iV PRODUCT NARRATiVE: PROSTHESES

EXECUTIVE SUMMARY

TO ACCELERATE ACCESS TO ASSISTIVE TECHNOLOGY (AT), it is critical to leverage the capabilities and
resources of the public, private, and non-profit sectors to harness innovation and break down barriers to
affordability and availability. Market-shaping interventions can play a role in enhancing market efficiencies,
as well as coordinating and incentivising stakeholders involved in demand- and supply-side activities. This
document will address the key barriers and opportunities to increase access to prostheses services. Since
there is a significant overlap in prosthetic and orthotic service delivery, access to orthotic services will also
benefit from the proposed interventions.
Globally, an estimated 1.5 million people undergo amputations every year and need to access prosthetic
services. The need is growing in low- and middle-income countries (LMICs). However, despite evidence
that using a prosthesis can improve quality of life and reduce mortality for amputees, the World Health
Organization (WHO) estimates that only 5-15% of amputees who need prosthetic devices in LMICs have
access to them.
The market for prosthetic solutions in LMICs is small, because prostheses need to be fitted through a
service delivery process that requires specialised infrastructure and personnel, both of which are in
short supply in LMICs. Governments have historically not invested in this sector, because they lack data
and awareness of the need and economic benefits. In the absence of government investments, non-
governmental organisations (NGOs) have developed service capacities, largely in response to emergencies
that sometimes operate in parallel to government systems. Without support from governments and donors
to integrate provision and expand capacity, prostheses are not accessible to most people that need them.
Innovative socket manufacturing technologies, including digital fabrication and direct-casted sockets,
have the potential to increase access. However, consensus is needed within the sector on the readiness
of these technologies to be deployed in LMIC markets.
A few companies supply most of the prosthetic components worldwide, and these are focused on high-
income markets that can bear more expensive and technologically advanced solutions. Alternative
suppliers offering affordable products are entering LMICs from emerging markets such as China, Turkey,
and India. However, limited transparency on the quality and performance of these components in LMIC
contexts inhibit their uptake. Additionally, prosthetic components should be available through a flexible
and responsive supply chain, since component selection is made by prosthetists/orthotists based on
assessments of users’ needs and use context. While components in high-income countries (HICs) are often
ordered individually from the manufacturer, logistics challenges in LMICs may not allow such an approach.
An opportunity exists to increase access to affordable, quality, and appropriate prosthetic components, but
will require more transparency and a more responsive supply chain.
High prices and poor perception of value of prosthetic services in LMICs, combined with high indirect
costs for users to travel, makes prosthetic services unaffordable to many of people who need them.
Prosthetic services can be made more affordable by: 1) increasing the number of service units (in
particular, by leveraging decentralised service models and the innovative technologies that enable
them); 2) establishing reimbursement schemes that encapsulate all costs to the user; and 3) leveraging
alternative forms of financing for both capacity-building and user financing.

I 1
 An opportunity exists to transform access to prosthetics services and products in LMICs, but this will
require a coordinated effort between: 1) governments to expand service capacity; 2) global stakeholders
to provide guidance on products and technologies; 3) suppliers to expand market presence and offerings;
and 4) donors to support these activities. To accelerate access to prosthetic services in LMICs, the following
strategic objectives have been defined:
• STRATEGIC OBJECTIVE 1: Develop foundational datasets to inform the investment case for
prosthetic services and guide the development of standards.
• STRATEGIC OBJECTIVE 2: Support countries to define appropriate policies and invest in the key
requirements of a functioning prosthetic provisioning system.
• STRATEGIC OBJECTIVE 3: Accelerate market validation and adoption of innovative technologies
that can simplify, decentralise, and lower the cost of prosthetic service provision.
• STRATEGIC OBJECTIVE 4: Accelerate the uptake of affordable, quality prosthetic components by
increasing market transparency to empower buyers to make value-based purchasing decisions.
• STRATEGIC OBJECTIVE 5: Strengthen regional supply mechanisms to increase affordability and
availability of quality prosthetic components.
These strategic objectives are supplemented by initial activities to support access to affordable, high-
quality, and appropriate prosthetic devices and services. ATscale, the Global Partnership for Assistive
Technology, is currently in the process of developing a prioritisation process to inform which of the
market-shaping activities proposed in this document will be incorporated into the Partnership’s action and
investment plan in order to guide activities and investments in the short-term. While that is underway, some
of these proposed activities will be undertaken in the immediate term by the AT2030 programme, funded
by UK aid, in line with its aim to test what works to increase access to affordable and appropriate AT.

2 PRODUCT NARRATiVE: PROSTHESES

INTRODUCTION

1. Assistive Technology and Market Shaping

Assistive technology (AT) is an umbrella term covering the systems and services related to the delivery of
assistive products such as wheelchairs, eyeglasses, hearing aids, prosthetics, and personal communication
devices. Today, well over 1 billion people require AT to achieve their full potential, but 90% do not have
access to the AT that they need. This unmet need for AT is driven by a lack of awareness of this need,
discrimination and stigma, a weak enabling environment, lack of political prioritisation, limited investment,
and market barriers on the demand and supply side. Market shortcomings limit availability, affordability,
and access to appropriate AT, and market shaping is proposed to address these root causes, as well as
serve the wider aim of ensuring improved social, health, and economic outcomes for people who require
AT. Increased access to AT is critical to achieve many global commitments, including universal health
coverage, the ideals of the United Nations Convention on the Rights of Persons with Disabilities, and the
ambitious Sustainable Development Goals. To accelerate access to AT, the global community needs to
leverage the capabilities and resources of the public, private, and non-profit sectors to harness innovation
and break down market barriers.
Whether by reducing the cost of antiretroviral drugs for HIV by 99% in 10 years, increasing the number of
people receiving malaria treatment from 11 million in 2005 to 331 million in 2011,1 or doubling the number of
women receiving contraceptive implants in 4 years while saving donors and governments USD 240 million,2
market shaping has addressed market barriers at scale. Market-shaping interventions can play a role in
enhancing market efficiencies, improving information transparency, and coordinating and incentivising
the numerous stakeholders involved in both demand- and supply-side activities. Examples of market-
shaping interventions include: pooled procurement, de-risking demand, bringing lower cost and high-
quality manufacturers into global markets, developing demand forecasts and market intelligence reports,
standardising specifications across markets, establishing differential pricing agreements, and improving
service delivery and supply chains.
Market-shaping interventions often require coordinated engagement on the demand and supply side (see
Figure 1). Successful interventions are tailored to specific markets after robust analysis of barriers and seek
to coordinate action on both the demand and supply side. These interventions are catalytic and time-
bound, with a focus on sustainability, and are implemented by a coalition of aligned partners providing
support where each has comparative advantages.

1 UNITAID and World Health Organization. UNITAID 2013 Annual report: transforming markets saving lives. UNITAID; 2013. Available from: http://unitaid.org/assets/UNITAID_An-
nual_Report_2013.pdf.
2 Suzman M. Using financial guarantees to provide women access to the modern contraceptive products they want to plan their families. Bill & Melinda Gates Foundation and
World Economic Forum; 2016 May. Available from: http://www3.weforum.org/docs/GACSD_Knowledge%20Hub_Using_Financial_Guarantees_To_Provide_Women_Access_
To_Modern_Contraceptives.pdf.

I 3
 FIGURE 1: ENGAGING BOTH DEMAND AND SUPPLY SIDE FOR MARKET SHAPING

DEMAND SiDE ENGAGEMENT SUPPLY SiDE ENGAGEMENT

Work with governments, DPOs, CSOs, Work with manufacturers and suppliers to:
and others to:
• Reduce the costs of production
• Build and consolidate demand around • Enhance competition
optimal products in terms of efficacy,
specifications, quality, and price • Enhance coordination
• Strengthen procurement processes • Encourage adoption of stringent quality
and programmes to utilise optimal standards
products • Optimise product design
• Improve financing and service delivery • Accelerate entry and uptake of new and
better products

Historically, AT has been an under-resourced and fragmented sector and initial analysis indicated that a
new approach was required. ATscale, the Global Partnership for Assistive Technology, was launched in
2018 with an ambitious goal to provide 500 million people with the AT that they need by 2030. To achieve
this goal, ATscale aims to mobilise global stakeholders to develop an enabling ecosystem for access to AT
and to shape markets to overcome supply- and demand-side barriers, in line with a unified strategy (https://
atscale2030.org/strategy). While the scope of AT is broad, ATscale has focused on identifying interventions
needed to overcome supply- and demand-side barriers for five priority products: wheelchairs, hearing
aids, eyeglasses, prosthetic devices, and assistive digital devices and software.
Clinton Health Access Initiative (CHAI) is delivering a detailed analysis of the market for each of the priority
products under the AT2030 programme (https://www.disabilityinnovation.com/at2030), funded by UK
aid from the UK government, in support of the ATscale Strategy. AT2030 is led by the Global Disability
Innovation Hub. What follows is a detailed analysis of prosthetic devices, one of the five evaluated priority
products.

2. Product Narrative
The product narrative defines the approach, identified by CHAI, to sustainably increase access to high-
quality, affordable AT in LMICs. The goals of this narrative are to: 1) propose long-term strategic objectives
for a market-shaping approach; and 2) identify immediate opportunities for investments to influence the
accessibility, availability, and affordability of prosthetic and orthotic (P&O) services. This document will focus
primarily on access to prosthetic services. However, given the overlap between P&O service delivery in
infrastructure and personnel, access to orthotic services will also benefit from the proposed interventions.
This report has been informed by desk research, market analysis, key informant interviews, and site visits
with relevant partners and governments to develop a robust understanding of the market landscape and
the viability of the proposed interventions. A list of all individuals interviewed or consulted during the
development process can be found in Annex A. This document is divided into two chapters:
• CHAPTER 1: MARKET LANDSCAPE, including market context, the current product landscape, state
of access and provision, supply chain analysis, and stakeholders’ current engagement, as well as
key market challenges and barriers to access on both the demand and supply side;
• CHAPTER 2: STRATEGIC APPROACH TO MARKET SHAPING, including strategic objectives
highlighting the long-term outcomes required to shape the market. A series of immediate next
steps or actions to support achieving each strategic objective are proposed. For any given
objective, the interventions are discrete testable opportunities that support the development of
longer-term scalable interventions and investments.

4 PRODUCT NARRATIVE: PROSTHESES

CHAPTER 1

MARKET LANDSCAPE

3. Market Context

3.1 There are an estimated 65 million people that live with limb amputations
globally, with 1.5 million people undergoing amputations – mostly lower
limb – each year. Most amputees need access to prosthetic services and this
need is expected to double by 2050.

No comprehensive data exists on the global incidence of amputations, but a recent study estimated that
65 million people live with limb amputations globally.3 Amputation is the action taken to surgically remove
a part of the body following trauma, disease, or congenital conditions and is the leading reason for the use
of prosthetic devices. A prosthetic device is an externally applied device used to replace wholly or in part
an absent or deficient limb segment. An orthotic device is an externally applied device used to modify the
structural and functional characteristics of the neuro-muscular and skeletal systems.4 Both are fitted using
common biomechanics, processes, and equipment. WHO groups P&O together since both concern the
use of externally applied devices to restore or improve mobility, functioning, and to correct deformities.
Although P&O services have overlapping human resource and infrastructure requirements, this document
will focus on the market barriers to access for lower-limb prostheses since more than 60% of the 1.5 million
amputations every year are lower limb.3 However, as a result of investing in the scale-up of prosthetic
services, access to orthotic services is also expected to also expand due to an increase in the number of
service points and trained personnel in LMICs.
An estimated 64% of people living with amputations are in LMICs.3 Regionally, about half are situated in
Asia (see Figure 2). The primary causes for amputation differ between HICs and LMICs. In HICs, around
80% of amputations are caused by complications of blood vessel diseases and diabetes5 that restrict
blood flow to various parts of the body. Foot ulcers, a common complication of sensory loss due to poorly
controlled diabetes, account for the majority of lower-limb amputations among diabetics.6 In LMICs, on the
other hand, most amputations result from trauma due to road traffic accidents, injury from current or past
conflicts, infections of the bone or tissue such as osteomyelitis or sepsis, and untreated birth defects.
The global need for prosthetic devices is expected to double by 2050.7 More amputations will take place
in LMICs due to a growing population, increasing road traffic accidents due to poor road conditions and
urbanisation, and changing demographics that lead to increasing prevalence of non-communicable
diseases such as diabetes. For example, diabetic patients are eight times more likely to undergo at least

3 McDonald CL, Westcott-McCoy S, Weaver MR, Haagsma J, Kartin, D. Global prevalence of traumatic non-fatal major limb amputation. Prosthet Orthot Int. Submitted 2020 March.
4 International Organization for Standardization. ISO 8549-1:1989 Prosthetics and orthotics – Vocabulary – Part 1: General terms for external limb prostheses and external ortho-
ses. 1989. Available from: https://www.iso.org/obp/ui/#iso:std:iso:8549:-1:ed-1:v1:en.
5 Excess glucose damages blood vessels, leading to vascular diseases such as loss of sensation in extremities. 12-15% of people with diabetes will develop foot ulcers due to
poor circulation, which increases their risk for infection and amputation.
6 Wraight P, Lawrence S, Campbell D, Colman P. Retrospective data for diabetic foot complications: only the tip of the iceberg?. Intern Med J. 2006;36(3):197-199. Available
from: https://doi.org/10.1111/j.1445-5994.2006.01039.x.
7 World Health Organization. WHO standards for prosthetics and orthotics. 2017. Available from: https://www.who.int/phi/implementation/assistive_technology/prosthetics_orthot-
ics/en/.

I 5
 one lower-limb amputation than non-diabetic patients8 and WHO estimates that incidence of diabetes will
rise from 415 million in 2015 to 642 million in 2040. The global P&O need is estimated to increase from
0.5% of the global population to 1% of the population by 2050.7

FIGURE 2: REGIONAL DISTRIBUTION OF PEOPLE LIVING WITH AMPUTATION (2017) 9

Number of People
with Amputations 17 million 14m 11m 5m 5m 5m 4m 3m 1m

Lower Limb 62% 71% 66% 75% 59% 74% 60% 70%
66%

Upper Limb 38% 29% 34% 25% 41% 26% 40% 30%
34%

East-Central Asia Europe South Asia North America Central-South Australia

America
Africa Middle East Southeast
Asia

3.2 Use of prosthetic devices improves quality of life and reduces mortality, but
only 5-15% of people in LMICs that need one have access.

Appropriate selection of prosthetic devices can improve user quality of life and reduce mortality. Prosthetic
use allows amputees to regain mobility and independence. For example, 80% of amputees in Vietnam
and India who had received functioning prostheses described themselves as employed.10,11 This permits
reintegration into work and community, raising quality of life measures such as well-being, productivity,
intimacy, health, and safety.12,13 In addition to improvements in their quality of life, a recent study in the US
suggests that prosthetic users have greater life expectancy following amputation, and 12-month mortality
rates are two times lower compared to non-users with similar disease and demographic profiles, though
this study does not control for the prevalence of co-morbidities.14 From a financial perspective, access to
appropriate prosthetic devices decreases the need for hospitalisation and associated acute care, resulting
in reduction of health expenditure. In the US Medicare system, the cost of providing prosthetic devices
was found to be fully amortised within 12 to 15 months due to a reduction of care in other settings.15
Although clinical, economic and social benefits of prosthetic use are documented in HICs, there is limited
evidence to draw conclusions in LMICs, resulting in low prioritisation and investment by governments.
8 Johannesson A, Larsson G, Ramstrand N, Turkiewicz A, Wirehn A, Atroshi I. Incidence of lower limb amputation in the diabetic and nondiabetic general population: a 10-year
population-based cohort study of initial unilateral and contralateral amputations and reamputations. Diabetes Care. 2008;32(2):275-280. Available from: https://doi.org/10.2337/
dc08-1639.
9 McDonald CL, Westcott-McCoy S, Weaver MR, Haagsma J, Kartin, D. Global prevalence of traumatic non-fatal major limb amputation. Prosthet Orthot Int. Submitted 2020 March.
10 Matsen S. A closer look at amputees in Vietnam: A field survey of Vietnamese using prostheses. Prosthet Orthot Int. 1999;23(2):93-101. Available from: https://doi.

org/10.3109/03093649909071619.
11 Adalarasu, K, Jagannath M, Mathur MK. Comparison on Jaipur, SACH and Madras Foot: A psychophysiological study. International Journal of Advanced Engineering Sciences

& Technologies. 2011;4(1), 187-192. Available from: https://www.doc-developpement-durable.org/file/sante-hygiene-medecine/handicaps/Protheses-Propylene/5.IJAEST-Vol-No-

6-Issue-No-2-Comparison-on-Jaipur,-SACH-and-Madras-Foot-187-192.pdf.
12 Powell B, Mercer S, Harte C. Measuring the impact of rehabilitation services on the quality of life of disabled people in Cambodia. Disasters. 2002;26(2):175-191. Available from:

https://doi.org/10.1111/1467-7717.00199.
13 Adegoke B, Kehinde A, Akosile C, Oyeyemi A. Quality of life of Nigerians with unilateral lower limb amputation. Disability, CBR & Inclusive Development. 2013;23(4). Available

from: https://doi.org/10.5463/dcid.v23i4.192.
14 Dobson, A, El-Ghamil, A, Shimer, M, DaVanzo, J. Retrospective cohort study of the economic value of orthotic & prosthetic services among medicare beneficiaries. American

Orthotic & Prosthetic Association; 2013. Available from: https://www.aopanet.org/wp-content/uploads/2014/01/Dobson-Davanzo-Report.pdf.

15 Dobson A, Murray K, Manolov N, DaVanzo J. Economic value of orthotic and prosthetic services among medicare beneficiaries: a claims-based retrospective cohort study,

2011–2014. J Neuroeng Rehabil. 2018;15(S1). Available from: https://doi.org/10.1186/s12984-018-0406-7.

6 PRODUCT NARRATiVE: PROSTHESES

Limited data in LMICs on the number of amputees, need for prosthetics, current coverage of prosthetic use,
and the clinical benefits and economic returns, make it difficult for policy-makers to ascertain the economic
and health burden, and to make appropriate budget allocations. Measuring the cost-effectiveness of
prosthetic provisioning through the reduction of the cost of care in other settings or in contribution to the
economy over time would drive increased awareness, attention, and urgency.
WHO estimates that prosthetics coverage in LMICs is only 5-15%. Although these numbers are not based
on comprehensive data, it indicates the low coverage in LMICs when compared to HICs. In Indonesia,
for example, an estimated 4 million people need P&O services, with 146,000 amputees.16 However, only
around 3,000 users (2% of amputees) have been fitted.17 In the US, on the other hand, 86% of lower-limb
amputees adopt prosthetic devices.18 Additionally, individuals will need multiple devices in their lifetime.

3.3 Prosthetic devices are available across a spectrum of materials and

technologies and are customised based on needs of the user.

Prosthetic devices are classified by the body part(s) they replace (Table 1) and their construction. Lower-limb
prosthetic devices are divided into several types, including: transfemoral (TF) or above-knee prostheses,
transtibial (TT) or below-knee prostheses, and partial foot and toe prostheses that are used for amputations
of the toe and foot. Exoskeletal (also referred to as conventional) prostheses have external walls that
provide shape to the device and also perform the weight-bearing function. They are usually manufactured
from one piece of raw material and have limited adjustability and customisability. In endoskeletal (also
referred to as modular) prostheses, weight is transmitted through a central shank from socket to foot and
to the ground.19 These are composed of multiple components, each of which serve different functions, and
can be mass-produced and then selected, assembled, and adjusted to adapt to a user’s lifestyle (Table 2).
Prosthetic devices are customised and fitted based on the needs of each user. Prosthetic sockets have
a high level of customisation since they serve as the interface between the prosthesis and the user.
They are individually fabricated after patient assessment and measurement, and take into consideration
the amputation, anatomy, and any underlying medical conditions to ensure comfort and fit. Prosthetic
components are also selected and customised to account for the measurements and lifestyle of the user.
Users in LMICs often require their P&O devices to function for a range of environmental and lifestyle
factors, such as activity (agricultural or labouring livelihoods), temperature, humidity (requiring waterproof
or anti-rust features), culture (being able to sit cross-legged or to squat; colouring of limb coverings or
cosmesis), and affordability. Poorly-fitted or low-functionality prosthetic solutions that do not meet users’
needs often lead to abandonment.

TABLE 1: TYPES OF PROSTHETIC DEVICES

UPPER LiMB TYPES BODY PART(S) REPLACED LOWER LiMB TYPES BODY PART(S) REPLACED

Shoulder, elbow, forearm, Transfemoral (TF)

Shoulder Knee, shin, ankle, foot
wrist, hand (above knee)

Transhumeral (TH) Transtibial (TT)

Elbow, forearm, wrist, hand Ankle, foot
(above elbow) (below knee)

Transradial (TR)
Wrist, hand Partial foot (PF) Part of the foot
(below elbow)

16 Indonesia Basic Health Research, Riskesdas. 2018.

17 CHAI expert consultation.
18 Boston Consulting Group. 2017. Global Prosthetics Market.
19 Hanger Clinic. Lower limb extremity componentry [Internet]. Hanger; 2020. Available from: http://www.hangerclinic.com/limb-loss/adult-lower-extremity/Pages/Lower-Extremi-

ty-Componentry.aspx.

I 7
 TABLE 2: COMPONENTS OF
MODULAR (ENDOSKELETAL)
LOWER LIMB PROSTHETIC
DEVICES

A prosthesis is typically assembled

from the following components: Liner
1) liners: soft material that ensure
Sock
fit and comfort; 2) socket: interface (worn under liner)

between the residual limb and the

prosthesis; 3) terminal device: the Socket
foot; 4) joints: knee, ankle; 5) pylon:
Rotator
allows adjustment of the length
of the prosthesis. The device is Knee
attached to the body using a Joint
suspension system: these range
from straps or leather to pin and Pylon

lock. In a modular prosthetic

Foot
device, the socket is usually made
to order from raw materials while
the other components can be
manufactured centrally and then
customised, based on selection of TRANSTIBIAL PROSTHESIS TRANSFEMORAL PROSTHESIS
size or adjustments to fit the users.

COMPONENT DESCRiPTiON RANGE OF RAW MATERiALS

Soft interface materials that ensure fit, comfort, and that Ethylene-vinyl acetate (EVA)
the prostheses stays attached to residual limb. Certain foam, silicone, gel, urethane,
suspension systems require use of liners. When used thermoplastic elastomer (TPE),
Liner, properly, they provide a cushioning effect within the pelite, wool, cotton.
sleeves, socket, help to minimise friction forces, and provide even
socks pressure distribution.
Socks can be used to adapt to changes in the volume of
the residual limb.

Where the prosthetic device attaches to the residual Polypropylene, thermoplastic

limb. Because the residual limb is not meant to bear elastomer (TPE), wood,
Socket body weight, sockets must be individually moulded and aluminium, glass-reinforced
meticulously fitted to ensure pressure is distributed, and to plastic (GRP), resin, carbon fibre.
avoid damage to skin and tissue.

Mimics the function of a natural knee by providing safety, Titanium, aluminium,

symmetry, and smooth movement while walking. High polypropylene, nylon, wood.
Knee joint
variations exist in activity level, functionality, technology,
and materials.

Connects the socket to the foot. Lightweight and absorbs Wood, titanium, aluminium, steel,
Pylon shock. carbon fibre, glass-reinforced
plastic (GRP), polypropylene.

Designed to be the point of contact between prosthesis Polypropylene, polyurethane,

Foot and contact surface, with different foot designs optimised wood, rubber, carbon-fibre.
for different functions or terrains.

Limb covering to mimic appearance of real limb. Can be Silicone, local fabrics,
Cosmesis readymade or custom-designed, or made from locally Ethylene-vinyl acetate (EVA)
sourced materials. foam.

8 PRODUCT NARRATiVE: PROSTHESES

Prosthetic components can be made from a wide range of materials which affect the durability, functionality,
and price of the device. Materials that are commonly used in LMICs, because of price and availability,
include wood, leather, rubber, aluminium, and polypropylene. These materials create affordable devices,
albeit with limited flexibility and suitability for different use cases. Advanced materials such as carbon fibre
and titanium are more expensive, but offer increased functionality, flexibility, and durability and are typically
lighter in weight. Material and component selection may impact whether the user is able to participate fully
in their desired daily activities, and whether the user continues to wear the device over time.
Prosthetic components are available in a range of basic to advanced technologies that affect functionality
and control. Prostheses built with basic mechanical components, which usually cost up to USD 2,000,
are user-controlled and have a limited range of movement and functionality, particularly in the knee and
ankle. More advanced components, which cost up to USD 15,000, allow for a wider range of motion
and incorporate pneumatic or hydraulic control systems, resulting in a more natural gait. Devices that use
microprocessors and other intelligent response controls that can sense the users’ activity level, gait, and
environmental changes to control the limb, and cost up to USD 70,000. These high-technology prostheses
are usually customised to the user’s desired lifestyle and are comfortable, lightweight, and feel like a real
limb to users. On the other hand, exoskeletal prostheses that are typically manufactured from one raw
material can be priced as low as USD 100-USD 500. See Figure 3 for examples of lower-limb prosthetic
devices.

FIGURE 3: EXAMPLES OF LOWER-LIMB PROSTHETIC DEVICES

ADVANCED MODULAR
BASiC MODULAR
CONVENTiONAL (EXOSKELETAL) 20 iNCLUDES HYDRAULiC, PNEUMATiC,
(ENDOSKELETAL) 21
OR MiCROPROCESSOR CONTROLS 22
Andrew Mayovskyy/Shutterstock
TerraPhoto-Shutterstock

Ottobock

Made from one type of raw material, Mechanical user-powered Advanced functional components
with limited customisation or variation components made from made from lightweight materials
of components. aluminium, steel, or rubber, designed for comfort and
amongst others. Modular activity (carbon fibre, titanium).
design permits customisation Some advanced joints employ
and selection of components hydraulic or pneumatic joints for
to suit user needs. smooth gait control. Others utilise
microprocessors equipped with
intelligent controls and sensors that
respond to the user and environment.
Though designed to be durable,
most advanced components often
have limited lifespans in LMIC
environments.

20 TerraPhoto.Shutterstock. Exoskeletor lower limb. Royalty Free ID: 154713758

21 Matammana Orthopedic Suppliers Company. Lower extremity prosthetics and orthotics [Internet]. 2020. Available from: http://www.orthopedic.lk/?p=lower_extremity.
22 Ottobock. Knee joint C-Leg [Internet]. 2013. Available from: https://www.ottobock.com.tr/en/prosthetics/lower-limb/solution-overview/knee-joint-c-leg/.

I 9
 3.4 WHO and the International Society for Prosthetics and Orthotics (ISPO) have
issued standards for the provision of appropriate prosthetic and orthotic
services, which requires specialised health professionals, infrastructure,
equipment, and supply chains.

In 2017, WHO, in partnership with ISPO and the United States Agency for International Development
(USAID), published Standards for Prosthetics and Orthotics, a two-part standards and implementation
manual for health systems providing P&O services.23 The standards outline recommendations to countries
on appropriate policy, products, personnel, and service provision in establishing a P&O services system
(Figure 4). Regarding the selection of prosthetic components, the standards highlight the following key
considerations:
• USER: level of amputation, clinical presentation of the residual limb, age, general health, weight,
strength, desired mobility level, type of work, and lifestyle.
• CONTEXT: environment (terrain, temperature, humidity), proximity to service providers for
maintenance, availability of local or imported materials and components, types of fabrication
equipment, and component supply available to the service provider.
• FINANCING: availability of reimbursements and eligibility of various component types, price of
components, longevity of components, and need for replacement.

FIGURE 4: 4-STEP PROSTHETIC SERVICE DELIVERY PROCESS

The prosthetist evaluates patient health, lifestyle, environment, and amputation

1. Assessment to prescribe an appropriate prosthetic solution (including selection of appropriate
components and materials to match user needs).

The prosthetist takes measurements and casts impressions of residual limb.

The cast of the stump is modified by the clinician to take into account individual
2. Fabrication & Fitting biomechanics and attributes. The prosthetist, in collaboration with prosthetic
technicians, fabricates the socket and assembles components. Finally, the
prosthetist fits and customises the prosthesis to the user’s needs.

User undergoes physical therapy and functional training to maximise benefits,

ensure safety, and continued use. Physical therapist coaches user in gait training,
3. User Training
and provides education on appropriate maintenance and care after the device
is provided.

When the prosthesis is optimally fitted, the prosthetist conducts requisite quality
and functionality checks, and delivers the prosthesis. Follow-ups with the patient
4. Product Delivery &
tracks outcomes and troubleshoots issues that may arise after a period of use and
Follow-up
are an important feedback loop. For new amputees, regular socket fit assessment
is needed as changes can occur as stump consolidation takes place.

23 WorldHealth Organization. WHO standards for prosthetics and orthotics. 2017. Available from: https://www.who.int/phi/implementation/assistive_technology/prosthetics_orthot-
ics/en/.

10 PRODUCT NARRATiVE: PROSTHESES

Prosthetic service units that provide prosthetic services can be expensive to set up, and require specialised
infrastructure and equipment. Different types of equipment and machinery, such as an oven, vacuum
suction and drills, are utilised to fabricate the socket that is moulded to the residual limb of the patient and
to assemble the prosthesis. In addition, other workshop areas are also required to ensure appropriate
services (see Figure 5). The estimated cost of establishing a prosthetic service unit in a LMIC ranges from
USD 200,00024 up to USD 400,00025 with machinery accounting for 50-80% of the cost.

FIGURE 5: PROSTHETICS AND ORTHOTICS SERVICE UNIT REQUIREMENTS 26

A Prosthetics and orthotics unit has 4 main areas:

1. Reception/waiting Area
Space
2. Clinical area
requirements
3. Workshop area (typically multiple rooms and workbenches)
4. Personnel area

• Patient assessment tools, casting tools, and materials

• Mould modification equipment: hand drills, sanding equipment, hand tools
• Socket casting equipment: oven, vacuum suction
Types of • Socket modification & assembly equipment: router, heavy-duty stand drills, vices and
equipment & clamps, saws
machinery • Physical therapy equipment: parallel bars, steps, ramps, cushions
• Furniture for non-workshop areas
• Workbenches, storage equipment for raw materials and components
• Computer for administration, inventory, and patient management

3.5 Trained and accredited prosthetists/orthotists are critical to the service

delivery process.

Prosthetists/orthotists assess, fabricate, and fit users with P&O devices. They undergo specialised
education and training which equip them to assess and educate the user, prescribe the appropriate
device, fabricate the custom-fitted components, and to fit the final device. ISPO and WHO have developed
guidelines for the training of prosthetists/orthotists27 which include the delineation of tasks of the various
personnel and guidelines for their training. In 2018, ISPO published the new ISPO Education standards
for prosthetics/orthotics occupations28 and updated the three levels of professional designations (see
Table 3): Prosthetists/Orthotists, Associate Prosthetists/Orthotists and Prosthetics/Orthotics Technicians.
Prosthetists/Orthotists and Associate Prosthetists/Orthotists are referred to as clinicians, who mainly
perform clinical work, while Prosthetics/Orthotics Technicians are referred to as non-clinicians. Over
the years, ISPO has implemented an accreditation process for training programmes to professionalise
the role of the prosthetist/orthotist internationally. Among the worldwide training institutions, there are
17 P&O schools which offer ISPO-accredited training in LMICs, of which 5 offer training at Prosthetist/
Orthotist level, 13 at Associate Prosthetist/Orthotist level and 1 at Prosthetic/Orthotic Technician level.

24 Cost estimates for establishing a P&O service unit in Myanmar. 2019.

25 CHAI Draft prosthetics services costing analysis. 2019.
26 World Health Organization. WHO standards for prosthetics and orthotics. 2017. Available from: https://www.who.int/phi/implementation/assistive_technology/prosthetics_orthot-
ics/en/.
27 World Health Organization. Guidelines for training personnel in developing countries for prosthetics and orthotics. 2005. Available from: https://apps.who.int/iris/han-

dle/10665/43127.
28 International Society for Prosthetics & Orthotics. ISPO education standards for prosthetic/orthotic occupations. 2018. Available from: https://cdn.ymaws.com/www.ispoint.org/

resource/resmgr/3_learn/ispo_standards_nov2018_sprea.pdf.

I 11
 There are also a number of non-ISPO-accredited training institutes in operation in LMICs, with varying levels of
effectiveness in graduating practitioners with adequate skills to deliver quality services. Training prosthetists to
ISPO standards has shown to positively impact developing new service capacity, appropriateness of prosthetic
and orthotic service delivery, clinical leadership, and driving development in professional communities in both
HICs and LMICs29 (see Case Study 1).

TABLE 3: DESIGNATIONS IN PROSTHETIC AND ORTHOTIC PROFESSiONS ACCORDING TO 2018

EDUCATiON STANDARDS (SEE ANNEX B FOR DETAILED DESCRIPTIONS) 30,31

PROFESSiONAL RECOMMENDED
RESPONSiBiLiTiES TRAiNiNG
DESiGNATiON NUMBER

CLiNiCiANS

• CLINICAL: assessment, 4 years full-time at 5-10 clinicians per

prescription, fitting, design, university level. million population,
Prosthetist/Orthotist fabrication, monitoring outcomes. Each service
Formerly: Category I • NON-CLINICAL: leadership of point should
Prosthetist/ Orthotist clinical team, management of have at least
service unit, training, education, one Prosthetist/
community demonstrations, Orthotist or
awareness-building. experienced
Associate
• CLINICAL: clinical assessment, 3 years formal Prosthetist/
Associate Prosthetist/ Orthotist.
prescription, technical design, structured.
Orthotist
fabrication, fitting of device,
Formerly: Category II monitoring outcomes.
Orthopedic Technologist

NON-CLiNiCiANS

Prosthetist/Orthotist • NON-CLINICAL: support 2 years formal 2 non-clinicians

Technician (Associate) Prosthetist/Orthotist structured or 4 per clinician.
Formerly: Category III in device fabrication, assembly, years on the job/
Prosthetic/Orthotic maintenance, repair. Not involved in-house training.
Technician/Bench Worker in direct services to the user.

Besides prosthetists and orthotists, multidisciplinary teams that include physical therapists and occupational
therapists are critical for pre-fitting and post-fitting rehabilitation. Without rehabilitation and physical therapy,
users may abandon their prosthesis due to discomfort or safety issues. These auxiliary rehabilitation
clinicians also offer opportunities to provide gait training or physical therapy outside a service unit setting,
since they are often integrated with health services. In some settings, rehabilitation clinicians are also
trained to provide device maintenance or repairs.

29 Sexton, S. Prosthetic & orthotics impact assessment. International Society for Prosthetics & Orthotics; 2012. Available from: https://cdn.ymaws.com/www.ispoint.org/resource/
resmgr/4_EXCHANGE/ispo_impact_assessment_tatco.pdf.
30 International Society for Prosthetics & Orthotics. ISPO education standards for prosthetic/orthotic occupations. 2018. Available from: https://cdn.ymaws.com/www.ispoint.org/

resource/resmgr/3_learn/ispo_standards_nov2018_sprea.pdf.
31 In 2005, ISPO and WHO defined the professional designations of prosthetics and orthotics workforce in the Guidelines for Training Personnel in Developing Countries for

P&O. In 2018, ISPO updated the professional designations in ISPO Education Standards for Prosthetic/Orthotic Occupations due to confusion caused by the categories used
in previous nomenclature. Both systems are widely referred to in the industry.

12 PRODUCT NARRATiVE: PROSTHESES

 CASE STUDY 1: PROSTHETIST/ORTHOTIST TRAiNING CENTRES IN SOUTHEAST ASIA AND
EAST AFRICA
Southeast Asia: Cambodian School of Prosthetics and Orthotics (CSPO)
CSPO was established in 1994 in collaboration with the Cambodian Ministry of Social Affairs to address
the shortage of trained prosthetists/orthotists in Cambodia and across Southeast Asia. CSPO is currently
upgrading its accreditation by ISPO to provide prosthetist/orthotist degree training and has been accredited
since 1998 for Associate Prosthetist/Orthotist diploma and Prosthetics/Orthotic Technician training. It
was the first ISPO-accredited school to receive ISO 9001 Quality Management System accreditation,
exhibiting international levels of production quality control. Since establishment, 327 individuals from
27 countries across the region and beyond have graduated from the school and entered the profession.

The establishment of the school led to quality improvements in P&O services across Southeast Asia.
Having local training capacity led to the expansion of services and developed a cadre of professionals
and leaders who rapidly transformed the quality of P&O services in the region. CSPO curriculum and
graduates have been used worldwide by Exceed to seed P&O training institutes in Sri Lanka, Indonesia,
the Philippines, and Myanmar. CSPO has developed the domestic capacity of prosthetists/orthotists,
enabling workforce nationalisation (instead of reliance on expatriate practitioners) across numerous
countries, and established professional associations who advocate for recognition of the profession and
policy changes to improve service capacity.

Anchored by CSPO, a P&O ecosystem has evolved in Cambodia. The ecosystem includes a social
enterprise that provides differentiated services for users at different income levels, and is part of a regional
component manufacturing and distribution company which also operates using a social enterprise model.

Despite this progress, the impact is limited by poor referral rates and awareness of prosthetic services.
Limited professional development and recognition of the prosthetist/orthotist profession also leads to
attrition and inequity for users outside urban areas.

East Africa: Tanzania Training Centre for Orthopaedic Technologists (TATCOT)

TATCOT was founded in 1981 with the support of German Technical Cooperation (now Gesellschaft für
Internationale Zusammenarbeit) and operates under the Directorate of Human Resources Development
for the Ministry of Health of Tanzania. TATCOT offers ISPO-accredited degrees and diplomas. As of
December 2017, 752 students have graduated: 134 Prosthetists/Orthotists and 370 Associate Prosthetists/
Orthotists, the remainder being specialised technicians. Graduates stem from 43 countries, including 32
in Africa.

Prosthetist/Orthotist and Associate Prosthetist/Orthotist degrees at TATCOT cost USD 44,500 and USD
25,725 respectively.32 TATCOT offers a Blended Learning Education programme that can allow Associate
Prosthetist/Orthotist diploma holders to upgrade to a Prosthetist/Orthotist degree while continuing to
work on the job. The curriculum combines online lectures with on-site practical teaching. TATCOT is
continuing to experiment with blended learning to provide continuing education as well as specialisation
training.

A 2012 USAID-funded assessment showed that TATCOT graduates have had lasting impact across
East Africa. In Tanzania, Kenya, and Uganda, graduates have improved quality of care, established
outreach services and mentorship, and established professional communities that enable professional
development.

In addition to being a leading training institute, TATCOT is a provider of P&O services in Tanzania. A
barrier to providing affordable services is the high cost of materials and components, most of which
need to be imported. To address this, TATCOT has worked with professional associations in Tanzania to
advocate for the inclusion of P&O components in central procurement processes by the Ministry of Health
for the national Medical Store.

32 Tanzania Training Centre for Orthopaedic Technologists. Prosthetics & orthotics - Bachelor of Science (BSc) [Internet]. 2018. Available from: www.tatcot.org/course_po_bsc.html.

I 13
 3.6 Donor funding is limited, with support mainly focused on training
prosthetists/orthotists and establishing service provision capacity.

Donor funding in the prosthetics sector has historically been prioritised for the training of prosthetists/
orthotists to ISPO-accredited levels. Nippon Foundation and USAID have been the leading donors to
support the establishment of ISPO-accredited schools. Building on the success of CSPO, between 2003-
2020, Nippon Foundation invested around USD 55 million for the expansion and establishment of
schools in the Philippines, Indonesia, Thailand, and Myanmar in collaboration with their governments and
implemented by Exceed Worldwide. These schools have graduated 600 practitioners as of December
2018. While some training institutes are established and staffed by international organisations, and
transitioned to local practitioners over time (see CSPO in Case Study 1), others, such as the
Sirindhorn School of Prosthetics and Orthotics, are founded with government ownership and local
workforce from the start. Training institutes in LMICs are typically established with funding from donor
organisations. Since the mid-1990s, USAID has supported the development of the prosthetist/
orthotist workforce by funding the development of regional ISPO-accredited schools and
scholarships for training personnel from 34 different countries. Additionally, through the Leahy War
Victims Fund, USAID has invested in the development of the WHO Standard for Prosthetics and
Orthotics Services, and established P&O services and service units in LMICs since 1989.
Other large contributors operate primarily in the humanitarian response field, such as the International
Committee of the Red Cross (ICRC), Humanity & Inclusion (HI) and Bhagwan Mahaveer Viklang Sahayata
Samiti (BMVSS). These organisations primarily focus on supporting the expansion of service
provision capacity and also run large rehabilitation programmes, and will therefore be discussed in detail
later in this document.

14 PRODUCT NARRATiVE: PROSTHESES

4. Market Assessment

4.1 The global prosthetic components market is estimated at USD 1.3 billion and
dominated by a few companies that primarily focus on HIC markets;
however, lower-cost suppliers are emerging.

The global prosthetic components market is valued at USD 1.3 billion and growing +3% every year.33 The US
and Germany are the largest markets in the world by value. China is the largest market by volume,
followed by the US and India. HIC markets can be characterised as high-value and low-volume, which
is primarily driven by higher pricing of components and the selection of more advanced technologies.
Regarding component type, microprocessor joints are estimated to account for more than 50% of global
market value, while mechanical feet account for 60% of global volume. India and Brazil are the fastest-
growing markets. The highest growth segments are high-tech components, including myoelectric hands
and microprocessor feet.
A few companies dominate the global market, with varying presence in LMICs (see Annex C). Ottobock
(Germany) is the leading global supplier of modular components. Founded post-World War I, the company
has achieved a strong market position by leading innovation and establishing networks of prosthetics clinics.
Ottobock is present in LMICs through distributors and service providers, as well as through acquisitions or
technology transfer partnerships. Össur (Iceland) is the second-largest leading supplier, estimated to be
half the size of Ottobock. Össur has regional presence in Europe, the Middle East, Southern Africa, and
the Americas, with sales growing fastest in the Asia-Pacific region. Proteor (France) and Blatchford (UK) are
long-standing companies who focus on HIC markets, but have also developed low-cost, basic solutions
targeted towards LMICs. Proteor components are commonly found in Francophone Africa, partially through
partnerships with HI, with whom they have developed an emergency prosthetic kit. Blatchford has formed
the Endolite subsidiary and line of prosthetics, which targets large LMIC markets such as China and India.
Prices for different prosthetic devices can vary considerably, depending on the brand, country of origin,
technology, and materials. Basic mechanical TF limbs are typically sold by the leading companies for
between USD 1,000 and USD 3,000. Manufacturers from China, India, Turkey, Russia, and Taiwan have
emerged offering lower-priced limbs, ranging from USD 100 to USD 500. In addition, some start-up
companies have developed specific components suited for a LMIC context, such as D-Rev’s ReMotion
Knee (USD 80) as well as the LegWorks All-Terrain Knee (USD 200). Select prosthetic solutions can be
found in Annex D. Many of these alternative suppliers have obtained internationally-recognised certificates
of quality, such as approval by the US Food and Drug Administration (FDA) and the European Commission
(CE marking), report conformity to ISO standards, and operate in LMICs.

4.2 LMIC markets for prosthetic devices are small as they lack capacity for
provision.

Lack of prioritisation of investment and coordination by LMIC governments limits the provision of prosthetics
and growth of a market. LMIC governments have largely not prioritised investments because they lack
awareness of the unmet need and value of providing prosthetic services. Further investigations to quantify
the return on investment of providing prosthetic services is needed to advocate for prioritisation and
investment. Additionally, prosthetic services and rehabilitation often fall within the responsibility of multiple
ministries, requiring coordination of investments between various groups, such as the Ministries of Health,
Social Welfare, Labour, Education and Veteran Affairs, which is often lacking.

33 Össur Investor Relations. Our markets [Internet]. Available from: https://corporate.ossur.com/corporate/investor-relations/our-business/our-markets.

I 15
 Developing sustainable markets for prosthetic services requires long-term planning and investment in
developing service capacity. In LMICs, the high cost of establishing and operating a prosthetic service
unit has limited the number of access points, which are often only found in tertiary-level teaching hospitals
in capital cities or urban centres. The lack of service points presents a logistical and financial barrier to
many users who must travel long distances. Expansion of service points requires an increased capacity
of accredited prosthetists/orthotists. Training for ISPO-accredited professional designations often requires
sponsorship and travel to a regional school. Once trained, it is proving challenging to retain prosthetists/
orthotists in the country due to poor working conditions, lack of professional recognition, and the ability for
accredited personnel to seek employment in the private sector or abroad. Due to the shortage of required
capacity in LMICs, personnel will sometimes take on responsibilities above their level of training.

TABLE 4: CAPACITY GAP OF P&O SERVICE UNITS AND PERSONNEL IN SELECT LMICS 34

NUMBER OF P&O P&O PERSONNEL

SERViCE UNiTS
COUNTRY
STATUS OF
(population)
iN-COUNTRY
NEED ACTUAL NEED ACTUAL
TRAiNiNG
iNSTiTUTiON

Kenya 50-150 4035 250-500 200 trained personnel, Not ISPO-Accredited.

(50 million) very few ISPO-accredited.

12-36 14 120-240 67 ISPO-accredited Accredited by ISPO.

(both public clinicians: 53 Associate
Rwanda
and private Prosthetists/Orthotists and
(12 million)
sector) 14 Prosthetists/Orthotists.

Indonesia 260-780 24 in general 1,300- 243 accredited clinicians. Accredited by ISPO.

(260 million) hospitals36 2,600

Though government financing may exist in some LMICs, current reimbursements for prosthetic services
and devices are largely insufficient. Table 5 compares reimbursements available and the associated
prices of prosthetics in select LMICs. The prices do not consider indirect costs typically incurred by the
user relating to travel or accommodation, etc. In addition, amputees may have already spent available
financial resources on upstream medical treatments that led to and include the amputation, particularly if
those services are also not covered through the public health system. To build upon the efforts countries
have made to date to offer coverage, additional analysis of the cost to users and the value of providing
prosthetic services is needed to build momentum for increased support.

34 World Health Organization. WHO standards for prosthetics and orthotics. 2017. Available from: https://www.who.int/phi/implementation/assistive_technology/prosthetics_orthot-
ics/en/.
35 CHAI expert consultation.
36 CHAI expert consultation.

16 PRODUCT NARRATiVE: PROSTHESES

TABLE 5: INSURANCE AND REIMBURSEMENT RATES FOR AMPUTEES FOR LOWER-LIMB
PROSTHETIC DEVICES

COUNTRY FiNANCiNG FOR USERS ELiGiBiLiTY CRiTERiA PRiCE (USD)

National Health Insurance Fund: Must be civil or public servants. TT: USD 500
Kenya provides reimbursement, up to a job- Pre-approval is required. TF: USD 1,000
dependent annual maximum.

Community-Based Health Insurance: Beneficiaries can access up TT: USD 360-1,000

used by 85% of Rwandans; does not to RWF 175,000 (USD 175) at TF: USD 600-1,000
generally cover prosthetic devices university teaching hospitals in
except at 2 university teaching Rwanda, which typically covers
hospitals. the cost of a prosthetic foot.
Rwanda
Rwanda Social Security Board: Only civil servants; requires
covers 85% of cost of device and 15% employee salary
services. contribution.

Military Medical Insurance: covers Only members of Rwanda

85% of cost of device and services. Defence Force and police staff.

National Health Insurance: covers Requires a prescription; can TT: USD 920
services, but prosthetic device only be accessed through TF: USD 1,700
coverage is Rp 2.5 million (USD 180) a government secondary
every 5 years. healthcare facility.
Indonesia
Other financial coverage is available
for people under social welfare from
certain provinces.

Novel financing mechanism for users, such as micro-loans and leases from financial institutions, could increase
affordability of prosthetic services, but have not yet been demonstrated or piloted. Since prosthetic devices
enable many users to return to work, there is an economic argument to be made for lenders. No such options
exist in LMICs today. Establishing funds to provide loans to amputees or assisting financial institutions to
understand the risk profile of lending to amputees can unlock user ability to afford prosthetic devices.

4.3 Lack of LMIC government investments has left a gap that has been filled by
non-governmental (NGOs) and faith-based organisations (FBOs).

NGOs and FBOs provide and support prosthetic services in LMICs. These organisations primarily
initiate programmes in response to conflict, natural disasters, or humanitarian crises. They provide
technical assistance, train clinicians, and establish supply channels. While NGOs and FBOs typically
work in partnership with governments, their individual deployment models result in parallel systems for
provisioning, procurement, supply, and user engagement. Governments become reliant on the funds and
technical inputs. Ownership and operations have been transferred to the local governments with varying
levels of success.
ICRC, BMVSS and HI are the largest international organisation and NGO providers in LMICs. ICRC and HI
support a broad network of rehabilitation service points in over 40 LMICs, and BMVSS is primarily focused
on India. ICRC and BMVSS each deliver around 25,000 prosthetic devices every year, while HI delivers
around 6,000 devices. They play a critical role in helping to fill the gap in prosthetic services in LMICs.
More information can be found in Annex E on these providers.
ICRC and BMVSS have developed products for low-resource settings. These products are consistent in
design and fabrication, which allows for streamlined centralised manufacturing to achieve lower costs and
simplified provisioning. The availability of these products has been impactful, particularly in conflict and

I 17
 emergency situations. However, these products provide limited customisability for different user lifestyles
and activity levels. ICRC’s polypropylene prosthetic technology is widely accepted and recognised
because of its suitability for deployment in LMIC contexts. Since 2019, ICRC has switched to Alfaset, a non-
profit arm of Swiss-based manufacturer Rehab Impulse. In contrast, studies suggest that BMVSS’s Jaipur
solutions are poorly accepted due to high failure rates and low durability, resulting in low adherence and
lack of technical and clinical acceptability.37
Beyond these three international organisations, additional NGO and FBOs are listed in Annex F.

4.4 Collaborations between the public sector and for-profit organisations may
have the potential to mobilise cross-sector investments to expand access.

Coordinating investments between the public and for-profit sector could drive expansion of services.
In the absence of government-funded services, a for-profit sector has emerged which caters mostly to
populations who can afford to pay out of pocket. Private providers offer a variety of prosthetic solutions,
varying in functionality, quality, and pricing. Quality can be a challenge in the private sector because of a
lack of regulatory oversight or frameworks. Private-public partnerships (PPP) and other mechanisms that
integrate the public sector and for-profit m odels c an a llow g overnments a nd p rivate s ector p roviders
to collaborate, co-invest, and integrate resources to jointly expand services while ensuring
quality. Demonstration and pilot projects are underway in LMICs (see Case Studies 2 and 3). These
models rely on willing government partners, appropriate policies (i.e. reimbursement, quality control)
that regulate and enable private-sector investments, and could be further expanded through
enabling the private sector to achieve financial sustainability.

CASE STUDY 2: PUBLIC-PRIVATE PARTNERSHIP IN THAILAND

Mahidol University is a public-sector institution that hosted the first ISPO Category I-accredited school
in Southeast Asia. Scandinavian Orthopaedic Laboratory (SOL) is a private sector enterprise in Sweden.
Together, the two partners collaborated in 2017 to create the Centre of Excellence for Prosthetics and
Orthotics (CEPO) to pilot PPPs as a new way to co-invest in P&O services.

In the past, public service units offered basic services and products free of charge, covered by national
insurance schemes. Issues in this public system included low quality of services and devices, and long
wait times. At a price premium, private providers offered a higher level of service and higher-priced
component options in well-equipped facilities with well-trained staff. To provide an alternative to the
public and private sector service levels, CEPO was established to serve a middle class who want to
access government reimbursement for prosthetic services, but also have a desire for faster access to
services and better quality components, and can afford to supplement public insurance funding. CEPO
also provides clinical training for P&O staff and other rehabilitation professions.

Partners share investments and costs, and assume profits and losses equally. Mahidol University invested
in the construction of the site, employs all local staff, and offers existing hospital administration systems for
patient records and payments. SOL invested in the equipment, furniture, and machinery required to achieve
high level of service. SOL also employs management staff and manages procurements, since procurement
restrictions prevent the government entity from selecting from a range of appropriate products.

CEPO has set a new standard for quality of P&O services through improved service unit management
and leadership, and increased quality of components. As a result, clinicians and users have begun to
request access to better-quality products and services in other public sector service units. While
profitability has not yet been achieved after 3 years, CEPO anticipates it will soon be profitable as
volumes increase through broader awareness and improved referrals. Moving forward, access to a
lower cost of capital for establishment could encourage additional private sector investments in service
expansion and to shorten the time to reach financial sustainability.

37 Jensen J, Craig J, Mtalo L, Zelaya C. Clinical field follow-up of high density polyethylene (HDPE)-Jaipur prosthetic technology for trans-femoral amputees. Prosthetics and Or-
thotics International. 2004;28(2):152-166. Available from: https://doi.org/10.1080/03093640408726700.

18 PRODUCT NARRATiVE: PROSTHESES

 CASE STUDY 3: EXCEED SOCIAL ENTERPRISE
Exceed Worldwide is a UK-based non-profit that has established five P&O schools in Southeast Asia and
supports the capacity development to train prosthetists/orthotists in the region. Exceed also supports
local prosthetic services and runs a social enterprise which provides differentiated services to users of
different income levels. By applying a government-recognised poverty assessment tool in Cambodia,
clients with suitable financial means are offered services and products which command a higher price
and profit, while low-income users are able to access quality services free of charge and products at cost-
recovery price. The services for low-income users are supported by the government and by the People
with Disability Foundation.

The social enterprise also operates a regional distribution company, which procures materials and
components from international and local suppliers in order to supply service providers across Southeast
Asia. All profits support philanthropic activities such as subsidised products and services for low-income
users and scholarships for training prosthetists/orthotists. Since its initial launch in Cambodia, Exceed
has expanded this model to Sri Lanka and the Philippines. The social enterprise is currently supported by
Innovate UK and researching similar models in Myanmar.

4.5 Collecting amputee data supports improved advocacy to drive investment in

prosthetic services and improvements to quality of care.

Amputee data is the starting point to drive awareness and prioritisation in prosthetic services; however,
very limited data is currently collected in LMICs. Investments in collecting such data and developing
registries help to illuminate the full need and monitor amputee outcomes. Data initiatives in LMICs include
examples such as ASCENT (see Case Study 4) and ICRC’s Patient Management System. Such initiatives
hold the potential to drive increased availability of prosthetic user data to motivate government resource
mobilisation for prosthetic services.
In order to accelerate data collection and the development of registries, global investments can be
made to develop foundational research and parameters for data collection. For example, defining the
core dataset of amputee data and outcome measures will underpin the efforts of countries to implement
registries. Creation of a global platform and governance for aggregation of country-level data will enable
consolidated insights. ISPO’s Industry Advisory Group has launched an initiative to outline the core
datasets and develop a framework for a global registry, but lacks resources to accelerate development
and implementation and could benefit from additional support. Following the development of a global
framework for data collection, investments in implementation and data collection efforts are needed to
underpin national and sub-national planning for service expansion. See Case Study 5 for an example of
the establishment of a user registry to collect such data.

CASE STUDY 4: AMPUTEE SCREENING THROUGH CELLPHONE NETWORKING (ASCENT) IN THE

PHILIPPINES
The ASCENT project was developed in 2010 to address the challenge of reaching under-served
communities on the islands of the Philippines. Health workers use mobile phones to record the medical
history and transmit data to a centralised web-based database with photographs and videos.

Utilising ASCENT has initiated the creation of a registry of amputees from remote communities and
vulnerable populations that were previously not visible to policy-makers. This data, along with other
advocacy efforts, led to the creation and implementation of the Philippine Health Insurance Z Mobility,
Orthosis, Rehabilitation and Prosthesis Help (MORPH) benefits package, which was launched in 2013.
The package allows users to access 15,000 pesos (about USD 300) for each lower-limb prosthesis. This
coverage was expanded in 2016 to 75,000 pesos (about USD 1,500) for TF prostheses.

ASCENT has not been scaled nationally or beyond the Philippines, but such tools represent potential
models for countries to consider when initiating user registries and data collection efforts.

I 19
 CASE STUDY 5: NATiONAL QUALiTY REGiSTRY FOR AMPUTATiON AND PROSTHESES
(SWEDEAMP) iN SWEDEN 38
SwedeAmp was developed in Sweden in 2010 in response to the lack of data on amputees and patient
outcomes from different treatment regimes in different regions and clinics. Utilising existing government health
registry platforms, SwedeAmp collects patient-level data, including pre-amputation situation, amputation (level,
technique used), prosthetic-fitting (device, personnel) and post-fitting (activity level achieved, and whether the
patient is able to return home and resume activities). Patient outcomes are tracked until death.

SwedeAmp can show trends and predict expected outcomes of a patient, given their age, diagnosis, and
location. Clinicians in the public and private sectors are mandated to manually input patient data, but progress
is underway to link certain data points from other registries and electronic records. Healthcare professionals
can access this dataset. Annual aggregated reports are made available to suppliers and private sector partners.

Implementing the registry has improved quality of care by allowing policymakers to identify issues in
patient care and develop interventions to improve quality, based on comparing amputee outcomes
across cities or facilities.39 As a result, local guidelines for amputee and prosthetic user care have been
published and strictly implemented to ensure consistency of high-quality practice.

4.6 The starting point for prosthetic services is a link between amputation and
rehabilitation, but poor referral pathways lead to patient drop-off.

The care pathway for prosthetic users starts with the surgical amputation of the limb. Amputees consult
with a rehabilitation specialist to be referred to prosthetic services. Amputees are then discharged for
healing and recovery, before arranging to visit a service provisioning unit. The prosthetics service delivery
process is then carried out. This consists of the user being assessed and measured by a prosthetist, who
then prescribes and fabricates a prosthesis. The user will thereafter be fitted, and undergo gait training to
learn to use and care for the prosthesis. Following the initial fitting, users often need to return to the service
unit for repairs, maintenance, and to make adjustments as their residual limb or lifestyle changes.
Many amputees never enter rehabilitation, with poor linkage, low awareness of services, and lack of post-
discharge follow-up as common gaps to successful referral. Lack of awareness of availability of prosthetic
services from surgeons and other health workers can impact the amputation procedure, sometimes leading
to requirements for revision surgery. After amputation, WHO recommends that patients should be assessed
for eligibility by a medical or rehabilitation clinician and referred to prosthetic services,40 but this often does
not happen in LMICs due to low awareness of services by health workers or lack of rehabilitation staff.
Patients are typically discharged from the hospital to heal after surgery, which can last up to six months.
There is often no post-discharge follow-up with amputees to ensure the patient has sought rehabilitative
care. Better integration and improved awareness of prosthetic services and benefits of prosthetic use in
healthcare workers at primary, secondary, and tertiary levels of the health system can improve referral.
In the absence of referral pathways, user associations help to fill the gap and empower amputees to access
prosthetic services. Through a network of peers, these groups provide counselling and information, even if
formal referrals are not obtained through the health system. For example, the International Confederation
of Amputee Associations (IC2A) is a non-profit organisation dedicated to improving the quality of life for
amputees through strengthening and sharing best practices between its 15 national amputee associations.
Objectives include developing peer support and mentorship models, and disseminating these models
across country-based user groups. IC2A national amputee associations advocate for users to be included
in government policy- and priority-setting. The IC2A champions policy changes such as setting best
practices in rehabilitation and prosthetic services, and the inclusion of P&O services and products in
government budgets and health insurance schemes.

38 Kamrad I, Söderberg B, Örneholm H, Hagberg K. SwedeAmp – the Swedish Amputation and Prosthetics Registry: 8-year data on 5762 patients with lower limb amputation show
sex differences in amputation level and in patient-reported outcome. Acta Orthopaedica. 2020;:1-7. Available from: DOI:10.1080/17453674.2020.1756101.
39 CHAI expert consultation.
40 World Health Organization. WHO standards for prosthetics and orthotics. 2017. Available from: https://www.who.int/phi/implementation/assistive_technology/prosthetics_orthot-

ics/en/.

20 PRODUCT NARRATiVE: PROSTHESES

 4.7 When patients are referred, the service point can be costly and difficult for
amputees to reach.

As discussed in Section 4.2, amputees often face significant financial and logistical barriers to access
services, including high indirect costs. Prosthetic service units are commonly situated in urban areas. For
example, among Indonesia’s archipelago of 17,000 islands, there are only 24 prosthetic service units; in
Kenya, some prosthetic users in rural counties need to travel over 500 kilometres to access services.
Amputees are already at a greater risk of poverty,41 and the cost of travel for the individual and family
members or personal assistants can be prohibitive. Additionally, wait times for fitting and fabrication, delays
in supply of components, and physical rehabilitation add to overnight accommodation costs.
Beyond the initial fitting, the clinical pathway continues with rehabilitation and patient management
occurring through multiple touchpoints during the first 1-2 years. Physical therapy is needed for numerous
weeks post-fitting to ensure the user mobility using the device. Changes in activity from adopting a
prosthesis will typically cause the residual limb to change in volume, which then requires prosthetists to
adjust the device to ensure continued comfort and fit. Repairs and maintenance in response to wear and
tear throughout the useful life of the device also require technical skills of the prosthetist. To ensure the
successful fitting, adoption and continued use of the prosthesis, users need to be able to regularly access
prosthetists and service units, which can incur significant indirect costs.
At present, most government reimbursement or insurance schemes do not account for these indirect costs.
Some NGOs assist users with costs of travel through free overnight accommodations or reimbursement of
travel expenses. One such example is 500 Miles in Malawi, where users are either provided with funds for
transport or transported directly to the central provisioning facility in Lilongwe, the capital city. However,
these schemes are few and far between. In their absence, users are largely left to raise funding from
donations or loans from friends and family.

4.8 Decentralisation can overcome these barriers, but presently focuses on pre-
and post-fitting activities in service provision and further investigation on
cost-effectiveness is needed.

WHO’s Standards for Prosthetics and Orthotics recommend a tiered approach to delivering prosthetic
services that is integrated with various levels of the health system. Specialised services are available at
the tertiary level, with standard services available at the secondary level. Decentralised services should be
available in the primary and community levels of the health system to ensure the widest range of services
can be provided as close as possible to users. Integration of prosthetic services to the lowest levels
ensures appropriate patient identification, referral, and follow-up can be conducted.
A number of promising models of decentralisation have been observed in LMICs, which include satellite
service centres, and patient outreach and referral through linkages with other community health programme
initiatives (see Table 6). Mobile clinics have also been deployed, but face challenges with quality control of
services and product delivery. Numerous challenges currently exist to scale these models.
Specialised human resources are needed throughout the process, which are limited in capacity and are
thus mostly found in central facilities to serve the highest volume of patients. The cost-effectiveness of
offering decentralised services needs to be further investigated: it typically requires significant additional
investment by the provider, while generating considerable savings for users. Additionally, the current
models for decentralisation focus on: 1) pre-fitting activities – providing referral, conducting the initial
measurement and patient assessment; and 2) post-fitting activities – providing follow-ups, maintenance of
devices, reassessment, and physical rehabilitation. These models do not yet permit the full decentralisation
of the end-to-end fitting and fabrication process. However, integration of digital and other innovative
technologies can potentially transform the process to enable full decentralisation in the future.
41 Banks L, Kuper H, Polack S. Correction: Poverty and disability in low- and middle-income countries: A systematic review. PLOS ONE. 2018;13(9):e0204881. Available from: https://
doi.org/10.1371/journal.pone.0204881.

I 21
 TABLE 6: DECENTRALISATiON MODELS FOR INTEGRATION OF P&O SERVICES IN LOWER LEVELS
OF HEALTH SYSTEMS

MODEL DESCRiPTiON SERViCES PROViDED

• Typically based in or travel to various communities ✓ Awareness-building

Community- to identify, refer, and rehabilitate users. ✓ Identification of users
based • May be linked with other community health initiatives. ✓ Assess and measure
rehabilitation
• Staffed by a range of clinicians, including ✓ Refer to services
(CBR) and
CBR workers, physical therapists, and prosthetists/
outreach ✓ Conduct follow up, physical
orthotists.
therapy, and basic repairs

• A vehicle or boat can provide a limited range of ✓ Awareness-building

prosthetic products and services. ✓ Identification of users
• Staffed with prosthetists/orthotists, physical ✓ Assess and measure
Mobile clinics therapists, social workers, and CBR workers.
✓ Deliver final products with
• Cost-effectiveness, patient adherence and quality support of a main centre
control may be a challenge in certain settings.
✓ Conduct follow-up and repair

• Small facility that is integrated into a lower-tier ✓ Assess and measure

decentralised health centre. ✓ Deliver products with support
Satellite • Visited by clinicians and therapists from a central of a main centre for fabrication
services full-service prosthetic service. unit. ✓ Conduct follow-up and repair
• Several satellite service sites may connect to a
full-service provisioning centre.

• Utilise digital tools, such as mobile phones and ✓ Identification of users

video conferencing, to: 1) connect a clinician to ✓ Assess and measure
Tele- an amputee for direct consultation; or 2) educate
rehabilitation and support auxiliary health workers at the ✓ Refer to services
community level. ✓ Conduct follow up, physical
therapy and repair

CASE STUDY 6: ASSOCIATiON OF PHYSICALLY DiSABLED KENYA (APDK) COMMUNITY-BASED

REHABILITATiON AND MOBILE P&O CLINIC PROGRAMME
APDK is the oldest non-profit organisation for persons with disabilities in Kenya. It operates a network
of 10 branches, each with comprehensive orthopaedic rehabilitation service, including prosthetic and
orthotic services, wheelchairs, and physical rehabilitation.

To reach vulnerable populations, APDK employs a mix of CBR programmes and mobile clinics that identify
and refer people with disabilities.
• CBR programmes were initiated in urban slums where people with disabilities were typically hidden
in homes due to social stigma. Workers educate the community and parents on the needs of people
with disabilities and the benefits of seeking services. CBR workers will also train parents and
caregivers on basic therapy techniques, and advocate for the referral of patients.
• Mobile clinics bring trained clinicians to rural communities, along with assessment and fitting tools.
Through the mobile clinics, patients can: 1) be assessed and referred to APDK’s main site; 2) referred
to a partner institution for surgical intervention; and 3) have a cast made and measurements taken of
the residual limb. The mobile clinic will return with the completed device. The mobile clinic returns to
each community 3-4 times per year, allowing fitted users access to maintenance or repair.
APDK is currently assessing the potential to integrate direct-casted sockets to the offerings available
through the mobile clinic. If proven successful and cost-effective, this model would permit users to be
fitted on the same day and closer to their home.

22 PRODUCT NARRATiVE: PROSTHESES

 4.9 Innovative socket fabrication techniques can expand prosthetic services,
but adoption is limited by product maturity, lack of clinical and economic
evidence, and implementation guidance.

While some pre-fitting and post-fitting activities have been successfully decentralised, the socket
fabrication step has remained largely tethered to a full-service prosthetic service unit. Traditional socket
fabrication follows a multi-step process (see Annex G), which is difficult to de-link from personnel and
infrastructure requirements. The prosthetist/orthotist’s expertise is required to shape the socket so that
weight is distributed in pressure-tolerant areas, which is specific to the patient’s residual limb. Socket fitting
is critical to the final comfort, mobility, and safety of the patient, and impacts adoption and adherence.
Socket fabrication in LMIC is affordable, but time-consuming and creates waste. Sockets in LMICs are
fabricated from polypropylene or resin, through lamination of fibres. Both materials are affordable
and durable. The socket fabrication and fitting process usually takes one to three days, depending
on the need for adjustments. Negative environmental impact is caused by wasteful intermediary outputs
that are disposed of, such as the cast of the residual limb and plaster positive mould. With traditional
casting, information is lost in the process; meaning some changes require the process to be repeated.
Innovative technologies can potentially decentralise socket fitting and fabrication, and enable full end-to-end
decentralisation of the prosthetic fitting process. Two different types of technologies exist: 1) direct casting;
and 2) digital fabrication. Direct casting technology forms the socket material directly on residual limbs to
create a socket, without the need of plaster casting or heavy machines. Fewer steps are required compared
to traditional socket fabrication and the process takes one to two hours. All equipment and materials needed
can be mobile. The current leading developers of direct casting technology are Amparo’s Confidence socket
and Össur’s IceCast. While direct casting technologies look promising, further investigation into the cost-
effectiveness and clinical acceptability in LMIC contexts is needed to drive adoption.
Digital fabrication utilises digital scanning to capture the shape of the limb, and software to make virtual
rectifications combined with fabrication of the final socket (or the intermediary mould) from the digital file. This
method replaces heavy machinery and equipment with digital tools, such as a scanner, mobile phone, laptop,
and 3D printer, thereby making it potentially more cost-effective to offer in more clinics. Several companies
are active in digital fabrication, with varying software, materials, and fabrication methods. Some companies,
such as Prosfit and Nia, print sockets with 3D printers, albeit through different fulfilment models (the process
of production, shipping, and delivery). Prosfit relies on centralised printers, which offers the benefit of
centralised quality control, but requires additional shipping considerations. Nia deploys on-site, lower-priced
3D printers. Rodin, Vorum, and Proteor combine digital scanning with fabricating the positive mould of the
socket using a centralised milling machine, which enables digital scans to be captured and sent to a central
service which can fabricate the final socket without requiring the user to travel. In terms of market readiness
in LMICs, Prosfit and Nia are the most advanced since they have conducted trials in LMICs, though further
evidence generation is needed to demonstrate acceptability. Rodin, Vorum, and Proteor are commercially
available in HICs, where they have focused their deployment, and currently have limited presence in LMICs.
Some 3D-printed sockets have experienced failures in laboratory testing, which differs from the slower
breakage or tearing observed in sockets fabricated through other methods. These failures, which may
be linked to the printing technology, could potentially cause injury or harm to users. Further research and
investigation into the root causes and mitigation strategies is needed.42 See Annex H for profiles of the
main developers of novel fitting technologies currently making progress in LMICs.
While most of these technologies are commercially available in HICs, they have yet to be widely adopted in
LMICs, driven by a lack of consensus on acceptability and financial implications due to insufficient clinical,
operational, and economic evidence. There is potential for digital fabrication to deliver and decentralise
prosthetic services more cost-effectively. Some technologies have undergone field testing in LMICs, but

42 Pousett,
B, Lizcano, A, Raschke, S. An investigation of the structural strength of transtibial sockets fabricated using conventional methods and rapid prototyping techniques.
Canadian Prosthetics & Orthotics Journal. 2019;2(1). Available from: https://doi.org/10.33137/cpoj.v2i1.31008.

I 23
 a lack of research standards to govern the set up and control of these trials often lead to inconclusive
results that are not generalisable to other settings. For buyers and implementers to have clarity on the use
of these technologies, establishing research standards, analysing cost-effectiveness, and implementation
guidance is needed to drive transparency and adoption.
Prosthetic liners are an important component to the use and comfort of prosthetic devices, and are critical
to the adoption of some novel socket technologies; but modern liners are cost-prohibitive in LMICs. Liners
act as the interface between the skin and the socket, and are used to secure the prosthetic device, reduce
slippage, ensure fit, adjust to volume change, and regulate temperature.
Over 70 types of liners are commercially available and fabricated from a number of materials. Silicone
liners are most common in HICs as the material balances comfort and durability. However, since liners
need to be replaced annually and are priced at USD 200 to USD 500, they are cost-prohibitive to most
users in LMICs. Socket socks, bandages, or foam are commonly used instead, but such alternatives have
short useful lives and often cause discomfort, which may lead to user abandonment of the entire device.
Modern liners decrease dependence on walking aids, improve suspension, improve weight distribution,
decrease pain, and increase comfort.43 Field evaluation to validate whether emerging affordable liners
are suitable in LMICs would enable wider adoption. Numerous innovative socket fabrication technologies
require modern liners in order to be attached to the residual limb safely and comfortably. Uptake of silicone
liners would enable wider adoption of these innovations.

4.10 Cost is a barrier to affordability for users and is mainly driven by the
cost of prosthetic components. Prosthetists lack the market intelligence
and transparency on quality of lower-cost components, which limits the
penetration of these components in LMICs.

With prices ranging from USD 700 to USD 3,000,44 prosthetic solutions from leading suppliers are not
affordable to many that need them, particularly the lowest-income users. Components for a basic mechanical
prosthesis – including the socket, knee joint, pylon, foot, and connectors – account for as much as 50-75%
of the total cost. Contributing to the high cost of devices are the high custom duties and taxes to import
components into many countries. Reducing the price of components is an opportunity to reduce overall
service cost. In LMICs, there are typically limited options of components available for purchase locally. Instead,
prosthetists or health administrators either hold stock of components – but have difficulties in predicting the
needs of users who seek care – or place individual orders directly from overseas suppliers after patient
assessment, leading to long lead times, inefficient and costly procurements, and logistical challenges.
There are a number of suppliers emerging in Asia offering affordable component options but prosthetists
in LMICs have little awareness that these options are available, leading to low market penetration. LMIC
practitioners are generally only aware of a few suppliers: Ottobock has earned a reputation for offering
high-quality and expensive components; the ICRC and Jaipur have developed low-cost technology with
decades of presence in market. Prosthetists have little knowledge of other suppliers and if they do, they
often do not know how these compare in terms of quality or performance. Although international standards
exist and Stringent Regulatory Authorities (SRA) regulate prosthetic components, SRA approval processes
generally allow for self-declaration of conformance instead of evaluation of a regulatory dossier. This can
lead to variability in quality and performance (see Figure 6 for further details). When existing standards
are insufficient to guide product evaluation, brand reputation, supplier marketing efforts and user’s ability
to pay drive the selection criteria. Market transparency is needed on the various supply options and their
comparative quality and performance in LMIC contexts. This can also help lower the barriers to entry for
more competitors in LMIC markets.

43 Stevens P, DePalma R, Wurdeman S. Transtibial socket design, interface, and suspension. Journal of Prosthetics and Orthotics. 2019;31(3):172-178. Available from: doi:10.1097/
JPO.0000000000000219.
44 Quotations and published pricing from suppliers for mechanical TF components.

24 PRODUCT NARRATiVE: PROSTHESES

 FIGURE 6: QUALITY AND REGULATORY GUIDANCE FOR PROSTHETIC COMPONENTS
Prosthetic limb components are categorised as medical devices by SRAs such as the FDA and the
European Commission (CE marking). In addition to SRA approval, some LMICs have regulatory processes
for registration of medical devices which may or may not include prosthetics. Prosthetic components fall
under the category of medical devices, which permits suppliers to declare self-conformity under US FDA
(Class II, 510(K) exempt) and CE (Class I).

There are numerous quality standards for prosthetics available from the International Organization for
Standardization (ISO), including: ISO 10328:2016 Prosthetics – Structural testing of lower limb prostheses
– requirements and test methods and ISO 22523:2006 External limb prostheses and external orthoses —
Requirements and test methods. These standards focus on the durability of the components and delineate
requirements for structural testing of a prosthetic component in a laboratory setting. To indicate that
products conform to these standards, suppliers can either invest in their own testing equipment or submit
their components to a third party with specialised equipment to test prosthetic limbs, which can cost up
to USD 50,000 for each set of components. Due to the high cost, some suppliers may opt to test only a
few components instead of its entire product line.

ISO standards do not stipulate how components should function in LMIC settings, which can be marked
by harsher environmental conditions and user lifestyles (i.e. agricultural or physical labour use cases).
WHO recommends that clinical user field tests are carried out to determine the strength, durability,
functionality, safety, and effectiveness of components. However, this is not a requirement under FDA or
CE as prosthetic components fall under the category of medical devices, which exempts suppliers from
clinical trials.

These gaps – 1) limited SRA oversight; 2) lack of LMIC considerations in standards; and 3) the high cost
of testing to standards – lead to a lack of visibility on the quality of components in the market for LMIC
providers. Without further quality guidance, prosthetists rely on anecdotal experience to evaluate quality.

4.11 Responsive supply channels are needed in LMICs and could be met via
regional distributors.

Because patient assessment is required before components can be selected, an assortment of solutions
needs to be locally available. Unfortunately, this is rarely found in LMICs since service providers often lack
access to the working capital needed to maintain a large volume of components. Additionally, it is difficult
to anticipate the needs of patients when making aggregate volume orders. See Annex I for limitations of
common supply channels observed in LMICs. Flexible ordering from local sources and supply channels
which can responsively supply tailored components to the individual users are needed.
Regional distributors aggregate volumes across buyers to purchase in bulk from international suppliers
and maintain a wider range of inventory that can effectively meet various user needs. Purchasing currently
occurs through disorganised, ad-hoc patterns with individual purchasers each choosing their own channels,
which includes placing individual orders directly with international suppliers. This leads to high delivery
costs and long lead times. Organisation and aggregation of ordering can improve quality and affordability
through expanded product options, reduction of delivery lead time, and logistical costs. Distributors that
focus on prosthetic components operate successfully in some LMIC markets (see Case Study 7) and
help drive efficiency and affordability by aggregating orders, negotiating volume-based pricing, offering
extended payment terms to buyers, and delivering responsively to providers. With additional support, they
can improve upon their capacity as an intermediary between buyers and suppliers and organise efficient
markets. Such support can help these distributors increase access to working capital financing, enable
geographic expansion, and expand warehouse capacity.

I 25
 CASE STUDY 7: ORGANISATION AFRICAINE POUR LE DÉVELOPPEMENT DES CENTRES POUR
PERSONNES HANDiCAPÉES (OADCPH)
OADCPH is a Togo-based non-profit regional distributor that links international manufacturers with
providers in Africa. OADCPH serves a network of 80 members in more than 30 African countries,
which includes public and private rehabilitation centres, individual prosthetists/orthotists, NGOs, FBOs,
and governments.

The annual membership fee is USD 80 and members must agree to abide by a code of ethics for setting
sustainable and affordable margins. OADCPH’s members benefit from negotiated pricing from bulk
orders placed annually from a range of international suppliers. OADCPH has a 600m2 warehouse for
storing inventory and can deliver components in a number of countries in as quickly as 24 hours.

Because of its reputation and access to prosthetists/orthotists in Africa, OADCPH has been able to
negotiate working capital financing with suppliers and in turn offers extended payment terms to buyers.
OADCPH also disseminates product information from suppliers to its members to better inform product
selection and purchasing decisions. OADCPH is currently piloting a 3D printing orthotics project with HI
to supply orthotic components to regional members from a 3D printer centrally housed at its warehouse.
OADCPH has also developed a regional training centre that offers a roster of training programmes
for prosthetists/orthotists and other rehabilitation professionals, covering technical skills, service unit
management, and administration and professional development.

Looking ahead, OADCPH is planning to expand warehousing capacity and its presence to East and Central
Africa. It hopes to access increased working capital financing to offer better payment terms to more
providers. It also hopes to strengthen its educational and training programmes, and sets ambitions on
setting up a regional component testing centre to evaluate the quality and performance of components
that passes through its distribution channels.

4.12 Irrespective of the delivery approach, human resource (HR) capacity is

a limitation, and novel ways of expansion and extending HR need to be
considered.

To support the adoption and scale-up of innovative fitting technologies, consideration needs to be made
for shifts in HR requirements. The traditional fitting process relies heavily on the skill level of the prosthetist/
orthotist in order to control quality, which also limits how quickly services can be expanded and whether
services can be decentralised. For novel technologies, certain steps such as digital scanning could
potentially be task-shifted to lower-level or non-P&O healthcare workers. Conversely, direct fitting or digital
rectification requires prosthetists/orthotists to be trained in new techniques and skills. Thus, the scale-up
of these technologies is highly dependent on adequate investment in training P&O and other clinicians to
successfully integrate these tools into their workflow.
Investing in capacity expansion of prosthetists/orthotists and leveraging models of HR extension are critical
to address the gap of prosthetists/orthotists in LMICs. Trained prosthetists/orthotists are central to ensuring
high-quality, well-fitted prosthetic solutions, regardless of the provisioning approach selected. Sufficient
capacity of prosthetists/orthotists is a key pillar of any functioning prosthetic services system. Investment is
needed to increase the number of prosthetists/orthotists, and to upskill and retain existing practitioners by
investing in training, developing career pathways, and adequate job benefits. Novel models are emerging
which use digital technologies to cost-effectively expand training and extend the reach of clinicians to
reach more patients, thereby lowering barriers to access. These models need further validation and
support in order to reach wider adoption and achieve impact.

26 PRODUCT NARRATiVE: PROSTHESES

TABLE 7: OPPORTUNITIES TO EXPAND AND EXTEND HR CAPACITY

MODEL DESCRiPTiON I

Virtual learning modules and online lectures, • Decreases the time on-site
Blended online- combined with practical technical skills through • Lower cost
offline P&O a short period of on-site learning at a regional
school or through mentorship in their current P&O • No loss of income for current
training practitioners who are upskilling
workplace and role.
by continuing employment

Mobile applications use motion sensors on the user • Remote services / no travel
Video- or to provide coaching prompts to facilitate gait training • Lower cost
phone-based without a physical therapist.
• Extends the reach of
rehabilitation Video conferencing for physical therapists to provide rehabilitation clinicians without
and gait training training advice and answer user questions during the need for travel
rehabilitation after the user has left the service centre.

Utilising digital scanning technologies, and under the • Extends certain skills of
supervision of rehabilitation clinicians (i.e. physical prosthetists/orthotists to other
therapists, prosthetists/orthotists, rehabilitation health workers
Task-shifting therapists), the assessment and measurement step • Reduces need for centrally
in the fitting process could be task-shifted to primary based rehabilitation clinicians
and community-level health workers. to travel

I 27
 5. Market Challenges
LMIC markets for prosthetic services have been limited by the lack of service capacity, with a need to rally
political prioritisation and funding to invest in expansion, and to support users to access prosthetic services.
The key demand and supply dynamics that have presented challenges to user access and sustainability
of the market are summarised in this section.

5.1 Demand

Policy-makers, clinical providers, and users lack awareness on the availability,

importance, and value of prosthetic services.
• POLICY-MAKERS: Do not recognise or understand the need, importance, and economic
impact of providing prosthetic devices. This is driven by the lack of local data on
amputees and affects prioritisation in policy-making, programming, and financing.

Awareness • PROVIDERS: Healthcare workers (i.e. physicians, surgeons) do not consider the need
for a prosthetic device during amputation and therefore an amputee may require
revision surgery in order to accommodate for prosthetic fitting. Primary health workers
who identify amputees are not aware of referral pathways for prosthetic services.
• USERS: Amputees discharged after surgery without referral or information may not be
aware of the availability of prosthetic services or how to access them. Amputees may
also not be aware of the health and economic benefits that prosthetic devices offer.

The political will in LMICs to develop and regulate service capacity is low. NGOs have
filled part of the gap, which sometimes results in parallel systems.
Services often fall under the purview of multiple Ministries, such as Health, Social Welfare,
and Veteran Affairs. Political buy-in and coordination is needed across all these agencies
Political Will in order to allocate sufficient funding and mobilise strategic planning. Due to the lack of
data and understanding of the economic benefits, governments have not exhibited the will
to invest in service capacity. The resulting gap has been partially addressed by NGOs and
FBOs, which has often led to parallel systems for provisioning and procurement. Though
NGOs often work in collaboration with and support government initiatives, government
leadership is needed to regulate the sector.

Funding for investments in prosthetic service capacity as well as for products and
services is inadequate. Out-of-pocket (OOP) expenditure is high.
Prosthetic services are expensive and not affordable to many people that need them.
Financing Where reimbursements or insurance schemes are available, they generally do not cover
the full cost of the device and service. Additionally, since there are few access points,
amputees must travel long distances to reach urban centres, incurring incremental
costs for travel, accommodation, and lost wages. These are rarely accounted for in
reimbursement schemes.

Provision is limited by a low number of trained prosthetists/orthotists and lack of

access points. Adoption of technologies to decentralised services is slow.
Delivering prosthetics requires specialised equipment and personnel. Thus, services are
tethered to physical service units, which are expensive to set up and therefore only found
in central locations. Decentralisation of the service delivery process is limited to certain
Provision
activities. LMICs do not have enough trained practitioners. Where trained HR capacity is
available, poor professional recognition, pay, and work conditions lead to high attrition.
Several socket fitting and fabrication innovations have the potential to untether those
steps of the service provisioning process from service units, but have not scaled due to a
lack of comprehensive implementation, and economic and clinical evidence.

28 PRODUCT NARRATiVE: PROSTHESES

5.2 Supply

Providers do not have enough product options to meet users’ varying needs and
current modular options in LMICs are expensive
Prosthetists/orthotists in LMICs need access to an adequate assortment of affordable
high-quality components to meet the needs of different users. LMIC supply options mainly
Supply consist of expensive components from a few leading global manufacturers and affordable
Landscape conventional prosthetic solutions. The latter may be sub-optimal for all users since they
lack customisability. Providers are not aware of the full range of affordable component
options from manufacturers in Asia as these companies have limited presence and have
not invested in LMIC market entry. As a result, users who desire modular components are
limited to options they cannot afford.

Providers in LMICs are not supported with responsive local supply chains that allow for
flexible ordering depending on patient prescription.
Very few regional or local distributors supply prosthetic components, so prosthetists
Efficient Supply often place individual orders directly with international manufacturers. This delays fitting
Channels and increases logistics costs and prices to end users. High custom duties and taxes for
importing components further challenges affordability. Distributors who can aggregate and
offer an assortment of prosthetic component options locally enable responsiveness to
better serve prosthetists and users.

5.3 Enablers

There is a no defined set of outcome measures to: 1) quantify economic benefits from
prosthetics; and 2) assess performance of new technologies or components.
The availability of numerous approaches to quantify various aspects and benefits
Data of prosthetics, such as quality of life, mobility, comfort score, walk tests, etc., lead
researchers to cherry-pick outcome measures, which leads to inability to generalise
results and compare products. A defined set of outcome measures will be critical to the
implementation of systematic data collection, serve as the baseline of research studies,
and to help inform economic return on investment.

There is a lack of market transparency to guide prosthetists and users on the quality of
different prosthetic solutions.
ISO quality standards focus on durability in laboratory testing and do not take into account
the performance of the components in a LMIC context or when fitted to a user. They are
Quality therefore insufficient to guide product selection. Since SRA approvals, such as CE and
FDA, are obtained through self-declaration with minimal oversight, not all components from
a supplier may have undergone the same durability testing. As such, providers cannot rely
on SRA approvals to indicate quality and performance of different components, leaving
prosthetists to rely on anecdotal feedback or ad-hoc field testing.

Lack of ‘gold standard’ research guidance has led to poorly designed clinical and
implementation studies that lead to inconclusive results and little guidance for market
actors
Research Studies conducted in the prosthetics sector lack consistency in the robustness of design
Standards to generate clinical, economic, and implementation evidence. As a result, prosthetics
research often generates inconclusive results that are difficult to generalise or apply to
other scenarios or settings. Defining minimum research standards is necessary to raise the
quality of studies conducted and produce industry-accepted findings.

I 29
 Photo Credit: CDPF

30 PRODUCT NARRATiVE: PROSTHESES

CHAPTER 2:

STRATEGIC APPROACH TO
MARKET SHAPING

6. Strategic Approach to Market Shaping and

Market Building
Increasing access to prosthetic services to address the unmet need of users in LMICs will require a multi-
faceted approach that leads to long-term, sustainable access. Interventions that address global barriers
to market access, encourage political prioritisation to increase prosthetic service capacity, accelerate
the scale-up of innovative fitting technologies, and ensure local availability of affordable high-quality
components are foundational to market access. This section proposes five strategic objectives and long-
term desired outcomes that will build and strengthen the market for prosthetics services.

STRATEGIC OBJECTIVE 1: Develop foundational datasets to inform the

investment case for prosthetic services and guide the development of standards.

Data
• Lack of data in LMICs hinders understanding how many amputees are (un)able to access
Barriers prosthetic services.
addressed
Awareness and financing
• Without such data, policymakers do not prioritise investments in expanding the sector.

• Mechanisms for structured data collection – such as registries – have proven to positively
impact investment and service delivery.
Rationale • To initiate data collection, consensus on a core dataset of amputee/user data is needed.
• Outcome measures and quantifying need can underpin the analysis of economic and health
benefits for investing in prosthetic services.

• Build consensus on outcome measures to underpin and standardise data collection and
guide research in prosthetics.
• Define the core data set useful to the industry, national, and international institutions to
Proposed support policymaking and funding.
activities
• Design and implement mechanisms for data collection at global and country levels.
• Develop the investment case – i.e. quantify economic returns to user, family, community,
economy – for donors and LMIC governments to invest in prosthetics services.

• Consensus on priority outcome measures and core data set.

Target
• Registry of amputees, adopted in LMICs, that is linked to a global platform.
outputs
• An investment case which quantifies economic benefits of investing in prosthetic services.

Long-term • Political prioritisation and long-term investments by policymakers and donors.

outcome

I 31
 STRATEGIC OBJECTIVE 2: Support countries to define appropriate policies and
invest in the key requirements of a functioning prosthetic provisioning system.

Political will and financing

• Low political will from LMIC governments leads to a lack of investment and leadership in
establishing prosthetic services.
• There is limited reimbursement for users, who then have high OOP expenditures.
Barriers
addressed Provision
• Prosthetic services require specialised human resources and infrastructure, both of which are
costly to establish. LMICs have limited number of service units, largely in urban centres.
• Users typically travel long distances, resulting in high indirect costs (i.e. travel, loss of income,
accommodation, and caregiver costs).

• Setting up a functioning prosthetic services system that is integrated with the healthcare and
related service (i.e. wheelchair) systems will require significant investment in infrastructure
and personnel.
Rationale • Affordability is a barrier; users cannot access enough funds to cover all costs, including
indirect costs.
• Models of co-investments with the private sector are emerging, but require validation and
support to achieve financial sustainability.

• Support governments to develop a costed plan for prosthetic service expansion and
coordinate funding with investments from different sources.
• Support governments to simplify market entry requirements (i.e. registration, duties) for
component suppliers and organise purchasing through local distributor channels.
Proposed
• Support LMICs to train, accredit, and hire prosthetists/orthotists to increase human resource
activities
capacity.
• Pilot innovative models of user financing.
• Validate and expand proven public-private partnership investment models for prosthetic
services.

• Increased capacity of accredited prosthetists/orthotists.

• Costed national plans, supported with dedicated long-term funding for prosthetic services
coordinated across various government and non-government sources. Policies that describe
Target outreach, referral, financing, and decentralised prosthetic services at various levels of the
outputs health system including primary, community, and rural communities.
• Clear market entry guidance for component suppliers.
• Reduced customs, taxes, and duties on imported prosthetic equipment and components.

• Increased coverage of prosthetic device use in countries with political will.

Long-term
• Improved availability of quality prosthetic services.
outcomes
• Affordable prosthetic component suppliers enter LMIC markets.

32 PRODUCT NARRATiVE: PROSTHESES

STRATEGIC OBJECTIVE 3: Accelerate market validation and adoption of
innovative technologies that can simplify, decentralise, and lower the cost of
prosthetic service provision.

Research standards
• No research standards to set minimum requirements for prosthetic research leads to poor
set-up and execution of research, leading to inconclusive results.
Provision
Barriers
addressed • Fitting innovations have the potential to decentralise certain aspects of provisioning, but have
been not been scaled due to a lack of implementation, and economic and clinical evidence
in LMICs.
• Implementers lack clarity on technologies which could be deployed to strengthen service
delivery models.

• LMIC implementers need further clarity on whether innovative fitting technologies are
suitable and cost-effective for their context, which requires further evidence gathering and
Rationale expert consensus.
• Current studies are not generalisable to other settings.

• Define research standards to set minimum requirements and guidance for researchers and
suppliers who conduct prosthetics research.
• Close evidence gap and drive consensus on innovative fitting technologies that are ready to
Proposed be scaled.
activities • Support high-potential innovators to improve business models and operations to enter LMIC
markets and achieve scale and financial sustainability.
▪ For example, support validation in LMIC settings to increase availability of affordable
silicone prosthetic liners.

• Minimum standards for conducting research and implementation guidance.

• New evidence on novel technologies.
Target
outputs • Policy guidance or industry consensus issued on adoption of novel technologies.
• Increased penetration of prosthetic liner use due to affordability, availability, and market
validation.

Long-term • Increased capacity to deliver services in LMIC settings with increased efficiency.
outcome

I 33
 STRATEGIC OBJECTIVE 4: Accelerate uptake of affordable, quality prosthetic
components by increasing market transparency to empower buyers to make
value-based purchasing decisions.

Supply landscape
• LMIC markets have limited component options, due to lack of provider awareness of more
Barriers affordable options and lack of incentives for those suppliers to invest in market entry.
addressed Quality
• Existing quality standards do not consider requirements for LMIC contexts, thus lack of
transparency on the durability and acceptability limits uptake.

• LMIC supply is largely limited to high-priced HIC suppliers or low-cost NGO options, which
may not be suitable or affordable to all users.
Rationale • Lower-cost components are available in global market but have little market penetration in
most LMICs, because of lack of information on these product options for buyers and low
market transparency on their quality and performance in LMIC context.

• Increase market transparency of the global supplier landscape to buyers.

• Drive transparency of quality of affordable components by developing a standard for
Proposed
evaluating suitability of components in LMIC settings.
activities
• Incentivise market entry of affordable high-quality component suppliers in LMICs through
developing market tools and roadmaps, and providing catalytic procurement.

Target • Improved guidance and clarity on product selection for clinicians, procurers, and users.
outputs

• Increased availability of affordable high-quality prosthetic components in LMICs.

Long-term
outcomes • Empowered buyers can make comparisons across component suppliers to select products
best suited to the needs of user and context.

STRATEGIC OBJECTIVE 5: Strengthen regional supply to increase affordability

and availability of quality prosthetic components.

Efficient supply channels

• Prosthetics components are selected based on amputee assessment; thus local, responsive
Barriers supply channels are needed to support providers.
addressed
• Lack of flexible supply forces prosthetists and other buyers to procure ad-hoc from overseas
suppliers, which can lead to delays in fitting and high costs to user.

• Regional distributors have emerged that maintain component inventory and aggregate
Rationale
volumes across numerous buyers to achieve better pricing and responsive supply.

Proposed • Strengthen regional distributors to access financing to expand capacity, improve service and
activity product offerings, and reach more buyers.

• Responsive supply channels that leverage effective regional or local distribution models.
Target
outputs • Increased affordability of prosthetic services due to reduction in wait times, more efficient
supply processes, and lower landed cost of components.

Long-term • A competitive, healthy local market of an assortment of affordable prosthetic component

outcome options ready to meet the needs of all users.

34 PRODUCT NARRATiVE: PROSTHESES

7. Next Steps
This document was developed to support the identification of activities that will support increased and
sustainable access to appropriate and affordable AT. As an overall investment and implementation strategy
is developed, some of these proposed activities will be undertaken in the immediate term by the AT2030
programme, which is funded by UK aid and led by the Global Disability Innovation Hub, to test what works
to increase access to affordable AT. Others will be complementary early investments that ATscale will take
on or will become foundational to ATscale’s long-term investment in the space.
As interventions are shown to be effective, the investment case outlining the magnitude and types of
investment needed will be further refined and developed. It is expected that different large-scale
investments and financial instruments will be needed to achieve long-term outcomes. For example,
system-strengthening grants may be needed to support the integration into the health system, while match
funding or co-investments may catalyse government procurement and investment. On the supply side,
donor investment may be leveraged to de-risk private investment in cost-effective supply mechanisms.

I 35
 ANNEXES

ANNEX A: LIST OF CONSULTATIONS FOR PRODUCT NARRATIVE DEVELOPMENT

ORGANISATION NAME

500 Miles Austin Mazinga

Amparo Lucas Paes de Melo

Association of Physically Disabled of Kenya (APDK) Benson Kiptum

Joseph Gakunga

Gladys Koech

Beijing JingBo P&O Qing Hong An

Beijing P&O Technique Centre Linda Zhu

Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS) D.R. Mehta

V.R. Mehta

Blatchford/Endolite John Ross

Cambodian School of Prosthetics and Orthotics (CSPO) Sisary Kheng

Click Medical Jimmy Capra

Clinton Health Access Initiative (CHAI) Jean Bosco Uwikirebera

CURE Hospital Seith Simiyu

Nelson Muoki

Michael Mbote

Exceed Carson Harte

Fujian Guozi Prosthetics Jianwei Pan

Humanity and Inclusion (HI) (formerly Handicap International) Isabelle Urseau

Abderrahmane Banoune

Jérôme Canicave

36 PRODUCT NARRATiVE: PROSTHESES

 ORGANISATION NAME

International Confederation of Amputee Associations (IC2A) Dr. Nils-Odd Tonneyold

Dieter Juptner

Jean-Pascal Hons-Olivier

Sandra Sexton

International Committee of the Red Cross (ICRC) Marc Zlot

Jess Markt

International Society of Prosthetics and Orthotics (ISPO) Friedbert Kohler

Claude Tardif

Jaipur Foot, Nairobi Kundan Doshi

Francis Asiema

Kenya Ministry of Health Alex Kisyanga

LegWorks Emily Lutyens

Metiz Elena Morozova

Mohamed Bassiouny

MiracleFeet Chesca Colloredo-Mansfeld

Nia Technologies Jerry Evans

Matt Rato

Organisation Africaine pour le Développement des Centres pour Masse Niang (also of FATO)
Personnes Handicapées (OADCPH)
Anarème Kpandressi

Ottobock Berit Hamer

Prosfit Alan Hutchison

Christopher Hutchison

Prosthetist/orthotist, Fiji Dean Clarke

Proteor Frederic Desprez

Puspadi Bali Ni Nengah Latra

Regal Prosthesis Oriana Ng

Rehab Impulse/Alfaset Roger Ayer

South Africa P&O / physical therapist Liezen Ennion

Johann Snyder

INCREASING ACCESS TO PROSTHESES AND RELATED SERVICES IN LOW AND MIDDLE INCOME COUNTRIES 37
 ORGANISATION NAME

ST&G Corporation Glenn Choi

SwedeAmp/CEPO Bengt Soderberg

Tanzania Training Centre for Orthopaedic Technologists (TATCOT) Longini Mtalo

Teh Lin Prosthetics Brian Chen

James Chen

University Don Bosco, El Salvador Monica Castaneda

University of Global Health Equity Claudine Humure

University of Melbourne Wesley Pryor

United States Agency for International Development (USAID) Michael Allen

Kirsten Lentz

Vorum Nam Vo

World Health Organization (WHO) Chapal Khanabis

38 PRODUCT NARRATiVE: PROSTHESES

ANNEX B: DESIGNATIONS IN PROSTHETIST/ORTHOTIST PROFESSIONS ACCORDING TO 2018
EDUCATiON STANDARDS (DETAILED)

DESiGNATiON RESPONSiBiLiTiES REQUiSiTE TRAiNiNG RECOMMENDED #

CLiNiCiANS

Prosthetist/Orthotist • Clinical Services: • 4 years of full-time • 5-10 prosthetist/

clinical assessment, study at university orthotist clinicians per
Formerly: Category I prescription, technical level. Curriculum million; though in HICs,
Prosthetist/ Orthotist design, fabrication, includes: practical it is usually 15-20 per
and fitting of devices; techniques for fitting/ million.
monitoring outcomes. fabrication techniques • Each service point
• Leadership: across a wide range should have at least
management of prosthetic-orthotic one qualified clinician,
of service units; device types. ideally Category I
advance models • Theoretical topics: Prosthetist/Orthotist
and/or methods clinical conditions, or an experienced
of service delivery anatomy, physiology, Associate Prosthetist/
by integrating best pathologies, Orthotist).
available evidence, biomechanics, • Each clinician can be
or new technologies; materials technology. expected to provide
supervising and • Clinic management: complete services to
training clinical and leading clinical 300-600 users per
non-clinical personnel; teams, inventory year.
participation in management, budget
community-based management, training
rehabilitation; and supervision,
advocacy for occupational hazards,
P&O services ethical code, research
and professionals methods.
in professional
organisations and
government agencies.
• Training, education,
community
demonstrations,
awareness-building.

Associate Prosthetist/ • Clinical Services: • 3 years of formal

Orthotist clinical assessment, structured education
prescription; technical which covers many of
Formerly: Category II design, fabrication, the topic areas of the
Orthopedic and fitting of devices; Prosthetist/Orthotist
Technologist monitoring outcomes. curriculum but to a
• Associate Prosthetists/ lesser depth, and with
and a greater focus on
Orthotists are capable
of carrying out all tasks clinical services and
Category II fabrication.
“Specialised” allocated to orthopedic
(according to their technologists, but • Associate training in
area of training (i.e. only in one speciality one single discipline
prosthetics, lower- branch. usually takes 12-18
limb orthotics, etc.) months. Thereafter,
Technologists they are named
according to their
area of expertise (i.e.
Associate Prosthetist,
Associate Lower Limb
Orthotist)

INCREASING ACCESS TO PROSTHESES AND RELATED SERVICES IN LOW AND MIDDLE INCOME COUNTRIES 39
 DESiGNATiON RESPONSiBiLiTiES REQUiSiTE TRAiNiNG RECOMMENDED #

NON-CLiNiCiANS

Prosthetist/Orthotist • Non-clinical services: • 2 years of formal • Each clinician should

Technician Support (Associate) structured or 4 years be supported by 2
Prosthetists/ of on the job/in-house non-clinicians; thus 10-
Formerly: Category Orthotists in device training. 20 non-clinicians are
III Prosthetic/Orthotic fabrication, assembly, needed per million.
• Curriculum includes
Technician/Bench maintenance, and practical technical • In decentralised
Worker repair. Expertise in training and basic units with a shortage
material science, understanding of of clinicians,
technical procedures, material science and increasing the ratio
and safe practices, safety procedures. of non-clinicians can
but does not have effectively extend the
clinical contact with service team.
users (i.e. making
fitting adjustments or
alignments).
• Not involved in direct
services to the user.
However, in LMICs,
lack of capacity often
means Prosthetist/
Orthotist Technicians
are also directly
working with patients,
typically under
the guidance of a
Prosthetist/Orthotist /
Associate Prosthetist/
Orthotist.

40 PRODUCT NARRATiVE: PROSTHESES

ANNEX C: GLOBAL COMPONENT SUPPLY LANDSCAPE

MECHANiCAL TF QUALiTY LMiC

SUPPLiER COUNTRY WEBSiTE
PROSTHETiC* CERTiFiCATiON AVAiLABiLiTY

Asia,
Beijing
China USD 250-500 www.en.jingbo-po.com ISO, CE Southern
Jingbo
Africa

South and
Blatchford/
UK/ India over USD 1,000 www.endoliteindia.com ISO, CE Southeast
Endolite
Asia

Fujian Guozi
China under USD 250 www.fpcfoot.com ISO, CE, FDA East Asia
Rehabilitation

Metiz Russia USD 500-1,000 www.metiz-ltd.com ISO, CE Asia

Hong Latin America,

Nobel
Kong/ USD 500-1,000 www.nobel.hk ISO, CE Asia, Middle
Prosthetics
China East, Africa

Asia, Latin
America,
Ortotek Turkey www.ortotek.com ISO, CE
Middle East,
Africa

Southeast
Asia,
Össur Iceland over USD 1,000 www.ossur.com ISO, CE, FDA
Southern
Africa

Asia, Africa,
Ottobock Germany over USD 1,000 www.ottobock.com ISO, CE, FDA
Latin America

Proactive
Technical India under USD 250 www.protechortho.com ISO, CE 50+ countries
Orthopedic

Proted Turkey USD 500-1,000 www.protedglobal.com ISO, CE 46 countries

French-
Proteor France over USD 1,000 www.proteor.com ISO, CE, FDA speaking
Africa

Asia, South
Teh Lin Taiwan USD 500-1,000 www.tehlin.com ISO, CE, FDA and North
Africa

* knee, pylon, ankle, foot, connectors.

I 41
 ANNEX D: SELECT PROSTHETIC COMPONENTS DEVELOPED FOR LMIC CONTEXT

TECHNOLOGY SUPPLiER PRiCE DESCRiPTiON AVAiLABiLiTY

ICRC under USD 100 Designing a low-cost Under

Switzerland carbon foot with development
Agilis increased comfort
www.blogs.icrc.org/
Prosthetic Foot and mobility.
inspired/2019/05/05/
affordable-feet-icrc-agilis-
prostheses

Blatchford/Endolite USD 500-1,000 Low-cost modular Predominantly

Alice Limb UK/India prosthetic India
components.
www.endoliteindia.com

LegWorks USD 200 Mechanical knee that ~30 countries

USA (in LMICs) gives a natural swing
without hydraulic
www.legworks.com or pneumatic
technology.
All-Terrain
Waterproof, can be
Knee
used in dusty, hot
environments. Can
be fitted for active
and low-mobility
amputees.

Proteor USD 500-1,000 Temporary prosthetic Available

France limb with partially- through HI
fitted socket, that
Emergency www.proteor.com can be strapped and
Limb adjusted to amputees
to provide temporary
mobility in emergency
settings.

ICRC USD 200-800 Launched in 1993, Available

Switzerland ICRC has developed throughout
prosthetic devices LMICs
‘ICRC’ www.icrc.org/en/doc/ composed of
Polypropylene assets/files/other/icrc- polypropylene
System 002-0913.pdf components that
are produced in
high volumes in
Switzerland.

D-Rev USD 80 Mechanical, ~30 countries

US (in LMICs) polycentric knee,
ReMotion Knee water-resistant and
www.d-rev.org durable; developed
through Jaipur.

42 PRODUCT NARRATiVE: PROSTHESES

ANNEX E: OVERVIEW OF PROMINENT INTERNATIONAL ORGANISATIONS PROVIDING PROSTHETIC
SERVICES 45
I BHAGWAN MAHAVEER
HUMANiTY &
ViKLANG SAHAYATA SAMiTi
iNCLUSiON (Hi)
(BMVSS)

www.icrc.org www.jaipurfoot.org www.hi.org

Independent international Registered Indian NGO with International independent

organisation that focuses the aim to provide mobility aid organisation focused
on humanitarian protection and dignity to people with on working with people
About and assistance for victims disabilities. with disabilities affected by
of armed conflict and poverty and exclusion and
situations of violence. conflict and disaster.

ICRC launched the Physical Founded in 1975, in Founded in 1982, in

Rehabilitation Programme response to polio crisis in response to landmine
Established
in 1979. India. victims in Cambodia and
Thailand.

170+ rehabilitation centres in 23 sites in India, with 94 rehabilitation projects

40+ countries in the Middle presence or partnerships in 49 countries, including
Geographical East, Africa, and Southeast in 27 countries. BMVSS Africa, the Middle East,
coverage Asia. has also held 73 temporary Asia, and Central and South
fitting camps in 30 America.
countries.

The Physical Rehabilitation BMVSS offers free HI initiates projects in

Programme was set up prosthetic devices through emergency response at the
to support the physical a broad network of service invitation of governments,
rehabilitation of amputees points across India and with the goal to transition
by providing technical through partners in other from emergency
support and training to countries. All users are fitted response to developing
establish services, and within one day. comprehensive services
Approach
to fit and supply mobility Supported by private and over time.
devices, prosthetic devices, public donors, including the
or wheelchairs. Support Ministry of External Affairs of
also includes long-term the Government of India.
rehabilitation, education,
and social and economic
inclusion.

In 2017, supported 144 To date, the organisation HI has supported access

rehabilitation centres in 36 has rehabilitated more to physical rehabilitation
countries, providing 26,000 than 1.8 million people with services and products to
prostheses through local physical disabilities, at a 277,194 people. In 2018,
partnerships. ICRC focuses rate of 60,000-80,000 it delivered 25,025 P&O
on conflict, humanitarian users per year. Primary devices.
Impact
crises, and natural disasters; focus of impact is India,
working through local where BMVSS produces
partnerships to ensure long- and delivers an estimated
term sustainability. 25,000 prosthetic limbs per
year, roughly 50% of the
total market.

45 Source: CHAI expert consultations with NGOs and organisation websites as denoted in Annex A.

I 43
 iNTERNATiONAL BHAGWAN MAHAVEER
HUMANiTY &
COMMiTTEE OF THE ViKLANG SAHAYATA SAMiTi
iNCLUSiON (Hi)
RED CROSS (iCRC) (BMVSS)

In 1993, ICRC developed BMVSS centrally HI does not produce its own
a low-cost polypropylene manufactures partially components and deploys
prosthetics solution, which formed prosthetic limbs modular components from
won the ISPO Blatchford and other components a range of international
Prize for innovation in its manufacturing suppliers. In partnership
because of its suitability for centre in Jaipur, India. with Proteor, HI has
deployment in LMICs. The intermediary product, developed an emergency
Until 2019, it was supplied made from rubber and prosthetic limb that can be
by Swiss-based CR polypropylene, is then fitted to any user to enable
Equipment. In 2019, heated and formed into the temporary mobility in
ICRC has switched to final prosthetic device at the conflict zones.
Alfaset, a non-profit arm site of fitting. The device HI has also been
of manufacturer Rehab features a low-cost non- conducting implementation
Impulse, also Swiss-based. articulated foot and shank. It research in the digital
cost USD 50 to produce. fabrication of orthotics
ICRC’s prosthetic solution
Technology BMVSS’s Jaipur Foot and prosthetic sockets,
is deployed in ICRC-
supported rehabilitation component revolutionised testing for acceptability,
centres, as well as being foot componentry when it cost-effectiveness of these
available for purchase by was released because it technologies in various
other providers and service was low-cost, had a flexible LMIC settings.
centres. keel and was able to be
used appropriately in an
Indian context (permitted
squatting, cross-legged
sitting, and used with
sandals). The overall Jaipur
lower-limb solution is
shown to be unsatisfactory
biomechanically, but
continues to be deployed
because of the low cost.

44 PRODUCT NARRATiVE: PROSTHESES

ANNEX F: SELECT REGIONAL NGO/FBOS

GEOGRAPHiCAL
ORGANiSATiON MODEL I
COVERAGE

Focused on • Sponsors the training and • Has fitted over

Malawi and accreditation of 18 prosthetists/ 3,500 users.
Zambia, some orthotists. • Sponsored the
presence • Offers free P&O services and training and
in Tanzania devices at the Kamuzu central accreditation of
(Zanzibar). hospital in Lilongwe as well as 18 prosthetists/
500 Miles
(Est. 2007) through community outreach orthotists at ISPO-
services. accredited training
www.500miles.co.uk • Provide funds to users who schools.
have to travel for transport and
accommodation.
• Funding comes from government,
and support from other local
partners and donors.

India (South, • Provides rehabilitation services and • Provided over

East and North- mobility devices including P&O to 220,000 assistive
Eastern States). the most vulnerable populations. devices and
• Provide prosthetist/orthotist training interventions.
through its Rehabilitation Research • Trained over 5,000
and Training Centre in Bangalore. rehabilitation
Mobility India • Develops and manufactures low- personnel.
(Est. 1994) cost components and mobility • Community
products that are designed for LMIC outreach
www.mobility-india.org
contexts. programmes
• Committed to employing persons have reached
with disabilities in its operations and 6,000 persons
in its training programmes. with disability, and
reached 402 urban
slums and rural
communities.

9 hospitals. • International Christian FBO. • Performed over

Programmes in • Establishes and operates 213K orthopaedic
27 countries, orthopaedic paediatric charitable operations on
including Kenya, hospitals, and offers a full range paediatric patients.
Uganda, Malawi, of care from surgical treatment to
Zambia, and rehabilitation and fitting of mobility
Ethiopia. devices.
CURE
(Est. 1996) • Specialised programmes focused
on birth defects and neuro-
www.cure.org orthopaedic disorders such
as club foot, spina bifida and
hydrocephalus.
• Although medical and surgical
interventions are provided free
of charge, mobility devices are
typically paid for OOP.

I 45
 GEOGRAPHiCAL
ORGANiSATiON MODEL iMPACT
COVERAGE

Kenya. • Charitable organisation that offers • Rehabilitated over

range of services to identify, 600,000 persons
rehabilitate, and reintegrate people with disabilities.
Association of the with disabilities. • In 2018, 1,698
Physically Disabled • Services include medical clients were
Kenya rehabilitation, provisioning of attended to, 53
(Est. 1958) mobility devices including P&O, orthopaedic
physical therapy, community-based operations
www.apdk.org rehabilitation, education, vocational sponsored and
and skills training, and micro- 497 orthopaedic
financing for entrepreneurs with devices provided.
disabilities.

Eastern • Non-profit organisation that focuses • Provides services to

provinces of on providing mobility devices and 580 people every
Indonesia. rehabilitation services to persons year, 400 of which
with disability. are for P&O devices:
160 TF, 100 TT, and
• Services include outreach to
Puspadi Bali repairs for ~200
remote islands to identify and refer
(Est. 1999) users.
amputees and build awareness,
production of lower limb P&O • Around 65% of the
www.puspadibali.org
devices, provision of wheelchairs, 20 staff are
and advocacy for policy reform at physically-disabled.
local and national levels.
• P&O devices are provided free of
charge.

15 countries, • Developed a ‘Limbox’ solution that • In 2018, LI delivered

including Kenya, contains all components required to 400 limbs.
Limbs International (LI) India, Indonesia, fit a TF amputee (not the socket). This
(Est. 2004) and Mexico. low-cost solution (USD 600) won the
Drucker prize for innovation in 2019.
www. • Utilises partners to identify potential
limbsinternational.org users who have access to a
community-based rehabilitation
programme and provides the Limbox
free of charge.

Guatemala, • Non-profit organisation that • 9,249 patient visits,

Ecuador, and provides support to develop local with 3,345 devices
US. capacity (training prosthetists and delivered since
Range of Motion local manufacturing), providing establishment.
Project medical care to those with physical
(Est. 2005) disability, and developing and
deploying innovative prosthetic
www.rompglobal.org technologies.
• Engages in advocacy and
awareness-building activities.

South & • Supported the establishment of • Established 5 P&O

Exceed Southeast Asia P&O training schools. schools in region
Worldwide (Cambodia, Sri and trained over
• Develops capacity of ISPO-
(Est. 1989) Lanka, 500 professionals.
accredited professionals for
Indonesia, expansion of services in region. • Supplied over
www.exceed- Philippines,
worldwide.org • Expanded P&O services through 55,000 custom-
Myanmar) made P&O
social enterprise model with
pricing based on ability to pay. devices.

46 PRODUCT NARRATIVE: PROSTHESES

ANNEX G: DESCRIPTION OF TRADITIONAL SOCKET FABRiCATION AND FITTING PROCESS

TRADiTiONAL SOCKET FABRiCATiON PROCESS

Made by wrapping residual

1. Negative mould limb with a wet plaster-of-Paris
bandage.

AS photo studio/Shutterstock
Made by filling the cast with
2. Positive mould a mixture of plaster-of-Paris
and water

SeventyFour/Shutterstock
Rectifications are made to the
3. Rectify
positive mold.

SeventyFour/Shutterstock

Socket is formed by draping

4. Socket formed polypropylene or using
laminated resins.
Orfit Industries

Final adjustments to the

5. Final changes socket made using machinery,
Florian Kopp/Alamy Stock Photos

suspension attached.

I 47
 ANNEX H: OVERVIEW OF SELECT NOVEL SOCKET FABRICATiON TECHNOLOGIES WITH POTENTIAL
FOR ADOPTION IN LMICS

COMPANY PRODUCT/iNNOVATiON COMMERCiAL STATUS

Confidence Socket (BK): • Commercially available in Europe, North

Thermoplastic direct-fitted America and Asia.
on residual limb in 2 hours. • Acceptability pilot/clinical trial in Kenya: results
Can be remoulded up to 10 expected in 2020.
Amparo times. Each socket arrives
(Est. 2014) structurally formed and needs
to be heated to be moulded
Germany to the residual limb. Fitted
on-site with a mobile tool
www.amparo.world set that can be transported
outside the prosthetic service
unit and bypasses the need
for orthopaedic workshop
equipment and machinery.

Össur icecast: Uses air • Commercially available globally.

Össur pressure to mould the socket • Clinical studies have been conducted in South
(Est. 1971) directly on the residual Africa and Indonesia to show it performs on a
limb without orthopaedic par with traditional sockets, but comfort issues
Iceland workshop machinery. The arise due to liner sores.
pressure casting system
www.ossur.asia/ loads the residual limb with • Durable and efficient, but 5-6x the cost of
prosthetic-solutions/ even pressure, eliminating the traditional sockets.
products/post-op- need for modification of the
solutions/direct-socket- socket shape. Carbon fibre
tool-kit and resin hardens to form the
final socket.

PandoFit: End-to-end solution • Commercially available globally.

that enables cost-effective • Sockets meet ISO standards and are regulated
building of prosthetic service as medical devices in Europe, Australia, and
provision capacity. Combines Singapore
3D scanning (which creates a
digital scan of the limb) with • Clinical investigation conducted in 2015.
cloud-based and/or offline • Clinical trials in Syria, Togo, and Madagascar in
rectification software to 2016 showed viability of solution and to improve
Prosfit design sockets. Socket is 3D prosthetist productivity; albeit cost of 3D printing
(Est. 2013) printed via a global network is much higher than traditional socket fabrication
of certified 3D manufacturing methods and not yet economically feasible.
Bulgaria partners (currently a non-
• Trial in Middle East in 2018-2019 combined
exclusive partnership with
www.prosfit.com telehealth approaches and PandoFit that
HP) which allows delivery
enabled task-shifting to local physiotherapists to
of products with consistent
fit 40 amputees in a challenging environment.
quality. The socket is printed
with PA12 Nylon and is • Prosfit is launching a capacity building project in
1kg lighter than traditional East Africa that offers training on the PandoFit
designs. solution, infrastructure development, tele-health,
data collection, and policy recommendations.
First phase is estimated to fit 200-250 users
and will cost EUR 0.5-EUR 1 million.

48 PRODUCT NARRATiVE: PROSTHESES

 COMPANY PRODUCT/iNNOVATiON COMMERCiAL STATUS

3D PrintAbility: On-site • Commercially available and currently recruiting

digital toolchain used to 3D early adopters.
print lower-limb prosthetics • Clinical trials in Cambodia, Uganda, and
Nia Technologies and orthotics. The toolchain Tanzania show performance and acceptability
(Est. 2015) includes: 3D scanner, NiaFit on a par with ICRC sockets. However, issues
rectification software, and 3D with socket cracking and discomfort caused by
Canada printer. Prosthetic sockets can (previous version) material.
be printed in 5-8 hours using
www.niatech.org polypropylene material. • Nia is a non-profit social enterprise. Currently
forming a new for-profit company and seeking
investors to commercialise NiaFit software in
developed countries.

I 49
 ANNEX i: DIFFERENT COMPONENT SUPPLY CHANNELS OBSERVED IN LMICS 46

FULFILLMENT #1: INDIVIDUAL ORDERS FROM INTERNATIONAL SUPPLIER

Prosthetist places individual order directly with international supplier

Prosthetist notifies amputee,

who returns to service
provider to be fitted
Prosthetist Shipping & logistics takes 1–2 months, is costly
assesses amputee,
who returns home

FULFILLMENT #2: PUBLIC SECTOR

Prosthetist checks inventory at central procurement If desired component is not available,2

store or at prosthetic service unit1 order direct from international supplier

If components are available,

fit amputee
Prosthetist Shipping & logistics takes 1–2 months, is costly
assesses amputee

1 Because central and provider procurements are made annually or periodically, it can be difficult to predict demand and stock the desired components. Components may not have a
long shelf life and bulk orders can also be delayed due to processing of order or customs challenges.
2 Alternatively, if desired components are not available, sub-optimal components that are available in stock may be chosen instead.

FULFILLMENT #3: NGO

NGOs have access to capital to negotiate

and procure regular stock of components

Prosthetist Amputee is fitted

assesses amputee right away

NGO has specialized

international suppliers(s)

FULFILLMENT #4: LOCAL OR REGIONAL DISTRIBUTOR Orders in bulk and

Local distributor offers negotiates volume pricing
inventory of a variety of with international
Prosthetist places order with component solutions from suppliers to serve a
local or regional distributor various international suppliers network of local
at different price points prosthetists and providers

Distributor manages customs

Amputee is fitted with clearance and import process
Prosthetist optimal solution
assesses amputee

Local distributor is able to respond

to the order in a short time period
and deliver the components locally

46 Diagrams from CHAI, based on CHAI expert consultations.

50 PRODUCT NARRATiVE: PROSTHESES

INCREASING ACCESS TO PROSTHESES AND RELATED SERVICES IN LOW AND MIDDLE INCOME COUNTRIES 51
THIS REPORT WAS DELIVERED UNDER THE AT2030 PROGRAMME, FUNDED BY UK AID.