Course Title: Biomedical Systems Design

Course Code: BE367

Instructor: Khalil A. Al-Hatab

Associate Prof. of Production Eng. & Metallurgy
Mechanical Eng. Department
[email protected]
Warning: only approved medical devices may be placed in the market and used for medical purposes. The approval
procedure must be performed under the regulation applicable in the target market (e.g., Medical Device Directive in the
European Union, or under FDA approval-clearance procedures in the USA).
 Chapter Three:
Product Definition
“The greatest mistake in the treatment of diseases is that there are physicians for the body and physicians for the
soul, although the two cannot be separated”.
Plato
 Chapter Outline
•The Product Definition Process
•Identifying Customer Needs
•Product Design Specifications (PDS)
•Quality function deployment (QFD)
•Benchmarking

3-3
 The Product Definition Process:
 There are as many different definitions for a medical device as there are regulatory and
standards organizations. Two of the more popular definitions are reviewed below.
1) Food and Drug Administration Definition: Section 201(h) of the Federal Food,
Drug, and Cosmetic Act defines a medical device as follows:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent,
or other similar or related article, including any component, part, or accessory, which
is:
• Recognized in the official national formulary, or the united states pharmacopeia, or
any supplement to them
• Intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of its principal intended purposes through chemical
action within or in the body of man or other animals and which is not dependent upon
being metabolized for the achievement of any of its principal intended purposes.
 The Product Definition Process:
 The Medical Device Amendments of 1976 expanded the definition to include:
• Devices intended for use in the diagnosis of conditions other than disease, such as
pregnancy, and
• In vitro diagnostic products, including those previously regulated as drugs.
 A significant risk device is a device that presents a potential for serious risk to the health,
safety, or welfare of a subject and is:
 Intended as an implant,
 Used in supporting or sustaining human life, and/or
 Of substantial importance in diagnosing, curing, mitigating, or treating disease or
otherwise preventing impairment of human health.
 A nonsignificant risk device is a device that does not pose a significant risk.
2) The European Union Medical Device Directives Definition: Various medical device
directives define a medical device as follows:
any instrument, appliance, apparatus, material or other article, whether used alone or in
combination, including the software necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
3- 5
 The Product Definition Process:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnosis, monitoring, alleviation of or compensation for an injury or handicap;
• Investigation, replacement or modification of the anatomy or of a physiological process;
• Control of conception (prevent or facilitate); and
which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function
by such means.
 Important feature of the definition are:
 Intended use and principal intended action terms gives manufacturers some opportunity to
include or exclude their product from the scope of the particular directive.
 The inclusion of the term software which is currently interpreted to mean that:
(1) Software intended to control the function of a device is a medical device (SaMD);
(2) Software for patient records or other administrative purposes is not a device;
(3) Software which is built into a device, for example, software in an electrocardiographic
monitor used to drive a display, is clearly an integral part of the medical device; and
(4) A software update sold by the manufacturer, or a variation sold by a software house, is a
medical device in its own right.
3- 6
The Figure below depicts in
phases of the waterfall design
The Product Definition Process:
process. Three Key Elements:
1. Design Input
2. Risk Analysis
3. Design Output
Design Input
 User Needs
• What & why stated in user
terms
 Marketing Requirements
• Measurable, engineering
terms

Needs identification: the fellows participate in a number of activities to

help them identify needs.
3- 7
The Product Definition Process:

The product definition process.

3- 8
 Product Definition Process:
Requirements are
defined considering
the market need and
the device is
designed to address
that
The
need. requirement
management is a
continuous process
throughout the project
since requirements are
validated (i.e., if they are
right), verified (i.e., if
their implementation is
correct) and updated
during the various steps
of product development.
3- 9
 Product Definition Scheme:
• Conduct research and clinical interviews to help identify potential needs;
• Attending industry conferences in order to better understand the current problems.
• Turn observations and
research into simple
need statements that
capture the problem, the
stakeholders affected,
and the desired
outcomes.
• Focus on gaining a deeper
understanding of the needs
and define criteria to
determine the importance
of a need.
• Conduct multiple rounds of needs screening
3- 10
 Needs Identification :
• Observations: is the most important
and efficient method of identify
needs.
• The goal of observation is to become
a part of the team and observe
problems through the eyes of the
different stakeholders, and to see
them from different perspectives.
• For each clinical rotation, the
fellows should document the date
and time of the rotation, the
procedures observed, the physicians
and clinical staff shadowed, and the
amount of time they shadowed, in
addition to any observations they Overview of the needs identification process
make during their rotation. 3- 11
 Needs Identification :
1.Preparing for observation:
 Once the fellows have set up clinical rotations, they need to perform initial research
into the procedure they are observing. This will help them understand:
 What is being done in the procedure,
 What the outcomes should be, and
 What type of providers they will be observing.
2. Observation techniques:
 Look for steps that require multiple hands or seem cumbersome, require extreme
precision or skill, require a great deal of time, or actions that, when asked why they
are performed in a certain way, elicit such responses as, “That is the way we were
taught,” or, “That is just how it is done,” and so on.
 It is important for the fellows to observe everyone involved in the procedure or process
and understand the needs of each stakeholder, including the patient, provider (physician,
nurse, tech, assistant, etc.), and the system.
3- 12
 Needs Identification :

Examples of what to look for during observation for each stakeholder involved in the procedure or
process. 3- 13
 Needs Identification :
• Industry Conferences: another great way to identify potential needs is to attend
conferences related to the focus area. This will help fellows to
 Understand the issues that the key opinion leaders (KOLs) see as important.
 Network with potential stakeholders and KOLs who might be interested in becoming
clinical mentors or advisors.
 Develop an understanding of the emerging technologies that address some of the
needs in the industry, as well as new techniques that are being implemented in
practice.
• Clinician Interviews and Market Research: to talk with clinicians and determine their
pain-points or frustrations. It is important to:
 Understand that stakeholders sometimes do not see the entire need, and are instead
aware of only a small part of the problem, so it is important to listen to them while also
being able to take a step back and understand what is truly driving their frustration.
 Market research is another great way to identify some of the major issues associated
with a clinical focus area. 3- 14
 Needs Identification :
 Numerous methods of obtaining new  How feasible is technical
product information exist including various
ways of collecting data, such as internal development?
sources, industry analysis, and technology  How do we get where we want to
analysis.
 Then the information is screened, and a go?
business analysis is conducted.  What are the chances of success?
 Regardless of the method of obtaining the  This section presents a method for
information, there are certain key questions: comprehensively needs identifying:
 Where are we in the market now? 1. The customer’s needs
 Where do we want to go? 2. The set of company’s needs
 How big is the potential market? 3. The company’s competencies, and
 What does the customer really want? 4. The outside competencies?
3- 15
 1. Identifying Customer Needs:
 Needs are independent of any  The customer survey is an important tool in
particular concept changing an idea into a product.
 Customer needs can be  The philosophy behind the method is to
developed without knowing how create a high-quality information channel
these needs will be addressed. between customers and the developers of the
 Also called “customer attributes” product. The goals of the method are to:
or “customer requirements”  Ensure that the product is focused on
 Specifications depend on the customer needs.
selected concept. They depend  Identify latent or hidden needs as well
on: as explicit needs.
 Provide a fact base for justifying the
 Customer needs
product specifications.
 What is feasible  Create an archival record of the needs
activity of the development process.
 What competitors offer
3- 16
 1. Identifying Customer Needs:
1. The Customer’s Needs
 Ensure that no critical customer  The objective of consumer analysis is to
need is missed or forgotten. identify segments or groups within a population
 Develop a common understanding with similar needs so that marketing efforts
of customer needs among members can be directly targeted to them.
of the development team.  Several important questions:
 Latent needs are those not yet widely 1. What is the end goal to be solved?
2. What is the need category?
recognized by most customers and not
3. Who is buying and who is using the product?
yet addressed by existing products. 4. What is the buying process?
 Quality has been defined as meeting 5. What are the medical constraints? Should we be
the customer needs. So, a quality concerned with patient confidentiality?
product is one that does what the 6. Does what I am selling require high- or low-
customer wants. involvement by the medical practitioner to
 What is the goal of the customer operate the device?
7. What are the technical constraints? Can we use
survey? (To match the needs of the
metals and plastics?
customer with the product concept). 8. How can the market be segmented?
3- 17
 1. Identifying Customer Needs:
Categorize of stakeholder:
 One way to do this is to create a
plot of the stakeholders, taking
into account their level of
interest and their level of power
(Figure).
 The stakeholder’s location on
the plot will help the fellows to
understand if they are primary
or secondary stakeholders and
the best way to engage them.
Stakeholder analysis plot.
3- 18
 The Product
1. Identifying Definition
Customer Process:
Needs:

The voice of the customer sub process.

3- 19
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
1. Gather raw data from customers:  Written surveys:
 Interviews:  Do not usually provide enough
 One or more development team information at this
members discuss needs with a  Observing the product in use:
single customer.  Watching customers use an existing
 Usually in customer’s product can reveal important details
or hidden customer needs.
environment Whom to ask?
 Typical duration: (1-2 hours)  Both end users and buyers
 Focus groups: 1. Lead users
 A moderator facilitates  Customers who experience needs
discussions (2 hours) with a group months or years ahead of the majority
of customers (8 to 12) of the marketplace

3- 20
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
1. Gather raw data from customers:
2. Non-traditional customers  Questions:
 Happy, dissatisfied, demanding  When and why do you use the product?
customers you had but lost,  Walk us through’ a typical session
customers you never had using the product
3. Extreme users  What do you like about the existing
 Customers who use the product in products?
unusual ways or have special  What do you dislike about the existing
needs. products?
Eliciting Customer Needs  What issues do you consider when
 The goal: an honest expression of purchasing the product?
the needs of the customer  What improvements would you make
 Interview: the end user (and the to the product?
buyer)
3- 21
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
1. Gather raw data from customers: 2. Interpret raw data in terms of customer needs:
Documenting Customer Interactions  Several team members should
a. Notes or comments interpret the needs
b. Audiotape recording  Tips for interpreting raw customer
c. Videotape recording data in terms of ‘customer needs’:
d. Still photography 1. Express the need in terms of what
The final result of the phase is a set of the product must do, not how it
customer statements might do it.
2. Interpret raw data in terms of customer 2. Express the need as specifically as
needs in the raw data
 Translate customer statements into 3. Use positive not negative phrasing
customer needs 4. Express the need as an attribute of
 Customer needs are written statements the product
interpreting based on the collected raw 5. Avoid the words ‘must’ and
data ‘should’
3- 22
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
Design Input – User Needs: 2. Interpret raw data in terms of customer needs-Example
Over the Needle Catheter
 Infuse fluids into subcutaneous
tissue
 Sharp enough to penetrate skin
easily
 Simple to remove needle from
catheter
Design Input – Marketing
Requirements:
Over the Needle Catheter
 Infuse fluids at 100 ml/hr,
backpressure not to exceed 10
psi
 Max insertion force through 5
mil latex = 3N
 Max force to remove needle =
1N
3- 23
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
3. Organize the needs into hierarchy:  The procedure:
 Around 50-300 customer needs  Organize the needs into the groups
 We need some useful according to the similarity of the needs
organization! (secondary needs)
 Create a hierarchy in the needs:  Eliminate redundant statements
 Primary needs - each one of which  For each group chose a label (primary
will be further characterized by a: need)
 Secondary needs: in cases of very 4. Establish the relative importance of the
complex products, the secondary needs needs:
may be broken down into a:  There are two basic approaches to the task:
 Tertiary needs (1) The consensus of the team members based
 The primary needs are the most on their experience with customers, or
general needs, while the secondary (2) Basing the importance assessment on
and tertiary needs express needs in further customer surveys.
more detail. 4. Reflect on the results and the process.
3- 24
 1. Identifying Customer Needs:
 Initial Needs Screening: Overview of needs screening activities
Once the fellows have
turned all of their
observations into need
statements, scoped and
validated them with
preliminary stakeholder
interviews, and performed
an initial round of filtering,
it is time for them to begin
researching the needs in
more detail.
3- 25
1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:

The different needs screening and the number of needs in each round.
3- 26
 1. Identifying Customer Needs:
The five-step Process of Identifying Customer Needs:
As seen from the next Figure, this process is iterative
and will most likely be performed multiple times
before the fellows arrive at their final needs.
The need criteria are the stakeholders’ key
requirements for any solution relating to the need.
These are often grouped by “must-have” and “nice-
to-have” criteria.
Once the fellows have identified their top 10–15
needs, they should begin developing a need
specification document, also known as an
opportunity specification document, for each of
their top needs.
This document will be essential for guiding concept
generation and selection, and will be constantly
Process for needs screening and selectionrevised throughout this innovation process.
The need specification document is a detailed document that
summarizes the market need and the information gathered
3- 27
 1. Identifying Customer Needs:
 Need Statements: is a one-sentence
description of the clinical need that
includes the problem or
opportunity, the stakeholder or
population affected, and the Components of a good need statement.
desired outcome.
 The need statements will start out as very broad, rough versions of a
need statement and, through iteration, scoping, and validation, will be
shaped and refined into a more descriptive need statement.
 It is important for the fellows to note that often times, there are
multiple desirable outcomes associated with a need. However, it is
important to include only the most important outcome in the need
statement.
3- 28
 2.The set of company’s needs:
 Segmentation analysis focuses on consumers as individuals.
 Market analysis takes a broader view of potential consumers to include market sizes
and trends.
 Market analysis also includes a review of the competitive and regulatory environment.

 Three questions are important in evaluating a market:

 What is the relevant market?
 Where is the product in its product life cycle?
 What are the key competitive factors in the industry?
3- 29
 3.The company’s competencies:
 A plan to beat the competition must be chosen.
 A company must look at itself with the same level of objectivity it looks at its
competitors.
 Important questions to assist in this analysis include the following:
 What are our core competencies?
 What are our weaknesses?
 How can we capitalize on our strengths?
 How can we exploit the weaknesses of our competitors?
 Who are we in the marketplace?
 How does my product map against the competition?
3- 30
4. The company’s competitors: 5. Completing the Product Definition:
 Once a company has objectively  In order to complete the product definition, an
organization needs to determine the following:
looked at itself, it must then look at
 How does the potential product fit with our
others in the marketplace: other products?
 What are the strengths of the  Do our current technologies match the
potential product?
competition?  How will we differentiate the new product?
 How does the product life cycle affect our
 What are their weaknesses?
plans?
 What are the resources of the  It is also important to consider:
1. The marketing mix of products,
competition? 2. Distribution networks,
 What are the market shares of 3. Pricing structure, and
4. The overall economics of the product plan.
the industry players?
Market Segmentation: Definition, Example, Types, Benefits (investopedia.co
m) 3- 31
 Product design specification (PDS):
 Specifications spell out in precise, measurable detail what the product has to do.
 Specifications represent an unambiguous agreement on what the team will
attempt to achieve in order to satisfy the identified customer needs.
 Create a product design specification (PDS) also called product requirements.

 The PDS is a document created during the problem definition activity very early in
the design process. It details the requirements that must be met in order for the
product or process to be successful.
3- 32
 Product design specification (PDS):
 The PDS is a document created during the problem definition activity very early in
the design process. It details the requirements that must be met in order for the
product or process to be successful.
 The PDS is a comprehensive document, which contains all the facts relating to the
product outcome, and should contain all the realistic constraints to be imposed
upon the design by the client.
 Write in engineering terms the problem, goal, function, constraints.
 Items in the PDS should be as quantitative as possible (e.g., the device must
weigh less than 2 kg, the device must fit in a 1 m 1 m 1 m space), and be ranked
in order of importance.
 The PDS is a dynamic document that should evolve as the project scope
develops. This is because frequently at the start of a project it is not always clear
what is achievable and to what extent certain parameters are essential.

3- 33
Product design specification (PDS):

3- 34
Overview of Quality Function Deployment (QFD):

3- 35
Overview of Quality Function Deployment (QFD):

3- 36
Overview of Quality Function Deployment (QFD):

3- 37
Overview of Quality Function Deployment (QFD):

3- 38
Overview of Quality Function Deployment (QFD):

3- 39
Overview of Quality Function Deployment (QFD):

3- 40
Overview of Quality Function Deployment (QFD):

3- 41
Overview of Quality Function Deployment (QFD):

3- 42
Overview of Quality Function Deployment (QFD):

3- 43
Overview of Quality Function Deployment (QFD):

3- 44
Overview of Quality Function Deployment (QFD):

3- 45
Overview of Quality Function Deployment (QFD):

3- 46
Overview of Quality Function Deployment (QFD):

3- 47
Overview of Quality Function Deployment (QFD):

3- 48
Overview of Quality Function Deployment (QFD):

3- 49
Overview of Quality Function Deployment (QFD):

3- 50
Overview of Quality Function Deployment (QFD):

3- 51
Overview of Quality Function Deployment (QFD):

3- 52
Overview of Quality Function Deployment (QFD):

3- 53
Overview of Quality Function Deployment (QFD):

3- 54
Overview of Quality Function Deployment (QFD):

3- 55
Overview of Quality Function Deployment (QFD):

3- 56
Overview of Quality Function Deployment (QFD):

3- 57
Overview of Quality Function Deployment (QFD):

3- 58
Overview of Quality Function Deployment (QFD):

3- 59
Overview of Quality Function Deployment (QFD):

3- 60
Overview of Quality Function Deployment (QFD):

3- 61
Setting the Final Specifications:

3- 62
Setting the Final Specifications:
Technical models of the product

3- 63
Setting the Final Specifications:
Cost model of the product

3- 64
Setting the Final Specifications:

3- 65
 Setting the Final Specifications:
Refining the specifications – Competitive map

3- 66