MANUFACTURING PROCESS

(VALUE CHAIN)
MediGold Surgical

Date Rev Prepared By Approved By

18-12-2023 00 Mr. Anjum Sarwar

18-12-2023 00

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1.0 Manufacturing Process (Value Chain)
In order to develop detailed understanding of the issues and problems faced by a particular industry, it is of
prime importance that an in depth analysis of the value chain is carried out. During the process of
manufacturing, value is being added at each stage of the manufacturing process, from the first stage of raw
material to the final stage of finished product, a product undergoes a series of processes until it attains its
final shape.

1.1 The Materials Used in Manufacturing

Raw material is of utmost importance in the production of surgical instruments and forms the first fob of the
value chain. The identification and sourcing of the proper raw material is very important. We select the one
which meets the requirements the instrument has to fulfill: cutting, clamping, retracting, etc. The basic raw
material used is stainless steel. Some other metallic alloys of brass, copper, titanium, grinding and polishing
chemicals and wheels and abrasives are also used but in very small proportion as compared to stainless
steel.

1.1.1 Surgical stainless steel

We are using AISI 400 and AISI 300 series of stainless steel. Kindly see related section for complete detail.

1.1.2 Tungsten Carbide

Tungsten carbide (TC), an alloy of tungsten and carbon, is used in the manufacture of such instruments as
needle holders, scissors, pin cutters, pliers and wire tighteners. Since the TC is harder than the steel used in
needles, pins and wires, it results in instruments with exceptional durability. Usually the TC is soldered or
welded to the jaws or working ends of instruments. TC inserts that are soldered can be separated from the
instrument and replaced when they become worn. TC that is welded to the stainless steel cannot be
separated, and therefore is not replaceable.

1.1.3 Aluminum
Certain instrument parts and cases are manufactured from aluminum, which is lightweight. Aluminum is
treated with an electrochemical process called anodization. This process forms an oxide layer on the surface
of the aluminum. The oxide layer can be colored with pigments and offers good corrosion resistance. Certain
cleaners, disinfectant solutions and abrasive brushes can damage the protective layer.

1.1.4 Plastics
We are also using a range of plastics in the manufacture of handles, gripping area, connected areas and other
parts according to customer requirements. They are specially formulated to withstand normal sterilizing
temperatures. We are using ABS mostly but sometimes PP, PC and other food grade plastics can also be used
after their validation regarding biocompatibility. But it depends upon the application, intended use and
criticality of the use of that particular area of the instrument.

1.1.5 Titanium
Titanium is becoming more widely used, particularly in the manufacture of implantation devices used to
repair fractures, e.g., plates and screws.
Titanium is an appealing choice for implants because of its proven biocompatibility. The high cost of using
titanium for instrument manufacture is often prohibitive. It is therefore primarily used in the manufacture
of microsurgical instruments, where its light weight is an important factor in avoiding surgeon fatigue. We
do not currently have any titanium instruments listed in our Sourcebooks, but they are available on a
custom-order basis.

1.1.6 Chrome Plating

Chrome plating may be applied to brass or non stainless, so-called carbon steel. While used widely in the
past, chrome-plated instruments have been made all but obsolete by stainless steel. In our product line,
many chrome instruments have been replaced by stainless steel, because of the tendency of the chrome
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layer to chip. Once chipped, the carbon layer beneath is exposed, which can contaminate fine stainless
steel instrumentation. In the long run, stainless steel is the most economical choice. Among other things,
stainless steel can be re-sharpened; chrome instruments cannot. This covers the materials used most
frequently in the manufacture of surgical instruments. Some instruments may contain other substances;
that information may be found under the product description in our Sourcebooks. If we do not mention a
specific material in our Sourcebooks, then the instrument is made from stainless steel.

1.2 First Production

Once the raw material is available and the tools are completed, first production can begin. Depending on
the instrument, the production process may require as many as 80 different steps.
1.3 Incoming Inspection
The first production receives special scrutiny from our QA department. A Device History Record (DHR)
and a Device Master Record (DMR) is established, which will then contain all information about the
product during its lifetime.
Once everything is in order, the QA department releases the product for sale.

1.4 Market Release and Follow-up

As the product goes out to a much larger user base, it is not unusual to make further refinements and
improvements on the product. All of our products, new and old are monitored to make sure they are
functioning as expected, and we commonly make adjustments to even our long established instruments.
This seven-step process may be abbreviated if prior raw material, tooling or product samples already
exist. However, under no circumstances, do we skip any of the steps involved in assuring our quality. It is
this process which allows us to proudly offer a lifetime guarantee for our every Certified Instrument.

1.5 The Manufacturing of Instruments

1.5.1 The People

Even with all the advances in technology, the craftsmen who make instruments play a truly decisive role.
They undergo many years of rigorous training before they are proficient in their trade. An apprentice
system, supervised by master craftsmen who are both experts in the field and skilled teachers, ensures a
steady influx of new instrument makers.
This system also has Quality Assurance team. They work very closely with our suppliers to ensure that the
quality we demand is built into the product from the start.

1.5.2 The Tools of the Trade

Since there are thousands of different instruments, the processes naturally vary. While a typical
instrument undergoes approximately 80 steps before completion, we will concentrate on the major steps.

1.5.3 Specifications
With every production order we place, we specify our requirements on the purchase order form,
specification sheets, drawings, and in some cases, we supply samples.

1.5.4 Die Making

The importance of any process of manufacturing cannot be under estimated, but some processes are of
crucial importance as the successful completion of other processes depends upon the accuracy and
precision through which the process is conducted. In surgical instruments manufacturing die making is
considered to be the critical stage.
Different dies are required at various stages of production, such as blanking dies forging dies, cold
stamping dies, etc. The basic raw material required for these dies is die steel, which is normally imported
at very high costs. The local industry in order to cut costs uses some substitutes of die steel, this includes
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steel from different sources, which can serve the purpose and bear the rigor of the processes in which dies
are used. For this purpose die manufacturers use Gola, local name given to rail track and also axle steel,
obtained from used axles of heavy vehicles, steels from some other sources is also used in the process.
Dies can either be made on machines or manually, usually the dies for items which are in great demand
are made mechanically. Machines
Used in the process are:
_ Hacksaw
_ Copy Milling Machine
_ Spark Erosion Machines
_ CNC Wire Cutting Machines
_ Heat-treatment equipment
_ Surface Grinding Machine

Almost all the firms falling in the high sales segment have in-house facility to develop dies. Copy milling
and spark erosion machines are also commonly used by this segment but CNC wire cutting and latest heat-
treatment equipment is only available to 3 or 4 units in the entire industry. The smaller units out-source
the process of die making. Some of the dies are still manually manufactured, this depends on two things.
Firstly, if the order is of small quantity it is not viable to get a die made on machines and secondly, if the
length of the instrument, for which the die is to made, is greater than the bed of the machines and
equipment available. The problem with the manually produced die is that it lacks accuracy, which causes a
great deal of wastage of raw material during the production process.

1.5.5 Steel Shearing and Blank Cutting/Forging

Every instrument starts out as a blank, or forging. Forging is the process of shaping malleable metals by
means of hammers and presses. During this process the blanks are heated and while red-hot, the blanks
are placed in a die and struck with a hammer, as a result the blank acquire the shape of the die. In the first
step after sorting of the material the steel sheets are cut into strips of a definite size. These strips of
Stainless steel is then cut into forging blanks with cutting dies depending on the dimensions of a particular
instrument. Equipment used in the process is:
_ Shearing Machine (Strip Cutting)
_ Eccentric Press (Forging Blanks)
There are generally two types: “hot forged” and “cold forged.” The majority of our instruments are hot
forged. Using very expensive, high-precision tools, pieces of pre-cut stainless steel bar stock are heated to
very high temperatures and literally shaped under the weight of a giant drop forge weighing many tons.
The quality of the forgings is critical, as errors or poor quality cannot be corrected later in the process.
Therefore, we are very careful in selecting our forgings.
Cold-forged blanks are made out of sheet metal or bar stock. Instead of being shaped under heat, they are
shaped using the force of heavy hammers. Still other blanks are made using laser cutters or milling
machines, which cut out or mill the desired shape.

1.5.6 Annealing
During the forging process the metal due to high temperature exposure and rapid cooling becomes hard and
brittle. To relieve the stresses from the forged instrument, the instrument is annealed by maintaining the forgings
at a known temperature to homogenize metastable condition and to soften the metal.
To properly anneal stainless steel, it has to be heated to 1050 °C and then allowed to cool down slowly. To
achieve the desired level of hardness electronically heated, environment controlled pit type furnaces are used.
To obtain homogenous annealing, throughout the surface of the instrument, bell type vacuum furnaces are used.
Another method and the most advanced method of achieving accuracy in the annealing process is the ‘Solution
Annealing’, which leaves the metal uniformly annealed, having the same hardness throughout the instrument
body.

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1.5.7 Trimming
In order to remove scale from the metal surface and debar the metal forgings from ‘flash’ on the sides of
the instruments formed during the forging process. Trimming of flash is done firstly using a trimming die
on the eccentric press and then the scale is removed using a Shot Blasting Machine.
1.5.8 Machining
Machining is required to make flat/grooved surfaces, or to make ratchets, serrations and joints in the
instruments. Once the instrument maker has verified the quality of the blanks to be used, the next process
is milling and/or turning. In the case of forceps, this process is used to create the basic shape of the box
lock, jaws and ratchets. Most of the instruments manufactured by the surgical industry consist of pairs.
The surfaces of the instruments, where the two pieces are joined together, need to be smooth and highly
precise so as to perform effectively and efficiently. The equipment also plays a crucial role in the
machining process.
1.5.9 Assembly
On a two-part instrument there is a male and a female part, which depending on the type of hinge used, is
then assembled. A typical forceps has a box lock, which is created by widening the female part under heat
and inserting the male part. They are then secured with a pin. Upon close inspection you can see the pin in
a finished instrument.
1.5.10 Filing and Grinding
The shape of the metal is still quite rough at this point, so it is necessary to file and grind the instrument
into its final shape. After going through all the above mentioned processes the instrument is filed to
remove any scale on the surface and to smooth out rough surfaces. This is a process done entirely by hand
and takes great skill. So this is a highly labor intensive process. Only hand files are used to carry out the
process. It requires a high degree of skill. The initial fitting and setting of the instrument is also conducted
manually at this stage. Instruments requiring cutting edges are also sharpened with the help of grinding
machines during the processes of filing and fitting.
1.5.11 Heat Treatment
Instruments requiring it undergo a process called heat treatment, tempering or hardening. This is
necessary to make the instruments hard enough to withstand the rigors of their usage. The process differs
somewhat according to the stainless steel chosen, but in all cases the stainless steel is brought to a very
high temperature and then cooled until it has reached the proper hardness. Achieving the right hardness is
extremely important. If the steel is too soft, it will wear out or bend prematurely; if the steel is too hard, it
will be brittle and break too easily.
In order to perform good quality machining the surgical instruments are annealed. The process of
annealing softens the instruments. To retain a peculiar shape, the instrument has to be hardened again.
The instruments requiring spring effect in their functionality prepared by using AISI 410 grade of stainless
steel which, require comparatively a lesser degree of hardness. Cutting instruments manufactured from
AISI 420 stainless steel require a greater degree of hardness. Heat treatment is also a very critical process
and if performed accurately a costly one too. Usually in the developing countries, the surgical industry
employs three different methods to perform heat treatment: _ Oil Quenching Method
_ Conveyor Belt Heat Treatment Furnace
_ Vacuum Heat Treatment
The oil quenching method is a standard technique for heat treating surgical instruments.
In this method the instrument is heated in a furnace and then quenched in oil. The drawbacks of this
method are that a scale appears on the surface on the surface of instruments due to oxidation which,
translates into additional costs. Another disadvantage of the method is that the furnaces used by the
industry are not temperature controlled so the desired level of hardness cannot be achieved.

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Another method for heat treating the instrument is using the conveyor belt system. The conveyor belt
furnace is tunnel shaped, the instruments are placed on the belt and they are heat treated according to
the requirement of the material. The advantage of using this system is that the desired temperature can
be achieved. But due to high costs the conveyor belt system is also very uncommon in the industry.
The most advanced technique used for heat treating the instruments is the vacuum heat treatment. In
this method the instruments are placed in vacuum furnace and heated at the desired temperature. After
heating the instruments are quenched in liquid nitrogen. In order to relieve the instruments of stresses
during the heat treatment and to remove the structural changes the instruments are also tempered using
a vacuum furnace. Vacuum heat treatment furnace is the single most expensive equipment used in the
surgical industry.
The proper hardness is measured in units called Rockwell Hardness (HRC). A typical hardness range for a
needle holder without tungsten carbide inserts is HRC 40–48. For scissors, the hardness ranges between
HRC 48–56. See below table for generic values

1.5.12 Electro polishing

In addition to hand polishing, the instruments now undergo electro polishing. This process chemically
removes foreign substances and makes the surface even more corrosion resistant, creating a thin layer
which acts as a protective film, known as passive or Passivation layers. If properly cared for during use,
these passive layers actually improve over time, ensuring the longevity of the instruments. Almost all the
instruments after being heat-treated are electro polished using electro polishing equipment. Certain parts
and sections of the instrument such as ratchets, serrations, etc. could not be properly polished and
finished by the conventional polishing techniques so the instruments undergo this process. It restores the
luster on the surface of the instrument. Some of the instruments after finishing are also electro-plated with
gold and other metals as per requirement.

1.5.13 Fitting
After the heat treatment, the craftsmen proceed to fine-tune the shape and mechanism of the
instrument. All unwanted sharp edges, burrs, etc. are removed so they will not inadvertently puncture

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the gloves of healthcare personnel. Scissors and other cutting instruments are sharpened and
adjusted. It is at this point that skilled workers transform the piece of steel into the finely honed
instrument surgeons rely on. This work is done entirely by hand.

1.5.14 Polishing Finishing

At this stage in manufacture the craftsmen proceed to the hand-polishing phase, which not only creates
the aesthetic look of a well-made instrument, but even more important creates a homogeneous surface,
a key element in rendering the instrument more corrosion resistant. Finishing of the surgical
instruments is done by using a number of different finishing wheels, leather belts and brushes. In the
first phase rough finish is done by leather grinding wheels. Grinding belts are used to perform finishing
job on the inner sides of rings of instruments like forceps and scissors. Wire brush wheels are used for
finishing knurled components of the instruments. Final finishing is done with the help of buffing and
satin finish wheels. Different types of chemical such as pink luster, white luster, emery, etc. is used in
the process. Some of the instruments are also sand blasted to give a dull finish to the instrument. The
job of sand blasting is done by using sand blasting machine which fires very fine sand particles on the
instrument leaving the instrument with a dull finish. Almost our all instruments receive a silk matte or
satin finish that reduces glare in the operating room. Great skill and experience are required to develop
a good feel for the work, removing just enough surface irregularities while staying within the
prescribed dimension limits.

1.5.15 Final Inspection

While quality is a concern at all points of the manufacturing and crafting process, it is at this stage that
we demand a final inspection which checks the functionality, critical dimensions and surface
conditions of the instrument. This inspection is performed when the instruments are shipped.

1.5.16 Testing and Cleaning

Before the instruments are finally packed they are tested so as to ensure the quality of instruments
against corrosion etc. For this purpose first of all a boil test is performed as per sample base in which
the instruments are boiled in a metal water container and afterwards are checked for rusting and
other deposits on the surface, if any. The other procedure performed at this stage is the ultrasonic
Cleaning. During this process the instruments are placed in an ultrasonic cleaner with
Trichloroethylene commonly known as Triclone N solution. The ultrasonic cleaner vibrates at a high
rate and the temperature of the sump is kept around 90°C. This process makes the instruments free of
any deposits and dust particles and, also to some extent sterile, from such part where ordinary method
of cleaning cannot help. For Non-Sterile products, disinfection with ethanol is also performed.

1.5.17 Labeling and Packaging

This is the final stage of the production process. The instruments are etched with the required labels
and markings with the help of electronic etching machines and stencils. Each reusable instrument is
finally packed in separate poly bags.

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1.5.18 Process Flow chart (General)

The above mentioned process flow can be summarized in chart as:

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