ASSIGNMENT

STUDY OF
MEDICAL DEVICES (PROSTHETICS)
WITH
CURRENT MARKET SCENARIO

SUBMITTED
TO
SIES COLLEGE OF MANAGEMENT STUDIES

BY
NAME- ABDHINI BISWAS
PGDM PHARMA 2016-2018
ROLL- 01
Prosthesis
In medicine, a prosthesis (plural: prostheses; from Ancient Greek prosthesis, "addition, application,
attachment is an artificial device that replaces a missing body part, which may be lost through trauma,
disease, or congenital conditions. Prosthetics are intended to restore the normal functions of the missing
body part. Prosthetic amputee rehabilitation is primarily coordinated by a prosthetist and an inter-
disciplinary team of health care professionals including psychiatrists, surgeons, physical therapists, and
occupational therapists. Prosthetics are commonly created with CAD (Computer-Aided Design), a software
interface that helps creators visualize the creation in a 3D form. But they can also be designed by hand.

Types
A person's prosthesis should be designed and assembled according to the patient's appearance and
functional needs. For instance, a patient may need a transradial prosthesis, but need to choose between an
aesthetic functional device, a myoelectric device, a body-powered device, or an activity specific device. The
patient's future goals and economical capabilities may help them choose between one or more devices.
Craniofacial prostheses include intra-oral and extra-oral prostheses. Extra-oral prostheses are further divided
into hemifacial, auricular (ear), nasal, orbital and ocular. Intra-oral prostheses include dental prostheses such
as dentures, obturators, and dental implants.
Prostheses of the neck include larynx substitutes, trachea and upper esophageal replacements,
Somato prostheses of the torso include breast prostheses which may be either single or bilateral, full breast
devices or nipple prostheses.
A penile prosthesis is used to treat erectile dysfunction.

Limb prostheses
Limb prostheses include both upper- and lower-extremity prostheses.

Upper-extremity prostheses are used at varying levels of amputation: forequarter,

shoulder disarticulation, transhumeral prosthesis, elbow disarticulation, transradial prosthesis, wrist
disarticulation, full hand, partial hand, finger, partial finger. A transradial prosthesis is an artificial limb that
replaces an arm missing below the elbow.
Upper limb prostheses can be categorized in three main categories: Passive devices, Body Powered devices,
Externally Powered (myoelectric) devices. Passive devices can either be passive hands, mainly used for
cosmetic purpose, or passive tools, mainly used for specific activities (e.g. leisure or vocational). An extensive
overview and classification of passive devices can be found in a literature review by Maat et.al. A passive
device can be static, meaning the device has no movable parts, or it can be adjustable, meaning its
configuration can be adjusted (e.g. adjustable hand opening). Despite the absence of active grasping, passive
devices are very useful in bimanual tasks that require fixation or support of an object, or for gesticulation in
social interaction. According to scientific data a third of the upper limb amputees worldwide use a passive
prosthetic hand.Body Powered or cable operated limbs work by attaching a harness and cable around the
opposite shoulder of the damaged arm. The third category of prosthetic devices available
are myoelectric arms. These work by sensing, via electrodes, when the muscles in the upper arm move,
causing an artificial hand to open or close. In the prosthetics industry, a trans-radial prosthetic arm is often
referred to as a "BE" or below elbow prosthesis.

Lower-extremity prostheses provide replacements at varying levels of amputation. These

include hip disarticulation, transfemoral prosthesis, knee disarticulation, transtibial prosthesis, Syme's
amputation, foot, partial foot, and toe. The two main subcategories of lower extremity prosthetic devices
are trans-tibial (any amputation transecting the tibia bone or a congenital anomaly resulting in a tibial
deficiency) and trans-femoral (any amputation transecting the femur bone or a congenital anomaly resulting
in a femoral deficiency).
A transfemoral prosthesis is an artificial limb that replaces a leg missing above the knee. Transfemoral
amputees can have a very difficult time regaining normal movement. In general, a transfemoral amputee
must use approximately 80% more energy to walk than a person with two whole legs.This is due to the
complexities in movement associated with the knee. In newer and more improved designs, hydraulics,
carbon fiber, mechanical linkages, motors, computer microprocessors, and innovative combinations of these
technologies are employed to give more control to the user. In the prosthetics industry a trans-femoral
prosthetic leg is often referred to as an "AK" or above the knee prosthesis.
A transtibial prosthesis is an artificial limb that replaces a leg missing below the knee. A transtibial amputee
is usually able to regain normal movement more readily than someone with a transfemoral amputation, due
in large part to retaining the knee, which allows for easier movement. Lower extremity prosthetics describes
artificially replaced limbs located at the hip level or lower. In the prosthetics industry a trans-tibial prosthetic
leg is often referred to as a "BK" or below the knee prosthesis.
Wheeled prostheses have also been used extensively in the rehabilitation of injured domestic animals,
including dogs, cats, pigs, rabbits, and turtles.

Different types of Prosthetic Leg Solutions

 Advanced Prosthetic Technology
 Above-Knee Limb Loss Solutions
 Below-Knee Limb Loss Solutions
 Hip Disarticulation
 Prosthetic Feet
 Partial Foot Prosthetics
 Lower Limb/Extremity Componentry
 Bilateral Above-Knee Bootcamp

Prosthetic Raw Materials

Prosthetic should be made lightweight to have a better convenience for the amputee. some of these
materials include:

 Plastics:
 Polyethylene
 Polypropylene
 Acrylics
 Polyurethane
 Wood (early prosthetics)
 Rubber (early prosthetics)
 Lightweight Metals:
 Titanium
 Aluminum
 Carbon Fibre

Patient procedure
A prosthesis is a functional replacement for an amputated or congenitally malformed or missing limb.
Prosthetists are responsible for the prescription, design and management of a prosthetic device.
In most cases, the prosthetist begins by taking a plaster cast of the patient’s affected limb. Lightweight, high-
strength thermoplastics are custom-formed to this model of the patient. Cutting-edge materials such as
carbon fiber, titanium and Kevlar provide strength and durability while making the new prosthesis lighter.
More sophisticated prostheses are equipped with advanced electronics, providing additional stability and
control.

Current technology and manufacturing

Over the years, there have been advancements in artificial limbs. New plastics and other materials, such
as carbon fiber, have allowed artificial limbs to be stronger and lighter, limiting the amount of extra energy
necessary to operate the limb. This is especially important for trans-femoral amputees. Additional materials
have allowed artificial limbs to look much more realistic, which is important to trans-radial and transhumeral
amputees because they are more likely to have the artificial limb exposed.

Manufacturing a prosthetic finger

In addition to new materials, the use of electronics has become very common in artificial limbs. Myoelectric
limbs, which control the limbs by converting muscle movements to electrical signals, have become much
more common than cable operated limbs. Myoelectric signals are picked up by electrodes, the signal gets
integrated and once it exceeds a certain threshold, the prosthetic limb control signal is triggered which is
why inherently, all myoelectric controls lag. Conversely, cable control is immediate and physical, and through
that offers a certain degree of direct force feedback that myoelectric control does not. Computers are also
used extensively in the manufacturing of limbs. Computer Aided Design and Computer Aided
Manufacturing are often used to assist in the design and manufacture of artificial limbs.
Most modern artificial limbs are attached to the stump of the amputee by belts and cuffs or by suction. The
stump either directly fits into a socket on the prosthetic, or—more commonly today—a liner is used that
then is fixed to the socket either by vacuum (suction sockets) or a pin lock. Liners are soft and by that, they
can create a far better suction fit than hard sockets. Silicone liners can be obtained in standard sizes, mostly
with a circular (round) cross section, but for any other stump shape, custom liners can be made. The socket
is custom made to fit the residual limb and to distribute the forces of the artificial limb across the area of the
stump (rather than just one small spot), which helps reduce wear on the stump. The custom socket is
created by taking a plaster cast of the stump or, more commonly today, of the liner worn over the stump,
and then making a mold from the plaster cast. Newer methods include laser guided measuring which can be
input directly to a computer allowing for a more sophisticated design.
One problem with the stump and socket attachment is that a bad fit will reduce the area of contact between
the stump and socket or liner, and increase pockets between stump skin and socket or liner. Pressure then is
higher, which can be painful. Air pockets can allow sweat to accumulate that can soften the skin. Ultimately,
this is a frequent cause for itchy skin rashes. Over time, this can lead to breakdown of the skin.
Artificial limbs are typically manufactured using the following steps:

1. Measurement of the stump

2. Measurement of the body to determine the size required for the artificial limb
3. Fitting of a silicone liner
4. Creation of a model of the liner worn over the stump
5. Formation of thermoplastic sheet around the model – This is then used to test the fit of the
prosthetic
6. Formation of permanent socket
7. Formation of plastic parts of the artificial limb – Different methods are used, including vacuum
forming and injection molding
8. Creation of metal parts of the artificial limb using die casting
9. Assembly of entire limb

Body-powered arms
Current technology allows body powered arms to weigh around one-half to one-third of what a myoelectric
arm does.

Sockets
Current body-powered arms contain sockets that are built from hard epoxy or carbon fiber. These sockets or
"interfaces" can be made more comfortable by lining them with a softer, compressible foam material that
provides padding for the bone prominences. A self suspending or supra-condylar socket design is useful for
those with short to mid range below elbow absence. Longer limbs may require the use of a locking roll-on
type inner liner or more complex harnessing to help augment suspension.

Wrists
Wrist units are either screw-on connectors featuring the UNF 1/2-20 thread (USA) or quick-release
connector, of which there are different models.

Voluntary opening and voluntary closing

Two types of body powered systems exist, voluntary opening "pull to open" and voluntary closing "pull to
close". Virtually all "split hook" prostheses operate with a voluntary opening type system.
More modern "prehensors" called GRIPS utilize voluntary closing systems. The differences are significant.
Users of voluntary opening systems rely on elastic bands or springs for gripping force, while users of
voluntary closing systems rely on their own body power and energy to create gripping force.
Voluntary closing users can generate prehension forces equivalent to the normal hand, upwards to or
exceeding one hundred pounds. Voluntary closing GRIPS require constant tension to grip, like a human hand,
and in that property they do come closer to matching human hand performance. Voluntary opening split
hook users are limited to forces their rubber or springs can generate which usually is below 20 pounds.
Feedback
An additional difference exists in the biofeedback created that allows the user to "feel" what is being held.
Voluntary opening systems once engaged provide the holding force so that they operate like a passive vice at
the end of the arm. No gripping feedback is provided once the hook has closed around the object being held.
Voluntary closing systems provide directly proportional control and biofeedback so that the user can feel
how much force that they are applying.
A recent study showed that by stimulating the median and ulnar nerves, according to the information
provided by the artificial sensors from a hand prosthesis, physiologically appropriate (near-natural) sensory
information could be provided to an amputee. This feedback enabled the participant to effectively modulate
the grasping force of the prosthesis with no visual or auditory feedback.
Researchers from École Polytechnique Fédérale De Lausanne in Switzerland and the Scuola Superiore
Sant'Anna in Italy, implanted the electrodes into the amputee's arm in February 2013. The study, published
Wednesday[ in Science Translational Medicine, details the first time sensory feedback has been restored
allowing an amputee to control an artificial limb in real-time. With wires linked to nerves in his upper arm,
the Danish patient was able to handle objects and instantly receive a sense of touch through the special
artificial hand that was created by Silvestro Micera and researchers both in Switzerland and Italy.

Terminal devices
Terminal devices contain a range of hooks, prehensors, hands or other devices.
Hooks
Voluntary opening split hook systems are simple, convenient, light, robust, versatile and relatively
affordable.
A hook does not match a normal human hand for appearance or overall versatility, but its material
tolerances can exceed and surpass the normal human hand for mechanical stress (one can even use a hook
to slice open boxes or as a hammer whereas the same is not possible with a normal hand), for thermal
stability (one can use a hook to grip items from boiling water, to turn meat on a grill, to hold a match until it
has burned down completely) and for chemical hazards (as a metal hook withstands acids or lye, and does
not react to solvents like a prosthetic glove or human skin).

Hands

Prosthetic hands are available in both voluntary opening and voluntary closing versions and because of their
more complex mechanics and cosmetic glove covering require a relatively large activation force, which,
depending on the type of harness used, may be uncomfortable.A recent study by the Delft University of
Technology, The Netherlands, showed that the development of mechanical prosthetic hands has been
neglected during the past decades. The study showed that the pinch force level of most current mechanical
hands is too low for practical use. The best tested hand was a prosthetic hand developed around 1945. In
2017 however, a research has been started with bionic hands by Laura Hruby of the Medical University of
Vienna.Some companies are also producing robotic hands with integrated forearm, for fitting unto a
patient's upper arm.
Commercial providers and materials
Hosmer and Otto Bock are major commercial hook providers. Mechanical hands are sold by Hosmer and
Otto Bock as well; the Becker Hand is still manufactured by the Becker family. Prosthetic hands may be fitted
with standard stock or custom-made cosmetic looking silicone gloves. But regular work gloves may be worn
as well. Other terminal devices include the V2P Prehensor, a versatile robust gripper that allows customers
to modify aspects of it, Texas Assist Devices (with a whole assortment of tools) and TRS that offers a range of
terminal devices for sports. Cable harnesses can be built using aircraft steel cables, ball hinges and self
lubricating cable sheaths. Some prosthetics have been designed specifically for use in salt water.[40]
Lower-extremity prosthetics

A prosthetic leg worn

Lower-extremity prosthetics describes artificially replaced limbs located at the hip level or lower. Concerning
all ages Ephraim et al. (2003) found a worldwide estimate of all-cause lower-extremity amputations of 2.0–
5.9 per 10,000 inhabitants. For birth prevalence rates of congenital limb deficiency they found an estimate
between 3.5–7.1 cases per 10,000 births.
The two main subcategories of lower extremity prosthetic devices are trans-tibial (any amputation
transecting the tibia bone or a congenital anomaly resulting in a tibial deficiency), and trans-femoral (any
amputation transecting the femur bone or a congenital anomaly resulting in a femoral deficiency). In the
prosthetic industry a trans-tibial prosthetic leg is often referred to as a "BK" or below the knee prosthesis
while the trans-femoral prosthetic leg is often referred to as an "AK" or above the knee prosthesis.
Other, less prevalent lower extremity cases include the following:

1. Hip disarticulations – This usually refers to when an amputee or congenitally challenged patient has
either an amputation or anomaly at or in close proximity to the hip joint.
2. Knee disarticulations – This usually refers to an amputation through the knee disarticulating the
femur from the tibia.
3. Symes – This is an ankle disarticulation while preserving the heel pad.
Socket
The socket serves as an interface between the residuum and the prosthesis, ideally allowing comfortable
weight-bearing, movement control and proprioception.[42] Socket issues, such as discomfort and skin
breakdown, are rated among the most important issues faced by lower-limb amputees.

Shank and connectors

This part creates distance and support between the knee-joint and the foot (in case of upper-leg prosthesis)
or between the socket and the foot. The type of connectors that are used between the shank and the
knee/foot determines whether the prosthesis is modular or not. Modular means that the angle and the
displacement of the foot in respect to the socket can be changed after fitting. In developing countries
prosthesis mostly are non-modular, in order to reduce cost. When considering children modularity of angle
and height is important because of their average growth of 1.9 cm annually.

Foot
Providing contact to the ground, the foot provides shock absorption and stability during stance.] Additionally
it influences gait biomechanics by its shape and stiffness. This is because the trajectory of the center of
pressure (COP) and the angle of the ground reaction forces is determined by the shape and stiffness of the
foot and needs to match the subject's build in order to produce a normal gait pattern. Andrysek (2010) found
16 different types of feet, with greatly varying results concerning durability and biomechanics. The main
problem found in current feet is durability, endurance ranging from 16–32 months These results are for
adults and will probably be worse for children due to higher activity levels and scale effects.

Knee joint
In case of a trans-femoral amputation there also is a need for a complex connector providing articulation,
allowing flexion during swing-phase but not during stance.
Microprocessor control
To mimic the knee's functionality during gait, microprocessor-controlled knee joints have been developed
that control the flexion of the knee. Some examples are Otto Bock’s C-leg, introduced in 1997, Ossur's Rheo
Knee, released in 2005, the Power Knee by Ossur, introduced in 2006, the Plié Knee from Freedom
Innovations and DAW Industries’ Self Learning Knee (SLK).
The idea was originally developed by Kelly James, a Canadian engineer, at the University of Alberta.
A microprocessor is used to interpret and analyse signals from knee-angle sensors and moment sensors. The
microprocessor receives signals from its sensors to determine the type of motion being employed by the
amputee. Most microprocessor controlled knee-joints are powered by a battery housed inside the
prosthesis.
The sensory signals computed by the microprocessor are used to control the resistance generated
by hydraulic cylinders in the knee-joint. Small valves control the amount of hydraulic fluid that can pass into
and out of the cylinder, thus regulating the extension and compression of a piston connected to the upper
section of the knee.
The main advantage of a microprocessor-controlled prosthesis is closer approximation to an amputee’s
natural gait. Some allow amputees to walk near walking speed or run. Variations in speed are also possible
and are taken into account by sensors and communicated to the microprocessor, which adjusts to these
changes accordingly. It also enables the amputees to walk down stairs with a step-over-step approach,
rather than the one step at a time approach used with mechanical knees. However, some have some
significant drawbacks that impair its use. They can be susceptible to water damage and thus great care must
be taken to ensure that the prosthesis remains dry.

Myoelectric
A myoelectric prosthesis uses the electrical tension generated every time a muscle contracts, as
information. This tension can be captured from voluntarily contracted muscles by electrodes applied on the
skin to control the movements of the prosthesis, such as elbow flexion/extension, wrist
supination/pronation (rotation) or opening/closing of the fingers. A prosthesis of this type utilizes the
residual neuromuscular system of the human body to control the functions of an electric powered prosthetic
hand, wrist, elbow or foot. This is different from an electric switch prosthesis, which requires straps and/or
cables actuated by body movements to actuate or operate switches that control the movements of the
prosthesis.
The USSR was the first to develop a myoelectric arm in 1958, while the first myoelectric arm became
commercial in 1964 by the Central Prosthetic Research Institute of the USSR, and distributed by the Hangar
Limb Factory of the UK.
Researchers at the Rehabilitation Institute of Chicago announced in September 2013 that they have
developed a robotic leg that translates neural impulses from the user's thigh muscles into movement, which
is the first prosthetic leg to do so. It is currently in testing.[55]

Robotic prostheses
Robots can be used to generate objective measures of patient's impairment and therapy outcome, assist in
diagnosis, customize therapies based on patient's motor abilities, and assure compliance with treatment
regimens and maintain patient's records. It is shown in many studies that there is a significant improvement
in upper limb motor function after stroke using robotics for upper limb rehabilitation.[56] In order for a
robotic prosthetic limb to work, it must have several components to integrate it into the body's
function: Biosensorsdetect signals from the user's nervous or muscular systems. It then relays this
information to a controller located inside the device, and processes feedback from the limb and actuator
(e.g., position, force) and sends it to the controller. Examples include surface electrodes that detect electrical
activity on the skin, needle electrodes implanted in muscle, or solid-state electrode arrays with nerves
growing through them. One type of these biosensors are employed in myoelectric prostheses.
A device known as the controller is connected to the user's nerve and muscular systems and the device itself.
It sends intention commands from the user to the actuators of the device, and interprets feedback from the
mechanical and biosensors to the user. The controller is also responsible for the monitoring and control of
the movements of the device.
An actuator mimics the actions of a muscle in producing force and movement. Examples include a motor
that aids or replaces original muscle tissue.
Targeted muscle reinnervation (TMR) is a technique in which motor nerves, which previously
controlled muscles on an amputated limb, are surgically rerouted such that they reinnervate a small region
of a large, intact muscle, such as the pectoralis major. As a result, when a patient thinks about moving the
thumb of his missing hand, a small area of muscle on his chest will contract instead. By placing sensors over
the reinervated muscle, these contractions can be made to control movement of an appropriate part of the
robotic prosthesis.
A variant of this technique is called targeted sensory reinnervation (TSR). This procedure is similar to TMR,
except that sensory nerves are surgically rerouted to skin on the chest, rather than motor nerves rerouted to
muscle. Recently, robotic limbs have improved in their ability to take signals from the human brain and
translate those signals into motion in the artificial limb. DARPA, the Pentagon’s research division, is working
to make even more advancements in this area. Their desire is to create an artificial limb that ties directly into
the nervous system.
Robotic arms
Advancements in the processors used in myoelectric arms has allowed developers to make gains in fine
tuned control of the prosthetic. The Boston Digital Arm is a recent artificial limb that has taken advantage of
these more advanced processors. The arm allows movement in five axes and allows the arm to be
programmed for a more customized feel. Recently the i-Limb hand, invented in Edinburgh, Scotland,
by David Gow has become the first commercially available hand prosthesis with five individually powered
digits. The hand also possesses a manually rotatable thumb which is operated passively by the user and
allows the hand to grip in precision, power and key grip modes.
Another neural prosthetic is Johns Hopkins University Applied Physics Laboratory Proto 1. Besides the Proto
1, the university also finished the Proto 2 in 2010. Early in 2013, Max Ortiz Catalan and Rickard Brånemark of
the Chalmers University of Technology, and Sahlgrenska University Hospital in Sweden, succeeded in making
the first robotic arm which is mind-controlled and can be permanently attached to the body
(using osseointegration).
An approach that is very useful is called arm rotation which is common for unilateral amputees which is an
amputation that affects only one side of the body; and also essential for bilateral amputees, a person who is
missing or has had amputated either both arms or legs, to perform tasks of daily living. This involves
inserting a small permanent magnet into the distal end of the residual bone of subjects with upper limb
amputations. When a subject rotates the residual arm, the magnet will rotate with the residual bone,
causing a change in magnetic field distribution. EEG signals which is electroencephalogram, a test that
detects electrical activity in the brain using small flat metal discs attached to the scalp, essentially decoding
human brain activity used for physical movement, are used to control the robotic limbs. This is very essential
being that it provides a more lively effect to the robotic limb, giving oneself control over the part as if it was
their own.

Robotic legs
Prosthesis design
The main goal of a robotic prosthesis is to provide active actuation during gait to improve the biomechanics
of gait, including, among other things, stability, symmetry, or energy expenditure for amputees. There are
several powered prosthetic legs currently on the market, including fully powered legs, in which actuators
directly drive the joints, and semi-active legs, which use small amounts of energy and a small actuator to
change the mechanical properties of the leg but do not inject net positive energy into gait. Specific examples
include The emPOWER from BionX, the Proprio Foot from Ossur, and the Elan Foot from Endolite. Various
research groups have also experimented with robotic legs over the last decade.Central issues being
researched include designing the behavior of the device during stance and swing phases, recognizing the
current ambulation task, and various mechanical design problems such as robustness, weight, battery-
life/efficiency, and noise-level.

Attachment to the body

Most prostheses can be attached to the exterior of the body, in a non-permanent way. Some others however
can be attached in a permanent way. One such example are exoprostheses (see below).
Direct bone attachment and osseointegration
Main article: Osseointegration

Osseointegration is a method of attaching the artificial limb to the body. This method is also sometimes
referred to as exoprosthesis (attaching an artificial limb to the bone), or endo-exoprosthesis.
The stump and socket method can cause significant pain in the amputee, which is why the direct bone
attachment has been explored extensively. The method works by inserting a titanium bolt into the bone at
the end of the stump. After several months the bone attaches itself to the titanium bolt and an abutment is
attached to the titanium bolt. The abutment extends out of the stump and the (removable) artificial limb is
then attached to the abutment. Some of the benefits of this method include the following:

 Better muscle control of the prosthetic.

 The ability to wear the prosthetic for an extended period of time; with the stump and socket method
this is not possible.
 The ability for transfemoral amputees to drive a car.
The main disadvantage of this method is that amputees with the direct bone attachment cannot have large
impacts on the limb, such as those experienced during jogging, because of the potential for the bone to
break.

Cosmesis
Cosmetic prosthesis has long been used to disguise injuries and disfigurements. With advances in modern
technology, cosmesis, the creation of lifelike limbs made from silicone or PVC has been made possible. Such
prosthetics, including artificial hands, can now be designed to simulate the appearance of real hands,
complete with freckles, veins, hair, fingerprints and even tattoos. Custom-made cosmeses are generally
more expensive (costing thousands of U.S. dollars, depending on the level of detail), while standard
cosmeses come premade in a variety of sizes, although they are often not as realistic as their custom-made
counterparts. Another option is the custom-made silicone cover, which can be made to match a person's
skin tone but not details such as freckles or wrinkles. Cosmeses are attached to the body in any number of
ways, using an adhesive, suction, form-fitting, stretchable skin, or a skin sleeve.

Cognition
Unlike neuromotor prostheses, neurocognitive prostheses would sense or modulate neural function in order
to physically reconstitute or augment cognitive processes such as executive function, attention, language,
and memory. No neurocognitive prostheses are currently available but the development of implantable
neurocognitive brain-computer interfaces has been proposed to help treat conditions such
as stroke, traumatic brain injury, cerebral palsy, autism, and Alzheimer's disease. The recent field of Assistive
Technology for Cognition concerns the development of technologies to augment human cognition.
Scheduling devices such as Neuropage remind users with memory impairments when to perform certain
activities, such as visiting the doctor. Micro-prompting devices such as PEAT, AbleLink and Guide have been
used to aid users with memory and executive function problems perform activities of daily living.

Prosthetic enhancement
In addition to the standard artificial limb for everyday use, many amputees or congenital patients have
special limbs and devices to aid in the participation of sports and recreational activities.
Within science fiction, and, more recently, within the scientific community, there has been consideration
given to using advanced prostheses to replace healthy body parts with artificial mechanisms and systems to
improve function. The morality and desirability of such technologies are being debated by transhumanists,
other ethicists, and others in general. Body parts such as legs, arms, hands, feet, and others can be replaced.
The first experiment with a healthy individual appears to have been that by the British scientist Kevin
Warwick. In 2002, an implant was interfaced directly into Warwick's nervous system. The electrode array,
which contained around a hundred electrodes, was placed in the median nerve. The signals produced were
detailed enough that a robot arm was able to mimic the actions of Warwick's own arm and provide a form of
touch feedback again via the implant.
The DEKA company of Dean Kamen developed the "Luke arm", an advanced nerve-controlled prosthetic.
Clinical trials began in 2008, with FDA approval in 2014 and commercial manufacturing by Universal
Instruments Corporation expected in 2017. The price offered at retail by Mobius Bionics is expected to be
around $100,000.
Oscar Pistorius
In early 2008, Oscar Pistorius, the "Blade Runner" of South Africa, was briefly ruled ineligible to compete in
the 2008 Summer Olympicsbecause his transtibial prosthesis limbs were said to give him an unfair advantage
over runners who had ankles. One researcher found that his limbs used twenty-five percent less energy than
those of an able-bodied runner moving at the same speed. This ruling was overturned on appeal, with the
appellate court stating that the overall set of advantages and disadvantages of Pistorius' limbs had not been
considered.
Pistorius did not qualify for the South African team for the Olympics, but went on to sweep the 2008
Summer Paralympics, and has been ruled eligible to qualify for any future Olympics.[citation needed] He qualified
for the 2011 World Championship in South Korea and reached the semifinal where he ended last timewise,
he was 14th in the first round, his personal best at 400m would have given him 5th place in the finals. At
the 2012 Summer Olympics in London, Pistorius became the first amputee runner to compete at an Olympic
Games.[78] He ran in the 400 metres race semifinals,[79][80][81] and the 4 × 400 metres relay race finals.[82] He
also competed in 5 events in the 2012 Summer Paralympics in London.

Industry Insights
The global robotic prosthetics market size was estimated at USD 790.8 million in 2016. The key factors
driving this market are global increase in the number of amputation cases, technological advancements, and
initiatives taken by government organizations, such as Centers for Disease Control and nonprofit
organizations like Amputee Coalition, to facilitate funding and purchases of prosthetic devices. Moreover,
the U.S. government is also investing in technologically advanced prosthetic limbs for soldiers and veterans,
which is further anticipated to propel this market over the forecast period.
Global rise in number of amputation cases owing to various risk factors such as accidents, severe injuries,
cancerous tumors in the bone or muscles of limbs, limb infection, and frostbite. Some other causes such as
obesity, diabetes, vascular disease, stroke, and arthritis also contribute to the increasing number of
amputation cases. According to the estimates published by the Amputee Coalition, approximately 185,000
amputations are performed in the U.S each year. These estimates represent a surge in demand for these
devices, which is expected to have a positive impact on the market.
U.S. robotic prosthetics market revenue by technology, 2014 - 2025 (USD Million)
Growing usage of connectivity technologies such as Bluetooth, microprocessor controller, and myoelectric
technology has resulted in boosting the demand for such devices. For instance, RHEO KNEE and SYMBIONIC
LEG 3. Furthermore, advancements in materials science have increased the use of thermoplastics and carbon
fiber materials in manufacturing robotic amputation devices, which is improving the overall efficiency of
devices. Increased adoption of these technologically advanced products in developed regions and rising
awareness about these advancements are amongst the few factors expected to boost the market over the
forecast period.

Technology Insights
On the basis of technology, the market is segmented into Microprocessor Controlled (MPC) prosthetics and
myoelectric prosthetics. In 2016, MPC prosthetics accounted for the maximum revenue share of the market
owing to the easy availability of products that use this technology as opposed to myoelectric products.
Increasing clinical research for developing novel devices that use MPC technology is also one of the key
factors responsible for the largest revenue share held by this segment. RHEO KNEE, Plie, PROPRIO, Elan, and
Knee Joint C-Leg are some MPC devices that are commercially available.
Moreover, increasing government involvement is one of the crucial factors anticipated to increase the
demand for these devices. Government agencies such as CDC and Defense Advanced Research Projects
Agency (DARPA) are undertaking and supporting research in this field. CDC is funding Amputee Coalition
National Limb Loss Resource Center that offers resources to people with limb loss. DARPA has funded several
researches for development of limb prosthetics. In addition, Revolutionizing Prosthetics Program is one of
the programs initiated and supported by DARPA.
However, myoelectric prosthetics segment is expected to grow at a lucrative rate of approximately 10.3%
over the forecast period. Some of the key factors that can be attributed for its growth include the
advantages associated with myoelectric prosthetics such as freedom of mobility and use of electro signals for
limb movement. Furthermore, increasing number of R&D initiatives undertaken by key players and growing
number of new product launches are factors expected to boost the market over the forecast period.

Extremity Insights
Lower body extremity and upper body extremity are two segments analyzed in our research scope. In 2016,
lower body extremity segment held majority of the revenue share of robotic prosthetics market owing to the
huge commercial presence of these devices and high number of lower body amputation cases across the
globe. Moreover, the lower body extremity segment is anticipated to grow at the fastest rate over the
forecast period owing to rising prevalence of diabetes and vascular disease, which further leads to an
increase in the number of lower limb amputation cases globally.
The demand for lower body prosthetics by geriatric population is growing at a rapid pace, which is one of the
crucial factors anticipated to increase the use of the devices. Technological advancements in upper and
lower limb prosthetics and growing adoption of advanced polymers in novel prosthetics are among the few
factors that are anticipated to propel the demand for these devices. According to various reports published,
approximately 80% of all lower extremity amputations are dysvascular amputations.
Nonprofit organizations, such as Amputee Coalition, are helping amputees gain necessary resources. It has
developed a fact sheet to help amputees obtain financial assistance for prosthetic services, durable medical
equipment, and assistive devices. Some government assisted programs are Arms Within Reach Foundation,
Amputee Blade Runners, Challenged Athletes Foundation, Chive Charities, Fighting Back Scholarship
Program, Heather Abbott Foundation, Limbs with Love, Limbs Preservation Foundation, National Amputation
Foundation. Presence of these programs is one of the key factors anticipated to improve the participation of
major market players in this industry.Robotic prosthetics market shares by extremities, 2016 (%)

Regional Insights
North America held the major revenue share followed by Europe in 2016. Increasing healthcare expenditure,
growing adoption of technologically advanced products, surging amputee population, and favorable
government initiatives with regard to robotic technology are some of the key drivers responsible for the
largest revenue share held by North America. According to Centers for Disease Control and Prevention, each
day more than 500 Americans lose a limb. Preservation-Amputation Care and Treatment (PACT) program
supported by the American College of Cardiology, American Heart Association, and the American Diabetes
Association is one of the initiatives undertaken by the government to prevent amputation in the region.
The U.S government is increasingly investing in research related to robotic technology, which is used in
amputation and artificial limb. In the area of upper limb prosthetics, DEKA arm was developed by DEKA
Research and Development Corp. with funding support of USD 40 million from DARPA under its
Revolutionizing Prosthetic Program. DEKA arm is an advanced prosthetic arm capable of performing multiple
power-driven movements. Its approval by FDA in 2014 paved the way for its manufacturing and marketing in
the Veterans Affairs (VA) health system.
However, Asia Pacific is expected to grow at the fastest rate in the coming years due to rapid economic
development, rising geriatric population, high diabetic population, and improving healthcare infrastructure
in emerging economies such as India, Philippines, Indonesia, and China. Rising number of amputees and
increasing incidence of foot ulcers associated with diabetes drive the demand for robotic prosthetics in the
market. According to National Healthcare Group, Singapore has one of the world’s highest rates of diabetes
related lower extremity amputation. The abovementioned factors are responsible for driving the demand for
technologically advanced prosthetics

Competitive Insights

Global market players in medical device segment

Healthcare firms have had years, really, to revamp their business models to jumpstart growth, but progress
has been tortoise-like—hampered by lingering Affordable Care Act uncertainty, new federal regulations,
hospital consolidations, purchasing decision instability, fickle reimbursement rates and demands for values-
based solutions. Nevertheless, medtech manufacturers realize that future profits depend on their ability to
evolve with the market, and many have begun their metamorphoses, whether it be through acquisition
(Medtronic-Covidien, Zimmer-Biomet, Smith & Nephew-ArthroCare, Danaher-Nobel Biocare), partnerships
(Novartis-Google[x]), restructuring (Philips N.V., Baxter International and Abbott Laboratories) or redefining
innovation. As St. Jude Medical Inc. CEO Daniel J. Starks noted, “Innovation is broader than delivering the
next breakthrough product. It is about partnering with physicians, hospitals, payers, patients and our
communities to challenge conventional thinking and create medical solutions that save and improve millions
of lives worldwide—while reducing healthcare costs for all.”

The key to success, of course, lies in the industry’s ability to buck tradition—which historically, has been a
virtual sacrilege among device companies. But disruptive change is underway. Companies no longer will be
able to earn premium margins by simply selling clinical features and new devices into established market
spaces. Rather, they will need to look at new segments and, particularly, new end-to-end solutions to secure
additional revenue and maintain margins, contends an A.T. Kearney report on forces currently shaping the
medical device industry.

TOP MEDICAL DEVICE MANUFACTURERS

1. Johnson & Johnson $27.50B

2. GE Healthcare $18.29B

3. Medtronic $17.00B

4. Baxter International $16.67B

5. Siemens Healthcare $15.77B

6. Philips Healthcare $11.17B

7. Cardinal Health $11.00B

8. Covidien $10.66B

9. Abbott Labs $10.11B

10. Stryker $9.66B

11. Danaher $9.38B

12. Becton Dickinson $8.45B

13. Boston Scientific $7.38B

14. Essilor $6.89B

15. Alcon $6.62B

16. B. Braun $6.59B

17. Fresenius $5.95B

18. St. Jude Medical $5.62B

19. 3M Healthcare $5.57B

20. Olympus Medical $4.79B

21. Zimmer $4.67B

22. Smith & Nephew $4.62B

23. Hospira $4.50B

24. Terumo $4.09B

25. CareFusion $3.84B

26. Getinge Group $3.42B

27. C.R. Bard $3.32B

28. Biomet $3.20B

29. Varian Medical $3.00B

30. Bayer $2.87B

2016 Top Markets Report Medical Devices
Overview and Key Findings
Introduction
The global medical devices market offers tremendous opportunity for manufacturers, as well as significant
challenges, for government policymakers seeking to support export competitiveness in overseas markets.
Creating new and sustained export opportunities for companies will require a concerted effort to remove or
diminish market access barriers, helping firms to capture a larger share of the world import market. Despite
uncertain economic conditions in key markets around the world, large and small players in the medical
device industry show adaptability and tenacity, and companies are optimistic about the future. Medical
device companies have found new opportunities for development in the face of uneven international
economic growth and continually-changing regulatory systems.

Top Markets: Key Findings and Methodology

Methodology
This report uses a widely accepted definition of medical devices, similar to that used by the World Health
Organization (WHO) and the United States Food and Drug Administration (FDA). A medical device is
defined as any piece of equipment or apparatus used to treat or diagnose an illness and comes into direct
contact with the patient. Pharmaceuticals and laboratory equipment are not within the scope of this
report.
International industry information and market profiles have been provided by the International Trade
Administration’s (ITA) Global Health Team. ITA’s Global Health Team, consisting of international trade
experts at United States Embassies and Consulates worldwide, as well as in all fifty states, and industry
experts in Washington, D.C., is dedicated to enhancing the global competitiveness of the U.S. health
industry, expanding its market access and increasing exports. It accomplishes this through in-depth research
and a variety of resources and services for U.S. companies, such as seminars, webinars and Gold Key and
Platinum Key Services. Relevant data were collected by surveying international posts with the template
questionnaire found at Appendix 2.
Data for current and forecast sales values of medical devices are sourced from statistics collected by the Census Bureau, the
International Trade Commission (ITC) and Business Monitor International (BMI).Market size and forecasts have been
estimated using a trade-based approach, as most countries are reliant on imports. Estimates have been
derived by looking at imports while considering domestic production, including exports. For practical
purposes, we define a generally-accepted range of HTS codes as the entire market.i HTS codes are used for
export forecast calculations in this report as they most accurately encompass international trade in medical
devices. This report uses trade data through the end of 2015.
Projections were based upon the current estimate size and conditions, considering factors such as expected need,
propensity of lifestyle disease, proposed spending, regulatory developments and other social factors, such as international
health projects, economic performance, trends in import levels, size and performance of domestic manufacturing sector,
national healthcare development plans and currency issues.

Because of remarkable advances in science and technology, including those in the health care industry, life
expectancy in many countries has been steadily growing. As a result, the expanding proportion of elderly
people promises further growth of demand for medical devices. The total combined quantitative rankings
reflect the degree to which they are existent in each market; aging populations in developing economies
now tend to expect therapies for health conditions that previous generations simply endured or that were
life-ending.
Aging populations worldwide, coupled with extended life expectancy, create a sustainable demand for
medical devices. As elderly populations’ healthcare is frequently government-subsidized in markets around
the world, home healthcare is also becoming of increased importance, as related technologies become more
effective, and healthcare budgets are more closely scrutinized.

Industry Overview and Competitiveness

U.S. medical device companies are highly regarded globally for their innovations and high-technology
products. Investment in medical device research and development more than doubled in recent decades,
and research and development investment in the domestic sector remains more than twice the average for
all U.S. manufacturers.
ii
The United
After
billion
and declining
forStates
development
spendingin 2011. in 2009,
From
this is expected
research
budgets
2013
element to to continue
bymore
by and
2020, development
approximately
larger
than to 3play
5 medical adevice
spending
leading
percent,
percent. role
while rebounded
theinrest
companies medical
are todevice
of the$2.9
expectedbillion
research
industry is in 2010
andtheir
to increase and
development.
expected to $7.3
research
increase
The medical device industry is highly diversified and produces a variety of products to diagnose and treat
patients, ranging from tongue depressors to complex programmable pacemakers. The medical devices
industry is known for producing high quality products using advanced technology resulting from significant
investment in research and development. During the last decade, the medical device industry experienced
unprecedented advancement in innovative and developed technologies, leading to the birth of new
therapies and growth in overall healthcare industry.
The major U.S. medical device companies include: Baxter®, Beckman Coulter®, Becton Dickinson®, Boston
Scientific®, GE Healthcare Technologies®, Johnson & Johnson®, Medtronic®, St. Jude® and Stryker
Corporation®, to name a few. In addition, the following medical device industry trade associations closely
follow the industry: Advanced Medical
Technology Association (AdvaMed), Dental Trade Alliance (DTA), Medical Device Manufacturers Association
(MDMA), Medical Imaging Technology Association (MITA) and the International Associatioof Medical
Equipment Remarketers & Servicers (IAMERS).

Size and Shape of the U.S. Medical Devices Industry

For purposes of estimating of the size and shape of the U.S. medical devices industry, the U.S. Census Bureau
(Census) uses the North American Industry Classification System (NAICS) codes in its five year Economic
Census, which was most recently executed in 2012. Those NAICS codes used by Census for this estimation
are as follows:

325413 In-Vitro Diagnostic Substances Manufacturer

 334510 Electro-medical and Electrotherapeutic Apparatus Manufacturing
- 334517 Irradiation Apparatus Manufacturing
- 339112 Surgical and Medical Instrument Manufacturing
- 339113 Surgical Appliances and Supplies Manufacturing
- 339114 Dental Equipment and Supplies Manufacturing
- 339115 Ophthalmic Goods Manufacturing

• In-vitro diagnostic substances (NAICS 325413) account for about 14 percent of value of shipment
(VOS) of total exports and includes chemical, biological or radioactive substances used for
diagnostic tests performed in test tubes, Petri dishes, machines and other diagnostic test-type
devices.

• Electro-medical equipment (NAICS 334510) represents the third largest subsector (17 percent of
VOS) and accounts for a variety of powered devices, including pacemakers, patient-monitoring
systems, MRI machines, diagnostic imaging equipment (including informatics equipment) and
ultrasonic scanning devices.

• Irradiation apparatus (NAICS 334517); about 8 percent of VOS, includes X-ray devices and other
diagnostic imaging as well as computed tomography equipment (CT).

• Surgical and medical instruments (NAICS 339112) comprises the largest subgroup (about 29 percent
of VOS) of the U.S. medical device industry. The category includes anesthesia apparatus, orthopedic
instruments, optical diagnostic apparatus, blood transfusion devices, syringes, hypodermic needles
and catheters.

• Surgical appliances and supplies (NAICS 339113) is the second largest U.S. medical device subsector
with about 22 percent of the total measured by VOS. The category covers a wide range of products,
including artificial joints and limbs, stents, orthopedic appliances, surgical dressings, disposable
surgical drapes, hydrotherapy appliances, surgical kits, rubber medical and surgical gloves, and
wheelchairs.

Generally accepted WHO definition of medical device and medical

equipment:
Medical device (brief): An article, instrument, apparatus or machine that is used in the prevention,
diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying
the structure or function of the body for some health purpose. Typically, the purpose of a medical device is
not achieved by pharmacological, immunological or metabolic means.
Medical equipment: Medical devices requiring calibration, maintenance, repair, user training and
decommissioning – activities usually managed by clinical engineers. Medical equipment is used for the
specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can
be used alone or in combination with any accessory, consumable or other piece of medical equipment.
Medical equipment excludes implantable, disposable or single-use medical devices.
• Dental equipment and supplies (NAIC 339114; 3 percent of VOS) consists of equipment, instruments and
supplies used by dentists, dental hygienists and laboratories. Specific products include dental hand
instruments, plaster, drills, amalgams, cements, sterilizers and dental chairs.

• Ophthalmic goods (NAIC 339115; 6 percent of VOS) includes eyeglass frames, lenses and related
optical and magnification products.

In 2015, the total value of U.S. industry shipments for the products covered by the NAICS categories
identified above was worth $43 billion and, in recent years, has experienced approximately 1.5 percent
annual growth. Median medical technology jobs paid 15 percent more than the average U.S. manufacturing
job. In the 2012 Economic Census, it was reported that the medical device industry employed more than
356,000 people in the United States, at over 5,800 establishments, earning an average wage between
$60,000 and $70,000. Most of these companies are small and medium-sized
Other NAICS product categories have also shown varying growth rates in both exports and imports
between 2007 and 2012. For example, exports of surgical appliances and supplies (NAICS 339113) grew by
22.5 percent and imports by 26 percent; exports of ophthalmic goods (NAICS 339115) grew by 7.5 percent
and imports by 33 percent.
The medical device industry is expected to remain highly competitive globally, partially because of national
characteristics that facilitate bringing new and innovative technologies to market. The industry has
increasingly embraced globalization, and an ever-growing number of multinational firms is aggressively
pursuing markets around the world. These firms are focusing greater attention on international sales, joint
ventures, mergers and acquisitions. Global demand for medical devices is driven by increasing expenditures
and activities on health care by developing markets with the building of new hospitals and clinics,
establishment of public health insurance and greater focus on health. In addition, global demand should
continue to grow due to lifestyle diseases, aging populations in major markets, new and significant emerging
markets and rising global income levels in developing countries. Further, global convergence of standards
and regulatory requirements should help facilitate global market growth and trade opportunities.

Key Trends
Cost Efficiency
Increased competition, developed and cross-bred therapies, and cost containment have more keenly
efficiency. By addressing therapies as an all-inclusive treatment package, medical device companies can
better assist providers in delivering on their obligations to patients, controlling costs and simplifying
transactions.

Export Market Mixture

As expected, the European Union (EU), Japan and Canada are extremely large and lucrative export markets
for medical devices. These stable, mature markets, however, have relatively low (3 to 5 percent) annual
growth rates. In order to facilitate expansion, medical device companies recognize that they must also look
at developing countries for future growth. In some of these, demand for medical devices is growing at
double digit growth in contrast to certain larger, slower growing markets in more developed countries.
Significant yet underserved populations in developing markets often grow steadily, face similar aging
populations and increasing lifestyle diseases and have an increased awareness of health technology
development. Furthermore, many markets deemed as “developing” have highly urbanized population
centers with rising expendable wealth, making certain sectors of markets interesting to exporters. A U.S.
exporter would be best served by investigating both larger developed markets as well as emerging, raw
markets in order to find the best export effectiveness.

Regulatory Convergence
For the medical device industry to fully realize its potential in developing markets, standards for regulatory
approval, risk management and quality must improve and continue along the path of international
convergence to meet global standards. To that end, the Global Harmonization Task Force (GHTF), formed as
a voluntary organization comprised of regulators and industry with five founding members consisting of the
United States, Canada, Japan, the European Union and Australia, had as its core objective streamlining and
harmonizing regulatory standards. Developing countries like India, China, Mexico and Brazil benefited in the
work of GHTF by considering that organization’s guidance documents while designing their own regulatory
systems.
In October 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada,
China, EU, Japan and the United States, as well as the WHO, met in Ottawa, Ontario, Canada to address the
establishment and operation of a new vehicle to further expand the work of the GHTF. The new
organization, the International Medical Device Regulators Forum (IMDRF), is a voluntary group of medical
device regulators from around the world who have come together to build on the strong foundational work
of the GHTF. IMDRF aims to accelerate international medical device regulatory harmonization and
convergence. The enhanced participation of developing countries’ medical device regulatory agencies in
IMDRF activities coupled with guidance issued by GHTF will be critical in establishing regulatory regimes for
medical devices that are distinct from traditional pharmaceuticals. Upon further development in this area,
the medical device industry will continue to evolve as a global industry and better direct its energies to the
development of even more innovative, life-improving and life-saving medical technologies.

Challenges, Barriers and Opportunities

The U.S. industry primarily faces competition from Germany (Siemens and Braun ), Japan (Hitachi , Medical
Corporation and Toshiba ) and the Netherlands (Philips Electronics ), in high-technology products. Notably,
as a result of its acquisition policy, Philips currently produces more medical devices in the United States than
in Europe. It is important to note that most of these foreign companies manufacture significant amounts of
medical devices (or components) in the United States. High quality but lower technology medical device
firms are being challenged by numerous lower-cost producers from China, Brazil, Korea, Taiwan, Mexico and
India, all of which are building up their domestic industries and beginning to compete globally. While the
United States will likely retain its competitive edge for the foreseeable future, international markets are
expected to remain competitive.

Key Export Policies

Opportunities for expansion of U.S. medical device exports will come from certain key ongoing policy and
activities. With respect to accessing developing countries, the contributions of IMDRF will play a significant
role in the international convergence of regulatory requirements that can lead to greater market
penetration. In addition, continued focus on reducing or eliminating tariffs in key markets and higher
reimbursement rates will also significantly influence growth. Further, assisting SMEs in export opportunities
through market information, trade missions and other trade promotion activities can also increase overall
exports for this industry.
• negotiate strongly to reduce or eliminate tariffs on medical devices
• address foreign governments’ regulatory policies that are inconsistent with international regulatory
convergence efforts and that may cause unfair discrimination against U.S. industry

• educate the industry on how to comply with foreign regulatory requirements

• provide export assistance opportunities similar to what foreign governments provide for their industries

U.S. medical device exports will need to understand what export requirements exist for their products. The
rules that U.S. companies must follow when exporting medical devices depend on whether their devices
have been cleared by the U.S. Food and Drug Administration (FDA). Medical devices that are legally
marketed in the United States may be exported anywhere in the world without prior FDA notification or
approval. Devices that have not been approved or cleared in the United States must follow the export
provisions of the Federal Food, Drug and Cosmetic (FD&C) Act.

Firms exporting products from the United States are often asked by foreign customers or foreign
governments to supply proof of the products’ statuses as regulated by the FDA. An export certificate is a
document prepared by FDA that has information about a product’s regulatory or marketing status in the
United States.

A Certificate to Foreign Government (CFG) is the most frequently requested type of export certificate, but a
Certificate of Exportability may also be requested when exporting devices under sections 801(e)(1) and 802
of the FD&C Act or when exporting Non-Clinical Research-Use-Only devices.
Depending on the medical device, there are three possible sections of the FD&C Act that may be applicable,
each with different requirements, if these have not been approved for sale in the United States.

Section 801(e)(1) of the FD&C Act governs the rules for exporting non-cleared Class I or Class II devices, not
including Class II devices subject to performance standards.
Section 802 covers exporting non-cleared Class II devices subject to performance standards, unapproved
Class III devices, devices for investigational use, devices intended for further processing and devices
intended for treatment of diseases not prevalent in the United States. Section 801(e)(2) governs export of
non -cleared Class III investigational devices, banned devices, devices for which a premarket authorization
(PMA) has not been approved as well as other devices which do not meet requirements of Section 802. For
more information on FDA export requirements for medical devices, please visit
http://www.fda.gov/MedicalDevices/DeviceRegulati onandGuidance/ImportingandExportingDevices/Exp
ortingMedicalDevices/default.htm.

Export Barriers
Regulatory and reimbursement requirements for medical devices vary from country to country, creating
complications for U.S. exporters. Certain countries, including India, some Latin American countries and parts
of Asia, still maintain high tariffs on some medical products, reducing the net sale price of medical devices.
U.S. firms also face increasing competition globally, especially from foreign firms that can successfully
compete on the basis of price. U.S. firms without sufficient resources to conduct necessary market research
are especially vulnerable.
• International Regulatory Environments: The medical device industry is highly regulated, and regulatory
environments in the United States and abroad have serious implications on industry performance. An
increasingly common practice among developing countries is the establishment of national regulatory
srequirements above and beyond the requirements of developed countries. Device firms tend to devote
tremendous amounts of time and money to determine such requirements, conduct additional clinical
trials and pay additional user fees. These national requirements may sometimes be established to
protect the domestic industry, to be a source of revenue for the government or both.

• International Reimbursement Payment Environments: Reimbursement or payment practices in certain

countries have also had negative impacts on the U.S. industry. Many countries around the world are
facing the same intensifying costs of health care as the United States and are trying to address costs by
reducing reimbursement rates, establishing price caps, requiring mandatory price reductions, using
diagnostic related groups (DRGs), limiting funds available for medical device purchases and/or requiring
inappropriate information about the product or pricing data from the manufacturer. Germany, France,
Japan, Taiwan, Korea, China and Brazil are all examples of major markets where industry has reported
that prices for medical devices and reimbursement rates have been potentially set lower than the value
of the technology, thus limiting the introduction of advanced technologies and making it difficult for U.S.
firms to be profitable in these markets. Most medical devices have a life-cycle of 18 to 24 months, which
makes reimbursement key for continued product innovation, including incremental improvements. The
U.S. government has encouraged foreign governments to take the overall value of advanced
technologies and other costs in healthcare delivery into greater consideration when establishing their
reimbursement rates.

• Regulatory Convergence Efforts: Convergence of medical device regulations is one way to reduce
the industry’s burden and ensure maximum accessibility of safe, effective medical devices by
patients. U.S. industry would like to see products “approved once, accepted everywhere.” ITA is
encouraging foreign governments to make use of guidance documents produced by international
bodies, most notably IMDRF, to encourage regulatory convergence and to eliminate or reduce
redundant and unnecessary regulatory procedures.

• IPR and Counterfeit Medical Devices: Although intellectual property rights (IPR) and counterfeiting
have not posed as significant a problem for medical device firms as they have in the pharmaceutical
industry, the sector is beginning to face related revenue losses with increasing frequency. IPR
violations include using medical device firms' patented technology to manufacture a competing
medical device or unauthorized use of a registered trademark. Similarly, counterfeit medical devices
are copies of patented medical devices that are manufactured and marketed without following the
requisite approval process, which can result in unsafe products on the market. IPR violations occur
in markets that may not fully respect or enforce patent protection, such as China. There is limited
data on counterfeit medical devices,but based on feedback from industry, the most frequent
incidences are in IVD reagents and solutions, contact lenses, medical test kits, combination products
and components parts, such as semiconductors used in imaging equipment. U.S. industry loses
market share to counterfeit products, and patients are subject to unnecessary risks. ITA, and other
USG agencies like PTO and USTR, is actively engaged in global, regional and bilateral dialogues to
address this problem.

• SMEs’ Lack of Resources: The majority of the U.S. medical device industry consists of small and medium-
sized firms that reinvest much of their revenue into research and development to make incremental
improvements to their technology. A majority of these companies do not have the resources to conduct
sophisticated export market research. In addition, many smaller companies are so focused on entering
 the U.S. market first that they put off exporting until they have become profitable in the United States.
The domestic market, however, can be more difficult to enter than some foreign markets due to
stringent FDA regulations and complex reimbursement policies with Medicare and Medicaid.

Opportunities
U.S. medical device exporters have and will continue to benefit from international trade agreements, such as
NAFTA and TPP.
In 1994, the North American Free Trade Agreement between the United States, Canada and Mexico
(NAFTA) entered into force, ultimately eliminating duties and quantitative restrictions for trade in medical
devices. NAFTA created the world’s largest free trade area to date, which now links 474 million people and
produces roughly $20.5 trillion worth of goods and services.
Trade between the United States and its NAFTA partners has soared since the agreement entered into force:
U.S. goods exports to the NAFTA partners have increased by 289 percent from 1993 to 2014 from $142
billion to $552 billion. U.S. two-way goods trade with Canada and Mexico exceeds U.S. goods trade with the
European Union and Japan combined. Annual exports of U.S. medical devices to Canada have more than
tripled since the year before NAFTA was signed into law, and exports of the same to Mexico have more than
quadrupled.
The Trans-Pacific Partnership agreement (TPP) is a trade agreement covering eleven U.S. trading partners:
Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam. It is
dedicated to increasing the trade of goods and services between member states. TPP goes beyond NAFTA in
many important ways, effectively updating trade relations between the partners and setting new, higher
standards for U.S. regional trade agreements. The agreement also includes dispute resolution mechanisms as
well as regulations relating to government procurement practices and intellectual property protections.
The agreement removes tariffs on medical devices, supports increased regulatory coherence among the
member states and widens stakeholder influence and transparency with respect to reimbursement and
pricing. Ultimately, the TPP will result in quicker approvals of medical devices, benefiting U.S. companies
that export to signatory partner countries. For more information on the benefits of the TPP including for the
medical device industry,
Figure 2: Trade flows by NAICS for Medical Devices Sector

2014 2015 2014 2015

Exports Exports Imports Imports
NAICS Code/Description
(USD (USD (USD (USD

Billions) Billions) Billions) Billions)

325413 – In Vitro Diagnostic Substance $6.0 $6.1 $3.3 $3.5

334510 – Electro-medical Apparatus $8.3 $7.5 $10.4 $10.3

334517 - Irradiation Apparatus $3.4 $3.6 $3.8 $3.7

339112 - Surgical and Medical Instruments $12.6 $12.4 $11.3 $12.3

339113 - Surgical Appliances and Supplies $9.3 $9.6 $12.9 $13.7

339114 - Dental Equipment and Supplies $1.2 $1.2 $1.2 $1.3

339115 - Ophthalmic Goods $2.7 $2.7 $5.1 $5.1

Total $43.5 $43.2 $47.9 $49.9

Figure 3: Medical Devices Market: Forecast for Growth, in USD

Billions

Region 2016 2017 2018 2019 2020

Americas 166.6 176.5 187.3 197.9 208.6

Asia/Pacific 68.7 72.6 77.6 82.9 88.6

Central/Eastern 14.6 15.7 17 18.1 19.1

Middle East/Africa 10 10.8 11.5 12.5 13.2

Western Europe 79.5 85.1 92.6 101.4 106.2

Total 339.5 360.8 386.1 412.8 435.8

Source: Worldwide Medical Devices Forecast to 2020

Recommendation- Thus from the analysis of the given data wrt to all other parameters it can
be said that surgical and medical instruments along with electro medical apparatus are the preferable
divisions of medical device to invest and start with for developing markets like Asia/Pacific and western
Europe
References

 Murdoch, George; Wilson, A. Bennett, Jr. (1997). A Primer on Amputations and Artificial
Limbs. United States of America: Charles C Thomas Publisher, Ltd. pp. 3–31. ISBN 0-398-
06801-1.
 ‘Biomechanics of running: from faulty movement patterns come injury.' Sports Injury Bulletin.
 Edelstein, J. E. Prosthetic feet. State of the Art. Physical Therapy 68(12) Dec 1988: 1874–
1881.
 Gailey, Robert. The Biomechanics of Amputee Running. October 2002.
 Hafner B. J.; Sanders J. E.; Czerniecki J. M.; Ferguson J. (2002). "Transtibial energy-
storage-and-return prosthetic devices: A review of energy concepts and a proposed
nomenclature". Journal of Rehabilitation Research and Development Vol. 39 (1): 1–11.

26