Emerging Medical FINAL PDF

Emerging Medical
Device Markets and
Technologies

July, 2008
111 Lomb Memorial Drive

Rochester, NY 14623-5608
Phone: (585) 475-5385 - Fax: (585) 475-5250
Purpose
The intent of this report is to provide insights to emerging medical device market
opportunities that have potential to be addressed by manufacturers in the Upstate New
York geographic area.
Medical devices, in the context of this report, are defined as: instruments, apparatus,
implements, machines, contrivances, implants, in-vitro reagents, or other similar articles
that are intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease. This is derived from the United States
Food and Drug Administration (www.fda.gov/cdrh/devadvice/312.html).
Disclaimer
There are likely many more opportunities for new products and markets than those
presented in this report and no representation is made, or should be taken by the reader
that this is an exhaustive presentation of new market opportunities. Recent industry
history illustrates that many technologies have been adapted to vastly different markets
than they were originally designed for and new markets will give rise to continued
adaptations and technology convergence. References in this report to any specific
commercial product, process or service by trade name, trademark, manufacturer or
otherwise does not constitute or imply endorsement, recommendation of any kind. We
do not assume any legal liability or responsibility for the accuracy, completeness, or
usefulness of any information, product, or process included in this report.
July 2008 ©Rochester Institute of Technology. All Rights Reserved

Table of Contents
Executive Summary .......................................................................................................... 1

Global Market Environment ........................................................................................... 3
Industry Composition....................................................................................................... 4
Largest US-based Medical Device Companies ........................................................... 4
International Competitors............................................................................................ 4
High Growth Categories................................................................................................... 5
Implantable Devices...................................................................................................... 5
Cardiac Rhythm Management ................................................................................ 6
Other Implantable Electro-Medical Devices .......................................................... 6
Orthopedic Implants................................................................................................. 7
Diagnostic Testing Devices ......................................................................................... 11
In-Vitro Diagnostics................................................................................................ 11
Ophthalmic Devices .................................................................................................... 13
Home Healthcare Products ........................................................................................ 17
Home Diagnostic Device Examples ........................................................................... 18
Home Monitoring Device Examples.......................................................................... 22
Contract Manufacturing Opportunities ....................................................................... 24
Biocompatibility .......................................................................................................... 24
Anti-Microbial Sterilization....................................................................................... 25
Device Coatings ........................................................................................................... 26
Drug Release Technologies......................................................................................... 26
Electronic Medical Device Connectivity ................................................................... 27
Materials and Processes ................................................................................................. 29
Materials ...................................................................................................................... 29
Computer-Based Product Design .............................................................................. 30
Computer Controlled Machining .............................................................................. 31
Surface Coating Application...................................................................................... 32
Sterilization.................................................................................................................. 32
Regulatory Factors.......................................................................................................... 34
Establishment Registration ........................................................................................ 34
FDA Medical Device Classifications.......................................................................... 35
FDA Approval Path .................................................................................................... 36
Premarket Notifications ......................................................................................... 36
Premarket Applications.......................................................................................... 36
Investigational Device Exemption (IDE) .............................................................. 37
Non-US Regulatory Requirements............................................................................ 37
July 2008 ©Rochester Institute of Technology. All Rights Reserved

Executive Summary
The global medical devices market continues to grow, driven by the aging worldwide
population and technological innovations in diagnostic and therapeutic medical devices.
Estimates place the current global market at $336 billion in annual revenues. The United
States is the largest consumer and producer of medical devices in the world.
Large, multi-product companies have the dominant share of revenues. These companies
have grown by acquiring smaller, innovative companies and they make extensive use of
contract manufacturing services. Most medical device manufacturing companies in the
United States have 50 employees or less. The US Department of Commerce reports that
there are over 8,000 companies in the U.S. engaged in the production of medical devices.
Device segments that are expected to have high growth include:

• Implantable devices, like: pacemakers, drug pumps, stents, and joint replacements
• Diagnostic testing devices, including clinical blood, urine, and tissue testing
• Home healthcare products and electronic monitoring devices
As the population ages, more joints are being replaced. Orthopedic devices for join
replacements are benefiting from new materials, including metallic alloys, ceramics, and
biocompatible plastics. New coating materials and application technologies that improve
orthopedic device performance and longevity are also improving patient outcomes.
Manufacturing processes for these devices are now being automated through the use of
CAD/CAM systems that communicate with CNC milling and grinding machines as well
as 5-axis Electronic Discharge Machines.
Diagnostic testing devices, at $34 billion in 2007 sales, currently represent about 10% of
the total worldwide market for medical devices. The fastest growing segment within
diagnostic testing is In-Vitro Diagnostics (IVD). These sophisticated devices are used in
clinical settings to assist with disease diagnosis through the analysis of blood, urine, and
tissue samples. IVD devices also have many consumable materials associated with them.
Ophthalmic devices represent over $17 billion in annual revenues globally and this
segment is also expected to continue growing because of the increased incidence of eye
diseases, such as glaucoma and macular degeneration in an aging population. Diagnostic
devices are increasingly being integrated into therapeutic devices, such as laser-based
surgical tools, that can provide patient specific corrective vision treatments.
Additionally, intra-ocular lens technologies have improved dramatically, expanding the
range of options available to patients and physicians for addressing the multiple vision
issues that can confront aging eyes.
Home health and remote patient monitoring, currently a $5.6 billion segment, is forecast
to grow at close to 70% annually for the next several years. Devices for monitoring
chronic diseases, such as blood glucose testing for diabetics, as well as screening devices,
such as pregnancy and fertility tests, are included in this category. Technical advances
that are making these tests more sensitive and accurate are presenting new opportunities
July 2008 ©Rochester Institute of Technology. All Rights Reserved. 1

to device manufacturers, as is expanding the range of tests to include cholesterol and
triglyceride levels, infectious diseases, and genetic tests. Remote patient monitoring
systems are now being used to monitor patients with Congestive Heart Failure, diabetes,
asthma and hypertension. Home monitoring and telemedicine services will allow aging
patients to remain in their homes and receive a high degree of medical care. Many
opportunities exist for developing diagnostic devices that are compatible with home-
based telemedicine communication systems.
Contract manufacturing opportunities abound in the medical device industry. Companies

with expertise in biocompatible product design, sterilization technologies, device
coatings, drug release technologies, and electronic device connectivity are especially
sought after and have high-value in the industry.
New materials and process technologies are enabling medical devices to be miniaturized,
which is particularly important for implantable devices. Many new materials also
improve biocompatibility and device safety. As an example, due to recent safety
concerns related to PVC and DEHP plastics, an opportunity currently exists for
manufacturing commodity devices with non-PVC/non-DEHP plastics, such as
intravenous tubing, drug delivery containers, catheters, and many other single-use
medical products.
Computer-based design and manufacturing technologies enable medical device creators

and manufacturers to design, test, and produce small and complex parts. These systems
also maintain documentation history required by regulatory authorities. Contract
manufacturing companies that have equipment compatible with leading CAD/CAM
software systems, such as SolidWorks and ProEngineer, are sought after because these
tools help improve overall economic efficiencies through reduced inventory needs,
production errors, and shortened cycle time for finished product availability.
While many opportunities abound for medical device manufacturers and medical
product design, machining, packaging, and sterilization contract businesses, the highly
regulatory nature of the business has been a key factor restraining new product
development. The US FDA requires manufacturers of medical devices to register their
establishments, comply with Good Manufacturing Practice specifications, and also
requires extensive data related to new products prior to permitting marketing and sales
of new devices in the United States. The FDA also regulates products that are
manufactured in the US but sold abroad.
The FDA provides extensive amounts of information concerning medical device

manufacturing requirements and there are many resources available to assist with
regulatory compliance, including computer-based tools that document device history
from initial concepts to finished product shipments. The potential rewards for
overcoming the regulatory hurdles could be well worth the effort.

Global Market Environment
Aging populations, technology innovations, and opportunities in non-U.S. markets are

driving forces in the continued worldwide growth of the medical device industry. The
world’s population is aging, particularly in the United States, the European Union, and
Japan. These three global regions constitute nearly 90% of medical device revenues.
The United Nations estimated that the number of people aged 60 or older will grow from
688 million in 2006 to almost 2 billion by 2050, representing 32% of world population.
Older people are more prone to chronic and degenerative diseases. Standard & Poors
reported that 80% of all people aged 65 or older have at least on chronic condition, such
as diabetes or arthritis.
Technologies that diagnose and improve the physical and mental health of the aging
population such as Magnetic Resonance Imaging (MRI), reconstructive implants for hips
and knees, as well as minimally-invasive surgical procedures are becoming widely used.
Home medical kits for monitoring chronic medical conditions, such as diabetes and heart
rhythm management, are also growing markets linked to the aging population.
Top Global Medical Device Markets
The medical products industry is
vast and includes many categories Canada
of products, leading to a range in United Kingdom
Italy
estimated global sales for medical
Country
China
devices. The U.S. Department of France
Commerce International Trade Germany
Association (DOC/ITA) estimated Japan
the U.S. market for medical and United States
dental equipment and supplies, 0 10 20 30 40 50 60 70 80 90 100

Billions of Dollars (2006)
using six NAICS codes comprising
the medical devices industry, at $82.4 billion in 2004-- which is stated to be half the world
market. AdvaMed (www.advamed.org), a U.S. based medical device trade organization,
estimated the global market for medical devices at $220 billion in 2006. EuroMed, the
European medical device trade association, estimated the global market at $235 billion in
2005. MX Magazine (www.devicelink.com/mx/archive/08/05/news1.html) estimates the
global market at $336 billion in 2008.
The United States is the largest producer of medical devices worldwide. S&P reports that
US medical device manufacturers receive 40% to 50% of their revenues in foreign
markets. Revenues come from direct exports as well as from sales made by foreign
subsidiaries, thus the current strength in foreign currencies may provide a benefit to US
producers. Global demand for medical devices and supplies is being driven by increasing
expenditures by on healthcare by nations around the world that are building hospitals and
clinics, implementing public health insurance programs, and focusing resources on
improving the health of their citizens.

Industry Composition
Large multi-product companies lead the medical device industry in terms of revenues,
though the DOC/ITA estimates that there are over 8,000 medical device manufacturing
companies in the U.S., most have fewer than 50 employees. Small companies tend to
create innovative medical devices, often through collaborations with researchers.
Regulatory requirements for approval and manufacturing of medical devices as well as
the costs of clinical research are factors that affect a company’s ability to develop new
medical technologies. Larger companies with resources to address these factors are in
more favorable positions to bring products to market. Consequently, well-funded
medical product manufacturers tend to buy small, innovative companies, or create
alliances with them in order to address new and expanded market opportunities.
Largest US-based Medical Device Companies
Total Sales 2007 Medical Device Foreign sales

Company (millions of Sales 2007 as % of total
dollars) (millions of
dollars)
Johnson & Johnson 61,095 21,736 52%
GE Healthcare 163,391 16,562 N/A
Medtronic 12,299 12,299 36%
Boston Scientific 8,357 8,357 39%
Abbott Labs 25,914 6,894 47%
Becton Dickinson 6,360 6,360 51%
Stryker 6,001 6,001 34%
Zimmer 3,898 3,898 41%
St. Jude Medical 3,779 3,779 42%
Alcon 5,560 3,286 50%
C.R. Bard 2,202 2,202 30%
Biomet 2,107 2,107 38%
Source: Standard & Poor’s Healthcare Products & Supplies Survey March, 2008
US firms have been building manufacturing and marketing centers in foreign countries to
improve manufacturing and distribution efficiencies, enabling delivery of products with
timeliness and at a lower-cost basis. Asia, Latin America, Ireland and Puerto Rico have
especially high concentrations of manufacturing facilities for US-based medical device firms.
International Competitors
The U.S. industry is mainly facing competition from Germany (Siemens), Japan (Hitachi
Medical Corp. and Toshiba), the Netherlands (Philips Electronics) and Italy (Marconi
Medical Systems) in high technology products. It is important to note that most of these
foreign companies manufacture a significant amount of their products in the United
States. High-quality but lower technology medical firms are being challenged by
numerous lower-cost producers in China, Brazil, Korea, Taiwan and India, countries
which are building up their domestic industries and also compete globally.

High Growth Categories
High-tech medical products that address health issues in the aging population have a
positive outlook for the future. Manufacturers and suppliers of lower-tech products to
hospitals, outpatient centers, and other medical facilities will face uncertain futures
because these products tend to be vulnerable to flat health insurance re-imbursement rates
that restrict purchases and profit margins.
Device segments that are expected to have high growth include:

Implantable devices, such as pacemakers, drug pumps, stents, and joint
replacements as well as devices related to minimally-invasive surgery
Diagnostic testing devices, such as those used for blood, tissue and genetic testing
as well as optical devices for glaucoma and macular degeneration screening
Home healthcare products, such as diabetic tests, liver function tests, and electronic
monitoring devices
Implantable Devices
Medical devices that are surgically introduced into the human

body with the intent that they remain in place after the
procedure are implantable devices for the purpose of this
report. Implantable devices may be further classified as
“active” if it uses a power source other than that directly
generated by the human body or gravity. Electro-medical
implants such as cardiac pacemakers, neuro-stimulators, and A stent is a tiny wire mesh tube used to
cochlear implants are examples of active implants. Devices prop open a coronary artery after it has
been cleared of a blockage in a
like: stents, heart valves, and orthopedic implants such as knee minimally invasive procedure called
and hip replacements are typically inactive. balloon angioplasty. The balloon is
inflated to compress the plaque against
the wall of the artery and to expand the
Implantable devices are increasingly used to reduce pain, stent. (Courtesy Medtronic, Inc.)
extend and improve patient’s lives. Cardiovascular (CV)
diseases, including: high blood pressure, heart attack, stroke,
congestive heart failure, and other ailments related to the heart
and circulatory system, increase in incidence with aging
populations. A wide range of implantable devices are now
used to treat CV diseases and several major manufacturers
make both active and passive implantable devices to address
this market. Examples include stents, pacemakers, and
implantable cardioverter defibrillators (ICDs) marketed by The Medtronic Intrinsic® implantable
cardioverter-defibrillator (ICD) is the
Medtronic (Minneapolis, MN). world’s first ICD with a new pacing mode
designed specifically to promote natural
heart activity and reduce unnecessary
Active implantable devices typically have several component pacing in the lower right chamber of the
parts that function as a system. In the case of cardiac heart. (Courtesy Medtronic, Inc.)
pacemakers, there are three key components: the implantable
pacing device, an electrical pacing lead that connects the pacing device to heart tissue,

and an external programming device, used by a physician in a hospital or clinic, that sets
operating parameters for the implanted device.
Cardiac Rhythm Management
Cardiac Rhythm Management (CRM) products include: pacemakers, implantable

cardioverter defibrillators (ICDs) cardiac resynchronization therapy (CRT) devices, and
related items. CRM products represented around $9.8 billion in North American sales in
2005. CRT has been the fastest growing segment of cardiology, driven by the
introduction of new, device-oriented treatments for congestive heart failure. Frost &
Sullivan forecasts a compound annual growth rate of 17% for CRT between 2005 and
2011.
Other Implantable Electro-Medical Devices
Muscle stimulators, neurological stimulators, insulin and pain

control drug pumps, and cochlear hearing aids are other
implantable electronic devices. There is an increasing use of
implantable devices for treatment of chronic diseases. Innovations
in microelectronics, microfluidics, and biocompatible materials will
enable future generations of implantable devices to be used for
even wider ranges of applications. The increasing incidence of
diabetes, in particular, is expected to drive growth for implantable
drug pumps.
Behind the ear cochlear implant
(photo credit: Hearing Loss
Product Components Association of Washington)
Many component parts are used to create implantable electro-medical products such as:
lithium-ion batteries; high-power capacitors; titanium, stainless steel, aluminum and alloy
enclosures; electronic device connectors and feed-throughs; lead-wire assemblies and
anchors; embedded software for implantable devices and external system programming
software; as well as bio-compatible coatings for implantable materials.
Manufacturing of these subcomponents is provided by a range of companies that are

typically have FDA and ISO certifications and may also have clean-room manufacturing
environments. An example of a CRM component manufacturing company in the region
is Greatbatch, Inc. in Clarence, New York (www.greatbatch.com).
Manufacturers
The largest manufactures of implantable electro-medical devices includes: Medtronic,

Inc. based in Minneapolis, MN (www.medtronic.com); St. Jude Medical, Inc. based in St.
Paul, MN (www.sjm.com); Boston Scientific Corporation based in Natick, MA
(www.bostonscientific.com); Biotronik based in Berlin, Germany (www.biotronik.com)
and Sorin Group in Saluggia, Italy (www.sorin.com).

Smaller developers and manufacturers are often acquired by larger companies. Examples
include ANS-Medical based in Plano, Texas which is now part of St. Jude Medical and
Guidant Corporation based in Indianapolis, Indiana which is now part of Boston
Scientific. Notable stand-alone companies include: Advanced Bionics, based in Sylmar,
California (www.advancedbionics.com) which is an example of a small, innovative
company that claims to be the only US based manufacturer of cochlear implants and
Angel Medical Systems, based in Shrewsbury, New Jersey (www.angel-med.com) which
is developing an implantable cardiac monitoring and alerting system.
Orthopedic Implants
The US orthopedics market, which accounted for more than 54%

of the global market in 2004, is experiencing record growth with
estimated compound annual growth rates projected at 12% through
2011 by Frost & Sullivan. Stryker Corporation reported that the
2007 worldwide market for reconstructive devices for knees, hips
and extremities was on the order of $11.8 billion in size. Knee
reconstructions constituted over 50% of the total market. Stryker
also reported the 2007 worldwide spinal market at approximately
$5.1 billion with Thoracolumbar implants (Relating to the thoracic
and lumbar portions of the vertebral column) having about 50%
share of the spinal market.
Depuy Sigma RP-F
Orthopedic Implant Materials Knee replacement
The most common materials used in orthopedic implants are metals and polyethylene
plastic. Some implants also use ceramics. Most metal implants are made from alloys of
pure metals to achieve particular characteristics. The most common metal alloys used in
orthopedic implants are stainless steels, cobalt-
chromium alloys, and titanium alloys. When properly
designed and implanted, the combinations of materials
can rub together smoothly while minimizing wear.
Stainless steels, cobalt-chromium alloys, titanium and

titanium alloys, and tantalum tend to be used for many
implants. Stainless steel is used for bone plates, bone
screws, pins and rods. The stainless steels used in
orthopedic implants are designed to resist the
chemicals and environmental conditions found in the
human body. Cobalt-chromium alloys are used in a
variety of joint replacement implants as well as some
fracture repair implants. Titanium and alloys with
titanium have higher flexibility and are used in some
Ceramic orthopedic Implant components
implants to aid in bone in-growth for better grip. from Morgan Technical Ceramics
(www.morgantechnicalceramics.com)

Trabecular metal, which is made from tantalum over carbon, is another strong, flexible,
biocompatible material that is porous and also allows tissue in-growth.
Ceramic materials are usually made with metal oxides, such as aluminum and zirconium
oxides. Ceramic materials used for implants are strong, resistant to wear, and
biocompatible. They are used mostly to make implant surfaces that rub together but do
not require flexibility, such as in the surfaces of a hip joint. Ceramic powders,
particularly hydroxylapatite, can also be used as coatings on implants to promote bone
growth into implants.
Medical-grade polyethylene for orthopedic implants is often used on the surface of one
implant that has been designed to come into contact with another implant used in joint
replacements. This grade of polyethylene is very durable and provides smooth contact
with minimal amounts of wear.
Implant Fabrication Processes
The most common fabrication methods used for metal implants are machining,
investment casting, hot forging, and cold forging. In some cases, specific fabrication
methods are necessary to achieve a complex shape.
Machining of implant materials is usually performed

with Computer Numerically Controlled (CNC)
machining of standard bar form materials. This allows
for high precision and repeatability of the final shape.
Cobalt-chrome stem caps for used in hip implants are
often manufactured using automated machining
processes for turning, grinding and polishing.
Investment casting is often used for implants that have

more complex shapes, such as knee implants. Metal is
melted and poured into a ceramic mold to create the
shape of the implant. Creating the wax inserts and
ceramic molds can be a time consuming process and
process controls are critically important. Some
orthopedic implant manufacturers are now using a
combination of solid-modeling Computer Assisted Willemin 408E 5-6 axis bar-fed milling
Engineering and Computer Aided Design CAE/CAD machine (www.willemin-macodel.com)
systems along with a rapid prototyping system to
automate the production of the wax molds. This allows the wax mold that is lost in the
investment casting process to be made with a minimum of labor and with high
repeatability.
Forging processes press materials into shape between molds. Implants made by forging
can be stronger than similar parts made by casting, though forging is limits the
complexity of the resulting shape. Some metals must first be heated to make them more

pliable to be shaped, which is hot forging; others are naturally more pliable and be shaped
at room temperatures, which is cold forging.
Polyethylene fabrication begins with Ultra High Molecular Weight PolyEthylene

(UHMWPE) powder which is then consolidated into a
solid piece. Different consolidation processes affect the
characteristics of the final implant. Three consolidation
processes that are widely used for implants are: ram
extrusion, compression molding, and net-shape
compression molding. The requirements of the implant
determine which of these processes is used. Ram
extrusion produces polyethylene material that requires
further machining. Compression molding presses
polyethylene into sheets that are cut and shaped to
create an implant. Net-shape compression molding FMP Acetabular System (hip replacements
produces an implant with smooth surfaces and from DJO Surgical) with highly cross-linked
Polyethylene liner (www.djosurgical.com)
consistent shapes by heating, and compressing
polyethylene powder. Cross-linking the polymer chains of polyethylene improves wear
reduction of finished material.
Post Fabrication Coatings
After fabrication, some implants can be treated to improve the physical characteristics of
the material and to help improve physical characteristics or function. Some of these
techniques change the material while others
simply add a coating to the surface for
enhancement. Heat treating, or annealing, is the
most common method for treating metal implants
to reduce brittleness. Other treatments include
nitriding, ion implantation, bone cement pre-
coating, porous coatings, and surface roughening.
Hydroxylapatite (HA) is used as a porous coating
Examples of magnified porous coatings for
to promote bone growth onto orthopedic implants. orthopedic implants. Courtesy of Zimmer, Inc.
HA powders are typically applied using robotic
plasma spraying to apply the HA particles, which are typically less than 100 micrometers
in size, onto preheated implant cores mounted in carousel trays.

Largest Orthopedic Companies
The top seven companies in orthopedics hold more than 80% of the global market share.
Five of these companies are based in the United States.
Reconstructive Spinal devices

Geographic
Company and website devices estimated estimated
location
market share market share
Zimmer
www.zimmer.com Warsaw, IN 26% 4%
DePuy/ Johnson & Johnson Warsaw, IN (reconstr.)

www.depuy.com Raynham, MA (spine) 21% 16%
Stryker
www.stryker.com Kalamazoo, MI 20% 9%
Smith & Nephew

www.smith-nephew.com London, U.K. 12% --
Biomet
www.biomet.com Warsaw, IN 10% 4%
Medtronic
www.medtronic.com Minneapolis, MN -- 41%
Synthes
www.synthes.com Solothurn, Switzerland -- 13%
Others N/A 11% 13%
Sources: Stryker Corporation 2007-2008 Fact Book and individual company websites

Diagnostic Testing Devices
Many medical devices are commonly used for diagnostic testing, such as thermometers,
sphygmomanometers (for measuring blood pressure), and stethoscopes. The growth rates
for these devices is holding steady. However, the growth rate for In-Vitro Diagnostics
(IVD) has been growing dramatically over the past several years. The IVD products
segment had an estimated worldwide market of $34 billion in 2007.
In-Vitro Diagnostics
IVD refers to testing systems used for analysis of blood, urine, tissue, or other bodily
fluids to detect disease, presence of pathogens, or other genetic abnormalities. These
systems typically include chemical reagents and analytical equipment, such as a
specialized microscope. Companies sell or lease the instruments to hospitals, clinics,
physician offices, and independent clinical labs. The chemical reagents mix with the
patient’s bodily fluid or tissue
sample and the instrument captures
data that can then be used to
provide a diagnosis.
Blood glucose testing is a strong

driver of IVD growth and is a VISTA Intelligent Lab System from
profitable sub-segment. Annual Siemens Healthcare Diagnostics
growth rates for blood glucose
testing are in the range of 13-14% for the next few years. Growth drivers include
worldwide population growth and increased detection of diabetes in the aging population.
Additionally, medical guidelines recommend that diabetics test their blood more
frequently throughout the day.
Near and mid-term growth opportunities for IVD testing devices include cardiac testing,
human immunodeficiency virus (HIV) testing and monitoring, and molecular diagnostics.
Molecular diagnostics are based on genetic analysis of patient samples and typically
provide higher sensitivity and specificity than conventional tests, which makes earlier
detection of diseases possible with lower rates of error. However, molecular testing is
much more expensive than conventional tests. Since this category of testing product did
not exist a decade ago, many new molecular tests are currently being developed. The
estimated global sales for molecular diagnostics are $3 billion in 2007 with about half of
those sales generated in the United States. Growth rates for IVD products are estimated to
be about 15% annually through 2009.
The IVD business to date is concentrated in seven companies that hold about 75% of the
world market share. However, since this segment is immature and in a high-growth
mode, there is room for many new players.

Top IVD Companies
Company headquarters Global IVD

Example IVD products
location and website market
share
Roche Diagnostics COBAS Blood Serum Analyzers

Basel, Switzerland ACCUTREND cholesterol field monitors
19%
www.roche.com/div_diag.htm LIGHTCYCLER Septifast PCR
DIMENSION VISTA intelligent lab system
Siemens Healthcare Diagnostics
(includes Dade Behring, Bayer Diagnostics
ADVIA Hematology systems
and Diagnostic Products Corp.) 18% SYSMEX hemostasis systems
Deerfield, Illinois STRATUS CS Acute care diagnostic system
http://diagnostics.siemens.com
Johnson & Johnson Ortho Clinical VITROS integrated systems
13%
Rochester, New York
www.orthoclinical.com
Abbott Laboratories ARCHITECT immunoassay system

12%
Abbott Park, Illinois PRISM chemiluminescent immunoassay
www.abbott.com CELL-DYN blood analyzer
Beckman Coulter, Inc. UNICEL SYNCHRON ACCESS Clinical System

6%
Fullerton, California COULTER LH 755 hematology workcell
www.beckmancoulter.com ACCESS 2 IMMUNOASSAY SYSTEM
Bio Merieux SA VIDAS automated multiparametric

6%
Marcy l’Etoile, France immunoassay system
www.biomerieux-diagnostics.com VITEK 2 bacterial detection system
Sources: Standard & Poor’s and company websites

Ophthalmic Devices
The eye-care industry has experienced growth from both treatments for age-related vision
disorders, such as: presbyopia, cataracts, macular degeneration, and glaucoma; and
cosmetic surgeries, such as: laser vision correction and implantation of refractive
intraocular lenses. The ophthalmic products market reached an estimated $17 billion in
2006, not including consumer eye-care products. Carl Zeiss Meditec reported that the
ophthalmic systems and devices segment of this market was at $2.2 billion in 2006 and
was growing at approximately 10% annually (presentation by James L. Taylor, Munich,
October 2007 available via www.meditec.zeiss.com). The worldwide market, like other
medical technologies, is concentrated in the United States and Europe. Manufacturers in
this segment include: Advanced Medical Optics, Bausch & Lomb, Canon, Kowa
Optimed, Nidek, Topcon, and Zeiss Meditec,
The ophthalmic medical device sector can be divided into three major segments:
Diagnostics, including handheld office-base diagnostic instruments

Cataract surgery products, including intraocular lenses (IOLs)
Refractive surgery products, including excimer and femtosecond lasers
Many diagnostic and therapeutic devices can be used for a range of ophthalmic
conditions. Common eye diseases and conditions are further described at the end of this
section to aid the reader’s understanding.
Diagnostic Devices
Diagnostic instruments are the key tools

for ophthalmologists and eye-care
professionals. These tools are used to
identify diseases and conditions of the
cornea and macula, but also to plan
vision-correction therapies. Many
diagnostic devices in this category are
considered to be capital equipment due
to their selling price and long useful life.
Purchases of new and replacement
devices is driven by growth in the
market or advances in technology;
which makes this a relatively slow
growth segment.
A trend in diagnostic instrumentation is Digital Slit Imaging System used for detecting cataracts, corneal
injury, macular degeneration, retinal detachment, and other eye
to combine diagnostic tests with clinical diseases by examining structures at the front of the eye.
assessment where diagnostic findings Kowa Optimed, Inc. Torrance, California. www.kowa-usa.com.
can be integrated into therapeutic

instrumentation, such as in laser-based corrective eye surgeries.

Cataracts
Cataracts are clouding of the eye's lens. The vast majority of cataracts are related to age.
Most people do not even realize they have a cataract, as cataracts grow very slowly.
When the cataract has become so dense that it compromises a patient's quality of life, the
patient and an ophthalmologist should discuss the appropriate time to remove it. Surgery
is the only treatment. By age 65, over 90% of people have a cataract and 50% of people
between the ages of 75 and 85 have lost some vision because of a cataract. In the United
States, cataract surgery is the most frequent
therapeutic procedure performed on people
age 65 and above and with over 2 million
cataract procedures are performed annually.
Cataract is the most common cause of
blindness in the world, although it is
treatable.
Diagnosis and treatment for cataracts has

been practiced for several decades though
recent advances in intraocular lens implant
technologies and surgical tools have
increased the treatment options available to
both patients and surgeons. Advances in
materials and implant technologies for IOLs
have made it possible to achieve ReZoom (Advanced Medical Optics) is a multifocal refractive
clear vision at multiple focal points with IOL that distributes light over five optical zones to provide
near, intermediate and distance vision. The first version of
multifocal and accommodating lenses. this multifocal IOL was brought to the U.S. market in the late
Innovations in this area have brought about 1990s; the ReZoom is the second-generation version and
was FDA-approved in March 2005. www.amo-inc.com
opportunities for new business entrants to this
segment that challenge long-time market
leaders.
Cataract surgery is considered to be one of the most commonly performed ophthalmic

surgical procedures in the world with about one-third of practicing ophthalmologists
performing this surgery. Until recently, the placement of IOLs began with removing the
patient’s clouded native lens and a synthetic lens was inserted to restore vision. Any
remaining visual impairments were then corrected with eyeglasses or contact lenses.
Today, refractive surgery and advanced IOLs present more treatment options.
Refractive Eye Defects
Presbyopia (aging of the lens in the eye and the muscles that control the shape of the
lens) commonly occurs after age 40, when the lens of the eye becomes more rigid and
does not flex as easily. The result is that it is more difficult to read at close range.
Presbyopia is a refractive error, which results from a disorder rather than from disease.
This normal aging process of the lens can also be combined with myopia, hyperopia or
astigmatism. A refractive error means that the shape of the eye does not bend light

correctly which results in a blurred image. Corrective lenses are usually prescribed for
treatment and new diagnostic devices as well as laser-
based corrective systems have been developed to
address this growing market.
Laser vision correction continues to evolve. These

systems have become more accurate and enable
patient-by-patient customization for vision
corrections. Laser vision correction and IOLs are
dynamic treatments and have created a spectrum of
options for treatments.
However, these systems are very expensive and

adoption of the technology is affected by economic
considerations. Most capital equipment The Technolas™ 217z Excimer laser and laser bed
manufacturers that provide laser vision correction used in Zyoptix treatments, has been designed to be
comfortable for the patient, yet effective, efficient and
systems charge a per-procedure fee for the use of the easy to use for the surgeon. www.zyoptix.com
system. The procedures themselves are
correspondingly expensive and not usually covered by insurance plans. It is estimated
that the global annual expenditures on purchases of refractive surgery products and
physician and facility fees is greater than $4 billion.
Glaucoma
Glaucoma is a group of eye diseases causing optic nerve

damage. The optic nerve carries images from the retina,
which is the specialized light sensing tissue, to the brain so
we can see. In glaucoma, eye pressure plays a role in
damaging the delicate nerve fibers of the optic nerve.
When a significant number of nerve fibers are damaged,

blind spots develop in the field of vision. Once nerve
damage and visual loss occur, it is permanent. Most people
don't notice these blind areas until much of the optic nerve
damage has already occurred. Blindness results if the entire
nerve is destroyed.
Glaucoma is a leading cause of blindness in the world,

especially in older people. Early detection and treatment by
an ophthalmologist is the key to preventing optic nerve
damage and vision loss from glaucoma.
Glaucoma treatments have historically been the Zeiss Meditec Stratus OCT incorporates Optical
largest segment of the ophthalmic pharmaceutical Coherence Tomography to provide comprehensive
sector, representing about 40% of revenues imaging and measurement of glaucoma and retinal
disease. www.meditec.zeiss.com.
worldwide.

With recent advances in treatments for back-of-eye
diseases new products to treat age-related macular
degeneration (AMD) will become dominant in the
sector over the next few years.
Because of the growing and aging population that

will be subject to glaucoma and AMD, considerable
attention will be focused on new device technologies
for AMD treatment as well as combination Nidek Handheld Fundus Camera NM200D
therapies that couple pharmaceuticals with device Used for imaging at the back of the eye to
screen for diabetes, glaucoma, macular
innovations. degeneration and other retinal diseases.
www.usa.nidek.com
Macular Degeneration
Macular degeneration is damage to or

breakdown of the macula of the eye. The
macula is a small area at the back of the
eye that allows us to see fine details
clearly. Macular degeneration makes
close work like threading a needle or
reading a book, difficult or impossible.
When the macula doesn't function
correctly, we experience blurriness or
darkness in the center of our vision.
Although macular degeneration reduces
vision in the central part of the retina, it
does not affect the eye's side or
peripheral vision. For example, you
could see a clock but not be able to tell
The Foresee Preferential Hyperacuity Perimeter (PHP) from
what time it is. Macular degeneration Notal Vision, based in Tel Aviv, Isreal. This is a non-invasive
alone does not result in total blindness. visual field analyzer for monitoring Age-related Macular
Degeneration. www.notalvision.com.
Most people continue to have some
useful vision and are able to take care of
themselves.

Home Healthcare Products
Major changes are expected in the home healthcare marketplace over the next three to
five years as people begin taking more direct charge of their health and manage their
wellness. The home health and remote patient monitoring market is currently close to a
$5.6 billion level and will continue to grow at close to 70% for at least the next three to
five years, according to a new strategic report published by Insight and Intelligence, a
Mary Ann Liebert company (www.liebertpub.com).
Existing diagnostic testing devices for end-use are evolving from Over-The Counter
(OTC) tests, which usually are simplified versions of established clinical laboratory or
Point-Of-Care (POC) based tests, to a new class of consumer diagnostics. Many existing
tests that can be purchased at pharmacies today are little more than sample collection
devices that are sent back to reference laboratories for analysis. New tests will be
technological advancements to meet the needs of consumers for rapid and effective
diagnosis and management of wellbeing.
Clinical diagnostic tests in the US only obtain FDA approval when the user is appropriately
qualified and the test environment is approved. The Clinical Laboratory Improvement
Amendments (CLIA) law specifies that laboratory requirements are to be based on the
complexity of the tests to be performed. The CLIA also established provisions for waiving
tests from a regulatory perspective if they meet certain requirements.
Waived tests are defined as simple laboratory examinations and procedures that are
cleared by the FDA for home use, employing methods that are simple and accurate,
rendering the likelihood of erroneous results negligible, or pose no reasonable risk of
harm to the patient if the test is performed incorrectly. Many providers of these
traditional laboratory waived tests are now converting them to tests suitable for sale to
consumers. As technological improvements make tests simpler and reduce the likelihood
of patient error, the number of diagnostic tests designed for home use or covered by the
CLIA waiver regulations will expand—increasing the number and range of tests available
to the consumer.
Diagnostic testing devices for the consumer market must also provide actionable
information for the individual being tested. The demands of the consumer and the
demands of a physician are often significantly different. Physicians typically seek
quantitative tests that enable them to create therapeutic regimes—they want to use the
numbers and inter-relationships with other factors to develop a course of action. Patients
tend to be more interested in tests that provide a positive or negative result—such as a
home pregnancy test—than those that are quantitative, such as at-home cholesterol tests.
Where the course of action is more obvious, as is the case with pregnancy test kits and
blood glucose monitors, patient acceptance has been widespread and the market has
developed significantly. Complete packages of test kit, education, and the means to
undertake specific actions, growth in new tests could be similar to that experienced to
date with diabetes home monitoring—which is an expanding market area by itself.

Home Health Categories
Two broad categories of home health monitoring devices are: 1) screening devices that
provide a diagnostic assessment for specific health conditions; and 2) monitoring devices
that collect body functioning data that can be either used directly by the patient or
transmitted to a clinical facility for further analysis.
Diagnostic screening tests can be further divided into:
Infectious disease detection tests--such as Streptococcal or HIV infections-- that

enable the patient to identify the condition and modify their behavior to prevent
transmission to others,
Chronic disease management testing--such as diabetes, high blood pressure,
congestive heart failure and kidney functioning—where regular testing can improve
the quality of life for individuals, and
Genetic screening—such as predispositions to heart diseases, certain cancers, and
drug efficacy prediction—which enables individuals to take actions and make
changes in their lifestyles to reduce their health risks.
Home Diagnostic Device Examples
Home testing devices, such as home pregnancy tests and hemoglobin tests for diabetics,
have been used for many years. New device technologies have improved ease-of-use and
accuracy of these tests. Additional test types are also becoming available for cholesterol,
fertility, and pathogen detection. A few examples are presented below.
Pregnancy and Ovulation
Inverness Medical Innovations, Inc. of

Waltham, Massachusetts
(www.invernessmedical.com) developed and
manufactures home pregnancy test kits
worldwide using the brand names of
ClearBlue, PERSONA, Accu-Clear, Fact- Above: Clearblue Home digital pregnancy test device
Plus and Clearplan. The company claims to have a consolidated #1 unit market share in
Below: Clearblue Easy Digital Ovulation Kit
the US, UK, France, Canada, Japan, Australia and Germany. They have also entered into
a Joint Venture Agreement with Proctor &
Gamble in 2007 under the name “Swiss
Precision Diagnostics” for development,
manufacturing, marketing, and sales of
both existing and to-be-developed
consumer diagnostic products.

Fertility Monitoring
Inverness Medical Innovations also makes the Clearblue Easy Fertility Monitor that
detects increases in luteinizing hormones and estrogen, which indicate times of increased
female fertility. This test
is an improvement in
sensitivity above the level
of other ovulation tests
and can inform users of up
to five additional days of
fertility surrounding peak
fertility days.
The test sticks are a

disposable component for
collecting urine samples.
The reader device is built
to read many samples over multiple ovulation cycles and is intended to last for years.
Glucose Monitoring
LifeScan, Inc., Milpitas, CA

(www.lifescan.com), a Johnson & Johnson Left: LifeScan OneTouch
Ultralink blood glucose
company, manufactures a line of blood monitoring system for use with
glucose meters for diabetes management. Medtronic Paradigm insulin
pump pictured below. Wireless
The company has recently developed a communication of glucose
meter that wirelessly communicates with levels enables rapid
adjustment of insulin dosing.
an insulin drug pump manufactured by
Medtronic. The benefits of the technology
are simplification of insulin bolus dosing
by eliminating the need for the patient to
enter data into the drug pump and rapid
control of dosing in response to glucose
level changes in the patient—such as
immediately before and after meals.
Many new blood glucose monitoring devices are expected to

be on the market in the next few years. The FDA Office of
In Vitro Diagnostic Device Evaluation and Safety lists over
20 glucose testing devices from 10 companies that have
received FDA 510(K) clearance since January, 2008.

Abbott Diabetes Care, based in Alameda, California and
a division of Abbott Laboratories, is introducing a
continuous glucose monitoring system called the
FreeStyle Navigator. By continuously monitoring
glucose levels, the system provides more and better
information than traditional finger-stick methods and
can lead to improved diabetes management.
The system has a glucose sensor and wireless

transmitter package that can be attached to the back of
the upper arm or to the abdomen and a small receiver Abbott Diabetes Care FreeStyle Navigator
continuous glucose monitor receiver.
system that can be worn on the patient’s belt or carried
in a purse. The device provides audible or vibrating
alarms before glucose levels become too high or low;
displays five directional arrows to help people
understand if glucose is rising or falling; and stores
historical data and glucose trend information for up to
60 days. The sensor and transmitter are designed to
accommodate showering, swimming and a range of
normal physical activities. FreeStyle Navigator sensor
and transmitter package
The sensor technology used in the FreeStyle Navigator uses amperometry to convert
glucose concentration in interstitial fluids to an electrical current. The filament used on
the sensor is 5mm in length, about the same thickness as several stands of hair.

Cholesterol Test Devices
Polymer Technology Systems of Indianapolis, Indiana (www.cardiochek.com) has

developed the CardioChek product line for point-of-care
diagnostic use and at-home cholesterol, triglycerides, HDL
cholesterol, glucose or ketones (fat metabolism) testing to
manage risks related to heart disease and diabetes.
The handheld analytical and display devices works with test

strips that hold a drop of blood from a finger stick that is
inserted into the device. The CardioChek provides results
within two minutes, is battery operated, and stores up to 30
test results for each type of test.
The company also manufactures a similar unit for use by The CardioChek system for
medical professionals that is CLIA-waived. consumer use. Made by
Polymer Technology Systems.
Infectious Disease Detection
Many tests are in development for use in the home for detection of a wide range of
infectious diseases, such as: influenza, strep throat, human
immuno-deficiency virus (HIV), malaria, lyme disease and
others. These tests are currently provided to clinical
laboratories and may eventually be available for home use
testing.
Devices that are currently on the market for use by clinicians

provide an insight to the design of future diagnostic devices for
infectious diseases.
Orasure Technologies, Inc. of Bethlehem, Pennsylvania

(www.orasure.com) markets the OraQuick ADVANCE Rapid
HIV-1/2 Antibody test which is an FDA approved and CLIA-
OraSure Technologies, Inc.
waived point-of-care test that provides accurate results for both OraQuick HIV rapid test
HIV-1 and HIV-2 in 20 minutes using oral fluid, finger-stick or
venipuncture whole blood or plasma specimens.

Home Monitoring Device Examples
The home “telemonitoring” market is an emerging market that electronically links

patients and home caregivers to remote healthcare support from doctors and other
healthcare service providers. Remote monitoring and interactive devices allows the
patient to send in vital signs on a regular basis to a provider without the need for travel.
Two notable organizations, the American Telemedicine Association (www.atmeda.org)

and the Telemedicine Information Exchange (http://tie.telemed.org) provide industry
information and list many manufacturers of telemedicine devices.
Some of the companies that are active in this market provide complete service
solutions—meaning that they provide proprietary devices for at-home biometrics,
networking infrastructure, data collection systems and remote call centers staffed with
nurses and physicians to support two-way communication between a healthcare provider
and a patient. Other companies provide devices or services that are integrated by
healthcare service companies to provide telemonitoring services.
Cardiocom, based in Chanhassen, Minnesota designs, manufactures, and supports all of

its products internally and has its own in-house research and development team and
manufacturing operations, along
with a full call-center staffed by
registered nurses. The products
and services operate as an
integrated system for specific
disease states. By incorporating
monitoring technology with
targeted, personalized care
management services and
advanced rule-based software,
Cardiocom provides a complete
patient management system.
Customizable monitoring
options are also available for
specific conditions. The two
largest disease management
services offered by Cardiocom
The Cardiocom Commander Home Monitor is an interactive home
are focused on cardiac conditions monitoring device for disease states such as CHF, Diabetes, COPD,
and diabetes. Other diseases that Asthma and Hypertension. The modular design allows selection of
the Cardiocom peripheral devices that provide the most appropriate
have dedicated systems include and cost-effective care for a patient. Patients also answer a series of
hypertension, end-stage renal questions about their current symptoms. Questions are both
displayed in large font and spoken. The data is transmitted over the
failure, high-risk obesity, COPD, patient's telephone line directly to a Commander Data Management
asthma, and obesity management. System at a remote telemedicine care facility.

Intel Corporation, based in Santa Clara, California, received FDA 510(K) clearance to
market the Intel Health Guide PHS 6000 in July, 2008 (www.intel/healthcare/telehealth).
This device enables two-way video communication between a remote patient and a
healthcare provider as well as connection to
biometric devices, such as heart rate, weight,
blood pressure, glucose, and other monitoring
devices.
The Intel Health Guide PHS6000 allows

patients to participate in a health session
personalized by the patient’s healthcare
professional for his or her specific situation.
During each session, the patient may measure
their vital signs, respond to health assessment
questions, receive educational information and
motivational messages, and surveys. Once the
session is completed, the results are made
available to authorized healthcare
professionals who can use the latest recorded
information to assess each patient’s health
status and to modify the patient’s care plan
accordingly.
Healthcare professionals can include

multimedia content as part of a patient’s
scheduled health session. Patients can also
access the content at anytime that is convenient
for them, and organizations can add additional
educational content to the patients’ libraries.
The system includes an integrated video camera, allowing healthcare professionals to

arrange and conduct two-way video calls with their patients. This helps them strengthen
their interaction with their patients by observing them performing specific tasks, or
providing advice and encouragement.
The Intel Health Guide PHS6000 may be connected to a variety of both wired and
wireless vital sign monitoring devices that have been tested and validated to ensure
interoperability with the Intel Health Guide PHS6000. From blood pressure monitors and
glucose meters to pulse oximeters, peak flow meters and weight scales, measurements
can be obtained as part of a regular session scheduled by the clinician or on an ad-hoc
basis.
Designing and manufacturing biometric devices that are compatible with the Intel PHS
6000 may be an opportunity for medical device manufacturers to participate in this
emerging and rapidly growing market.

Contract Manufacturing Opportunities
The rising tide of worldwide growth in medical devices has led many Original Equipment
Manufacturers (OEMs) to outsource some or all of the manufacturing for new products.
This provides the OEM with the ability to expand their revenues without excessively
increasing their long-term capital investments as well as a solution to finding specialized
manufacturing talent.
The future for OEM/contract manufacturer relationships is expected to be lucrative in

specialist areas. The trend towards the incorporation of outsourced technologies is
particularly prevalent in product areas related to implantable and in-vitro diagnostic
devices where the fusion of biotechnology, chemistry, and medical device technologies is
occurring. Manufacturers with capabilities for designing, manufacturing, and packaging
handheld diagnostic and therapeutic devices that combine nanotechnology, chemistry,
and biology are also expected to have high demand in the near future.
Companies that provide contract manufacturing services of many types and varieties
abound in the United States, as evidenced by viewing the hundreds of company listings in
the Medical Design Buyers Guide (www.medicaldesign.com). While there is a large
base of existing companies in the medical devices market, continued growth and
technological advancements will provide many opportunities for new entrants.
High-value opportunities are emerging

for contract manufacturers with
expertise in biocompatibility, anti-
microbial sterilization, device coatings,
drug release technologies, and
electronic medical device connectivity.
The sections that follow provide more
insight to these areas of expertise as
well as examples of technologies and
companies that may be either A mechanical heart valve from ATS Heart valve made from the
Medical, Minneapolis, Minnesota. aortic valve of a pig sewn
customers or partners for www.atsmedical.com. into a supporting stent made
medical device manufacturers. of polypropylene and Dacron
cloth. bme.biomed.dal.ca.
Biocompatibility
Biocompatibility refers to the use of synthetic or

natural materials used to replace part of a living
system or to function in intimate contact with
living tissue including materials that are safe
and conformable for human implantation, such
Cross-section drawing of heart showing placement of
as: heart valves, stents, and joint replacements. mechanical heart valve. www.worldmedassist.com.
Because the human body has complex chemical
and mechanical systems, the shape, geometry and surface treatments of the completed
device are also factors that affect biocompatibility.

Anti-Microbial Sterilization
While disinfection of materials that contact human tissues is always a concern of modern
healthcare professionals, Hospital Acquired Infections (HAIs) are a high concern due to
an increase in antibiotic resistant bacteria. Sterilizing substances or processes that kill or
inhibit the growth of microbes, such as bacteria, molds, or viruses are in increased
demand in hospital and outpatient clinics.
Chemical disinfecting agents, such as ethanol, isopropanol, phenolics, quaternary

ammonium salts, peroxides and glutaraldehyde kill micro-organisms almost
instantaneously but do not provide long-term protection. Triclosan and chlorhexidine
gluconate are now being incorporated into sutures and surgical preparation cloths to
reduce surgical site infections. Long-term micro-organism hostile surfaces are now being
made with silver, titanium dioxide, zinc oxide, and copper. (source: The Expanding Role
of Biocides in Medical Devices, Medical Device Link,
http://www.devicelink.com/mddi/archive/08/03/003.html.)
Biosafe, Inc., Pittsburgh, Pennsylvania (www.biosafe.com), manufactures a polymeric

material that physically disrupts the target organism’s cell membrane on contact. The
Biosafe material molecularly bonds to treated substrates and makes the material itself
antimicrobial. The material is said to be safe and effective against a broad spectrum of
fungi, bacteria, algae, and yeast. Biosafe material is available in solid and liquid forms as
well as in plastic resin masterbatch formulations. Applications include use for medical
textiles, wound dressings, catheters, surgical instruments, and architectural surfaces in
patient care rooms.
Getinge Group, a Swedish company with US headquarters in Rochester, New York

(www.getinge.com)and Steris
Corporation based in Mentor, Ohio
(www.steris.com) manufactures many
products for disinfection of medical
devices for manufacturers and medical
facilities. Steam sterilizers, or
autoclaves, are probably the most
common types of sterilizers in use
today. These systems come in many
different sizes and configurations to suit
particular needs. Other sterilization
devices for production systems include
steam and air mix sterilizers, Ethylene
A large steam sterilizer from Getinge
Oxide (EtO) sterilizers, electron beam
irradiation, and Vaporized Hydrogen
Peroxide (VHP) sterilizers. Both Getinge and Steris provide technical consultation
services for sterilization device selection. Steris also provides outsourced sterilization
services.

Device Coatings
Coatings are often used on medical devices for adding properties to surfaces for
biocompatibility, lubricity, anti-microbial action, electrical functions, and corrosion
resistance. These coatings help alleviate undesirable complications such as bacterial
infections, blood clot formation, and tissue trauma caused by device insertions. Typical
medical device applications include coatings for: stents, cardiac assist devices,
electrosurgical tools, mandrels and molds, catheters, elastomeric seals, needles and
epidural probes, and medical electronics. Many different coating materials and
application processes are used in the medical device industry. Polymeric materials can be
used in dry and solvent-based solutions (including water) for dip and spray material
applications. Various metals and alloys, such as titanium, tantalum, and titanium nitride
are applied with Physical Vapor Deposition (PVD).
AST Products, Inc. based in Billerica, Massachusetts (www.astp.com) produces a line of

coating materials for use on medical devices. These coatings are for solvent-free
processing and several types are available for lubricity, antimicrobial surfaces, and
hydrophilic, anti-thrombogenic and anti-encrustive treatments. The coatings are said to
be used in a wide variety of medical devices that have been approved by the FDA.
Specialty Coating Systems, based in Indianapolis, Indiana (www.scscoatings.com)

specializes in parylene conformal coatings. Parylene provides biocompatibility and
biostability as well as moisture, chemical and dielectric barrier protection. It also has a
low co-efficient of friction for lubricity. The company also provides coating services on
an outsourced basis.
Isoflux Biomed, based in Rochester, New York

(www.isofluxbiomed.com) provides coatings and PVD application
technologies at the nano- and micro-scale levels. These surface
treatments can enhance cell growth and promote bone in-growth in
implanted devices, such as orthopedics. They can also be used for
radiopaque coatings that provide improved x-ray visibility for stents
and other implantable devices where improved visibility for Titanium Nitride coating with
positioning and post-implant visualization using x-ray imaging are surface features averaging
approximately 75 nanometers
important considerations. from Isoflux Biomed.
Drug Release Technologies
Medical devices and drug delivery are converging and new methods of delivery beyond
ingestible pills and injectable liquids, such as transdermal patches, are now being used.
Device and drug combinations include functional augmentation of the device with a drug,
and drug delivery by an implanted device. Implantable devices can also use drug
coatings to increase their useful lifetimes and improve biocompatibility, such as coatings
on pacemaker leads or in drug eluting stents. New therapeutic approaches combine semi-

permeable polymer coatings for encapsulated cell therapies, such as islet cell
encapsulation for in situ insulin delivery for diabetes treatments.
Various combinations of materials can provide biodegradable drug coatings, extended

release coatings, and coatings that improve healing processes. The following companies
provide some examples of available drug coating technologies:
Surmodics, Inc. based in Eden Prairie, Minnesota (www.surmodics.com) manufactures

several drug coating products for medical devices. Their “Bravo” drug delivery polymer
matrix allows variations in the ratios of the polymers used in the coating to control drug
delivery rates and mechanical properties. This type of coating has been used for Drug
Eluting Stents (DES), a $4 billion segment of the global medical device market. The
Bravo coating technology can be used on metals, such as stainless steel, nitinol, titanium,
and cobalt chromium as well as polymers such as silicone, nylon, and high-density
polyethylene and polypropylene. It is also compatible with several coating processes,
including spray and dip-coating techniques. This allows medical device manufacturers to
automate production lines.
MIV Therapeutics, Inc. based in Atlanta, Georgia (www.mivtherapeutics.com) produces

drug delivery coatings based on hyroxyapatite and lipid-based materials. Hydroxyapatite
is naturally found in bone and tooth enamel. It is considered to be biocompatible and
does not trigger immune responses that are associated with some polymeric coatings.
The hydroxyapatite and lipid coatings are new and not widely used on medical devices
that are currently on the market.
3M Drug Delivery Systems, based near St. Paul, Minnesota

(http://solutions.3m.com/wps/portal/3M/en_WW/DDS/DrugDeliverySystems/ ) has been
providing transdermal drug delivery patches and component materials for over 20 years
and is said to provide 80% of the drug delivery patches in the US market. The
Microstructured Transdermal System (MTS) is a state-of-the-art micro-needle system for
transcutaneous drug delivery including vaccines, proteins and peptides to the dermal and
epidermal layers of the skin. 3M combines pharmaceutical expertise, formulation
chemistry, and adhesive know-how to develop transdermal drug delivery systems to
customer specifications.
Electronic Medical Device Connectivity
Electronic medical device connectivity is information systems technology that supports

remote data collection and analysis as well as workflow improvements through
Electronic Health and Electronic Medical Records (EMR) systems. The use of EMRs is
increasing throughout the medical system because it can help improve overall
productivity, reduce errors, and consequently improve patient outcomes while lowering
coasts. Connecting medical devices to the EMR system is important for further reducing
data input errors and improving the timeliness of data availability to caregivers.

Digital Picture Archiving and Communication Systems (PACS) is an example of medical
device connectivity that has become
widely used among radiologists for
storing radiological images and
making them available via secure
remote access to other medical
professionals involved in the
diagnosis and treatment of a patient.
Most PACS handle images from
several imaging systems including:
ultrasound, magnetic resonance,
PET, computed tomography,
endoscopy, mammography, and
digital x-ray images.
Connectivity of other medical devices, such as infusion pumps, blood analyzers, glucose
meters, ventilators, EKG units, and other devices into EMR systems will be a future
growth opportunity for embedded systems and software companies. Manufacturers who
are developing devices with EMR capabilities include: Cerner, GE Healthcare, Lantronix,
and Welch Allyn.
PACS image example. Source: www.wikipedia.com.
Cerner Corporation, based in Kansas City,
Missouri, (www.cerner.com) is a major
provider of computerized information technology systems to the healthcare industry.
They have created architecture for EMR systems called “CareAware” that connects
people and medical devices to improve workflows. Cerner is partnering with many
device manufacturers to certify the interoperation of devices with the CareAware
architecture. GE Healthcare and Welch Allyn are two companies that are Cerner
CareAware partners.
Lantronix, based in Irvine, California, (www.lantronix.com) is a secure computer

communications networking company. Lantronix offers embedded wired and wireless
(802-11b) solutions that can be easily incorporated into new equipment designs, as well
as solutions that can quickly network-enable existing equipment. Wireless affords the
benefit of not having to run wire through the hospital or laboratory and adds a great deal
of flexibility by making equipment truly mobile components of the Ethernet network.
Putting devices on the network gives staff an easy way to track equipment eliminating
wasted time spent trying to locate or account for missing devices.
Lantronix has developed remote patient monitoring and device management components
and systems for several manufacturers, including Bayer Diagnostics and Welch Allyn.

Materials and Processes
Technological advancements in the medical device industry are increasing the demands
on product designers to use new materials and maintain compliance with regulatory
requirements. Product engineers are tasked with turning those designs for new devices
into realized products that can be made at a reasonable profit. Additionally, products that
require sterilization have challenges related to the materials used, packaging, and
production processes cycle-times. New design and production tools are available to
medical device manufacturers for coping with these multiple challenges.
Materials
New materials for use in medical devices range from metal alloys, such as nitinol and
cobalt-chromium, to ceramics and plastics. Nitinol is a combination of nickel and
titanium that shape-memory characteristics. Nitinol is used for
implantable devices, such as stents, as well as surgical tools
such as kidney stone removal devices, where the shape
memory characteristics and high yield strength can be used to
advantage. However, nitinol can be difficult to machine and its
abrasive qualities make it hard on tooling. Companies active
Nitnol stent made by Pulse Systems
in Nitinol material and device development include Nitinol Development Corporation,
based in Concord, California.
based in Fremont, California (www.nitinol.info ), Pulse Systems, based in Concord
www.pulsesystems.com
California (www.pulsesystems.com), and 3M
(http://solutions.3m.com/wps/portal/3M/en_US/orthodontics/Unitek/solutions/archwires/Nitinol/ ).
Ceramics, composed principally of alumina and zirconia, provide high strength and
electrically insulting characteristics. Ceramic parts are used in electrosurgical
instruments to protect surgeons from the electric current running through the device.
Zirconia is a very rigid material and can be machined to tight tolerances. Orthopedic
devices and component parts for a wide range of implantable medical devices are now
being made with ceramics. Companies that are active in this area include CoorsTek,
based in Golden, Colorado (www.coorstek.com) and Morgan Technical Ceramics, a U.K.
company with U.S. offices in Bedford, Ohio (www.morgantechnicalceramics.com).
Plastic formulations can replace metals for use in some medical devices. Plastics can be
easier to machine and have electrical insulation properties similar to ceramics. Plastics
such as PEI, LCP and PEEK cost much less than ceramics, though plastics tend to move
more than ceramics when machining. Some biodegradable polymers are now used for
production of bone screws, which dissolve over time when implanted in the human body
and do not require a surgical procedure to remove them once they have served their
purpose.
New plastics are also being used to replace PVC materials for single-use disposable
medical devices due to concerns about long-term negative effects of plasticizers used in
PVC. Plasticizers used to make PVC flexible can migrate to varying degrees into the

surrounding environment. Results from
some animal trials have put health
authorities on alert by showing high levels
in the body of diethylhexyl phthalate
(DEHP)--the most commonly used PVC
plasticizer--which may have adverse affects
on reproduction and/or development. The
validity of the tests is disputed, but various
groups are taking a precautionary approach
to the use of PVC in general and DEHP in
particular. In the US, the FDA no longer
recommends DEHP for some applications,
including enteral feeding, dialysis and
tubing for newborns, young children and
pregnant women.
VisIV polypropylene-based, non PVC and DEHP free
However, PVC is still one of the most Intra-Venous drug dispensing container from Hospira,
frequently used polymers for medical Lake Forest, Illinois (www.hospira.com)
devices. Some 30% of the total world

market for plastics in medical devices is accounted for by PVC. Around 95% of all
medical-grade PVC goes into flexible containers, tubing and gloves, mainly single-use
devices. A market opportunity exists for developing non-PVC plastic versions of many
single-use products that are currently made of PVC. An example of a company that is
doing this is Hospira, based in Lake Forest, Illinois (www.hospira.com).
Computer-Based Product Design
New medical devices must comply with regulatory and market requirements and be
economically feasible for manufacturing, testing and sterilizing. Computer aided design
and manufacturing systems such as SolidWorks (www.solidworks.com) and
Pro/Engineer Wildfire (www.ptc.com) for 3-D solid modeling and mechanical design,
supporting Product Data Management (PDM) modules for the design software, and
ANSYS (www.ansys.com) for mechanical analysis.
Tools like Pro/Engineer include extensions that allow designs to be translated for CNC
machines and 2-axis to 5-axis milling and turning operations; enabling quicker cycle
times from concept to manufacturing. Analytical tools provide simulations for a wide
range of tests such as structural fatigue, thermal analysis, and fluid dynamics. Product
Data Management tools permit requirements and design traceability throughout the
product development cycle and support the FDA’s regulatory requirements. Use of
integrated computer software systems like SolidWorks enables medical product design
companies to work with contract manufacturers that can use those files on their CNC
equipment; reducing risks of error in translating the designs to a manufactured product.
An on-line listing of contract manufacturers who work with SolidWorks files can be
found at www.suppliersource.com.

Computer Controlled Machining
Many machining technologies have some type of computer control system interfaces that
allow precision cutting control and automation of the manufacturing process. Electronic
Discharge Machining (EDM) is used for production of medical devices such as
orthopedic implants, which are made of conductive metals, like stainless steel, and
titanium. EDM uses an electric arc to sculpt intricate geometries on conductive materials
to a dimensional accuracy on the order of ± 0.0001 inch. Widely viewed as a reliable and
precise machining technology, EDM provides burr-free, multi-axis machining of parts
that, because of hardness or shape may be difficult or impossible to machine by other
methods.
Wire EDM, or electrical discharge wire cutting, uses a thin piece of wire as the cutting
electrode. The process is similar to contour cutting with a band saw, though the wire
cutting edge never actually touches the material. The
heat of the electrically conductive wire vaporizes the
material by the action of rapidly occurring electrical
discharges that are applied to the work surface in a non-
conductive solution. 5-axis wire EDM machines are
capable of producing geometries that cannot be produced
with any other maching techniques and are capable of
interpolation in nanometers. Companies that make EDM
machines include: Agie, Fanuc, Makino, and Mitsubishi,
as well as many others.
Other manufacturing technologies that are used for Fanuc Wire EDM system.
micro-sized components used in the medical device www.methodsmachine.com
industry include:
CNC Milling, which uses computer-controlled cutting tools to sculpt materials to

tolerances of ± 0.0002 in.
Metal Injection Molding, which produces complex shapes, multiple wall thicknesses
and surface detailing in a single component to tolerances of ± 0.004 in.
Photochemical Etching, which creates 2-D profile geometry on thin, flat parts to
tolerances of ±0.001 in. on materials that may be as thin as 0.002 in.
Precision Metal Stamping, for producing complex shapes and intricate geometry
through a series of stations in a progressive die to tolerances of ±0.001 in., at speeds
of hundreds of parts per minute.
Swiss Screw Machining, for production of seamless cylindrical components with
capability for cross-drilling and slotting.

Surface Coating Application
Surface coatings are used to provide or enhance

biocompatibility, enhance electrical properties, to provide
chemical and moisture barrier properties, to influence
frictional properties, to improve hygienic properties, or to
improve cosmetic perception of a finished product.
These coatings may also facilitate the application of other
coatings and to control the extraction or release rates of
compounds within the substrate materials.
Incorporating Physical Vapor Deposition (PVD) and

Chemical Vapor Deposition (CVD) coating systems as
well as more traditional spray and dip coatings into
production processes for medical devices can be
challenging. Many PVD and CVD coatings are applied ICM 10 batch PVD system from Isoflux,
Rochester, New York. www.isoflux.com.
either by outsourced service providers or in batches. On-
line directories, such as www.thomasnet.com and www.globalspec.com can be useful
resources in locating contract surface coating specialty firms as well as providers of PVD
and CVD equipment for use directly at the manufacturing site.
Sterilization
Sterilization processes include: steam, or autoclaving; Ethylene Oxide gas (EtO) applied
under vacuum; Gamma ray ionization; and cold plasma-based sterilization. Cold plasma
is a recent alternative for low-temperature sterilization of biomedical devices created by
applying an electric or magnetic field to a hydrogen peroxide solution. Materials,
volume, surface texture and features
all create a need for different cleaning
and sterilization procedures.
Product material compatibility, device

designs, and manufacturing process
integration are key considerations for
selecting a sterilization process. As an
example, gamma and e-beam radiation
are rapid sterilization methods, though
gamma irradiation can damage some
products or packaging and e-beam
radiation can be harmful to products E-Beam sterilization system from Getinge, a Swedish company with
containing batteries or electronic US headquarters in Rochester, New York. www.getinge.com.
components and can also degrade
rubber and polypropylene. However, gamma radiation is very useful to sterilize enclosed
places and e-beam is widely used for sterilization of packaged products.

Ethylene oxide (EtO) sterilization is
widely used, though some plastics
absorb large amounts of EtO and require
extended periods of post-sterilization
aeration. Complete EtO sterilization
cycles can take two to three days.
Some devices that require sterilization of

cavities below a surface layer may either
not be candidates for EtO sterilization or
require higher temperatures and vacuum
chambers for getting the EtO into those
cavities. An advantage of EtO is that
many pallets of medical devices and
packaged materials can be sterilized
simultaneously in the same device. EtO
diffuses several millimeters into surfaces
and penetrates all kinds of packing A large-scale EtO sterilizer system from Getinge
materials.
Validation of sterilization takes the form of biological and parametric indicators.

Biological testing consists of sending samples from the sterilization batch to a testing
service that cultures the devices to growth any bacteria remaining on the devices.
Biological testing typically takes two to seven days to
complete. Parametric testing requires measurements of
EtO concentration, relative humidity and product
temperature in the sterilization chamber to determine
sterility. Parametric testing requires tight validation of
measurement devices, though it can speed turn-around
times compared to biological validations.
Most sterilization equipment manufacturers, such as

Biological sterilization test kit from Steris,
Getinge and Steris, have consulting groups that help in based in Mentor, Ohio. www.steris.com.
selection of sterilization methods and equipment.
There are also sterilization consulting companies that can provide guidance without
allegiance to one manufacturer’s product line. Sterilization can also be outsourced to
contract firms that provide consulting services as well as production volume
sterilizations.

Regulatory Factors
The medical device industry is heavily regulated and, according to AdvaMed, compliance
with FDA regulatory requirements is the top factor influencing companies’ ability to
develop new medical technologies. The US Food and Drug Administration (FDA) is the
principal federal agency responsible for protecting the public from unsafe or ineffective
products and they monitor the manufacture, transport, storage, importation, and sales of
foods, drugs, medical devices, and cosmetics--totaling over $1 trillion in annual sales.
Establishment Registration
Manufacturers must obtain FDA approval of their products before they can sell them in
the United States or export them abroad but does not regulate devices that are both made
and sold abroad. Establishments involved in the production and distribution of medical
devices intended for marketing or leasing in the United States are required to register
with the FDA. This process is known as “establishment registration” and it applies to
operators engaged in the manufacture, preparation, propagation, compounding, assembly,
or processing of a medical device intended for commercial distribution.
Establishment registration includes manufacturers, contract manufacturers and contract

sterilizers that place the device into commercial distribution, specification developers,
repackagers or relabelers, reprocessors of single-use devices, remanufacturers, US
manufacturers of export only devices, and manufacturers of components or accessories
that are ready to be used for any intended health-related purpose and are packaged or
labeled for distribution. Fees apply for this registration and the 2008 fee is $1,706. More
information about FDA establishment registration can be found at:
http://www.fda.gov/CDRH/devadvice/341.html.
Registration of an establishment is not an approval of the establishment or its products by

the FDA. It does not provide clearance to market medical devices. Medical device
manufacturers are required to provide extensive documentation of their products’ safety
and effectiveness before giving marketing approval. More information about FDA
compliance requirements for medical devices can be found at
www.fda.gov/CDRH/comp/gmp.html .
Device Claims Require Supporting Data
In order to receive FDA clearance for marketing a medical device, the FDA requires
manufacturers to give the agency data supporting their claims for their devices; the
amount of evidence required depends on the degree of risk to the patient using the device.
Devices may fall into one of three general classifications for new submissions, depending
on potential risks.

FDA Medical Device Classifications
The FDA requires manufacturers to provide them with data to support any marketing and
clinical claims made for their devices. The amount and type of data required varies
depending on the degrees of risks to patients.
The FDA has three categories for new medical devices submitted for review that are
based on the relative degrees of risk.
Class I Devices: include commodity products such as stethoscopes, scalpels, and

other commodity products that pose relatively little patient risk. Makers of these
products need only register their establishment, conform to Good Manufacturing
Practices (GMP) and notify the FDA at least 90 days before they start marketing
the devices. GMPs are standards set by the FDA for ensuring manufacturing
quality. More information about GMP requirements can be found at
www.fda.gov/CDRH/comp/gmp.html.
Class II Devices: include devices that present a moderate degree of risk to the
patient. Examples include x-ray machines, endoscopes, and surgical lasers.
Manufacturers have to provide the FDA with some evidence of safety and
efficacy and meet certain performance standards. In addition, they are
responsible for post-market surveillance and maintenance of patient registries.
Class III Devices: these are sophisticated products that present significant risk to
patients and must go through extensive clinical trials before undergoing FDA
reviews. Included in this category are life supporting devices, such as implantable
cardiac pacemakers, angioplasty catheters, stents, and similar devices that prevent
potentially dangerous medical conditions such as heart attacks and cardiac
arrhythmias.
FDA Modernization Act
The Medical Device User Fee and Modernization Act of 2002 brought new
responsibilities, resources, and challenges to the FDA. Three important provisions that
affect manufacturers are:
• Pre-market review user fees, including reviews of reprocessed single-use medical

devices, for funding the device application review process.
• Manufacturing facilities are inspected by accredited third party inspectors under
carefully prescribed conditions
• New regulatory requirements apply to re-processed single-use devices, including
a pre-market report submission. Reprocessed single use devices are defined as
those originally intended for one use, or use on a single patient, that have been
used but are then reprocessed to allow subsequent use as though they were new.

FDA Approval Path
Manufacturers of new medical devices typically start the FDA approval process using
one of two types of filings—a premarket notification or a premarket application.
Complex devices may also require an Investigational Device Exemption (IDE), which is
an FDA approval to use the device in clinical trials.
Premarket Notifications
Premarket notifications are also known as 510(k). This is a more commonly used filing
and applies to devices that are Substantially Equivalent (SE) to approved products
already on the market. Many Class I devices are exempt from the 510(k) process,
although other regulations apply. Once the device is determined to be SE, it can then be
marketed in the U.S. The SE determination is usually made within 90 days and is made
based on the information submitted by the submitter. Detailed information about the
510(k) process can be found at www.fda.gov/CDRH/DEVADVICE/314.html.
In many cases, descriptive data and a labeling review are sufficient, though some devices
may require further clinical studies to support a 510(k). Before marketing a device, each
submitter must receive an order, in the form of a letter, from FDA which finds the device
to be substantially equivalent and states that the device can be marketed in the U.S. This
order "clears" the device for commercial distribution. The submitter may market the
device immediately after 510(k) clearance is granted.
The FDA does not perform 510(k) pre-clearance facility inspections. The manufacturer
should be prepared for an FDA quality system inspection at any time after 510(k)
clearance.
Premarket Applications
Premarket applications (PMA) apply to most Class III devices due to the level of risk.
PMA is the most stringent type of device marketing application required by FDA. The
applicant must receive FDA approval of its PMA application prior to marketing the
device. PMA approval is based on a determination by FDA that the PMA contains
sufficient valid scientific evidence to assure that the device is safe and effective for its
intended use(s). An approved PMA is, in effect, a private license granting the applicant
(or owner) permission to market the device. The PMA owner, however, can authorize use
of its data by another.
FDA regulations provide 180 days to review the PMA and make a determination. In
reality, the review time is normally longer. Before approving or denying a PMA, the
appropriate FDA advisory committee may review the PMA at a public meeting and
provide FDA with the committee's recommendation on whether FDA should approve the
submission. After FDA notifies the applicant that the PMA has been approved or denied,
a notice is published on the Internet (1) announcing the data on which the decision is
based, and (2) providing interested persons an opportunity to petition FDA within 30

days for reconsideration of the decision. More information about PMA can be found at:
http://www.fda.gov/CDRH/DEVADVICE/pma/.
Investigational Device Exemption (IDE)
An investigational device exemption (IDE) allows the investigational device to be used in

a clinical study in order to collect safety and effectiveness data required to support a
Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission
to the FDA. Clinical studies are most often conducted to support a PMA. Only a small
percentage of 510(k)’s require clinical data to support the application. Investigational use
also includes clinical evaluation of certain modifications or new intended uses of legally
marketed devices. All clinical evaluations of investigational devices, unless exempt, must
have an approved IDE before the study is initiated.
Clinical evaluation of devices that have not been cleared for marketing requires:
• An IDE approved by an institutional review board (IRB). If the study involves a

significant risk device, the IDE must also be approved by FDA;
• Informed consent from all patients;
• Labeling for investigational use only
• Monitoring of the study and;
• Required records and reports.
An approved IDE permits a device to be shipped lawfully for the purpose of conducting
investigations of the device without complying with other requirements of the Food,
Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution.
Sponsors need not submit a PMA or Premarket Notification 510(k), register their
establishment, or list the device while the device is under investigation. Sponsors of
IDE's are also exempt from the Quality System (QS) Regulation except for the
requirements for design control. More information about IDEs is available at:
http://www.fda.gov/cdrh/devadvice/ide/index.shtml.
Non-US Regulatory Requirements
The US leads the world in medical technologies and is the leading exporter of medical
products. Therefore, compliance with regulatory requirements for overseas markets are
very important for continued revenue growth.
Non-US regulatory requirements for new medical devices vary significantly. The largest
markets for medical equipment outside of the US are the European Union (EU), Japan,
Canada, China, Brazil, Taiwan and Australia. Japan, Australia, and the EU have
regulatory processes that are similar to the US FDA in that they establish criteria for
approval based on the device’s risk to the patient and the commercial availability of
substantially equivalent devices. Many countries in Latin America and Asia have
minimal regulatory requirements, though the expectation is that this will change in the
years ahead.

The process for obtaining marketing approvals in overseas nations ranges from months to
years. Some nations permit human studies earlier in the product development cycle than
the US allows. Others, such as Japan, have standards very similar to the US FDA.
The EU countries require medical devices and products to have a Conformité Européene
(CE) mark before they can be sold. The CE mark indicates product conformance to EU
standards for safety, construction, and performance. An oversight organization
comprised of representative from EU member states reviews supporting data for new
medical devices and grant CE marks to approved products. The CE mark allows
products to be sold in any EU country without separate approvals from each member
country. The EU regulatory process for devices has traditionally been less demanding
than the US FDA processes, though it is expected that the EU processes will become
more stringent in the future.

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Emerging Medical

111 Lomb Memorial Drive

July 2008 ©Rochester Institute of Technology. All Rights Reserved

Executive Summary .......................................................................................................... 1

July 2008 ©Rochester Institute of Technology. All Rights Reserved

Device segments that are expected to have high growth include:

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 1

Contract manufacturing opportunities abound in the medical device industry. Companies

Computer-based design and manufacturing technologies enable medical device creators

The FDA provides extensive amounts of information concerning medical device

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 2

Aging populations, technology innovations, and opportunities in non-U.S. markets are

of products, leading to a range in United Kingdom

the U.S. market for medical and United States

dental equipment and supplies, 0 10 20 30 40 50 60 70 80 90 100

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 3

Largest US-based Medical Device Companies

Total Sales 2007 Medical Device Foreign sales

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 4

Device segments that are expected to have high growth include:

Medical devices that are surgically introduced into the human

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 5

Cardiac Rhythm Management

Cardiac Rhythm Management (CRM) products include: pacemakers, implantable

Other Implantable Electro-Medical Devices

Muscle stimulators, neurological stimulators, insulin and pain

Manufacturing of these subcomponents is provided by a range of companies that are

The largest manufactures of implantable electro-medical devices includes: Medtronic,

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 6

The US orthopedics market, which accounted for more than 54%

Stainless steels, cobalt-chromium alloys, titanium and

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 7

Implant Fabrication Processes

Machining of implant materials is usually performed

Investment casting is often used for implants that have

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 8

Polyethylene fabrication begins with Ultra High Molecular Weight PolyEthylene

Post Fabrication Coatings

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 9

Reconstructive Spinal devices

DePuy/ Johnson & Johnson Warsaw, IN (reconstr.)

Smith & Nephew

Others N/A 11% 13%

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 10

Blood glucose testing is a strong

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 11

Company headquarters Global IVD

Roche Diagnostics COBAS Blood Serum Analyzers

Abbott Laboratories ARCHITECT immunoassay system

Beckman Coulter, Inc. UNICEL SYNCHRON ACCESS Clinical System

Bio Merieux SA VIDAS automated multiparametric

Sources: Standard & Poor’s and company websites

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 12

 Diagnostics, including handheld office-base diagnostic instruments

Diagnostic instruments are the key tools

can be integrated into therapeutic

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 13

Diagnosis and treatment for cataracts has

Cataract surgery is considered to be one of the most commonly performed ophthalmic

Refractive Eye Defects

July 2008 ©Rochester Institute of Technology. All Rights Reserved. 14

Laser vision correction continues to evolve. These

However, these systems are very expensive and

Diagnostics, including handheld office-base diagnostic instruments

Infectious disease detection tests--such as Streptococcal or HIV infections-- that

CNC Milling, which uses computer-controlled cutting tools to sculpt materials to