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Device Markets and
Technologies
July, 2008
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.
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.
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
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.
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.
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
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 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.
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.
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-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.
Implantable Devices
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.
Manufacturers
Orthopedic Implants
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.
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.
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.
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
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.
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.
Zimmer
www.zimmer.com Warsaw, IN 26% 4%
Stryker
www.stryker.com Kalamazoo, MI 20% 9%
Biomet
www.biomet.com Warsaw, IN 10% 4%
Medtronic
www.medtronic.com Minneapolis, MN -- 41%
Synthes
www.synthes.com Solothurn, Switzerland -- 13%
Sources: Stryker Corporation 2007-2008 Fact Book and individual company websites
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.
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.
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:
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
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.
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.
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
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.
Macular Degeneration
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.
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.
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.
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.
Glucose Monitoring
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.
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.
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.
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.
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.
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.
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.
Biocompatibility
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.
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).
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-
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 has developed remote patient monitoring and device management components
and systems for several manufacturers, including Bayer Diagnostics and Welch Allyn.
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
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.
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:
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.
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.
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.
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 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.
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:
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
Clinical evaluation of devices that have not been cleared for marketing requires:
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.
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 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.