Medical Devices - Managing The Mismatch

7/22/2014 COMMENTS ON THE REPORT OF THE WORLD HEALTH ORGANIZATION, MEDICAL DEVICES: MANAGING THE MISMATCH GMTA - Glo
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COMMENTS ON THE REPORT OF THE WORLD HEALTH

ORGANIZATION, MEDICAL DEVICES: MANAGING THE
MISMATCH
The Global Medical Technology Alliance (GMTA) represents medical technology associations whose members supply nearly
85 percent of the medical devices and diagnostics purchased annually around the world. These members produce the medical
devices, diagnostic products and health information systems that are transforming health care through earlier disease
detection, less invasive procedures and more effective treatments and range in size from the largest to the smallest medical
technology innovators. They bring medical technology to patients around the world in every setting.
The GMTA is eager to play a constructive role in helping to resolve the worlds healthcare problems. We believe that the
medical technology industry is actively developing innovative solutions, supporting health system capacity-building, and
training health care providers to address many of the recognized problems of health care in the developing world
The GMTA would like to put forward a specific suggestion for consideration for the medical technology industry and World
Health Organization (WHO) to work together to address the aligned 15 public health needs identified in this report. We
recommend the establishment of an expert advisory group that would include industry to work with a WHO group on the
identified public health needs and develop solutions to address specific situations, on the ground, in a country. It is very
possible that there may be companies already working and innovating in these countries to address these issues, and we could
help identify work underway and best practices.
When addressing use of technology for more advanced treatments, there are inputs that must be considered, such as
improving human resource training, expertise, spare parts for equipment, maintenance, reliable power supply, clean water, etc
which would require local government support. Involvement by the local government would be very important to the success
of such an effort. An expert advisory group could also be used to explore how local manufacturing could be encouraged for
local conditions. Another suggestion would be to break the issues into substantive groups and provide room for more than
one working group to consider the range of issues and make recommendations on solutions.
We look forward to working constructively with the WHO to help address the concerns identified in the Report.
General Comments
http://www.globalmedicaltechnologyalliance.org/comments-on-the-report-of-the-world-health-organization-medical-devices-managing-the-mismatch.html
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The GMTA welcomes the opportunity to comment on the WHOs report Medical Devices: Managing the Mismatch (the
Mismatch report). This report helps to elevate a much needed discussion on the importance of medical devices as part of a
sustainable healthcare infrastructure. We appreciate the Mismatch reports recognition of the development of increasingly
innovative medical technology by the private sector during the past 50 years. The Mismatch report also highlights the
diversity and complexity of the 10,000 major categories of medical devices and diagnostics. In addition, this report makes an
important contribution by distinguishing medical devices from pharmaceuticals, especially in the need for training in the use of
medical technology. We strongly endorse the role medical devices can play in improving patient lives, as documented by the
Mismatch report.
We are concerned that the Mismatch report does not consistently address a number of key factors including the importance of
incremental innovation, the need to consider healthcare needs in their overall setting, and the role of market forces in
rewarding, or punishing, companies that manufacture medical technology. Some chapters of the report recognize these forces,
but in other sections, these factors are ignored.
The mismatch in this report appears to be based on the false assumption that public health needs can first be identified by
some external agent and then industry can be directed to manufacture medical technology on the basis of those needs. That is,
somehow the right medical products would have been developed and not the vast array of marvelous technologies on the
market if only the mismatch had been identified in advance. We take issue with the statement, that research is often not
based on public health needs. While we recognize that the full array of devices appropriate for every setting on the face of the
globe and for every disease may not be available today, our contribution to improving global public health is nothing short of
remarkable.
We believe an important element missing from the Reports discussion of the wider context of the complete health-care
package necessary to address public health needs is recognition of infrastructure needs such as access to electricity and
clean water and the role of government in providing that infrastructure. The Mismatch report seems to focus on requiring
medical devices to conform to the overall healthcare setting, instead of promoting a more integrated approach appropriate to
the needs of each country. The Mismatch recommendations also do not appear to be placed in the context of overall resource
allocation for healthcare in low resource countries. In preparing the Priority Medical Device project, which appears to be the
foundation for the Mismatch report, the major recommendations relate to ensuring countries purchase the correct relative mix of
medical technologies. This is an important issue. However, for low resources countries, the larger question in terms of priorities
is whether scarce resources would be better allocated to tackling other problems. For example, the UN estimates that 884 million
people lack access to safe drinking water and 39 percent of the worlds population lacks adequate sanitation. Solving these
severe problems would not only be major triumphs in themselves but also substantially improve the performance of some
medical devices and diagnostics in low resource countries.
The report does not acknowledge the global spread and interrelationship of major diseases and the resulting concerted effort
needed to resolve them. For example, WHO predicts that 700 million adults will be obese by 2015. Obesity causes a range of
health ailments including diabetes. WHO predicts that countries with the most cases of diabetes in 2030 will be China and India
both rapidly growing emerging markets, not low resource countries. And, both countries have expanding medical
technology industries that are developing medical technologies to address their countries healthcare needs. Thus, the 10/90
concept, which was developed in 1990, is out of date in terms of both the location and nature of the problems and the efforts
underway to resolve them.
As Dr. Nancy E. Oriol, Dean for students at Harvard Medical School, explains, The same factors that determine todays health
will determine tomorrows health: access to clean water, safe air, adequate food and societys determination to practice healthy
lifestyles. And, as the UKs Chief Executive of NICE, Sir Andrew Dillon, stressed, given that there is a limit to how much can
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be spenton healthcarea system should focus on things that make the most difference.
When placed in this broader context, attention should be devoted to determining how countries can best use limited healthcare
resources, including the purchase of medical technology. The medical technology industry is actively engaged in addressing
global health system disparities. We too are searching to find solutions to the 4 As highlighted in the report: Availability,
Accessibility, Appropriateness and Affordability. Indeed, the market forces that brought forth the current medical technology
marvels are at work on new generations of products. Some of these medical technologies are already being manufactured for a
variety of economic and environmental settings, with the prospect of many more in the future. These advances are being made
not only in companies that are viewed as current market leaders such as those listed in the Mismatch report but are also
coming from rapidly emerging markets, such as China, India and Brazil. Companies in emerging markets are creating frugal
technologies for their own people and plan to export such medical devices to others in the future.
Comments on the Body of the Report
Medical Devices
There is some discussion in the report on the differences between pharmaceuticals and medical devices. A key difference
between the two is rapid innovation this combined with the high number of competitors in the field, leads to a downward
pricing trend for new technology. The report reflects a misunderstanding of how innovation works as pointed out in section
2.2.2. Future Trends, second paragraph: the lure of technology is strong, but the cost-effectiveness, real need, and likely
usefulness of many innovative technologies are questionable. For example, ultrahigh-field strength MRIs, robotic assisted
surgical systems, and proton radiation therapy have uncertain benefits and high financial costs.
A good example of technology that had uncertain benefits and high financial costs is cellular telephones. In the 1980s, this
was a very new technology that was very expensive, difficult to use, and available only in the developed world. Given rapid
innovation, the design improved and the prices dropped dramatically. Now, in 2010, it is a technology that is common place and
has become extremely important in the developing world, including for healthcare. The same will hold true for those
technologies above.
In Annex I to our response, please find a matrix describing some of the key ways and differences in how medical devices
innovate.
Within the Public Health Needs section, there is a criticism of physicians preference. While training and information is needed
to be able to make an informed decision, we believe that the appraisal and decision of using a specific device should rest with
the healthcare professional. We would like to emphasize the positive role of industry to develop training programs for
physicians and health care works.
In Annex II, please find a list of examples of industry working in low resource settings to help develop sustainable, local
healthcare infrastructures around the world.
The description of the Priority Medical Devices Project encourages the questions: is there confirmation and validation of the
data? It appears that the data are frequently misaligned and contradictory. There is a marked difference in the list of 15 diseases
(table 4.1) and the list of priorities as produced by the survey of 4 countries. In table 4.5, for example, cancer and cardiovascular
diseases in general are raised as top priority in the country survey while not appearing in the top 15 from the WHO. An aligned
priority list from countries and WHO would be very useful in targeting efforts and identifying resources to address these needs
and disease states.
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Medical Devices: Problems and Possible Solutions

HTA
While we recognize the potential value of using Health Technology Assessment (HTA) for the allocation of resources to
healthcare products and services, its application to medical devices must recognize their special and unique characteristics and
avoid the pitfalls of using the criteria traditionally developed for pharmaceuticals and medical services. HTA is difficult to adapt
to local situations which vary and is difficult to maintain current in the face continuous modification of devices and technology
leaps. These, and other complexities, were raised during the HTA sessions at the First Global Forum on Medical Devices in
Bangkok.
From a methodological standpoint, it is imperative that HTA for medical devices allow for the fact that the benefits of medical
devices are realized over an extended period of time that goes beyond the typical time horizon used for HTA (usually a year or
less) whereas most of costs are accrued upfront. For many medical devices, benefits of devices are realized over several years
(e.g. orthopedic hips, joints, and also cardiovascular products like stents, pacemakers). This introduces a potential asymmetry
between benefits and costs as calculated in standard HTA processes and biases the results against devices. For drugs, each
units benefit and costs are almost contemporaneous. In addition, due to the operator effect present in devices, any (context)
independent measurement of benefits as done for pharmaceutical in HTA is nearly impossible. This must be accounted for.
From a process standpoint, as we look to different models of HTA around the world (NICE, etc) it is important that we adopt a
broad approach to the type of HTA mechanism that may be used. A key element is the inclusion of stakeholder input and
transparency of decision-making by HTA bodies. This is often overlooked or excluded in any one-shot and unilateral decisionmaking process to the detriment of the soundness of the ultimate decision-making as it can preclude the use of evidence and
data best known to and understood by the supplier of the technology.
Post Market Surveillance
There is a mention in the report of the failure of existing Post Market Surveillance systems, but there are no data to support
these claims. That being said, it is likely that there may be under reporting due to lack of personnel and training to do such
surveillance. Member states should focus their effort on adverse events as it has been proven to be the most efficient way to
monitor a market in a dynamic innovation climate. Industry can play a role in training on how to gather data on use of devices,
and set up registries. The National Competent Authority Report program of the Global Harmonization Task Force (GHTF) is a
platform that could be further developed by including third world countries with WHO support and possibly financing.
Clinical Guidance
Industry supports clinical guidance provided they are elaborated with the adequate experts, from a technology standpoint
(Industry) and from a use standpoint (Users). Local priorities, skills and use differ from one country to another and bundling all
developing countries under blanket guidance may create another gap by giving an artificial big picture not supported by local
use data.
Dealing with Corruption
The report correctly states that corruption is an issue that should be addressed to improve patient access to needed medical
technology. Industry supports establishment of ethical and sales codes of conduct. The root cause for corruption may in most
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cases lie with the user/purchaser. Industry values the development of mechanisms for good procurement practices that may be
enforced locally. The GMTA members are working to establish harmonized codes of ethics for their corporate members and
work on this issue is on-going within the Asia-Pacific Economic Cooperation organization as well as in other forums.
Please find a list of the websites for these codes in Annex III.
Developing a Single Nomenclature
The purpose of a medical device nomenclature system is to facilitate identifying, processing, filing, storing, retrieving,
transferring, and communicating data about medical devices, particularly for the identification of devices involved in adverse
incident reports. There is a need for a common nomenclature and harmonization between existing regulatory systems.
There are two major nomenclature systems Universal Medical Device Nomenclature (UMDN) and Global Medical Device
Nomenclature (GMDN). Nomenclature is used to exchange data in the healthcare community by describing medical devices
with similar features, characteristics and intended use. GMDN forms the basis of medical device regulations in many
jurisdictions. UMDN is mainly used by health institutions. GMDNs structure is based on risk, so it is not only used in
purchasing; it is also used between regulatory bodies for market surveillance and adverse incidents reporting.
We offer the following current status of nomenclature efforts in various countries:
USA: UMDNS is adopted for healthcare purposes, while CDRH nomenclature is used for regulatory purposes. FDA has two
people constantly working with the GMDN Agency. In its draft UDI regulation and pilot program, FDA includes GMDN.
Canada: Currently Canada is not requiring GMDN for registration, but captures GMDN codes if they are provided.
Japan: JMDN is a translation of an early version of GMDN. It is used for regulatory purposes to define all classes of devices
and was established in 2005. There are currently no ongoing contacts with the maintenance agency and the new terms
developed by it. Coherence on the international level and the creation of new terms are therefore an issue. However, there is
currently no plan to join an international effort. The Ministerial Notification #298 (July 20, 2004) lists JMDN and their
classification.
Australia: The GMDN is mandatory within the TGA system and is detailed in the legal framework.
EU: The European Commission has undertaken the translation of all current terms into the 20 official languages of the EU. This
will remove the barrier for the implementation of the EU post-market vigilance system (EUDAMED).
GHTF: GMDN is accepted by GHTF as the definitive nomenclature to be used for generic identification. The GMDN Agency
has recently reformed its governance structure to ensure it is sustainable, accessible and transparent to address the increasing
interest of regulators and industry. It is currently working on funding models to make the nomenclature freely available.
Asian Harmonization Working Party (AHWP): has two nominees on the board of trustees of the GMDN Agency and five
nominees on policy advisory group.
We believe WHO has a role to support GHTF efforts in working with the GMDN Agency and making GMDN a single and
globally accessible nomenclature. WHOs support would add considerable weight for a global acceptance of the GMDN
nomenclature
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Barriers to using medical devices

The report states that lack of training is not the only cause of use errors, mistakes often results from a combination of factors
such as poor equipment design, poorly written labels and failures to read equipment manuals.
GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of
medical devices, the lack of which is a source of the problems identified. The purpose of the GHTF is to encourage
convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices,
promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished
is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents provide a
model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities.
The GHTF guidance document on Essential Principles of Safety and Performance of Medical Devices GHTF/SG1/N41R9:2005
provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant
to each medical device. These are grouped as:
Chemical, physical and biological properties.

Infection and microbial contamination.
Manufacturing and environmental properties.
Devices with a diagnostic or measuring function.
Protection against radiation.
Requirements for medical devices connected to or equipped with an energy source.
Protection against mechanical risks.
Protection against the risks posed to the patient by supplied energy or substances.
Protection against the risks posed to the patient for devices for self-testing or self-administration.
Information supplied by the manufacturer.
Performance evaluation including, where appropriate, clinical evaluation.
The manufacturer selects which of the design and manufacturing requirements are relevant to a particular medical device,
documenting the reasons for excluding the others. The Regulatory Authority and/or Conformity Assessment Body should
verify this decision during the conformity assessment process.
The guidance document on labeling: Labeling for Medical Devices GHTF/SG1/N43:2005, requires labeling to serve to
communicate safety and performance related information to users of medical devices and/or patients as well as to identify
individual devices In particular, instructions for use should be written in terms readily understood by the intended user
and, where appropriate, supplemented with drawings and diagrams. Some devices may require separate information for the
healthcare professional and the lay user.
Regarding translation, ideally training manuals would be available in all languages in a way that would convey the same
meaning in all languages. However the industry does not yet have them in all languages in developed countries due to the
huge cost and safety issues associated with translation and complying with standards. One option may be to explore the
increased use of symbols in accordance with international standards.
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Barriers to Innovation
Medical device regulation
Medical device regulation regimens are established in over 70 countries in the world. Medical device regulation should ensure
safety and performance of medical devices as well as timely access to these devices. Two major reasons for the lack of
regulatory systems are the lack resources and capability, and ignorance of the medical device sector and the work that has
been done by GHTF.
In 1993, WHO published its guiding principle for medical device regulation. In this guidance, it clearly indicates the following:
Implementing a full regulatory programme can be very expensive and demanding on resources. The work of the GHTF and the
trend to use international standards are, in effect, tackling this problem by steering manufacturers more and more toward
producing medical devices with uniform standards. The methods and procedures relating to governmental regulations are also
converging. These developments create opportunities for countries to establish low-cost programmes that promote the safety
and performance of medical devices by taking full advantage of what others have already done in this field. Local adoption of
harmonized recommendations will facilitate international exports of medical devices manufactured locally.
Pre-market approval is one of the most important aspects of any comprehensive policy. The difficulty of establishing a local
pre-market review team is not just financial but also depends on whether specialized scientific and clinical expertise is available
in the country. However, with the work of the GHTF and the ability to look at approval decisions in other countries, it is now
feasible for many countries to avoid the expense of a local premarket review team. Most medical devices today are
manufactured in developed countries which have comprehensive regulatory systems in place that follow the Essential
Principles of Safety and Performance of Medical Devices recommended by the GHTF.
As an alternative to a local pre-market review team, a government can adopt a policy of accepting devices that are
manufactured in compliance with the regulations of another country with a sound regulatory system. The choices include, for
example, devices with an Australian, Canadian or Japanese license, devices with a European CE mark, or devices that have
been granted marketing clearance by the US-FDA. In this way the citizens of the importing country will be assured of the same
risk exposure as the citizens of the exporting countries. The government can require that local manufacturers make submissions
for compliance acceptance to a country that has an accepted pre-market review team. In fact, this is what the manufacturers
have to do anyway if they want to sell internationally. The convergence of national regulatory systems can facilitate the
exportation of these products to international markets as well. In avoiding the expense and effort of a pre-market review team, a
government can concentrate on implementing vendor and device registration and surveillance programmes for devices in use.
Overcoming cost barriers
The report states, in low resource setting, the origin of this barrier is lack of local research infrastructure and capacity to
develop promising ideas in other words, new ideas originate from those outside the context in which a device will be used.
We would again point to Annex II to the list of examples of industry working with and for the improved healthcare
infrastructure in low resource settings around the world.
The role of technology transfer from developed countries to developing countries is one possible way to overcome cost
barriers to innovation. It is imperative that the products resulting from any technology transfer are proven to be clinically safe
and effective, and that design and manufacturing processes are well established. Technology transfer can help reduce the cost
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due to mass manufacturing, localizing materials and labor. The cost may be reduced if the local system is efficient and safe and
this would also help develop local manufacturing infrastructure and capability in developing countries. National policy should
support and encourage the necessary infrastructure development to allow successful and sustainable technology transfer.
The role of multinational companies
Multinational companies play an important role in reducing cost through local sourcing, local establishment of R&D centers,
partnering with local suppliers and research institutes. Especially in recent years, multinational companies are increasing their
investment in developing countries as they seek to provide appropriate products for the customers in those countries.
Through their investment both financial and in talent, partnerships with local universities, institutes and companies,
infrastructure and local capability, this helps to build capability and infrastructure in developing countries.
Towards Appropriate Medical Devices: Options for Future Research
The report states that a universal lack of standardization in the medical device arena (such as the lack of standardized
laboratory equipment and consumables) has great impact on diagnostic tools and negatively affects their effective use.
Solutions to allow for greater standardization would be most beneficial and help to encourage universal use of generic
diagnostic tools. We would like to point out that international standards exist for most medical equipment.
The report states: the provided examples highlight that although cutting-edge technologies to develop new medical devices
has its place, research in developing current medical device to make them appropriate to specific contexts, particularly for lowincome settings, is also urgently needed.
We urge WHO to encourage public/private partnerships to address healthcare systems gaps. Individual patients, clinicians,
governments, and health care systems, no matter how poorly resourced, benefit from many medical technologies through
programs supported by the medical technology industry. The medical technology industry works directly, and in partnership,
with leading non-governmental organizations (NGOs), academic/medical institutions, and governments.
In Conclusion
The GMTA applauds WHO for the work that went into developing this report and for allowing us the opportunity to provide
our views. As a variety of stakeholders, including industry, search to find solutions to the 4 As highlighted in the report:
Availability, Accessibility, Appropriateness and Affordability, it would be very useful to find ways to combine our resources
and work together.
There are improvements that the medical device industry can make, and we strive to do so, but in order to achieve real success
in addressing healthcare needs, the industry must have the opportunity to work collaboratively with stakeholders. This is the
best way to develop and produce technology that addresses the needs of patients and healthcare providers in local settings.
Medical technology plays a complementary role in improving and saving lives and contributing to societal and broad economic
goals. Local governments and non-governmental groups also have their roles and must seek to fulfill them.
A suggestion we have put forward in our response is the establishment of an expert advisory group that would include
industry to work with WHO on the identified public health needs and develop solutions to address specific situations, on the
ground, in a country. The medical technology industry has a long history of working to develop sustainable solutions to
improve healthcare infrastructures around the world and these efforts are increasing. We look forward to identifying ways
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with WHO to find solutions to these critical health issues.

December 6, 2010
ANNEX
Annex I Matrix of innovation differences for medical technology
Annex II Examples of industry capacity building efforts for local healthcare workers in low resource settings
Annex III Links to Codes of Ethics for the Medical Technology Industry
Annex 1 Description of How Medical Devices Innovate and How it Differs from Pharmaceutical Innovation
Medical Devices
Pharmaceuticals
Industry Composition Over 80% small and medium-sized

companies
Very large multinationals dominate
Active Components Generally based on mechanical,

electrical, and materials engineering
Based on pharmacology and chemistry; now encompassing

biotechnology, genetic engineering, etc.
Most act through physical interaction with the body or
Products are administered by mouth, skin, eyes, inhalation, or
body part.
injection and are biologically active; effective when absorbed

into the human body. Often act systemically on the entire body.
Product Development Wide variety of products and

applications from thermometers and bandages to
Products are usually in the form of pills, solutions, aerosols, or
pacemakers to x-rays
ointments
Designed to perform specific functions and approved on
Product development by discovery, trial, and approved on basis
the basis of safety and performance
of safety and efficacy
Products developed by engineers, in many cases together
Products developed in laboratories by chemists and
with doctors or nurses in a clinical setting.
pharmacologists.
Intellectual Property Concerns Continuous innovation and Extensive research and development of a specific compound or
iterative improvements based on new science, new
molecule; takes several years for a new drug to enter the product
technology, and new materials
pipeline
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Short product life cycle and investment recovery period
Intensive patent protection, including data exclusivity and patent
(typically 18 months on market). Little patent linkage
linkage, needed due to extensive product life cycle and long
possible. Data exclusivity is important.
investment recovery period.
Majority of new products bring added functions and clinical Usually large step innovation
value based on incremental improvements
Support Provided Large investment in manufacturing,
In most cases, no service or maintenance.
distribution, and user training/education; plus need to

provide service and maintenance (for many high tech
devices)
Annex II
EXAMPLES OF MEDICAL TECHNOLOGY INDUSTRY CONTRIBUTIONS TO HEALTH SYSTEM CAPACITY BUILDING

IN DEVELOPING COUNTRIES
The medical technology industry is actively engaged in addressing global health system disparities. It is proactively
developing innovative solutions, supporting health system capacity-building, and training health care providers to address
many of the recognized problems of health care in the developing world.
The following examples demonstrate how individual patients, clinicians, governments, and health care systems, no matter how
poorly resourced, benefit from many medical technologies through programs supported by the medical technology industry.
The medical technology industry works directly, and in partnership, with leading nongovernmental organizations (NGOs),
academic/medical institutions, and governments.
GLOBAL
Global Health Scholars Program More than 60 medical residents, teaching faculty and career physicians take part in the
Johnson & Johnson Global Health Scholars Program., which selects the most promising candidates from major American
institutions, and sends them for six weeks or longer to one of six overburdened health care sites in places such as Eritrea,
Indonesia, Liberia, South Africa, Uganda and Central America. The program gives visiting physicians and students an
opportunity to learn how to diagnose and treat complex diseases, and gives patients access to more doctors who can
contribute to better diagnoses and treatments. Working in remote and/or overburdened healthcare communities challenges
most visiting scholars to think innovatively and resourcefully given the limited amount of medications and medical equipment,
the long-processing times for basic tests, and the inability of patients to pay for expensive healthcare treatments. It is a highly
beneficial and rewarding experience for both scholars and patients.
Improving Clinical and Laboratory Services (focus: HIV/AIDS and TB) Limited access to clinical and laboratory health services
is one of the largest constraints to battling disease in developing countries. Through collaboration with over 20 health
agencies, universities, NGOs and international agencies, Becton Dickinson (BD) has conducted over 270 Good Laboratory
Practice (GLP) workshops in more than 50 developing countries, providing hands-on training to more than 2200 laboratory
workers. This training is focused on implementation of Standard Operating Procedures (SOPs) for immune system monitoring
of HIV/AIDS patients (CD4 testing). It also teaches fundamental laboratory practices such as quality control and blood
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sampling, and is presently being expanded to cover TB testing procedures.

Associated with this GLP workshop initiative, BD has established eight training centers in locations around the world including
Africa, Asia, Eastern Europe and South America. For example, BD has collaborated with Stellenbosch University in South
Africa and the Kenyan Medical Research Institute (KEMRI) in Kenya to open training centers in these countries. These
centers have fully outfitted laboratories with equipment donated by BD, and when not in use for training purposes, the
laboratories are available for actual patient monitoring and HIV/AIDS research.
In 2000, BD, together with the Program for Appropriate Technology in Healthcare (PATH) developed a training manual entitled
Giving Safe Injections: Using Auto-Disable Syringes for Immunization. This manual was created for healthcare workers who
inject vaccine and includes information on how to administer a vaccination without harming the recipient or the healthcare
worker. BD healthcare professionals continue to engage with local Ministries of Health, national organizations and
international agencies to train thousands of healthcare workers each year. Since 2000, BD has conducted over 250
Immunization Injection Safety Trainings in 49 countries throughout Asia, Africa, Eastern Europe, Middle East and Latin
America.
BD is an HIV/AIDS collaborating partner of the Millennium Village Project. This commitment includes funding for the projects
global HIV/AIDS coordinator and in-country health coordinators, as well as collaboration on diagnostic and clinical
infrastructure and core competency needs.
BD and the US Global AIDS Coordinators Office (responsible for coordinating the
U.S. Presidents Emergency Plan for AIDS Relief or PEPFAR) started a pilot project in Mbarara University, Uganda for
laboratory and clinical practice training. Through the PEPFAR agreement, BD has provided laboratory strengthening and
training in Africa and established tuberculosis (TB) reference labs. In October 2007, BD and PEPFAR announced an expanded
collaboration to include a five- year public-private partnership aimed at improving laboratory practices in African countries
severely affected by HIV/AIDS and TB.
Advanced Medical and Community Health Information Centers
The Medtronic Foundation is a long-time partner of WiRED International. WiREDs mission is to provide medical and
healthcare information in developing and war-affected regions. Begun 10 years ago, WiRED has installed more than 100
Medical Information Centers and Community Health Information Centers on four continents (Latin America, Africa, the Balkans
and the Middle East). Among a range of programs, WiREDs Medical Information Centers deliver the latest technical
information to professional health care providers, medical school faculty and students. These centers offer on-board medical
libraries, and where Internet connectivity is available, access to on-line resources including the WHOs HINARI database. This
rich source of medical information (more than 1,200 biomedical journal titles and thousands of texts) offers physicians and
healthcare workers in disadvantaged regions access to world-class medical libraries.
WiREDs Community Health Information Centers present healthcare information to patients, primary care givers, the general
public and the media. WiRED also supports disease prevention programs for young people. Local groups run these Centers
and WiRED provides the equipment and program material, the training and ongoing support.
WiRED recently added a telemedicine program that provides medical educators and practitioners access to outside training
programs, seminars, workshops and clinical assessment opportunities. WiREDs technicians install the high-end, video
conferencing equipment. Educational material and patient consultations are provided through professional U.S. medical
associations & partnerships with organizations such as the University of California, San Francisco Medical School, and
Massachusetts General Hospital. WiRED is working to extend its telemedicine program to India, using a new design which it
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will test with Calicut Medical College (CMC) and field hospitals in Calicut in the southern Indian state of Kerala. Although
many large urban medical schools in India have access to the latest medical information, other less developed areas lack
opportunities for physicians & other medical professionals to stay current. CMC has no program now through which Indian
doctors and medical experts outside engage in routine educational exchanges. WiRED will test the relay approach to
Continuing Medical Education (CME), involving a consortium of American medical institutions and Calicut Medical College
(CMC). Following each teleconference with American medical educators, the CMC will add observations and comments and
then retransmit the digital recordings to seven regional hospitals throughout the Calicut state network. The content of this
program will include lectures, grand rounds, patient assessments, video conferencing and satellite communications equipment,
and other material as needed for the CMC.
Occupational Injury Surveillance
In collaboration with the University of Virginia, BD works to deploy the EPINet occupational injury surveillance system at no
charge to health care facilities. This system, already in use in 27 countries, protects clinicians through precise tracking of the
sources of sharps injury and other blood exposures, facilitating data collection and planning of appropriate exposure
prevention policies.
Primary Care Physician Training and Education
Welch Allyn has supported partnership projects between NGOs and Universities in which deliver equipment and educational
programs to advance the skills of primary care physicians in emerging countries (Central Asia, Vietnam, Kosovo and South
Africa). These programs improve the physicians ability to assess, diagnose, treat and manage chronic conditions such as
hypertension which leads to cardiovascular disease. The Physicians with Heart Program, a collaborative effort of Heart to Heart
International and the American Academy of Family Physicians, has trained hundreds of physicians in the Central Asian
Republics since its inception in the 1990s, using a train the trainer model to empower sustainable change. Welch Allyn has
supported similar educational partnerships in Kosovo with AmeriCares and Dartmouth Medical College, and has equipped
training centers in medical universities in Vietnam and South Africa to support professional medical education programs. These
efforts promote primary care skills aimed at keeping patients with chronic conditions healthier and more productive longer, and
address the shortage if skilled healthcare professionals in these countries.
Development of Advanced Pediatric Cardiac Care
The Medtronic Foundation is a long-time partner of Childrens HeartLink (CHL). This NGO works in partnership with health
care centers in developing countries to promote sustainable cardiac care for children with congenital or acquired heart disease.
Founded in 1969, CHLs goal is to empower local experts to prevent, treat and cure pediatric heart disease in their own
populations. Last year, CHL provided 844 training opportunities, reaching over 40,000 children at their partner sites. CHL has 11
partner sites in China, India, Malaysia, Kenya, S. Africa, Ukraine, Costa Rica and Ecuador.
CHL supports its partner sites in a variety of waysincluding sending hospital personnel from underserved countries to the
U.S. and other world medical centers for training; bringing surgical teams from the U.S. & Europe to work side by side to train
colleagues in developing countries; donating medical equipment/supplies; providing financial support to perform surgeries on
impoverished children; working to develop and strengthen education campaigns about the prevention of heart disease
acquired through rheumatic fever and Chagas disease; helping to create regional networks of support in which more advanced
hospitals assist their lesser developed counterparts; assisting in the training and retention of cardiac team members, and
helping hospitals start charitable foundations to fund care for needy children. CHL medical volunteers come from prestigious
pediatric cardiac programs such as the Mayo Clinic & the Lucile Packard Childrens Hospital of Stanford University (U.S.), &
Birmingham Childrens Hospital (U.K.).
Developing Specially-Designed Products
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To help prevent inappropriate reuse of disposable syringes and needles, BD developed several auto-disable products in close
collaboration with the World Health Organization (WHO) and several other international agencies. These devices include
products such as the BD SoloShot range of injection devices and BD Uniject pre-filled injection device. To date, BD has
shipped over four billion auto-disable syringes to 90 countries in Asia, Africa, Middle East, Eastern Europe and South Latin
America.
BD also developed an innovative, unique new injection device for the Stop TB program of the Global Drug Facility to safely
inject streptomycin for TB patients in developing countries, most of whom are HIV-positive. The BD Chek HIV Multi-Test,
launched in Africa in March of 2006, provides rapid results in just 10 minutes for detection of antibodies to HIV-1, HIV-1
Subtype O, and HIV-2. In 2007, BD launched the BD Vacutainer CD4 Stabilization Blood Collection Tube in Africa. The tube
stabilizes CD4 cells for longer time periods and at higher temperatures, enabling more samples to be taken in remote areas and
transported to central labs for HIV/AIDS testing.
Operation Smile
Stryker Corporation assists in Operation Smile, headquartered in Norfolk, Virginia, is a worldwide childrens medical charity that
helps children with surgery to correct cleft lips and other issues. Operation Smile currently supports international and local, incountry medical missions to 26 countries and its partner countries include: Bolivia, Brazil, Cambodia, China, Colombia, Ecuador,
Egypt, Ethiopia, Gaza Strip/West Bank, Haiti, Honduras, India, Jordan, Kenya, Mexico, Morocco, Nicaragua, Panama, Paraguay,
Peru, Philippines, Russia, South Africa, Thailand, Venezuela, and Vietnam. Since 1982, more than 115,000 children and young
adults have been treated by thousands of volunteers worldwide and thousands of healthcare professionals have been trained
globally.
Operation Smile integrates its partnerships with leading medical teaching institutions into its in-country medical education
programs. Our partners in education include Yale University, Chang Gung Hospital and University (Taiwan), Duke University
and the University of Southern California. Thousands of students in more than 500 Operation Smile Student Associations in
the United States and around the world build awareness, raise funds and educate students about values of commitment,
leadership and volunteerism. The annual Operation Smile Physicians Training Program (PTP) brings doctors and nurses from
around the world to the United States for advanced training in their specialized skills. Since 1987, more than 700 health care
professionals have attended the program, held at our headquarters in Norfolk, Virginia.
Establishing Neurosurgical Residency Programs
Integra LifeSciences Holdings Corporation provided an in-kind donation in 2007 of over $4 million worth of neurosurgical
medical devices to the Foundation for International Education in Neurological Surgery (FIENS). We are very grateful for
Integras generous donation, which furthers the foundations mission to establish permanent neurosurgical residency
programs at our sites in Central America, South America, Africa and Asia, said Merwyn Bagan, MD, MPH, FACS and Chair of
the FIENS Executive Committee. Founded in 1969, the foundations mission is to address the critical lack of trained
neurosurgeons in the developing world. Its volunteers provide on-site training and education to neurosurgeons around the
world, teach their techniques to local neurosurgeons, and set up neurosurgery residency programs. FIENS volunteers also
provide critical assistance in the operating room.
Addressing Health & the Environment
Johnson & Johnson has partnered with local groups in Africa and in Asia to address health and environmental issues. In
Kenya, it helped to open dispensaries beginning in 2006. Before the dispensaries were available, families had to travel 6 to 8
hours to get to a health care facility. Most children were not immunized. Mortality rates for women and babies were high. In
addition, prior to the partnership, education about how to purify water, prevent disease and practice good hygiene was
nonexistent.
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The water wells were open, which exposed available water to contamination from the environment. Through the partnership,
wells were covered and pumps were installed to keep the water clean.
In Nepal, Johnson & Johnson focused on protecting forests and improving air quality. Traditionally, villagers have relied on
woodburning stoves and the forests trees to fuel them. Today, villagers are learning about the harmful emissions from woodburning stoves and how to use biogas units instead, which are fueled by cattle manure. A healthy environment is necessary for
people to be healthy.
AFRICA
Improving Clinical and Laboratory Services
BD and the International Council of Nurses (ICN) recently announced a multi-year initiative to provide health and wellness
services to healthcare providers working on the front lines in four African nations. This collaboration will help address the risk
to health workers in sub-Saharan Africa associated with the very high levels of disease prevalence in their healthcare
environment.
HIV/AIDS Programs in South Africa:
Siemens has been a pioneer in the establishment of an HIV/AIDS Workplace program in South Africa. Key features of the
program include its non-discriminatory nature, a commitment to the confidentiality of information, the continuation of benefits
for employees who are shown to be HIV positive and the management of employment termination due to ill health. In 2004,
Siemens South Africa received the Global Business Coalition on HIV/AIDS Award for Business Excellence in the Workplace.
Siemens has signed an agreement with a church association (Community of SantEgidio) to invest ca. one million Euros to
lower the costs of laboratory testing by 35 percent to combat HIV resistance to drug therapies. The agreement was signed at
the fifth international conference of the Drug Resource Enhancement against AIDS and Malnutrition (DREAM) Project.
According to Mario Marazziti, spokesman for the Community of SantEgidio, in order for AIDS therapies to be effective, the
distribution of medicine must go hand in hand with the constant monitoring of how these drugs react in the human body. Lab
tests are now considered necessary to establish whether HIV patients are becoming resistant to drug therapies.
Siemens has donated two Siemens Sonoline ultrasound units to Chris Hani Baragwanath and Tshepong Hospitals in Cape
Town, South Africa. These donations support efforts to combat HIV/AIDS by assisting the hospitals research into the
disease. The Siemens donation saved the hospitals some R80,000 funds that are now being used for laboratory
investigations.
Rebuilding the Ranks of Healthcare Professionals In Somalia
Two decades of civil wars have resulted in a rapid decline in qualified health care professionals in Somalia. The Hermann
Gmeiner School of Nursing was established in 2002 to train healthcare professionals from the local population with the support
of Johnson & Johnson. Students attending the school complete a three-and-a-half-year program that includes a WHOapproved curriculum. In 2009, 16 individuals graduated from the school. And they did so in the midst of frequent mortar attacks
and terrorist raids that often displaced them from their classrooms.
Healthcare Training and Infrastructure Development
BD collaborates with the Academic Alliance Foundation and the Infectious Disease Institute at Makerere University in Uganda
to develop training programs on clinical, public health, and laboratory practices for clinicians and researchers from throughout
sub-Saharan Africa.
Through the BD Volunteer Program, BD sends teams of its associates to remote health facilities to help build local health
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capacity through training, construction, health services and laboratory strengthening. In 2005, BD collaborated with the
Catholic Medical Mission Board (CMMB) to send teams of BD associates to five health centers in Zambia to help expand the
countrys capacity to diagnose and treat infectious diseases such as HIV/AIDS. Recognizing the need for follow up, BD
associates returned to Zambia in 2006 to continue their work at the same health centers. In 2007, BD collaborated with Direct
Relief International to send BD associates to two health centers in Ghana. BD employees trained local health care providers,
constructed a new health facility, upgraded existing laboratory capabilities and incorporated clean water solutions at existing
facilities, bolstering the clinics abilities to provide vitally needed services to their patients.
Prevention of Rheumatic Heart Disease
To help prevent rheumatic heart disease (RHD), the most common cause of heart disease and of heart failure in patients under
age 30, the Medtronic Foundation has supported the World Heart Federations RHDnet, a tool to share knowledge globally,
and to encourage more countries to address the problem. The Foundation also supported the establishment of an Africa RHD
Registry, which is particularly important for effective delivery of the antibiotic prophylaxis that can prevent rheumatic fever
from progressing to being a debilitating disease. It also enables researchers to get the epidemiological data which is needed
both to better understand the disease, to effectively plan interventions, and to advocate for health resource allocation.
Medtronic employees have also been active in raising funds to prevent RHD.
In addition, the Medtronic Foundation has partnered with the University of Cape Town in South Africa on the development of
the A.S.A.P. program to raise awareness of the public and healthcare workers about RHD, determine the incidence of RHD
through surveillance, advocate for improved public policy to prevent and treat RHD, and work towards the establishment of
primary & secondary prevention programs of RHD at the community level in South Africa. The University is working with the
Pan African Society of Cardiology (PASCAR) to encourage development of similar programs in several other African countries.
HIV/AIDS Training and Education
BD provided philanthropic support to Save the Children for the establishment of clinics for HIV-positive children in Ethiopia.
Abbott Fund and the Government of Tanzania have partnered to develop one of Africas most comprehensive initiatives to
strengthen a countrys health care system and train staff to meet the needs of people with HIV and other life-long diseases.
This partnership has expanded testing and treatment at more than 80 health centers throughout Tanzania, bringing HIV
services into some remote regions for the first time. In Dar es Salaam, Tanzanias largest city, the program is building state-oftheart clinical diagnostic laboratories and a three-story outpatient center at the countrys leading reference hospital, training
more than 10,500 health care workers and providing voluntary HIV counseling and testing for more than 130,000 people.
The Johnson & Johnson/UCLA Management Development Institute(MDI) was created in 2006 as an intensive one-week
program designed to enhance the management skills of health care leaders of East African organizations devoted to the care,
treatment and support of people and their families living with HIV/AIDS. Johnson & Johnson, its Tibotec subsidiary and the
African Medical Research Foundation help the Ugandan NGO Sikiliza Leo to provide HIV testing, counseling, treatment and
care in rural Uganda. Since March 2003, HIV testing and counseling have been offered to 3,586 community members, of whom
559 have tested positive for HIV. A total of 272 persons receive Home Based Care and a first group of 20 are now receiving
ARV therapy. The program has also established two day-care facilities that support some 250 orphans and vulnerable children
in Mulanda and Lwala parishes. Psychosocial development, education, nutrition and care are offered to children from 3 to 8
years of age. The program has been recognized by the American Embassy, and a grant has been provided to improve facilities
and food.
Imaging Training and Infrastructure Development
Philips Medical Systems assisted the Government of Tanzania in rehabilitating the diagnostic services and operating theaters
of district and regional hospitals spread over an area of 945,000 km2. The project furnished 98 hospitals with diagnostic
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equipment, such as X-ray, ultrasound scanners and laboratory photometers, and equipment for surgical and dental treatment.
Buildings were rehabilitated, and water treatment units and power generators were installed to ensure availability of clean water
and electricity. Training was provided for hospital staff and service engineers.
Nurse Training and Education and Retention
The Medtronic Foundation is supporting Childrens HeartLink to develop a model program that addresses the problem of
critical care nurse retention, and provides nurse training. Many developed countries have growing nursing shortages (which
will only increase with aging populations), and they look to developing countries to solve their recruiting needs. As a result,
some hospitals in South Africa are known to have an 80% annual turnover in critical care nurses. This affects the quality of
care for patients. This pilot project engages nursing staff, educators, cardiac service professionals & hospital administrators in
South Africa and abroad to develop programs for nurse retention & professional development through one model project
which, if successful, could be replicated in other sites.
The Medtronic Foundation is also supporting the University of Witswatersrand to help South Africa cope with emerging forms
of heart disease and the resulting massive increase in patients with acute coronary syndromes using cardiac clinic services at
Baragwanath Hospital. This hospital, which serves Soweto and the region around Johannesburg, is the largest hospital in the
southern hemisphere, with 3,500 beds. Many medical professionals have little knowledge of heart disease and are ill-equipped
to deal with it. Soweto has only 12 primary care clinics for its 1 million inhabitants. Primary care clinics are regularly staffed only
with nurses, not doctors. Few of the nurses know the symptoms of heart disease or chronic heart failure (CHF). There are no
CHF treatment protocols or management plans. For patients treated for heart failure in hospital, there is often no follow-up at
their community clinic after discharge. The goal of this program is to improve the local capacity of selected community-based
nurses in the primary care clinics in Soweto to recognize and manage heart disease and heart failure, and to liaise with
Baragwanath Hospital so they can provide expert medical care across the whole continuum of the health care system. Once the
nurses are trained, they can refer patients directly to Baragwanath hospital, without the need for a referring doctor. If
successful, this model can be extended to include all 12 primary care clinics in Soweto.
World Cup pool donated to charitable organization Mercy Ships
Siemens Learning Campus @ Med group donated some 10,000 Euros to Mercy Ships. Since July 2006, a Mercy Ship hospital
ship has been anchored in the harbor of Tema, Ghana where physicians on board have performed more than 1,000 eye
operations primarily on people with cataracts.
Training and Education on Diabetes
The Medtronic Foundation supports Kids & Care South Africa to develop & publish books and films for children about living
with diabetes. These materials are distributed to diabetic children & their families, and to schools in South Africa. This initiative
is part of a nationwide diabetes education program.
ASIA
India
Medical Education Padyatra:
Transforming Standard of Patient Care Johnson and Johnson in India launched a new Professional Education-initiative, the
Medical Education Padyatra in line with their philosophy of Transforming Standard of Care. Planned for approximately 300
cities across India over a period of seventeen month period, the padyatra will meet surgeons and learn about their practice,
share best practices and effectively usher in change. The faculties will conduct workshops on Advances in Hernia and Best
Practices for Surgical Site Infections. These two areas are of great significance with almost 2 % of the adult population in India
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suffering from Hernia and Surgical Site Infection constituting almost 20% of all hospital acquired infections. Customized
curriculum, tong insights and focus, top faculties and great team organizing and engaging back to back programs and creating
an environment for adoption to best practices. The MedEd Padyatra started from Gujarat in the month of April 2009 has now
achieved a national foot print and covered 15 states. From East to West and from North to South in the last six months Med Ed
Padyatra has touched 5200 Health Care Professionals in 202 cities. These doctors will now benefit thousands of patients with
the new learning/best practices.
For the cause of patient care, eminent faculties are joining the Padyatra to perpetuate and share best practices. Medical
Education Padyatra seeks to raise the bar with respect to standard of care.
Nurture: Nursing magazine for nurses
In ever challenging healthcare environment, the need for keeping abreast with best practices and personal enrichment of
knowledge and skill is very critical for nursing professionals for superior support to the surgical team. Understanding this need
Johnson & Johnson launched Nurture magazine, which features current best practices in nursing world, nursing etiquettes,
well illustrated surgical procedure and many more inspiring nursing articles. Launched throughout all of India on May 12th 2009
International Nurses Day reaching 21000 nurses across all nursing homes and top hospital. By now four issues have been
circulated in India. The success encouraged them to launch the same in Bangladesh in the Bangla language. Nuture is
committed to enhancing knowledge of nurses.
Improving Chronic Care In India, Baxters International Foundation partnered with Charities Aid Foundation in New Delhi,
India, in 2006 to establish a chronic care initiative to increase awareness and improve access and availability of treatment
options for conditions such as heart disease, diabetes and obesity among high-risk populations.
Training and Education on HIV/AIDS
BD partners with Hindustan Latex, Ltd. to help prevent the reuse of syringes in India through the introduction of auto-disable
syringes, education and training of healthcare workers, and the implementation of advocacy programs with the Government of
India. According to a WHO report, unsafe injections are the second leading cause of HIV spread in India.
The Medtronic Foundation has partnered with the India Diabetes Research Foundation for an initiative in 10 Indian states to
train 960 doctors, 600 health educators/dieticians, and 4,000 paramedical field staff in diabetes over five years. India has the
worlds largest diabetes population, estimated at 40 million, but many health professionals have little knowledge of the disease.
IDRF will encourage participants to join in the establishment of a network of Diabetes Prevention & Control Centers, and will
raise awareness of all stakeholders including policymakers, health managers, high-risk groups and the general population on
prevention of diabetes and its complications.
The Medtronic Foundation has also supported the Madras Diabetes Research Foundation in a program to train doctors and
allied specialists in diabetes and related complications. MDRF will train physicians, ophthalmologists, diabetes educators,
nurses and technicians.
China
Hospital Equipment in Rural China
In April 2007, Siemens together with the Clinton Global Initiative kicked off a 5-year rural healthcare project in China with a total
investment volume of US $10 million. The project, which is supported by Chinas Ministry of Health, will help improve
healthcare in rural areas of China. Luochuan County in Yanan, Shaanxi province, was the site of the first project
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implementation. Siemens has equipped the local county hospital in Luochuan County with a full range of diagnostic imaging
equipment including ultrasound, X-ray and CT scanners. Since appropriate knowledge is crucial to the healthcare delivery
process, Siemens is also providing medical and application training to support physician education at the hospital. Siemens is
also installing water treatment equipment to prevent health threats to the environment from the hospitals wastewater.
Townships are also included in the project scope, as they play an important role in the delivery of first-line healthcare services
in rural China. A total of six township health centers surrounding the county hospital will receive X-ray and ultrasound
equipment from Siemens. Once the equipment upgrades are complete, Siemens will ensure this rural healthcare network has the
appropriate technical infrastructure to provide quality services to the local population. On-site research activities will also
evaluate and monitor the efficiency and effectiveness of healthcare delivery at the project sites to drive a process of
continuous improvement.
In China, BD in partnership with Project HOPE, an international health education and humanitarian assistance organization, has
renewed its 1998 commitment to the China Diabetes Education Program (CDEP). CDEP provides comprehensive diabetes
training to local medical and healthcare providers, also known as Trained Trainers. To date, outreach efforts by Trained
Trainers across 800 local hospitals and community care centers have successfully trained nearly 37,000 medical professionals
and about 170,000 patients with diabetes. The programs efforts have won strong support from Chinas Ministry of Health and
government offices at various levels. More than 30 million Chinese citizens are currently estimated to have diabetes, a figure
forecast to rise to as many as 100 million by 2010. Due to patient education and training issues, however, many affected people
are unaware of healthcare measures that can alleviate and postpone associated complications.
Developing Advanced Orthopedic Care
In China, Stryker has outreach programs focusing on its orthopedic expertise to replace knees and hips in individuals in
underserved areas around the globe, in a partnership with Operation Walk, a not-for-profit, volunteer medical services
organization. Operation Walk provides free surgical treatment for patients in developing countries and the United States that
have no access to therapies for arthritis or other debilitating bone and joint conditions. It also educates in-country orthopedic
surgeons, nurses, physical therapists and other health care professionals. Strykers first partnership with Operation Walk was
with its Chicago branch on a trip to China in 2005. The teams performed 56 total joint replacements at Huaxi Hospital in
Chengdu, China, during a one-week period. A year later, Operation Walk Chicago and Stryker traveled to two locations in
China, Chengdu and the Zhejiang Traditional Hospital in Hangzhou. There medical teams performed more than 80 total joint
replacements. For both trips, Stryker donated more than 130 implants, necessary instrumentation and manpower from both the
U.S. and Stryker China.
Training and Education of Senior Chinese Government Health Officials
The Medtronic Foundation has supported the Harvard School of Public Health program to educate senior government health
officials, mostly policy makers, as well as hospital administrators, to improve the quality of patient care in China. The objective
is to help China produce a critical mass of well-informed and highly responsible leaders and executives who can develop and
implement sound policies while dealing with local issues. Specific objectives are (1) to develop participants comprehensive
understanding of the major global, national, and regional health developments and health system reform issues; (2) to sharpen
participants problem-solving, analytic, strategic planning, and leadership skills; (3) to equip participants with a spectrum of
international working models of health development and policy practice against which they may judge and weigh local issues
and options; and (4) to analyze the particular functional challenges shaping modern Chinas health policy environment and
healthcare marketplace.
Training Healthcare Workers in China
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With the understanding that health education is essential in making healthcare accessible to medically underserved
communities, in partnership with the Chinese Red Cross Foundation, Philips launched the Rural Healthcare Program in 2006.
This three-year initiative will educate 300 village doctors in Beijing, Shanghai and Guangzhou and includes sponsoring a trainthe-trainer program for those who will work with rural doctors. The program will also establish 10 Philips clinics and hospitals.
Philippines, Taiwan, Vietnam, Singapore
Caring, Rebuilding Storm-Ravaged Lives and Communities
Severe storms and floodwaters struck Taiwan, the Philippines and Vietnam in 2009. Johnson & Johnson helped many of the
displaced and wounded in these countries by donating disaster relief packages that included consumer products,
pharmaceuticals, trauma care kits and medical devices.
In the Philippines, typhoons affected 2.5 million people. Johnson & Johnson partnered with AmeriCares, the Asian
American Institute, Direct Relief International (DRI), Heart to Heart International, HOPE Worldwide, Medical Teams
International, Save the Children and others to provide relief. Employees from Johnson & Johnson Philippines
volunteered in soup kitchens, helped package and distribute supplies, and raised funds for organizations like World
Vision and the Corporate Network for Disaster Response.
In Vietnam, storms affected more than 200,000 people. Johnson & Johnson partnered with Direct Relief International,
Save the Children and the Kim Long Charity Clinic to provide relief. Johnson & Johnson Consumer Companies Inc. and
McNeil Consumer Healthcare gave products to AmeriCares and DRI. In addition, Janssen-Cilag Vietnam donated and
distributed food to 100 households in Quang Nam.
In October 2009, towering waves slammed into Samoa, American Samoa and Tonga, destroying villages and lives.
Johnson & Johnson partner with Direct Relief International and local health centers to provide antibiotics and wound
care supplies. Several operating companies in the region provided products and monetary support to help those
affected by the tsunami.
Training Midwives and Expanding Healthcare Education into Rural Communities
Johnson & Johnson Philippines created the Midwives Leadership Development Program (MLDP) in cooperation with the
Integrated Midwives Association of the Philippines (IMAP), Inc. to train and strengthen the leadership and health care skills of
midwives. The program gives midwives an opportunity to take part in an intensive training program that aims to enhance their
knowledge and leadership skills and develop them to become more effective health professionals. Since 2004, the MLDP has
trained more than 100 midwives across the country. In the Philippines, midwives are valued for the important role they play in
the health of the Filipino people, especially in the countrys far-flung communities. The job often goes well beyond caring for
expecting mothers and attending to the birth of babies, providing educational information about renal disease, tuberculosis and
sexually transmitted infections.
Imaging Training and Infrastructure Development
Philips Medical Systems is assisting the Department of Health in the Philippines to upgrade medical equipment for diagnosing
and treating chronic diseases of the heart, lungs and kidney in national and regional hospitals throughout the country as part
of their The project furnished sophisticated medical equipment to improve five specialist heart-lung-kidney centers in the
Philippines. Equipment for noninvasive procedures, diagnostic imaging, operating theaters, recovery and patient monitoring
areas, as well as items for hemodialysis and bronchoscopy were included. Buildings were rehabilitated and training for hospital
staff and service engineers was provided. Equipment will be supported with long-term comprehensive warranty and
maintenance contracts. Period: 2005 2011
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Advanced Hospital Management

Johnson & Johnson, in cooperation with the Singapore Management University, runs a Regional Hospital Management
Program. The program helps hospitals in the Asia-Pacific region improve their management and operations so they can deliver
better health care services. Professors from renowned institutions in Singapore and the
U.S. review modern hospital management principles and techniques with 50 senior hospital administrators from different Asian
countries during this five-day seminar. Since its inception in 1997, 368 hospital administrators from 305 different health care
institutions have participated in the program, increasing the interaction among administrators in the Asia-Pacific region and
strengthening the leadership capabilities of hospital managers.
CENTRAL & EASTERN EUROPE
Advanced Cardiology Training and Education
The Medtronic Foundation is a long-time partner of the American Austrian Foundation which provides in cardiology for
doctors from Russia and Central & Eastern Europe. Since 1994, AAF has operated a program based in Austria called the Open
Medical Institute, offering postgraduate educational programs in medicine. Over 7,000 physicians from 30 countries have
participated. There are 3 programs: Seminars physicians attend for one week in their medical specialty, taught by faculty from
prestigious U.S. universities (Cornell, Columbia, Duke); Internships providing postgraduate training at Austrian hospitals for
one month in Cardiology, Neurology and Internal Medicine; and Satellite symposia to reach more doctors and see conditions
in the target countries, seminar faculty travel to the region just before or after a seminar to conduct two-day satellite symposia.
The symposia consist of six state of the art lectures, a panel discussion with experts from the region, case presentations, &
visits to local hospitals.
Development of Advanced Pediatric Cardiac Care
The Medtronic Foundation supports the Heart to Heart organization to enable it to develop pediatric cardiac centers of
excellence in Russia. Medical teams from prestigious U.S. hospitals work side by side with colleagues in Russia to train them in
cardiac surgery & catheter lab interventions for newborns and very young children. In Russia, there are only four cardiac
centers where a newborn can get access to cardiac surgery. About 20,000 children are born in Russia each year that will be
waiting for heart surgery. Heart to Heart plans to set up six new regional self-sustaining pediatric cardiac centers of
excellence, so that all regions of Russia can offer excellent cardiac care to children.
Development of Advanced HIV/AIDS care
BD provided philanthropic support to Save the Children for the establishment of clinics for HIV-positive children in Eastern
Europe.
Mending the Hearts of Children in the Ukraine
Siemens loaned an ACUSON Cypress system to Childrens HeartLink for a mission trip to the Clinical Regional Hospital in
Lviv, Ukraine. In one week, the team of volunteer doctors and nurses treated 27 critically ill children, including 12 surgeries and
15 interventional catheterization procedures.
LATIN AMERICA
Diabetes Training and Education
Abbott partners in Bolivia with Direct Relief International, a leading international relief organization, to support outreach
activities of El Centro Vivir Con Diabetes, a group dedicated to the education, care and counseling of low-income adults and
children with diabetes. The Abbott Funds grant supports diabetes education, expands public outreach campaigns, trains
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health care personnel in diabetes management and develops a core group of diabetes educators. Donated glucose screening
and monitoring equipment has helped screen approximately 8,000 people for the disease and monitors the condition of
thousands more.
HIV/AIDS Training and Education
Johnson & Johnson works with The Associacao Saude da Familia (ASF) to mobilize community support in poor favelas in
Sao Paulo, Brazil, to protect young people from unwanted pregnancies and sexually transmitted diseases. This includes raising
awareness and spreading information about HIV/AIDS. In these teeming slums, where drugs and violent crime are a constant
reminder of the fragility of civil societies, ASF works with local community leaders, and municipal and state governments, to
implement its programs to encourage safer and healthier behavior. In its newest program, ASF trains laypersons in poor
communities to become outreach workers. They make door-to-door visits providing HIV prevention education and offer
voluntary testing and counseling services. With a grant from Johnson & Johnson, ASF was able to expand the scope of this
program, and to help local health care units to provide diagnosis, prevention, treatment and care for people living with
HIV/AIDS.
Johnson & Johnson supports an educational program in Mexico with the Instituto Mexicano de Investigacin de Familia y
Poblacin (IMIFAP), for youth that utilizes the existing national network of middle schools to teach students about HIV
prevention before they become sexually active, increasing the likelihood that these adolescents will practice safe sex in the
future. IMIFAP engages all levels of the community from the Ministries of Health and Education, to the school administrators
and local politicians, to the teachers and students. The program includes teacher training, a software program, and Web site
support. The 10,400 schools in Mexico with Internet access bring this program to more than 300,000 students. For those
schools without Internet access, IMIFAP trains teachers and students to run the program, and has partnered with UNETE, a
member of The Resource Fund, to raise educational levels using technology to distribute the program in more rural and remote
areas.
New Mission Hospital in Peru
In September 2007, Siemens donated a CT scanner to a new mission hospital in Peru. Some 750,000 people live within a three
hour radius (by car) of Curahuasi the lost city of the Incas. Until recently, the region did not have a hospital. The new
hospital is equipped with 50 beds, four operating rooms, an intensive care unit, a lab and X-ray facilities.
The Medtronic Foundation has funded the Juvenile Diabetes Association (ADJ) of Brazil for a train the trainer program,
educating 40 public and private health professionals (physicians, nurses, psychologists, and nutritionists) in diabetes. These
health professionals will in turn train 1,200 others during the first year. The course will cover diabetes types 1 and 2: how to
treat the disease in coordination with a specialist, the emotional support needed by patients, and how to teach the patients
their own role in managing the disease. The course requires that the health professionals develop a plan for introducing
diabetes educational programs in their area.
Mexico Diabetes Program
Johnson & Johnson, in cooperation with Project Hope, developed in 2005 a 5 Steps for Self Care course for healthcare
providers and their patients dealing with diabetes. Over 150 healthcare workers in 25 clinics were trained in the course. By 2009,
over 2,500 patients were counseled and it is estimated that over 75,000 community members were reached. The program has
shown proven results in decreasing risk of complications associated with diabetes and has won several awards.
KEY FEATURES OF THE MEDICAL TECHNOLOGY INDUSTRY
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Industry
Relatively young, very diverse industry made up of a few large companies and a large number (~80% of industry) of
small- and medium-sized enterprises (SMEs) over 10,000 worldwide.
Products/Innovation
Very large number (tens of thousands) and broad variety of products ranging from syringes, hospital beds and
bandages to implantable pacemakers/defibrillators, prostheses and pumps and human tissue products.
Products traditionally based on mechanical, electrical and materials engineering and often designed in cooperation
with doctors and nurses.
Continuous innovation and iterative improvements based on new science, advances in diagnostic and therapeutic
and related technologies and available materials.
Very short product life cycles and investment recovery periods approximately 18-24 months on the market.
Essential Support Services
High and ongoing distribution and training costs, often underpinned by a requirement to provide services and
maintenance (especially for high tech devices).
Often integral part of medical procedures, so user training and education are essential for safe and effective use of
products.
Annex III
The Global Medical Technology Alliance (GMTA) represents medical technology industry associations from several regions
Asia, Europe and North America which account for over 90 percent of the medical technology used around the world. We
want to assure the WHO that we are committed to the highest ethical standards.
Scientific research as well as practical experience applied to the design, development and refinement of medical technology is
the essence of our industry. We work closely with physicians and health care providers to ensure that they are properly trained
to utilize our technology and to continually refine our technology, all for the greater benefit of patients.
GMTA is composed of both national and regional associations, all which have adopted written commitments to the highest
ethical standards. Our members have worked for several years to develop, adopt and implement strict ethics codes to ensure
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that our member companies understand and adhere to these standards. The variations in countries legal and regulatory
systems are reflected in the different versions of industry compliance codes, but the underlying principles of the codes are
being harmonized internationally. Our member organizations continually refine and update these codes to guarantee that they
remain both relevant and comprehensive. The codes ensure that a health care practitioners treatment and technology selection
is based on the best interests of the patient.
Here are links to the codes:
MTAA and MTANZ
This is a shared code:
http://mtaa.org.au/pages/images/5th%20Edition%20and%20guidance%20material%20cl
ean%20copy%2027%20Oct%2009.doc.pdf
EUCOMED
http://www.eucomed.org/~/media/680287A3BCD745D9AEE1FF70B9705C85.ashx
http://www.eucomed.org/~/media/7B93DCC3E60946E699D032B567C3F88F.ashx
MEDEC
http://www.medec.org/en/code
AdvaMed
http://www.advamed.org/MemberPortal/About/code/; http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081B21912D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf
GMTA
GMTA is the Global Medical Technology Alliance. Its members are national or regional medical technology
associations, which represent innovative companies that currently develop and manufacture 85 percent of the
worlds medical devices, diagnostics and equipment. It provides a forum for the development and advocacy of
policies that support innovation in medical technology to address patients healthcare needs. Medical
technologies save, support, and improve lives every day around the world. Please go to About GMTA for
membership criteria and process, and for the governance rules.
Contact GMTA
You can contact GMTA at: info@globalmedicaltechnologyalliance.org
Documents
News
Position papers
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Medical Devices - Managing The Mismatch

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7/22/2014 COMMENTS ON THE REPORT OF THE WORLD HEALTH ORGANIZATION, MEDICAL DEVICES: MANAGING THE MISMATCH GMTA - Glo

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COMMENTS ON THE REPORT OF THE WORLD HEALTH

Medical Devices: Problems and Possible Solutions

Barriers to using medical devices

Chemical, physical and biological properties.

with WHO to find solutions to these critical health issues.

Industry Composition Over 80% small and medium-sized

Very large multinationals dominate

Active Components Generally based on mechanical,

Based on pharmacology and chemistry; now encompassing

Most act through physical interaction with the body or

Products are administered by mouth, skin, eyes, inhalation, or

injection and are biologically active; effective when absorbed

Product Development Wide variety of products and

Products are usually in the form of pills, solutions, aerosols, or

Designed to perform specific functions and approved on

Product development by discovery, trial, and approved on basis

the basis of safety and performance

of safety and efficacy

Products developed by engineers, in many cases together

Products developed in laboratories by chemists and

with doctors or nurses in a clinical setting.

technology, and new materials

Short product life cycle and investment recovery period

Intensive patent protection, including data exclusivity and patent

(typically 18 months on market). Little patent linkage

linkage, needed due to extensive product life cycle and long

possible. Data exclusivity is important.

investment recovery period.

In most cases, no service or maintenance.

distribution, and user training/education; plus need to

EXAMPLES OF MEDICAL TECHNOLOGY INDUSTRY CONTRIBUTIONS TO HEALTH SYSTEM CAPACITY BUILDING

sampling, and is presently being expanded to cover TB testing procedures.

Advanced Hospital Management

Essential Support Services

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