Publications/ Asia
| Published in Pacific Bridge Medical Webcast |
April 2008 |
| By Pacific Bridge Medical |
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"East is East and West is West," said Rudyard Kipling. However, managing Asian cultural diversity is a lot more complex for Western companies. Each country has its own culture, history, ideology, language, and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and even linguistic traits can make a world difference in managing Asian employees effectively. Find out more in this webcast.
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| Published by MPO |
January 2008 |
| By Ames Gross and Momoko Hirose
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When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they have smaller populations, these markets all have well-developed healthcare systems and are receptive to advanced products. In addition, their medical device markets are growing rapidly and, in many instances, are more easily accessible to foreign manufacturers. Before venturing into these territories, however, regulatory professionals will need to keep track of current changes to be successful. This article discusses recent regulatory developments in Singapore, Malaysia, Hong Kong, the Philippines, and Taiwan. |
| Published by Pacific Bridge Medical |
2008 |
| By Ames Gross and John Minot |
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Sourcing manufactured goods in Asia has become common as more and more companies take advantage of the lower overhead, lower labor costs, and increasing technical capabilities available in Asia. Medical device companies can procure a wide array of medical devices and products from Asian suppliers at significantly lower cost and relatively high quality. This report helps medical device manufacturers and distributors better understand how to source from Asia. The report covers topics such as how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and other issues related to the sourcing equation. This report will also offer advice on how to avoid and troubleshoot problems and pitfalls that may arise in the course of the sourcing process, as well as include information about insurance, sterilization, payment arrangements, freight forwarding, and customs.
Furthermore, we will include Microsoft Excel spreadsheet templates on CD-ROM with this report that will facilitate your transportation and shipping decisions when dealing with multiple SKUs being shipped in one container. The templates allow you to create your own configurations to determine the optimal number of units/shippers of each SKU to fill a container. After you input the number of shippers of the first SKU, the template will calculate how much space remains in the container to load other SKUs. In addition, it will also calculate freight costs for both air and ocean shipments for the various configurations. |
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| Published by Pacific Bridge Medical |
2007 |
| By Ames Gross and John Minot |
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| This report provides a comprehensive list of clinical research organizations throughout Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia, and Thailand. Included for each CRO is the contact information, description of services, and comments about the CRO. The report also includes a short overview of regulatory procedures for obtaining government approval to conduct clinical trials in each Asian country. |
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| Published by RA Focus |
January 2008 |
| By Ames Gross and Momoko Hirose
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Asia’s growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India’s GDP figures progressed from 7% to 9% over the same period. These countries’ medical device markets are growing at similarly high rates as their populations demand better healthcare to match their new living standards. On the other hand, Japan and Korea, with slower GDP growth (2% in Japan and 5% in Korea in 2006), are also attractive, mature markets for medical devices. This article discusses recent medical device regulatory developments in these major markets. |
| Published in Pacific Bridge Medical Webcast |
November 2007 |
| By Pacific Bridge Medical |
|
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"East is East and West is West," said Rudyard Kipling. However, managing Asian cultural diversity is a lot more complex for Western companies. Each country has its own culture, history, ideology, language, and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and even linguistic traits can make a world difference in managing Asian employees effectively. Find out more in this webcast.
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| Published by RA Focus |
November 2007 |
| By Ames Gross and John Minot
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The multiple advantages of lower overhead, lower labor costs, and increasing technical capabilities are leading more medical product manufacturers to establish facilities in Asia. However, manufacturing in Asia is a more complex proposition than its reputation for cheap, reasonable-quality products might suggest. Differences in language, culture and business practices can require a significant investment of resources to achieve a productive working relationship with a medical device supplier or subcontractor.
This article will go into more detail on specific countries, such as China, India, and Singapore.
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| Published by Pacific Bridge Medical |
2007 |
| By Ames Gross and John Minot |
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This report reviews the orphan drug regulations in countries throughout Asia and discusses various business issues associated with the registration of an orphan drug. The research, development, and marketing of drugs for rare diseases is not always financially beneficial for pharmaceutical companies, so they are generally reluctant to develop and market them under "standard" conditions and requirements. As a result, some countries have implemented regulations specifically for pharmaceuticals used to treat rare diseases, termed "orphan drugs." Several Asian nations have developed orphan drug legislation. Orphan drug laws in Asia may benefit companies; however, each country has specific registration requirements that can pose significant challenges. This report will address these country-specific regulations and provide a list of approved orphan drugs and orphan drug associations in Asian countries. |
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| Published by MPO |
October 2007 |
| By Ames Gross and John Minot
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Not Every Asian Country Is Created Equal, and Knowing the Differences Can Help Avoid Pitfalls
There’s no denying that China has become a dominant manufacturer in the world market, and developing countries such as Vietnam and India are coming up quickly behind it. When it comes to outsourcing opportunities, some Asian countries have significant advantages—low labor costs, widely available technical talent and, in some cases, business-friendly regulations. In this environment, many medical device companies are turning to Asia to find a new supply of companies to source their products or even set up their own factories. |
| Published in Pacific Bridge Medical Webcast |
September 2007 |
| By Pacific Bridge Medical |
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Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter or expand in these markets is key to surviving in the competitive global market. From setting up your own branch in Japan to conducting clinical trials in India, this webcast CD will delve into the key business and regulatory issues in China, Japan, and India.
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| Published in Pacific Bridge Medical Webcast |
March 2007 |
| By Pacific Bridge Medical |
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"East is East and West is West," said Rudyard Kipling. However, managing Asian cultural diversity is a lot more complex for Western companies. Each country has its own culture, history, ideology, language, and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and even linguistic traits can make a world difference in managing Asian employees effectively. Find out more in this webcast.
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| Published
in Specialty Pharma |
March 2007 |
| By Ames Gross and Momoko Hirose |
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With steadily
increasing drug development costs and significant time spent on clinical
trials, outsourcing clinical trials in Asia has rapidly become an appealing
option for many firms. As developing a single drug can cost more than
$200 million and take at least 10 years, Asia (except Japan) offers
a less expensive, less time-consuming process for clinical trials.
Simultaneously, increased demand and awareness for various medical
drugs and health services have encouraged many of these countries to
develop their own Contract Research Organizations (CROs), and many
U.S. firms have eagerly turned to these options to survive in a growing
competitive global market. |
| Published in Pacific Bridge Medical Webcast |
January 2007 |
| By Pacific Bridge Medical |
|
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Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter or expand in these markets is key to surviving in the competitive global market. From setting up your own branch in Japan to conducting clinical trials in India, this webcast CD will delve into the key business and regulatory issues in China, Japan, and India.
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| Published
in Specialty Pharma |
September/October 2006 |
| By Ames Gross |
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Asia has huge potential for orphan drug medications
and treatments. Asia’s population is nearly 4 billion, close to
two-thirds of the world’s 6.4 billion inhabitants. Most Asian countries
are experiencing GDP growth over 5% and Japan’s economy is growing
for the first time in a decade.
While some Asian countries such as Japan and Singapore have highly
advanced healthcare systems, others, such as China and Indonesia, are
still striving to improve their systems. As each Asian country’s
healthcare system differs, the potential for an orphan drug’s
success will also vary throughout the region. |
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| Published in Bone
Zone |
May 2006 |
| By Ames Gross and Nancy Loh |
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Asia has a population of over 4 billion people,
and represents about 60% of the world’s population. Annual economic
growth rates in the Asian countries have been as high as 8 or 10% over
the past decade, in comparison with some developed countries where growth
has been 4% or lower. In many Asian countries, this rapid economic growth
has led to increased personal incomes, improved public health care, and
longer life expectancies.
The Asian market for orthopedic devices today is valued at about $1.5
billion, with average annual growth in recent years of over 5%. Hip
implants have the largest share of the market, with over 40%; trauma
devices account for about 35%, and knee implants account for about
25%. On a global scale, Asia accounts for about one-quarter of world
demand for orthopedic products. The Asian orthopedic device market is
forecasted to reach nearly $2 billion in 2009. |
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| Presented at the
Orange County Regulatory Affairs Discussion Group |
October 2005 |
| By Ames Gross |
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Pharmaceutical and medical device markets
are expanding throughout Asia. This presentation covers the medical device
and pharmaceutical markets in Taiwan, Hong Kong, Malaysia, Singapore,
India and Vietnam, and provides country-specific information about drug,
device and IVD regulations in these countries. Specific topics include
registration, pricing and reimbursement, manufacturing and GMP, import
licenses, patents, and clinical trials in these countries. |
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| Published in MD&DI Guide to Outsourcing |
August 2005 |
| By Ames Gross and Rachel
Weintraub |
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As competition in the global medical device
market intensifies, U.S. medical companies are increasingly seeking out
ways to reduce costs in manufacturing, R&D, clinical trials and other
medical services. Many Asian countries offer a lower cost of labor (China
and India) and skilled labor force. Combining this with the region’s
fast-growing economies and quickly aging populations (Japan’s elderly
population is currently 19.48 percent, versus about 12.5 percent in the
U.S.), these conditions provide promising opportunities for U.S. medical
device companies outsourcing to Asia. |
| |
Presented at the
MD&M East Conference
|
June 2005 |
| By Ames Gross |
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| This presentation provides information
on the medical device regulatory environments for
Japan
,
China
,
Taiwan
,
Hong Kong
,
Korea
,
Malaysia
,
Singapore
, the
Philippines
and
India
.
Some of the specific topics covered include
Japan
’s new Pharmaceutical Affairs Law (PAL) and Marketing Authorization
Holder (MAH) System; the medical device registration process in
China
; and the reimbursement process in
Taiwan
. |
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| Presented at Bio-Collaborations
Asia
for IBC Life Sciences |
May 2005 |
| By Ames Gross |
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| This presentation provides insightful information
on building distributor networks, setting up your own office in Asia, and
marketing strategies in the Asian region. Specifically, business structure
options for China and Japan are described, as well as some recruiting strategies
for staffing offices in these countries. Regulatory information on pharmaceutical
promotion, sampling and pricing is included for Singapore, Malaysia, Vietnam,
and other countries. |

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| Published in Regulatory Affairs
Focus, a publication of the Regulatory Affairs Professionals Society
(RAPS) |
May 2005 |
| By Ames Gross and Rachel Weintraub |
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To expand their sales in the Asian medical
markets, medical companies need to stay abreast of the new and changing
regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs).
New or improved regulations are implemented frequently in Asia, including
changes in GMP standards, drug price controls and medical device regulatory
systems. This article discusses some of the recent and more significant
changes in the region’s medical regulations. Countries impacted
by these new regulations and covered in this article include Japan, Hong
Kong, China, Malaysia, Taiwan and Vietnam. |
| |
| Presented at Contract Manufacturing Conference
of Barnett International |
May 2005 |
| By Ames Gross |
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This session will investigate manufacturing
and subcontract manufacturing in China. Topics to be discussed include
how to set up a factory in China and steps to import medical products.
Outsourcing R&D and clinical trials with a focus on India will also
be covered.
- Key considerations when setting up manufacturing in China
- The best ways to import medical products from China
- Outsourcing opportunities in India |
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| Presented at Annual Drug
& Device Safety Summit of Barnett International |
May 2005 |
| By Ames Gross |
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The global pharmaceutical industry is one
of the fastest growing markets in the world, worth nearly $550 billion.
The Asian region is a major contributor to this market; the pharmaceutical
markets in Japan and China alone are worth approximately $80 billion.
With an aging population and rising healthcare standards, there is a
far greater push for more stringent pharmaceutical laws and safety regulations
in the region. This presentation will cover the Asian countries, including
Japan, China, Taiwan, Singapore, Malaysia, India and Vietnam. A country-by-country
look into the pharmaceutical regulatory processes, including post-market
surveillance and adverse drug reaction (ADR) monitoring, will be discussed,
as well as:
- Japan’s PMDA, PAL and generic drug industry
- New GMP regulations for China, Japan and Vietnam
- Pharmaceutical patent regulation updates for Taiwan, Singapore and India
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| Presented at RAPS 2004 Annual Conference |
October 2004 |
| By Ames Gross |
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| As Asian nations are faced with aging populations,
increased life expectancies, proliferation of major diseases, and higher
disposable incomes, many Asian governments are looking to spend more on
healthcare, particularly imported medical devices. With Asian medical device
markets rapidly expanding, regulatory agencies are continuously revising
and updating new medical device regulations. China’s State Food and
Drug Administration (SFDA) is responsible for several recent updates and
revisions on regulations such as: new labeling and packaging requirements,
sample testing and registration procedural issues. In Taiwan, the Executive
Yuan’s Department of Health (DOH), is the regulatory agency responsible
for the new and updated medical device regulations, including: registration
documents for product renewal or new products, new classification requirements,
Post Marketing Surveillance (PMS) regulations, and Quality System Documentation
(QSD) requirements, among many other updates. This presentation discusses
current and revised medical device regulations for China, Taiwan and South
Korea. It also includes brief descriptions of the expanding medical device
markets in Singapore, Japan, Hong Kong, India and Vietnam. |
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| Published in Medical Device & Diagnostic
Industry Magazine |
July 2004 |
| By Ames Gross and Rachel Weintraub |
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| With the growth of Asian economies spurring
on the expansion of Asian medical markets, medical and pharmaceutical companies
in the West are increasingly looking to Asia for outsourcing. Western medical
device and pharmaceutical companies have begun to outsource research and
development, clinical trials, manufacturing, healthcare services and drug
discovery—benefiting from lower costs and increased productivity.
A high number of qualified and Western-educated engineers, scientists and
technicians, from countries like China and India, are also returning to
their home country to work in the growing medical industries. Although
there are still small discrepancies with intellectual property (IP) protection,
good manufacturing practices (GMPs), and other international standards,
Asian countries are working to implement stricter regulations. This article
highlights the benefits of Western companies outsourcing to Asian countries
such as China, India and Malaysia |
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| Published in Medical Device & Diagnostic
Industry Magazine |
July 2003 |
| By Ames Gross and Caroline Tran |
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| Heart disease continues to be one of the leading causes of
death in Asia. As countries like Japan, China, Taiwan and the Philippines
have a greater demand for medical devices and pharmaceuticals to help treat
cardiovascular disease, many foreign medical companies have entered into
the Asian market. Moreover, as many of these Asian countries’
governments undergo restructuring and decrease the amount of medical coverage
they provide, people are demanding more western products and are willing
to pay for them, as they have often been proven more efficient than local
products. |
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| Published in Medical Device & Diagnostic
Industry Magazine |
May 2003 |
| By Ames Gross and Caroline Tran |
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| Despite the slowing economies, Asia still continues to offer
medical device manufacturers many investment opportunities. With information
and updates on China, Malaysia, Thailand, the Philippines and ASEAN, this
article highlights the benefits and advantages of manufacturing medical
devices in Asia. Asian countries offer significant tax exemptions and other
investment incentives for manufacturing companies, therefore more and more
foreign investors are focusing on Asia. Additionally, the ASEAN Free Trade
Area (AFTA) will come into effect in 2003, providing for greater economic
efficiency, productivity and competitiveness by eliminating tariff and
non-tariff barriers in Asia. |
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| Published in Food and Drug Law Institute (FDLI)
Update |
March/April 2003 |
| By Ames Gross and Caroline Tran |
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| This article covers some of the changing dynamics of the
regulatory scene in Asia for pharmaceuticals and medical devices, with
information and updates from China, Korea, Japan and Taiwan. Drug prices
and reimbursement rates have been cut as governments take steps to control
healthcare expenses and shift the burden of drug costs to the people. Product
registration and distribution procedures for foreign drug makers are becoming
easier in order to attract investment and spur competition. New legislation
has created a more transparent process for registering medical devices.
Asia holds great promise for medical products as long as companies remain
current on regulatory trends. |
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| Published in Medical Device
& Diagnostic Industry Magazine |
October 2002 |
| By Ames Gross and Caroline Tran |
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| Slowing economies have not stopped Asian countries from moving
ahead with medical device regulatory reforms. Asian consumers demand high-quality
healthcare products, making it worthwhile for American manufactures to
be active in the region. Procedures and practices vary according to country.
This article highlights developments and offers advice on how to deal with
Asian medical regulators, including the Ministry of Health, Labor, and
Welfare (MHLW) in Japan, the State Drug Administration (SDA) in China,
the Korea Food and Drug Administration (KFDA), the Bureau of Pharmaceutical
Affairs and Department of Health (DOH) in Taiwan, and the Health Sciences
Authority in Singapore. Topics include procedures for importing, licensing
and registering medical devices, good clinical practice (GCP) and good
manufacturing practice (GMP) guidelines, clinical trial requirements, and
product classification descriptions. |
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| Published in MX Magazine |
November/December 2001 |
| By Ames Gross and Shawna Lepage |
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| The Asian market as whole is huge, comprising some 3.5 billion
people – 60% of the world total. Each country, though, has its own
culture, business norms, and regulations, and companies investing in the
region need to be aware of the differences. This article provides information
on building an effective distribution network, decision making procedures,
the establishment of a joint venture or subsidiary, the art of negotiation,
manufacturing practices, and gaining market access through mergers and
acquisitions. |
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| Presentation at Regulatory Affairs Professional
Society (RAPS) Conference |
August 2001 |
| By Ames Gross |
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| Despite sluggish economies in some countries, Asia still
represents future growth opportunities in healthcare products. Over the
next 20 years, Asian healthcare markets are expected to grow at a rate
two and a half times that of the West. A rising standard of living throughout
the region means patients will have the resources to acquire modern medical
devices and pharmaceuticals. As the globalization of healthcare continues,
regulatory practices for pharmaceuticals and medical devices will be further
harmonized. This report examines emerging regulatory trends and issues
in China, Japan, Hong Kong, India, Indonesia, Malaysia, the Philippines,
Singapore, South Korea, Taiwan and Thailand. |
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| Presentation at HIMA Conference |
September 2000 |
| By Ames Gross |
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| Regulations for medical devices vary by country in Asia and
are always changing. India and Malaysia, which previously did not have
regulations for product registration, have recently adopted stricter and
more comprehensive guidelines. In Taiwan, where registration rules were
different for domestic and foreign products, the process has now been made
fairer for foreign companies. The gradual adoption of international standards
is taking place in Thailand, where only local standards previously applied.
Countries with inadequate or unclear laws, like China, have set up new
governing bodies for devices and drugs. Japan also revised its policies.
Korea, however, has done little to implement promised reforms. These issues
are discussed, with analyses of medical device markets, key regulatory
issues, medical device registration requirements, and explanations of national
regulatory bodies. Countries include China, Japan, South Korea, Taiwan,
and Malaysia. |
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| Published in Medical Device
& Diagnostic Industry Magazine |
July 1999 |
| By Ames Gross and Gayatri B. Koolwal |
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| Recovering economies throughout Asia offer promising markets
for foreign medical device firms as well as opportunities for local product
development and manufacturing. Before the Asian financial crisis, regional
medical device markets grew at double-digit rates. Patients wanted the
technologically innovative, cost-effective devices that foreign medical
manufactures could provide. Many Asian countries became dependent on imports.
Those factors – strong demand and lack of domestic competition – remained
after the crisis. Furthermore, currency depreciation made it cheaper to
establish local facilities for manufacturing and product development. This
article features examinations of Japan, China, Singapore, Taiwan, India,
Thailand and Malaysia. |
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| Published by Pacific Bridge Medical |
April 1999 |
| By Ames Gross |
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Despite Asia’s short-term economic crisis, Asia will
bounce back soon and still be a dominant factor in the 21st century. Similarly,
there will be many opportunities for international medical companies in
Asia. Before an international medical company can sell its products in
Asia, however, unique and difficult regulatory issues will need to be dealt
with. This article focuses on four regulatory issues in Japan, Taiwan,
and Korea. They are:
- Direct versus indirect medical device registration in Japan
- Registration and copying medical devices in Taiwan
- Medical device registration in Korea
- Classifying pharmaceutical products in Japan |
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| Published by Pacific Bridge Medical |
September 1998 |
| By Ames Gross |
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| Review of economic statistics and healthcare trends in China,
Hong Kong, India, Indonesia, Malaysia, Philippines, Singapore, South Korea,
Taiwan, and Thailand. Healthcare information includes total spending, physician/patient
ratios, services, and private/public hospital ratios. |
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| Published in Medical Device & Diagnostic
Industry Magazine |
July 1998 |
| By Ames Gross and Gayatri B. Koolwal |
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| Despite its currency crisis, Asia still offers medical device
manufacturers opportunities. Concern has risen that Asians have lost their
purchasing power, meaning a decrease in U.S. exports to Asia and an unstable
economic environment in which to invest. However, not all manufacturers
have fled the region. Several companies feel that the crisis has opened
new opportunities for manufacturing in Southeast Asia. Indonesia, Thailand,
Malaysia, and South Korea have suffered the most from currency depreciation,
but as a result, these countries are now inexpensive places to establish
manufacturing bases. Manufacturing in Asia is less expensive and can be
a profitable way to enter the medical technologies market there. The cost
of labor and raw materials are both low. Furthermore, Hong Kong, China,
Taiwan, Singapore and the Philippines are expected to grow between 5%-8%
a year and continue to import medical products. |
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| Published in Spectrum: Health Care Delivery and
Economics |
April 1998 |
| By Ames Gross and Timothy G. McDonald |
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| Southeast Asia is becoming an increasingly important market
for medical products, including products for diagnosing and treating infectious
diseases. Pharmaceutical and diagnostics firms can take advantage of shorter
regulatory procedures required in Brunei, Cambodia, Indonesia, Laos, Myanmar,
the Philippines, Singapore, Thailand, and Vietnam by marketing products
in these countries before doing so in other Asian nations. Also, early
registration in a Southeast Asian country allows companies to collect real
world data that can be used to register a product in countries with stricter
guidelines, such as Japan. This report focuses on three diseases: HIV/AIDS,
malaria, and cholera, and discusses strategies for regulatory approval
and production, as well as epidemiology and pathophysiology, diagnosis,
pharmacological treatment, vaccines and prevention programs. As HIV/AIDS
becomes more prevalent, markets for products will grow. However, continued
development and better health standards will lower the occurrence of malaria
and cholera, and subsequently reduce demand for products. |
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| Published in Vivo: The Business and Medicine
Report |
February 1998 |
| By Ames Gross and Alisa DiCaprio |
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| The growth rate of HIV and AIDS cases in Asia is the highest
in the world. The dynamic nature of the Southeast Asian markets, in conjunction
with the rapid spread of HIV and AIDS has spawned a region of incredible
potential for diagnostic, therapeutic, and vaccine technologies, as well
as related drugs and equipment. Companies that are able to establish a
presence in Southeast Asian HIV and AIDS markets will now find a much more
hospitable environment. This article discusses the nature of HIV/AIDS in
affected countries, including Malaysia, the Philippines, and Thailand,
and government prevention policies. There is also information about the
market for rapid diagnostic tests and therapeutic products, registration
time frames, insurance reimbursement rates, and clinical trials. |
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| Published in Vivo: The Business and Medicine
Report |
October 1997 |
| By Ames Gross |
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| Over the last ten years, Asia’s cancer rate has drastically
increased, as standards of living improve and industrialization factors
like, smoking, high-fat diets and pollution escalate. Asia’s governments
are very aware of the cancer crisis, and in turn have begun improving their
facilities to treat the deadly disease. Many countries in the region use
surgery, chemotherapy and radiation therapy to treat cancer, which in turn
requires sophisticated equipment provided by Western manufacturers. Western
firms are also able to introduce cancer treatment products with vast success,
as many companies have agreed to joint ventures in countries like China
and Malaysia. Additionally, Western companies have realized the importance
of traditional medicine in the region, and Western scientists are joining
international efforts to study traditional medicine. This article discusses
the cancer situation in Asia, and provides guidance on regulatory issues,
intellectual property protection and business relationships in the Asian
marketplaces. |
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| Published in Spectrum: Health Care Delivery and
Economics |
August 1997 |
| By Ames Gross and Elaine C. Conavay |
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| This article contains analyses of healthcare trends and policies,
and the role of foreign medical companies in China, Hong Kong, Indonesia,
Malaysia, Philippines, Singapore, South Korea, Thailand and Vietnam. As
Asia continues to be the fastest growing region in the world, economic
and population growths have a profound effect on Asia’s healthcare
needs. In order to accommodate the demand for better healthcare services,
governments are shifting from subsidized and government-run facilities,
to private sector facilities. Consequently, this shift takes off some of
the burden of healthcare expenditure. Moreover, the standard of living
is improving and more middle class patients are demanding better healthcare
facilities and sophisticated medical treatment. This demand provides ample
opportunity for foreign medical device and pharmaceutical manufacturers
to invest in the Asian medical marketplace, as healthcare providers will
need to obtain sophisticated products necessary to meet the rising standards. |
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| Published in Spectrum: Health Care Delivery and
Economics |
June 1997 |
| By Ames Gross |
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| Growing healthcare reforms throughout Asia offer optimistic
future prospects for multinational pharmaceutical companies. Southeast
Asia has the world’s fastest growing pharmaceutical market; while
China’s pharmaceutical sales have reached up to $10 billion and will
continue to grow. Despite the issues of intellectual property protection,
differing disease needs, chaotic drug distribution, and reimbursement and
pricing concerns, foreign pharmaceutical companies are establishing joint
ventures and investing millions of dollars into the region’s pharmaceutical
markets. Some companies who have established joint ventures in China include
Bayer, Glaxo Wellcome, and SmithKline Beecham. This article goes over the
status of pharmaceutical markets in China, Indonesia, Thailand, the Philippines,
and Malaysia. Additional topics include the existing healthcare systems,
domestic markets, and the business activity in the region’s markets. |
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| Published in Compliance Engineering |
1997 Reference Guide |
| By Ames Gross |
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| As Gross Domestic Product (GDP) numbers soar in Asia, governments
are eagerly spending more money on health and medical-related devices,
further opening up medical markets to international investment. Foreign
medical technology firms investing in Asian markets are experiencing rapid
success by manufacturing their products in Asia, rather than outside the
continent. Most foreign companies have established joint ventures in the
region, such as Hewlett-Packard’s Medical Products Group, giving
them a competitive edge over companies who manufacture elsewhere. Asian
countries often offer special interest rates, tax exemptions, free-trade
zones, and export incentives. This article goes over the benefits of manufacturing
in Asian countries and includes success stories of joint ventures in the
medical equipment and device markets, pharmaceutical markets, and health
and personal care product markets. |
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| Published in Medical Device
& Diagnostic Industry Magazine |
May 1996 |
| By Ames Gross and Laura Mancini |
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| This article serves as a comprehensive guide for U.S. medical
manufacturers looking to find a distributor in Asia. Topics include checking
a distributor’s background, negotiating a distribution agreement,
Asian legal systems, exclusive vs. nonexclusive distribution, sales targets,
and other responsibilities of the distributor. Since personal relationships
are the foundation for a smooth partnership with an Asian distributor,
U.S. medical manufacturers should be able to acknowledge the many differences
in doing business in Asia, and work with those differences to enjoy great
success in the Asian medical markets. |
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| Published in Medical Device
& Diagnostic Industry Magazine |
January 1996 |
| By Ames Gross |
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| As medical technologies become more widespread and advanced,
multitudes of lives are prolonged by more modern and improved healthcare,
particularly in Asia. Asia’s aging population has pushed governments
to reform healthcare systems to accommodate this challenge. Subsequently,
that has created more business opportunities for foreign medical manufacturers
who can specifically address the medical needs of Asia’s elderly.
Countries like Singapore, Japan and Malaysia have all opted for privatization,
which provides high quality care and shorter wait times, while other countries
still emphasize the public sector. This article discusses the aging population
situation in Asia and the opportunities that this issue presents for foreign
medical device manufacturers. |
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| Published in Clinica |
November 1994 |
| By Ames Gross |
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An exceptional economic boom in the Asia Pacific
region has spurred a large expansion
in dental markets, providing remarkable prospects for foreign manufacturers
of dental equipment. Dental hygiene and cosmetics have become major consumer
health priorities as many more consumers can afford additional dental procedures.
Japan is Asia’s largest dental market and even with the National
Health Insurance (NHI) scheme covering only acute dental care, patients
are willing to pay for many more non-acute dental procedures. Singapore
boasts a high-technology dental system, encouraging neighbors from Indonesia,
Thailand, Malaysia and the Philippines to come seek dental service. Hong
Kong sustains a prosperous import market and plays an important role as
the gateway to mainland China’s dental market. This article highlights
the major aspects of these three dental markets in Asia and the potential
success for foreign dental equipment manufacturers in the region. |
 |
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| Published in Medical Industry Executive |
October 1993 |
| By Ames Gross |
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| This article is an overview of business opportunities for
medical product manufacturers in the Asia Pacific region. Topics include
Japan’s import requirements, registration procedures, and the keiretsu
system; China’s slow decentralization of its healthcare system; the
market growth of Indonesia, Thailand, Malaysia, Korea, Singapore and Taiwan;
and business relationships between Western and Asian partners. |
 |
 |
| Published by Pacific Bridge Medical |
|
| By Ames Gross |
 |
| A basic guide to conducting business in China, Japan and
Southeast Asia. Topics include personal and business relationships, negotiating,
gift-giving, body language, introductions and language and cultural differences. |
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|
Asia
China & Hong Kong
India
Indonesia
Japan
Korea
Malaysia
The Philippines
Singapore
Taiwan
Thailand
Vietnam
|