This document describes the Medical Device Gateway (MDG) program, a Chinese-Finnish network aimed at commercializing medical device technologies. The program seeks to bring Chinese medical device innovations to European markets through Finnish companies, and to open Chinese markets to Finnish medical ventures. It identifies opportunities in the large and growing Chinese IVD market and regulatory changes making it more accessible. The document outlines the program's operations of establishing strategic partnerships between Finnish and Chinese organizations to more quickly develop and place new products on global markets.

1. Ilpo Kuronen
www.hyvinvointiklusteri.fi
www.kuopioinnovation.fi
Health and Well-being Cluster Program
Medical Device Gateway (MDG)
A Chinese – Finnish network for commercialization of medical device technologies.

2. IDEA
Europeanization of Chinese
medical device technology through
Finnish ventures.
Opening up Chinese markets for
Finnish medical device ventures.
WinWin

3. OPPORTUNITY
6,3 billion $
2,5 billion $
2,5 billion $
IVD China 2007
Promising IVD Market in China
There has not been a year in the last decade in which the IVD market in China has failed to grow. Combined
with this impressive overall growth, a number of recent trends in the Chinese healthcare environment are
making China an increasingly attractive and important market opportunity for in vitro diagnostics companies.
Although there are a number of challenges for diagnostic manufacturers to understand and overcome, the
market for clinical diagnostics in China (both reagents and instruments) remains one of the most promising
emerging markets in the world. Meanwhile, the double-digit growth rate and opportunities for foreign firms will
expand as China’s regulation of medical devices moves more in line with international practices.
The State Food and Drug Administration of PRC (SFDA) promulgated the “Registration Management Act for In
Vitro Diagnostics Reagent (Trial)” and put in force from June 1, 2007. It is widely expected that the future
Chinese IVD market will become more regulated with clearer standards, enable further broadening and
development of the industry segment.

4. OPPORTUNITY
6,3 billion $
2,5 billion $
2,5 billion $
Market Overview
Emergence of Niche Segments Drives Growth in European IVD Market
Valued at $6.60 billion in 2005, the European in-vitro diagnostics (IVD) market is expected to grow at a compound annual
growth rate (CAGR) of 6.0 per cent from 2005 to 2012, reaching $9.95 billion in 2012. While well-established segments such
as those for immunoassay and clinical chemistry currently contribute more than half of the market revenues, future market growth
is likely to hinge on the immense potential of two niche segments, molecular biology and point-of-care testing (POCT). "Despite
increasing price erosion, competition and industry consolidation as well as lack of sufficient reimbursements, the European IVD
market is growing due to the emergence and rising adoption of molecular testing and near patient testing," notes the analyst of this
research service. "The genomics revolution, combined with developments in automation technology, has definitely set the pace in
this market."
Major market participants are increasingly focusing on these potentially high-growth areas in an attempt to consolidate their
positions in the IVD market. Despite growing maturity and fierce competition, leading participants continue to maintain a revenue
growth of 3 to 5 per cent due to their market visibility, financial strength and customers’ brand loyalty.
Growing Awareness and Adoption of Emerging Technologies Augurs Well for IVD Market
An increase in the adoption of new technologies is likely to be a key factor driving the growth of the European IVD market over the
forecast period. Awareness among patients and laboratories about emerging technologies is greater than ever before, especially in
new areas such as molecular testing. Laboratories are realizing the need for automation and its many advantages. IVD
manufacturers are cashing in on this trend and are actively working to innovate laboratory analyzers and other automated solutions
as well as introduce novel technologies. In fact, the last decade has witnessed the emergence of numerous technologies that have
gained popularity and carved a niche for themselves in the IVD market.
"Established participants and many start-up companies are constantly refining and developing new technologies in this market,"
says the analyst. "These developments are more intense in areas such as molecular diagnostics and POCT." One of the major
reasons behind these huge investments is the emergence of strong intellectual property (IP) laws. The potential of acquiring
financial gains from IP patents is driving continuous innovation by many of the smaller companies, which might otherwise be wary
of entering the fiercely competitive IVD market.
Frost & Sullivan August 30, 2006

5. TECHNOLOGY
IVD & IVDD
- reagents
- measuring devices
- platforms
- sensors
- radiation devices
- orthopedical devices
- surgery devices
Fitness & Health
- measurement of physical condition

6. Who to participate

7. Who to participate

8. COMPETITORS
6,3 billion $
2,5 billion $
2,5 billion $
Ref: Medical product Outsourcing: June 2006

9. What creates value
Change of:
- Ideas
- Innovations
- Technology
- Products
- Outscoring opportunities

10. How to create value
Acquisition of
innovations
New
technology
New
products
New sales REVENUE
REVENUE New sales
Old / tailored
products
Old innovation
(technology)
New
opportunity

11. Why us?
Born Global
Sharon Ballard in Superchoaching® program (Jyväskylä 2008).
“During my visit in Finland I have seen this problem so many times, Finns wake up, you have to
think globally”.
Do it faster
What means to be the first in markets?
“Hi big shark, I have an innovation, I can develop a device which is much fancier that the one which is offered
by your competitor. It may take a few years to develop it but then we make business”.
“Hi big shark, I have an idea and a business opportunity. To make business we need technology and fast. I
know where to get it, are you interested in making business”.

12. Why program?
Regulatory barriers
SFDA is our primary strategic alliance since we must know what they expect from us.
This program can establish good practices and contacts to get over regulatory
hurdles faster.
Finnish ventures are already placed products on EU markets under IVD Directive
79/98EU. Excising technology awaits for Europeanization which is an opportunity.
Innovation channel: China Finland
Medical industry is changing rapidly and new innovations must be placed on markets
faster. If we don’t do it, someone else does. MDG program can create connections to
Chinese research organizations and enterprises. These connections are valued as
creation of new products and revenues.

13. Operations
Direct contacts and visits to potential
partners
Strategic alliances conform the backbone of the program. The
partners can be found from seminars, conferences, personal
contacts etc. Our job is to locate the potential partners and lead
them into the table.
- SFDA (Chinese federal drug administration)
- Leading Science Parks
- Chinese technology provides
- Chinese retail ventures (marketing & sales)

14. Financials
Elucidation
phase
Contacting phase /
operative actions
Agreements,
technology
transfer, sales
2008 2009 2010
2000 €
20 000 €
200 000 €

15. Contact:
Ilpo Kuronen, PhD
Programme Director
Kuopio Innovation Ltd
B.O.Box 1188, FI-70211 Kuopio
GSM +358 45 139 3757
ilpo.kuronen@kuopioinnovation.fi