How U.S. Medical Device Startups Benefit From Early Clinical Uses In Europe

ENCINITAS, CA, January 13, 2011 (Press-News.org) acroMIS announced it has added a white paper titled: Launching Your Medical Device Products In Other Countries to the resources available from acroMIS for VC firms, entrepreneurs, start-up, and early-stage device companies. In a detailed process description, acroMIS International Medical Consulting explains how U.S. medical device startups can benefit from early clinical uses in Europe. The first part of the paper is titled, New European Markets Can Bring Tangible Value to U.S. Device Companies, and describes the strategy for the implementation of early clinical uses in Europe. The second part is titled, Free Movement Of U.S. Devices Within The European Market, and focuses on how to implement European CE marking requirements. The third part is titled, European In-country Opportunity Assessment: Commercial Implementation and Business Development of U.S. Medical Innovation, and focuses on the pathway to early clinical uses and commercial success in Europe.

"acroMIS is committed to bringing the expertise of how to go international to U.S. start-up companies, so writing the white paper as a How-To Manual was a logical choice for us," says Haio Fauser, managing director and co-founder of acroMIS. "By offering the know-how for device implementation and development outside of the U.S., we've made it easy for VC firms, entrepreneurs, start-up, and early-stage device companies to get a powerful head-start on their international clinical and marketing goals."

In the U.S., medical device start-up companies are applying a new strategy. They are doing their innovative device development business outside the U.S. on account of changing economic and regulatory policies. More than 80 percent of the senior device executives participating in an industry survey indicated that these changes are making it more attractive to do business outside of the U.S.1 Studies like, Gone Tomorrow?2 report that in the U.S., global leadership in medical innovation and the resulting biomedical development is, ...ours to lose. This study goes on to say that, while other nations have aggressively pursued medical innovation as an economic growth strategy, we have allowed our ecosystem for medical innovation to decline. The Business & Medicine Report In Vivo 3 claims to have identified the changing face of medical technology innovation, and reports that progress in technology usually results from collective efforts and economic forces that come together to create an eco-system which fosters innovation. The report states, ...the delicate balance of these forces is beginning to change...and offers opportunities to those, in the U.S. and around the world, who find themselves well-positioned to adapt to new modes of innovation. Josh Makower, MD, a consulting professor of medicine at Stanford University, goes a step further in his study, FDA Impact on U.S. Medical Technology Innovation,4 which claims that Unpredictable, inefficient, and expensive regulatory processes are jeopardizing America s leadership position in medtech innovation. Furthermore, the Boston-based company CenterWatch, which gathers data on clinical trials, has found a significant growth in investigators who are working on clinical trials for the U.S. market in countries outside the U.S.

About the author:

Haio Fauser, MBA, is a medical device expert in launching new technologies and developing new business opportunities. He is the managing director and co-founder of acroMIS, which focuses on implementation and development consulting. Mr. Fauser mission at acroMIS is to implement and develop medical device technology in new markets using cost effective and sustainable methods. His clients benefit from his international business development experience and his global network of friends in the industry.

References:

1. Industry Survey, FDANews, Newsletter, July 26, 2010;
2. Gone Tomorrow?, Battelle Technology Partnership Practice, June 2010;
3. The Changing Face Of Medical Technology Innovation, In Vivo, September 2010;
4. FDA Impact on U.S. Medical Technology Innovation, Josh Makower, MD, Stanford University, November 2010.

To obtain a copy of the white paper contact acroMIS call (650) 336-8641 or send an email to: info@acroMIS.com.