ZURICH--(BUSINESS WIRE)--A prominent European-based medtech executive and investor is urging the United States medical device industry to consider Europe as “the new model for success” in funding innovative companies that are developing technology to saves lives and enhance the quality of life.
“The environment for investment in Europe is clearly becoming more attractive as the product development pathway remains relatively predictable in terms of time and expectations,” insists Dr. Stephan Rietiker, MD. “The proposed changes to the regulatory and healthcare systems in the U.S. are creating unsatisfactory delays for innovators and uncertainty for investors, particularly as it is not clear if the proposed changes will alter the system for the better, while opponents try to steer the proposals for change off course.”
Dr. Rietiker is chairman of the investment platform, AurigaVision. Since 2005, he has served as a Senior Advisor to Brown Brothers Harriman's medtech M&A advisory practice focused on European, privately held companies. In addition, he is Chairman of RepRegen and Phytoceuticals and has served as a Director of a number of developmental-stage medtech companies. Previously, he was CEO of Sulzer Medica (later Centerpulse), responsible for restructuring the company, which led to its acquisition by Zimmer in 2003. He qualified as a medical doctor at the Medical School of the University of Zurich in 1982 and then spent five years in medical practice before moving into the healthcare industry. Dr. Rietiker began his business career with Roche in 1987 and held various positions with increasing responsibility in marketing and general management with Boehringer Mannheim and Schering-Plough before becoming VP/GM Europe for Covance Central Laboratory Services.
“Although the funding environment in the U.S. has been relatively stable, small companies are feeling the pinch as competition for funds increases,” says Dr. Rietiker. “Aside from funding, companies in the U.S. or those seeking access to the U.S. market are feeling the strain for other reasons that could present significant threats to innovation. The lack of transparency and predictability of the 510(k) regulatory approval processes is triggering calls for the system to change. The major points facing review include the antiquated principle of the split predicate, the lack of clarity over the definition of substantial equivalence, and a lack of understanding of how to approve an innovative new device for which no predicate exists. Without clarity on these principles an innovator will face increasing costs and uncertain delays in gaining regulatory approval and entry to the marketplace.”
Click here for the complete article “Crossroad” authored by Dr. Rietiker (rietiker@aurigavision.com) with Fiona MacLaughlin, PhD, MRPharmS.