Medical device companies have become increasingly concerned with the potential for new FDA regulations to negatively impact their ability to remain competitive in the global market. Earlier this summer, the Advanced Medical Technology Association (AdvaMed) put together a series of recommendations on how to shape regulatory policy in order to deal with this particular problem head-on.
AdvaMed called its recommendations a “Competitiveness Agenda,” which is designed to ensure that future medical device innovations are not driven to move outside of the United States but continue to be developed by American companies. Divided into six main points, the Competitiveness Agenda is intended to balance the need to protect the health and safety of the public while ensuring that the pace of technological development is not unduly slowed by an inefficient regulatory bureaucratic process.
Of the six main policy recommendations made by AdvaMed, three were directed specifically at the legislative and regulatory apparatus at the federal level. AdvaMed called on the FDA to reduce the amount of time taken to review and approve medical devices, have the government formally prioritize health and life science innovation, and tailor Medicare and Medicaid reimbursement policies to provide financial support for new treatments. At the same time, private insurers in the U.S. must also be encouraged to develop a more open mind towards the same types of innovative devices.
The second half of AdvaMed’s recommendations focused on the economic aspect of medical device innovation. The Agenda advocated both the adoption of tax policies and credits that favored technological research and development, as well as an increased investment in America’s scientific infrastructure in order to create an environment where discoveries can be brought to market quickly and efficiently. AdvaMed would also like to see the U.S. government take a hard look at its current foreign trade policies and do what it can to influence favorable conditions for American manufacturers and exporters.
There is no question that these recommendations represent sweeping changes from both legislative and procedural perspectives within the medical device industry. The call for changes to America’s economic policies – especially during a time when it is difficult to find a sector of the economy that is not struggling due to the recent financial crisis – could also be seen as a tall order. It is impossible to deny, however, that the United States is running the risk of falling behind Europe and other major medical device development centers in terms of innovation. AdvaMed – and MDCI – feel that it is far from too late to intervene and reconfigure the current medical device environment to foster technological development and improve regulatory policies.
MDCI Blogging Team