May 24, 2011

A new survey conducted by Northwestern University and funded by the Institute for Health Technology Studies (InHealth), a nonprofit research institute whose board consists of AdvaMed, Johnson & Johnson and Stryker executives, finds that smaller medical device manufacturers are favoring Europe over the US for product commercialization at an increasing rate.

Based on online responses from more than 350 medical device professionals, the survey shows that 80% of respondents chose to approach EU regulators first to discuss and plan device submissions, while four percent of respondents opted to approach the FDA as their first regulator of choice.

The survey’s device-specific section furthermore showed that 65% of respondents’ devices attained CE Marking before 510(k) clearance; US review times typically take twice as long as EU processes, the survey indicated.

A broad majority (76%) of respondents large and small reported finding FDA 510(k) preparation and submission requirements unclear; that percentage bears particular significance given that 98% of respondents cited predictability of regulatory requirements as a key factor in whether to undertake new product development efforts.

The survey found that smaller-tier medical device manufacturers are significantly impacted by delayed and protracted FDA review processes. Product development efforts for smaller firms take an average of nearly 27 months compared to about 18 months for larger manufacturers with more resources at their disposal. Along with longer product development time frames come longer FDA review times: Smaller firms reported average review times of 330 days, whereas larger firms reported 177-day review periods. Considering that smaller manufacturers have been responsible for developing some of the more cutting-edge devices and technologies, regulatory processes that stifle their paths to market can only lead to a “brain drain” in the US, argue the survey authors.

In order to better support innovative product development in the US market, the survey authors prescribe a familiar remedy: stronger collaboration between industry and regulators as well as more consistency in establishing and enforcing regulatory requirements.


  • Stewart Eisenhart