By Tricia Rodewald
“Uncertainty” is a main theme coming out of this year’s AdvaMed convention.
 
Uncertainty about 510(k) process reforms. Uncertainty about FDA and healthcare reform. Uncertainty about the future of medical device innovation.
 
From the smallest start-up to the largest OEM, uncertainty affects industry’s ability to do business in a productive, innovative, and confident way.
 
Two industry leaders (David Perez, president and CEO of CardianBCT Inc. and Terumo Transfusion, and Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary of Boston Scientific) weighed in during a “CEOs Unplugged” session about how they see all this uncertainty affecting their business. Among the key points the covered:

• It’s taking longer and costing more to innovate, but the medtech industry has a fundamental responsibility to patients to keep improving. Tactical, specific strategies are needed to improve predictability and transparency with FDA.
• There are unintended consequences when there is no predictable course of action to take with innovation. This makes it difficult to offer patients better products that improve outcomes.
• The drivers of the innovation engine are engineers and R&D people. That engine runs most efficiently and seamlessly if industry can predict how innovative products will be received. For example:
  • If we apply x amount of effort to y and achieve z outcome internally, there’s a predictable outcome in terms of when you can go to market and what kinds of reimbursement structures you’ll have in the United States and beyond.  

Without that predictability, innovation will stall.

• The medical advances that tend to benefit patients the most are the big, game-changing innovations that carry the most risk. An uncertain industry with limited predictability is unlikely to take those risks.

Although there’s a strong current of uncertainty in the medical technology space, few are sitting idly by, just waiting to see what happens. By and large, industry has determined that, at the end of the day, it wants the same outcomes as FDA— reliable, quality products that benefit patients—and it is committed to working collaboratively toward that goal.
 
If tweaks and changes can be made to make FDA processes more efficient and predictive, innovation can and will thrive.