Pro-dex

Uncertainty in MedTech

One thing’s for certain: There’s a lot of uncertainty in today’s MedTech industry

Byline: 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 the industry’s ability to do business in a productive, innovative, confident way.

Two industry leaders (David Perez, President and CEO of CardianBCT, Inc. & Terumo Transfusion and Tim Pratt, EVP, Chief Administrative Officer, General Counsel and Secretary of Boston Scientific Corp.) weighed in during a “CEOs Unplugged” session about how they see all this uncertainty affecting their business: 

• It’s taking longer and costing more to innovate. But MedTech has a fundamental responsibility to patients to innovate and keep improving. Tactical, specific strategies are needed to improve predictability and transparency with the FDA.
• There are unintended consequences when you don’t have a 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 innovation engine runs most efficiently and seamlessly if the industry knows things like:
  
  
  • 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 U.S. and beyond.

If you don’t have 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, the MedTech industry has determined that, at the end of the day, they want the same outcomes as the FDA— reliable, quality products that benefit patients—and they are 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.