How the FDA and Device Industry Can Collaborate to Spur Innovation

Ever heard of the FDA's Office of Science and Engineering Laboratories? Not many medical device designers and experts raised their hands when Dale Wahlstrom of LifeScience Alley asked that question during his keynote address at MD&M Minneapolis.

It turns out that this little-understood office corrals academics and private researchers to reproduce the research provided by medical device companies to make sense over which company is right and which is wrong.

"They have a test, and that is how they would look at your product," Wahlstrom, president and CEO of the Minnesota-based trade association, as well as the BioBusiness Alliance of Minnesota, said during a Tuesday morning keynote address.

Helping medical device company officials better understand the workings of the office is but one of areas of collaboration behind the Medical Device Innovation Consortium that LifeScience Alley helped roll out at the end of 2012, Wahlstrom says.

The overall goal is the institution of "regulatory science," in other words the development of methods, tools, and resources for better managing the total product life cycle of a medical device. The idea is to get cutting-edge medical technology into the U.S. market faster without compromising safety.

Wahlstrom repeated words that he said actually came from the FDA: "faster, cheaper, safer." He flips through slides showing some of the Consortium's initial projects:

William Murray, most recently CEO of Envoy Medical, became CEO of the Consortium in August.