Absorption Systems LP CEO Patrick Dentinger is the head of one of the few companies that may benefit from an increasingly strict regulatory clearance process for drugs and medical devices. Absorption Systems is a contract research organization, or CRO, and as the Food & Drug Administration changes the rules for its 510(k) medical device clearance process, the company is offering medtech developers more options to clinically test their products outside of humans, saving the companies time and money.
In a single word, I would characterize the medical device landscape as “improving.” Venture capital dollars are returning to the medical device space, particularly in the areas of diabetes, obesity and cardiovascular diseases.
As the FDA becomes more stringent in its 510(k) approval process, it will require more definitive preclinical efficacy and safety testing before allowing the use of a device in humans – in some cases even requiring companies to redo studies. This trend, while time-consuming and expensive for device developers, will ensure medical devices that reach the market are safe and effective for human use. The new rules will also benefit preclinical CROs, like Absorption Systems, that are assisting medical device companies to rapidly move toward IDE, 510(k) or PMA regulatory filings.
MassDevice New Year’s Special P/review
- P/review: Introduction
- P/review: Paul LaViolette
- P/review: Stephen Ubl
- P/review: David Lucchino
- P/review: Euan Thomson
- P/review: Brian DeChristopher
- P/review: Christopher Delporte
- P/review: Don Hardison
- P/review: Brent Hudson
- P/review: Hamid Tatabaie
- P/review: Patrick Dentinger
- P/review: Nancy Briefs
- P/review: Brian Concannon
- P/review: Ryan Howard
- P/review: Ed Berger
- P/review: Top stories of 2010
We are keeping an eye on innovative gastric bypass and cardiovascular devices that have the potential to improve patient outcomes. I predict the cutting edge will be with those companies developing solutions for long-standing problems such as restenosis and severe chronic thrombosis treatment.