Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must keep in mind are related to the path to market, but have you ever thought about competitive regulatory strategy? Going with the PMA approach might be a better business strategy than using the 510(k), despite the entrenched mentality that it’s a longer, more difficult road.

Today we’re going to talk to regulatory guru, Mike Drues. Mike is the president of Vascular Sciences and he is well-versed on the entire process medical device companies go through to get their products on the market. He’s going to share his insight on competitive regulatory strategy and how it can help you make good business decisions.

Some of the highlights of the show include:

● The pitfall of seeing the regulatory process only as a matter of jumping through hoops and the importance of seeing the bigger picture.

● What regulatory strategy is and how it differs from the path to market.

● How competitive regulatory strategy differs from regular regulatory strategy and how you can use it to your advantage.

● Some potential objections to using the PMA and how Mike responds.

● Thoughts on how to use guidance documents as a competitive weapon.

● Why one might consider a de novo classification as part of their regulatory strategy.

● Why you should always be looking for a different, better way to get through the regulatory process.