Developing a Regulatory Strategy


Manage episode 347870072 series 1017311
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What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.

Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.

Some of the highlights of this episode include:

  • What regulatory strategy is and what it isn’t
  • Why a good regulatory strategy is so important
  • What competitive regulatory strategy is
  • The mistake of focusing on only one company
  • How the EU MDR is affecting regulatory strategy
  • What causes delays in complying with regulations
  • The industry record on post-market surveillance
  • Reimbursement and regulatory strategy

Memorable quotes from Mike Drues:

“Let’s not forget my old friend, competitive regulatory strategy.”

“It’s never too soon, in my opinion, to start thinking about regulatory strategy.”

“As a general rule, we have done an abysmal job on post-market surveillance across the board.”

“I consider this whole thing to be a poker game, in every sense of the word.”


Mike Drues LinkedIn

How to Construct an Effective Regulatory Strategy

Jon Speer LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

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