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Quality and regulatory professionals in the medical device industry have to deal with a lot.

In this episode, Mike Drues of Vascular Sciences shares 15 of his highly effective habits and tips to help you lead your organization.

You have an opportunity and obligation to explain the current regulatory structure in the industry - embrace it, don’t resist it!



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Some of the highlights of the show include:

● Poker Game: Relationship between a company and the FDA is like a poker game; even if someone understands the regulations, doesn’t mean they win

● Think Globally: Startups and new companies make the mistake of not considering international regulatory strategies; satisfy needs of various places

● Consider Regulatory from the Beginning: It’s never too early to think about regulatory in product development lifecycle; minimize burdens and problems

● Don’t Reinvent the Wheel: When it comes to clinical trials, data, and real-world evidence - can they be justified, even if the FDA asks for them?

● Competitive Regulatory Strategy: If you follow in somebody else’s footsteps, you’ll never go anywhere new

● Don’t Just Copy Others: Lots of sheep in medical device industry who take the path of least resistance; not aware of their options

● Know All of Your Options: Know about available options, as well as the advantages and disadvantages of each, to get your medical device on the market

● Don’t be Myopic About Risk: All conventional risk approaches are limiting; some aspects of risk are important to consider but not addressed in them

● New is Not Necessarily Your Friend: If you think you’re working on a newer, novel device, you’re probably not: Regulation? Guidance? Reimbursement?

● Use Label Expansions to Your Advantage: Tempting to bring a product with all the bells and whistles to market, but higher likelihood of being unsuccessful

● Design Your Label Like You Design Your Device: Spend time and money on label design; use all tools available to express your message

● No Submission Should Ever be Rejected: 75% of first-time 510(ks)s are rejected; minimize or eliminate rejections through advanced communication with agency

● Communicate Early and Often with FDA: It’s not the FDA’s job to tell you what to do; tell, don’t ask and lead, don’t follow

● Don’t Treat FDA or Other Regulatory Agency as Your Enemy: Don’t approach agency as beta tester or with minimum done to get it to sign-off on a product

● Don’t be the Regulatory Police: Don’t tell a company what they can’t do, but what they can do; don’t let regulation hold you back



Mike Drues

7 Habits of Highly Effective People

510(k) Forms

Understanding the Many Connotations of Risk in Medical Device Development and the Consequences of Getting Them Wrong

Greenlight Guru



“Just because somebody understands the rules of poker, i.e. the regulations, does not necessarily mean that they are going to be a good poker player...and win the game.” - Mike Drues

“It’s never too early...to begin considering your regulatory.” Mike Drues

“Just because FDA asks you to do a clinical trial, doesn’t necessarily mean that you have to do it.” - Mike Drues

“I think people fall in love with wanting something to be new.” - Jon Speer



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.