How to Construct an Effective Regulatory Strategy

What is a regulatory strategy? What are the components involved?
In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy.

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Some highlights of this episode include:

• Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics).
• Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options.
• Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market.
• Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment.  
• Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn’t always make sense for products and technology. 
• Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan.
• Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly.
• Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.

Related Resources:

FDA - Medical Devices

De Novo

Premarket Approval Application (PMA)

Premarket Notification 510(k)

FDA Design Control Guidance

Class I Exemption

Wellness Exemption

Erika Andersen

Devon Campbell of Prodct

Stephen Covey

Mike Drues

Vascular Sciences

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable Quotes from this episode:

“Strategy is a hope for future.” Jon Speer

“Strategy is key. Your strategy is not necessarily to win the game, that’s the outcome. The strategy is how you get there, considering all your different options.” Mike Drues

“I will never tell a company what not to do. I refuse to play the regulatory police.” Mike Drues

“I’m getting sick and tired of people...say they want the quickest, easiest, cheapest way to get their device on the market.” Mike Drues

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