Managing Business Risk as a Medical Device Company


Manage episode 291436910 series 1017311
By Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, and Consultants; R. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant.

Together, Mike and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.

Some highlights of this episode include:

  • Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.
  • There are consequences to a company’s distribution model and selling strategy. Each has a different set of contracts and risks that need to be assessed and receive recommendations.
  • Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usually the biggest risk for entrepreneurs and startups.
  • Mike often says that there are three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.
  • Jon defines risk management as a platform with intentionally built workflows related to ISO 14971. Greenlight Guru mitigates risk for companies as they operate quality systems to manage information and handle audits.
  • What you do and don’t do influences and represents your risk profile. Don’t make insurance an afterthought to achieve better outcomes and goals.
  • Do everything you can to be the best company. Don’t just do the minimum, but go above and beyond to change the quality of life.

Memorable quotes from Michael Cremeans:

“What I’m going to do is help people map out where they’re headed. What could go wrong? Who’s going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on?”

“How can you figure out what they need if you haven’t asked them about their company?”

“There’s three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.”

“Do not sign a contract until you’ve talked to me.”



Mike Cremeans on LinkedIn

Mike Cremeans: Risk and Insurance Consulting

FDA - Device Approvals, Denials, and Clearances

FDA - Guidances

ISO 14971

ISO 13485:2016

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

371 episodes