077: The Best Thing You Can do to Prevent Problems with the FDA

Kris is the president of Advantu, a company that helps you build products that your customers will love. With over 20 years experience in software quality, he knows how to find problems that others will miss, reducing your time to market.

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More about Kris’s background:

Kris has spent several years in software quality for several industries including automotive and financial. He added medical to that experience about 10 years ago when he participated in a risk analysis run by KPMG. When he isn’t working, he enjoys running and is starting up training for a marathon.

What Kris is an expert at:

Risk — being able to look at a system and identify all high risk areas that could haunt you later if not addressed early on. It’s essential not to cut corners or skip fundamental tasks. Especially in the medical industry, people use products differently than indicated so there needs to be measures to mitigate those risks.

Something that Kris has done recently to increase his expertise:

Kris believes the best way to learn something is to teach it or do it yourself. He’s a huge networker and got involved in a cyber incubator where he is now a mentor working with companies to teach them and helps them implement risk analysis as well as safeguarding in their companies.

One thing that medtech entrepreneurs or startups don’t know that they need to know:

Work with experts that know the FDA guidelines. They can help you get your device to market. This is a highly specialized industry with several niches and it’s a long process so hire a regulatory strategist that’s dealt specifically with your niche.

Success story that Kris had recently:

He worked with a fortune 100 company on a brand new product that married two systems. These two systems were delivering medicine and he integrated a risk reduction program for their system integration. The plan revealed lots of problems they were able to solve.

Example of someone that have used Kris’s advice:

If you go to the FDA site, you can see all of the medical device companies that have recalls. Some of them have multiple recalls and continue to have them. If they would just trust the process and build risk mitigation into their product development plan, this would drastically reduce the recalls.

Kris’s best advice He can give to medtech entrepreneurs:

Design with customers in mind. Marketing gives the best input for design. Talk to people that use the technology you’re working on so you can solve their problems.

Kris’ best book recommendation and why:

Founders Dillema by Noah Wasser — covers pitfalls that can and do happen in startups.

Best way to get in touch with Kris:

He’s got a checklist that goes through the FDA process as well as a podcast launching soon where he talks with industry leaders. Get in touch with him (and listen to the podcast) on advantu.com or directly at kkelly@advantu.com

Host: Meghan Alonso
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Host Company: Imua Services
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iTunes: bitly.com/Inspire

About the Author

Meghan M. Alonso
Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for her award winning medical device podcast, Inspired by Imua, the chapter she wrote in best selling book “Put a Shark in Your Tank, and her valuable connections in the medical industry. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD companies through development and manufacturing. When she isn’t helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable husky Abby, crossfitting, enjoying great restaurants and fine wine with her husband, and soaking up the sun the nearest beach.

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