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 about 10 years ago when he was brought in to do risk analysis 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 be haunting later if not addressed early on. It’s essential not to cut corners or skip essential 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 is an advocate of 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 implement risk analysis and safeguarding into 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 __’s 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.

Kris’s best advice you can give 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’s best book recommendation and why:

Founders Dillema by Noah Wasser — covers pif alls 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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