Working with the FDA to develop a medical product is a challenge. (And that's putting it lightly) That's why we're grateful to have Matt Goulet from Primordial Soup- a medical development consultancy in the Twin Cities- share industry secrets on how to successfully take medical concepts from start to finish.

In this episode we discuss what it took for P-Soup to build their ISO-13485  compliant shop and how they continue to masterfully design and engineer complicated medical products for their clients.  We talk specifically about the different medical device classes, how those differences impact design approach, and how to successfully integrate FDA requirements in the design process from the start.

Matt talks about how he -personally- would develop a medical device if he were a business owner, and gives us an uncensored perspective on exactly what it takes to make it in the industry. We talk about challenges that have arisen due to working remotely during a global pandemic, and how to keep a business in motion when working with strong personalities internally.

More about Matt Goulet

Matt has worked at a number of firms developing award-winning products for major brands like SC Johnson, Case, Bomag, GE Medical, Rubbermaid, Shur-Line, and Ace. For the past 14 years he’s worked at design consultancies developing a myriad of different products, but his latest and greatest work has been in developing medical devices at Primordial Soup for the past 7 years. He is the lead Industrial Designer for P-Soup and is charged with overseeing the entire development process as design and engineering staff collaborate to take concepts from start to finish. 

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