Regulatory is a big deal for medical device companies. Whether it’s a startup or established business, a strong understanding of regulations and regulatory strategy is vital for product success in the marketplace.
Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research where she specializes in quality and regulatory business advice. Isabella joins Jon Speer to explain how medical device companies can establish a solid foundation for fundraising and product success through a heightened regulatory focus.
“The one thing that we try to encourage people to do is develop a minimum viable product.” Isabella Schmitt
“There are different milestones along the path to regulatory approval, and their timelines tend to be unrealistic.” Isabella Schmitt
“Utopia would be to understand what the need is first, and then to develop a product based on addressing that particular need.” Jon Speer
“If you spend all this time perfecting this technology, and there’s not really a clear market or a clear need for it, it’s going to be a tough road to go.” Jon Speer
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The Global Medical Device Podcast powered byGreenlight Guruis where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...