Hosted by Melita Ball · 🇺🇸 US · EN-US · 13 episodes
Established thought leaders with verified media credentials.
Bringing a medtech device to market is complex—but it doesn’t have to be chaotic. On Mastering MedTech, regulatory strategist and MBCA Consulting founder Melita Ball helps founders navigate the path from concept to clearance. This podcast demystifies the regulatory maze, offers proven startup frameworks, and unpacks real stories from founders, engineers, and compliance experts.
Melita Ball hosts Mastering MedTech, a technology show with 13 episodes published.
Most founders think marketing can wait until they have a working prototype or need to raise money. By the time you need a pitch deck or professional website, it's already too late to do them well. Whit Slightham knows th
There are precisely two things that will sink a medtech company: finance and regulatory. Get either one wrong and you're done. Steve Duddy has spent decades in the CEO chair learning this lesson the hard way. In this epi
FDA clearance used to feel like the finish line. Robert Hamilton thought so too when he founded NeuraSignal. Then he learned the hard way that regulatory approval is just the beginning. In this episode, Robert shares the
Getting FDA clearance used to be the finish line. Now it's just the starting gate. Cindy Grabowski has watched medtech acquisition timelines stretch from three years to eight-plus years across her 30-year career, and she
Most technical founders spend years perfecting their device, only to discover there's no market willing to pay for it. Anita Bell has seen this pattern repeat hundreds of times in her 20+ years as Director of the Univers
Great technology is not enough. Marco Flavio Marinucci has spent 20 years watching brilliant medtech products fail because founders didn't understand the healthcare ecosystem they were entering. In this episode, Marco br
Seventy-one percent turnover. Production excursions every 89 days. Low engagement across the board. Graydon Hansen walked into Abbott's largest medical device plant in China facing these challenges and turned it into a t
Most medtech founders want to skip straight to building their product. Veronica Kingston has spent 30 years watching that approach lead to expensive recalls, failed regulatory submissions, and collapsed acquisition deals
Starting a medtech company without legal guidance is like performing surgery without sterilizing your instruments. Elizabeth Parsons has seen brilliant innovations die not from failed technology, but from preventable leg
AI is transforming clinical research faster than regulations can keep up. Olivia Longacre has spent over a decade on the front lines of global clinical trials, and she's watching MedTech companies make a critical mistake
AI is transforming clinical research faster than regulations can keep up. Olivia Longacre has spent over a decade on the front lines of global clinical trials, and she's watching MedTech companies make a critical mistake
Rick Holecek walked into a quality nightmare: 27 open CAPAs from a botched audit report, a semi-paper-based system struggling to keep up with growth, and a small team stretched impossibly thin. As VP of Quality at Irrima
In this episode of Mastering MedTech, host Melita Ball sits down with Marie Wesselhoft, President and Co-founder of ZelosDx, to discuss what it really takes to build and scale a medtech startup on the bleeding edge of in
Bringing a medtech device to market is complex—but it doesn’t have to be chaotic. On Mastering MedTech, regulatory strategist and MBCA Consulting founder Melita Ball helps founders navigate the path from concept to clear
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Mastering MedTech is hosted by Melita Ball. The show is categorised under technology and has published 13 episodes.
Mastering MedTech has published 13 episodes.
Mastering MedTech regularly covers technology. It sits in the technology category.
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Mastering MedTech hasn't explicitly signalled guest openness in recent episodes. That doesn't rule out pitching. your hook just needs to be especially compelling and relevant to their recent content.
Episodes of Mastering MedTech average 38 minutes. a focused format where a clear narrative arc and tight preparation matter most.
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