A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health and hosted by Kris Tatiossian and Olivia Webb, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vijay Pande, Julie Yoo, Vineeta Agarwala, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg ...
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Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity
Manage episode 477100946 series 2788129
Content provided by Project Medtech. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Project Medtech or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role of thorough market research in achieving success. Tune in for valuable insights on building compliant, secure, and market-ready medical devices.
Niki Caporali Spaniel LinkedIn
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website
274 episodes
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Manage episode 477100946 series 2788129
Content provided by Project Medtech. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Project Medtech or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
In this episode, Duane Mancini explores the critical aspects of medtech regulation and product development with Niki Caporali Spaniel and Chad Gibson of CMD Medtech. Niki shares her expertise in post-market clinical follow-up and navigating the complexities of the Medical Device Regulation (MDR). Chad emphasizes the importance of integrating cybersecurity throughout the product lifecycle, rather than treating it as an afterthought. They both discuss the significance of robust design controls, the pitfalls of inadequate planning, and the power of leveraging professional networks. The conversation highlights how regulatory considerations should inform decisions across all business functions, and the crucial role of thorough market research in achieving success. Tune in for valuable insights on building compliant, secure, and market-ready medical devices.
Niki Caporali Spaniel LinkedIn
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website
274 episodes
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Similar to Project Medtech
A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health and hosted by Kris Tatiossian and Olivia Webb, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vijay Pande, Julie Yoo, Vineeta Agarwala, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg ...
…
continue reading
Flash Forward is a show about possible (and not so possible) future scenarios. What would the warranty on a sex robot look like? How would diplomacy work if we couldn’t lie? Could there ever be a fecal transplant black market? (Complicated, it wouldn’t, and yes, respectively, in case you’re curious.) Hosted and produced by award winning science journalist Rose Eveleth, each episode combines audio drama and journalism to go deep on potential tomorrows, and uncovers what those futures might re ...
…
continue reading
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…
continue reading
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…
continue reading
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…
continue reading
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continue reading
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…
continue reading
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…
continue reading
Science Friction's latest series is: Cooked. We dig into food science pickles. Why are studies showing that ice cream could be good for you? Do we really need as many electrolytes as the internet says? And why are people feeling good on the carnivore diet? Nutrition and food scientist Dr Emma Beckett takes us through what the evidence says about foods like meat, ice cream and potatoes — and unpicks why nutrition studies can be so conflicting and confusing. All six episodes of Cooked are avai ...
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continue reading
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