Medtech Insight - Medtech Connect

In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Scott Trevino, senior vice president of cybersecurity at TRIMEDX about the new cybersecurity oversight given to the FDA as a part of the 2023 Omnibus Appropriations bill passed in December.

Medtech Connect Episode 3: A Deep-Dive Into FDA’s Cyber Reforms

In this episode of Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews, Kelliann Payne, partner at Hogan Lovells. Payne advises artificial intelligence (AI) medical device manufacturers with premarket submissions and helps them navigate the complicated regulatory landscape. She laid out the current FDA regulations for AI medical devices and explained the importance of predetermined change control plans, a new cyber regulation from the Consolidated Appropriations Act of 2023.

Medtech Connect Episode 4: Intelligent Devices

In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed

Medtech Connect Episode 5: EU Horizontal Regulations And Digital Tech

In this episode, MedTech Insight regulatory reporter speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations and Erez shares a personal story about why the safety of medical devices matters so much to him.

Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations

In this episode, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft, what pieces of the guidance still might need clarification, and how they expect to see the industry change as DCTS become mainstream.

Medtech Connect Episode 7: Decentralized Clinical Trials

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

MTC Episode 10 TCET

Medtech Connect Episode 10: Breaking Down The Transitional Coverage Of Emerging Technologies

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