Podcast Episodes
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The 2026 Surgical Robotics Shake-Up: FDA Approvals, Specialization, and New Competition
This episode explores the transformative shift in the surgical robotics market, predicting a move away from a single-player monopoly by 2026. We anal…
6 months, 2 weeks ago
FDA's New Cybersecurity Era: Why SBOMs and Secure Architecture are Non-Negotiable for MedTech by 2026
This episode examines how U.S. FDA regulations have repositioned cybersecurity as a core feature of medical devices. We discuss the impact of the Con…
6 months, 3 weeks ago
FDA's 2026 TEMPO Pilot: The Bridge to Reimbursement for Digital Health?
This episode delves into the U.S. FDA's upcoming Total Product Life Cycle (TPLC) Advisory Program, known as TEMPO, set to launch in 2026. We explore …
6 months, 3 weeks ago
U.S. FDA vs. Wearables: The 2026 Regulatory Showdown for Digital Health
This episode explores the evolving regulatory landscape for digital health, focusing on the U.S. FDA's projected stance in 2026. We dissect the criti…
6 months, 3 weeks ago
FDA's 2026 AI Device Scrutiny: Lifecycle Governance and Real-World Performance
This episode explores the FDA's expected regulatory landscape for AI-enabled medical devices in 2026. We discuss the critical shift from pre-market a…
6 months, 3 weeks ago
Home-Use Device Recalls & Firmware Updates: Navigating the MedTech Logistical Nightmare
This episode delves into the top health technology hazard: the logistical challenges of communicating recalls and firmware updates for home-use medic…
7 months ago
Securing the MedTech Supply Chain: Blockchain vs. 3D-Printed Counterfeits
The rise of sophisticated 3D-printed counterfeit medical devices presents a grave threat to patient safety and brand integrity. This episode delves i…
7 months ago
Self-Healing Logistics: Automating Medical Device Supply Chains in a Volatile World
This episode explores the rise of "self-healing" supply chains, an AI-driven solution designed to combat the logistical nightmares caused by modern g…
7 months ago
AI Diagnostic Bias: Navigating FDA and Global Regulations to Avoid Market Withdrawal
This episode explores the growing regulatory pressure on medical device manufacturers to mitigate algorithmic bias in AI-powered diagnostics. We disc…
7 months ago
ASC Sales Strategy: Adapting MedTech for the 2026 Procedure Shift
This episode explores the strategic pivot required for MedTech companies as over 500 surgical procedures shift to Ambulatory Surgery Centers (ASCs) b…
7 months, 1 week ago