Episode 218 | Niki Caporali Spaniel and Chad Gibson at CMD Medtech | Navigating Medtech Regulations: Post Market Clinical Follow-up to Cybersecurity
Project Medtech · 2025-04-15 · 39 min
Episode notes
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 Chad Gibson LinkedIn CMD Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website Midwest Showcase Registration
More from Project Medtech
All episodes →- Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss56 / 100
- Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund51 / 100
- Episode 264 | Will Kaigler & Megan Shaw | From Innovation to Impact: Crafting Medtech Culture and Success in Pittsburgh45 / 100
- Episode 263 | Mark Domyahn, Partner at JD Lymon Group | Strategic Reimbursement Planning for Medtech Innovators
- Episode 262 | Huzaifah Salat, MD, Physician Executive | Pioneering Lung Cancer Diagnosis & Driving Clinical Insight in Healthcare Innovation