Global Medical Device Podcast powered by Greenlight Guru

#414: Why Global Certification is the Future of Clinical Research in Latin America

#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It

#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

#411: Unlocking U.S. MedTech Market Access: State-Specific Compliance Pitfalls Medical Device Companies Miss

#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

#409: How Iterative Management Transforms MedTech Teams: Faster Execution, Smarter Decisions

#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit

#407: Cybersecurity in MedTech: FDA Compliance, Patient Safety & the Hidden Risks You’re Missing

#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2

#405: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1

#404: MedTech 101: What You Need to Know About the Medical Device Industry

#403: Global Perspective on Medical Device Reimbursement

#402: How to Attract Real Talent in the Medical Device Industry

#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity

#400: The State of the Medical Device Industry

#399: How To Approach Culture Differences

#398: Game-Changing Connections in MedTech: Inside LSI with Scott Pantel

#397: Winning Over Skeptics: the Key to Product Adoption in Healthcare

#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

#389: Pre-determined Change Control Plans

#388: Elements of an Effective CAPA Program

#387: The case for Real World Evidence Studies

#386: The Danger of In-Home Use Medical Devices, Pt. 2

#385: The Trouble with Home-Use Devices, Pt. 1

#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

#383: What Standards Apply to My Device?

#382: Design of Experiments - How and When to Use DOE

#381: MedTech Advice from an Accidental Entrepreneur

#380: Navigating the Complex World of Combination Products with Subhi Saadeh

#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

#378: Who Owns the Design Controls Process?

#377: Designing a Medical Device for a Global User

#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

#375: Direct to Consumer - The Future of Healthcare

#374: Clinical Evidence - The Key to Market Adoption

#373: Creative Clinical Recruitment

#372: Getting Hired In MedTech

#370: Meet a Guru: Jamie Bihary

#371: Achieving ISO 13485 Certification

#369: Advice to Medical Device Inventors

#368: Institutional Review Boards (IRBs)

#367: Interviewing the Interviewer

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

#365: Medical Device Reporting: The Do's and Don'ts