Podcasts

The Global Medical Device Podcast

The GMDP is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Catch Up On Recent Episodes


Streamlining The Device Marketing Authorization Process

Episode 83

The New Special 510(k)

Episode 82

What's New With PMAs

Episode 81

How to Efficiently Raise Funds for Your Medical Device Company

Episode 80

7 Habits of Highly Effective True Quality Medical Device Professionals

Episode 79

Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

Questions to Ask Before Hiring Your Consultant

Episode 77

What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76

Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

15 Habits of Highly Effective Regulatory Professionals

Episode 74

How to Embrace Risk for Safer Devices

Episode 73

What you Need to know About FDA's Progressive Programs

Episode 72

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Episode 71

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Episode 70

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Episode 69

How Human Factors Impact Your Medical Device

Episode 68

How to Think About Quality and Regulatory as Your Company Scales

Episode 67

How to Design for Compliance with IEC60601

Episode 66

FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Episode 62

Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

How to Ensure Your Quality Management System is Effective and Benefits Patients

Episode 60

5 Most Common Problems with Your CAPA System

Epsidoe 59

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Episode 58

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Episode 57

Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56

An Overview of What Medical Device Developers Need to Know About Human Factors

Episode 55

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

Lessons to Be Learned From Recent FDA Inspections

Episode 51

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

How Process Excellence Leads to Product Excellence

Episode 47

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Episode 45

Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

Episode 43

The Intersection of Medical Device Usability and Risk Management

Episode 42

How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

Episode 40

An Overview of What Device Makers Need to Know About CAPA

Episode 39

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Episode 38

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Episode 37

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

Episode 35

2016 Medical Device Regulatory Trends Year in Review

Episode 34

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Episode 33

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Episode 32

Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

Episode 31

Understanding the New FDA Guidance on Changes to 510(k)

Episode 30

Understanding the New FDA Guidance on Changes to 510(k)

Episode 29

Preparing for the Changes to the EU Medical Device and In-Vitro Diagnostics Regulations

Episode 28

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Episode 27

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Episode 26

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Episode 25

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Episode 24

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Episode 23

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Episode 22

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

Episode 21

Tips to Help You Prepare for an FDA Inspection

Episode 20

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Episode 19

Integrating Business Elements into Your Product Development Process with Therese Graff

Episode 18

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Episode 17

The Difference Between Intended Use and Indications of Use with Mike Drues

Episode 16

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Episode 15

Medical Device Product Development Project Management Best Practices With Peter Sebelius

Episode 14

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Episode 13

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

Episode 12

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Episode 11

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

Episode 10

How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

Episode 9

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

Episode 8

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

Episode 7

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

Episode 6

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Episode 5

Risk Management from a Regulatory & Product Development Point of View

Episode 4

How to Improve Your Medical Device Design Reviews Bonus Episode

Episode 3 Plus

How To Improve Your Medical Device Design Reviews

Episode 3

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Episode 2

Best Practices for Implementing Design Controls for the Medical Device Industry

Episode 1