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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

Project Management for Product Development of Medical Devices

Episode 233

Assessing the Global Regulatory Landscape

Episode 232

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

Episode 231

When to Throw the Least Burdensome Flag on FDA

Episode 230

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Episode 229

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Episode 227

Meet a Guru: Maryann Mitchell

Episode 226

Why Storytelling Matters for Medical Device Companies

Episode 225

A Breakthrough Device that Aims to Prevent Osteoporosis

Episode 224

Understanding FDA's New Intended Use Rule and its Implications

Episode 223

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Episode 222

Tips for Running Better Management Reviews

Episode 221

Meet a Guru: Ryan Behringer

Episode 220

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

Managing Clinical Data Activities

Episode 218

Explaining the Role of Importer under EU MDR

Episode 217

Preparing Your Pre-Submission with the Content FDA Wants to See

Episode 216

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

Episode 215

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Episode 214

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Episode 213

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Episode 210

Building Your Brand as a Medical Device Professional

Episode 209

Understanding the Value of a Medical Device Guru

Episode 208

Meet a Guru: Etienne Nichols

Episode 207

Meet a Guru: Laura Court

Episode 206

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Episode 204

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202

Managing Business Risk as a Medical Device Company

Episode 201

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

For the Love of Internal Auditing

Episode 199

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198

Knowing vs. Doing as Medical Device Professionals

Episode 197

Pivoting Operations to Meet PPE Demand during Pandemic

Episode 196

Pros & Cons of Being a Physician turned MedTech Inventor

Episode 195

3 Systems of Risk for Medical Devices from FDA

Episode 194

Quality Management for IVD Devices vs Medical Devices

Episode 193

Understanding the Investigational Device Exemption (IDE) Process

Episode 192

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Episode 190

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Episode 189

Meet a Guru: Sara Adams

Episode 188

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Episode 187

Building a Startup in the MedTech Industry

Episode 186

Meet a Guru: Karen Schuyler

Episode 185

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Episode 184

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

Preparing for Remote and On-Site Inspections and Audits

Episode 182

How does EU MDR impact your Quality Management System?

Episode 181

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Episode 179

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

5 Actionable Lessons Learned from the RADx Initiative by NIH

Episode 177

What are the Strategic Priorities for CDRH in 2021?

Episode 176

Understanding and Handling Different Types of Feedback

Episode 175

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Episode 174

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Episode 173

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Episode 172

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Episode 171

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Episode 168

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

Why Biocompatibility Should be Addressed by Every Medical Device Company

Episode 166

Meet a Guru: Erica Loring

Episode 165

What is a Multiple Function Device?

Episode 164

Challenges related to Home Use Devices

Episode 163

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

Meet a Guru: Wade Schroeder

Episode 160

What are the Audit Etiquette Rules I Should be Following?

Episode 159

Meet a Guru: Tom Rish

Episode 158

Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

Protecting the Intellectual Property of your Medical Device Technology

Episode 156

Meet a Guru: Jesseca Lyons

Episode 155

How to Build a QMS for a Medical Device

Episode 154

Meet a Guru: Taylor Brown

Episode 153

What is Regulatory Due Diligence for Medical Devices?

Episode 152

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

How Being Strategic During A Career Transition Can Yield The Best Opportunities

Episode 150

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Episode 149

How to Construct an Effective Regulatory Strategy

Episode 148

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Episode 147

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Episode 146

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Episode 144

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

How to Approach Verification and Validation for Cloud Software

Episode 142

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Episode 141

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

How to Integrate Usability into your Medical Device

Episode 139

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Episode 134

4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

5 Tips for Hiring Medical Device Advisors

Episode 132

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

How to Solve the Medtech Value Equation with Quality Data

Episode 127

Why Supplier Quality Management Is So Important

Episode 126

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

Preparing for EU MDR

Episode 124

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

Challenges with Pediatric Medical Devices

Episode 119

Implementing Changes to SaMD under New EU MDR

Episode 118

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

Right-sizing your QMS

Episode 116

Challenges with Pediatric Medical Devices

Episode 115

When Should You Start a QMS?

Episode 114

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

Importance of Software Requirements in Product Development

Episode 111

4 Facts That May Surprise You About FDA

Episode 110

Design History File Ready Ideation: An Innovative Approach To Product Development

Episode 109

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

Challenges with MedTech Innovation

Episode 107

Is Your Medical Device Company CAPA Happy?

Episode 106

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104

EU MDR: Not All Doom and Gloom

Episode 103

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

How to Make De Novo a Viable Option for your Medical Device

Episode 101

The 100th Episode: A Few of My Favorite Moments

Episode 100

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Episode 98

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

Nonbinding Feedback is a New Guidance You Should Know About

Episode 96

How and When to Consider Human Factors

Episode 95

Who Should Own Your QMS?

Episode 94

Design Validation vs. Human Factors Validation

Episode 93

Medical Device Product Development Value Proposition

Episode 92

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Episode 90

Aligning True Quality and Compliance with MDDAP

Episode 89

Explaining the Significance of Voluntary Consensus Standards

Episode 88

Medical Device Industry Predictions for 2019

Episode 87

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

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

What Device Makers Need To Know About The FDA Pre-Submission Process (Part Two)

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