All Episodes
Medtech Matters — 163 episodes
A Preview of MDUFA VI: Changes and Highlights, Part 2
A Preview of MDUFA VI: Changes and Highlights, Part 1
The Value in Partnering for Sterility Testing
ECRI's 2026 Top 10 Health Technology Hazards
Measuring Regulatory/Quality Team Member Performance
FDA's Third-Party Review Program
Triaging Your QMS: Considerations Based on the New QMSR
A Deep Dive into E&L and Biocomp Testing
Planning for FDA Shutdowns Now and in the Future
Should Wellness Products Come with a Warning?
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
Why Are One-Third of MAUDE Reports a Problem?
FDA Guidance on Off-Label Communication, Part 2
FDA Guidance on Off-Label Communication, Part 1
Development Considerations for OTC Medtech, Part 2
Development Considerations for Over-the-Counter Medtech, Part 1
Device Descriptions in Regulatory Submissions
Regulatory Ramifications Due to the Presidential Election
Regulatory Considerations with an Assisted Suicide Machine
Predetermined Change Control Plans, Part 2
Predetermined Change Control Plans, Part 1
What is a CAPA and How Do You Best Use It?
You Got a 483 from the FDA. Now what?
Revisiting Real-World Evidence
The Most Dangerous Devices to Hit the Market
Headline-Generating Medical Device Safety Concerns
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
Examining Institutional Review Boards
Reimbursing Breakthrough Designation Products
Strengthening the 510k Program
Medical Device Manufacturing Recalls
AI Predetermined Change Control Plan
Can You Use a Recalled Device as a Predicate?
Leading Issues from FDA Inspections (or History Repeating Itself)
To Regulate or Not to Regulate…LDTs, Part 2
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
What Happens When the EUA Period Ends?
What Does 510k Exempt Actually Mean?
How Can Off-Label Use Be Promoted?
FDA's Intended Use Rule’s Relation to Labeling
Gaining an Advantage Through Class II Special Controls
FDA’s Refuse to Accept Policy for 510(k)s
Initiating a Voluntary Medical Device Recall
A Letter to File Deep Dive
Humacyte’s Bioengineered Tissue Platform Technology
Koya Medical Restores Mobility for Compression Therapy Patients
NeuroPace’s Aid in Tracking and Treating Epilepsy
Aidoc Is Improving Patient Outcomes Through AI
Performing a Gap Analysis on FDA's Regulatory Protocols
Stereotaxis’ Robotic Surgery System for Interventional Procedures
Fighting Tumors with Varian’s FLASH Technology
RSIP Vision’s Diagnostic Imaging Advancements
FDA’s Cybersecurity Playbook
Video Capture of Surgery with Theator
GE Healthcare’s Chief Digital Officer’s 2022 Predictions
DePuy Synthes Strives for Knee Restoration
Femasys Targets Fertility and Women’s Health
Front Line’s COBRA-OS Helps Prevent Bleed Out
Pristine Surgical’s Single-Use Endoscopes
Discussing Spine with Medtronic's Carlton Weatherby
Aligning Regulatory and Commercial Strategies
Medtech Manufacturing at the U.S.-Mexico Border
Surgical Instrumentation Update from Ethicon
De Novo Final Rule
Options with an Overly Burdensome FDA
Molli Surgical's Breast Tumor Marker
Three Systems of Risk
Glooko’s Remote Patient Monitoring for Diabetics
Valencell’s Wearable Biomedical Sensors
Regulating IVDs and LDTs
LifeSource Discusses Organ Donation Technologies
Facility Falsified Sterilization Data
Knobbe Martens Talks Trade Secrets
Canary Medical’s ‘Smart’ Implants
Implicity’s Cardiac Device Remote Monitoring
PixCell's Rapid Blood Test Diagnostics
Discussing Asensus Surgical’s Senhance Robotic Surgical System
Top 483s of 2020
Legacy DNA’s Market Strategy Advice
NeuTigers’ Edge-Based AI for Healthcare
Medtronic's Pillcam and GI Genius
COVID Diagnostics from Beckman Coulter
Single-Use Device Reprocessing
A Biomechanics Measuring Mesh
A Digital Stethoscope & Digital Health
Non-Dilutive Funding
BDP Reimbursement Delay
Robotic-Driven Percutaneous Procedures
Biomorphic Programmable Polymers
Treating Hearts Post-Attack
FDA’s Ambiguity on Hyaluronic Acid
Update on FDA's STeP Designation
Continuous Molecular Monitoring
Hologic’s Breast Health Happenings
Optimizing Remote Electrophysiology Monitoring
Medtronic's Robotic Surgery Status
Emergency Use Authorizations
Surgeons Scrubbing In Virtually
Talking Robotics with Zimmer Biomet
CDRH 2021 Priorities
A Non-Contact ECG Sensor
Communicating with the FDA
Talking Medtech with Joe Mullings
A Robotic Surgery Subscription
Point-of-Care Ultrasound
AI-Enabled Cardiac Diagnostics
Organ Donation Matching
Virtual Reality for Surgery
Biocompatibility and Nitinol Guidances
Economical Orthopedic Implants
Vital Signs Monitoring Via Telehealth Interface
Multiple Function Device Products
Breakthrough Designation Program Update
50th Episode: A Look Back
Combination Products Update
Binding vs. Nonbinding FDA Feedback
Real World Evidence Revisited
FDA Pre-Sub Best Practices
Scott Whitaker of AdvaMed on Medtech's Response to COVID-19
COVID-19, Part 2
COVID-19, Part 1
EtO Sterilization Concerns
FDA's eSTAR Program
Human Factors/Usability, Part 2
Human Factors/Usability, Part 1
Change Management, Part 2
Change Management, Part 1
Safety and Performance Based 510k
The Special 510k Program
Beyond 510(k)/PMA—Safer Technologies Program
Benefit-Risk Determinations
Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program
Beyond 510(k)/PMA—De Novo 101
Mike on Medtech: The NYT Editorial Board Statement
The Alternative Summary Reporting Program
Do we need a pre-sub for 483s? (Part 2)
Do we need a pre-sub for 483s?
FDA's Material Evaluation
510k Modernization
Personalized Healthcare
My Holiday Wish List (Part 2)
My Holiday Wish List (Part 1)
Regulating the Practice of Medicine
The Bleeding Edge, Part 3
The Bleeding Edge, Part 2
The Bleeding Edge, Part 1
Breakthrough Designation Program
15 Tips for Getting New Products Through FDA
Voice-Enabled Medtech
Changing Pathway to Market?
3D Printing Healthcare at the Point of Care
Quality vs. Regulatory
The 'New' Alternative 510k
Regulatory Approval Pathway for Biomaterials
Pre-Sub with the FDA
Human Factors
MDUFA IV and Its Impact on Medtech Innovation
Off-Label Use
Biomaterials, Biocompatibility, and Bioabsorbable
3D Printing in Healthcare
Reimbursement for Engineers
Device Incident Reporting
Real World Evidence