Medtech Matters
By Medical Product Outsourcing
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Subscribers: 6
Reviews: 0
Episodes: 158
Description
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
| Episode | Date |
|---|---|
|
FDA's Third-Party Review Program
|
May 14, 2026 |
|
Triaging Your QMS: Considerations Based on the New QMSR
|
Apr 17, 2026 |
|
A Deep Dive into E&L and Biocomp Testing
|
Mar 11, 2026 |
|
Planning for FDA Shutdowns Now and in the Future
|
Oct 27, 2025 |
|
Should Wellness Products Come with a Warning?
|
Sep 11, 2025 |
|
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
|
Jun 25, 2025 |
|
Why Are One-Third of MAUDE Reports a Problem?
|
Jun 10, 2025 |
|
FDA Guidance on Off-Label Communication, Part 1
|
May 30, 2025 |
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FDA Guidance on Off-Label Communication, Part 2
|
May 30, 2025 |
|
Development Considerations for Over-the-Counter Medtech, Part 1
|
Jan 23, 2025 |
|
Development Considerations for OTC Medtech, Part 2
|
Jan 23, 2025 |
|
Device Descriptions in Regulatory Submissions
|
Jan 07, 2025 |
|
Regulatory Ramifications Due to the Presidential Election
|
Nov 26, 2024 |
|
Regulatory Considerations with an Assisted Suicide Machine
|
Nov 20, 2024 |
|
Predetermined Change Control Plans, Part 2
|
Sep 24, 2024 |
|
Predetermined Change Control Plans, Part 1
|
Sep 24, 2024 |
|
What is a CAPA and How Do You Best Use It?
|
Sep 03, 2024 |
|
You Got a 483 from the FDA. Now what?
|
Aug 22, 2024 |
|
Revisiting Real-World Evidence
|
Jun 18, 2024 |
|
The Most Dangerous Devices to Hit the Market
|
Jun 11, 2024 |
|
Headline-Generating Medical Device Safety Concerns
|
May 02, 2024 |
|
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
|
Mar 19, 2024 |
|
Examining Institutional Review Boards
|
Mar 06, 2024 |
|
Reimbursing Breakthrough Designation Products
|
Jan 02, 2024 |
|
Strengthening the 510k Program
|
Dec 19, 2023 |
|
Medical Device Manufacturing Recalls
|
Oct 03, 2023 |
|
AI Predetermined Change Control Plan
|
Sep 19, 2023 |
|
Can You Use a Recalled Device as a Predicate?
|
Jun 20, 2023 |
|
Leading Issues from FDA Inspections (or History Repeating Itself)
|
Apr 04, 2023 |
|
To Regulate or Not to Regulate…LDTs, Part 2
|
Feb 07, 2023 |
|
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
|
Jan 31, 2023 |
|
What Happens When the EUA Period Ends?
|
Dec 13, 2022 |
|
What Does 510k Exempt Actually Mean?
|
Nov 29, 2022 |
|
How Can Off-Label Use Be Promoted?
|
Nov 15, 2022 |
|
FDA's Intended Use Rule’s Relation to Labeling
|
Nov 01, 2022 |
|
Gaining an Advantage Through Class II Special Controls
|
Oct 25, 2022 |
|
FDA’s Refuse to Accept Policy for 510(k)s
|
Oct 18, 2022 |
|
Initiating a Voluntary Medical Device Recall
|
Oct 11, 2022 |
|
A Letter to File Deep Dive
|
Oct 04, 2022 |
|
Humacyte’s Bioengineered Tissue Platform Technology
|
Mar 08, 2022 |
|
Koya Medical Restores Mobility for Compression Therapy Patients
|
Mar 01, 2022 |
|
NeuroPace’s Aid in Tracking and Treating Epilepsy
|
Feb 22, 2022 |
|
Aidoc Is Improving Patient Outcomes Through AI
|
Feb 15, 2022 |
|
Performing a Gap Analysis on FDA's Regulatory Protocols
|
Feb 08, 2022 |
|
Stereotaxis’ Robotic Surgery System for Interventional Procedures
|
Feb 01, 2022 |
|
Fighting Tumors with Varian’s FLASH Technology
|
Jan 27, 2022 |
|
RSIP Vision’s Diagnostic Imaging Advancements
|
Jan 25, 2022 |
|
FDA’s Cybersecurity Playbook
|
Jan 20, 2022 |
|
Video Capture of Surgery with Theator
|
Jan 18, 2022 |
|
GE Healthcare’s Chief Digital Officer’s 2022 Predictions
|
Jan 13, 2022 |
|
DePuy Synthes Strives for Knee Restoration
|
Jan 11, 2022 |
|
Femasys Targets Fertility and Women’s Health
|
Jan 06, 2022 |
|
Front Line’s COBRA-OS Helps Prevent Bleed Out
|
Jan 04, 2022 |
|
Pristine Surgical’s Single-Use Endoscopes
|
Dec 14, 2021 |
|
Discussing Spine with Medtronic's Carlton Weatherby
|
Nov 30, 2021 |
|
Aligning Regulatory and Commercial Strategies
|
Nov 16, 2021 |
|
Medtech Manufacturing at the U.S.-Mexico Border
|
Nov 09, 2021 |
|
Surgical Instrumentation Update from Ethicon
|
Nov 02, 2021 |
|
De Novo Final Rule
|
Oct 26, 2021 |
|
Options with an Overly Burdensome FDA
|
Oct 19, 2021 |
|
Molli Surgical's Breast Tumor Marker
|
Sep 14, 2021 |
|
Three Systems of Risk
|
Sep 07, 2021 |
|
Glooko’s Remote Patient Monitoring for Diabetics
|
Aug 31, 2021 |
|
Valencell’s Wearable Biomedical Sensors
|
Aug 24, 2021 |
|
Regulating IVDs and LDTs
|
Aug 10, 2021 |
|
LifeSource Discusses Organ Donation Technologies
|
Aug 04, 2021 |
|
Facility Falsified Sterilization Data
|
Jul 27, 2021 |
|
Knobbe Martens Talks Trade Secrets
|
Jul 20, 2021 |
|
Canary Medical’s ‘Smart’ Implants
|
Jul 13, 2021 |
|
Implicity’s Cardiac Device Remote Monitoring
|
Jul 06, 2021 |
|
PixCell's Rapid Blood Test Diagnostics
|
Jun 29, 2021 |
|
Discussing Asensus Surgical’s Senhance Robotic Surgical System
|
Jun 17, 2021 |
|
Top 483s of 2020
|
Jun 08, 2021 |
|
Legacy DNA’s Market Strategy Advice
|
May 25, 2021 |
|
NeuTigers’ Edge-Based AI for Healthcare
|
May 19, 2021 |
|
Medtronic's Pillcam and GI Genius
|
May 11, 2021 |
|
COVID Diagnostics from Beckman Coulter
|
May 04, 2021 |
|
Single-Use Device Reprocessing
|
Apr 27, 2021 |
|
A Biomechanics Measuring Mesh
|
Apr 22, 2021 |
|
A Digital Stethoscope & Digital Health
|
Apr 13, 2021 |
|
Non-Dilutive Funding
|
Apr 06, 2021 |
|
BDP Reimbursement Delay
|
Mar 30, 2021 |
|
Robotic-Driven Percutaneous Procedures
|
Mar 23, 2021 |
|
Biomorphic Programmable Polymers
|
Mar 16, 2021 |
|
Treating Hearts Post-Attack
|
Mar 09, 2021 |
|
FDA’s Ambiguity on Hyaluronic Acid
|
Mar 02, 2021 |
|
Update on FDA's STeP Designation
|
Feb 26, 2021 |
|
Continuous Molecular Monitoring
|
Feb 23, 2021 |
|
Hologic’s Breast Health Happenings
|
Feb 16, 2021 |
|
Optimizing Remote Electrophysiology Monitoring
|
Feb 09, 2021 |
|
Medtronic's Robotic Surgery Status
|
Feb 02, 2021 |
|
Emergency Use Authorizations
|
Jan 26, 2021 |
|
Surgeons Scrubbing In Virtually
|
Jan 19, 2021 |
|
Talking Robotics with Zimmer Biomet
|
Jan 12, 2021 |
|
CDRH 2021 Priorities
|
Jan 08, 2021 |
|
A Non-Contact ECG Sensor
|
Jan 05, 2021 |
|
Communicating with the FDA
|
Dec 15, 2020 |
|
Talking Medtech with Joe Mullings
|
Dec 08, 2020 |
|
A Robotic Surgery Subscription
|
Dec 01, 2020 |
|
Point-of-Care Ultrasound
|
Nov 24, 2020 |
|
AI-Enabled Cardiac Diagnostics
|
Nov 18, 2020 |
|
Organ Donation Matching
|
Nov 02, 2020 |
|
Virtual Reality for Surgery
|
Oct 28, 2020 |
|
Biocompatibility and Nitinol Guidances
|
Oct 26, 2020 |
|
Economical Orthopedic Implants
|
Oct 22, 2020 |
|
Vital Signs Monitoring Via Telehealth Interface
|
Oct 20, 2020 |
|
Multiple Function Device Products
|
Sep 16, 2020 |
|
Breakthrough Designation Program Update
|
Aug 28, 2020 |
|
50th Episode: A Look Back
|
Aug 10, 2020 |
|
Combination Products Update
|
Jul 08, 2020 |
|
Binding vs. Nonbinding FDA Feedback
|
Jun 10, 2020 |
|
Real World Evidence Revisited
|
May 14, 2020 |
|
FDA Pre-Sub Best Practices
|
Apr 24, 2020 |
|
Scott Whitaker of AdvaMed on Medtech's Response to COVID-19
|
Apr 17, 2020 |
|
COVID-19, Part 2
|
Apr 08, 2020 |
|
COVID-19, Part 1
|
Apr 01, 2020 |
|
EtO Sterilization Concerns
|
Mar 30, 2020 |
|
FDA's eSTAR Program
|
Mar 03, 2020 |
|
Human Factors/Usability, Part 2
|
Feb 03, 2020 |
|
Human Factors/Usability, Part 1
|
Feb 03, 2020 |
|
Change Management, Part 2
|
Jan 20, 2020 |
|
Change Management, Part 1
|
Jan 20, 2020 |
|
Safety and Performance Based 510k
|
Dec 05, 2019 |
|
The Special 510k Program
|
Nov 13, 2019 |
|
Beyond 510(k)/PMA—Safer Technologies Program
|
Oct 16, 2019 |
|
Benefit-Risk Determinations
|
Sep 16, 2019 |
|
Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program
|
Aug 06, 2019 |
|
Beyond 510(k)/PMA—De Novo 101
|
Jul 02, 2019 |
|
Mike on Medtech: The NYT Editorial Board Statement
|
Jun 17, 2019 |
|
The Alternative Summary Reporting Program
|
May 24, 2019 |
|
Do we need a pre-sub for 483s? (Part 2)
|
May 09, 2019 |
|
Do we need a pre-sub for 483s?
|
May 09, 2019 |
|
FDA's Material Evaluation
|
Apr 02, 2019 |
|
510k Modernization
|
Jan 25, 2019 |
|
Personalized Healthcare
|
Jan 03, 2019 |
|
My Holiday Wish List (Part 2)
|
Dec 11, 2018 |
|
My Holiday Wish List (Part 1)
|
Dec 04, 2018 |
|
Regulating the Practice of Medicine
|
Oct 26, 2018 |
|
The Bleeding Edge, Part 3
|
Sep 26, 2018 |
|
The Bleeding Edge, Part 2
|
Sep 07, 2018 |
|
The Bleeding Edge, Part 1
|
Sep 05, 2018 |
|
Breakthrough Designation Program
|
Aug 10, 2018 |
|
15 Tips for Getting New Products Through FDA
|
Jul 03, 2018 |
|
Voice-Enabled Medtech
|
May 17, 2018 |
|
Changing Pathway to Market?
|
Apr 25, 2018 |
|
3D Printing Healthcare at the Point of Care
|
Mar 23, 2018 |
|
Quality vs. Regulatory
|
Mar 02, 2018 |
|
The 'New' Alternative 510k
|
Jan 29, 2018 |
|
Regulatory Approval Pathway for Biomaterials
|
Jan 02, 2018 |
|
Pre-Sub with the FDA
|
Nov 06, 2017 |
|
Human Factors
|
Oct 09, 2017 |
|
MDUFA IV and Its Impact on Medtech Innovation
|
Sep 07, 2017 |
|
Off-Label Use
|
Aug 25, 2017 |
|
Biomaterials, Biocompatibility, and Bioabsorbable
|
Jul 24, 2017 |
|
3D Printing in Healthcare
|
Jun 05, 2017 |
|
Reimbursement for Engineers
|
May 05, 2017 |
|
Device Incident Reporting
|
Mar 30, 2017 |
|
Real World Evidence
|
Feb 24, 2017 |