Best Medtech Solutions Podcasts (2025)

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The Global IVD Maze: A Pure Global Deep Dive into Market Access Strategy, IVDR Hurdles, and Tech-Driven Solutions 3:21

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22h ago3:21

3:21

This episode of MedTech Global Insights explores the immense opportunities and hidden complexities of taking an In-Vitro Diagnostic (IVD) device to the global market. We move beyond a single-country approval and dive into the strategic challenges of navigating a fragmented international regulatory landscape, where success depends on more than just …

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Garrett Schumacher | Product Security Director, Velentium Medical & Co-Founder/CTO, GeneInfoSec | Navigating the Future of Medical Device & Genetic Security 31:55

5h ago31:55

31:55

Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlight…

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Mastering the Maze: A Pure Global Guide to Global Market Access for Cardiovascular Drug-Eluting Stents 3:08

4h ago3:08

3:08

In this episode of MedTech Global Insights, we explore the dynamic and challenging world of cardiovascular drug-eluting stents (DES). We uncover the technological evolution from early generation devices to today's advanced bioresorbable scaffolds and discuss the immense clinical impact they have had.While innovation is thriving, bringing a new DES …

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568 - Reducing the Hidden Tax on Healthcare: Real Solutions with AI and Technology 41:28

2h ago41:28

41:28

In this episode of Talking HealthTech, Peter Birch speaks with Dr Greg McDavitt, physician executive and director of healthcare industry strategy at ServiceNow, and Andrew Dome, Chief Digital Information Officer at Uniting New South Wales Act, about the "hidden tax" on healthcare. The discussion examines the non-financial burdens that affect effici…

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Pure Global Presents: Mastering the MDSAP Audit (AU P0002.008) - Key Criteria for Global MedTech Market Access 3:37

2h ago3:37

3:37

In this episode of MedTech Global Insights, we dissect the audit criteria of the Medical Device Single Audit Program (MDSAP), focusing on the specific requirements detailed in the influential AU P0002.008 audit model. We explore how this single audit program, crucial for market access in the US, Canada, Australia, Brazil, and Japan, has evolved and…

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Engineering the Healthcare Dataverse: From data chaos to clear insights 24:02

4d ago24:02

24:02

Healthcare data is exploding, from clinical records to wearables, and with it comes both opportunity and chaos. In this episode, experts Abhishek Wagle and Anand Rao explore the Healthcare Dataverse, a digital ecosystem where data engineering, AI, and cloud technologies converge to improve care, reduce costs, and drive health equity. Key Highlights…

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From Device Malfunction to FDA Report: A Pure Global Guide to Mastering 21 CFR Part 803 Compliance 3:40

8h ago3:40

3:40

Navigating the FDA's Medical Device Reporting (MDR) regulation, 21 CFR Part 803, is a high-stakes requirement for any MedTech company in the US market. A single misstep in reporting an adverse event can lead to warning letters, product recalls, and significant delays in future approvals. This episode provides a practical guide to understanding your…

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Mastering Medical Device Safety: Pure Global's Expert Guide to the ISO 10993-1 Biological Evaluation Requirements 3:29

4h ago3:29

3:29

In this episode of MedTech Global Insights, we dissect the essential requirements of ISO 10993-1 for the biological evaluation of medical devices. We explore the critical shift from a simple checklist to a comprehensive, risk-based approach, which is now the gold standard for regulatory bodies worldwide.We break down what this risk management proce…

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Pure Global's Ultimate Guide to Structuring Your EU IVDR 2017/746 Technical File for Market Success 4:16

3h ago4:16

4:16

This episode of MedTech Global Insights offers a deep dive into one of the most challenging aspects of European market access: structuring the technical file for the EU In Vitro Diagnostic Regulation (IVDR 2017/746). We break down the key requirements of Annex II, providing a clear roadmap for manufacturers to follow.We move beyond theory to discus…

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Beyond User-Friendly: Mastering IEC 62366-1 for Safer MedTech and Streamlining Global Market Access with Pure Global 3:30

6h ago3:30

3:30

This episode of MedTech Global Insights demystifies the critical IEC 62366-1 standard for usability engineering. We move beyond theory to explore how a structured, safety-focused design process is essential for preventing use-related errors that can lead to patient harm. Learn about the key stages of the usability engineering process, from initial …

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Navigating the Maze of IEC 62304: A Pure Global Masterclass on Medical Device Software Lifecycle and Global Compliance 3:50

9h ago3:50

3:50

In this episode of MedTech Global Insights, we demystify IEC 62304, the international standard for medical device software lifecycle processes. We break down the essential requirements that every MedTech innovator needs to know, from initial planning and risk-based safety classification to rigorous testing and post-market maintenance.This is not ju…

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From Hazard to Market Approval: Pure Global Decodes the Practical Application of ISO 14971 for Medical Devices 4:02

6h ago4:02

4:02

In this episode of MedTech Global Insights, we break down the practical application of ISO 14971:2019, the essential standard for medical device risk management. We move beyond theory to provide a clear, step-by-step framework for identifying, analyzing, and controlling risks throughout your product's lifecycle.This isn't just about ticking a compl…

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567 - How Digital Health Is Reshaping Musculoskeletal Care in Australia and Beyond 43:44

9d ago43:44

43:44

In this episode of Talking HealthTech, Peter Birch speaks with Jason Ward, co-founder and CEO of EQL, about the evolution of digital health in musculoskeletal (MSK) care across Australia and the UK. Jason discusses the story behind founding EQL and the factors that shaped its approach to digital MSK care. He also examines the different funding and …

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From 21 CFR Part 820 to the QMSR: Pure Global's Deep Dive into the FDA's New Quality System for MedTech Innovators 4:12

1d ago4:12

4:12

In this episode of MedTech Global Insights, we explore the monumental shift in the U.S. FDA's approach to quality systems for medical devices. We break down the transition from the long-standing 21 CFR Part 820 regulation to the new Quality Management System Regulation (QMSR), which harmonizes with the global standard ISO 13485. This isn't just a r…

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Bench-top Biotechnology: Advancing bioprocessing with open source 25:20

1d ago25:20

25:20

As tools at the forefront of innovation in medicine and biotechnology, bioreactors are increasingly taking centre stage in research facilities and industrial labs alike. From acting as the fermentation vessels that give us beer to enabling a greener, more sustainable way of treating wastewater, bioreactors have played a key role in ensuring the qua…

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Mastering the MedTech Clinical Evaluation Report (CER): A Deep Dive with Pure Global on MEDDEV 2.7/1 rev 4 Compliance and Avoiding Common Pitfalls 3:45

3d ago3:45

3:45

In this episode of MedTech Global Insights, we demystify one of the most critical documents for European market access: the Clinical Evaluation Report (CER). Navigating the stringent requirements of MEDDEV 2.7/1 revision 4 is a major challenge for many MedTech companies, often leading to costly delays and rejections from Notified Bodies.We move bey…

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Live! #90 – PMCF Surveys That Survive Scrutiny 1:11:42

3d ago1:11:42

1:11:42

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠RQMplus.com⁠⁠. PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, …

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Live! #89 – Compliance for EU Market Access with BSI, Brabners, and RQM+ 1:02:17

12d ago1:02:17

1:02:17

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠. Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical docum…

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The Ultimate Guide to EU MDR GSPR Compliance: How Pure Global Helps You Avoid Critical Notified Body Findings 3:35

4d ago3:35

3:35

This episode of MedTech Global Insights provides a deep dive into the General Safety and Performance Requirements (GSPR) of the EU MDR 2017/745, Annex I. We move beyond the checklist and explore the real-world challenges and regulatory expectations associated with these critical requirements.We uncover the most common pitfalls that can lead to Noti…

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MDSAP Explained: A Pure Global Guide to Participating Countries for MedTech & IVD Market Access 3:49

5d ago3:49

3:49

In this episode of MedTech Global Insights, we explore the Medical Device Single Audit Program (MDSAP), a revolutionary framework allowing MedTech and IVD manufacturers to satisfy the quality management system requirements of multiple countries through a single audit. We break down how this program can dramatically reduce audit fatigue and accelera…

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Unlocking US Market Access: A Pure Global Masterclass on Navigating the 510(k) Submission for AI-Powered Medical Devices (SaMD) 3:03

6d ago3:03

3:03

As MedTech companies increasingly integrate artificial intelligence into Software as a Medical Device (SaMD), navigating the regulatory landscape becomes significantly more complex. The standard 510(k) pathway was not designed for adaptive algorithms, forcing the FDA and manufacturers to pioneer new approaches for ensuring safety and effectiveness …

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Sarah Ptach | President & CEO, Canyon Labs | Elevating MedTech Standards, Leadership in Innovation, & Patient-Centric Culture 33:53

6d ago33:53

33:53

Sarah Ptach, President and CEO of Canyon Labs, discusses her journey from professional sports and advertising to leading Canyon Labs, a company specializing in medical device and pharmaceutical testing. Inspired by her father's Parkinson's diagnosis, Sarah transitioned to healthcare to make a meaningful impact. She delves into her leadership philos…

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Unlocking Global MedTech Markets: A Deep Dive into IEC 81001-5-1 Cybersecurity with Pure Global 3:57

7d ago3:57

3:57

In this episode of MedTech Global Insights, we explore the new cornerstone of medical device security, the IEC 81001-5-1 standard. As healthcare technology becomes increasingly connected, the risk of cyber threats poses a significant danger to patient safety and can create major barriers to market entry. We break down what this standard means for m…

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Cracking the Code: How Pure Global Helps SaMD Startups Navigate ISO 13485 Compliance 3:55

8d ago3:55

3:55

SaMD developers operate in a fast-paced, agile world, but the medical device industry is governed by the structured ISO 13485 standard. This episode demystifies how to merge these two worlds, transforming compliance from a roadblock into an integrated part of your development lifecycle. We explore practical, real-world strategies to build a robust …

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Care pathway adherence: The key to better outcomes, not just better processes 23:55

12d ago23:55

23:55

In this episode of The Shaping Healthcare Podcast, Dr. Priyanka Lakhani and Kaushik Raha discuss the challenges of care pathway adherence and how AI is stepping up to solve them. Key insights you’ll hear: Why care pathway adherence is difficult to achieve in real-world clinical practice How AI helps personalize care, monitor adherence, and manage d…

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566 - Balancing Technology and Human Touch: Delivering Better Outcomes for Patients and Clinicians 29:04

8d ago29:04

29:04

In this episode of Talking HealthTech, Peter Birch speaks with Mecaela Couper, specialist solution consultant for healthcare, Colby Rook, senior account executive for healthcare, and Dr Greg McDavitt, physician executive and director for healthcare, all from ServiceNow. The discussion covers the role of artificial intelligence and technology in red…

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From Lab to Clinic: Building Safer Tools for Mothers and Babies: 42 31:49

17d ago31:49

31:49

In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother. Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech’s Andy Rogers for Episod…

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Unlocking MedTech Innovation: A Deep Dive into the FDA's AI Change Control Policy with Pure Global's Expertise 3:32

17d ago3:32

3:32

In this episode of MedTech Global Insights, we dissect the FDA's groundbreaking final guidance on Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices. We explore how this new framework moves beyond the traditional, rigid regulatory submission process, creating a streamlined pathway for manufacturers to innovate and improve …

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Cracking the Code: A Pure Global Deep Dive into Clinical Evaluation Requirements for SaMD under the EU MDR 3:19

10d ago3:19

3:19

This episode of MedTech Global Insights delves into the rigorous clinical evaluation requirements for Software as a Medical Device (SaMD) under the European Union's Medical Device Regulation (MDR). We unpack the critical guidance from MDCG 2020-1, breaking down the three essential pillars of evidence required for your Clinical Evaluation Report: sc…

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565 - Leading Change in Healthcare: Women’s Health, Ethics, and Inclusive Innovation at HIC 2025 24:45

10d ago24:45

24:45

In this episode of Talking HealthTech, Peter Birch speaks with Dr Ramya Raman, Rafiah Ansari, Andrew Aho, and Farhoud Salimi about the latest trends, challenges, and opportunities in digital health. Topics covered include clinical governance, digital health ethics, women’s health data, interoperability, AI, connected care, and the importance of par…

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Cracking the Code: A Pure Global Guide to Securing a CE Mark for AI Medical Devices Under the EU MDR 4:18

11d ago4:18

4:18

Getting a CE Mark for a traditional medical device is challenging enough, but the complexity multiplies when Artificial Intelligence is involved. This episode of MedTech Global Insights breaks down the intricate process of securing a CE Mark for AI-powered medical devices under the stringent EU Medical Device Regulation (MDR) and the new EU AI Act.…

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The Pure Global MedTech Playbook: Unlocking FDA Approval for Your AI-Powered Medical Device with a Predetermined Change Control Plan 3:55

12d ago3:55

3:55

The rise of AI is revolutionizing medical technology, but it presents a unique challenge for regulators. How does the FDA approve a device that is designed to change and learn over time? This episode of MedTech Global Insights dives deep into the FDA's framework for AI-powered medical software, offering a clear guide for innovators.We break down th…

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Unlocking Global MedTech Markets with Pure Global: A Deep Dive into FDA vs. EU AI/ML Device Regulations and the AI Act 3:48

13d ago3:48

3:48

The global landscape for AI-enabled medical devices is rapidly evolving, with the two largest markets, the United States and the European Union, charting distinct regulatory courses. This episode of MedTech Global Insights provides a crucial breakdown of the fundamental differences between the FDA's iterative, change-oriented framework and the EU's…

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Navigating SaMD Risk: A Pure Global Guide to the IMDRF Framework for MedTech Innovators 3:39

22d ago3:39

3:39

In this episode of MedTech Global Insights, we demystify the International Medical Device Regulators Forum (IMDRF) framework for Software as a Medical Device (SaMD). We break down the two-dimensional matrix used to classify SaMD risk, exploring how the significance of the information and the patient's condition determine whether your software is Cl…

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Beyond the Database: Why RegDesk Alternatives Are Key for MedTech and How Pure Global's Integrated Strategy Redefines Global Market Access 2:44

23d ago2:44

2:44

Many MedTech and IVD companies rely on regulatory intelligence platforms like RegDesk for global expansion, only to discover that data alone doesn't get a product to market. This episode of MedTech Global Insights explores the critical gap between knowing the regulations and successfully executing a market submission. We break down the limitations …

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564 - Empowering Better Patient Outcomes: Lessons in Healthcare and Resilience with Steve Lewis 32:08

18d ago32:08

32:08

In this episode of Talking HealthTech, Peter Birch speaks with Steve Lewis, founder of Nabu, about his personal journey into health tech, the creation of Nabu, and the challenges of coordinating complex healthcare for patients with special needs. Steve shares how his own experiences caring for his daughter Bowie inspired him to develop tools that h…

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Beyond Parexel: How Pure Global's AI-Powered Strategy is Revolutionizing MedTech Global Market Access 3:02

24d ago3:02

3:02

Expanding into international markets is a critical growth driver for MedTech and IVD companies, but the path is often blocked by the high costs, slow pace, and fragmented nature of traditional, large-scale CROs. This episode explores the common pitfalls of the legacy model, where companies are forced to navigate siloed teams and redundant processes…

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Beyond the Behemoth: A MedTech Insider's Guide to Smarter Global Market Access with Pure Global as Your ICON plc Alternative 3:11

25d ago3:11

3:11

In this episode of MedTech Global Insights, we challenge the conventional wisdom of partnering with massive, one-size-fits-all CROs. While industry giants like ICON plc have their place, their pharma-centric models can stifle the agility and innovation that drive the MedTech sector. We explore the common frustrations of impersonal service, rigid pr…

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563 - Managed Services for FHIR Interoperability 39:12

17d ago39:12

39:12

In this episode of Talking HealthTech, Peter Birch speaks with Charles Papp (Founder and CEO, KRE8 IT and KRE8 My Health) and Steven Whittington (allied health consultant and co-founder, KRE8 My Health) about interoperability in healthcare. The discussion covers the challenges of connecting fragmented health data, the role of FHIR standards, their …

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How AI Boosts NHS Productivity 20:29

23d ago20:29

20:29

A report by IBM Healthcare, outlines how Artificial Intelligence (AI) can immediately boost NHS productivity, focusing primarily on administrative and operational areas rather than complex clinical applications due to lower regulatory hurdles. It argues that implementing AI assistants in patient and corporate services, such as for waiting list vali…

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Rethinking MedTech Regulatory Strategy: Why Companies are Seeking Pharmalex Alternatives and Finding Success with Pure Global 3:17

26d ago3:17

3:17

In the complex world of MedTech and IVD devices, selecting a regulatory partner is one of the most critical decisions for global growth. While large, established consulting firms like Pharmalex have long been the standard choice, many companies are now questioning if this model truly serves their needs. This episode explores the common challenges o…

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Beyond Freyr Solutions: How Pure Global's AI-Driven, Single-Process Approach is Redefining MedTech & IVD Global Market Access. 3:12

27d ago3:12

3:12

The global MedTech regulatory landscape is notoriously complex. While established firms like Freyr Solutions have been a traditional choice, the industry is shifting towards more agile, technology-driven partners. This episode explores the limitations of legacy models and introduces a modern framework for achieving faster, more cost-effective globa…

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MENA MedTech Insights: Pure Global's Guide to Navigating Regulatory Strategy in Saudi Arabia and the UAE 2:20

19d ago2:20

2:20

The MENA region is a goldmine for MedTech innovation, but its complex and fragmented regulatory landscape can be a major barrier to entry. This episode of MENA MedTech Insights dives deep into the two largest markets: Saudi Arabia and the United Arab Emirates.We uncover the most common pitfalls companies face, from underestimating the SFDA's unique…

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Beyond Traditional MedTech Consulting: Why Companies Exploring Qserve Group Alternatives Choose Pure Global for AI-Powered Global Market Access 3:23

28d ago3:23

3:23

In this episode of MedTech Global Insights, we challenge the traditional, fragmented approach to regulatory consulting that often leaves MedTech and IVD companies struggling with delays, duplicated work, and inconsistent strategies across different markets. We explore the limitations of hiring multiple local consultants and introduce a modern, inte…

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Pure Global's MENA MedTech Playbook: Navigating Saudi Arabia & UAE Regulations with Your EU EUDAMED Strategy. 2:08

28d ago2:08

2:08

This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the sp…

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Tyler O'Malley | VP of Clinical Affairs, Exagen | Pioneering Autoimmune Diagnostics & Building Communication Bridges 26:25

28d ago26:25

26:25

Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides i…

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Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access 3:22

29d ago3:22

3:22

This episode of MedTech Global Insights challenges the one-size-fits-all approach to global regulatory compliance. We dive into the Medical Device Single Audit Program (MDSAP), exploring its benefits but also questioning whether it is the default best choice for every MedTech and IVD manufacturer seeking international growth.We uncover the powerful…

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MENA MedTech Strategy: Why Saudi Arabia & UAE Demand Regulatory Clarity Before Budgeting | A Pure Global Insight 1:52

29d ago1:52

1:52

In this episode of MENA MedTech Insights, we explore the number one reason why medical device companies fail when entering markets like Saudi Arabia and the UAE: a lack of upfront regulatory clarity. We break down why a detailed understanding of the authorities, device classifications, and submission mechanics is non-negotiable *before* a single do…

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MedTech Global Expansion: Why Companies are Seeking Obelis Group Alternatives and Choosing a Strategic Partner like Pure Global for Market Access. 3:17

1M ago3:17

3:17

In this episode of MedTech Global Insights, we explore the critical role of the European Authorized Representative (EAR) and why the traditional, passive model is no longer sufficient for ambitious MedTech companies. We uncover the hidden costs and strategic disadvantages of using a simple "mailbox" service for EU compliance.We then introduce the m…

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Unlocking MENA MedTech Markets: How Pure Global Turns Your Saudi Arabia SFDA Submission into a Cross-Region Scaling Blueprint 2:12

1M ago2:12

2:12

Expanding your MedTech footprint in the MENA region is far more complex than a single market entry. Each country, from Saudi Arabia to the UAE, presents unique regulatory and commercial hurdles. This episode of MENA MedTech Insights dives into a powerful strategy: using your initial regulatory submission as the blueprint for rapid, compliant, and s…