Medical & health devices
Product design & engineering
434 episodes across 27 shows cover medical & health devices. The shows that cover it most are Global Medical Device Podcast, Let's Combinate and The Next Byte Podcast. The most recent, from 13 Oct 2026, is “When Production Overtakes Prototyping: Materialise’s Next Phase of AM” from Additive Snack.
Medical, health and wellness devices, clinical use and their regulatory path.
434 episodes from 27 shows, most relevant and most recent first.
434 episodes
Founder Feature: The OB/GYN Formulating Pharmaceuticals for Period Care - Margo Harrison of Wave Bye
Margo Harrison, founder and CEO of Wave Bye, explains her strategy for launching a proactive, pharmaceutical-grade treatment for period pain and bleeding, targeting a market release between late 2027 and early 2029. She details the science…
250. MIT’s Injectable Mini Liver Could Save Thousands of Lives
MIT researchers Professor Sangita Batia and post-doc Vardhan Kumar developed INSIGHT, an injectable 'satellite liver' using hydrogel beads and hepatocytes to support failing livers without surgery. The hosts discuss how this material…
#451: Building a MedTech Powerhouse: The 5 Stages of Founder Success
Etienne Nichols, host of the Global Medical Device Podcast, outlines the five stages of building a medical device company, emphasizing that success depends on hiring the right specialized experts at each phase rather than just having good…
#447: Solving the Pediatric MedTech Gap with Edwin Lindsay
Edwin Lindsay, a MedTech operator and QARA leader who co-founded SureMakers and runs Compliant Solutions, discusses the systemic barriers to pediatric medical device development, noting that these devices face adult-level regulatory risks…
#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead
Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic…
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246. Future of Bone Repair Starts with a 3D Printer
The hosts discuss a breakthrough by researchers from ETH Zurich, Empa, and the University of Freiburg in creating a 3D printable bone scaffold that hardens at room temperature. They explain how this enzyme-driven process using alkaline…
Paradromics CEO Matt Angle on building the highest data rate brain-computer interface, hermetic sealing vs. Neuralink, and what makes BCIs last a decade in the body.
Matt Angle, CEO of Paradromics, explains the engineering behind the Connexus brain-computer interface, which achieves over 200 bits per second and is designed to last more than a decade in the body. He contrasts Paradromics' hermetic…
245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
Julia Anthony, founder and Chief Strategy Officer of Solution Medical, explains how her company is developing a drug-device combination product to simplify emergency hydrocortisone administration for patients with adrenal insufficiency…
244 - 5 Critical Quality Differences Between Drugs and Devices
Subhi Saadeh, a consultant specializing in drug-device combination products, explains five critical quality differences between pharmaceuticals and medical devices. He contrasts the drug industry's focus on consistent manufacturing of…
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243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work
Subhi Saadeh, Founder of Let’s Combinate, explains why selecting commercially available finished medical devices for combination product kits creates significant regulatory and quality challenges. He argues that an 'already approved'…
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S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA
Bob Hankins, Director of Engineered Component Development at TE Connectivity, discusses leading global engineering teams in the regulated medical device space, focusing on complex components like catheters and structural heart devices. He…
225. Detecting Disease Using Menstrual Pads
Hosts Daniel and the narrator discuss Metro AI, a smart sanitary pad developed by researchers at ETH Zurich, which transforms period products into diagnostic tools. The device uses a test strip with reactive antibodies to detect biomarkers…
#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
Staci Miller, a Human Factors and UX Strategist at GenUX, explains why medical device submissions stall when human factors (HF) is treated as a late-stage box-checking exercise rather than an integrated part of ISO 14971 risk management…
#426: Software as a Medical Device: Securing Your Digital Future
Jose Bohorquez and Mohamad Foustok from CyberMed explain that Software as a Medical Device (SaMD) must be treated as a medical device from inception, integrating security into the architecture rather than treating it as an afterthought…
#430: MedTech Language: Patient, Customer, or Partner?
Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, discusses the semantic and cultural shifts in MedTech language, specifically the transition from 'patient' to 'person' or 'care partner.' She argues that the etymology of…
223. Artificial Sweeteners For Treating Cancer?
The hosts discuss research from Texas A&M University where scientists replaced toxic platinum additives in conductive hydrogels with sorbitol, a sugar found in chewing gum, to create safer, softer, and more flexible electronic implants…
230: Shark Tank, Advanced Prosthetics, and How PSYONIC's Ability Hand is Driving Accessibility for Humans and Robots Featuring PSYONIC CEO & Founder Dr. Aadeel Akhtar
Dr. Aadeel Akhtar, CEO and Founder of PSYONIC, discusses the development of the Ability Hand, the world’s first touch-sensing bionic hand, and the company's mission to make advanced prosthetics accessible through Medicare coverage and the…
235 - ICH Q8: How Pharmaceutical Development Actually Works
Subhi Saadeh, founder of Let’s ComBinate, explains the structure and practical application of ICH Q8 (Pharmaceutical Development), a guideline for harmonizing regulatory submissions. He details how to define the Quality Target Product…
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233 - Most Teams Misunderstand Specifications | ICH Q6
Subhi Saadeh, founder of Let’s Combinate and former member of the ICH Q6(R1) subteam, explains the critical role of specifications in defining and controlling drug products and drug-device combination products. He breaks down the three…
192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)
Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the definition and classification of drug-device combination products. He distinguishes between drug-led products, such as prefilled syringes where the drug provides…
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218. Organ-on-a-chip: Our Best Shot At Beating Cancer?
Hosts discuss 'cancer-on-a-chip' technology, a microfluidic device developed by a team including PhD student Muhammad to simulate metastasis. The chip uses femtosecond laser machining and 3D sugar printing to create channels that mimic…
216. Exoskeleton + Digital Twin Aid Stroke Recovery
The hosts discuss a modular rehabilitation system developed by researchers at the Technical University of Munich that combines functional electrical stimulation (FES), an exoskeleton, and a digital twin to aid stroke recovery. The system…
#427: Medical Device Reimbursement - Pitfalls to Avoid
Haley King, co-founder and CEO of Paxos Health, explains the critical distinction between FDA approval and securing reimbursement, detailing the three pillars of coding, coverage, and payment. She highlights the challenge of navigating CPT…
#418: Biocompatibility Brief - What Medical Device Companies Need to Know
Marina Daineko, a MedTech expert and chemist specializing in biological evaluations, explains the critical importance of integrating biocompatibility into a company's Quality Management System (QMS) rather than treating it as an isolated…
When Production Overtakes Prototyping: Materialise’s Next Phase of AM
Bart van der Schuren, CTO of Materialise, explains how the company transitioned from a 1995 service bureau to a production powerhouse, recently surpassing prototyping with serial manufacturing. He details the three pillars of…
#464: Why LLM Unpredictability is a Liability in MedTech
Tyler Harmon, CEO of Iaso Automated Medical Systems, explains why the inherent randomness in Large Language Models (LLMs) makes them unsuitable for safety-critical medical devices compared to deterministic algorithms like Convolutional…
Episode 162: The robot doctor will see you now - Robot Talk Live
Claire Asher hosts a live episode of Robot Talk at Imperial College London with George Mylonas (Imperial College London), Antonia Tzemanaki (University of Bristol), and Tom Vercauteren (King's College London/Hypervision Surgical). The…
207 - What 99.999% Reliability Really Means
Alan Stevens, Global Head of Complex Devices at AbbVie and former FDA/CDRH leader, explains the FDA's 2020 draft guidance on 'five nines' (99.999%) reliability for life-saving drug-device combination products like epinephrine and naloxone…
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
Subhi Saadeh, Quality Professional and host of Let's Combinate, explains that drug-device combination products fail due to a lack of harmony across three levels: global regulatory alignment, sponsor-CXO collaboration, and internal…
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211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
Mark Kramer, founding director of the FDA’s Office of Combination Products (OCP) and now Principal at Eliquent Life Sciences, explains the history and regulatory framework for combination products in the U.S. He details how the 1990 Safe…
212. One Cure For All Snake Venoms Via AI
Hosts discuss research by Dr. Timothy Patrick Jenkins of the Technical University of Denmark and Nobel laureate Dr. David Baker of the University of Washington, who used AI to design proteins that neutralize snake venom. The team focused…
Episode 159: Robot sensing and manipulation - Maria Koskinopoulou
Maria Koskinopoulou, an Assistant Professor at Heriot-Watt University and co-leader of the ARM²Lab, discusses integrating perception and manipulation in robotics for medical and sustainability applications. She details autonomous…
#368: Institutional Review Boards (IRBs)
Dr. Mike Drues joins host Etienne Nichols to explain the role of Institutional Review Boards (IRBs) in medical device clinical trials, distinguishing between traditional and commercial IRBs. He details the critical difference between…
#386: The Danger of In-Home Use Medical Devices, Pt. 2
Regulatory expert Mike Drues joins host Etienne Nichols to discuss the unique challenges of in-home medical devices, focusing on labeling, usability, and cybersecurity. They argue that manufacturers must explicitly define the 'intended…
S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements
Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He…
#385: The Trouble with Home-Use Devices, Pt. 1
Regulatory expert Mike Drues joins host Etienne Nichols to discuss the unique challenges of home-use medical devices, defining them by their intended use environment rather than just location. They analyze the Philips Respironics recall…
184. Bionics Help Amputees Take Big Strides Forward
Hosts Daniel and Forbode discuss research from MIT’s Extreme Bionics Lab, led by Professor Hugh Herr and postdoc Hung Yun Song, on a new surgical technique called Agonist-Antagonist Myoneural Interface (AMI). The AMI surgery reconnects…
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
Subhi Saadeh, host of Let's Combinate and Quality Professional, explains the distinct regulatory frameworks of Quality by Design (QbD) and Design Controls for drug-device combination products. She contrasts QbD's focus on manufacturing…
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175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
Bill Facteau, President and CEO of Earlens Corporation, explains how their light-based, direct-drive hearing device overcomes the frequency limitations of traditional air conduction hearing aids by vibrating the eardrum directly. He…
174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
Ben Locwin, a healthcare executive and quality/regulatory subject matter expert, discusses the science, manufacturing, and regulatory landscape of GLP-1 receptor agonists like Ozempic and Wegovy. He explains that while these drugs have a…
S5E27 Andy Schieber | Work Ethic, Medical Device Commercialization, & Ophthalmology Devices
Andy Schieber, founder of Ingenarious Consultants and Head of Engineering at Rivermark Medical, discusses his journey from a farm upbringing to leading early-stage medical device development. He explains the challenges of commercializing…
182. Ex-Apple Engineer Creates Skincare Smart Patches
Dr. Simeon New, an ex-Apple engineer who worked on the Apple Watch's ECG and temperature sensors, explains his transition to creating a 'living bioelectronic patch' for treating psoriasis. The device combines a flexible PCB with…
#380: Navigating the Complex World of Combination Products with Subhi Saadeh
Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He…
#443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli
Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD), discusses the unique quality assurance challenges of generative AI in the medical device industry. He explains that unlike traditional…
201. Non-invasive Memory Booster
Hosts Daniel and the other speaker discuss a non-invasive memory booster developed by researchers at EPFL, specifically the Hummelab and the Laboratory of Cognitive Science. The device uses transcranial temporal interference stimulation…
#348: Considerations for IVD
Carmen Brown, regulatory and quality affairs manager at Proxima Clinical Research, explains the specific regulatory pathways for In Vitro Diagnostics (IVDs) under the FDA's CDRH. She details how IVD risk classification (Class 1, 2, or 3)…
MicroPython with Matt Trentini
Matt Trentini, Principal Software Engineer at Planet Innovation, explains how his team uses MicroPython for professional embedded development, including Class B medical devices. He details the benefits of the interactive REPL and the Unix…
221 - What Is ICH and Why It Matters
Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, explains the International Council for Harmonisation (ICH) and its critical role in drug-device combination products. He details the history of ICH, from its…
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171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
Subhi Saadeh, host of Let's Combinate and Quality Professional, explains why pre-filled syringes (PFS) are classified as combination products and how regulatory requirements vary by region. He details the US FDA's Primary Mode of Action…
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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
David Grosse-Wentrup, Research Director at Design Science Group, explains the FDA's new URRA draft guidance, which formalizes the use of Use-Related Risk Assessments (URRA) to justify waiving full human factors validation studies for…