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- Per-Episode Audience
Est. listeners per new episode within ~30 days
10,001 - 25,000 - Monthly Reach
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25,001 - 75,000 - Active Followers
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5,001 - 15,000
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On the show
Recent episodes
CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement with Georg Digel, Founder of Elevate CAPA
Apr 22, 2026
45m 27s
Remanufacturing Single-Use Medical Devices with Ulrike Marczak, CEO at Vanguard
Apr 15, 2026
41m 26s
The Bio-Based Pipette at comparable costs to conventional Plastic | Bastien Manuel, Commercial Director at elm-plastic
Apr 8, 2026
45m 18s
How Advisory Boards Can Help You Make Strategically Sound Decisions with Jordan Morrison, Founding Partner at Synera Advisory
Apr 1, 2026
49m 26s
Recycling is Just an Extension of Linearity with Patrick Zimmermann, Managing Director at FKuR Kunststoff GmbH
Mar 25, 2026
45m 52s
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| Date | Episode | Description | Length | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 4/22/26 | CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement with Georg Digel, Founder of Elevate CAPA | A lot of MedTech companies treat CAPA as a compliance exercise. They open a record, close a record, and survive the audit. Georg Digel has spent his career watching what happens when that's the only goal… and it's not pretty. Georg is the Founder and Owner of Elevate CAPA. He has spent years helping MedTech companies build CAPA systems that actually work: ones that identify real problems, trace them to their root cause, and prevent them from coming back. Here's what we get into: Why CAPA is o... | 45m 27s | ||||||
| 4/15/26 | Remanufacturing Single-Use Medical Devices with Ulrike Marczak, CEO at Vanguard | This episode is brought to you by Vanguard, a company specializing in remanufacturing single-use medical devices to as-good-as-new condition. A device labeled "single-use" gets thrown away after one patient. That makes sense for a syringe. It makes a lot less sense for a cardiac catheter that costs thousands of euros. Ulrike Marczak is the CEO of Vanguard, a company that has been remanufacturing complex single-use medical devices for 30 years. They take used devices from hospitals, fully refu... | 41m 26s | ||||||
| 4/8/26 | The Bio-Based Pipette at comparable costs to conventional Plastic | Bastien Manuel, Commercial Director at elm-plastic | Bastien Manuel recognized that sustainability was inevitable for most medical plastic manufacturers. At elmplastic, he proactively established his business with that future in mind. He's Commercial Director at elm-plastic GmbH, a Germany-based, family-owned converter of plastic and manufacturer of pharmaceutical plastic devices. In 2025, they launched what they believe is the only commercially available bio-based plastic oral dosing device on the market: a sustainable pharmaceutical pip... | 45m 18s | ||||||
| 4/1/26 | How Advisory Boards Can Help You Make Strategically Sound Decisions with Jordan Morrison, Founding Partner at Synera Advisory | This episode is brought to you by Synera Advisory. Most MedTech founders treat FDA clearance like it's the finish line. Jordan Morrison has an entire bookshelf of cleared devices that can't sell to prove it isn't. She's Founding Partner at Synera Advisory, a physician-backed advisory group supporting founders from concept through commercialization. In this episode, she explains why so many MedTech startups run out of road after clearance, and what to do instead. Here's what we get into: Why F... | 49m 26s | ||||||
| 3/25/26 | Recycling is Just an Extension of Linearity with Patrick Zimmermann, Managing Director at FKuR Kunststoff GmbH | This episode is brought to you by FKuR Kunststoff GmbH, a leading producer and distributor of bio-based and compostable plastics. "Recycling is just an extension of linearity." Patrick Zimmermann posts the same sentence on LinkedIn, and it always gets a reaction: He's the Managing Director at FKuR Kunststoff GmbH, a company that's been working with bio-based and compostable plastics for decades. So when he says recycling doesn't close the loop, he's not being cynical. He's being precise... | 45m 52s | ||||||
| 3/18/26 | How to Build a Medical Device That Actually Sells with Lisa Voronkova, CEO of OVA Solutions | If you want to make your medical devices more sustainable, let's talk—: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical Most MedTech founders build the wrong device because they skip the steps that actually matter before the engineering starts. Lisa Voronkova is CEO of OVA Solutions, an R&D shop that has developed over 200 medical devices from scratch, and author of Hardware Bible. In this episode, she breaks down exactly where founders go wrong, what the developmen... | 46m 34s | ||||||
| 3/11/26 | How AI Can 10x Medical Device Development with Prof. Dr. Christian Johner | If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical What if you could cut the time it takes to develop a medical device in half? In this episode, I sit down with Prof. Dr. Christian Johner, founder of the Johner Institute and one of Europe's most recognized experts in medical device, regulatory affairs and software. He has spent decades helping manufacturers navigate complex regulatory hurdles, and recen... | 44m 39s | ||||||
| 3/5/26 | Why Sustainability and Compliance Are Becoming the Same Thing with Julian Lotz, BIOVOX | If you're a MedTech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical What if the plastic in your current medical device ends up restricted before your product reaches the end of life? Julian Lotz, CEO and Co-Founder of BIOVOX, joins the podcast to talk about where material compliance is heading and what to do about it now. His argument is straightforward: patient protection and environ... | 53m 40s | ||||||
| 2/11/26 | The Real Cost of Medical Waste (And Why Hospitals Are Changing Their Approach) with Andy Marshall | This episode is sponsored by Sterilis Solutions: https://sterilissolutions.com "How much is medical waste actually costing us?" is one of the questions hospitals are finally asking out loud. The problem is, most facilities don't realize they're dealing with a 10-20% annual cost increase—plus safety risks and sustainability pressure that isn't going away. In this episode, I speak with Andy Marshall, CEO of Sterilis Solutions, about how onsite sterilization changes the equation for hospitals, w... | 41m 50s | ||||||
| 1/28/26 | How Do You Know Your Medical Device Material Will Pass Biocompatibility Testing? with Marina Daineko | "Is this material going to be biocompatible?" is one of the most commonly asked questions in medical device development. The problem is, there's no such thing as a biocompatible material. In this episode, I speak with Marina Daineko, Biocompatibility Consultant at Intrinsic Medical Group, about how biological risk assessment actually works, what mistakes companies make early in development, and how to incorporate biocompatibility thinking during prototyping without running full testing on eve... | 59m 40s | ||||||
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| 1/21/26 | Can Chemical Recycling Solve MedTech's Sustainability Crisis? with Reinier Grimbergen | Chemical recycling is often presented as a silver bullet. But is it actually viable for medical-grade plastics? In this episode, I speak with Reinier Grimbergen, CTO of Blue Circle Olefins, about what chemical recycling really is, how it differs from mechanical recycling, and where it actually makes sense for MedTech. This conversation is technical, practical, and grounded in industrial reality. We talk about pyrolysis vs gasification, energy trade-offs, feedstock constraints, economics, and ... | 53m 23s | ||||||
| 1/7/26 | How to Innovate Faster in MedTech: Solving the Speed-to-Market Problem with Spencer Jones | Why does it take so long to bring a medical device to market? And what can we actually do about it? Spencer Jones is a serial entrepreneur and the founder of XO MedTech and MedTech Vendors. In this episode, he breaks down the real problems slowing innovation in medical technology and shares practical solutions that work. This isn't about motivation. It's about the structural issues that make MedTech innovation slow, expensive, and isolating—and the systems that can fix them. Inside this episo... | 1h 01m 21s | ||||||
| 12/31/25 | How Do You Choose The Right Sterilization Method For Your Device? with Manuel Grandy | If you are building or scaling a medical device, sterilization problems will catch up with you. Usually later in the process than you want. In this episode, I speak with Manuel Grandy, Consultant and Managing Partner at SteriComp GmbH, about what sterilization actually means in practice and why so many teams underestimate it until regulators start asking uncomfortable questions. We talk about ETO gas, gamma radiation, and why there is no universally “correct” sterilization method. The right c... | 43m 22s | ||||||
| 12/24/25 | Is Sustainability Actually Strategic? with Casper Venbjerg Hansen | Many companies say sustainability matters, but only a few treat it as part of their strategy. One of them is Ambu, a global MedTech company and the market leader in single-use endoscopy. In this episode, Casper Venbjerg Hansen, Senior Director, Sustainability, Public Affairs, Risk and Compliance at Ambu A/S, explains how sustainability guides their decisions and why Ambu committed to it early. Casper walks through Ambu’s long history with sustainability, including why they redesigned their en... | 43m 30s | ||||||
| 12/17/25 | Understanding LCAs: The Hidden Factors That Shape Environmental Impact with Thomas Kägi | Many organizations rely on LCAs (Life Cycle Assessments) to guide sustainability decisions, but the method is only as reliable as the data and assumptions used to build it. In this episode, Thomas Kägi, Member of the Board at Carbotech AG, explains how to structure an LCA so that the results reflect real environmental impact and not just guesses or incomplete boundaries. Thomas describes how the functional unit sets the entire frame for an analysis, why the use phase can overshadow production... | 46m 51s | ||||||
| 12/10/25 | Why Hospitals Say No: The Harsh Truth About MedTech Commercialization with Jim Surek | Hospitals review new devices through a process that is far more complex than most teams expect. In this episode, commercialization specialist Jim Surek explains how he evaluates medical technologies and the three-part funnel he uses to predict whether a product will find traction. Jim describes how clinical performance, economic outcomes, and strategic or operational effects shape hospital decisions and why progress in only one area is not enough. In this conversation, we cover: Why clinical ... | 46m 36s | ||||||
| 12/3/25 | What If Engineers Could Innovate Instead of Wasting Time on Documentation with Karl J. Larsson (Aligned) | Every MedTech company wants to innovate faster, but most are slowed down by one thing they barely realize is consuming half their development time: technical documentation. In this episode, Karl J. Larsson, co-founder of Aligned, explains how Word- and Excel-based documentation structures create massive inefficiencies, audit delays, and innovation bottlenecks, and how a lean, software-driven approach transforms both speed and confidence. In this conversation, Karl and Lucas discuss: Why up to... | 44m 44s | ||||||
| 11/26/25 | Is the Packaging of Implants the Next Big Sustainability Challenge in MedTech? with Marcel Kunz (Straumann Group) | Marcel Kunz, Head of Packaging at Straumann Group, has spent his career making dental implant packaging safe, sterile, and sustainable. In this episode, he joins Lucas Pianegonda to share Straumann’s six “Golden Rules” for designing medical packaging that balances compliance with circularity — plus the story behind his toothbrush project that turned blister waste into a useful consumer product. They cover: The real cost of sterile barrier systems in MedTech Why Straumann won’t wait ... | 41m 51s | ||||||
| 11/17/25 | Building the First Bio-Based Breathing Circuit with Thomas Willemsen (GaleMed Group) | When Thomas Willemsen became CEO of GaleMed Group, he saw an opportunity to redefine medical consumables for a sustainable future. In partnership with Gradical, his team created the BioVent-Circuit — the world’s first anesthesia and ventilation circuit made from sugarcane-based bioplastic. In this conversation, Thomas and Lucas Pianegonda discuss: • How GaleMed turned a concept into a validated, high-performing product • Why sustainability is a strategic advantage, not a cost burd... | 43m 28s | ||||||
| 11/12/25 | Redesigning a Single-Use Medical Device to SLASH Waste and Cost (Case Study) with Pablo Yániz González | Industrial design engineer Pablo Yániz González, who recently graduated in Integrated Product Design at TU Delft's Faculty of Industrial Design Engineering, set out to make a single-use inflator more sustainable and ended up designing a hybrid device that can be reused up to 1,000 times. In this episode, Pablo joins Lucas Pianegonda to discuss how hospitals can reduce waste without adding burden for clinicians, what “hybrid-use” design really means, and how to navigate the long, expensive roa... | 39m 55s | ||||||
| 11/5/25 | How “Hybrid-Use” Medical Devices Can Cut Waste AND Save Hospitals Millions with Dr. Axel Boese | Dr. Axel Boese has spent years studying how hospitals can innovate sustainably — and one of his biggest insights challenges the status quo of “single-use.” In most hospitals, medical tools are used once and then thrown away. For something like a cheap plastic syringe, that makes sense. But with a €600 stapler or a €1,300 catheter, the practice becomes both unsustainable and financially wasteful. That’s where hybrid-use comes in. Instead of discarding the entire device, hospitals can reu... | 47m 38s | ||||||
| 10/22/25 | Arne Jaksch - Toxicological Risk Assessment | Arne Jaksch is an expert in toxicology and managing director of his own company Jaksch Life Science Consulting. He supports medical technology, pharmaceutical and chemical companies in the biological and toxicological evaluation of their products. In our discussion we dive deep on how a toxicological risk assessment is performed and what difficulties companies usually face when doing these. This episode was sponsored by Jaksch LifeScience Consulting GmbH - JAKSCH LIFESCIENCE CONSULTING... | 41m 17s | ||||||
| 10/15/25 | Maximilian Hofmann - Challenges in MedTech Sustainability | Maximilian Hofmann is Sustainability Manager at Raumedic a leading component supplier, CDMO and medical device manufacturer for some of its products. In the 4 years at Raumedic he established sustainability management systems, ISCC-PLUS certifications for two sites and introduced eco-design into Raumedics development process. Despite all the efforts sustainable products are struggling to take off, in this podcast we want to explore the current challenges of sustainable product development in ... | 44m 50s | ||||||
| 9/24/25 | Isobel Filipova - Holistic MedTech Design | Isobel Filipova is an expert in sustainable design in medical technology and the founder of her own consultancy, where she helps medtech companies redesign medical device for sustainability. With a background in industrial design and medical devices, she has developed a unique approach that balances usability, compliance, and environmental impact. Her work focuses on transforming single-use medical devices into more sustainable multi-use solutions. In our discussion we talk about the holistic... | 51m 06s | ||||||
| 9/3/25 | Damian Carr - Catheter Technology | Damian Carr is a distinguished expert in catheter innovation and globally recognized for his pioneering contributions to minimally invasive medical technologies. He is the author of “The Catheter R&D Handbook and founder of Eyedea Medtech Education where he educates medtech companies and suppliers alike on catheter technology and design. In our discussion we talked about the great clinical benefits that minimally invasive surgical devices bring but also about their single use nature and o... | 43m 55s | ||||||
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