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Gradical Podcast - The Podcast about Plastics in Medical Technology
Lucas Pianegonda
29 episodes
1 week ago
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...
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Life Sciences
Science
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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...
Show more...
Life Sciences
Science
Episodes (20/29)
Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
Show more...
1 week ago
43 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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2 weeks ago
43 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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3 weeks ago
46 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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 ...
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4 weeks ago
46 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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1 month ago
44 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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 ...
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1 month ago
41 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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1 month ago
43 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Redesigning a Single-Use Medical Device to SLASH Waste and Cost (Case Study) with Pablo Yániz González
Industrial design engineer Pablo Yániz González 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 road from prototype to regulatory approval. They cover: The tradeoffs between reuse and remanufacturing in hospi...
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1 month ago
39 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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2 months ago
47 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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2 months ago
41 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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 ...
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2 months ago
44 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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3 months ago
51 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...
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4 months ago
44 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Monika Kriete - Medical TPUs
Monika Kriete is an expert for medical TPU and Technical Marketing Manager at Lubrizol Medical Solutions. She studied material science at the university of Berlin and then moved into the polymer industry working for Covestro before moving to Lubrizol in 2022, where she supports her customers in matters of processing and material selection of medical TPUs. In our discussion we talk about importance of talking about requirements, about the importance of an independent plastic evaluation and the...
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5 months ago
43 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Jim Giger - Product Development in MedTech
Jim Giger is an experienced leader in Innovation and product development. In his stellar career he managed development and innovation teams across multiple industries including medical device. Currently he is R&D Director at Hamilton Medical, where he aims deliver innovation in the critical care sector. In our discussion we talk about the innovation process, how to develop medical devices and what challenges arise during the process. Plastic evaluation is our core expertise at Gradical. W...
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5 months ago
48 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Beat Keller - Safety of Electrical Medical Devices
Beat Keller is a regulatory expert and electrical engineer with deep knowledge in electric and electronic devices. He has over 15 years of experience in the medical device field and has been working in several standardization working groups for electrical and electronic devices also for IEC 60601-1. He recently founded his own consultancy swiss medical device consulting GmbH where he helps medical device companies be compliant. In our discussion we talk about how to test a electrical device a...
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6 months ago
45 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Daniel Delfosse - Regulatory Developments
Daniel Delfosse is an expert for Regulations and Innovation. He spent his career in R&D positions at Mathys Ltd Bettlach before joining Swiss MedTech 5 years ago where he now is Vice Director and Head of Regulation and Innovation. He summarizes the past years of regulatory developments including the implications of MDR. Then we discuss upcomming regulations such as the EU Green Deal and PFAS restrictions. Micro-Training for Medical Plastics! In just 2 hours, gain compact and practical ins...
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7 months ago
46 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Dr. Chris DeArmitt - Plastic Myths
Dr. Chris DeArmitt is a world-class Plastic consultant and independent environmental expert. Chris had a stellar career in the plastics industry at firms such as BASF before starting his own consultancy Phantom Plastics. In 2020 he wrote the plastics paradox, where he tackles persistent myths about the environmental impact of plastics. He founded a non-profit called plastics research council to further the mission of spreading the scientific truth about plastics. In his recently released seco...
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8 months ago
46 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Dr. Jenci Kurja - Sustainable Growth
Jenci Kurja is an expert for sustainable growth and plastics. He hold s PhD from Eindhoven University of Technology in Polymer Science and had a stellar career in the plastic industry for the last 25 years. First at Milliken & Company and then at his current employer Plastiflex where he is now Chief Growth officer and Chief Sustainability Officer. In our discussion we talk about how to incorporate sustainable plastics in medical technolgoy and how growth an sustainability are intercoupled...
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10 months ago
48 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
Monir El Azzouzzi - Clinical Evaluation
Monir El Azzouzzi is the founder and CEO of Easy medical device, a swiss based regulatory affairs consulting firm. Monir hosts his own podcast – the easy medical device podcast – where I have had the honor of being a guest on material selection. Monir provides all kind of regulatory affairs services including clinical evaluation, the topic of todays podcast. In our discussion we shed light on the clinical evaluation, clinical tests and on how to argue equivalency. Still looking for more...
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10 months ago
46 minutes

Gradical Podcast - The Podcast about Plastics in Medical Technology
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...