MedTech Sustainability by Design
MedTech Sustainability by Design is the podcast where the world's leading experts in medical device, sustainable plastics, eco-design, and regulatory compliance share their expertise. Each episode cuts through the complexity of plastic selection, regulatory changes, medical device engineering or sustainable plastics — so MedTech engineers and start-up teams can build devices that are good for the patient, good for the planet and profitable.Your host, Lucas Pianegonda, is a globally recognized expert for plastics in medical technology. As founder of Gradical, a consultancy dedicated to making MedTech more sustainable with plastics, Lucas has guided dozens of medical device, IVD and pharma co...
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 one of the most misunderstood pr...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 refurbish them, put their own CE mark on them, and send them back. Safe, legal, and up to 50% cheaper...
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 pipette made exclusively made from bio-sourced materials. In this episode, he discusses their approach, how they achieved it, and why the cost argument against sustainable medical plastics is less compelling than most procurement t...
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 FDA clearance and a reimbursement strategy are two completely different thingsThe...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.
Here's what we get into:
Why every recycling diagram y...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 development process actually looks like from clinical need to commercialization, and why FDA clearance is really just your entry ticket in...
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 recently, he has turned his focus to something that is changing everything: generative AI and large language models in...
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 environmental protection are being regulated by the same logic, and the materials in your device sit right at t...
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, what's actually driving the shift away from third-party waste haulers, and why waste is th...
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 every grade.
This conversation is technical, practical, and based on real consulting work. We talk about the ISO 10993-1 framework, extractables and...
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 why some recycling routes can deliver virgin-quality polymers suitable for medical and food-contact applications.
Inside this episode, you...
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 episode, you will learn:
✔ Why clinical innovators stru...
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 choice depends on materials, device design, supply chain constraints, and how well you understand the science behi...
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 endoscopes in 2009 to make future recycling possible. He shares how sustainability became strategic in 2022 when hospitals be...
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 in environmental impact, and how to work with supplier-specific data when it is a...
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 gains must connect to measurable economic valueHow Jim structures a commercialization assessmentHow hospitals view workflow changes and...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 50% of product development time is spent on documentationHow inconsistent files create “audit anxiety” and costly revi...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 until 2034 to adapt to PPWR How a recycling experiment became a proof of concept for innovation Ho...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 burden
• The challenges of market adoption in Europe and the U.S.
• How Gradical helped bridge regulatory and materials expertise
•...
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 road from prototype to regulatory approval.
They cover:
The tradeoffs between reuse...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 reuse the critical components while protecting them with inexpensive, disposable covers that maint...
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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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 medtech.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast...
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 understanding of sustainability and the involvement of all stakeholders interests at early stages.
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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 opportunities for more sustainable design.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Yo...
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 role of sustainability in new medical devices.
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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.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast and bring you...
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 and what things to look out for in the material selection.
Do you enjoy this podcast? Then s...
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.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast and bring you relevant...
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 second book “Shattering the Plastic Illusion” he clears up many more myths about plastics. The book is free, download it now.
Do you enjoy this...
Michael Pirner - Films for Medical Applications
Michael Pirner is CSO at PEKU Folien a leading manufacturer of PE-films in Europe. He had a stellar career in the hygiene and medical film industry and is a true expert in the field of medical film and packaging production. In our discussions we talk about the application of films and packaging in medical device and pharmaceutical packaging, their different requirements and design for sustainability.
Still looking for more regarding plastics in medical technology?
Visit our website and inform yourself on the services of Gradical.
Check out our market report on medical grade...
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 in the years to come.
This episode was sponsored by Plastiflex.
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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.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comme...
Julian Lotz - Biobased Medical Grades
Julian Lotz is cofounder and CEO of BIOVOX a german start-up focused on making medical grade plastics more sustainable. He is an expert for sustainable medical grades and especially for biobased grades. In our discussion Julian elaborates on enivornmental impacts, the difference between biobased and biodegradable and on how to make the future of healthcare more sustainable.
Do you enjoy this podcast? Then subscribe, rate it on your platform, and join the discussion on LinkedIn! Your feedback and comments help us improve the podcast and bring you relevant topics. Let’s form a better world with plastics!
...Mihajlo Milenkovic & Giuseppe Fiandaca - Medical Grade Plastic Market Report
This special episode we will have two guests Mihajlo Milenkovic and Giuseppe Fiandaca. Mihajlo is principal at The Strategists network a strategy consulting firm focused on medical technology. Giuseppe Fiandaca is Cofounder and Managing Director at Polyneers a consulting firm for medical grade plastics. Together with Gradical these two companies jointly put together a market report regarding the medical grade plastic market. More info on the market report under www.medicalgradeplastics.de
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Dr. Stefan Rössler - Mass Balance Approach
Dr. Stefan Rössler is an expert for the massbalance approach and auditor for massbalance certifications at TÜV-SÜD. After his PhD in chemical engineering he worked a couple of years in industry as a business and technical consultant before he joined TÜV SÜD as an auditor and global product manager for ISCC certifications. We talk in detail about different chain of custody options, sustainable feedstocks and the ISCC-PLUS certification process.
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Dr. Vinny Sastri - Quality Management in Medical Device
Vinny Sastri is an expert in quality management and medical grade plastics. He holds a PhD in Chemistry from the Rutgers University. After a stellar career at BASF, Honeywell and GE-Plastics he founded his own consultancy where he focuses on quality management. He is a certified Six Sigma black belt and his book plastics in medical device is without peers. He recently started as senior vice president global quality at Avanos medical a company providing solutions for Pain Management and Chronic Care. Lets hear our discussion!
This episode was sponsored by www.avanos.com
Here...
Kim Laursen - Compounding for Medical Applications
Kim Laursen is the Managing Director of Melitek A/S a medical compounder based in Denmark. With his nearly 30 year of experience he is a true expert in the field of medical compounding. In our discussion we talk about what advantages a compounder dedicated to medical end market brings, about sustainability and how to attract key talent.
This episode was sponsored by Melitek
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Jonathan Demierre - Eco-Design
Jonathan Demierre is an expert for eco-design and lead the team Sustainability Engineering at Helbling. He holds a PhD in Energy Systems from the EPFL Lausanne and worked at the Sustainable Engineering Lab of Columbia university in New York before joining Helbling. His whole career is centred around sustainability and eco-design. We talk about the sustainability and how it is embedded in the design process and why you should not put goals on means.
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Steve Maxson - MedTech Extrusion
Steve Maxson is an expert for medical extrusion and currently Innovation and Business Developer at US-Extruders. He has over 20 years of experience in the medical extrusion business and hosts his own podcast Med-Ex The Medical Extrusion Podcast where he covers all things medical extrusion. On the side he also runs his own consulting business maxsoninsightservices.
In our discussion we talk about catheter manufacturing, PFAS, regulatory topics and sustainability.
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