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Explorez tous les épisodes du podcast MedTech Sustainability by Design

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TitreDateDurée
How “Hybrid-Use” Medical Devices Can Cut Waste AND Save Hospitals Millions with Dr. Axel Boese05 Nov 202500:47:38

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 maintain sterility. The result: less waste, lower cost, and a smarter path to sustainability.

In this episode, Dr. Boese joins Lucas to explore what’s driving hospitals toward single-use, how adopting hybrid-use could cut waste from high-value medical devices by up to 75%, and how the next generation of medtech professionals can balance patient safety, performance, and environmental impact.

Connect with Axel:

LinkedIn: linkedin.com/in/axel-boese-a7b43a188?originalSubdomain=de

Axel’s company, MEDICS GmbH: https://medics-md.de/

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, and innovation:

🟣Apple Podcasts: https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢Spotify:  https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Arne Jaksch - Toxicological Risk Assessment22 Oct 202500:41:17

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.



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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Dr. Jenci Kurja - Sustainable Growth26 Feb 202500:49:28

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.

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Monir El Azzouzzi - Clinical Evaluation19 Feb 202500:47:05

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 comments help us improve the podcast and bring you relevant topics. Let’s form a better world with plastics!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Julian Lotz - Biobased Medical Grades05 Feb 202500:47:33

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Mihajlo Milenkovic & Giuseppe Fiandaca - Medical Grade Plastic Market Report20 Dec 202400:51:37

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

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Dr. Stefan Rössler - Mass Balance Approach13 Dec 202400:57:07

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.

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Dr. Vinny Sastri - Quality Management in Medical Device23 Oct 202400:45:33

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 a link to the book "Plastics in Medical Device": https://amzn.to/4gVldHf

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Kim Laursen - Compounding for Medical Applications02 Oct 202400:45:41

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

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Jonathan Demierre - Eco-Design18 Sep 202400:46:08

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. 

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Steve Maxson - MedTech Extrusion04 Sep 202400:43:56

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.

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Patrick Kothe - Medical Device Sales22 Aug 202400:59:49

Our todays guest is Patrick “Pat” Kothe is an expert in sales and marketing of medical devices. He is the CEO of EM Device a medical device start-up based in Austin Texas, helping doctors better treat abscesses. He had a stellar career in Sales and Marketing and his passion are innovative start-ups and career development. He is the host of the “Mastering Medical Device” Podcast, a personal favourite of mine where I had an interview in 2023.

Check also the episode of Pat interviewing Lucas Pianegonda All Plastics Are Not Equal - Choosing the Right One For Your Device — Mastering Medical Device

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Maximilian Hofmann - Challenges in MedTech Sustainability15 Oct 202500:44:50

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 and bring you relevant topics. Let’s form a better world with plastics!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Anja Gottschalk - Polyolefins for Medical Technology14 Aug 202400:46:50

Our guest today is Anja Gottschalk, she is an application developer for medical technology and an expert in medical grade polyolefins. She is an member of the VDI's "Plastics in Medical Technology" committee and was involved in the development of the 2017 VDI guideline "Medical Grade Plastics". She gave an overview over the most important polyolfefins PE and PP and then we dove further into the topic of sustainability in polyolefins.


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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Isobel Filipova - Holistic MedTech Design24 Sep 202500:51:06

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.

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Damian Carr - Catheter Technology03 Sep 202500:43:55

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! Your feedback and comments help us improve the podcast and bring you relevant topics. Let’s form a better world with plastics!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Monika Kriete - Medical TPUs04 Aug 202500:43:10

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. 

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Jim Giger - Product Development in MedTech23 Jul 202500:47:19

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 relevant topics. Let’s form a better world with plastics!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Beat Keller - Safety of Electrical Medical Devices24 Jun 202500:44:32
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 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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Daniel Delfosse - Regulatory Developments20 May 202500:45:11

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 topics. Let’s form a better world with plastics!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Dr. Chris DeArmitt - Plastic Myths24 Apr 202500:45:48

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 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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

What If Engineers Could Innovate Instead of Wasting Time on Documentation with Karl J. Larsson (Aligned)03 Dec 202500:44:44

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 documentation
  • How inconsistent files create “audit anxiety” and costly review cycles
  • The real impact of moving from documents to design controls
  • How automation strengthens change control and accelerates market access
  •  Why freeing engineers from paperwork fuels innovation and sustainability

🎧 If you’re tired of documentation slowing your R&D team down, this episode is your roadmap.


Connect with Karl J. Larsson:
Website: https://www.aligned.ch
LinkedIn: https://www.linkedin.com/in/karl-johan-larsson-bab4312/

Connect with us:
If you’re a MedTech company struggling with documentation or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105

🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, and innovation:

🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/


#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Is the Packaging of Implants the Next Big Sustainability Challenge in MedTech? with Marcel Kunz (Straumann Group)26 Nov 202500:41:51

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
  •  How sustainability connects patient safety with long-term impact

If you work in medical packaging or device design, this episode will change how you think about “waste.”


Connect with Marcel:

https://ch.linkedin.com/in/marcel-kunz-4250b373

Connect with Straumann:
https://www.straumann.com/group/us/en/home.html

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, and innovation:

🟣Apple Podcasts https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢Spotify https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Building the First Bio-Based Breathing Circuit with Thomas Willemsen (GaleMed Group)17 Nov 202500:43:28

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
 • What it takes to build category leadership in eco-consumables

📍 See the BioVent-Circuit at the GaleMed booth Hall 11/C51 during the Medica Fair in Düsseldorf, starting November 17

Connect with Thomas Willemsen:
LinkedIn: https://tw.linkedin.com/in/thomas-willemsen-32696b21

Connect with GaleMed: https://www.galemed.com/en

Connect with us:

If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, and innovation:

🟣Apple Podcasts https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢Spotify https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq

📺Watch these episodes on YouTube: https://www.youtube.com/@GradicalGmbH

🌍 Learn more about Gradical: https://gradical.ch/

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Redesigning a Single-Use Medical Device to SLASH Waste and Cost (Case Study) with Pablo Yániz González12 Nov 202500:39:55

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 and remanufacturing in hospitals
  • Designing inflators that maintain safety and simplicity
  • The “Tesla lesson” for medtech
  • Why getting from prototype to MDR approval is a 3-year journey before sales even begin

If you’re an engineer or medtech innovator thinking about sustainability, this episode is for you.

Connect with Pablo:
LinkedIn: https://www.linkedin.com/in/pablo-yaniz-gonzalez

Connect with us:
If you’re a medtech company struggling to make your devices more sustainable, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability, materials, and innovation:
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Why Hospitals Say No: The Harsh Truth About MedTech Commercialization with Jim Surek10 Dec 202500:46:36

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 value
  • How Jim structures a commercialization assessment
  • How hospitals view workflow changes and resource requirements
  • How reimbursement shapes the path from prototype to adoption
  • What separates market-changing ideas from incremental improvements

🎧 If you want to understand how hospitals make purchasing decisions and how to position your device for success, this episode is a focused and practical guide.


Connect with Jim Surek:
LinkedIn: https://www.linkedin.com/in/jimsurek

Connect with us:
If you're a MedTech company evaluating commercialization risk or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation:

🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #Sustainability #MedTech #MedicalDevices

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Understanding LCAs: The Hidden Factors That Shape Environmental Impact with Thomas Kägi17 Dec 202500:46:51

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 available. He also breaks down when uncertainty matters, how to start with a screening LCA, and why rules such as ISO standards and EPDs are essential for making comparisons that are fair.


In this conversation, we cover:

  • Why an LCA only makes sense when the underlying question is clear
  • How system boundaries shape the outcome of a study
  • Why the use phase can account for most of a product's impact
  • How to work with databases and supplier-specific data
  • When uncertainty in LCA data matters and when it does not
  • How standards create comparability across different products

🎧 If you want a practical understanding of how environmental impact is measured and how to avoid common mistakes, this episode provides a grounded and straightforward guide.


Connect with Thomas Kägi:

LinkedIn: https://www.linkedin.com/in/thomas-k%C3%A4gi-262648a0/

Connect with us:

If you're a MedTech company evaluating commercialization risk or sustainability challenges, let’s talk: https://lucaspianegonda.clickfunnels.com/optin1756907952105


🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation:
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How to Innovate Faster in MedTech: Solving the Speed-to-Market Problem with Spencer Jones07 Jan 202601:01:21

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 struggle to translate their ideas into manufacturable devices 

✔ How the "glue person" who connects clinical needs to engineering is rare and critical 

✔ Why most innovators should try to get their competitors to steal their ideas (seriously) 

✔ How lean development and rapid customer feedback prevent year-long mistakes 

✔ Why engineers should see surgical cases and clinicians should visit manufacturing facilities

✔ Where AI can save massive time in MedTech (hint: it's documentation) 

✔ Why most MedTech teams need better vendor selection frameworks

Spencer shares real examples from his experience taking devices from idea through FDA clearance, raising $10M in venture capital, and working across vascular access, laparoscopic surgery, and orthopedic devices.

If you want to move faster, work smarter, and stop burning time on preventable mistakes, this conversation will help.

If you're a MedTech company struggling to make your devices more sustainable, CLICK here: https://lucaspianegonda.clickfunnels.com/optin1756907952105


Connect with Spencer Jones:
XO MedTech: https://xomedtech.com/
LinkedIn: https://www.linkedin.com/in/medtech-innovation/

Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How Do You Choose The Right Sterilization Method For Your Device? with Manuel Grandy31 Dec 202500:43:22

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 behind the standards.

Manuel explains why sterile does not mean clean, why following a standard word-for-word is sometimes not enough, and how small decisions like where you place a biological indicator can delay approval by months.

If you work in MedTech development, quality, regulatory, or manufacturing, this episode will help you avoid painful surprises and make better decisions much earlier.


Connect with Manuel Grandy:
LinkedIn: https://www.linkedin.com/in/sterilisation/

Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #MedTech #MedicalDevices #Sustainability

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Is Sustainability Actually Strategic? with Casper Venbjerg Hansen24 Dec 202500:43:30

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 began asking for better environmental performance.

We talk about single-use and reusable systems, the real footprint of reprocessing, and why raw materials drive a large part of emissions. Casper also explains how Ambu introduced bioplastics across all endoscope categories, how their takeback and recycling program works, and what it means to design for circularity from the start.

If you want a practical look at how sustainability becomes a business advantage, this episode gives you a clear introduction.


Connect with Casper Venbjerg Hansen:
LinkedIn: https://www.linkedin.com/in/casper-venbjerg-hansen-322853/

Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

 #GradicalPodcast #MedTech #MedicalDevices #Sustainability

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Can Chemical Recycling Solve MedTech's Sustainability Crisis? with Reinier Grimbergen21 Jan 202600:53:23

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 will learn:
✔ What chemical recycling actually means at the molecular level
✔ Why mechanical recycling alone likely caps out around 40 percent
✔ Why higher energy use can enable higher-quality recycled polymers
✔ How chemical recycling could unlock circular plastics for medical applications
✔ What determines the economics of chemical recycling at scale

If you work in MedTech and want to understand where chemical recycling actually fits, this episode will help you think more clearly about materials, sustainability claims, and long-term feasibility.

🔗 Connect with Reinier Grimbergen:
Blue Circle Olefins: https://bluecircle-olefins.com/
LinkedIn: https://www.linkedin.com/in/reiniergrimbergen/

Connect with us:
🎧 Subscribe to the Gradical Podcast for insights on MedTech sustainability and innovation
🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

If you're a MedTech company struggling to make your devices more sustainable, CLICK here: https://lucaspianegonda.clickfunnels.com/optin1756907952105

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How AI Can 10x Medical Device Development with Prof. Dr. Christian Johner11 Mar 202600:44:39

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 MedTech development.

Prof. Johner is precise, direct, and clear-eyed about where this is going. He explains why AI is a multiplier for competence (and incompetence), how to get precise and reproducible outputs from AI instead of wasting your time, and why his number one piece of advice is simply: just start.

We also get into his bold prediction that the current regulatory gateway model (submit, wait, get approved, launch) is going to be replaced by continuous device updates, much like how software works today. And he explains exactly what needs to change to get there.

If you work in MedTech and you are not yet using AI seriously in your development process, this episode will change how you think about that.


🔗 CONNECT WITH PROF. DR. CHRISTIAN JOHNER: 

Johner Institute: https://www.johner-institut.de 

LinkedIn: https://www.linkedin.com/in/christianjohner/

🔗 CONNECT WITH US: 

🎧 Subscribe to the Gradical Podcast for insights on MedTech materials and innovation 

🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Learn more about Gradical: https://gradical.ch/ 

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #MedTech #MedicalDevices #AI #GenerativeAI #MedicalDeviceDevelopment #RegulatoryAffairs

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Why Sustainability and Compliance Are Becoming the Same Thing with Julian Lotz, BIOVOX05 Mar 202600:53:40

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 that intersection.

We cover which regulations are actually coming, which materials are at risk, what the PFAS problem looks like in practice, and why the companies getting their material strategy right today will be in a structurally better position by 2030.

The core takeaway: 80% of your compliance is determined at the design stage. The later you deal with this, the more expensive it gets.


🔗 CONNECT WITH JULIAN LOTZ: 

BIOVOX: https://www.biovox.eu 

LinkedIn: https://www.linkedin.com/in/julian-lotz/

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Learn more about Gradical – https://gradical.ch/ 

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #MedTech #MedicalDevices #Sustainability #MaterialCompliance #PFAS #GreenDeal

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

The Real Cost of Medical Waste (And Why Hospitals Are Changing Their Approach) with Andy Marshall11 Feb 202600:41:50

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 the number one sustainability focus for healthcare facilities—not CO2.

This conversation is practical, data-driven, and based on real implementations. We talk about needlestick injuries (over 1,000 per day in the US alone), the difference between landfill, incineration, and onsite treatment, and why medical device companies need to think about material selection from a disposal perspective.

If you work in MedTech and want to understand what hospitals actually care about when it comes to sustainability, this episode will help you design better devices and communicate value to customers who are tired of watching waste costs climb every year.

🔗 CONNECT WITH ANDY MARSHALL:
Sterilis Solutions: https://sterilissolutions.com
LinkedIn: https://www.linkedin.com/in/andrewrmarshall1/

Connect with us:


🎧 Subscribe to the Gradical Podcast for insights on MedTech materials and innovation


🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Learn more about Gradical: https://gradical.ch/
📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch

#GradicalPodcast #MedTech #MedicalDevices #Sustainability #MedicalWaste #WasteManagement #HealthcareSafety #Plastics

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How Do You Know Your Medical Device Material Will Pass Biocompatibility Testing? with Marina Daineko28 Jan 202600:59:40

"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 leachables, CMR substances, and why a structured plastic selection process helps you mitigate biological risk before it becomes a costly problem.

If you work in MedTech and want to understand how to think about biocompatibility earlier in development, this episode will help you make better material decisions and avoid expensive surprises late in the process.

🔗 CONNECT WITH MARINA DAINEKO: 

Intrinsic Medical Group: https://www.intrinsicmedicalgroup.com/

LinkedIn: https://www.linkedin.com/in/marinadaineko/

Connect with us: 

🎧 Subscribe to the Gradical Podcast for insights on MedTech materials and innovation 

🟣 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Learn more about Gradical: https://gradical.ch/ 

📩 Work with Lucas and the team: lucas.pianegonda@gradical.ch


#GradicalPodcast #MedTech #MedicalDevices #Sustainability #Biocompatibility #Plastics #ISO10993 #MaterialSelection

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How to Build a Medical Device That Actually Sells with Lisa Voronkova, CEO of OVA Solutions18 Mar 202600:46:34

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 into the real competition.

We also get into how lean startup thinking translates (and doesn't translate) to MedTech, why manufacturing decisions belong in phase two, how to document without losing your mind, and where sustainability has a real seat at the design table.

Lisa's number one piece of advice: don't build anything until you've validated the problem. The most expensive mistake in MedTech is building the wrong device.

🔗 CONNECT WITH LISA VORONKOVA: 

OVA Solutions: https://ovasolutions.com/

LinkedIn: https://www.linkedin.com/in/lisa-voronkova/

Hardware Bible: https://www.amazon.com/Hardware-Bible-Medical-Device-Scratch/dp/B0FB4XL71K

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Gradical: https://gradical.ch/ 

📩 Work with us: lucas.pianegonda@gradical.ch


#GradicalPodcast #MedTech #MedicalDevices #MedicalDeviceDevelopment #RegulatoryAffairs #MedTechStartup #FDA #HardwareDevelopment

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

The Bio-Based Pipette at comparable costs to conventional Plastic | Bastien Manuel, Commercial Director at elm-plastic08 Apr 202600:45:18

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 teams believe.

Here's what we get into:

  • How eco-design can offset the higher price of bio-based raw materials
  • Why volume, scale, and long-term contracts change the equation entirely
  • How a family-owned business moves faster on sustainability than PE-backed competitors
  • Why early adopters of sustainable medical plastics are gaining a strategic market advantage now
  • An overview of the current regulatory requirements for pharmaceutical companies and what developments are expected next

If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical


🔗 CONNECT WITH BASTIEN MANUEL:

Website: https://elmplastic.com/de/

LinkedIn: https://www.linkedin.com/in/bastianmanuel/

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Gradical: https://gradical.ch/ 

📩 Work with us: lucas.pianegonda@gradical.ch


#MedtechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #MedicalDevices #Bioplastics #SustainableMedTech #Pharma

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

How Advisory Boards Can Help You Make Strategically Sound Decisions with Jordan Morrison, Founding Partner at Synera Advisory01 Apr 202600:49:26

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 things
  • The difference between physician founders and engineer founders, and where each gets stuck
  • How to build an advisory board without burning through equity
  • Why US value analysis committees will kill your device if you can't make a financial case
  • The lean three-person board structure that can take you to Series A

If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical


🔗 CONNECT WITH JORDAN MORRISON: 

LinkedIn: https://www.linkedin.com/in/ajordanmorrison/

Synera Advisory: https://syneraadvisory.org/

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Gradical: https://gradical.ch/ 

📩 Work with us: lucas.pianegonda@gradical.ch


#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #MedicalDevices #FDAclearance #Reimbursement #AdvisoryBoard

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Recycling is Just an Extension of Linearity with Patrick Zimmermann, Managing Director at FKuR Kunststoff GmbH25 Mar 202600:45:52

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 you've ever seen is leaving something out 
  • Why "zero waste" runs into a physics problem
  • The difference between biodegradability and compostability
  • How bio-based materials can fill the gap recycling can't 

If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical

🔗 CONNECT WITH PATRICK ZIMMERMANN: 

FKuR Kunststoff GmbH: https://www.fkur.com 

LinkedIn: https://www.linkedin.com/in/patrick-zimmermann-5a49588b/

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Gradical: https://gradical.ch/ 

📩 Work with us: lucas.pianegonda@gradical.ch


#GradicalPodcast #CircularEconomy #Recycling #Bioplastics #Sustainability #PlasticsIndustry

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement with Georg Digel, Founder of Elevate CAPA22 Apr 202600:45:27

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 processes in medical technology 
  • The difference between a non-conformity and a CAPA
  • What auditors actually find when they inspect CAPA systems 
  • Why "death by CAPA" happens and how to avoid it 
  • How management culture makes or breaks the whole thing 
  • What a lean, functional CAPA process looks like in practice

🔗 CONNECT WITH GEORG DIGEL: https://www.linkedin.com/in/georgdigel/?locale=de

🔗 CONNECT WITH US:
🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Gradical: https://gradical.ch/ 
📩 Work with us: lucas.pianegonda@gradical.ch


#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #CAPA #QualityManagement #MedicalDevices #ContinuousImprovement #QMS #Compliance

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Remanufacturing Single-Use Medical Devices with Ulrike Marczak, CEO at Vanguard15 Apr 202600:41:26

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 for the hospital.

Here's what we get into:

  • The difference between reprocessing and remanufacturing
  • Why remanufacturing makes sense economically, ecologically, and operationally for certain devices
  • How Vanguard tests every single device 100%
  • Which devices are good candidates, and where the business case breaks down
  • What OEM manufacturers should be thinking about when they design for the future

If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical


🔗 CONNECT WITH ULRIKE MARCZAK: 

Vanguard: https://www.vanguard.de/vanguard-ag/ 

LinkedIn: https://www.linkedin.com/in/ulrike-marczak-138045115/

🔗 CONNECT WITH US: 

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554 

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq 

📺 YouTube – https://www.youtube.com/@GradicalGmbH 

🌍 Gradical: https://gradical.ch/ 

📩 Work with us: lucas.pianegonda@gradical.ch


#MedtechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #CircularEconomy #SingleUse #Remanufacturing #MedicalDevices #Sustainability #HealthcareInnovation

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

The Sustainable Plastic That's Actually CHEAPER Than Fossil Fuels with Alex Braun, Chairman of Pillar Ltd20 May 202600:51:57

Most sustainable plastics cost two to six times more than oil-based alternatives. That's why you don't see them everywhere. Alex Braun decided to fix that.

Alex is the Chairman of Pillar Ltd, an Israeli industrial R&D company with 26 years of experience building materials for the world's largest manufacturers. Out of that work came three startups: PlasticBack, which chemically recycles PVC at under 100 degrees Celsius. Snow Polymers, which makes bio-based plastic at oil prices without requiring new machinery. And Inteligels, a smart wound care polymer that washes off with cold water instead of being peeled off a burn.

Here's what we get into:

  • Why most sustainable plastics fail commercially before they ever reach the market
  • How Snow Polymers makes bio-based plastic price-competitive with fossil fuels using industrial waste as feedstock
  • Why PVC is the fourth-largest plastic produced but the last to be recycled, and what PlasticBack does about it
  • How Inteligels eliminates the most painful procedure in hospitals
  • The R&D model that lets Pillar Ltd take risks that neither startups nor corporates can

This episode is sponsored by Pillar Ltd.


If you want to make your products more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical

🔗 CONNECT WITH Pillar Ltd: https://www.Pillar Ltd-ltd.com/about-us

🔗 CONNECT WITH US:
🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Gradical: https://gradical.ch/ 
📩 Work with us: lucas.pianegonda@gradical.ch


#MedTechSustainabilityByDesign #GradicalPodcast #SustainablePlastics #Bioplastics #ChemicalRecycling #PVC #WoundCare #DeepTech #MaterialScience

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

The Autoinjector Redesigned: Less Plastic, Lower Cost, Same Safety with John Palmer-Felgate, Founder & CTO of Eco-Inject06 May 202600:45:26

Over a billion autoinjectors are used every year. Almost all of them are single-use. Almost all of that plastic gets incinerated.

John Palmer-Felgate spent 30 years designing medical devices. At some point, he decided to actually fix the problem.

John is the Founder and CTO of Eco-Inject, a UK startup that has built a sustainable autoinjector from the ground up using 100% bio-based polymers, fewer components, and a completely rethought internal architecture.

Here's what we get into:

  • Why you can't just swap in sustainable materials and call it a day
  • How John reduced the device to five simple plastic moldings
  • Why the production line footprint is a quarter of the current standard
  • How Eco-Inject achieves a lower cost of goods and better sustainability at the same time
  • The commercial reality of selling sustainability to pharma procurement 

This episode is sponsored by Eco-Inject.


If you want to make your medical devices more sustainable, let's talk: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical

🔗 CONNECT WITH JOHN PALMER-FELGATE: https://www.linkedin.com/in/john-palmer-felgate/ 

🔗 CONNECT WITH ECO-INJECT: https://www.linkedin.com/company/eco-inject/posts/?feedView=all

🔗 CONNECT WITH US:
🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Gradical: https://gradical.ch/ 
📩 Work with us: lucas.pianegonda@gradical.ch


#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #AutoInjector #SustainableDesign #MedicalDevices #Bioplastics #DrugDelivery

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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Don't Do Ego-Design | Bart Verleije, Voxdale03 Jun 202600:56:21

"Do not do ego-design." A professor told Bart Verleije that in school, and it shaped how he has built medical devices ever since.

Bart is Commercial Director at Voxdale, a Belgian design and engineering firm, with more than 1,400 projects over 19 years. He explains how a napkin sketch becomes a certified, manufacturable device, and where most MedTech projects go wrong before they reach a patient.

In this episode:

- His BURST framework: Business, User, Regulatory, Sustainability, Technology

- Why design for manufacturability has to start on day one

- How to stop feature creep and trade off conflicting requirements

- The Ergotrics story: an inflatable system for turning and proning patients


If you develop devices, this one will change how you scope your next project.


Connect with Bart: https://www.linkedin.com/in/bartverleije/

Voxdale: https://www.voxdale.be


00:00 From a napkin sketch to a certified device

00:56 Meet Bart Verleije: 1,400+ projects, 19 years at Voxdale

01:45 Commit to your product before you build it

05:05 "Do not do ego-design"

06:42 Why every stakeholder needs at least a neutral stance

09:56 The BURST framework: Business, User, Regulatory, Sustainability, Technology

15:46 Design for manufacturability from day one

20:30 The operational cost teams overlook

23:20 A healthy take on AI in documentation

28:29 Database-first documentation and regulation as code

30:13 The conservation of misery: trading off requirements

34:04 Only five value drivers make the board

37:28 "How do you know this?" Breaking false requirements

40:11 Over-requirement is the biggest cost driver

41:33 From a highway traffic jam to proning patients

45:10 The toothpaste factory and the 20-dollar fan

48:17 Bart's advice: commit, talk to experts, stay in your lane

55:28 Closing



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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

Corporate Sustainability Made Easy with Matthew Yamatin, Thermo Fisher17 Jun 202600:56:23

How does a company with 120,000 colleagues and 500,000 products put a number on its carbon footprint and actually act on it?

Matthew Yamatin is Global Director Sustainability at Thermo Fisher Scientific. He built the corporate sustainability program from scratch after joining in 2022 and now runs it across eight business groups.

In this episode:

- The scalable method Thermo Fisher uses to calculate product carbon footprints across half a million products

- Why mass balance is the only realistic path to non-fossil plastics in a regulated industry

- How biogenic carbon accounting actually works, and where the greenwashing debate sits

- Why bio-based plastics stay tied to the oil price, and what it takes to decouple them

- How to keep a sustainability program simple enough to move


If you work in sustainability, procurement, or product development in life sciences or medtech, this gives you a model you can copy.


Connect with Matthew: https://www.linkedin.com/in/matthewyamatin/

Thermo Fisher Scientific: https://www.thermofisher.com


00:00 How a 120,000-person company tackles sustainability at scale

01:16 The shampoo aisle problem

06:21 Inside Thermo Fisher

12:43 Scope 1, 2, 3 and the GHG Protocol

15:23 PCF vs CCF

17:50 The scalable PCF method

24:21 Why mass balance is the only scalable path

30:27 Biogenic carbon explained

40:59 Why bio-based costs more

44:10 Building a program from scratch

49:33 Find your North Star KPI

55:14 Closing



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!

If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.

You can also check our Youtube Channel with lots of free trainings and resources here: Lucas R. Pianegonda - YouTube

Website: www.gradical.ch

© My Podcast Data