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 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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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

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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 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 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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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

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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.

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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. 

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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. 

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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. 

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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.

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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.

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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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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.

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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 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.

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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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