Gradical Podcast - The Podcast about Plastics in Medical Technology

Lucas Pianegonda
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Gradical is the plastics expert for medical technology. We help medical technology companies to select the right plastic for their application. This takes into account technical suitability, regulatory requirements and sustainability aspects. The Gradical podcast covers all topics relating to plastics in medical technology. Sustainability, sterilization, the medical grade concept, biocompatibility and many other topics await you in this podcast. The host Lucas Pianegonda is a plastics expert for medical technology and asks the guest experts the right questions. For more information on gradical and it's services visit www.gradical.chRecommended Reading "Plastics in Medical Device": https://amzn.to/4gVldHf

  1. How to Build a Medical Device That Actually Sells with Lisa Voronkova, CEO of OVA Solutions

    1D AGO

    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 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.

    47 min
  2. How AI Can 10x Medical Device Development with Prof. Dr. Christian Johner

    MAR 11

    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 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.

    45 min
  3. Why Sustainability and Compliance Are Becoming the Same Thing with Julian Lotz, BIOVOX

    MAR 5

    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 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.

    54 min
  4. The Real Cost of Medical Waste (And Why Hospitals Are Changing Their Approach) with Andy Marshall

    FEB 11

    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 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.

    42 min
  5. How Do You Know Your Medical Device Material Will Pass Biocompatibility Testing? with Marina Daineko

    JAN 28

    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 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.

    1 hr
  6. Can Chemical Recycling Solve MedTech's Sustainability Crisis? with Reinier Grimbergen

    JAN 21

    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 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.

    53 min
  7. How to Innovate Faster in MedTech: Solving the Speed-to-Market Problem with Spencer Jones

    JAN 7

    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 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.

    1h 1m
  8. How Do You Choose The Right Sterilization Method For Your Device? with Manuel Grandy

    12/31/2025

    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 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.

    43 min
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About

Gradical is the plastics expert for medical technology. We help medical technology companies to select the right plastic for their application. This takes into account technical suitability, regulatory requirements and sustainability aspects. The Gradical podcast covers all topics relating to plastics in medical technology. Sustainability, sterilization, the medical grade concept, biocompatibility and many other topics await you in this podcast. The host Lucas Pianegonda is a plastics expert for medical technology and asks the guest experts the right questions. For more information on gradical and it's services visit www.gradical.chRecommended Reading "Plastics in Medical Device": https://amzn.to/4gVldHf

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