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.

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.

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.