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.

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.

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.

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.

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.

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.