"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.

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.

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.