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PFAS in MedTech: What You Need to Do Now! co-hosted by Swiss Medtech

PFAS are in your device. They are also in your process water, your cooling fluid, your packaging and your piping. Most medtech companies cannot say where.

This is a special episode ...hosted by Swiss Medtech, with Barbara Mettler asking the questions. Three guests, three angles on the same problem.

Prof. Dr. Martin Scheringer from ETH Zurich explains what PFAS actually are, why the carbon-fluorine bond makes them so useful and so persistent, and why the real environmental damage sits around the production plants rather than in the finished device.

Arne Jaksch, toxicologist at Jaksch LifeScience Consulting, makes the argument that will change your plan for next year: your supply chain will be interrupted long before any grace period ends. Roughly fourteen to fifteen chemical companies worldwide produce the PFAS polymers medtech relies on, and two large European suppliers have already told customers it is the last round to order.

Lucas Pianegonda from Gradical takes the practical side. How to find PFAS in a bill of materials, why supplier questionnaires come back half empty, and which applications turn out to be far easier to replace than the industry assumes.

You will also hear why replacing a PFAS in an existing product realistically takes three years, why assessing an alternative is harder than assessing the thing you already use, and what the essential use concept from the 1980s Montreal Protocol has to do with your next design review.

CHAPTERS

00:00 Why Swiss Medtech asked for this episode

02:14 One thing to do about PFAS today

05:06 What PFAS are, and why the carbon-fluorine bond matters

07:49 Lake Zug fish: why the discussion started now

08:08 Forever chemicals, and roughly 15,000 substances

09:17 Why medtech is affected more than it thinks

11:41 Patient safety versus environmental protection

12:54 The do-it-all chemicals

15:11 Where PFAS actually sit in a medical device

19:15 Polymeric versus low molecular weight, and the PFOS legacy

21:22 Do not start with supplier questionnaires. Start with a fluorine test

25:36 Will the supply chain dry out

27:28 Price jumps in multiples, not percentages

28:54 Why substitution takes about three years

32:22 Assessing alternatives, and the footprint where fluoropolymers are made

36:29 Why PTFE is hard to beat, and the catheter liner I got wrong

39:52 Essential use and non-essential use

41:25 Electronics, packaging and the waste stream

43:43 A step by step method for finding your PFAS

46:00 Where companies get stuck

47:04 The most common mistake

48:57 Regulation is coming, 2027 or 2028 does not change it

51:05 There are more solutions than you think

53:37 Essential use is fluid, not fixed

58:01 The biggest low hanging fruit

1:03:30 Do not hide behind the fact that you are medtech

1:04:18 Closing summary

This episode was hosted by Swiss Medtech. The Expert Group Sustainability and the National Regulatory Conference in October continue the discussion.

CONNECT:
Swiss Medtech https://www.swiss-medtech.ch

Barbara Mettler https://www.linkedin.com/in/barbara-mettler-a5705722/

Martin Scheringer, ETH Zurich https://www.linkedin.com/in/martin-scheringer-547b5452/

Arne Jaksch, Jaksch LifeScience Consulting https://www.jlsc.ch

ABOUT THE PODCAST:
MedTech Sustainability by Design is the show for people choosing better plastics in medical technology.

Book a free consultation: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical.

Gradical: https://www.gradical.ch

#GradicalPodcast #Sustainability #MedTech #MedicalDevicesShow More

PFAS in MedTech: What You Need to Do Now! co-hosted by Swiss Medtech

Green Claims, EmpCo and the ACT Label, With James Connelly CEO of My Green Lab

From September 2026, the EU stops accepting green claims that nobody has verified. Self-certified labels are banned. Fines run up to 4% of annual revenue. So how many sustainability claims ...in life science and medtech actually survive this?

To find out I talked to James Connelly, CEO of My Green Lab, the non-profit behind the ACT Ecolabel, the first third-party verified eco-label for laboratory products. Over 5,300 labs in 62 countries have engaged with My Green Lab certification, including 42 of the 50 largest biotech and pharma companies.

In this episode:

- How the ACT 2.0 label works: a 100-point weighted score covering everything from corporate sustainability goals to end of life, verified by an independent auditor with no on-site visit required
- What the Empowering Consumers for the Green Transition Directive actually bans, and what "verifiable" means for your own claims
- Why self-certified green leaves are now explicitly banned under EU law, and what to use instead
- The line between a defensible CO2 claim and one that gets you in regulatory trouble
- Why medical devices don't have an ACT-style label yet, and what would have to change first
- What ACT certification actually costs and how long it takes

CHAPTERS

00:00 The claim that just got banned
01:35 Welcome, James Connelly
01:37 My Green Lab vs the ACT Ecolabel
03:30 Inside the ACT 2.0 100-point score
05:43 How the certification process works
07:23 Why there is no on-site audit
09:16 Where ISCC+ and mass balance certifications fit in
10:21 Scaling to thousands of SKUs
14:33 How long certification takes, and the push to three months
15:37 What ACT certification costs
18:19 Bronze to green, and why nobody has hit green yet
21:49 Where the Digital Product Passport fits in
24:52 What the Empowering Consumers Directive actually bans
27:35 Why self-certified green leaves are now banned
32:29 How to document a defensible CO2 claim
36:06 The line between a defensible claim and a risky one
38:17 Why medical devices don't have an ACT label yet
43:22 The medtech conversations already underway
44:42 James's advice: stop analyzing, get started

CONNECT WITH JAMES CONNELLY: https://www.linkedin.com/in/james-connelly-55909024/

ABOUT THE PODCAST: MedTech Sustainability by Design is the show for people choosing better plastics in medical technology. Book a free consultation: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical

Gradical: https://www.gradical.ch
#GradicalPodcast #Sustainability #MedTech #MedicalDevicesShow More

How We Do Plastic Selection in 2 Hours With AI

Six weeks. That is what we guarantee clients for a plastic material recommendation. This video is about how we cut that down to 2 hours, and everything that broke on ...the way there.
Back in spring I recorded a podcast episode with Prof. Dr. Christian Johner on AI in medical device development, and it changed how I think about my own work. So in March we started rebuilding our GradeMatch material selection process around AI, end to end.
This is not a video about prompting an LLM better. It is about the data and the process behind it, and how you can replicate it.
In this video:
• Why "just ask AI" fails, and the three defaults that keep MedTech stuck with the wrong material
• The foundations you need before AI helps at all: polymer and medical domain expertise, a proven selection process, and trustworthy data
• What happened when we let AI scrape 155 polymer manufacturer websites: 23,000 grades in about a week, and a database full of duplicates, wrong supplier pairings and generic values
• "AI ADHD": what happens to output quality once you fill up the context window, and how we fixed it
• Where we landed: 19,700 verified grades across 97 polymer types, plus a price model with a 5.8% mean error
• A live demo of the full workflow, from client call to ranked recommendation
• Six test cases, all at expert level, and the insulin pen case where the AI caught something I missed
• Where it still breaks, and why the human expert stays in the loop
The 2-hour turnaround applies to injection-moulding grades where no supplier requests are needed.
CHAPTERS
00:00 Why this video: from 6 weeks to 2 hours
01:33 What the Christian Johner interview convinced me of
02:46 The three defaults that keep MedTech stuck
03:44 Why "just ask AI" fails
04:34 The domain expertise you need before AI helps at all
05:41 How this started: an invite to speak on AI in plastic selection
06:22 Our baseline: the GradeMatch material selection process
07:33 Where AI works immediately: data sheets and call transcripts
09:02 Mistake one: letting AI search the open internet for grades
10:20 155 manufacturers, 23,000 grades, and the data hangover
13:53 AI ADHD: what the context window does to your output
15:19 The fix: one grade at a time, and a database that says no
16:45 Where we landed: 19,700 verified grades, 97 polymer types
17:27 Modelling price, the property that is never on a data sheet
19:08 The full workflow, start to finish
21:15 Live demo: a polycarbonate recommendation in real time
22:41 The result: 6 weeks to 2 hours, and the case where AI beat me
23:43 Where this still breaks: the honest limitations
24:48 The human stays in the loop, and three rules before you automate
25:55 The GradeMatch Claude Skill, free if you book a call
26:49 Wrap-up and the Christian Johner episode

REFERENCED IN THIS EPISODE: Prof. Dr. Christian Johner's interview on AI in medical device development. Watch it here: https://www.youtube.com/watch?v=6c_0Pu8Mu7Y
FREE GRADEMATCH CLAUDE SKILL: Questionnaire, selection process and value analysis, ready to run on your own system. Book a 45-minute call and we will set it up with you: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical
ABOUT THE PODCAST: MedTech Sustainability by Design is the show for people choosing better plastics in medical technology. Hosted by Lucas Pianegonda, who has helped more than 40 MedTech companies choose the right plastic for their application.
Gradical: https://www.gradical.ch
#GradicalPodcast #MedTech #AI #MaterialSelection #MedicalDevices #SustainabilityShow More

Microextrusion: Better Catheters With Less Waste

Why are most catheters still built by hand, glued and heat-shrunk together, when the whole thing could come off one line as a single continuous part?

Simone Maccagnan is Business Development ...Manager at Gimac International, the family company his father Giorgio founded in 1983. For over 40 years Gimac has built precision microextrusion and co-extrusion machines for medical tubing.

Most minimally invasive devices are still assembled by hand: a mandrel, a hand-tied liner, braiding, a heat-shrink outer layer and a glued soft tip. It is slow, wasteful and hard to validate. Microextrusion offers a different route, and in this episode Simone makes the case for it.

You will learn how a single tube can change stiffness along its length, why controlling molecular weight and crystallinity decides whether a thin-wall tube is safe, and how inline measurement can cut revalidation and scrap. We also cover the honest limits: fluoropolymers, PFAS, and where automation helps versus where the artisan still wins.

CHAPTERS

00:00 Why are we still gluing catheters?

01:37 What Gimac builds, and 45 years of medical extrusion

02:57 Extrusion is not the simple cousin of injection molding

05:44 Multilumen tubing and controlling geometry along the length

07:22 Dynamic extrusion: soft tip, stiff shaft, one continuous part

10:50 How catheters are still made by hand today

12:33 Understand the polymer first, then automate

16:51 "We have always done it this way" kills innovation

19:06 Process analytical technology and inline spectrometry

23:58 Fewer revalidations, better quality control

25:19 Continuous production and near-shoring

29:27 The cost case: Damian Carr's factor of four

31:34 Waste, automation and the human-machine balance

37:41 Fluoropolymers and PFAS: use them where they earn it

44:01 Augmented intelligence, not artificial intelligence

52:23 Simone's advice: stay curious, challenge the process

This episode was sponsored by Gimac.

GET IN TOUCH WITH GIMAC: https://www.gimac.com

ABOUT THE PODCAST: MedTech Sustainability by Design is the show for people choosing better plastics in medical technology. Book a free consultation: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical . Gradical: https://www.gradical.ch

#GradicalPodcast #Sustainability #MedTech #MedicalDevicesShow More

The Sustainable Plastic That's Actually CHEAPER Than Fossil Fuels

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 Braun 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

*CHAPTERS:*
00:00 – Introduction
01:30 – How Pillar Ltd works and why it's the opposite of a startup
07:00 – Spin-offs and how new companies get created
10:00 – PlasticBack: chemical recycling of PVC under 100°C
16:00 – LCA and price competitiveness
20:00 – Snow Polymers: bio-based plastic at oil prices
27:00 – Applications and target markets 33:00 – Inteligels: the bandage that washes off
42:00 – FDA clearance and regulatory path
48:00 – Alex's personal story and what drives him
52:00 – Final advice for startups

🔗 *CONNECT WITH ALEX BRAUN:*
🔗 *CONNECT WITH Pillar Ltd:* https://www.pillar-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

#MedTechSustainabilityByDesignPodcast #GradicalPodcast #SustainablePlastics #Bioplastics #ChemicalRecycling #PVC #WoundCare #DeepTech #MaterialScienceShow More

The Autoinjector Redesigned: Less Plastic, Lower Cost, Same Safety | John Palmer-Felgate

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

*CHAPTERS: *
00:00 – Introduction
01:19 – John's background and what elegant design actually means
02:46 – Why patients drove single-use devices
05:31 – The design principles behind Eco-Inject
10:15 – Results: component count, cost, and sustainability
13:00 – The procurement problem
14:54 – Who will drive adoption?
23:55 – Bioplastics and the education gap
26:38 – NHS, ESG targets, and the regulatory push
32:11 – The startup story
40:44 – What's coming next
41:25 – Final advice

🔗 *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 #DrugDeliveryShow More

CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement | Georg Digel

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

*CHAPTERS:*
00:00 – Introduction
01:00 – What is CAPA and why does it matter?
05:45 – When to open a CAPA vs. when not to
09:45 – What auditors actually find
11:56 – Corrective vs. preventive action
12:14 – Risk management and CAPA
20:35 – Hiring for quality mindset
24:00 – Change management and why "if it's compliant, don't fix it" kills improvement
25:11 – How to simplify your processes
28:38 – NC vs. CAPA: combined or separate?
33:57 – Making things actually get done
39:55 – Big company vs. small company
43:05 – Final advice

🔗 *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 #ComplianceShow More

Remanufacturing Single-Use Medical Devices | Ulrike Marczak, CEO at Vanguard

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

*CHAPTERS:*
00:00 - Introduction
01:00 - What does Vanguard actually do?
04:00 - Remanufacturing vs. reprocessing
06:00 - The economic case for hospitals
08:00 - Which devices make sense to remanufacture
13:00 - How the business model works
17:00 - Is it actually safe?
20:00 - Post-market surveillance and regulation
24:00 - How Vanguard sometimes finds issues the OEM missed
25:00 - Working with OEMs
30:00 - Design and material decisions that matter
33:00 - Electronics, hybrid devices, and complexity
36:00 - Ulrike's path to becoming CEO
42:00 - Final advice for the industry

🔗 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 #HealthcareInnovationShow More

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