{"id":613,"date":"2026-02-11T15:13:15","date_gmt":"2026-02-11T15:13:15","guid":{"rendered":"https:\/\/gradical.ch\/youtube\/"},"modified":"2026-04-16T16:40:15","modified_gmt":"2026-04-16T16:40:15","slug":"youtube","status":"publish","type":"page","link":"https:\/\/gradical.ch\/en\/youtube\/","title":{"rendered":"YouTube"},"content":{"rendered":"\t\t
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\n <\/ayg-player> \n <\/div>\n
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PFAS in MedTech: What You Need to Do Now! co-hosted by Swiss Medtech<\/h2> \n \n 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.
\n
\nThis is a special episode ...<\/span><\/span>hosted by Swiss Medtech, with Barbara Mettler asking the questions. Three guests, three angles on the same problem.
\n
\nProf. 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.
\n
\nArne 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.
\n
\nLucas 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.
\n
\nYou 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.
\n
\nCHAPTERS
\n
\n00:00 Why Swiss Medtech asked for this episode
\n
\n02:14 One thing to do about PFAS today
\n
\n05:06 What PFAS are, and why the carbon-fluorine bond matters
\n
\n07:49 Lake Zug fish: why the discussion started now
\n
\n08:08 Forever chemicals, and roughly 15,000 substances
\n
\n09:17 Why medtech is affected more than it thinks
\n
\n11:41 Patient safety versus environmental protection
\n
\n12:54 The do-it-all chemicals
\n
\n15:11 Where PFAS actually sit in a medical device
\n
\n19:15 Polymeric versus low molecular weight, and the PFOS legacy
\n
\n21:22 Do not start with supplier questionnaires. Start with a fluorine test
\n
\n25:36 Will the supply chain dry out
\n
\n27:28 Price jumps in multiples, not percentages
\n
\n28:54 Why substitution takes about three years
\n
\n32:22 Assessing alternatives, and the footprint where fluoropolymers are made
\n
\n36:29 Why PTFE is hard to beat, and the catheter liner I got wrong
\n
\n39:52 Essential use and non-essential use
\n
\n41:25 Electronics, packaging and the waste stream
\n
\n43:43 A step by step method for finding your PFAS
\n
\n46:00 Where companies get stuck
\n
\n47:04 The most common mistake
\n
\n48:57 Regulation is coming, 2027 or 2028 does not change it
\n
\n51:05 There are more solutions than you think
\n
\n53:37 Essential use is fluid, not fixed
\n
\n58:01 The biggest low hanging fruit
\n
\n1:03:30 Do not hide behind the fact that you are medtech
\n
\n1:04:18 Closing summary
\n
\nThis episode was hosted by Swiss Medtech. The Expert Group Sustainability and the National Regulatory Conference in October continue the discussion.
\n
\nCONNECT:
\nSwiss Medtech https:\/\/www.swiss-medtech.ch<\/a>
\n
\nBarbara Mettler https:\/\/www.linkedin.com\/in\/barbara-mettler-a5705722\/<\/a>
\n
\nMartin Scheringer, ETH Zurich https:\/\/www.linkedin.com\/in\/martin-scheringer-547b5452\/<\/a>
\n
\nArne Jaksch, Jaksch LifeScience Consulting https:\/\/www.jlsc.ch<\/a>
\n
\nABOUT THE PODCAST:
\nMedTech Sustainability by Design is the show for people choosing better plastics in medical technology.
\n
\nBook a free consultation: https:\/\/calendly.com\/lucas-pianegonda-gradical\/discovery-call-gradical<\/a>.
\n
\nGradical: https:\/\/www.gradical.ch<\/a>
\n
\n#GradicalPodcast #Sustainability #MedTech #MedicalDevices<\/span>Show More<\/a><\/ayg-description>\n <\/div>\n <\/div>\n
\n
\n
\n
\n \"PFAS
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
PFAS in MedTech: What You Need to Do Now! co-hosted by Swiss Medtech<\/div>\n \n \n
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.
\n
\nThis is a special episode ...<\/span><\/span>hosted by Swiss Medtech, with Barbara Mettler asking the questions. Three guests, three angles on the same problem.
\n
\nProf. 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.
\n
\nArne 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.
\n
\nLucas 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.
\n
\nYou 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.
\n
\nCHAPTERS
\n
\n00:00 Why Swiss Medtech asked for this episode
\n
\n02:14 One thing to do about PFAS today
\n
\n05:06 What PFAS are, and why the carbon-fluorine bond matters
\n
\n07:49 Lake Zug fish: why the discussion started now
\n
\n08:08 Forever chemicals, and roughly 15,000 substances
\n
\n09:17 Why medtech is affected more than it thinks
\n
\n11:41 Patient safety versus environmental protection
\n
\n12:54 The do-it-all chemicals
\n
\n15:11 Where PFAS actually sit in a medical device
\n
\n19:15 Polymeric versus low molecular weight, and the PFOS legacy
\n
\n21:22 Do not start with supplier questionnaires. Start with a fluorine test
\n
\n25:36 Will the supply chain dry out
\n
\n27:28 Price jumps in multiples, not percentages
\n
\n28:54 Why substitution takes about three years
\n
\n32:22 Assessing alternatives, and the footprint where fluoropolymers are made
\n
\n36:29 Why PTFE is hard to beat, and the catheter liner I got wrong
\n
\n39:52 Essential use and non-essential use
\n
\n41:25 Electronics, packaging and the waste stream
\n
\n43:43 A step by step method for finding your PFAS
\n
\n46:00 Where companies get stuck
\n
\n47:04 The most common mistake
\n
\n48:57 Regulation is coming, 2027 or 2028 does not change it
\n
\n51:05 There are more solutions than you think
\n
\n53:37 Essential use is fluid, not fixed
\n
\n58:01 The biggest low hanging fruit
\n
\n1:03:30 Do not hide behind the fact that you are medtech
\n
\n1:04:18 Closing summary
\n
\nThis episode was hosted by Swiss Medtech. The Expert Group Sustainability and the National Regulatory Conference in October continue the discussion.
\n
\nCONNECT:
\nSwiss Medtech https:\/\/www.swiss-medtech.ch<\/a>
\n
\nBarbara Mettler https:\/\/www.linkedin.com\/in\/barbara-mettler-a5705722\/<\/a>
\n
\nMartin Scheringer, ETH Zurich https:\/\/www.linkedin.com\/in\/martin-scheringer-547b5452\/<\/a>
\n
\nArne Jaksch, Jaksch LifeScience Consulting https:\/\/www.jlsc.ch<\/a>
\n
\nABOUT THE PODCAST:
\nMedTech Sustainability by Design is the show for people choosing better plastics in medical technology.
\n
\nBook a free consultation: https:\/\/calendly.com\/lucas-pianegonda-gradical\/discovery-call-gradical<\/a>.
\n
\nGradical: https:\/\/www.gradical.ch<\/a>
\n
\n#GradicalPodcast #Sustainability #MedTech #MedicalDevices<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"Green
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
Green Claims, EmpCo and the ACT Label, With James Connelly CEO of My Green Lab<\/div>\n \n \n
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 ...<\/span><\/span>in life science and medtech actually survive this?
\n
\nTo 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.
\n
\nIn this episode:
\n
\n- 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
\n- What the Empowering Consumers for the Green Transition Directive actually bans, and what \"verifiable\" means for your own claims
\n- Why self-certified green leaves are now explicitly banned under EU law, and what to use instead
\n- The line between a defensible CO2 claim and one that gets you in regulatory trouble
\n- Why medical devices don't have an ACT-style label yet, and what would have to change first
\n- What ACT certification actually costs and how long it takes
\n
\nCHAPTERS
\n
\n00:00 The claim that just got banned
\n01:35 Welcome, James Connelly
\n01:37 My Green Lab vs the ACT Ecolabel
\n03:30 Inside the ACT 2.0 100-point score
\n05:43 How the certification process works
\n07:23 Why there is no on-site audit
\n09:16 Where ISCC+ and mass balance certifications fit in
\n10:21 Scaling to thousands of SKUs
\n14:33 How long certification takes, and the push to three months
\n15:37 What ACT certification costs
\n18:19 Bronze to green, and why nobody has hit green yet
\n21:49 Where the Digital Product Passport fits in
\n24:52 What the Empowering Consumers Directive actually bans
\n27:35 Why self-certified green leaves are now banned
\n32:29 How to document a defensible CO2 claim
\n36:06 The line between a defensible claim and a risky one
\n38:17 Why medical devices don't have an ACT label yet
\n43:22 The medtech conversations already underway
\n44:42 James's advice: stop analyzing, get started
\n
\nCONNECT WITH JAMES CONNELLY: https:\/\/www.linkedin.com\/in\/james-connelly-55909024\/<\/a>
\n
\nABOUT 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<\/a>
\n
\nGradical: https:\/\/www.gradical.ch<\/a>
\n#GradicalPodcast #Sustainability #MedTech #MedicalDevices<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"How
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
How We Do Plastic Selection in 2 Hours With AI<\/div>\n \n \n
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 ...<\/span><\/span>the way there.
\nBack 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.
\nThis 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.
\nIn this video:
\n\u2022 Why \"just ask AI\" fails, and the three defaults that keep MedTech stuck with the wrong material
\n\u2022 The foundations you need before AI helps at all: polymer and medical domain expertise, a proven selection process, and trustworthy data
\n\u2022 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
\n\u2022 \"AI ADHD\": what happens to output quality once you fill up the context window, and how we fixed it
\n\u2022 Where we landed: 19,700 verified grades across 97 polymer types, plus a price model with a 5.8% mean error
\n\u2022 A live demo of the full workflow, from client call to ranked recommendation
\n\u2022 Six test cases, all at expert level, and the insulin pen case where the AI caught something I missed
\n\u2022 Where it still breaks, and why the human expert stays in the loop
\nThe 2-hour turnaround applies to injection-moulding grades where no supplier requests are needed.
\nCHAPTERS
\n00:00 Why this video: from 6 weeks to 2 hours
\n01:33 What the Christian Johner interview convinced me of
\n02:46 The three defaults that keep MedTech stuck
\n03:44 Why \"just ask AI\" fails
\n04:34 The domain expertise you need before AI helps at all
\n05:41 How this started: an invite to speak on AI in plastic selection
\n06:22 Our baseline: the GradeMatch material selection process
\n07:33 Where AI works immediately: data sheets and call transcripts
\n09:02 Mistake one: letting AI search the open internet for grades
\n10:20 155 manufacturers, 23,000 grades, and the data hangover
\n13:53 AI ADHD: what the context window does to your output
\n15:19 The fix: one grade at a time, and a database that says no
\n16:45 Where we landed: 19,700 verified grades, 97 polymer types
\n17:27 Modelling price, the property that is never on a data sheet
\n19:08 The full workflow, start to finish
\n21:15 Live demo: a polycarbonate recommendation in real time
\n22:41 The result: 6 weeks to 2 hours, and the case where AI beat me
\n23:43 Where this still breaks: the honest limitations
\n24:48 The human stays in the loop, and three rules before you automate
\n25:55 The GradeMatch Claude Skill, free if you book a call
\n26:49 Wrap-up and the Christian Johner episode
\n
\nREFERENCED 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<\/a>
\nFREE 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<\/a>
\nABOUT 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.
\nGradical: https:\/\/www.gradical.ch<\/a>
\n#GradicalPodcast #MedTech #AI #MaterialSelection #MedicalDevices #Sustainability<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"Microextrusion:
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
Microextrusion: Better Catheters With Less Waste<\/div>\n \n \n
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?
\n
\nSimone Maccagnan is Business Development ...<\/span><\/span>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.
\n
\nMost 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.
\n
\nYou 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.
\n
\nCHAPTERS
\n
\n00:00 Why are we still gluing catheters?
\n
\n01:37 What Gimac builds, and 45 years of medical extrusion
\n
\n02:57 Extrusion is not the simple cousin of injection molding
\n
\n05:44 Multilumen tubing and controlling geometry along the length
\n
\n07:22 Dynamic extrusion: soft tip, stiff shaft, one continuous part
\n
\n10:50 How catheters are still made by hand today
\n
\n12:33 Understand the polymer first, then automate
\n
\n16:51 \"We have always done it this way\" kills innovation
\n
\n19:06 Process analytical technology and inline spectrometry
\n
\n23:58 Fewer revalidations, better quality control
\n
\n25:19 Continuous production and near-shoring
\n
\n29:27 The cost case: Damian Carr's factor of four
\n
\n31:34 Waste, automation and the human-machine balance
\n
\n37:41 Fluoropolymers and PFAS: use them where they earn it
\n
\n44:01 Augmented intelligence, not artificial intelligence
\n
\n52:23 Simone's advice: stay curious, challenge the process
\n
\nThis episode was sponsored by Gimac.
\n
\nGET IN TOUCH WITH GIMAC: https:\/\/www.gimac.com<\/a>
\n
\nABOUT 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<\/a> . Gradical: https:\/\/www.gradical.ch<\/a>
\n
\n#GradicalPodcast #Sustainability #MedTech #MedicalDevices<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"The
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
The Sustainable Plastic That's Actually CHEAPER Than Fossil Fuels<\/div>\n \n \n
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.
\n
\nAlex Braun is the Chairman of ...<\/span><\/span>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.
\n
\n*Here's what we get into:*
\n\ud83d\udf84 Why most sustainable plastics fail commercially before they ever reach the market
\n\ud83d\udf84 How Snow Polymers makes bio-based plastic price-competitive with fossil fuels using industrial waste as feedstock
\n\ud83d\udf84 Why PVC is the fourth-largest plastic produced but the last to be recycled, and what PlasticBack does about it
\n\ud83d\udf84 How Inteligels eliminates the most painful procedure in hospitals
\n\ud83d\udf84 The R&D model that lets Pillar Ltd take risks that neither startups nor corporates can
\n
\n*This episode is sponsored by Pillar Ltd.*
\n
\n*If you want to make your products more sustainable, let's talk:* https:\/\/calendly.com\/lucas-pianegonda-gradical\/discovery-call-gradical<\/a>
\n
\n*CHAPTERS:*
\n00:00 \u2013 Introduction
\n01:30 \u2013 How Pillar Ltd works and why it's the opposite of a startup
\n07:00 \u2013 Spin-offs and how new companies get created
\n10:00 \u2013 PlasticBack: chemical recycling of PVC under 100\u00b0C
\n16:00 \u2013 LCA and price competitiveness
\n20:00 \u2013 Snow Polymers: bio-based plastic at oil prices
\n27:00 \u2013 Applications and target markets 33:00 \u2013 Inteligels: the bandage that washes off
\n42:00 \u2013 FDA clearance and regulatory path
\n48:00 \u2013 Alex's personal story and what drives him
\n52:00 \u2013 Final advice for startups
\n
\n\ud83d\udd17 *CONNECT WITH ALEX BRAUN:*
\n\ud83d\udd17 *CONNECT WITH Pillar Ltd:* https:\/\/www.pillar-ltd.com\/about-us<\/a>
\n
\n\ud83d\udd17 *CONNECT WITH US:*
\n\ud83c\udfa7 Apple Podcasts \u2013 https:\/\/podcasts.apple.com\/us\/podcast\/gradical-podcast-the-podcast-about-plastics-in\/id1773569554<\/a>
\n\ud83d\udfe2 Spotify \u2013 https:\/\/open.spotify.com\/show\/4vNQ6rPE2CQUGgQtEY3sYq<\/a>
\n\ud83d\udcfa YouTube \u2013 https:\/\/www.youtube.com\/@GradicalGmbH<\/a>
\n\ud83c\udf0d Gradical: https:\/\/gradical.ch\/<\/a>
\n\ud83d\udce9 Work with us: lucas.pianegonda@gradical.ch<\/a>
\n
\n
\n#MedTechSustainabilityByDesignPodcast #GradicalPodcast #SustainablePlastics #Bioplastics #ChemicalRecycling #PVC #WoundCare #DeepTech #MaterialScience<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"The
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
The Autoinjector Redesigned: Less Plastic, Lower Cost, Same Safety | John Palmer-Felgate<\/div>\n \n \n
Over a billion autoinjectors are used every year. Almost all of them are single-use. Almost all of that plastic gets incinerated.
\n
\nJohn Palmer-Felgate spent 30 years designing medical devices. At some ...<\/span><\/span>point, he decided to actually fix the problem.
\n
\nJohn 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.
\n
\n*Here's what we get into:*
\n\ud83d\udf84 Why you can't just swap in sustainable materials and call it a day
\n\ud83d\udf84 How John reduced the device to five simple plastic moldings
\n\ud83d\udf84 Why the production line footprint is a quarter of the current standard
\n\ud83d\udf84 How Eco-Inject achieves a lower cost of goods and better sustainability at the same time
\n\ud83d\udf84 The commercial reality of selling sustainability to pharma procurement
\n
\n*This episode is sponsored by Eco-Inject.*
\n
\n*If you want to make your medical devices more sustainable, let's talk:* https:\/\/calendly.com\/lucas-pianegonda-gradical\/discovery-call-gradical<\/a>
\n
\n*CHAPTERS: *
\n00:00 \u2013 Introduction
\n01:19 \u2013 John's background and what elegant design actually means
\n02:46 \u2013 Why patients drove single-use devices
\n05:31 \u2013 The design principles behind Eco-Inject
\n10:15 \u2013 Results: component count, cost, and sustainability
\n13:00 \u2013 The procurement problem
\n14:54 \u2013 Who will drive adoption?
\n23:55 \u2013 Bioplastics and the education gap
\n26:38 \u2013 NHS, ESG targets, and the regulatory push
\n32:11 \u2013 The startup story
\n40:44 \u2013 What's coming next
\n41:25 \u2013 Final advice
\n
\n\ud83d\udd17 *CONNECT WITH JOHN PALMER-FELGATE:* https:\/\/www.linkedin.com\/in\/john-palmer-felgate\/<\/a>
\n\ud83d\udd17 *CONNECT WITH ECO-INJECT:* https:\/\/www.linkedin.com\/company\/eco-inject\/posts\/?feedView=all<\/a>
\n
\n\ud83d\udd17 *CONNECT WITH US:*
\n\ud83c\udfa7 Apple Podcasts \u2013 https:\/\/podcasts.apple.com\/us\/podcast\/gradical-podcast-the-podcast-about-plastics-in\/id1773569554<\/a>
\n\ud83d\udfe2 Spotify \u2013 https:\/\/open.spotify.com\/show\/4vNQ6rPE2CQUGgQtEY3sYq<\/a>
\n\ud83d\udcfa YouTube \u2013 https:\/\/www.youtube.com\/@GradicalGmbH<\/a>
\n\ud83c\udf0d Gradical: https:\/\/gradical.ch\/<\/a>
\n\ud83d\udce9 Work with us: lucas.pianegonda@gradical.ch<\/a>
\n
\n
\n#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #AutoInjector #SustainableDesign #MedicalDevices #Bioplastics #DrugDelivery<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
\n
\n
\n \"CAPA
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement | Georg Digel<\/div>\n \n \n
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 ...<\/span><\/span>happens when that's the only goal\u2026 and it's not pretty.
\n
\nGeorg 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.
\n
\n*Here's what we get into:*
\n\ud83d\udf84 Why CAPA is one of the most misunderstood processes in medical technology
\n\ud83d\udf84 The difference between a non-conformity and a CAPA
\n\ud83d\udf84 What auditors actually find when they inspect CAPA systems
\n\ud83d\udf84 Why \"death by CAPA\" happens and how to avoid it
\n\ud83d\udf84 How management culture makes or breaks the whole thing
\n\ud83d\udf84 What a lean, functional CAPA process looks like in practice
\n
\n*CHAPTERS:*
\n00:00 \u2013 Introduction
\n01:00 \u2013 What is CAPA and why does it matter?
\n05:45 \u2013 When to open a CAPA vs. when not to
\n09:45 \u2013 What auditors actually find
\n11:56 \u2013 Corrective vs. preventive action
\n12:14 \u2013 Risk management and CAPA
\n20:35 \u2013 Hiring for quality mindset
\n24:00 \u2013 Change management and why \"if it's compliant, don't fix it\" kills improvement
\n25:11 \u2013 How to simplify your processes
\n28:38 \u2013 NC vs. CAPA: combined or separate?
\n33:57 \u2013 Making things actually get done
\n39:55 \u2013 Big company vs. small company
\n43:05 \u2013 Final advice
\n
\n\ud83d\udd17 *CONNECT WITH GEORG DIGEL:* https:\/\/www.linkedin.com\/in\/georgdigel\/?locale=de<\/a>
\n
\n\ud83d\udd17 *CONNECT WITH US:*
\n\ud83c\udfa7 Apple Podcasts \u2013 https:\/\/podcasts.apple.com\/us\/podcast\/gradical-podcast-the-podcast-about-plastics-in\/id1773569554<\/a>
\n\ud83d\udfe2 Spotify \u2013 https:\/\/open.spotify.com\/show\/4vNQ6rPE2CQUGgQtEY3sYq<\/a>
\n\ud83d\udcfa YouTube \u2013 https:\/\/www.youtube.com\/@GradicalGmbH<\/a>
\n\ud83c\udf0d Gradical: https:\/\/gradical.ch\/<\/a>
\n\ud83d\udce9 Work with us: lucas.pianegonda@gradical.ch<\/a>
\n
\n
\n#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #CAPA #QualityManagement #MedicalDevices #ContinuousImprovement #QMS #Compliance<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n
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\n
\n \"Remanufacturing
Now Playing<\/div><\/svg> \n <\/div>\n
\n \n
Remanufacturing Single-Use Medical Devices | Ulrike Marczak, CEO at Vanguard<\/div>\n \n \n
This episode is brought to you by Vanguard, a company specializing in remanufacturing single-use medical devices to as-good-as-new condition.
\n
\nA device labeled \"single-use\" gets thrown away after one patient. That makes ...<\/span><\/span>sense for a syringe. It makes a lot less sense for a cardiac catheter that costs thousands of euros.
\n
\nUlrike 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.
\n
\n*Here's what we get into:*
\n\ud83d\udf84 The difference between reprocessing and remanufacturing
\n\ud83d\udf84 Why remanufacturing makes sense economically, ecologically, and operationally for certain devices
\n\ud83d\udf84 How Vanguard tests every single device 100%
\n\ud83d\udf84 Which devices are good candidates, and where the business case breaks down
\n\ud83d\udf84 What OEM manufacturers should be thinking about when they design for the future
\n
\nIf you want to make your medical devices more sustainable, let's talk: https:\/\/calendly.com\/lucas-pianegonda-gradical\/discovery-call-gradical<\/a>
\n
\n*CHAPTERS:*
\n00:00 - Introduction
\n01:00 - What does Vanguard actually do?
\n04:00 - Remanufacturing vs. reprocessing
\n06:00 - The economic case for hospitals
\n08:00 - Which devices make sense to remanufacture
\n13:00 - How the business model works
\n17:00 - Is it actually safe?
\n20:00 - Post-market surveillance and regulation
\n24:00 - How Vanguard sometimes finds issues the OEM missed
\n25:00 - Working with OEMs
\n30:00 - Design and material decisions that matter
\n33:00 - Electronics, hybrid devices, and complexity
\n36:00 - Ulrike's path to becoming CEO
\n42:00 - Final advice for the industry
\n
\n\ud83d\udd17 CONNECT WITH ULRIKE MARCZAK:
\nVanguard: https:\/\/www.vanguard.de\/vanguard-ag\/<\/a>
\nLinkedIn: https:\/\/www.linkedin.com\/in\/ulrike-marczak-138045115\/<\/a>
\n
\n\ud83d\udd17 CONNECT WITH US:
\n\ud83c\udfa7 Apple Podcasts \u2013 https:\/\/podcasts.apple.com\/us\/podcast\/gradical-podcast-the-podcast-about-plastics-in\/id1773569554<\/a>
\n\ud83d\udfe2 Spotify \u2013 https:\/\/open.spotify.com\/show\/4vNQ6rPE2CQUGgQtEY3sYq<\/a>
\n\ud83d\udcfa YouTube \u2013 https:\/\/www.youtube.com\/@GradicalGmbH<\/a>
\n\ud83c\udf0d Gradical: https:\/\/gradical.ch\/<\/a>
\n\ud83d\udce9 Work with us: lucas.pianegonda@gradical.ch<\/a>
\n
\n
\n#MedtechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #CircularEconomy #SingleUse #Remanufacturing #MedicalDevices #Sustainability #HealthcareInnovation<\/span>Show More<\/a><\/div>\n <\/div> \n<\/div> <\/div>\n <\/div>\n \n
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