{"podcast":{"title":"Let's Combinate - Drugs + Devices","slug":"let-s-combinate-drugs-devices-4474248","podcast_index_feed_id":4474248,"rss_url":"https://anchor.fm/s/6770b9a0/podcast/rss","website_url":"https://letscombinate.com","image_url":"https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg","author":"Subhi Saadeh","episode_count":261,"summary":"Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!","last_synced_at":"2026-09-07T22:17:41.545168+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248"},"episode":{"title":"232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk","slug":"232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibility-risk","published_at":"2026-04-01T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibility-risk","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/232---MedTech-Material-Selection-Cost--Compliance--Sustainability--and-Biocompatibility-Risk-e3h8k0t","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/117771741/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-2-31%2F421162729-44100-2-e8cef0aa5ab17.mp3","summary":"Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we’ve always used this” or rely on a molder’s preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk. Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle. The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation. ⏱️ Timestamps 00:00 Welcome and Guest Intro 00:43 Why Materials Drive Cost 02:17 Common Selection Pitfalls 03:35 Data-Driven Framework 06:10 Early Choices Prevent Rework 09:17 Processing Methods Overview 10:23 Polymer Categories Explained 12:58 Regulatory Risks and PFAS 19:26 GRAS and Prop 65 Basics 23:21 Biocompatibility Early Screening 28:55 ISO 10993 Updates 30:36 What Toxicologists Do 33:41 Where to Find Lucas 34:07 Closing Lucas Pianegonda Website: https://www.gradical.ch/ Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/ Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQ ISO 10993…","meta_description":"Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2054,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibility-risk/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibility-risk.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}