232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
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 Overview: https://www.iso.org/standard/68936.html
California Prop 65: https://www.p65warnings.ca.gov/
GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-gras
Lucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development.
Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.