232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

Let's Combinate · 1 Apr 2026 · 34m

What this episode covers

Lucas Pianegonda, founder of Gradical, explains why medtech companies must move away from defaulting to legacy materials or molder preferences toward a structured, data-driven material selection framework. He details how early decisions on polymers like polycarbonate or PTFE impact total cost of goods, regulatory compliance, and sustainability, warning that late changes can cause multi-year delays and expensive retooling. The conversation covers the distinction between material grades and device-level biocompatibility, the risks of PFAS and additives, and the specific requirements of ISO 10993 for toxicological evaluation.

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