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  1. Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
  2. 275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1
275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders · Aug 4, 2026

From lab to clinic: CEO Eva-Maria Balet on creating a collagen implant, scaling to GMP, and navigating MedTech's regulatory landscape.

Life Science Startups Succeed by Solving a Clinical Need, Not Commercializing a Discovery

The most impactful life science ventures start with a clear, unmet clinical need and design research to solve it. This patient-centric approach provides direction and motivation, contrasting with the common model of finding an application for a recent scientific discovery.

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1 thumbnail

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·11 hours ago

A PhD in Science Provides Excellent Training for Startup Founders

The rigorous training of a scientist—learning how to learn, managing uncertainty, and iterating toward solutions—provides a powerful and directly transferable skill set for the unique challenges of building a company from the ground up.

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1 thumbnail

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·11 hours ago

MedTech's Biggest Hurdle Isn't Discovery, It's Creating a GMP-Ready Manufacturing Process

The primary challenge for many MedTech innovations is not the initial science but translating a lab process into a robust, scalable, and GMP-compliant manufacturing system. This requires a shift from proving a concept to ensuring consistent quality and patient safety.

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1 thumbnail

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·11 hours ago

MedTech Founders Must Define a Product's 'Mode of Action' to Determine its Regulatory Path

Understanding whether a product's primary function is physical (medical device) or pharmacological (drug) is a critical first step for founders. This self-classification, validated early with experts, dictates the entire regulatory framework, saving significant time and resources.

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1 thumbnail

275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders·11 hours ago