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

Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest.
In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she built her company around a single principle: start with a real clinical need and build backward, collaborating with clinicians from day one so every experiment serves a patient.
Highlights & Topics:
• Why starting with clinical needs—not just scientific excitement—creates meaningful real-world impact in life sciences (02:38)
• How Eva-Maria’s fascination with biotechnology guided her from cell factories to developing scaffolds for tissue repair (03:51)
• The unmet challenges in current soft tissue repair treatments and where new solutions are needed (05:51)
• What makes Regenosca’s fully-engineered collagen implant, TissueSpan, different from existing meshes and biological materials (07:09)
• The biological mechanisms behind tissue regeneration using a temporary collagen scaffold (08:28)
• Translating lab-scale research into a robust, scalable, and regulatory-compliant production process (10:34)
• The practical realities and hurdles of navigating the medical device vs. biologic regulatory pathways (11:59)
• Advice on building regulatory expertise into your founding team or leveraging consultants effectively (13:31)
• The importance of interdisciplinary teams and trust when forming biotech startups (14:36)
Smart insight: Eva-Maria put it plainly: what works in the lab has to work reliably every single time you produce it for a patient. That shift, from proving a concept to controlling a process, from raw materials through in-process controls to final product testing, is the same discipline any CMC scientist recognizes: science alone doesn't get a product to patients. Reproducibility does.
This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.
• Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome
• Episodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic
• Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer
• Episodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho
Connect with Eva-Maria Balet:
LinkedIn: linkedin.com/in/eva-maria-balet-72561737
Regenosca website: regenosca.com
Support the show (buzzsprout.com/2263581/support)