ScaleApp Podcasts with Prof Dan Isenberg
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ScaleApp Podcasts with Prof Dan Isenberg
Episode #21 - Ketryx! - Accelerating Regulatory Compliance for Pharmas and Device Makers - CEO/co-founder, Erez Kaminski
Background / Introduction
What is the biggest bottleneck keeping the stream of drugs and devices from getting to market? R&D? Capital? Maybe, but managing regulatory compliance is right up there. Safely speeding time to market for pharmaceutical and medical device makers is huge.... IF you can pull it off. 50% of time to market is in regulatory compliance.
Enter Erez Kaminski and Ketryx. Managing AI for Amgen, Erez saw first‑hand how slow, costly, and error‑prone compliance work is for safety‑critical products. He and Jan Poschko founded Ketryx in 2021 to help regulated teams design, develop, test, and deploy by automating and validating documentation and evidence generation. With active support and financing from E14, the MIT Media Lab affiliate fund, Erez got Ketryx into the market and into customers’ workflows significantly decreasing time to market and resource inefficiency. 25 million patients covered, 2% of all FDA clearances. Backed by E14, Ubiquity Ventures, 53 Stations, Lightspeed, and Transformation Capital.
Favorite Quotes
“Move fast and break nothing.”
“Patients are dying and we’re sitting here working on paperwork.”
“First we focused on safe. Then we focused on speed. Then we focused on innovation.”
“Great people produce great things.”
“Staff for slope, not just intercept—recruit teachable high‑performers and invest in mentorship so the organization can scale.”
Key Themes
- Regulatory drag is massive: evidence packages can run to thousands of pages per version; compliance can consume ~50% of time‑to‑market.
- AI can safely generate, trace, and review compliance evidence when embedded deeply in product workflows.
- Trust is earned through delivery and measurable ROI.
- Safety first, then speed, then broader innovation.
- Talent and culture: hire exceptional, high‑IQ/EQ contributors and develop them rapidly;
Key Takeaways
- Adoption hinges on risk‑sensitive buyers; early wins with innovative leaders create momentum in conservative industries.
- Clear economic case: shorter time‑to‑market, less burnout, and higher product safety build a durable enterprise ROI story.
- Leadership, leadership, leadership.