Most medtech founders want to skip straight to building their product. Veronica Kingston has spent 30 years watching that approach lead to expensive recalls, failed regulatory submissions, and collapsed acquisition deals. As Senior Director of Quality Management Systems and Design Quality Assurance at Thermo Fisher Scientific, she's worked with startups, navigated mergers and acquisitions, and remediated global compliance disasters.
In this episode, Veronica breaks down the biggest misconception about design controls (that you can retrofit them later), explains why the most expensive mistake startups make is ignoring the framework upfront, and reveals the three compliance issues that consistently require remediation. She shares practical advice on when to bring in quality and regulatory expertise, how to build teams that can navigate gray areas, and what to do when you're facing your first FDA 483.
Timestamps:
[00:00:00] Introduction to Veronica Kingston's 30-year quality career
[00:03:10] The biggest differences between small and large company quality approaches
[00:05:10] What design controls really are and why they matter
[00:09:10] The biggest misconception: that you can retrofit design controls
[00:11:00] Forgotten elements: supplier controls and design for manufacturability
[00:13:05] Essential elements needed before you start building
[00:14:55] What to say to founders who claim they're too busy for planning
[00:16:15] The value of fractional quality leadership
[00:17:50] Hiring experienced vs inexperienced talent: when and why
[00:19:50] Key skills that make someone successful in startup quality roles
[00:21:35] Building and developing quality teams
[00:23:00] Crisis management: digging out of regulatory holes
[00:25:00] The top three compliance issues requiring remediation
[00:27:15] Advice for companies facing their first FDA 483
[00:30:10] How regulatory issues impact exit strategy and acquisition
[00:31:10] Rapid fire: essential advice for medtech founders
Follow Melita and Veronica:
Connect with Melita:
LinkedIn: https://www.linkedin.com/in/melitaball
Website: https://www.mbcaconsulting.com/about-us
Connect with Veronica:
LinkedIn: https://www.linkedin.com/in/veronica-kingston-377725b7/