Most medical device companies think quality systems slow them down. Kyle Rose proves the opposite is true.
Kyle Rose is the founder and president of Rook Quality Systems, a consulting firm that helps early-stage medical device companies build efficient, compliant quality management systems. With 13 years of experience and nearly 40 employees, Rook has guided companies through FDA submissions, acquisitions, and their first audits by focusing on lean processes over bureaucracy.
In this conversation, Kyle shares stories from the trenches: the software company that accidentally logged thousands of "complaints" in Zendesk, the smart pill dispenser that failed to block light properly, and the COVID diagnostics work that helped get critical products to market fast. He explains why quality systems actually help companies catch problems before they become catastrophic, how AI is changing regulatory submissions, and why more over-the-counter medical devices could transform healthcare access.
Timestamps:
[00:01:30] Introduction to Rook Quality Systems
[00:02:10] Kyle's journey from industry to consulting
[00:05:20] Professional lessons and standout moments
[00:08:05] When software companies realize they're medical devices
[00:09:15] The Zendesk complaint story
[00:13:05] Success story: acquisition and first FDA audit
[00:15:20] When companies don't buy into quality systems
[00:16:40] The FDA warning letter discussion
[00:19:00] How quality systems catch device failures
[00:19:50] The smart pill dispenser light-blocking failure
[00:24:30] How tech is changing consulting and compliance
[00:28:45] MDSAP and international standards
[00:31:15] FDA's Medical Device Development Tools program
[00:34:00] Regulatory pathways that need improvement
[00:37:10] What would help FDA reviewers most
[00:42:05] Verifying hyperscalers like AWS and Google
[00:44:35] Rapid-fire questions
Follow Shannon and Kyle:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
Connect with Kyle:
LinkedIn: https://www.linkedin.com/in/kyle-rose-rook
Website: https://rookqs.com/