The Case for Engaging Regulatory Early

Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in practice.

Leland and Nick get into why risk tolerance is the thing that catches scaling companies, the hidden costs of rework beyond timeline, how regulatory input changes product decisions across geographies, and what regulators are scrutinizing more closely now.

A few of Leland's key takeaways:

• Early means concept phase, not pre-submission. Even your IP narrative can matter years later in a submission
• Companies often run more testing than they need. Efficiency means answering the right questions with the least data
• Risk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMA
• Post-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory one
• Rework isn't just timeline, it's product cost and a supply chain issue
• Biocompatibility interpretation varies by geography and can change what you develop and when
• AI, usability, and management review are all getting closer regulatory attention
• Build a scalable QMS. It's the bedrock, and it isn't an afterthought

About Leland KeytLeland Keyt is VP of Regulatory Affairs and Quality Assurance at Apreo Health, which is running a US pivotal study for an implantable airway scaffold for severe emphysema. She has over 20 years in medical devices across startups, mid-size companies, and multinationals, previously serving as Chief Product Officer at Biorithm and Senior Director of RA/QA at Pulmonx, where she navigated FDA's Breakthrough Device Program to a 178-day PMA approval.

About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/