LTR 126: Adam Foresman on Proactive Compliance and Future of MedTech

Summary“Compliance can’t just be a once-per-year audit anymore. It has to be continuous, proactive, and built into the way we work every day.”In this Let’s Talk Risk! conversation, Naveen Agarwal speaks with Adam Foresman, Co-Founder and CEO of Ryden Solutions, about building the first platform for continuous compliance gap analysis in the life sciences industry. Adam shares his journey from leading quality and regulatory affairs at a diagnostic AI startup, where he managed hundreds of requirements as a department of one, to envisioning a “virtual FDA inspector” that continuously highlights QMS health and compliance gaps. The discussion explores how regulatory bodies like FDA and EU notified bodies are already deploying AI to review submissions, why trust and validation remain critical for adoption, and how companies can prepare their culture and QMS for this shift. Adam emphasizes that while AI can streamline audits, inspections, and submissions, Quality professionals must remain vigilant, collaborative, and open to continuous improvement. The message is clear: proactive compliance, powered by AI, is quickly becoming the new standard for life sciences organizations.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:08 – Introducing Adam Foresman01:00 – From Quality Leader to Startup Founder02:56– What Proactive Compliance Really Means04:23 – AI Agents for Regulatory Gap Assessments07:21 – Trust and Validation in AI Systems13:00 – Real-World Use Cases and Benefits19:06 – Preparing for an AI-Enabled Future22:16 – Standardization, Culture Shift & Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and automation tools for clinical evaluation.LTR: Contrasting US and EU approaches to AI regulation.ACHIEVE: PMS Workshop.Key Takeaways* Proactive compliance shifts QMS from periodic audits to continuous monitoring.* A “virtual FDA inspector” can highlight compliance gaps in real time.* Seamless EQMS integration is critical for adoption and user trust.* AI-driven platforms must be validated with rigorous accuracy testing.* Regulators like FDA and EU notified bodies are already using AI for submissions.* Trust in AI systems depends on transparency, validation, and human oversight.* Real-world use cases show benefits in inspections, audits, and onboarding.* False positives are manageable if systems allow human review and override.* Culture shift toward openness and continuous improvement is essential.* Quality professionals should focus on collaboration and adaptability in an AI-driven future.KeywordsProactive Compliance, Continuous Auditing, QMS, Regulatory Affairs, FDA, EU MDR, AI in Quality, Gap Analysis, EQMS Integration, Trust in AIAbout Adam ForesmanAdam Foresman is Co-Founder and CEO of Ryden Solutions, a platform that automates compliance gap analysis and audits for life science companies. He has led global quality and regulatory affairs at VideaHealth, driving approvals and compliance for AI/ML diagnostics, and held senior roles at Midmark Corporation, Dentsply, and Hollister. Adam holds engineering degrees from Purdue University, an MBA from Indiana University’s Kelley School of Business, and multiple ASQ certifications, including Six Sigma Black Belt.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe