I'm focused on launching my podcast, serving my coaching and project clients, and enjoying the days as they come. I'll be back to regular weekly-ish newsletters/blog posts in September.
Meanwhile, here are a few items that have caught my eye in the past month:
Regulatory Innovation
Scott Gottlieb, former FDA Commissioner, on regulatory innovation and AI: Congress Must Update FDA Regulations for Medical AI. Note: I wonder if Dr. Gottlieb would come back for a second term if Trump is elected? Gottlieb was lauded as one of the more successful bipartisan-supported Trump picks. In this article, he raises the specter of regulating the whole firm's approach to AI, not just a single product. This is Pre-Cert under a different name, and I support the concept. He's got one thing wrong, though. If the regulation is at the firm level, it will drastically slow M&A. (Can you imagine medtech companies harmonizing a quality system before any acquisition? It would certainly slow the path to patient access.) Instead, I hope policymakers consider Total Product Performance as a regulatory consideration. This would include quality processes, supply chain management, data provenance, anti-bias verification and validation, etc. This approach isn't far from current statutory authority and guidances on quality. But, as with cybersecurity, FDA CDRH needs more explicit authority in this area.
The 100% Private AI Multitool Do you want to trial GenAI tools on regulatory documents or private tradesecrets? I have no affiliation with this company. There are other open-source models that run on laptops. It's not all privacy-losing for GenAI and LLMs.
FDA Launches Health Care at Home Initiative to Help Advance Health Equity
Regulatory Science Tools Catalog | Center for Devices and Radiological Health
Medtech Cyber Notes
FDA issues letter supporting continuation of DMCA exemption for repair of medical devices
Vulnerability Forecasting Technical Colloquium Cardiff, Wales (UK), September 28-29, 2023
CISA Secure by Design publication Note: This doc implores US businesses and critical infrastructure stakeholders to incorporate security into every stage of product development lifecycles. I'm glad this document exists and I believe in its purpose. HOWEVER. I'd like to point out a bit of difficulty with one of its messages: "Managers should make investments that are invisible to customers." This is, by economic definition, irrational for businesses. If customers cannot perceive the investment, the investment cannot be recouped in the price and, therefore, is irrational for a business. This is one of the functions of regulation: make invisible product attributes visible/required. Lawmakers and industry policymakers need to be able to identify "invisible" product attributes and regulate them accordingly.
Personal Note
Our new dog, Cuda, is smart, observant, full of puppy energy, losing his baby teeth, showing his preferences (belly rubs over butt scritches), and is definitely toy-driven. He's fun and a lot of work.
~Shannon, the Optimistic Optimizer