MedTech Leading Voice newsletter, issue 167
The AI Infrastructure Question MedTech Hasn't Answered Yet
MedTech Leading Voice — Issue 167
📝 From the Editor
Back from Boston and still thinking about IMSC26. I spent the week talking with risk experts, regulators, and engineers, and one theme kept surfacing: the people who manage risk for a living are often the least visible. More on that below in the Postscript.
This week, the regulatory conversation continues its shift from AI capability to AI infrastructure and governance. The European Commission's proposed Cloud and AI Development Act raises a question MedTech teams will need to answer soon: where does your AI actually run, and who controls it?
Look for the article on Dr. Michelle Tarver's CDRH presentation, coming this week.
— Sean Smith
🧠 Featured Post
The Cloud and AI Development Act: Sovereignty Enters the AI Infrastructure Conversation
Danny Van Roijen detailed the European Commission's proposed Cloud and AI Development Act and its cloud sovereignty framework for AI infrastructure providers.
The proposal addresses where and how AI infrastructure is hosted, introducing sovereignty requirements for cloud providers supporting AI systems. For MedTech teams building or deploying AI-enabled devices, this raises practical questions about infrastructure dependencies, data residency, and the regulatory expectations attached to the cloud environments their systems rely on. As AI governance moves from discussion to oversight, the infrastructure layer is becoming part of the compliance conversation.
📌 This Week's Top Posts (In no special order)
- Christian Rosenzweig defined independence requirements for medical device penetration testing and the role of internal versus external testers.
- A 4-level Claude framework for progressing from basic prompting to AI-powered systems and agents was outlined by Chris Donnelly.
- Antiksha Joshi discussed hidden organizational factors that contribute to recurring data integrity findings in life sciences organizations.
- Beat Keller simplified US medical device classification using two FDA databases to determine device class and regulatory pathway.
- A tutorial on searching FDA 510(k) medical device clearances, predicates, and manufacturers was shared by 510k Database.
- Raymond Kelly summarized the FDA’s updated human factors guidance and its implications for 510(k) submission strategies.
- Early QMSR inspection trends and the FDA’s increased focus on risk-based quality system requirements, overviewed by Vanessa Rivel.
- In his latest article, Ayub Yancheshmeh explored industrial safety principles and medical device risk management through the lens of IEC 60601-1 and ISO 14971.
- Nedal Abusharkh highlighted the importance of early safety and regulatory planning in bringing medical devices to market.
- The growing regulatory and business risks of ethical sourcing within medical device supply chains were underlined by Farida Ali.
- Danny Van Roijen detailed the European Commission’s proposed Cloud and AI Development Act and its cloud sovereignty framework for AI infrastructure providers.
- Barbara Pirola reviewed emerging risk, governance, and validation challenges associated with autonomous agentic AI systems.
- Kiran Kumar Prabu broke down why MedTech audits stall over risk-management culture rather than technology.
🎯 Featured Event
User-Critical Packaging: 7 Decisions That Make or Break Your MedTech Launch
MedTech Leading Voice and ClariMed present a live session with Canyon Labs on Wednesday, June 17 at 11:00 AM ET, featuring Kelley Kendle (CEO & Chair, ClariMed), Jenny Collinson (Director of Human Factors Strategy & Advisory, ClariMed), Sarah Rosenblum Ptach (President & CEO, Canyon Labs), and Connor Francek (Packaging & Sterilization Engineer, Canyon Labs).
Packaging is now a patient-safety user interface, and ISO 11607 Section 7 has made aseptic presentation usability mandatory. Submissions lacking packaging usability data increasingly draw requests for additional information from regulators. The session covers seven packaging decisions every team has to make and how to integrate packaging and human factors work across the lifecycle — especially valuable for teams preparing 510(k) or PMA submissions or managing packaging-related CAPAs.
🗓️ Upcoming Events & Webinars
June 12, 2026 | 11:00 AM ET — In Silico Evidence and the Future of Clinical Evaluation, featuring Surash Surash, Clinical Reviewer at TÜV SÜD.
💥 Weekly 510(k) Roundup
June 1, 2026 | From Marcus Engineering, LLC
60 clearances this week, including 7 first-time clearances (🚀).
Featured first-time clearances:
- 🚀 HistoSonics, Inc. — software for its histotripsy system, which treats liver tumors using focused ultrasound waves, destroying tumors from outside the body without an incision.
- 🚀 SDIP Innovations Pty. Ltd. — first FDA clearance for the JAZBI™ Resorbable Bone Void Filler, a calcium phosphate scaffold that supports new bone growth before being gradually absorbed by the body.
- 🚀 Entire Medical Ltd. — first FDA clearance for the ENTire IRE System, which treats enlarged tonsils and adenoids using controlled electrical pulses rather than physically removing tissue.
📋 Regulatory Roundup
June 1, 2026 | By Martin King
Regulators continue advancing lifecycle-based oversight.
This week's key strategic signals: EUDAMED becomes operational reality, with mandatory use of the first four modules now in force; IVDR transition pressure continues as the application deadline for Class C legacy devices passes, keeping certification readiness, notified body capacity, and submission quality as critical risks; AI governance enters the mainstream as regulators move from discussion to oversight and accountability; cybersecurity becomes a core compliance discipline as NIS2 and connected device security expectations expand; Real-World Evidence accelerates globally; regulatory digitalisation gathers pace across EUDAMED, CTIS, IDMP, PMS, and ePI; and faster approvals pair with stronger oversight through reliance pathways and adaptive assessments.
The update also notes that FDA CDRH is celebrating 50 years of medical device regulation and that the European Medicines Agency is marking 20 years of SME support.
🔥 Postscript
At IMSC26 last week, I ran an impromptu session on marketing yourself as a MedTech leader, even if you find marketing cringeworthy. The room was full of people who manage risk for a living: global risk directors, a neurosurgeon leading medical safety for a device maker, a 35-year systems engineer who calls himself a great engineer and a terrible marketer.
Most of them were more comfortable flying under the radar than posting on LinkedIn
We built a LinkedIn post together, live, with every voice in the room in it, and ran it through an editor I built that strips out the tells that make writing read like a machine wrote it.
Want it? It's the same anti-slop editor and slop detector I use. Grab the prompt here >>
Join us for the MLVX Co-Create kickoff, June 30 at 10 AM ET. Details to follow.
Sean 🐝
Also published on LinkedIn: issue 167.