If you have time for an espresso — must‑read items
- FDA escalates J&J neurovascular coil recall to Class I after reports including a death and serious injuries. A reminder that post-market surveillance and field actions can move fast when failure modes are severe. LINK
- A new EPA rule finalized in February 2026 eliminates “off‑cycle” credits, including those tied to auto stop/start. This changes the compliance math and could accelerate feature reshuffles across model lines. LINK
- Stellantis takes a ~$26B hit as it rethinks its EV strategy. Another signal that EV demand forecasts and capital allocation assumptions are being rewritten across OEMs. LINK
- Modular Medical starts validation production lots for its Pivot tubeless insulin patch pump. It’s a concrete “from prototype to scale” milestone ahead of a planned launch pending FDA clearance. LINK
- Waymo turns to DoorDash drivers to close robotaxi doors left open by riders. It’s a small operational detail that highlights real-world scaling friction in autonomy deployments. LINK
If you’re sipping a latte — additional reads
- Ars Technica review: 2026 Nissan Leaf framed as a strong budget EV, even in cold-weather testing. Useful signal on where “value EV” expectations are landing. LINK
- Ars Technica highlights Kia’s PV5 electric van design and pricing in the UK. Worth watching for commercial/fleet electrification momentum and packaging innovation. LINK
- GM again changes the recommended oil for recalled 6.2‑liter L87 V‑8s. This time it’s framed as a supply/cost-driven swap (availability matters when recalls scale). LINK
- FDA clears Eyas Medical Imaging’s Ascent 3T neonatal MRI system. Specialized imaging that can sit nearer NICUs points to continued device innovation in constrained clinical environments. LINK
- Battery makers pivot some EV battery capacity toward energy storage as AI/data-center demand rises. Manufacturing flexibility is becoming a competitive advantage as end-markets swing. LINK
- Consumer Reports “best EVs” roundup (via Jalopnik) underscores a broader bench of credible EV options. Helpful for gauging mainstream buyer sentiment beyond early-adopter brands. LINK
If you’ve got a venti anything — deeper dives
- Regulatory/quality: FDA’s QMSR shift (ISO 13485:2016 alignment) is about to get real. Even companies that “already have ISO” should expect different inspection conversations: traceability, CAPA rigor, supplier controls, and design-to-production linkages become harder to hand-wave when a standard is incorporated by reference. LINK
- Manufacturing strategy: EV volatility is pushing plant strategy toward optionality. The battery-to-storage pivot and the 2026 factory project pipeline both point to a world where capital projects must be reconfigurable—product mix shifts, automation upgrades, and supply-chain resilience are no longer “nice to have.” LINK
- Commercialization reality check: scaling is as operational as it is technical. Between validation lot ramp-ups in medtech and “edge case” autonomy ops (like open doors), the winners will be the teams who design for manufacturing, service, and field reliability—not just lab performance. LINK
What it means for customers
Across both automotive and medtech, the theme is execution under changing rules: compliance incentives are shifting (EPA credits), quality expectations are tightening (QMSR/ISO 13485 alignment), and scaling is exposing operational edge cases. Customers should prioritize partners who can prove manufacturing readiness, supply continuity, and field-quality discipline—because the cost of “almost ready” is rising.