Field notes from the operating side of the table.
Specific observations on medical device due diligence, manufacturing scale-up and post-close execution: the things that don't show up cleanly in a data room.
What "the FDA submission is on track" actually means
"On track" can mean two very different things: a clean submission still waiting on FDA, or one already answering an Additional Information request. Four things worth verifying before close.
READ →Three questions I'd ask a CDMO before committing a program to them
A capabilities deck tells you what a CDMO can do. It doesn't tell you what they're already doing for everyone else competing for the same production slots.
READ →The diligence report and the 100-day plan answer different questions
Diligence asks whether the operation can support the deal thesis. The 100-day plan asks what has to happen first, in what order, and who owns it. Treating them as one document is where early value gets lost.
READ →Five things I look for in medical device manufacturing diligence
Real capacity instead of nameplate capacity, validation status instead of a validation binder, CAPA trends instead of CAPA counts, single points of failure, and how much of the operation lives in one person's head.
READ →The 14-week quote that became nine months
A vendor quoted 14 weeks for equipment central to the ramp plan. By the time the PO went out after close, the real lead time was closer to nine months. Nobody misrepresented anything.
READ →The prototype is beautiful. The manufacturing process is not.
Design verification answers whether the design works. It doesn't answer whether it can be built the same way, correctly, by someone other than the person who invented it, at volume, forever.
READ →Shorter versions of these notes, and the discussion around them, are posted on LinkedIn. Follow along there for new posts each week.