Case studies

Five invisible decisions. Six-figure consequences.

These are patterns we see across medical device, SaMD, IVD, and digital health startups. The five decisions below look small in year one and become six-figure costs by year three. We do not name clients. The patterns are what matter.

Case A

The QMS that could not produce the audit trail.

Speaks to
VP Quality, COO

Case B

Salesforce bought to customize as an inventory system.

Speaks to
CEO, CFO

Case C

Four vendors when one would have done.

Speaks to
COO, CFO

Case D

The hospital security review founders do not plan for.

Speaks to
CEO, Compliance Lead

Case E

Signing the BAA is the easy part.

Speaks to
CEO, CTO

Recognize the pattern in your own stack?

Thirty minutes. Three risks named. No commitment.