Angel and seed investors usually run lighter diligence than a later-stage fund, but their questions cover the same ground: regulatory pathway, clinical evidence, reimbursement and team. A founder with answers ready for the questions below makes that diligence faster. Here is a pre-raise checklist.
1 Regulatory: pathway, predicate, and timeline
Know your device class, your pathway (510(k), De Novo or PMA), your predicate if you have one, and a realistic timeline. For software, know whether the product is a device at all. "We think it's a 510(k)" is not an answer.
Have ready
Pathway, predicate (with its 510(k) or De Novo number) and the equivalence or evidence basis.
2 Clinical: claims tied to evidence
Every claim should map to the study that supports it. Registered trials and their status are public on ClinicalTrials.gov.
Have ready
Your evidence ladder: what you have, what the next readout proves, and when.
3 Reimbursement & commercial: who pays, and why now
A coding/coverage/payment thesis and a credible first-customer story. (See our article on the reimbursement question.)
Have ready
Comparable-code reasoning + a named beachhead segment.
4 Team: relevant, named experience
Investors check prior-company history. Name the experience that's relevant; if there's a gap, show the hire/advisor plan filling it.
Have ready
Who has done a version of this before — and the plan for the gaps.
The bottom line
Pre-raise diligence isn't a score; it's a map of the questions an investor will ask. A founder who has checked each one, and knows where the gaps are and how they'll be closed, arrives ready for the conversation.
Know what an investor will find — first
Start with a free 20-minute call, or buy an automated Quick Screen for a cited first read drawn from public sources.