Roughly three in four medtech startups never reach a meaningful exit. When an early-stage investor passes on a deal, it is rarely because the science is bad — it is because a specific, knowable risk surfaced in diligence that the founder either had not addressed or could not answer cleanly. The good news: those risks are knowable before you raise, and most are visible in public data an investor's analyst will pull in the first afternoon.
Here are the five an investor checks first, what the public record reveals, and how to close each before it costs you the round.
1 Regulatory pathway clarity
The first question is simple: do you know your pathway, and is it the right one? A founder who says "we'll do a 510(k)" for a device with no clean predicate, or who is unclear whether they are Class II or Class III, signals risk immediately. Investors check the FDA 510(k) and PMA databases for your class, your predicate, and how comparable devices cleared.
How to close it
Name your pathway, your predicate (with its K- or P-number), and your evidence basis before the first meeting. If you are pre-submission, a documented Q-Sub plan beats a confident guess.
2 Clinical evidence depth
Investors map your claims against what the clinical record can actually support. Registered trials are public on ClinicalTrials.gov; so are terminations and the reasons behind them. A thin or absent evidence base is fine at seed — but only if your plan to build it is specific (endpoints, sample size, sites, timeline), not aspirational.
How to close it
Show the evidence ladder: what you have, what the next readout proves, and when. Tie each marketing claim to the study that will support it.
3 IP defensibility
A patent number is not a moat. Investors look at whether your filings actually cover the product as built, how crowded the space is, and whether a fast-follower could design around you. The USPTO record tells most of this story.
How to close it
Be able to explain, in one paragraph, what your core claims protect and what they do not. Acknowledge the whitespace honestly — investors trust founders who know their own gaps.
4 Reimbursement path
The most common silent killer. A cleared device with no coverage and no code is a science project, not a business. Investors check CMS coverage determinations and the CPT landscape for whether someone will actually pay for your device once it ships.
The trap
"We'll figure out reimbursement after clearance" reads as an unmanaged risk. Even a directional coverage thesis — comparable codes, payer logic, the gap you'll need to close — beats silence.
5 Team & execution credibility
Finally: has this team done a version of this before? Investors look for operators who have navigated FDA, scaled manufacturing, or carried a comparable device to market. Prior-company history is largely public — and it cuts both ways, so frame it honestly.
How to close it
Name the relevant experience explicitly. If there's a gap (e.g. no regulatory lead), show the hiring plan and the advisors filling it in the interim.
What diligence can — and can't — tell you
An honest assessment will not promise that closing these five risks guarantees a raise; no assessment does, and anyone who claims to predict your outcome is selling you something. What it can do is show you exactly what an investor will find before they find it — every figure traceable to a public source you can verify yourself — so you walk into the room having already answered the hard questions.
That is the entire point of pre-raise diligence: not a score, but a navigation map. Diagnose the risk, show the path to close it, and arrive prepared.
See what an investor will find — first
We'll run a complimentary Signal Brief on your company's space — a short, fully-cited read on the competitive and regulatory landscape, drawn entirely from public sources. No cost, no pitch.