For Life Science Founders
The same physician and biomedical-engineer diligence an investor would run on you — across regulatory, clinical, IP, and commercial. See your gaps first, on your timeline.
This is the same read we run for VCs, PE firms and strategic acquirers — pointed at you instead of at a deal. Founders can come to us directly, or through their fund, accelerator or university TTO. The value is the same either way: you see what their diligence will surface, before they run it.
Know your regulatory and clinical risk profile before investors ask. Identify gaps early so you can address them on your timeline, not theirs.
See the whole picture first — including the parts you would rather investors, regulators and partners heard from you.
Your Assessment Team
Led by Arvind Ravinutala, MD (practicing physician, P&T Committee Chair) and Aswini Ravinutala, BME (biomedical engineer, 10+ years in medical devices; R&D Manager, Spiro Medical). Meet the full team →
What you actually get
The Index is the cover of your report. The eight domains behind it are what makes it worth reading — each scored on its own evidence, each carrying its own confidence.
Confidence-weighted across the eight canonical domains. It is a summary of the evidence, not a verdict on the company — there is no color band, no “ready” or “not ready”, and no score at which we tell you to raise. That judgment is yours, and the eight numbers below are how you make it.
Illustrative. Regulatory, clinical, IP, reimbursement, commercial, team, financial and competitive. A domain the evidence cannot support says Insufficient and names the document that would fix it, rather than being averaged into the Index as if it were known.
Why the eight matter more than the one
The Index tells you roughly where you sit. The eight tell you which part of the business is carrying the risk — and a company can be strong on seven and have the eighth end the conversation. That is the one you needed to find.
Why the confidence band
A 6.2 built on forty cited filings is not a 6.2 built on two. The band tells you which one you are looking at, so you know where to push back — and we expect you to.
How a Founder Report runs, from intake to debrief.
You complete a short intake form and you upload your materials securely — deck, regulatory correspondence, IP status, clinical data. Everything is optional; we build from the public record either way. We confirm scope and timeline, and ask questions only where an answer would change the read.
Vantage assembles the record across all eight domains. Your physician then reviews the clinical, regulatory and reimbursement reading, and your engineer reviews the technical, IP, manufacturing and quality reading, before the report is released.
You receive the report: per-domain findings, the evidence behind each, and the gaps a reader will ask about first. Then a 30-minute debrief with Arvind Ravinutala, MD, to walk through the findings and push back on anything you disagree with. You are welcome to bring your board or a co-founder.
If you are heading out to raise, the Complete Package ($15,000) adds eight investor-readiness sections, and your Founder Report fee credits in full toward it.
Three ways in, priced to where you are. The Founder Report and Complete Package are reviewed by a physician and a biomedical engineer before they reach you; the Quick Screen is automated. Factual claims are cited to their sources.
Quick Screen
Founder Report
Complete Package
36 sections — the Founder Report plus eight investor-readiness sections.
Start the Complete PackageSame engine, same citations, same two reviewers. The Complete Package adds the eight sections written for the person on the other side of the table.
Which one, plainly. Take the Founder Report if you are working out where you actually stand — it is the diagnostic. Take the Complete Package if you are going out to raise, or into a partnering conversation, in the next two quarters: the extra eight sections are the ones a VC or a BD team reads most closely.
You are not choosing badly either way. The Founder Report fee credits in full toward the Complete Package if you upgrade later — so starting smaller costs you nothing but time.
We do not predict which companies succeed — nobody can, and anything claiming to is selling a backtest. We surface what the public record and your own materials already contain, so a sophisticated reader can see the risks and the potential that others miss.
Investors scrutinize clinical and regulatory strategy, and you may be expert in one. The Founder Report covers both — across all eight diligence domains — in 48 hours.
Success Pathway
How founders can use the report in a raise.
You have per-domain findings with their confidence bands, the cited evidence behind each one, and a prioritized list of what a reader will ask about first.
The report shows the gaps and the evidence behind them. What to do about them is your decision, on your timeline.
If you choose, you share the report in your data room. Investors run their own diligence; the report shows them you have already read the record they will read.
You go into investor meetings knowing what the record shows, including the parts you would rather they heard from you first.
What You'll Receive
Every assessment includes these components in your deliverable.
Eight domains scored independently, each with a Bayesian confidence interval that widens where the evidence is thin, and summarized in the Vantage Index. There is no readiness verdict, and a domain we cannot support is marked Insufficient, and named, rather than averaged into a number that hides it.
Where the record is strong, where the biggest risks sit, and why investors will ask about them.
The gaps a reader will ask about first, each anchored to a named record, with what the record would need to show to read differently and what comparable companies did. No owners, deadlines or instructions: what to do is your decision.
For each domain, the detailed findings and the evidence behind them: regulatory records, trial registries, patents, CMS data and comparable companies. This is the evidence behind every score, so you can check it rather than take it.
A conversation with Arvind Ravinutala, MD: walk through the findings, ask follow-up questions and push back on anything you disagree with.
Strategic Guidance
How 510(k) classification drives your timeline. Common delays and how to avoid them.
What stops physicians from using your technology. How to assess workflow integration early.
Beyond pitch decks. What due diligence questions VCs always ask about regulatory and clinical risk.
What founders ask us first
Questions founders often ask — and how we answer them before any check is cut.
Q · Predicate strategy
"VCs keep asking about my 510(k) predicate. What's the cheapest way to know if it actually holds up?"
A Founder Report reads your predicate against FDA's public record: the predicate's own clearance history, recent clearances under the same product code, and any recalls tied to it. What no outside read can tell you is how an FDA reviewer will respond; a Pre-Submission meeting is how you ask FDA directly.
Q · Reimbursement reality
"We're pre-revenue. How do I figure out what payers will actually pay before I commit to a price?"
The Founder Report ($7,500) reads what CMS sources show for your space: candidate codes, national and local coverage determinations, and Medicare payment rates where they exist, with the gaps that would matter for a coverage decision called out. What commercial payers will pay is not in the public record; that takes payer conversations.
Q · Adoption risk
"Our pilot data looks great. Why do investors still treat adoption as our biggest risk?"
Because pilot environments rarely reflect the workflow of the staff who would use the device every day. The report reads adoption against what the record shows for comparable launches in your space and names the workflow questions a clinician reader will raise.
Across All Modalities
Medical Devices & Sensors
Surgical instruments, diagnostic devices, wearables, monitoring equipment. Assessment reads the 510(k), De Novo or PMA pathway, clinical workflow integration and manufacturing feasibility.
Drugs & Biologics
Small molecules, monoclonal antibodies, cell and gene therapy. Assessment reads the IND and trial record, manufacturing scale-up questions and reimbursement.
Diagnostics & Digital Health
In vitro diagnostics, LDTs, software-as-medical-device, clinical decision support. Assessment reads CLIA and FDA pathways, validation evidence and health-system integration questions.
Combination Products
Device + drug, device + software, software + pharma. FDA's Office of Combination Products assigns the lead center; the assessment reads the product's primary mode of action and the regulatory complexity that follows.
Efficiency & Expertise
You could hire consultants, interview payers, and do your own regulatory research. Here is how the two approaches compare; the DIY figures are illustrative ranges, and your costs will vary.
Your approach
DIY Research
Vantage approach
Integrated Assessment
What changes
Side by Side
10 clinical, regulatory, and technical red flags investors look for.
Get the ChecklistA single missed clinical or regulatory question can cost far more than the diligence that would have surfaced it.
A 48-hour, eight-domain read on your own company. Move to the Complete Package if you are heading out to raise.
Email arvind@vantagebiomed.com directly
The Founder Report covers all eight diligence domains in 48 hours; the Complete Package adds the eight sections investors read most closely.