Case Studies
Anonymized examples showing how our analysis identifies risks that standard due diligence misses.
Historical Analysis
Retrospective Analysis: We applied our framework to documented public outcomes — the same patterns we identify in retrospect are what we screen for in real-time.
Each pattern we identify strengthens our proprietary database. These retrospective analyses validate the same framework we apply in real-time assessments.
Diagnostics | 2003-2018 | $700M+ raised
Elizabeth Holmes promised blood tests from a finger prick that could detect hundreds of conditions. Investors including Rupert Murdoch, the Walton family, and major VCs poured in over $700 million, valuing the company at $9 billion. The technology never worked. Holmes was convicted of wire fraud in 2022 and sentenced to 11+ years in prison.
Investors relied on charisma over evidence. A basic technical review would have revealed that running 200+ tests from microliters of blood violated fundamental physics and chemistry. No accredited lab validated the results. The defense at trial even argued that investors failed to conduct adequate due diligence.
Public Retrospectives
Every retrospective below uses publicly documented outcomes — court filings, FDA action letters, SEC disclosures, and bankruptcy proceedings. We applied the same 25-category framework to the public record.
Orthopedic implants · Public outcome: $1.5B+ recall (2024), Chapter 11 filing
Polyethylene packaging that failed to protect the insert from oxidation led to a multi-generation recall covering hundreds of thousands of knee, hip, and ankle implants. The company filed for Chapter 11 in 2024.
Prescription digital therapeutics · Public outcome: $1.6B SPAC (2021), bankruptcy ~24 months later
Three FDA-authorized prescription digital therapeutics. No durable payer pathway. Coverage stayed limited, prescribing did not scale, and the company filed for bankruptcy and sold its assets.
Infant monitoring · Public outcome: FDA warning letter, ~18-month US sales halt of flagship
The Smart Sock was marketed as a wellness product. FDA disagreed: pulse-oximetry claims meant the device required clearance. The company pulled the flagship from US sale, then re-entered with the cleared BabySat.
These are the same patterns the framework screens for in real time — across regulatory, reimbursement, clinical, manufacturing, IP, and commercial categories. See how a Score works →
Medical device and digital-health failures rarely come from unknowable risks. They come from a small set of repeating patterns — wellness vs. medical-device misclassification, predicate strategy without a backup, packaging or QMS shortcuts, ASP modeled without a payment policy, KOL endorsement instead of independent clinical evidence. The framework names them, in writing, before they cost real money.
What a Score Looks Like
Most assessments don’t end in “walk away.” They end in a written list of what to fix and in what order. This is an illustrative example of that output for a fictional orthopedic implant company — the format and rigor mirror a real Score.
Transparency note: This is an illustrative walkthrough, not a paid engagement. Patterns and remediation steps reflect the framework’s actual output. We’ll cite real client work by name when sponsors permit.
Framework Validation
How our proprietary framework would have flagged the risks that ultimately derailed a promising medical device — using publicly available outcome data.
Transparency note: This is a retrospective analysis — not a paid engagement. We applied our framework to a real company's publicly documented trajectory to demonstrate what the assessment would have caught. Company details anonymized.
In the Headlines
Recent high-profile failures and growth misses mapped to the Vantage Score framework. Each company's setback traces back to risks our proprietary assessment is designed to catch.
Orthopedic Implants · TPG Portfolio
Defective packaging caused oxidation in implants. Recalls expanded across product lines over 3 years, triggering 2,600+ lawsuits and bankruptcy.
Maps to Vantage Framework:
Digital Therapeutics · SPAC at $1.6B
FDA-cleared prescription digital therapeutics. Assumed clearance meant payer coverage. Payers refused reimbursement at $300+/therapy. Sold for $6M in bankruptcy.
Maps to Vantage Framework:
Smart Baby Monitor · SPAC at $2.6B
Marketed pulse oximetry as consumer device without FDA clearance. FDA enforcement letter 3 months post-IPO destroyed the business model overnight.
Maps to Vantage Framework:
Handheld Ultrasound · Stock near $1-2
Revolutionary hardware, but only ~15% of exams properly billed. Workflow friction — not device quality — is the adoption bottleneck. Revenue consistently misses targets.
Maps to Vantage Framework:
VR Surgical Robotics · 87% Decline
Promised first human surgery "next year" since 2022. Still pre-revenue with $24M cash against $35M annual burn. NYSE compliance warning issued.
Maps to Vantage Framework:
Aquablation · Revenue Growing, Stock Falling
57% revenue growth wasn't enough. Saline shortage cost ~2,000 procedures (single-source risk). Market penetration at only ~10% — far slower than projected.
Maps to Vantage Framework:
If a stalled device company in your portfolio looks like any of these case studies, our Investment Forensics service can identify exactly where things went wrong — and whether they're fixable.
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Founder's Corner
Founders of stalled or failed medical device companies share their stories. We analyze each through our proprietary framework — identifying the specific failure patterns and what could have been caught earlier.
Our Case Study ApproachOur case studies are built from documented medical device outcomes — real companies, real failures, real lessons. As prospective engagements join our retrospective analysis, the platform becomes the most comprehensive risk intelligence resource in medtech.
A surgical instrument startup spent 14 months on a 510(k) submission before discovering their predicate device had been reclassified. $1.8M burned on a pathway that no longer existed.
Category Tag
Regulatory Pathway (A2)Status
Could have been caught at Week 2
An physician-led diagnostic tool cleared FDA in 11 months — then sat unused. The device added 12 minutes to a procedure physicians complete in 8. No one changed their workflow.
Category Tag
Clinical AdoptionStatus
Matches historical precedents in our database
A digital therapeutic achieved strong clinical outcomes and FDA clearance. Payers refused coverage at the company's price point. Revenue never exceeded 15% of projections.
Category Tag
Reimbursement StrategyStatus
Matches historical precedent in our database
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