Case Studies
What the public record showed about companies whose outcomes are now known. No client work and no unnamed founders.
Historical Analysis
Each retrospective uses publicly documented events — court records, FDA letters and recalls, SEC filings and bankruptcy proceedings — and asks which questions the record put on the table. Hindsight makes those questions look obvious; the point is the kind of question a structured read raises, not a claim that anyone could have predicted the outcome.
Diagnostics | 2003–2018
Theranos said its devices could run a wide range of blood tests from a finger-stick sample, and it raised hundreds of millions of dollars from investors. After reporting in 2015 questioned its technology, the company collapsed. A federal jury convicted founder Elizabeth Holmes in January 2022 of conspiracy and wire fraud against investors, and she was sentenced in November 2022 to 135 months in prison. Source: U.S. Department of Justice.
A claim that a new technology outperforms established laboratory methods is a claim about evidence. The diligence questions are where that evidence is published, who has independently reproduced it, and which regulatory route the tests run under.
Public Retrospectives
Each uses publicly documented events — FDA letters and recalls, SEC filings and bankruptcy proceedings — and the questions a structured read asks of them.
Orthopedic implants · Public record: polyethylene component recalls (2021–22); Chapter 11 filed October 29, 2024 (MedTech Dive)
Polyethylene inserts were packaged in bags without an oxygen-barrier layer, which can allow oxidation. Recalls expanded across knee, hip, ankle and shoulder product lines, and the company filed for Chapter 11 in October 2024.
Prescription digital therapeutics · Public record: 2021 SPAC listing; Chapter 11 filed April 7, 2023
Pear had FDA-authorized prescription digital therapeutics and listed through a SPAC in 2021. It filed for Chapter 11 in April 2023 and its assets were sold in bankruptcy. The retrospective looks at the coverage and prescribing-economics questions a reader could see in the public record.
Infant monitoring · Public record: SPAC listing July 2021; FDA warning letter October 2021
In October 2021, three months after its SPAC listing, Owlet received an FDA warning letter saying the Smart Sock was being marketed as a medical device without clearance. Owlet stopped selling the Smart Sock in the US and introduced the Dream Sock in early 2022.
The same categories — regulatory, reimbursement, clinical, manufacturing, IP and commercial — structure every Vantage report. See how a Report works →
Many setbacks in this space trace to questions that were visible in the public record — wellness versus medical-device classification, predicate strategy without a backup, packaging and quality systems, price assumptions without a payment policy, endorsement in place of independent clinical evidence. A structured read puts those questions in writing. It cannot tell you how a company will turn out.
A Quick Screen gives an automated first read within 24 hours; a Diligence Report is reviewed by a physician and a biomedical engineer.