Best Test Commercialization Chain
Align every dependency required to move a medical test into routine use
- Difficulty
- Expert
- Time to result
- ~months to results
- Steps
- 7
- Confidence
- 91%
The Best Test Commercialization Chain treats diagnostic innovation as a linked system rather than a simple invention problem. A technically excellent test must first be protected and transferred from its research institution, placed inside a viable company, funded, clinically validated, and trusted beyond the founding team. The company must then navigate governmental stakeholders, payer relationships, procedural billing codes, reimbursement economics, marketing, sales, and practitioner adoption. Each dependency affects the others: a test can work perfectly yet remain unattractive to a large laboratory if reimbursement, demand, or operating economics fail. The framework therefore asks founders to map the entire path from discovery to paid clinical use and identify the weakest link before spending heavily. Its central lesson is that building a better test and proving it works are necessary but insufficient conditions for changing medical practice.
Origin
Strom calls the hypothetical invention “the best test,” or TBT, in a presentation showing how a clinically excellent prostate-cancer test can plausibly end with a major laboratory declining to adopt it.
Core principles
- 01Technical superiority does not guarantee adoption
- 02Commercialization is a chain of interdependent approvals and incentives
- 03Intellectual property, funding, regulation, coding, reimbursement, and sales must align
- 04A broken dependency can make an excellent test commercially nonviable
- 05Build complementary scientific and business expertise early
How to run it
- 1
Prove the clinical value
Define the condition, intended population, use case, and required sensitivity and specificity. Reproduce the findings beyond the original discovery team.
Pro tip Frame the evidence around a decision the test will improve, not merely a biomarker it can detect.
Watch out Private-company evidence may attract skepticism without independent replication.
- 2
Secure the asset
Work with the research institution or technology-transfer office to establish patents, licenses, and clear commercial rights.
Pro tip Resolve ownership before raising substantial outside capital.
Watch out Disordered intellectual property can block partnerships and financing.
- 3
Build the company and capital base
Create the organization and obtain enough funding to validate, manufacture, regulate, launch, and support the test.
Pro tip Recruit business expertise that complements the scientific founders.
Watch out Funding only assay development leaves downstream market-access work stranded.
- 4
Navigate clinical infrastructure
Engage regulators, governmental stakeholders, laboratories, and practitioners whose approval or cooperation is required for use.
Pro tip Identify each stakeholder's evidence threshold before designing studies.
Watch out Clinical usefulness alone does not create institutional trust.
- 5
Establish payment
Secure appropriate procedural codes, payer relationships, reimbursement pathways, and economics that work for both the company and adopting laboratories.
Pro tip Model denied claims and collection rates, not just nominal reimbursement.
Watch out A test that cannot be reliably paid for will struggle regardless of clinical merit.
- 6
Create market adoption
Build marketing, sales, education, and practitioner workflows that make ordering and interpreting the test practical.
Pro tip Explain how the result changes patient management in language clinicians can use.
Watch out Do not rely on a better-mousetrap assumption.
- 7
Test the complete chain
Evaluate whether all dependencies fit together well enough to support sustainable, scaled use. Repair the weakest link before expanding.
Pro tip Review the chain whenever regulation, reimbursement, or clinical guidance changes.
Watch out One misaligned component can make the whole test unprofitable.
In the wild
Strom describes a person inventing a blood test that determines with high sensitivity and specificity whether someone has prostate cancer. The inventor proceeds through patenting, company formation, fundraising, and the broader commercialization process, only to reach a plausible endpoint where Quest Diagnostics declines the test because the interconnected economic and operational pieces do not fit.
→ The example shows that an excellent assay can fail commercially despite strong technical performance.
Liquid Diagnostics developed a saliva platform Strom believed was game-changing and functional, but the underfunded company lacked marketing, sales, and payer-relations capacity. Expecting the superior technology to attract demand on its own did not produce broad adoption.
→ The company possessed working technology but still needed a viable business and market-access pathway.
Common mistakes
Believing the better mousetrap wins
Technical quality does not automatically produce awareness, reimbursement, distribution, or practitioner adoption.
Treating commercialization as a single approval
A diagnostic test must satisfy multiple governmental, payer, coding, laboratory, and market dependencies rather than clear one universal gate.
Underfunding downstream capabilities
A company can complete the science yet stall because it cannot hire marketing, sales, or payer-relations specialists.
Is it for you?
Best for
It is best for scientists, university spinouts, and diagnostic founders moving a validated discovery toward routine clinical adoption.
Not ideal for
It is not ideal for unregulated consumer products that do not depend on clinical evidence, reimbursement, or practitioner adoption.
From the transcript
“I talk about somebody who invents the best test. I call it TBT.”
“whether or not a test will be profitable depends on so many different interchangeable parts, and if the parts don't all fit together correctly, it…”
“So I felt if I built a better mouse trap, that the world would come to my door. But that has not happened.”
From the episode
Charles Strom on the Diagnostics Industry
Charles Strom