# How to Not Build Most of It

The infrastructure for a [dFDA](../../knowledge/solution/dfda.llms.md)^([1](../references.llms.md#ref-dfda-spec-paper-2025),[2](../references.llms.md#ref-dfda-impact-paper-2025)) won’t cost billions to build. Because you’re not building most of it. Your species already figured out how to get strangers to build software for free. You call it “open source.” It runs most of the internet. You just forgot to point it at medicine.

The strategy: build the foundation (core API and data standards), pay bounties for the parts nobody wants to build first, and let strangers build everything else for free. Because some of them are dying.

## The Open Platform Model

Linux started as one person in Finland writing a kernel. Today it runs most of the internet, every Android phone, and the world’s fastest supercomputers. WordPress: a small core, 60,000+ plugins built by other people. Open-source platform models are a multi-trillion-dollar economic reality^([3](../references.llms.md#ref-open-source-platform-multi-trillion-dollar-reality)). Combined value of Linux, WordPress, Android, and Chrome: trillions. Combined cost to build the cores: billions. You used this method to build the infrastructure for cat videos. You have not used it to build the infrastructure for clinical trials.

A dFDA follows the same structure. Build the core (APIs, data standards, identity, consent). Developers build everything else (trial matching, analysis dashboards, EHR connectors, patient apps). Except these developers are also dying of the diseases, so they’re more motivated than the average WordPress contributor.

## Bounties: Paying for Results, Not Promises

An open platform mostly builds itself, but sometimes you need specific features that nobody’s volunteering to create.

Your traditional approach is grants: “Here’s money. Build something. Let us know how it goes.” The bounty approach: “Build this specific thing. If it works, you get paid. If it doesn’t, you don’t.” One of these has produced the NIH’s track record. The other has produced the internet. I’ll let you figure out which is which.

The [Right to Trial & FDA Upgrade Act](https://papers.acceleratedmedicine.org/right-to-trial.html)^([4](../references.llms.md#ref-right-to-trial-paper-2025)) deliberately does not prescribe how anyone builds the evidence systems. That leaves operators free to post bounties for critical features nobody is building yet (pay on delivery, not on promise); pay hackers to find security vulnerabilities and report them instead of exploiting them (cheaper than getting hacked); fund connectors to major EHR systems where everyone benefits but nobody wants to go first; and offer prizes for breakthrough components. This is how your species built private spaceflight. It is also how you keep your military’s computers from being hacked. You just have not tried it on the thing that kills [150 thousand](../../knowledge/appendix/parameters-and-calculations.llms.md#sec-global_disease_deaths_daily) of you every day.

## This Already Works

Governments already use bounties and prizes^([5](../references.llms.md#ref-us-government-prize-and-bounty-programs)) to solve complex problems, and they consistently outperform traditional procurement. XPRIZE produced private spaceflight. NASA Centennial Challenges produced lunar landers and space robotics. The Department of Defense pays hackers to break into its own systems. All succeeded. All cost less than the traditional “hire a contractor and hope” approach.

The alternative is the one your species defaults to: build everything from scratch, slowly, expensively, and badly. Then hold an awards dinner about it. I have attended your awards dinners. The food is adequate and nobody mentions the dead.

1\.

Sinn, M. P. *The Continuous Evidence Generation Protocol: Two-Stage Validation (RWE → Pragmatic Trials)*. <https://papers.acceleratedmedicine.org/dfda-protocol.html> (2025) doi:[10.5281/zenodo.18203375](https://doi.org/10.5281/zenodo.18203375)

*We present the Predictor Impact Score (PIS), a novel composite metric operationalizing Bradford Hill causality criteria for automated signal detection from aggregated N-of-1 observational studies. Combined with pragmatic trial confirmation (based on evidence from 108+ embedded trials), this two-stage framework would generate validated outcome labels at 44.1x lower cost than traditional Phase III trials. This enables continuous, population-scale pharmacovigilance and precision dosing recommendations.*

2\.

Sinn, M. P. *Ubiquitous Pragmatic Trial Impact Analysis*. <https://papers.acceleratedmedicine.org/dfda-impact.html> (2025) doi:[10.5281/zenodo.18243914](https://doi.org/10.5281/zenodo.18243914)

*Only 15 diseases/year get their first treatment each year. With 6,650 diseases lacking effective treatments, the backlog would take 443 years to clear. Integrating pragmatic trials into standard healthcare increases trial capacity 12.3x, cutting that timeline from 443 years to 36 years. The average untreated disease gets a treatment 212 years earlier, saving 10.7 billion deaths at \$9.62 per year of healthy life saved.*

3\.

Grand View Research. Open-source and platform-as-a-service multi-trillion dollar market. *Grand View Research: Open Source Services Market* <https://www.grandviewresearch.com/industry-analysis/open-source-services-market-report>

*Open source services market: \$30.2B (2023) → \$81.4B (2030) at 16.5% CAGR; other estimates \$135.9B by 2033 Open source cloud platform: \$6.23B (2024) → \$18.12B (2033) at 12.8% CAGR Platform as a Service (PaaS): Growing at 12.6% CAGR Broader cloud computing market: Projected \$1.5 trillion by 2033 at 15% CAGR Current market in tens of billions, approaching multi-trillion valuations in long term Additional sources: https://www.grandviewresearch.com/industry-analysis/open-source-services-market-report \| https://www.precedenceresearch.com/open-source-services-market*

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4\.

Sinn, M. P. *Right to Trial & FDA Upgrade Act*. <https://papers.acceleratedmedicine.org/right-to-trial.html> (2025) doi:[10.5281/zenodo.19076852](https://doi.org/10.5281/zenodo.19076852)

*A universal right to try, with evidence. The Act authorizes commercial access after initial human safety testing and makes every covered treatment use teach us something.*

5\.

NASA. U.s. Government use of prize and bounty programs. *NASA* <https://www.nasa.gov/news-release/nasa-and-x-prize-announce-winners-of-lunar-lander-challenge/>

*NASA’s Centennial Challenge, initiated in 2005, has paid out more than \$7.6 million. The Ansari XPRIZE demonstrated significant leverage: \$10 million was awarded to the winner, but more than \$100 million was invested in new technologies in pursuit of the prize. NASA launched its own incentive scheme in 2005 called Centennial Challenges. Additional sources: https://www.nasa.gov/news-release/nasa-and-x-prize-announce-winners-of-lunar-lander-challenge/ \| https://www.xprize.org/past-challenges \| https://www.herox.com/blog/985-prize-challenges-governments-secret-weapon-for-inn*

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6\.

World Health Organization. WHO global health estimates 2024. *World Health Organization* <https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates> (2024)

*Comprehensive mortality and morbidity data by cause, age, sex, country, and year Global mortality:  55-60 million deaths annually Lives saved by modern medicine (vaccines, cardiovascular drugs, oncology):  12M annually (conservative aggregate) Leading causes of death: Cardiovascular disease (17.9M), Cancer (10.3M), Respiratory disease (4.0M) Note: Baseline data for regulatory mortality analysis. Conservative estimate of pharmaceutical impact based on WHO immunization data (4.5M/year from vaccines) + cardiovascular interventions (3.3M/year) + oncology (1.5M/year) + other therapies. Additional sources: https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates*

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