Regulation and innovation have historically been opposing forces. But they don’t have to be. A team can train a diagnostic model in weeks, then wait years for approval, and months for permission to ship a minor update. That’s because most regulatory processes were built for a world with manual workflows and static products.
James Dewar and Jamie Cox experienced this firsthand working on software medical devices at Babylon Health, where they encountered significant delays getting their devices assessed.
Inspired by that experience, they built Scarlet, the AI-native certification body that bridges trust, safety, speed, transparency, traceability, and rigor. Scarlet is designated by governments to assess regulated products and issue the certifications they need to enter the market. It is the only body in Europe specializing in software and AI, holds authority in the UK, and is recognized by the US FDA as a trusted third-party reviewer. Scarlet has the same legal standing as century-old incumbents, but with an AI-adapted process underneath.
Efficient time to market while raising the bar
Delay does not equal rigor. Customers who churned from incumbents describe legacy reviews as inconsistent, opaque, and archaic. With Scarlet, customers upload documentation in any format and receive rapid feedback on the completeness of their submission. Qualified reviewers make regulatory judgments, while Scarlet’s technology handles the time-consuming work of processing and organizing documentation.
Scarlet’s tech, process, and people advantages minimize unnecessary delays for innovative manufacturers. Teams that switched to Scarlet told us their process went deeper into their technical documentation than anyone else. Each finding cites sources and specific clauses, keeping submission requirements standardized.
It’s game-changing for regulators too. Assessments that are consistent, traceable, and fully evidenced are far easier to audit. At any moment, regulators can see the reasoning behind any approval and denial. The clear and detailed rationale for each decision and certification is mapped on the Scarlet platform.
Moats are incredibly rare in this era. Scarlet regulatory designations represent a substantial barrier to entry. Before issuing a single certificate, Scarlet had to build trust with regulators for years and have all their processes audited by multiple governments. Each new certification scheme widens the market, deepens the moat, and compounds their advantages. Along with their technology, people, and process flywheels, Scarlet is strongly positioned to become the global certification leader for the AI era.
Second-order effects
If companies can reliably bring their products to market fast, their ambition grows. They spend more on research and ship devices they would have otherwise shelved. If they can rely on a consistent and fast time-to-market, they can invest in more life-changing products. They can plan their whole commercial organization from marketing to manufacturing around a credible and near-term launch date. In this way, Scarlet is a market enabler and grows the AI and software medical device ecosystem.
We’re thrilled to partner with James, Jamie, and the entire Scarlet team to make their AI-native certification platform even more global and help even more customers.
James Dewar, Scarlet Co-founder, said:
“Headline understands how innovation and regulation should go hand-in-hand, and how our approach enables the most ambitious technology companies in the world to get their AI products to patients at scale. We’re very excited to have Nancy and the Headline team as partners as we build out our global presence.”
Every day, Scarlet is bringing access to life-saving technology. They’re the platform helping regulation work with and for innovation.
