Case study · Regulatory strategy & platform delivery

Executive-ready decisions and a live participant platform, at population scale

Our Future Health is the UK’s largest-ever health research programme, working to recruit and genetically characterise millions of UK adults. As it moved toward returning genomic insights to participants, Emergent Systems supported three connected pieces of work — regulated-software advisory, structured strategy work, and hands-on principal-engineer delivery.

Client

Our Future Health

Role

Software Architect (Digital Health) / MedTech Consultant

Stage

2024–2026 (2 years)

Focus

Regulatory strategy · Architecture · Delivery

The context

As the programme moved toward returning genomic insights to participants, it encountered unresolved questions at the intersection of regulation, software, and clinical responsibility — where the right path wasn’t owned by any one team.

Phase 1 — Regulatory strategy enablement

Led a cross-functional discovery into whether OFH should return Type-2 diabetes polygenic risk scores within a grace window ahead of EU Medical Device Regulations coming fully into effect. Working with Regulatory Affairs, Product, and engineering leads, the discovery mapped regulatory routes, SaMD boundaries, architecture options, and confirmatory testing pathways — structured around a conceptual framework developed to shape the options space.

The resulting presentation informed the executive decision to focus on near-term delivery of non-clinical health feedback, avoiding premature regulatory and clinical exposure.

Phase 2 — Engineering leadership: the Health Insights platform

Acted as principal engineer and architect for Health Insights, a new OFH capability to deliver health reports to participants, launched to the first participant cohort and now serving over 1.5 million study participants.

Led end-to-end delivery across service architecture (Python / FastAPI, Next.js, PostgreSQL, Keycloak-based OIDC).

Designed a SaMD-aligned delivery pattern enabling third-party distribution without PII exfiltration, deployed on OFH’s internal cloud platform.

Delivered the programme’s first production multi-factor authentication flow.

Oversaw the first-cohort launch, including operational runbooks and QC, and engaged closely with the security team to ensure ISO 27001 compliance.

Delivered lightweight “epic” templates adopted by the team for cross-cutting oversight by security, clinical, and product.

Phase 3 — Regulatory discovery: the minimum-viable path for genetic risk scores

Following launch of non-clinical Health Insights, led the discovery, analysis, and writing of a strategic report on the regulatory path for returning medically-actionable reports to participants.

The approach defined candidate use cases (e.g. direct-to-participant, recontact, and others), then took a single use case through user-journey mapping, hypothetical architecture, applicable regulations, and responsibility mapping — surfacing regulatory impacts, laboratory compliance requirements (ISO 15189), and potential SaMD / IVD components. The report opened with structured context for executive and board readers, before presenting prioritised conclusions and recommendations across regulatory, implementation, organisational impact, cost, and risk.

Outcomes

Conceptual framework adopted to shape the executive decision on the T2D regulatory path.

Health Insights launched to the first participant cohort, including OFH’s first production MFA flow.

ISO 27001-aligned delivery evidence and process improvements.

Regulatory discovery report reshaped strategy on medically-actionable participant feedback and informed subsequent executive and board discussion.

Next case study

Technical due diligence — Platform acquisition →

All work