Reinvent R&D in Lifesciences
Accelerate faster to improve standard of care and transform patient outcomes
Why transform MedTech R&D
New FDA compliance paradigms are reshaping R&D. From SaMD to PMA, changes such as the PCCP framework and the current ISO 14971 are making Class III development more complex, with more moving parts and more evidence to keep up to date. To deliver faster, more affordable and more accessible devices, teams need a different operating model: live data, AI-assisted risk analysis, and a risk file that evolves with the product. That is how they advance pipelines, lift productivity and deliver better outcomes for patients.
of Class III risk failure is uncovered faster with AI than with traditional methods.
Basis: [add Phasefour benchmark, method and source before publishing].
How MedTech R&D is changing
Dynamic risk management is advancing Class III R&D
Leading teams no longer treat the risk file as a document set frozen at design freeze. They feed it with live adverse event and complaint data, link every hazard to its software item under IEC 62304, and plan changes through a PCCP, so evidence stays current while the product keeps improving.
What we do
Build an FMEA risk profile for every competing device, fed by real-time adverse event data from the pipeline. See which failure modes recur, how severe they are, and where your design can do better before you commit to a clinical plan.
- Adverse event, recall and complaint signals scored as FMEA inputs
- Competitor RPN benchmarks against your own design
- Feeds endpoint, sample size and study design decisions
Triage competitor label claims and failure-mode RPNs side by side. Find the indications and performance claims no one owns yet, and which emerging designs can reach them first. Brighter cells mean a higher field-derived RPN; a dashed column is open territory.
FDA review of Class III products carries more moving parts every year. Connect your IEC 62304 software lifecycle, ISO 14971 risk management and PMA submission in one living record, and update risk management data as signals arrive instead of at the next review.
What you'll achieve
Faster pipeline decisions
Competitor risk profiles and live signals shorten the path from concept to a confident clinical plan.
Fewer late-stage surprises
Failure modes that matter surface early, before they become deficiency letters or design changes.
Audit-ready change control
PCCP-planned updates and a traceable risk file keep software and hardware changes defensible.
Claims you can substantiate
White-space maps point to claims and indications that are open and supportable with your evidence.
Our leader
One engine, two markets
We built FMEA risk cards to underwrite data centers. The same discipline now governs Class III pipelines, with the FDA in the audit seat.
A second operating unit
Everything above is AI enablement consulting. Everything below is a separate, turnkey AI product platform dedicated only to data center underwriting.
DC Underwriter Risk Intelligence Platform
Transform insurance with AI-powered workflows for global data centers: liquid cooling, real-time pricing and FMEA risk cards in one governed view.
of AI proofs of concept in data center underwriting never make it to production.
Figure from the current Phasefour site. Add the source before publishing.
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Executive alignment
Align goals and workflows.
Start -
Discovery sprint
Identify friction and backlog.
Sprint-based -
Proof of value
Validate workflows and impact in real conditions.
Production-ready MVP
AI readiness maturity framework: a structured, sprint-based path from executive alignment to a governed, production-ready MVP that scales.
AI-powered insurance
Automate insurance workflows to accelerate decisions, improve efficiency and reduce risk. Streamline claims, underwriting and servicing with AI-powered workflows built to scale.
Workflow automation
Streamline underwriting, claims and servicing workflows.
Cloud-native platform
Built on Azure, Fabric and Copilot technologies.
Governed AI
Manage compliance and risk controls.
Explore our AI Data Center Thermal Management Showcase and discover how we can supply change, together.