Health Ventures Partners x SWART Evaluation briefing note
Moving beyond just clinical safety evidence for MDR, the importance of Health Tech Assessment grade evidence for clinical and cost effectiveness.
It has long been understood that clinical safety evidence and obtaining and maintaining the appropriate medical device regulation certification is vitally important. In fact, it is now being viewed as a competitive edge and a milestone for investors.
What has less been accepted is the importance of robust clinical and cost effectiveness evidence, and adoption and usability in the real world. Despite NICE’s Evidence Standards Framework and national policy and support (see the Med Tech Funding Mandate), we have routinely seen both the adoption of poorly evidenced technologies and the failure to adopt well-evidenced technologies throughout the NHS. This begs the question: why invest in inherently risky, lengthy, and costly evidence generation that is not being asked for? It has often been seen as a “nice to have” or “the right thing to do” but not necessarily a commercial imperative for innovators.
This is changing, with a clear policy direction towards evidence-based reimbursement, the NHS Rules Based Pathway for Medtech, NICE’s updated medtech assessment pathways and long-discussed value based procurement.
So, now is the time to care, and here’s why.
At a glance:
• Regulatory approvals ≠ reimbursement. Clearance lets you sell but HTA-grade evidence supports adoption and reimbursement.
• Policy is aligning around evidenced-based reimbursement. The aim is to move towards clearer national signals, value-based procurement, and, where prioritised, TA-style appraisals for Health Tech. Commissioners operating on longer-term contracting cycles and more strategic population-level footprints want to see clear evidence of return on investment; in return, the potential for strategic partnerships is on the table, moving away from narrower contracts annually renewed.
• The evidence threshold is rising. Earlier adoption is possible if you meet higher thresholds on comparators, economics, and real-world implementation.
• A proactive health economic evidence generation strategy is fundamental to securing reimbursement and demonstrating value to NICE.
What’s changing (practically):
• NICE pathways: Clearer routing between EVA to Full Health Tech Guidance and (for priority tech) Technology Appraisal, plus LSA for categories already in use, meaning it’s easier to understand how to navigate the routes through NICE guidance.
• Rules-Based Pathway: A more predictable link between evidence standards and commissioning and funding decisions, meaning there may be a more predictable pay-off from investment in evidence generation in future.
• Procurement: Shift from unit price to whole-pathway outcomes and value-based procurement (emphasising whole-system impacts on productivity, capacity, and equity).
• Evidence expectations: Stronger emphasis on comparative effectiveness, transparent economic models, and reproducible real-world data.
Why this matters for innovators:
• The promise of faster, clearer decisions when your evidence meets appropriate thresholds and is relevant to a defined payer decision and comparator.
• Enhanced pricing power from credible budget-impact and cost-effectiveness.
• Lower go-to-market friction: implementation-ready packs (IG/cyber, training, workflow) shorten adoption cycles (with the potential introduction of an “Innovator Passport”).
• Improved investor confidence due to clearer market access requirements: clearer route to scale and defensible valuation based on established evidence thresholds.
Why Health Economics matters:
• Translate clinical value into financial terms and demonstrate return on investment compared to other, competing, demands on limited healthcare resources.
• Inform and defend pricing decisions from credible budget-impact and cost-effectiveness analyses.
• Early health economic insight can shape your evidence generation strategy from the outset, reducing the chance of inconclusive studies and pilots and poor investments.
• Make your value stories more compelling by underpinning them with transparent economic models.
What to do now:
Identify the likely assessment route (EVA / Full guidance / TA / LSA) for your product and the decision-maker.
Define comparators, endpoints (clinical + PROs), model structure, and key budget-impact scenarios.
Perform an evidence gap analysis. Be honest about weaknesses in design, data quality, and external validity.
Generate pragmatic studies. Run prospective RWE or pragmatic trials with NHS partners, pre-specify analyses, and publish transparently.
Package for adoption. Build a compelling business case, implementation guide, and a post-adoption monitoring plan.
Evidence checklist:
• Reimbursement route identified.
• Appropriately designed study(s), with clear inclusion/exclusion criteria, strong pathway fit, and pre-specified outcomes.
• Credible comparators agreed with clinical partners.
• Health-economic value proposition and early model structure aligned to reference case and sensitivity/scenario analyses to strengthen value-for-money arguments.
• Prospective RWE/implementation protocol with milestones established.
• Adoption guide: training, IG/cyber, interoperability, deployment plan, budget-impact summary.
• Clear whole-pathway value case (costs, capacity, productivity) established.
• Phased budget-impact and early cost-effectiveness with risk-share options where appropriate.
Co-authored with Isaac Ezro, Daniel Revell-Ward and Nicholas Swart.
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Disclaimer: This briefing note is provided for general information purposes only and does not constitute professional advice. While every effort has been made to ensure the accuracy of the information at the time of writing, it should not be relied upon as the basis for any business, regulatory, or investment decision. Readers should seek appropriate professional or legal advice before taking any action based on the contents of this document.