We’re excited to share that our former colleague Stine Pearson has led a new publication in the International Journal of Technology Assessment in Health Care, with contributions from NHTA’s Anders Mærkedahl and an excellent team of co-authors.
Title: Assessment of Medical Device Features in Health Technology Assessment: A Review of NICE Medical Technology Guidance
Read the full paper: https://doi.org/10.1017/S026646232510041X
What the study explored
The research reviewed all 68 Medical Technologies Guidances (MTGs) published by the UK’s National Institute for Health and Care Excellence (NICE) between 2010 and 2023, aiming to identify what factors influence whether a medical technology is recommended for routine clinical adoption.
Key findings
- Evidence matters most: The only factor significantly linked to recommendation was whether product claims were directly supported by clinical evidence — regardless of study type or quantity.
- The number or type of claims, or even the presence of RCTs, did not predict recommendation outcomes. However, we see a trend, that a few good and targeted claims are better than many.
- Lack of sufficient evidence was the main reason for non-recommendation (in 86% of cases).
Why it matters
For MedTech developers, the message is clear:
Success in HTA and market access isn’t just about having strong clinical results — it’s about aligning your access and evidence strategies from the very beginning. This means:
- Using the PICO framework (Population, Intervention, Comparator, Outcomes) to ensure your evidence directly supports your product claims.
- Starting early in the product development phase so that market access needs shape your evidence plan, not the other way around.
- Planning studies around key milestones, ensuring data is available when it’s most critical for decision-making.
- Knowing the reimbursement pathways in your target markets early, so your evidence speaks directly to payer requirements.
By connecting claims, evidence, and access strategy early, you increase your chances of achieving a favourable reimbursement decision or HTA recommendation — and ultimately, of getting innovative technologies to patients faster.”
