Case Study

EU Market Access and Evidence Collection Strategy for Non-Invasive Platform for Women’s Health Application


A medical device company developed a non-invasive, image-guided platform in women’s health to be used as alternative to currently established surgical and minimally invasive options. The procedure, performed in the ambulatory setting, is safe and is associated with a speedy recovery time relative to alternatives. The device company needed an EU market access and evidence development strategy and a work around for a firmly entrenched standard of care.

Boston Healthcare Approach

There was a negative perception of platform because a previously launched competitor failed to capture market and routine funding. Also, there was a minimal evidence base and turf battle challenges between gynecologists (performing standard of care) and radiologists. Boston Healthcare’s in-market teams conducted primary research with key influencers and purchasers at national, regional and local levels. We profiled competitor coding, HTA and access positions, and performed a literature search to define the clinical, economic, and patient-reported outcomes (PRO) associated with treatment of condition, and evaluated the economic value proposition of procedure.


The medical device company is now exploring uses in more favorable applications areas. There is now considerable interest in platform, especially in areas with broader clinical impact. Currently, evaluating a coverage with evidence development strategy in Germany.