Medical device clinical trials have unique challenges โ narrow patient populations, device-specific eligibility criteria, post-market surveillance requirements, and FDA IDE/PMA timelines that punish every enrollment delay. Hekma is built for this.
Device-specific match precision: CPT codes + UDI + surgical notes
Who This Is For
Medical device and MedTech companies (Class II and Class III devices, SaMD, combination products, implantables, diagnostics, surgical robotics) running FDA-required clinical studies, IDE trials, PMA studies, or post-market surveillance (FDA 522, PMCF, registry studies).
Example
Looking for patients with confirmed moderate-to-severe aortic stenosis who have not had prior TAVR/SAVR and are surgical candidates per STS score? We run that exact query across our hospital network using CPT codes and clinical notes โ not just ICD-10 diagnosis codes.
The Device Trial Problem
Problem: Narrow patient criteria with implant and procedure history requirements
Why It's Different
Device trials do not just filter on diagnosis โ they filter on prior procedure, implant type, device manufacturer, surgical approach, and anatomical specifics. Social media ads cannot do this.
How Hekma Solves It
Hekma pulls CPT procedure codes, device UDI data, and surgical notes from hospital EHRs. We match against your device-specific I/E criteria at precision no campaign can touch.
Problem: Site selection is device-specific
Why It's Different
Your trial needs sites with the right surgical team, OR infrastructure, and device training program. A patient database that ignores site capability is useless.
How Hekma Solves It
We map patient population to sites with verified device capability โ surgical volume, implant training status, board certifications. Patients at the right sites.
Problem: Post-market surveillance requirements
Why It's Different
FDA 522 studies, PMCF, and registry studies require multi-year patient tracking. Most CTMS platforms aren't built for longitudinal follow-up.
How Hekma Solves It
Hekma CTMS supports multi-year tracking with automated follow-up scheduling, PRO collection, device performance monitoring, and AE surveillance โ aligned to ISO 14155 and EU MDR/IVDR.
Regulatory Alignment
CPT codes, UDI data, surgical notes, and post-market surveillance โ all covered in one platform.