Delivered on 40+ projects, bringing PoC and OTC products to market
We help innovators chart the course to bring diagnostic solutions closer to the patient—whether at the point of care, in urgent care and clinic settings, or through over-the-counter access. Our team blends deep regulatory insight with hands-on experience guiding CLIA-waived studies and submissions, navigating the distinct pathways that decentralized testing demands. We understand the performance, usability, and workflow challenges unique to these environments and design studies that meet those requirements without compromise. From early feasibility through FDA clearance, we provide the strategic direction and operational precision to steer your program confidently from concept to market—ensuring diagnostics that perform reliably wherever care is delivered.
PoC, OTC and Urgent Care Projects
Regulatory, clinical and quality projects
WHERE WE SHINE
Markets
The MDC team has worked with IVD manufacturers across a wide range of therapeutic areas helping to bring diagnostics innovation to market where it’s needed most to impact patients.
Infectious Diseases & Microbiology
Partnered with 40+ infectious disease, microbiology and women's health firms
Clinical Chemistry & Hematology
CLIA-waived, PoC & OTC
Experts after 60+ projects in point of care and over-the-counter testing