Case Studies

Regulatory & Human Factors

Streamlining Drug Reconstitution Enhancing Safety and Efficiency: Capa Valve

Enabled by the RTO grant from UK Edge Innovate UK Business Growth, Health Tech Enterprise has collaborated with the team at Capa Valve to carry out a rigorous usability study to evaluate how intended users interacted with two versions of the Capa Valve PFS-LS-RD (Pre-Filled-Syringe, Liquid Solid, Reconstitution & Delivery) syringe. The data from the study […]

Regulatory & Human Factors

A Liquid Biopsy Test that Screens and Predicts Cardiovascular Disease – MultiplAI

MultiplAI can now make informed, strategic decisions about their market entry and regulatory pathway. The insights provided helped the company refine their priorities and navigate the key steps required to obtain regulatory approvals.

Regulatory & Human Factors

Introducing an innovative pain management infusion pump to the UK and EU markets – Daiken Medical

Daiken Medical, a Japanese Medical Device Manufacturer, were seeking regulatory approval to launch one of their innovative patient-controlled analgesia (PCA) infusion pumps in Europe, with a particular focus on the UK market.