Medical device technology assessment

A university research team had worked for a number of years on the development of a novel interventional cardiology device. Recent progress had been made with pre-clinical testing on pigs, as well as a collaboration with a leading medical device company.  This recent activity had led the University to seek clarification on the status of the project from a third party with specialist expertise.  Alacrita was asked to provide a reality check on the status of the project, including current activities and a top level sanity check on its technical feasibility.

The following work programme was conducted to meet the objectives of the assignment:

• Technical expert review of the history of the project, its current status, the principles and technologies behind the product concept(s), and the clinical implications of the proposed innovation;
• Desk research necessary to fill any gaps in knowledge, drawing upon public domain information and Alacrita’s databases;
• Interview an interventional cardiologist (IC) in order to gain their views on the deficiencies of existing devices and the need for improvements in performance.
• Report a top level review of the technical feasibility of the proposed concept(s) to highlight any potential red flags on either performance or manufacturability.