Conducting due diligence on a novel interventional cardiology device

Challenge

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 preclinical testing on pigs, as well as a collaboration with a leading medical device company. This recent activity led the university to seek clarification on the status of the project from a third party with specialist expertise. The team needed a reality check on the status of the project, including current activities and a top-level sanity check on its technical feasibility.

Solution

We conducted the following 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, drawing upon public domain information and our databases.
• Interview with an interventional cardiologist to gain their views on the deficiencies of existing devices and the need for improvements in performance.
• A top-level review of the technical feasibility of the proposed concept(s) to highlight any potential red flags on performance or manufacturing.

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