Case Study

Arthroscopic surgical toolset for regenerative scaffold

Our client, a spin-out from the University of Cambridge and MIT, had developed products that were based on a leading collagen biomaterial platform for the production of scaffolds for cartilage, meniscus, ligament and tendon repair. The start-up came to Team to develop a device that could deliver the regenerative scaffold into the knee to encourage the simultaneous repair of both articular cartilage and the bone to which it is attached.

We arranged and conducted usability assessments with surgeons and key opinion leaders throughout the development, to understand how surgeons currently did it, the issues they face, as well as their response to the proposed designs. The designs were generated building on this valuable evidence base, developing a minimally invasive, flexible product that could prepare the site and then accurately deliver the scaffold without the need to do any terminal customisation during surgery.  As the knee joint is a complex three dimensional form it was very important that we developed a device that could make a hole perpendicular to the cartilage surface. It also needed to be easily and accurately aligned using conventional arthroscopic equipment (i.e. compensate for the restricted visibility of a 2D camera viewing from a single direction).

The delivery device needed to have the implant supplied sterile and pre-loaded. Immediately prior to delivery the scaffold is mixed with sterile fluids or autologous blood products and once it has been placed, the device is pulled away, leaving the scaffold firmly in place.

We worked with the client to manufacture moulded parts and prepare documentation for EU regulatory approval. In 2009 the company and their novel technology was acquired by TiGenix.

“Team worked closely with us to really understand the users and then ensured that the device was designed in a way that surgeons wanted and crucially kept time in surgery to a minimum. Working at the cutting edge of RegenMed, it was essential that we worked with an experienced development partner who could understood RegenMed, and could translate our science into a robust and reliable product. Plus, their advice on the regulatory side was extremely foresighted”

Andrew Lynn, founder of Orthomimetics & General Manager at TiGenix