A leading orthopaedic manufacturer asked for assistance to develop a novel idea for the treatment of osteonecrosis. The device and surgical approach were completely unique to any current design which they manufactured and the product was very price sensitive.
The initial approach involved gathering suitable data from which to clearly define the project which was obtained through the markets and surgeons using a mixture of questionnaires and interviews. Design inputs were obtained from a selected group of surgeons and a suitable value proposition prepared. One of the main challenges of the project was the ability to design and manufacture a product to meet the relatively low cost so that it could be positioned correctly in the market and be suitably reimbursed. Fruition developed the necessary instrumentation so that a truly minimally invasive approach would be used and is repeatable independent of surgeon ability. To manufacture the implant a unique design was developed including the design and manufacture of a new machine which cut the initial manufacturing time from 3 to 4 hours to 20 minutes. All designs were proven through extensive testing to complete the risk management documentation necessary for regulatory submission and CE compliance.
The new implant system has been developed so that it can be positioned correctly within the very price sensitive market of the Asia Pacific region. All the necessary risk management has been conducted to initiate a clinical study for the system. In order to protect this unique idea throughout the development Fruition has transferred 7 patents to the client for the instruments, implant and process.