Awarded grant funding by the TSB of £250k for a £559k project
As an approved supplier to one of the largest orthopaedic implant manufacturers in the world, InterVision Global have identified a market need for a flexible inspection system for orthopaedic implants. The proposed Automated Implant Verification & Identification System (AIVIS) will be able to verify the product and size type as well as uniquely identify the component with a laser mark for identification and serialisation.
Wrong labelling and manufacturing issues contributed to the recall of 1287 knee and hip replacement implants between 2002 and 2013 in the US, which is why medical device regulations demand that processes are properly validated.
This project develops a fully-automated prototype that can verify & laser mark batches of 1-20 different implant components. By qualifying the system software to GAMP guidelines in advance for use with different product families, the lengthy development process is significantly reduced to allow new products to come to market more quickly & all new programs to leverage the systems’ current validation.
Throughout the project TBAT supported progress through:
– Generation of Project Monitoring documentation at Project Kick Off
- Second Level Plan
- Risk register
- Exploitation Plan
- Project Spend Profile
– Project Plan development, review and financial forecasting
– Attendance at Quarterly Review meetings
– Point of contact with Innovate UK Monitoring Officer
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