An orthopaedic company wanted to relaunch a monoblock hip stem which they had previously sold. The need was driven for a low priced option so costs had to be minimized and controlled.
The last time the implant was manufactured was in 2009 since which the standards and requirements have significantly changed. All new tooling and instrumentation was required to make the implant and the technical file compiled for suitable CE compliance.
The original designs were checked and new castings validated for each size. The manufacturing process for the part had to be designed and validated including machining, polishing, finishing, cleaning and packing. New packaging was designed to reduce the overall cost and this was tested and validated. A new technical file was produced in accordance with ISO 13485 and 14971 and complied to the new MDR 2017/745. Fruition provided the engineering and project management resource for this project to ensure it was delivered to cost and schedule.
- 19 SKU’s launched
- Instrumentation manufactured for launch
- 7 months from initiation to launch
- Cost target achieved