Development of an instrumented hammer to assess the stability of hip implant during surgery: assessment of the commercial feasibility

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Total hip replacement is widely used by orthopedic surgeons, with more than one million procedures per year worldwide. Failures still occur because of a bad implant primary stability or to the occurrence of fractures, inducing pain and increased costs for the healthcare system. Although implant primary stability is the main determinant of the implant success, it remains difficult to be assessed in clinical practice. Impactor is based on results obtained in the ERC CoG project BoneImplant and aims at developing and validating a medical device consisting in a decision support-system allowing the surgeon to assess the stability the acetabular cup and of the femoral stem. Such medical device is needed by the clinicians in order to adapt their surgical strategy. The objective of Impactor is i) to achieve a minimum viable product (MVP) that will be validated in vitro and in anatomical subjects, and ii) to investigate its commercial potential and design a subsequent commercial exploitation strategy via spin-off creation or licensing of the technology. We will explore the possibility to license the technology to WaveImplant, an already existing spin-off of the same laboratory. The originality of the approach is to use an orthopedic hammer instrumented with piezoelectric sensors, which does not modify the clinical protocol since implants are impacted in bone. Regulatory issues will be at the heart of the development and we will work in order to clear the regulatory pathway of the future medical device. The team is constituted by members with complementary skills (including engineers, a business developer and an orthopedic surgeon expert in implantology). Impactor will allow the promotion of innovative solution and services in orthopedic surgery. The long-term vision is for the technology to become a reference in orthopedic surgery. Strong impacts are associated to Impactor, in particular for surgeons, patients, implant manufacturers, the technology and the economy.