Advanced pre-clinical and pre-surgical assessment of musculo-skeletal medical devices

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Background

The orthopaedic implant market is worth in excess of €30B per annum globally with articulating joint replacements representing the largest orthopaedic sector. Growth in the sector of between 2% and 5% is expected over the near term due to the rapid demographic shift. Pre-clinical assessment, both experimental and in silico, is a series of necessary steps for the development, optimisation and validation of medical devices. It comprises the testing of implants using assessments that conform to agreed standards as well as those that are more bespoke and focus on the specific requirements and perceived usage of the device. However, once introduced the new technologies are not always successful clinically and may harm the patient. This may require an expensive intervention to correct the loss in the patient’s quality of life and greater mortality risk. These deficits in implant outcomes have brought into focus the role of pre-clinical simulation and the wider regulatory science that supports these activities.

The goal of the research topic is how best to facilitate improvements in pre-clinical in silico, in vitro and in vivo testing within an orthopaedic context to allow a reduction in the adverse events that occur in implants once marketed. Such advances maybe accrued through advances in the measurement, analysis and deployment of real world data that can better define the scenarios in which the implants are used, more advanced simulators that can mimic adverse scenarios across a range of input conditions and the greater deployment of in silico tools with which to identify possible mechanism of failure. It will also explore how the combination of technologies can be combined to streamline the future R&D cycle. In silico tools provided a range of possibilities but also a range of challenges in relation to validation, appropriate inputs and the overall association to experimental science to allow a more effective support for the pre-clinical testing process. This is underpinned by a desire for an accelerated product introduction process achieved at less risk and reduced cost to the implant manufacture and the wider community.

The scope of the research topic is defined by the novel and innovative processes and technologies that may allow a more effective and robust pre-clinical testing process within the musculo-skeletal context. Sub topics could include:

1. The development and utilisation of pre-clinical testing regimes that incorporate a fuller appreciation of the degradation mechanisms occurring at both articulating and non-articulating surfaces within medical implants.
2. Pre-clinical testing regimes that reflect the burgeoning non-wear related failure mechanisms in orthopaedic implants such as those that focus on stress-shielding/bone modelling/remodelling and/or implant position factors.
3. Novel bioreactor systems for the pre-clinical testing of tissue-engineered or natal tissue implants.
4. How novel pre-clinical assessment of nano-particle/biological processes can enable compliance with the newly implemented MDR regulation.
5. Models that identify patients at risk of a skeletal deleterious event and/or advancing pathology, which allows personalisation of the treatment process, identification of the appropriate intervention and reduce the need for unnecessary surgery.

Keywords: in situ techniques, sensing, advanced biomaterials, real world data, regulatory science and standards, functional simulation, in silico simulaiton, medical implants, orthopedic implants

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