Smart medical devices and their surgical implantation for use in resource-constrained settings

“Smart” technologies, i.e. micro-electronic sensor/actuator systems provide novel functionalities to surgically-implanted active medical devices. “Smart” active implants involve microelectronic components and are placed inside the body of the patient to achieve the desired physiological response. They open up therapeutic avenues for a wide range of medical handicaps, complex chronic conditions and lesions, thanks to their integrated diagnostic capabilities, and may help addressing hitherto unmet medical needs. Challenges involved in the development of these devices include but are not limited to miniaturization, sensor robustness, wireless power supply, etc. Such devices require specific surgical implantation procedures, dependant on the type of device and on the intended use, with the successful surgical implantation and activation of such smart medical implants, being crucial steps for their functioning. The device targeted and its intended use is open for applicants to choose (e.g. orthopaedic, neural, cardiovascular, metabolic, etc.), but should at the start of the proposed work be at a TRL of minimum four and will necessitate appropriate tailored surgical procedures and interventions. Surgical conditions account for approximately 30% of the global burden of disease and have a huge social and economic impact. However, of the 300 million surgical interventions undertaken globally every year only around 6% occur in low-income countries, where a third of the world’s population lives. There is therefore a strong need for high-quality, affordable surgical interventions for implanting “smart” active medical devices suitable for resource-limited or -constrained clinical settings. Resource-constrained settings are clinical environments that are affected by limitations such as lack of medical staff, scarcity of medical equipment or medicines supply, etc. To address this gap, the sustainability of both the medical device and the applied surgical intervention, including the necessary equipment and operating skills, are essential elements. Implantation procedures should be fully compatible with resource-constrained environments and minimally invasive approaches should be favoured. Hence, research and innovation activities should comprise medical device design, regulatory work, clinical stages and developmental iterations, reaching a TRL of at least seven, and involve key medical specialists (e.g. surgeons) and/or other health care professionals, developers, patients and relevant regulatory bodies as appropriate. The work proposed should take into account the new EU legal framework on medical devices with the targeted implants meeting all the essential requirements as defined therein.