Thanks to their integrated diagnostic capabilities, may help to address hitherto unmet medical needs
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 "Unlocking the full potential of new tools, technologies and digital solutions for a healthy society". To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes.
- Medical device developers provide sustainable and affordable smart active implants validated in the operational environment.
- Medical professionals in resource-constrained clinical settings use sustainable and affordable surgical procedures for smart active implants.
- Patients have access to sustainable and affordable smart medical devices suitable for minimally invasive surgical implantation through further clinical studies.
"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, may help to address 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, depending 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. orthopedic, neural, cardiovascular, metabolic, etc.), but should at the start of the proposed work be at a TRL of a minimum of 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.