SERENE-IoT addressed the needs of patients being followed remotely by healthcare professionals by developing, in Europe, advanced smart e-health IoT medical devices & an end-to-end architecture.
The SERENE-IoT project contributed to the development of high-quality connected healthcare services and diagnostic tools based on advanced smart healthcare Internet of Things (IoT) devices, fully manufactured in Europe. It thereby enabled a high level of ‘quality of service’ for patients being followed remotely by professional caregivers, and at a lower cost than traditional care provided today.
Background, objectives of the project and challenges
Regarding the introduction of IoT technologies, the major project objectives were:
1) development of three clinical prototypes of new medical devices supporting security, safety and privacy, and their complete validation within a secured end-to-end IoT system platform
2) provision of clinical investigation plans associated with each device
3) implementation of a secured IoT system platform to validate the three prototypes in real-world scenarios, including the proposed healthcare data structure
4) demonstration and evaluation of the benefits obtained from this new secure, remote healthcare control and monitoring system. It should be noted that a reduction in healthcare expenses was expected.
These objectives will lead to new market opportunities for the European healthcare industry by establishing a basis for the creation of new business models.
SERENE-IoT addressed three main medical challenges in the following domains:
- Remote healthcare – by moving care services from hospital to home and investigating two medical use-cases: (1) the first wearable low-power ‘Medical IoT Module’, bringing connectivity to connected infusion / nutrition pump systems in Medical Device class IIx, and (2) a post-surgery infection detection system
- Early detection – investigating a methicillin-resistant bacteria (MRSA) mobile diagnostic device
- Fall prevention – by investigating wireless insoles for gait analysis and fall prediction
In line with the medical innovation cycle up to the clinical prototype stage, three devices, one per domain (as described below), were developed and subsequently validated by healthcare professionals over the course of the project. The certification and industrialisation phases will follow the end of SERENE-IoT project under the responsibility of the relevant MedTech OEM. The main technology aspects addressed by the project were low-power, multi-protocol connectivity; end-to-end system security; interoperability; and more adequate computing power.
SERENE-IoT delivered the three following technical prototypes:
- A Medical IoT Module, investigated in two different medical devices (class IIx)
- A connected methicillin-resistant staphylococcus aureus (MRSA) detector
- A pair of wireless insoles for fall prevention
The three technical prototypes were integrated into an installation, along with the relevant dedicated platforms, at the Grenoble University Hospital (CHUGA). The complete solution, dedicated to real world use of the three prototypes, was installed in the hospital infrastructure to carry out an end-to-end demonstration in clinical settings with dedicated application layers. The Medical IoT Module was integrated with two different application layers: ‘PatHView’ dedicated to the nutrition pump case, and ‘MedAL’ for the surgical site infection (SSI) detection case. MedAL was also used with the connected MRSA detector. For the wireless insoles, the ‘Gait-F’ application layer for fall prevention was also duplicated into a ‘Gait-R’ version which was implemented in a rehabilitation use-case proposed thanks to the project collaboration.
All three technical prototypes received feedback from clinicians to enable continuation of the medical innovation cycle.
The Medical IoT Module received feedback from the artificial nutrition unit and the digestive surgery unit (of CHUGA) regarding both use cases (the nutrition pump and the SSI case). Clinical investigations on real patients were still running at the end of the SERENE-IoT project in the nutrition pump case (Medical IoT Module), highlighting the strong level of clinician interest in this prototype. The connected MRSA detector received feedback from the Hospital Hygiene Dept (CHUGA) and from KUM (University Hospital of Munich), while the wireless insoles received feedback from the Geriatrics and Ortho-geriatrics departments in CHUGA. For all the prototypes, projects are being finalised to continue the next steps of the medical innovation cycle.
Read the full impact summary here.