The Work Packages (WPs) of the ETERNITY program are consistent with a large industrial development program in the area of future medical systems and devices. The ESRs will be trained to work in multi-disciplinary and multi-cultural teams, with a new mindset tuned towards the inclusion of the three main elements of a risk-based approach into innovative design methods (e.g., concurrent engineering and agile/scrum design methods). For this inclusion to occur, each ESR will develop through their research the missing dedicated tools and techniques and apply them to a representative set of medical devices under development. This hands-on training is supplemented with several scientific professional courses and an immersive training where the ESRs can fine-tune their interpersonal skills, while addressing the societal challenges (SCs) of the ETERNITY program.
The solid diversity of industrial cases, covering most of the relevant environments and devices, at different stages of the design process, will ensure that the network runs smoothly, while strengthening the interactions and the exchange of academic and non-academic resources. From the regulatory perspective, ETERNITY covers all 4 key medical environments: hospital, homecare, transportation and the special environment of medical imaging and treatment systems.
The proposed research network consists of academic and industrial Beneficiaries and Partners Organisations, (representative of the medical technology sector), ensuring all the required application expertise are present in the program. A total of 14 individuals projects have been defined, which contribute to one or more WPs. Through their project definition and their (common) secondments, each ESR will have a mix of requirements, design and system-level verifications. While each ESR project has been defined as a stand-alone contribution, several collaboration points have been planned to bring complementary results together and give extra value-added to the project. The inter-relation between each ESR projects and their corresponding core WP are described below.
WP1: Electromagnetic Risk Identification
WP1 focuses on the left part of the risk-based approach’s V-model (Figure 3), i.e., the identification of EMI-related risks and their criticality. The goal is to characterize the EMI-related risks stemming from the operating electromagnetic environment and/or the susceptibility of the medical system under development. ESRs 1 and 2 will develop approaches to effectively characterize a medical environment in terms of EMI risks for general medical devices (ESR1) and digital communication systems (DCS) (ESR2) more specifically. Complementary to that, ESR3 will work on holistic methods to identify EMI risks for large medical systems comprising multiple devices.
WP2: Electromagnetic Risk-Reduction Methodologies
WP2 contributes to ETERNITY’s second step in the risk-based approach with techniques and measures (T&Ms) that effectively reduce the EMI risks (identified with the methods of WP1) to the level that they are acceptable for safety. Methodologies in hardware, middleware and software are considered. ESR4 will directly support the designers of medical systems with the risk-based EMI-aware design of medical systems, while ESR5 and ESR6 will work together on increasing the EMI-robustness of medical devices by ensuring the EMI resilience of wireless communication systems.
WP3: Validation & Verification Methodologies (WP3)
WP3 completes the risk-based approach’s V-cycle and targets novel methodologies to verify, validate and argument that the applied risk-reduction (WP2) effectively addresses the identified risks (WP1) over the full lifecycle. ESRs 7 and 8 have roles that run parallel to those of ESRs 1 and 2 in WP1. On the one hand, ESR7 takes up the challenge to establish equivalent, reconfigurable, simple, set-ups that reproduce the complex interactions (for diverse scenarios) that a medical device encounters in its real environment. On the other hand, ESR8 will define time-domain EMI immunity tests that consider multiple, transient interference sources and, as such, increase the EMI testing coverage for medical DCS. While ESRs 7 and 8 mainly consider verification and validation before system deployment, ESR9 will focus on EMI verification and validation after system deployment with novel low-cost EMI sensors that continuously monitor the EMC environment as well as the effectiveness of the applied EMI risk-reduction techniques during operation.
WP4: Application Case Studies
WP4 pilots ETERNITY’s risk-based EMI approach, combining the previous 3 WPs. In total, 4 ESRs will be working on case studies covering the full design cycle from early concept to final certification, in 4 different medical environments (hospitals, homecare, transportation, and “special environment” in which medical imaging and treatment systems operate). These case studies will not only use the results of the ESRs from WPs 1–3, but also provide them with essential practical feedback.