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Health.E Lighthouse Support Initiative

Periodic Reporting for period 1 - HELoS (Health.E Lighthouse Support Initiative)

Reporting period: 2019-07-01 to 2020-09-30

The objective of the HELoS CSA is to support the Health.E Lighthouse Initiative Advisory Service (LIASE) in its ambition to accelerate innovation in medical devices (“Moore for Medical”). Health.E will accelerate the innovation in medical devices and systems by stimulating the development of open technology platforms and standards , thereby moving away from the inflexible and costly point solutions that presently dominate electronic medical device manufacturing. Open technology platforms, supported by roadmaps, will generate the production volumes needed for sustained technology development, resulting in new and better solutions in the healthcare domain. Health.E will:
• Translate the needs of medtech and pharma into opportunities for ECS (electronic components and systems);
• Build on the ECS Strategic Research Agenda and identify the gaps;
• Stimulate initiatives:
- towards open technology platforms and standards for medical devices;
- to anticipate the requirements for regulatory, Notified Bodies, clinical trials and market access;
- to better apply to the current care practices, necessary conditions for market access.
• Connect to European initiatives and relevant communities including PPPs such as ECSEL, IMI, Eureka, and relevant industry associations.

In the HELoS CSA, three main components are identified that need to be connected in order to address the complex issue of innovation in the medical industry:
• Connecting existing networks: ECSEL projects, (inter)national and regional projects and initiatives;
• Addressing and connecting scientific/technical issues and non-technical aspects e.g. legal, regulatory, standardization, ethical, economic (cross-cutting issues);
• Extending the network of stakeholders and markets across Europe (spreading excellence, facilitating international collaboration, new applications);
• The dissemination of the results of this initiative to the stakeholders and the general public.
The main objective of the first 15-month period of HELoS was to set up a community of stakeholders of the Health.E domain. This was done by means of the following activities:
• The coordinators of 14 European cooperative projects (Horizon 2020, ECSEL, PENTA) in the healthcare & ECS field were invited to join the Health.E Lighthouse initiative. They provided information on their projects and shared their views and input on technology requirements for emerging medical domains.
• A White Paper has been prepared on the identification of 13+ emerging medical domains that can be served now and in the future by the ECS industry. This White Paper will be released in the public domain.
• An online workshop was organized in September 2020 with the objective to develop a vision for the Health.E community. It was attended by 49 participants, representing the HELoS consortium, industry, RTOs, universities, the European Commission (DG RTD and DG CONNECT), and the ECSEL Joint Undertaking. The following questions were addressed:
- Which Open Technology Platforms in ECS for medical devices are under development? What is the technology offering resulting from projects?
- Do they fit the future needs of the emerging medical domains identified?
- What is missing?
The results of the workshop have been incorporated and elaborated in the White Paper.
The Health.E Lighthouse, supported by the HELoS CSA, as an initiative to bring together a community of industries, universities, research institutes, healthcare organizations and policy makers, is unique in its kind in Europe and the world. In this way, a European ecosystem has been created that has the capability to identify and build open technology platforms that will enable and accelerate ECS-driven innovation in emerging medical domains. This will constitute the technological backbone for the digitization of healthcare in the digital age.