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 and KDT 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.
