Periodic Reporting for period 2 - HELoS (Health.E Lighthouse Support Initiative)
Periodo di rendicontazione: 2020-10-01 al 2022-04-30
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 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.
• 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.
A first workshop was organized online in September 2020. It was attended by participants from RTOs, projects connected to the lighthouse, and other stakeholders, such as policymakers and healthcare organizations to come to an inventory of emerging medical domains relevant to the ECS community. This resulted in the following un-prioritized list:
• Bioelectronic medicines
• Organ-on-Chip
• Personal ultrasound
• Radiation free diagnostics and interventions
• Smart minimally invasive instruments
• Second generation of surgical robots
• Smart drug delivery
• Intelligent wound care
• Ambulatory monitoring
• Point-of-care diagnostics
• Remote sensing and monitoring
• E-Health
• Advanced therapies using genes, cells and tissues
In a first white paper published by the Health.E lighthouse “Emerging Medical Domains for the ECS industry” these emerging domains are presented in an attractive way accessible to non-experts, and their societal relevance and relevance to the ECS industry are discussed.
A second online workshop was organized in May 2021 to analyse and collect recommendations on how these emerging medical domains can be served by the ECS industry. The basic message is that innovation in healthcare can be accelerated if the lessons learned in microelectronics (“Moore’s Law”) are applied in the healthcare domain (“Moore for Medical”). For this to happen it is essential to share pre-competitive technology know-how across the multidisciplinary value chain of technology providers (industry, academia, institutes). This will enable the creation of open technology platforms that can be utilized to stimulate innovation in healthcare in the fastest, most expedient and most cost-effective way.
A number of possible challenges were identified that have to be addressed in the process of setting up open technology platforms for the (micro) fabrication of ECS-based medical devices. These are the following:
• Ownership and financing
• Ease of use and access
• Duplication and benchmarking
• Excellence versus innovation
• Product lifecycle
• Data platforms
• Regulations and certification
These challenges and how they can be tackled, together with recommendations on how the ECS industry, the healthcare community and policymakers can cooperate in the best way to stimulate the creation of open technology platforms are discussed in the second whitepaper published by the Health.E Lighthouse, entitled “Open Technology Platforms for Emerging Medical Domains.”
Finally, these two white papers and the experiences of projects, industry, RTOs and policymakers related to open technology platforms for medical devices were shared in a public symposium, which took place on 8-9 March 2022 at High Tech Campus in Eindhoven the Netherlands with more than 150 participants.
In a third and final white paper, intended for policymakers, a top five prioritization of the emerging medical domains was made based on their relevance for the ECS community. In this document, recommendations are given to bridge the gaps in the Strategic Research Agenda for European leadership.
The white papers published by the Health.E Lighthouse are available at Publications | Health E (health-lighthouse.eu).
• Bioelectronic medicines
• Organ-on-Chip
• Personal ultrasound
• Radiation free diagnostics and interventions
• Smart minimally invasive instruments
• Second generation of surgical robots
• Smart drug delivery
• Intelligent wound care
• Ambulatory monitoring
• Point-of-care diagnostics
• Remote sensing and monitoring
• E-Health
• Advanced therapies using genes, cells and tissues
In a first white paper published by the Health.E lighthouse “Emerging Medical Domains for the ECS industry” these emerging domains are presented in an attractive way accessible to non-experts, and their societal relevance and relevance to the ECS industry are discussed.
A second online workshop was organized in May 2021 to analyse and collect recommendations on how these emerging medical domains can be served by the ECS industry. The basic message is that innovation in healthcare can be accelerated if the lessons learned in microelectronics (“Moore’s Law”) are applied in the healthcare domain (“Moore for Medical”). For this to happen it is essential to share pre-competitive technology know-how across the multidisciplinary value chain of technology providers (industry, academia, institutes). This will enable the creation of open technology platforms that can be utilized to stimulate innovation in healthcare in the fastest, most expedient and most cost-effective way.
A number of possible challenges were identified that have to be addressed in the process of setting up open technology platforms for the (micro) fabrication of ECS-based medical devices. These are the following:
• Ownership and financing
• Ease of use and access
• Duplication and benchmarking
• Excellence versus innovation
• Product lifecycle
• Data platforms
• Regulations and certification
These challenges and how they can be tackled, together with recommendations on how the ECS industry, the healthcare community and policymakers can cooperate in the best way to stimulate the creation of open technology platforms are discussed in the second whitepaper published by the Health.E Lighthouse, entitled “Open Technology Platforms for Emerging Medical Domains.”
Finally, these two white papers and the experiences of projects, industry, RTOs and policymakers related to open technology platforms for medical devices were shared in a public symposium, which took place on 8-9 March 2022 at High Tech Campus in Eindhoven the Netherlands with more than 150 participants.
In a third and final white paper, intended for policymakers, a top five prioritization of the emerging medical domains was made based on their relevance for the ECS community. In this document, recommendations are given to bridge the gaps in the Strategic Research Agenda for European leadership.
The white papers published by the Health.E Lighthouse are available at Publications | Health E (health-lighthouse.eu).
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.