Series of Round Table meetings results in recommendations for easing the journey of healthcare innovations as they go from idea to market.
After a year of research and Round Table discussions, the EIT Health Think Tank has released its recommendations for clearing obstacles from the “innovation pathway”, which is the journey a product or service takes from idea to market entry, and into the recipient’s hands.
The EIT Health Think Tank is a forum of experts and thought leaders collaborating to shape the future of healthcare in Europe. Think Tank participants explore a specific topic on the European health agenda each year, meeting in a series of regional Round Tables to share knowledge and ideas.
During 2019, the EIT Health Think Tank addressed the topic of “Optimising Innovation Pathways: Future Proofing for Success”. After regional Round Table meetings produced individual reports, the results have now been compiled into a single report entitled “Round Table Series: Recommendations – Future-proofing Europe’s digital health innovation pathway”.
Each innovation type – whether it is a medicine, a device or software – can take a different journey from idea to market, depending on factors such as geography, policy or regulatory requirements. For traditional medicinal products and devices, the steps of the innovation pathway in EU member states are relatively clear and well-defined. However, in recent years there has been rapid growth in a new sector: digital health products, such as software or digital diagnostic tools. The evolving landscape poses new challenges across the whole system, and these were the challenges the EIT Health Think Tank sought to address.
Throughout 2019, leading healthcare experts, innovators and partners from across Europe explored the issue in seven regional Round Table discussions. These discussions focused on unique regional concerns and solutions, and resulted in individual reports from each host country: Belgium, France, Germany, Portugal, Spain, Sweden and UK. In parallel, EIT Health developed findings through desk research and interviews with those working in healthcare, and other relevant stakeholders. The knowledge gathered from the Round Tables and the research is contained in one main report, which addresses the situation from a pan-EU perspective.
The key findings
Feedback from the Round Table discussions identified several key aspects that need to be addressed to optimise the pathway for digital health technologies and deliver impactful health solutions to citizens:
- Clear regulatory requirements for digital health technologies should be developed with appropriate stakeholder involvement.
- Evidence requirements for Health Technology Assessment (HTA) of digital health technologies should be developed with appropriate stakeholder involvement.
- Regulatory and HTA processes and requirements for digital health technologies should be aligned with each other and communicated to all stakeholders.
- A Europe-wide approach to HTA of digital health technologies should be implemented with the proposed legislation for sustainable EU cooperation on HTA.
- “Process standards” rather than “product standards” are needed to account for the continuous innovation and evidence-generation required for digital health technologies.
- The ability to regulate and assess an integrated system and methods, not just individual products, is required.
- There is a need for a process for continuous evaluation, surveillance (similar to post-marketing pharmacovigilance) and where necessary, disinvestment of obsolete technology. This can help reassign valuable, and often scarce, resources to identify new needs and innovations.
Read the report
To learn more about the 2019 Think Tank process and findings, and to download the main publication as well as the seven Round Table reports, please visit this page.
This article was first published on 3 June by EIT Health.