1、EUROPEAN REPORT 2020 Round Table Series: Recommendations Future-proofing Europes digital health innovation pathway Start reading Table of contents Conclusions Round Table meeting feedback The purpose of the EIT Health Think Tank Round Table series Round Table series 2019 overview The purpose of the

2、EIT Health Think Tank Round Table series The EIT Health Think Tank is a forum of experts and thought leaders collaborating to shape the future of healthcare in Europe. This could ultimately ensure patients and citizens have access to healthcare innovations that could potentially transform outcomes.

3、Each year a topic high on the European health agenda is selected for deeper exploration in meetings, which take place at Round Tables across the EIT Health regions. These draw on the experience, knowledge and skills of experts from EIT Healths broader community. These regional meetings focus on spec

4、ific local needs, opportunities and barriers, while also identifying successful solutions and examples of best practice that could be replicated at a European level. The Think Tank aims to ensure that expert recommendations are translated into realistic and meaningful outcomes, accelerating innovati

5、on in health for the benefit of all European citizens - so they are able to live longer, healthier lives. Round Table series 2019 Overview THINK TANK TOPIC For the 2019 Think Tank Round Table Series, participants discussed the topic Optimising Innovation Pathways: Future Proofing for Success. The in

6、novation pathway describes the progress healthcare innovations make from a need and an idea to a product or service on the market that is adopted, or even becomes the standard of care. For traditional medicinal products and devices, the steps of the innovation pathway in EU member states are relativ

7、ely clear and well-defined. However, in recent years there has been rapid growth in a new sector: medical and health technology products, such as software or digital diagnostic tools. The evolving landscape poses new challenges across the whole system. These include: product development, testing, ge

8、neration of evidence, proof of value, implementation, usability and adoption of these novel medical and health technologies. Innovators and other stakeholders developing these products can often face difficulties in achieving widespread adoption, due to local procurement barriers or other infrastruc

9、tural challenges. Such barriers can delay potentially impactful solutions from reaching patients and citizens. Optimising Innovation Pathways: Future Proofing for Success was chosen to address these challenges, as well as accelerate and streamline the sustainable adoption of innovations for the bene

10、fit of patients and citizens. Round Table series process for 2019 Seven Round Tables were held across Europe in 2019 across Belgium, France, Germany, Portugal, Spain, Sweden and the UK. Each meeting aimed to identify, clear, actionable recommendations to improve the pathway process. Each EIT Health

11、region was asked to select a specific innovation type as a focus for their Round Table based on the regional or national health innovation landscape either hardware technologies, digital health or healthcare solutions. For the 2019 Round Table Series, all regions selected digital health. For the pur

12、pose of the Round Tables, digital health was defined as software- based solutions that focus on healthcare interventions (related to patients or users health). These solutions are classified as: Medical devices, regardless of the kind of technology, if they have a medical indication (diagnostic, pre

13、vention, therapeutic, etc.). Wellness products, if they do not have a medical indication. ROUND TABLES 2019 THE ROUND TABLE SERIES To provide additional context and background for the Round Table discussions in 2019, desk research was undertaken to examine the digital health ecosystem in each region

14、, the current innovation pathway, key stages and gatekeepers, and the requirements that need to be met to move through the pathway. To incorporate their perspective in the discussions, local innovators within the EIT Health Partner community, with experiences of navigating the pathway, were intervie

15、wed. This information was used to help map the existing pathway process, and provide insight into the practicalities of working through the pathway in the real-world setting. To allow comparative analysis of the discussions and recommendations between regions, the Round Tables had a common agenda. S

16、ESSION I Based on EIT Healths research findings, the proposed description of the digital health innovation pathway in the region was reviewed and participants discussed whether it reflected todays reality. SESSION II The individual phases of the innovation pathway in the region were discussed and su

17、ggestions made for how these could be optimised; best practices in each phase were identified. SESSION III A list of proposals for actionable recommendations for each of the pathway phases was developed, identifying key stakeholders where possible. In healthcare, the best-known pathway is for pharma

18、ceuticals. This particular pathway is characterised by regulatory and cost-effectiveness assessment or reimbursement approval, along with several phases of development and clinical trials, before entry to market. Other health technologies, such as digital health technologies, share a comparable regu

19、lated environment. Pathways for these innovations are also assumed to follow similar milestones, progressing from an idea until a product or solution becomes widely adopted by the market. Based on the desk research, a proposed innovation pathway for digital health was developed for discussion at the

20、 Round Tables. The pathway took into account where certain additional milestones are relevant, such as assessments of the impact on healthcare budgets or cost-effectiveness. The resulting framework is a genericised pathway to develop innovations in the digital health field; starting with the clinica

21、l need and idea, progressing through development, market entry, and eventually adoption (Figure 1). Although often considered a linear path towards successful and sustainable adoption of the innovation, it is in fact a continuous (often reiterative) and cyclical pathway, where certain steps can be r

22、evisited or repeated to support continuous research and development, and the design and development of new innovations. Round Table meeting feedback MAPPING THE CURRENT INNOVATION PATHWAY FOR DIGITAL HEALTH PHASEIDEATIONDEVELOPMENTMARKET ENTRYADOPTION NEEDIDEA PROOF OF CONCEPT PROOF OF FEASIBILITY P

23、ROOF OF VALUE INITIAL CLINICAL TRIAL VALIDATION OF SOLUTION APPROVAL AND LAUNCH CLINICAL / COST ASSESSMENT STANDARD OF CARE REIMBURSEMENTOBSOLESCENCESTAGE 8725 Developing a proposed innovation pathway framework for digital health1. FIGURE 1 Although the development of innovation in health

24、care faces the same challenges as other high-technology innovation areas, the complexity of the stakeholders involved, the regulatory barriers to market entry and the complex processes associated with market adoption create a shared pathway which innovators must navigate. This often involves passing

25、 three Valleys of Death or Desert Crossings for innovations points at which a new idea going through the pathway may fail to progress. These work as either gateways or major barriers: INNOVATION VIABILITY Do you have the required resources and can you make an assessment of whether it is both commerc

26、ially viable and sustainable? MARKET APPROVAL Do you have the ability to scale-up the product and meet requirements from regulators? MARKET ADOPTION Will your product be used and adopted in the clinical setting? Will it be reimbursed/procured by those who purchase healthcare (ie payors)? FIGURE 1. (

27、ON PREVIOUS PAGE) The Innovation Pathway as presented at the Round Table Meetings ROUND TABLE MEETING FEEDBACK IDEATION GRASPING THE UNMET NEED The ideation phase relates to when the innovation is being created. At this time, innovators must be able to articulate a clear potential solution to an exi

28、sting problem, which addresses current shortcomings (an unmet need or a limited existing solution). Innovators must also contribute to new approaches to healthcare. The innovation should result from a specific identified or validated unmet need by healthcare professionals, patients or citizens. The

29、key question innovators must answer in this phase is: Does my technology help solve an identified clinical need? ROUND TABLE MEETING FEEDBACK DEVELOPMENT DE-RISKING TOWARDS THE MARKET The development phase is vital to take the idea, or initial prototype of the innovation, into a product that can be

30、made available to users. This is the phase for thinking about what resources are needed to move it forward into the market. The development phase is also the time to align with other relevant stakeholders, avoiding later failures which could have been dealt with earlier in the pathway (either by add

31、ressing them early on, or by pivoting to other ideas due to new insights or priorities). This is a phase common to all innovators, regardless of their geographical location. The main differences between countries are the supporting resources available, and existing networks to reach out to all stake

32、holders. The critical question innovators must answer in this phase is: Do I believe the product can be taken into the market in a viable way? ROUND TABLE MEETING FEEDBACK MARKET ENTRY VALIDATION OF GATEKEEPERS REQUIREMENTS The market entry phase is about being able to deliver the innovation in a sc

33、alable way, while maintaining quality, and generating and collecting supporting evidence for the market. This is a key stage of the pathway, given the oversight from regulatory bodies and the requirement of the right evidence that demonstrates the product works and is safe. Wellness products do not

34、need any additional approval to start selling, but medical devices require marketing authorisation before any commercial activity. Increasingly, even non-medical devices may now be required to collect impact evidence. At this stage, innovators need to have the required regulatory pathway confirmed,

35、as many innovations can fit into one or other category, depending on product claims and function. What evidence needs to be collected depends on how the digital health solution is categorised. This dictates whether healthcare systems will pay for it and make it available. Given the increasing costs

36、of compliant clinical trials, regulatory filings, or engaging with partners, the development phase is critical to avoid unnecessary changes and failures. The key question innovators must answer in this phase is: Can I scale delivery while assuring quality and safety? What evidence do I need to meet

37、regulators and the target stakeholders requirements? ROUND TABLE MEETING FEEDBACK ADOPTION GAINING ACCESS, BUSINESS SUSTAINABILITY AND WIDER DISSEMINATION Adoption has become one of the main challenges for innovators today. Meeting regulatory requirements, then reimbursement, followed by adoption is

38、 no longer a valid expectation. Demonstrating the product has value is now more complex, while reimbursement or procurement is pressured by budget constraints in healthcare systems, and there is an increasing need for evidence of economic and other impacts on healthcare beyond typical effectiveness

39、and safety requirements. While medical device regulation is uniform across Europe, adoption of innovation depends on regional ecosystems and frameworks, which create the need for innovators to address this region-by-region. Moreover, innovators face different requirements, and often different stakeh

40、older needs, which may limit diffusion and scale beyond initial markets. The critical question innovators must be able to answer when entering this phase is: What evidence about innovation usage and impact do I need more of, so the product will be used in the clinical setting and I can be sure it wi

41、ll be paid for? ROUND TABLE MEETING FEEDBACK Testing the reality of the proposed innovation pathway for digital health 2. Innovation in digital health requires looking beyond the immediate clinical need as a starting point. Stakeholder diversity and new health approaches enable a wider focus on area

42、s including wellbeing, prevention, home healthcare. These areas extend beyond the more traditional treatment-focused innovation and so require consideration of different user and system needs. During the ideation and development stages, issues such as usability, interoperability and integration beco

43、me more relevant in digital health, which must embrace a wider spectrum of stakeholders perspectives and involvement beyond the technical and clinical aspects of the technology. A wider co-creation process is needed with input and perspective from patients and citizens, as well as experts in humanis

44、tic sciences, such as anthropology, to get broader insights on other dimensions of human life. The addition of those with commercial or investment experiences at this earlier stage would also help strengthen the development of an appropriate business plan, enhancing prospective commercial success. A

45、 stepwise, linear representation of the pathway does not reflect the need to take all phases of the pathway into account from the start. Later phases, such as those impacting market entry and adoption, need to be considered from the beginning of the process. The Valleys of Death were important parts

46、 of the pathway where innovations were informally or formally filtered to identify the most promising and viable. This is key to allow resources to be focused on innovation solutions with the greatest potential for impact. Innovators can learn from failure and take forward solutions that hold the gr

47、eatest promise. Before discussing how best to optimise the innovation pathway for digital health technologies, the proposed pathway description was discussed within each Round Table Meeting, in order to review and validate how it reflects the current reality for digital health innovation in each par

48、ticipating country. The general feedback resulting from this was: Due to the fact that digital health technologies are still in their infancy and evolving, the proposed innovation pathway faces specific challenges in different phases and will therefore require adaptation to reflect the new paradigm.

49、 As a result, many of the requirements and specific steps are still being defined among the various stakeholders and there is clear need for improvement. Iteration, Insights and Stakeholder Feedback PHASE IDEATION DEVELOPMENT MARKET ENTRY ADOPTION NEEDIDEA PROOF OF CONCEPT PROOF OF FEASIBILITY PROOF OF VALUE INITIAL CLINICAL TRIAL VALIDATION OF SOLUTION APPROVAL AND LAUNCH CLINICAL / COST ASSESSMENT STANDARD OF CARE REIMBURSEMENTOBSOLESCENCEMILESTONE 8725 FIGURE 2 ROUND TABLE MEETING FEEDBACK Digital health innovation pathway