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DIGIVITALITY - Enhanced marketability and financing of digital health innovations in CE through strengthened cooperation and improved policies

Název projektu: DIGIVITALITY - Enhanced marketability and financing of digital health innovations in CE through strengthened cooperation and improved policies
Registrační číslo: CE0100328
Název výzvy: Interreg CENTRAL EUROPE 2021-2027
Programová priorita: P1 - Cooperating for a smarter central Europe
Realizace projektu: 1. 8. 2023 - 31.12. 2025
Řešitel projektu: Doc. Ing. Jan Mužík, Ph.D.
Popis projektu: Most CE countries lag behind as regards digitisation of healthcare. Digital health innovations struggle to access and proliferate public healthcare systems. There is a lack of proven procedures and collaboration mechanisms that would empower start-ups to scale up and introduce innovative solutions. At the same time, policy improvements in more developed countries open a new horizon for innovators in digital healthcare, with Germany’s Digital Health Care Applications (DiGA) scheme being the frontrunner, offering a standardised process for doctor-prescribed digital health apps reimbursed by statutory health insurance. DIGIVITALITY accelerates the uptake of advanced digital technologies in CE healthcare systems by improving framework conditions and strengthening innovation capacities to facilitate fast-track, multi-dimensional feasibility validation of novel digital health solutions via challenge-driven, open innovation based collaboration among start-ups, major med-tech companies, hospitals & universities; and fostering the development of public financing options for digital innovations in CE health policies. To address shortages of CE healthcare systems, DIGIVITALITY develops the blueprint for a fast-track, multi-dimensional feasibility validation process, whereas selected digital health innovations parallely undergo 1) product & technology development; 2) business case development; 3) medical-clinical feasibility validation; and 4) early phase health technology assessment. The Digital Health Innovation Playbook, being DIGIVITALITY’s key project output, “codifies” the learnings of the pilot feasibility validation process, that is designed to boost the scale-up and market entry potential of digital health innovations via challenge-driven, open innovation based collaboration of start-ups, med-techs, hospitals and innovation hubs. Besides, DIGIVITALITY also fosters the development of public financing options for digital innovations inspired by the German DiGA scheme, thus promoting not only the generation but also the uptake of digital health applications in public healthcare systems.
Cíl projektu: DIGIVITALITY addresses shortages identified in CE healthcare systems (low level of digitisation and innovation uptake; lack of structured, open innovation based collaboration between start-ups and major med-tech companies; insufficient financing of digital innovations) in one coherent process built around a joint learning, match-making, testing and validation curve inviting all major ecosystem actors (innovation facilitators, health-care providers & financers, med-tech & pharma companies, as well as start-up innovators).
The process starts in WP1 with tailored capacity building, best fitting the specific contribution of various types of PPs and APs (i.e. innovation hubs, hospitals and large med-techs) to the planned activities, also building on a common methodological basis and a sound understanding of the German DiGA scheme.
Start-ups are invited in WP2 to develop novel digital health applications that are based on real market needs (i.e. driven by “market-pull” and not “technology-push”), thus creating the basis for a sustainable, challenge-driven innovation process. As a next step, transnational quadruplets of collaborative innovation development and validation teams are generated via careful matchmaking, including a med-tech partner with a realised market challenge, a start-up providing an innovative digital healthcare solution properly answering the challenge, a hospital partner interested in exploring the validity of the solution for potential uptake, as well as an innovation hub, assigned to facilitate the process and providing business mentoring.
The core process in WP2 lies on the foundations above: a challenge-driven, open innovation-based, multidimensional feasibility validation process of preselected digital health applications ensured by parallel, interrelated contributions from all main types of partners:
- business case development for market conformity via mentoring support of innovation hub PPs;
- consultation based feasibility validation in medical/clinical setup by hospital PPs;
- product and technology development support provided by med-tech APs;
- early phase health technology assessment (eHTA) by a specialist PP (SYR);
- permanent transnational level oversight by an Expert Panel led by the LP.
By the careful preparation, collaborative and closely monitored implementation and finetuning of this complex exercise, DIGIVITALITY aims to develop the blueprint for multi-dimensional feasibility validation of digital health innovations, inspired by the fast-track approval process of the German DiGA scheme. The “Digital Health Innovation Pipeline” that the project develops substantially increases the potential of digital health innovations to answer real needs of the healthcare sector, to scale-up and to meaningfully contribute to the digitization of healthcare. A transnational peer-review exercise will ensure that learnings and experiences of the pilot actions - consisting of the above elements and being parallely implemented in 5 countries - are systematically gathered and feed the development of a “Digital Health Innovation Playbook”, that “codifies” the piloted feasibility validation process and gives step-by-step guidance for its future, widespread application by all types of involved stakeholders.
The key novelty of DIGIVITALITY lies in the fact that it addresses the supply and demand for health innovation at the same time: besides generating a pipeline for the development of feasible and marketable digital health innovations, it also boosts their uptake by public healthcare systems. On the one hand, it does so by involving hospitals as testbeds, creating tools for their efficient and effective collaboration with start-ups in validating their innovative solutions, and collecting insights on possible integration of digital healthcare solutions in their medical practice. On the other hand, WP3 promotes the uptake of digital health applications in public health insurance schemes by raising policy-makers’ awareness and interest towards their health economy impacts, and advocating for the adaptation of the German DiGA scheme in CE countries.
Besides, DIGIVITALITY’s approach is novel in the sense that it combines specific focus areas of usual start-up programmes into one integrated and coherent framework: business mentoring services of innovation hub PPs are supplemented by medical/clinical feasibility validation hosted by hospital PPs and complex product & technology development support provided by med-tech APs, while early-phase health technology assessment tailored to digital solutions adds a new dimension for innovation upscaling and enhanced potential for improved financing. Involvement of major med-tech companies into a transnational project is also a crucial novelty, allowing direct access to justified, market-based knowledge on actual needs, challenges and current standards of the sector from key industry players.
Řízení projektu: Taking advantage of the similarities of DIGIVITALITY countries in terms of innovation ecosystem maturity, market and regulatory environments, the project multiplies upscaling potential of digital healthcare solutions, by establishing a transnational space for joint learning, challenge definition, innovation scouting, matchmaking, validation and policy improvement process. Inspired by the above learnings, PPs will work on strengthening innovation capacities and facilitating procedures that can create a solid pipeline for development of high potential digital health applications. For this reason, DIGIVITALITY puts high emphasis on tailored capacity building of key types of partners (innovation hubs, med-techs and hospitals), enabling them to properly deliver their foreseen contributions. INNO already has established training programs that channel know-how and methods from developed healthcare ecosystems, providing a sound basis to design and deliver trainings within the project:
- Training innovation hubs in process facilitation, stakeholder management, start-up scouting, business mentoring and policy advocacy activities (D.1.1.2) will be largely based on the ‘Connect & Experience’ programme, a learning and collaboration platform providing strategic tools for developing innovation communities and enhance start-up growth, as well as deep immersion in practical learnings of the Israeli healthcare innovation ecosystem.
- Open Innovation Training for large med-techs (D.1.1.3) will build on INNO’s annual end-to-end innovation program ‘Disrupt Me!’, helping healthcare companies to advance with disruptive technologies provided by start-ups, to build open innovation strategies, scout and implement start-up collaborations.
- Innovation management capacity building for hospitals (D.1.1.4) will use the experience of ‘HOSTED’, a Healthcare Innovation Leaders Bootcamp, supporting the managerial staff of hospitals/clinics to lead effective processes of innovation management in health organisations and integrate new technologies into their workflow.

As regards start-up scouting and mentoring activities, DIGIVITALITY builds on the wide range of start-up support programmes run by its innovation hub PPs. These provide important learnings on key gaps and weaknesses of the innovation process that digital health start-ups experience (e.g. data security & interoperability issues, ethical and safety standards, IPR and business confidentiality). DIGIVITALITY will increasingly focus on these items when developing the tools supporting validation process, piloting their application and drafting the Digital Health Innovation Playbook. Available knowledge of existing activities will be further enriched by open innovation based product & technology development support provided by med-tech & pharma companies and the engagement of a hospital validation partner.

Another key professional foundation for DIGIVITALITY is the methodology for early phase health technology assessment (eHTA) of digital applications. SYR has substantial experience in eHTA, as well as in developing and applying models to assess possible impacts of innovative solutions. Integration of eHTA aspects in the pilot feasibility validation process gives an important insight for startups on how to measure and quantify health economy impacts and how to demonstrate their comparative strengths against existing medical practice. SYR will capitalise its knowledge gathered in H2020 funded COMED, HECoPerMED and HTx projects to foster the development of value propositions potentially suitable for passing reimbursement decisions of health insurance providers.


Hodnocení: spravovat