A Strategic Innovation Program in Medical Technology

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A Strategic Innovation Program in Medical Technology A strategic research and innovation program financed by VINNOVA, Sweden s innovation agency MedTech4Health addresses one of the largest global social challenges and stimulates the international competitiveness of industry in Sweden and research in a globally growing market MedTech4Health - the role of technology in today's and tomorrow's health

Vision Medicinteknisk industri verksam i Sverige är internationellt ledande med hjälp av ett världsunikt forsknings-och innovationssystem, där forskning, vård, och industri samverkar och bidrar till bättre hälsa!

A Strategic Innovation Program in Medical Technology Short facts Participating parties 3 year project with option to prolong for 3+3 years 10 M for the first 3 years Starting in 2016 Research institutes 11 counties 7 University hospitals 10 Universitys 64 Medtech companies

A Strategic Innovation Program in Medical Technology Short-term goals Increase patient perspective for innovation in health care Improve exchange between cross competencies Health and social care directly involved in innovation processes National coordination Long term goals A patient-centered and efficient healthcare system in terms of health outcomes per cost Continued national and international success of MedTech companies in Sweden Sweden internationally recognized for excellence in medical technology innovation, research and education www.ctmh.se info@ctmh.se

Medtech4Health Key Initiativs KI One: Project calls Project calls with patient focus. Mobility boost checks. KI Two: Shortening Valley of Death Bridging the gap by verification in the clinical setting and pilot studies Cross competencies educations (technology, medicine, clinic) KI Three: Network, Attitudes and collaboration International collaborations Health care innovator of the year award Advocacy, education and information for decision-makers

SP Sveriges Tekniska Forskningsinstitut Svensk förening för medicinsk t eknik och fysisk (MTF) Swedish Medtech, branschorganisationen för medicinteknikföretag VÄSTRA GÖTALANDSREGIONEN VGR Chalmers Tekniska högskola Göteborgs Universitet Högskolan i Borås Västra Götalandsregionen, VGR Nodrepresentant: MedTech West NORRLANDSREGIONEN Luleå tekniska universitet Umeå universitetet Norrbottens läns landsting Västerbottens läns landsting Nodrepresentant: Centrum för medicinskt t eknik och fysik (CMTF) UPPSALA Uppsala universitet Landstinget i Uppsala län Nodrepresentant: Centrum för bildanalys (CBA) STOCKHOLM Karolinska Institutet Kungliga tekniska högskolan Stockholms läns landsting Nodrepresentant: Centrum för t eknik i medicin och hälsa (CTMH) ÖSTRA MELLANSVERIGE Linköpings universitet Mälardalens högskola Örebro universitet Landstinget i Västmanland Södermanlands läns landsting Örebro läns landsting Östergötlands läns landsting Berörda kommuner i resp. län Nodrepresentant: Novamedtech Parties ) Industry: 64 Patient organizations: 5 Research institute: 3 Univ Hospital: 7 Academy: 10 Others: 15 Total: 108 SKÅNE Lunds Universitet Region Skåne Nodrepresentant: Skånskt centrum för medicint eknik (under bildande)

Activities 1. Innovation calls 2. Innovator in residence Pilots with support from counties/hospitals 3. Mobility boost for clinical innovation 4. Education and Development of Cross-competences 5. Verification of innovations in a clinical environment 6. Translational Hubs 7. Support for certification and approval process 8. Accelerating international collaboration 9. Health care innovator of the year award 10. Increased awareness and knowledge through collaboration

1. Innovation calls Description: Supporting for applications for R&I projects in biomedical engineering. Selected to make the greatest contribution and that also have commercial potential. Patient and clinical relevance will be a primary evaluation criterion. Projects should be multi-professional and run in close collaboration of the health-care system, industry, the academic community and, where appropriate, patients (users) and/or patient organizations. Number of projects: 15-20 calls / year Budget: 15-20 MSEK / year in total. Targeted groups: Partnering teams from the healthcare sector, industry, institutes, the academic community, and, where appropriate, users and/or patient organizations.

2. Innovator in residence Description: A call for clinical staff engaging in critical moments for medtech innovations, such as participating in expert groups for procurement or assessment of new medical technology. This activity is to support health care in its own process of development and change Clinicians are expected to analyze the clinical needs where innovative processes and/or products are required. Number of projects: 5-8 projects / year. Up to 1 MSEK / application. Budget: 3-5 MSEK / year Targeted groups: Nurses, doctors, health-care staff.

3. Mobility boost Description: Mobility Boost is a check granted to SMEs, but for financing costs of others, namely their partners in the project, being clinicians, researchers or patient organizations. The needs may vary in summarizing available scientific evidence for the novel method or product, in advice on how to organize a clinical study, in formalizing a method, for example. 200,000 SEK to be paid to the collaborating clinical or academic parties. The SIP nodes will aid in connecting the right parties. Number of projects: 10-15 / year. Up to 200k SEK / project. Budget: 3 MSEK / year Targeted groups: SME

4. Education and Development of Cross-competences Description: Support new and further develop existing initiatives creating opportunities for Education and Development of Cross-competencies. An educational setting where students or professionals, such as medical/clinical, engineering, organization or industrial design, meet to focus on needs in the every-day realities of patients and health care. Educational efforts combining professionals and/or students should be encouraged and supported. Number of projects: 4-8 strong initiatives / year. Budget: Starting in 2016. Budget 1 MSEK in 2016 and ramping up to 3 MSEK in 2018 from VINNOVA, with equal co-financing from project partners. Targeted groups: BME relevant educations across Swedish universities.

5. Verification of innovations in a clinical environment Description: This funding will make it possible to set time aside for leading technology users to take part in both the planning and the conduct of tests of new equipment in the clinic. Equipment intended for use in a clinical environment often needs to be tested already at the prototype stage. It has become increasingly difficult for medical staff with many clinical duties to take part in clinical trials. This activity will reduce the burden of adapting the environment to the test situation, and offer support for the verification of new technology. Number of projects: Annual calls with a maximum of three projects granted each year. Budget: 750,000-1.5 MSEK with an equal amount of cofinancing from project partners. Targeted groups: SME and research groups in BME, medicine, economics and design.

6. Translational hub Description: Set up of a national network of experienced medtech professionals (entrepreneurs, CTOs, patent lawyers, venture capitalists) to support promising projects with useful advice and networks. Set up a national and area-specific angel-investor network for medtech. These activities will be coordinated with other actors in the R&I field. Budget: Establishment of the translational hub will commence in 2017 with a budget of 1 MSEK/year from VINNOVA. Targeted groups: The academic community, institutes and SMEs where research is conducted

7. Support for certification and approval process Description: To speed up and facilitate the certification process regarding regulatory requirements. Companies that provide such assistance on a commercial basis will be identified and mapped according to expertise and offering in the product-development chain. The program may develop database-driven systems and templates to generate the documentation needed for regulatory submissions. Offer focused courses in the field in close cooperation with existing companies. A consortium of individuals and companies will be formed with experience in the approval procedure, which will provide training in the certification and approval process for newly formed companies in the medtech field and for researchers with plans to form such companies. Budget: A consortium will be formed. 1 MSEK per year from VINNOVA is allocated for this activity. Targeted groups: SMEs in Sweden, Medtech Research, Innovation and Development in health care and the academy.

8. Accelerating international collaboration Description: Creating and strengthening gateways for international collaboration between researchers and SMEs. The SIP nodes may aid as hubs from which collaboration with innovation clusters in other countries can be developed Support of an advocacy platform for influencing initiatives in the EU, including the EIT InnoLIFE KIC granted in 2014. Within the imaging field, Swedish Bioimaging may serve as a bridge to Euro-Bioimaging and its Industry Board (http://www.eurobioimaging.eu/content-page/eurobioimaging-industry-board). Budget: Starting in autumn 2016. Yearly budget of 1MSEK from VINNOVA, with equal co-funding from applicant partners. Targeted groups: Investors, the academic community, entrepreneurs, industry and the health care sector.

9. Health care innovator of the year award Description: An annual award for clinicians involved in procurement, expert groups, clinical studies with a high impact on the innovation of health-care processes enabled through new technology. The award would be developed in collaboration with Swedish Medtech and media, such as Dagens Medicin. Budget: 0,5 MSEK / year starting 2016. Targeted groups: Nurses, doctors and health-care staff developing health care processes.

10. Increased awareness and knowledge through collaboration Description: The activities will include a series of events such as round-table-discussions, delegation trips, workshops and conferences. Information and results from the events will be disseminated widely among the BME community. Purpose is to increase awareness and knowledge amongst decision makers regarding the challenges of innovative BME and its great potential for both patients and for adapting health care. Some initial themes might be reimbursement models for innovative, qualitative and sustainable health care, Models for early implementation of innovative BME and procurement, and patient empowerment. Budget: : 0,5 MSEK / year starting 2016. Targeted groups: Hospital staff and management, decision makers in county councils and regions, politicians on the regional as well as the national level, the medtech industry, governmental agencies.

Organization Governing Board Program office Advisory board 20 % support from 6 noders Swedish Medtech and SP- Swedish Technical Research Inst Governing board Members from counties, regions, academy, ndustry and research institutes VINNOVA Advisory board Industry/SME 3 st Key Opinion Leaders Healthcare 3 st Patient rep/other program (e.g. SIP) 1-3 st Program office Reidar Gårdebäck - ProgrDir Project leaders Nodes+institute

SIP Governing Board Namn Titel Organisation Magnus Lindholm CEO Baxter Medical AB Tomas Mora-Morrison s Founder Cambio Healthcare system Tomas Puusepp / Sören Johansson Eva Malmström/Kerstin Tham Member of the Board Elekta/former CEO (alternate) Dean/pro-vicechancellor Elekta AB- BG Peter Värbrand Deputy Vice-chancellor Linköping Univ KTH Royal Institute of Technology/Karolinska Institute - BG Erik Höglund Deputy Vice-chancellor Luleå University of Technology Gunilla Westergren- Thorsson/Lars Dahlin Anders Carlberg Dean/Vice-chancellor R&D Director Regional Development Lund University Torbjörn Kronander CEO Sectra AB Regional Development, Region Västra Götaland

SIP Governing Board, continued Namn Titel Organisation Hannie Lundgren R&D Director Region Skåne Maria Khorsand CEO SP Technical Research Institute of Sweden Maria Englund Personal direktör Stockholm County Council Anna Lefevre Skjöldebrand CEO Swedish Medtech Olle Larkö/Mats Viberg (alternate) Dean/Senior vice president University of Gothenburg/Chalmers University of Technology - MP Sune Larsson Research Director Uppsala University hospital Uppsala county council Anders Sylvan Director Västerbotten County Council University Hospital of Umeå Mats Palerius CEO Zenicor AB Jan Marcusson R&D director healthcare Region Östergötland

Medical technology is a part of the solution to meet future challenges