1. The Basque Foundation for Health and Innovation Research www.bioef.org Demotek Demonstration Unit of Innovative Technologies in Health An opportunity for the Health System to know the utility of innovative products, before including them in its portfolio of service An opportunity for the healthcare-related Companies to test their technologies or products according to the evaluation criteria of the Health System

2. Demotek: What is it? DEMOTEK Department of Health Healthcare Industry  The Demostration Unit of Innovative Technologies in Health Care- DEMOTEK, has been recently created by the Department of Health of the Government of the Basque Country to help industrial players oriented to the health services market, mainly small and medium enterprises (SMEs), to prove the effectiveness and efficiency of their new products or solutions in the daily clinical practice of the Basque Public Health System.  The SERVICE consists in the design and management of pilot experiences with the new product, so that a defined number of physicians can use it in their clinical practice, in a limited number of patients and for a specified time.  The main OBJETIVE is to demonstrate the effectiveness, clinical utility and economic impact (cost-effectiveness, budget impact analysis) of the new product or technology

3. Objetive Use in Patients Regulatory Approval Product Development Proof of Principle Clinical trials Utility Effectiveness Economic Impact Comercialization DEMOTEK provides research services focused on the design and execution of custom-tailored trials, to assess the effectiveness and economic impact of healthcare related-products, such as medical devices or equipment, diagnostics tests, rehabilitation systems or ICTs. Demostration studies are post-approval studies, they are carried out when the product or solution is ready to enter the Health market

4. Healthcare related-products All type of Medical Devices: - In vitro diagnostic tests. - Genetic test for personalized medicine. - Advanced rehabilitation systems. - Image analysis equipment. - Systems of wireless and dynamic ECG. - Wireless falls detectors. - Systems of wireless Electroencephalography (EEG) - Etc.

5. How does DEMOTEK operate?  Multicenter demostration studies are carried out on daily clinical practice using a small group of physicians from each hospital of the Basque Public Health System, a number of patients and for a limited time. Primary Health Care - 320 Health Centers grouped in 7 Health Areas Hospitals - 12 General Hospitals (4.278 beds) - 4 medium and long stay Hospitals Mental Health - 4 psyquiatric services in general hospitals - 4 psychiatric Hospitals (777 beds) - 3 Outpatient Mental Health Areas

6. OIKER- BIOEF DEMOTEK Epidemiology and Methodology Units Protocol design Results analysis Ethics Committees of Clinical Research Physicians and Nurses of Public Basque Health System Finantial Management of the Hospitals O+Ehun: Nodal biobank within the health system Experts in Economic Evaluation Home-Strategic Partner Network DEMOTEK collaborates with different departments or entities of the Public Health System to offer their services.

7. Process Flow Final Report Design of the protocol & budget Approval Product Presentation 123456 The company presents the innovative product to Demotek indicating that phase of development. Approval by Demotek of the product as a candidate to be introduced in demonstration studies. Design of the clinical research protocol and Budget Calculation. Negotiation with the promotor and signing the service contract between the company and BIOEF. Approval of the Ethics Committee of Clinical Research and project development Data analysis and submission of final report to the company. Negotiation & signing of the contract Development of the project

8.  Promotes the knowledge of the product by the future prescriber.  Helps in the assessment of the effectiveness, efficiency and acceptance of its new product in the health sector.  Facilitates the implementation of the new product or technology in the market.  Allows the dissemination of the results in a clinical environment. Conclusions: Benefits for the Company DEMOTEK COMPANY HEALTH SYSTEM DEMOTEK helps to bridge the gap that exists between the commercialization/marketing and the Health System promoting business competitiveness.

9.  Promotes public-private partnerships.  Promotes the R&D in the HealthCare centers and clinical research groups that participate in the demonstration studies.  Physicians can check the effectiveness of the new products or technologies before the subsequent decision of their inclusion in the portfolio of services.  Patients know about the new technologies.  Demotek provides scientific evidence in situ locations for assessment of the Compared Effectiveness Agency of the Public Administration.  Helps to the Healthcare systems to choose those valuable cost-effective solutions with proven benefit that could contribute to their sustainability. Conclusions: Benefits for the Health System

10. Demotek Contact: Lorea Mendoza ArtecheMiren Begoña Zubero lmendoza@bioef.orgmbzubero@bioef.org Head of DEMOTEK Project Management The Institute of Health Research (o+Iker) The Basque Foundation for Health and Innovation Research (BIOEF) Plaza Asua, 1. 48150 Sondika, Bizkaia Phone.: +34 94 453 85 00 Ext. 232 Fax: +34 94 453 04 65 www.bioef.org Demonstration Unit of Innovative Technologies in Health