empirica Gesellschaft fr Kommunikations und Technologieforschung mb H

empirica Gesellschaft für Kommunikations- und Technologieforschung mb. H Oxfordstr. 2, 53 111 Bonn, Germany e-Mail: info@empirica. com Phone: + 49 (228) 985 30 0 Fax: + 49 (228) 985 30 -12 Conducting PCPs: in-depth example and lessons learned from an ongoing e. Health PCP Strahil Birov empirica Technology Research V

17 1988 e. Health Jane Doe ► Policies & Strategies ► IT for cross-border health ► e. Health interoperability ► In Silico Medicine ► Person-centred care ► Business development ► e. Health service innovation e. Care & Ageing Jane Doe ► Policies, Strategies, Markets ► AAL ► e. Care service innovation ► Integrating care ► Impact assessment ► Business models ► Employment 35 e. Skills & Work Jane Doe ► e-Leadership ► Strategies & Governance ► Monitoring and forecasting ► Education and training ► New ways of work 18 Inclusive Society Jane Doe ► e. Accessibility ► Social innovation Research & Innovation Jane Doe ► Knowledge transfer ► Entrepreneurship ► Business innovation ► R&I systems and policy Energy Jane Doe ► Decision Support ► Management ► Evaluation & Cost Benefit Analysis ► RTD and documentation V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 2

Experience with public procurement Proe. Health study (2010 -12) - enhancing procurement of ICT healthcare solutions, good procurement practices on EHRs and procurement guidelines for EU countries Pro. Empower PCP (2016 -20) Procuring innovative ICT for patient empowerment and self-management for type 2 diabetes mellitus (currently entering PCP phase 3) HSMonitor PCP (awaiting results) on innovative ICT-enabled monitoring to improve health status and optimise hypertension care Preparation of a new PCP on next generation sequencing (personalised medicine) Collaboration partnerships with 80+ EU regions and cities as potential procurers Key areas of expertise • • overall project and procurement management, support and coordination, including full technical support to the procurers in the tendering process and the selection of procurers in each phase Coordination of the work towards defining technical specifications Organization of Open Market Consultations and facilitation of demand-supply dialogue Management of dissemination, exploitation and large scale impact modeling of the PCP V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 3

The Pro. Empower project 3 ½ year project; 4. 2 million (3 million for procurement) Procurers from four regions in Europe who care for 12 million diabetes patients Supported by a team of researchers, consultants and healthcare providers Identified a number of challenges (unmet needs) in the current way diabetes care is provided in their regions Set off to procure a continuous disease self-management solution that will make person-centred care a reality. A market analysis showed that offer only partial solutions are on offer, with lacking integration into healthcare processes V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 4

Identifying unmet needs Unmet needs Healthcare systems world-wide are reactive and fragmented. Fragmentation leads to gaps in treatment. Overreliance on pharmacotherapy is proving insufficient. Medication fails if patients do not change their lifestyle. Lacking patient ownership: responsibility is delegated to doctors. Patients have diabetes for 12 years before diagnosed Progress needed Personalised care: Replacing reactive care with proactive and timely delivery of support employing risk stratification. Multi-disciplinary care: adopting a team-based approach with strong coordination of all action. Person-centred care: Giving the patient the steering wheel and enabling ownership. Self-management support: Educating patients to selfmanage a healthier lifestyle. Changing life style & nutrition effectively impedes diabetes. Self-help & peer support: Creating a supportive environment that reduces external barriers for healthy lifestyles and coping with the disease. Early detection: actively detecting people with diabetes or pre-diabetes V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 5

Deciding what instrument to use PCP PPI When? Requires R&D to get new solutions developed. Problem clear, but pros/cons of competing solutions not compared/validated yet. No commitment to deploy yet. Requires solution which is almost on the market/already on the market in small quantity, but not meeting public sector requirements for large scale deployment yet. No R&D involved. What? Public sector buys R&D to steer development of solutions to its needs, gather knowledge about pros/cons of alternative solutions, to avoid supplier lockin later. Public sector acts as launching customer/early adopter/first buyer for innovative products and services that are newly arriving on the market. How? Public sector buys R&D form several suppliers in parallel (comparing alternative solution approaches), in form of competition evaluating progress after critical milestones, risks and benefits of R&D) shared with suppliers to maximise incentives for the wide commercialisation. Public sector acts as facilitator establishing a buyers group with critical mass that triggers industry to scale up its production chain to bring products on the market with desired quality/price ratio within a specific time. After a test and/or certification, the buyers group purchases a significant volume of products. V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 6

Timeline and phases Specifications draft Open Market Consultation Call for tender Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Specifications draft Example based on the Pro. Empower PCP V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 7

Specifications - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Procurement specifications are a must and are usually very detailed • e. g. for a procurement of construction services to build a 20 km road the procurer will specify the materials to be used, the number of lanes, maximum road pressure/durability, etc. To allow innovativeness in PCP and PPI procurement, a balanced set of specifications is required It is recommended to involve a multi-disciplinary team comprising: • experts in the field (technical, legal, business, organisational, etc. ) • end-users of the products/services to be procured • other affected stakeholders (e. g. financial partners, third parties that will be impacted by the procurement) Approach followed in the Pro. Empower PCP: a set of requirements, use cases and process models V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 8

Specifications – approach Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Involve a multi-disciplinary team to inform your specifications • understand better your existing infrastructure (systems) • organisational, staff & business environment and requirements • legal and regulatory environment and requirements Interviews with users and procurement staff are useful Based on all the input, draft • requirements (functional, non-functional, organisational, legal and regulatory, …) • use cases to describe the expected functionalities • process models to illustrate processes that have to be in place V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 9

Specifications – examples Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 10

Specifications – examples Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Choose a balanced approach (not too detailed descriptions to allow for innovative ideas; describe what needs to happen, not how it should happen) V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 11

OMC - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Open and inclusive dialogue between end users, buyers and suppliers Purpose • In a systematic and equal, way make room for value adding interaction • Raise awareness about the procurement among relevant bidders • Information about the desired procurement (unmet needs, specifications), intentions of the project and PCP process • Get feedback and add new perspectives on both the process/method and content of the procurement • Validate the procurers’ analysis and assumptions V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 12

OMC - approach Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Conference attendance Direct communication Workshops Feedback form Newsletters V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 13

Call for Tenders - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Official launch of the PCP via a Call for Tenders • Publication in the 'Supplement to the Official Journal' of the EU if the tender volume is above certain values (check here) • A document with all the necessary information – budget, specifications, tendering rules, IPR, conditions (exclusion, selection, compliance criteria), process rules, contracting, etc. • Supporting documents: application templates, declarations Value-based procurement is encouraged • Defining appropriate award criteria to include aspects such as qualitative, technical, sustainable, social aspects • Selecting the most economically advantageous tenders (MEAT) based on price and quality (e. g. price-quality ratio of 30/70) V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 14

Call for Tenders - approach Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Application period (2 months) Evaluation of the tenders by a multidisciplinary team (scoring, ranking) Award notification and feedback V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 15

Call for Tenders - examples Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 16

Phase I - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Objectives • elaborate the solution design and determine the approach to be taken to develop the innovative solutions • demonstrate the technical, financial and commercial feasibility of the proposed concepts and approach to meet the procurement requirements Approach • Suppliers use the evaluation comments to finalise their approach on paper • This phase lasted for 2 months in Pro. Empower Results • Written report and presentation • Offer for the next phase V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 17

Phase II - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Objectives • Develop, demonstrate and validate prototypes in lab conditions • Development of prototype systems in two versions Approach • Test prototypes with end users • This phase lasted for 2 months in Pro. Empower Results • Written report and presentation/demonstration on site • Offer for the next phase V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 18

Phase II - considerations Specifications draft Open Market Consultation Call for tenders Phase 1 Solution design Phase 2 Prototype development Phase 3 Piloting & testing Objectives • Development of pilot systems for an extended test under real-life conditions at all procurer sites. • Pilot systems installed and tested in each pilot site • Operation maintained in parallel at full quality Approach • Piloting of the services, provision of all necessary equipment (e. g. devices for patients) • Pilot evaluation Results • Piloted solution • Written final report • Business offer for buying the solution (in the future) V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 19

Lessons learned so far Unmet needs: clearly identify them and begin brainstorming ideas (draft specifications) Specifications: start with a draft, refine during the Open Market Consultation with input from industry and academia Aim to use a value-based approach (price & quality) when evaluating tenders Work closely with the suppliers during the phases, try to allow for flexibility in the contracting approach Be prepared (politically and financially) to continue with a PPI following a PCP project V 27/02/2019 Conducting e. Health PCPs: in-depth example and lessons learned from an ongoing PC 20

empirica Gesellschaft für Kommunikations- und Technologieforschung mb. H Oxfordstr. 2, 53 111 Bonn, Germany e-Mail: info@empirica. com Phone: + 49 (228) 985 30 0 Fax: + 49 (228) 985 30 -12 Thank you for your attention! Strahil Birov strahil. birov@empirica. com V