Mobile Assistance for Groups Individuals within the Community STROKE REHABILITATION – MAGIC PROJECT

EUROPEAN COMMISSION DG Communications Networks, Content and Technology Sustainable and Secure Society - Health and Well-being

Le esigenze di sviluppo della sanità ligure e le opportunità

offerte dalla programmazione comunitaria

Genova, 18 aprile 2018

Palazzo della Borsa

Via XX Settembre, 44 – Genova

Pre-Commercial Procurement (PCP)

Laura Donnini

Azienda Ospedaliera Ospedali Riuniti di Ancona

Il ruolo dei “procurers”: esperienze progettuali a confronto

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Innovation procurement can drive innovation from the demand side. This enables faster modernization of public services while opening market opportunities for companies in

Europe. Horizon 2020 provides EU funding to start innovation procurements. This funding is targeted at potential buyers of innovative solutions: groups of public procurers, possibly together with other types of procurers that are providing services of public interest and

have similar procurement needs

Pre-Commercial Procurement (PCP) can be used by procurers when there are no near-to-the-market solutions yet that meet all the procurers' requirements and new R&D is needed to get new solutions developed and tested to address the procurement need. PCP can then compare the pros and cons of alternative solutions approaches and de-risk the promising innovations step-by-step via solution design, prototyping, development and first product

testing. PCP is a public procurement of R&D services that does not include the deployment of commercial volumes of end-products

Overview

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Per espresso disposto della direttiva 2004/18/UE art. 16, par. 1, lett. f), la disciplina sui contratti pubblici (D.lgs. n. 50/2016 Nuovo Codice Appalti), non si applica agli

appalti di servizi concernenti servizi di ricerca e sviluppo diversi da quelli i cui risultati appartengono esclusivamente all'amministrazione aggiudicatrice perché li usi nell'esercizio della sua attività, a condizione che la prestazione del servizio

sia interamente retribuita da tale amministrazione.

Le procedure di aggiudicazione di detti contratti sono, comunque, sottoposte ai principi generali contenuti nel Codice dei contratti pubblici e relativi a servizi, lavori

e forniture, ovvero ai principi di apertura, non discriminazione, economicità, efficacia, concorrenza, parità di trattamento e imparzialità, trasparenza e pubblicità

e proporzionalità

Normativa di riferimento

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Giornata di lancio dei bandi H2020 SC1 – Societal Challenge “Health,

demographic change and wellbeing”

Roma, 15 dicembre 2017

Università Sapienza - AULA MAGNA, Roma

EUROPEAN COMMISSION DG Communications Networks, Content and Technology Sustainable and Secure Society - Health and Well-being

• This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 687228

• Co-Fund PCP (70% EU & 30% Buyers Group)

• Successful in PHC-27 PCP call – “Self-Management of Health & Disease & Patient Empowerment Supported by ICT”

• The MAGIC Buyers Group is aiming to use novel applications of technology to empower patients and enhance the intervention of Rehabilitation Therapy in

order to Maximise the level of functional independence at six month post stroke as measured by the Modified Rankin Score and Bartel Index.

EUROPEAN COMMISSION DG Communications Networks, Content and Technology Sustainable and Secure Society - Health and Well-being

PCP AS AN OPPORTUNITY

• for public procurers of health and social care to really have their ‘problems solved’ by innovative, dynamic SMEs

• for SMEs to create marketable solutions in the service environment

• for Patients to be empowered through targeted technology design

THE SOLUTION

• Has to be revolutionised post hospital discharge

• Has to be redesigned using innovative technologies

• Has to optimise recovery at 6-months post stroke

• Has to involve patients and their carers

• Has to empower

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Buyer Group

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Partners

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WP1 Project Management (BSO) WP 2 Preparation Phase and delivery of Phase 0 (BSO) WP3 Creation and execution of PCP call (BSO) WP4 Administration of the Solution Providers and Monitoring Pilots (ASL TO 3) WP5 Solution validation (UDA) WP6 Evaluation of impact, review and recommendation (BSO) WP7 Communication and dissemination (AUH)

Action and Management

PCP Funding…

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PCP Stages

MAGIC Deliverables Phase 2 due 20:04:18

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MAGIC Stages

Phase 2

Objective:

At the end of phase 2, R and D providers will have

1. Developed and demonstrated prototypes (limited number of first products or test series) which meet the challenge of the PCP call and

2. Will have presented advanced plans for conducting clinical / field trial in phase 3, including application for ethical approval if required.

Output and results:

Prototypes are demonstrated that contain the potential to

meet the specification outlined

Submission of clinical/ field trial protocol (inclusive of

ethical approval if required).

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MAGIC Stages Phase 3

Objective

Field-testing of a limited set of first products.

A set of prototype(s) or first test products or services resulting from the R&D, are

needed for R&D purposes and it is reasonable to assume trial will consist of a

minimum of 150 patients in 2 cycles of 6-months of 75 patients involved in each

region concurrently and the equipment is expected to remain in situ for ongoing post

project testing.

Output and

Results

1. R and D providers will have completed field/clinical trial, in the environment of

the patients own home, of a limited set of new solutions.

2. The R and D provider will have presented a research report containing an analysis

of objective data. As a minimum objective data will be presented in relation to:

a. Measures of Body Structure & Function (Power, Mobility, Balance, etc.)

b. Measures Personal Independence (Barthel Index).

c. Measures of participation in selected rehabilitation activity (Duration minutes).

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The MAGIC PCP has enabled the Northern Ireland buyers, health care providers and stroke charities to come together and understand the extent of our rehabilitation shortfall within the community. All stroke physicians across the region are keen to see three large scale feasibility field trials be delivered locally and test very different and innovative solutions. Indeed, there is a welcome receptivity and openness to all innovative technologies being developed and where engagement between clinician, patient and solution developer has occurred the suppliers have been encouraged to be creative. We want our post stroke patients to become empowered and independent through the use of their own system at home to encourage activity. Indeed, where the individual can be self-motivated and compliant with activity without ongoing support from a practitioner is crucial if we are to see effective recovery with more post stroke patients given the demographic trends. PCP has enabled innovation, research, discovery and development and in particular has condensed the size of the devices being developed; technical complexity on the inside and small user friendly intuitive devices on the outside

Opinion by Julie-Ann Walkden Magic Project manager (BSO)

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Opinion by Prof.ssa Maria Gabriella Ceravolo – Clinica di Neuroriabilitazione Ospedali Riuniti (AN)

L’iniziativa ha avuto un buon successo in quanto i dispositivi sviluppati sono tutti interessanti, riflettono reali esigenze funzionali dei pazienti con ictus, e contemporaneamente, benché incorporino molta tecnologia, sembrano abbastanza accessibili sia dal punto di vista dell’Usabilità da parte di soggetti con deficit motori e cognitivi, sia dell’Accessibilità (ovvero del loro potenziale utilizzo a domicilio, piuttosto che in una struttura di riabilitazione). Alcuni dei dispositivi sono suscettibili di stimolare la motivazione dei pazienti al loro utilizzo più di altri e di ottenere maggiori e più rapidi vantaggi (questo è solo il mio punto di vista, ma i prodotti che si basano sulla realtà virtuale immersiva avranno molto più impatto di quelli che impiegano i sensori di movimento indossabili) Al fine di fornire una valutazione dell’impatto clinico più affidabile possibile, sarebbe utile che ogni buyer avesse la possibilità di testare su uno stesso gruppo di soggetti tutte le soluzioni proposte. Mi spiego meglio: se centri diversi sperimentano soluzioni diverse, l’esito rischia di essere condizionato dalla variabilità dovuta alle caratteristiche dei pazienti arruolati e all’esperienza dei terapisti coinvolti. Se ogni centro e ogni paziente ha la possibilità di fare esperienza con tutti i dispositivi, le variabili individuali vengono ridimensionate.

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Conclusions

the strengths • Buyers, health care providers and stroke associations network • On going results: technical complexity on the inside and small user friendly intuitive

devices on the outside

the weaknesses • Administrative and law matters • Ethical committee approval process, choices about clinical trials sites