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Can Healthcare SMEs meet the challenges of 4P medicine?
P4 Medicine
7/7/2017 2
Pre
dic
tive
• Identification of individual risks of developing certain diseases based on the person’s genetic profile and other personal information
Pre
ven
tive
• Methods and treatments to avoid, reduce and monitor the risk of developing certain diseases
Pe
rso
na
lise
d
• Clinical interventions based on the unique genetic, medical and environmental characteristics of each patient-citizen, and genomic profile of his/her diseases
Pa
rtic
ipa
tory
• Citizens are fully engaged in personal health management
Economic drivers of medtech
25 000 companies
550 000 jobs
106 Bn€/y
500 000 medical devices
40 000 IVD tests
7/7/2017 3
Medtech sales
7/7/2017 4
Medtech device areas
7/7/2017 5
Political priorities
7/7/2017 6
• Focus on innovation to stimulate investment
• Encourage more SMEs and businesses to join H2020,
• Maximise synergies between H2020 and EU’s priorities Juncker
• Open Science
• Open Innovation
• Openess to the World Moedas
• Digitization of society
• Digital Single Market Gabriel
4 major challenges in healthtech
7
Need for cross-technology products
New EU regulatory framework
Digitization of healthcare
New business models
7/7/2017
EU landscape in healthcare
7/7/2017 8
•Speed up the development of better and safer medicines for patients
IMI
•Promotes entrepreneurship and innovates in healthy living and active ageing
EIT Health
• Integrated, innovative and smart healthcare solutions for European patients
ESTHER
ESTHER Objectives
7/7/2017 9
Maintain the competitiveness of
healthtech industry in a changing regulatory
environment
Support SMEs from R&D&I to market
access
Deliver value based healthcare solutions with outcome based
payment
Leverage EU vision for healthtech
Networking and mapping
ESTHER Platforms and Joint Actions
ESTHER in FP9
• Companies
• Initiatives, PPPs, ETPs…
• Regions
• RTOs and research
infrastructures
• Clinical centers
• R&D priorities established
• Projects proposed to existing
programmes
• NOBEL Coordination and
Support Actions
• Implementation under existing
instruments
Integration of priority actions in a
single initiative ESTHER PPP-like
How? • Informal structure
• Existing networks (Medtech
Europe, ETPN, EARTO, ECRIN,
Vanguard..)
Existing funding tools and support
measures (regional, national,
European)
Joint Undertaking in healthtech
2016 2020 2018
Roadmap towards FP9
Stakeholders along the value chain
11
Basic
research
Technology
development
Marketing
CE marking
HTA, reimbursement
Patients
Regulatory
approval
Manufacturing
Buyers
Universities
RTOs
Medtech companies
HTA agencies, health insurances
EMA, national agencies
CMO, OEM
Notified bodies
Hospitals, patients
Clinical
validation Hospitals, CROs
7/7/2017
Patient advocacy groups
Patients
ESTHER structure
European association (AISBL) with members all along the value chain of healthtech
Large companies
SMEs
Trade associations
Technology providers
Clinicians
Regions & clusters
Others: payers, patients advocacy groups, HTAs…
Industry lead (Medtech-Europe)
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ESTHER Task Force
7/7/2017 13
EC Units Core Group Advisers
Helene CHRAYE
Heico FRIMA
Fergal DONELLY
R&I/Ind tech.
Patrick BOISSEAU
CEA
Martina GLIBER
BioMerieux
Sinead KEOGH
IMDA
Françoise CHARBIT
CEA
Bertrand LOUBATON
Adaptherapy/EFPIA
Florent SURUGUE
SNITEM
Arnd HOEVELER
Bernd RAINER
R&I/Health
Klaus-Michael
WELTRING
Bioanalytik-muenster
Casper GAROS
Philips/COCIR
Yves BAYON
Medtronic
Andreas LYMBERIS
Jaakko AARNIO
Miguel GONZALES-
SANCHO
Ronan BURGESS
CONNECT
Paul GALVIN
Tyndall
David TALLON
Stryker
Furio GRAMATICA
Don Gnocchi
Hans-Otto MAIER
BBraun
Michel CATINAT
GROW
Serge BERNASCONI
MedTech Europe
Ekkehard LEBERER
Sanofi/EFPIA
Andrzej Jan RYS
SANTE
John BRENNAN
MedTech Europe
Didier BAZILE
Sanofi/EFPIA
Katja REPPEL
REGIO
Tanja VALENTIN
Medtech-Europe
Matteo SANTIN
ESB
Contacts [email protected]
ESTHER Working Groups
Industry
& National associations
RTOs
Clusters & Regions
Hospitals
KOL
Clinical Centres
Public Procurers
HTA Agencies
Payers
Patients
Technology Platforms
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ESTHER - Industry
ESTHER-VANGUARD Regions
7/7/2017 16 ESTHER General presentation
ESTHER-EARTO group of RTOs
7/7/2017 17 ESTHER General presentation
R&D&I
•Roadmaps / convergence Kets/digital in medtechs •Financial support to cross-KETs projects •Financial support to innovation in SMEs •Support technology platforms incl .DIH •Open labs for prototyping and characterisation
Clinical validation
• Support to clinical research and validation infrastructures
• Financial support to SMEs (proof of concept in first patient)
• Public procurement on Healthcare Innovation (on innovative products?)
• Access to networks of KOLs
Manufacturing
• Supply chain building in Europe (ex: FCH JU)
• Interegional cooperation and use of ESF
• Pilot lines to facilitate industrialisation
• Living labs to evaluate business models and social acceptance
HTA
• Harmonisation of HTA criteria
• Support HTA cross European activities
• Reinforcement of medico economic studies in SMEs
Market approval
• Support to transition of SMEs to MDR and IVDR
• Support to export in emerging economies
Support to translation of innovation in SMEs : TAB, HelpDesk
Start-up accelerator : Catapultor
ESTHER actions all along the value chain
se
rvic
es
Timing (tentative)
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De
plo
yme
nt
2016 2018 2017 2019 2020
100%
0%
Task Force
Mapping
Influencing
Support to clusters and regions
Impact assessment
Mapping
Legal association
SME instrument
Support to R&D
Support to clusters
…
Legal Partnership SME instrument
Support to R&D
Support to clusters
Risk financing
…
Take home message
❶ ESTHER is a totally new holistic way of supporting the medtech industry
❷ ESTHER combines synergistic actions all along the value chain
❸ ESTHER is mostly directed to innovative SMEs as reservoir of growth and value
7/7/2017 20
Thank you for your attention
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