1. NMBP : Cross-cutting KETs for diagnostics at the point-of-care co-funded by LEIT-NMBP (DG RTD) and LEIT-ICT (DG CONNECT) Opening 20 Sep 2016 Closing 19 Jan 2017 Single stage submission
15 M€ - 100% funding
Research & Innovation Actions (RIA)
3 - 5 M€ per proposal

2. Outline Overview Cross –cutting KETs EU Funding for medtech
EU Medtech market
NMBP-13 Objectives, scope, requirements and impact, TRLs
Technology and Applications overage
Research and Innovation Actions (RIA)
Expected impact

3. Biophotonics (LEIT-ICT) Bioelectronics-MNBS (LEIT-ICT)
Cross-cutting KETs
Biophotonics (LEIT-ICT)
Bioelectronics-MNBS (LEIT-ICT)
Nano, Materials, Bio- and Production Technologies (LEIT-NMBP)
ECSEL (JU)
EPoSS (ETP)
Photonics 21 (PPP)
Nanomedicine (ETP)
CONVERGING Micro–Nano-Bio-ICT
X-KET For Healthcare
pHealth & Care (SC1)

4. EU Funding for Medtech and nanomedicine
FP7 (2007 – 2014)
Total ~ € 730 million funding to 155 projects
- NMP Projects, ~ 430 mio € funding
Diagnostics & imaging, (targeted) nanopharmaceutics, biomaterials for implants and regenerative medicine, neuro-nano / smart implants
- ICT MNBS projects, ~ 145 mio €
- HEALTH - 31 Projects ~ 150 mio €
Excluding: European Research Council, Marie-Curie
HORIZON 2020 – Workprogramme 2014
Total ~ 530 million € EU funding to 280 projects
Programmes:
LEIT: NMBP + ICT (NMBS) + SME Instrument
Societal Challenge 1 (HEALTH) + SME Instrument
INFRASTRUCTURE
European Research Council
Marie-Skledowska-Curie Training Networks and Bursaries

5. Medtech Market
The European Medtech market size is estimated at roughly € 100 billion
Around 8% of sales revenue is ploughed back into research and development
Almost 25,000 medical technology companies in Europe
95% of MedTech companies are SMEs, the majority of which are small and micro-sized companies
medical technologies
Innovation cycle is months
New patent every 50 minutes
Source : Eucomed

6. NMBP-13 – Objective & Requirements
Objective: further development into a clinical setting of novel MNBS platforms, techniques and systems that have already been proven in a laboratory setting (laboratory Proof-of-Concept)
Focus applications:
In vitro/in vivo diagnostics that are deployed at the point of care;
Therapy monitoring at the point of care.
The work includes:
Translation from the pre-clinical phase to early clinical testing, including design and pilot manufacturing in appropriate volume for clinical testing (small series), pre-clinical and early clinical testing.
include a business case and exploitation strategy
Facilitate clinical data harvesting
Demonstrate clear compliance with applicable Good Laboratory /Clinical / Manufacturing Practices
Attention to the requirements for Health Technology Assessment (HTA); Standardisation issues; Gender specific issues

7. RIA - Research & Innovation Actions
MNBP-13 – RIA Scope
RIA - Research & Innovation Actions
Novel MNBS Platforms / Techniques / Systems
Validation in pre-clinical & clinical test settings:
prototyping,
design and pilot manufacturing
small series manufacturing,
pre-clinical and clinical testing,
clinical data harvesting
Validated in clinical setting, addressing real needs in applications of:
In vitro/in vivo diagnostics that are deployed at the point of care;
Therapy monitoring at the point of care.

8. NMBP-13 – RIA Technology Readiness Level ?
TRLs 3-4 to 5-6
Activities of direct clinical & industrial relevance
Medium time to market
- actual system proven in operational environment (competitive manufacturing in the case of key enabling technologies; or in space)
- system complete and qualified
- system prototype demonstration in operational environment
- technology demonstrated in relevant environment (industrially relevant environment in the case of key enabling technologies)
- technology validated in relevant environment (industrially relevant environment in the case of key enabling technologies)
- technology validated in lab
- experimental proof of concept
- technology concept formulated
- basic principles observed

9. NMBP-13 – RIA - Expected Impact Research & Innovation Actions
Progress the development of advanced integrated MNBS based diagnostic health platforms, techniques or systems from the laboratory Proof-of-Concept to the clinical setting;
Establish a world-class European competitive industrial R&D and manufacturing competence in Micro-Nano-Bio Systems integration for healthcare diagnostics applications;
Strengthening the industrial value chain and progress to marketisation;
Provide affordable systems with unique features that address specific well identified requirements in healthcare;
Address priority needs in healthcare diagnostics and / or therapy monitoring, for the benefit of patients;
Early involvement of regulatory bodies and patients in the new developments
Technologies
Industry/Economy
Users/Society

10. Thank you for your attention
Research in Key Enabling Technologies:
Digital Agenda for Europe – Components and Systems:
Horizon 2020 on the web: