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1
3
The Process of Design
• Stage 1 - Identify Clinical Problem
• Stage 2 - Project Proposal
• Stage 3 - Conceptual Design
• Stage 4 - Preliminary Design
• Stage 5 - Mock-Up
• Stage 6 - Preliminary Prototype
• Stage 7 - Walk-Through
• Stage 8 - Final Prototype
• Stage 9 - Testing
• Clinical Rotations
• Global Health Module
• Invention Innovation and Design
• Business of Bioengineering Innovation
and Design
4
Traslational Science Roadmap (Cambridge)
1st Phase: Emerging
• Ideas, innovation, researchers’ visions
• Spin-off’s, start-up’s
2nd Phase: Pacing
• Form technical/industry associations
• Work on customer education, start lobbying, consolidate
• Define technological roadmaps
3rd Phase: Key
• Define policy roadmaps
• Interact with all stakeholders, consolidate
4th Phase: Base
• Marketing strategy…
(technological push)
(market pull)
(active push / pull)
Source: Phaal, R.,Farrukh,C.J.P.,Probert,D.R. A framework for supporting the management of technological knowledge. International Journal of Technology Management 2004 , 27(1), 1–15.
SCIENCE
MARKET
5
Actual system “efficacy proven” successful clinical trials
Actual system completed and “qualified”  pilot clinical trial
System prototype demonstration in relevant environment
System/subsystem model/prototype demonstration in a relevant environment
Component/breadboard validation in relevant environment
Component/breadboard validation in laboratory environment.
Analytical and experimental critical function and/or characteristic  proof of concept
study.
Technology concept and/or application formulated
Basic principles observed and reported
Technology Readiness Levels (TRLs): evaluating the level of development of a
technology adapted to biomedical divecies
6
Integrated Open Innovation supply chain
TRL
7
Integrated Open Innovation supply chain
8
Actual system “efficacy proven” successful clinical trials
Actual system completed and “qualified”  pilot clinical trial
System prototype demonstration in relevant environment
System/subsystem model/prototype demonstration in a relevant environment
Component/breadboard validation in relevant environment
Component/breadboard validation in laboratory environment.
Analytical and experimental critical function and/or characteristic  proof of concept
study.
Technology concept and/or application formulated
Basic principles observed and reported
Technology Readiness Levels (TRLs): evaluating the level of development of a
technology adapted to biomedical divecies
9
Integrated Open Innovation supply chain
10
GERMANY
FRANCE
ITALY
SERBIA
• TECNALIA nodes = Accelerators
• Situated next to world-leading
univerities in one of our strategic
research lines
• Facilitates the division of work,
intense collaboration and rapid
transfer of knowledge to the
market
The Node as a tool for Open Innovation
11
ICTUS
12
Stroke
13
Health System Cost: 68 bill.$ and 27 bill.€ a year in US
and EU:
• 0.27% of gross domestic product was spent on
stroke by national health systems
• stroke care ∼3% of total health care
expenditures
• mean lifetime cost: ∼ $180.000 in US and 45.000
€ EU…
cost of a paralyzed patient is more than triple
($540.000).
• (90%) of costs comes in the form of chronic
outpatient care and rehabilitation.
OUR TARGET 486.000$/patient
ACTUAL STROKE COSTSTARGET PATIENTS
EU national projections for the period 2006 to 2025 showed 1.5 million and 1.9 million
new cases of stroke a year in men and women, respectively, at a present value of 51.5
and 57.1 billion EUR, respectively.
Complete Paresis
OUR TARGET
30%
Stroke Patients
3.6 Million and 2 more million a year in USA+EU
Impaired
35%
Death
35%
OUR
TARGET
No available
Therapy
Unmet Need
Big Market
IS-MORE Target
14
Neurorehabilitation case:
Clinical Brain-Machine-Interfaces (BMIs)
• Motor Restoration Neural Interfaces(STROKE)
• Communication (ALS)
Using the feedback of the closed loop neuroprothesis to induce plasticity and
motor recovery via classical or operant conditioning.
Stage1: Identify clinical problem (clinical rotation)
Analyze the afferent pathways closing the loop of a BCI to restore
communication in the completetly locked in state.
N. Birbaumer, A. Ramos Murguialday and L. Cohen, Brain-Computer-Interface (BCI) in paralysis. In: Current opininon
in Neurology Vol. 21(6):634-638, 2008
15
16
Visuo-Motor
Neural Network
Stage 2:
Project Proposal (Hypothesis)
17
18
Chronic Severely Paralyzed Stroke Patients
Inclusion criteria:
1. paralysis of one hand with no active finger extension;
2. time since stroke of at least 10 months (chronic stage);
3. age between 18 and 80 years;
4. no psychiatric or neurological condition other than stroke;
5. no cerebellar lesion or bilateral motor deficit (unilateral stroke);
6. no pregnancy;
7. no claustrophobia;
8. no epilepsy or medication for epilepsy during the last 6 months;
9. eligibility to undergo magnetic resonance imaging (MRI);
10. ability to understand and follow instructions.
19
Patients Groups
Experimental
Contingent +
Control
Sham (Random)
Stage 7 - Walk-Through
Stage 8 - Final Prototype
Stage 9 - Testing
20
BCI in chronic Stroke patients: BCI Intervention
Ramos-Murguialday et al. Annals of Neurology 2013
21
Movement Restoration
22
EMG improvement
24
Conclusions of the clinical controlled pilot study
• Only experimental group learned to use the BCI
• Only experimental increased significantly FMA scores, EMG and Laterization
Index
• We proved. Efficacy of using BCI in chronic stroke rehabilitation!
• However:
• Low number of patients
• Limited motor improvement
• Limited Resources (Time, funding)  Rehab.; CE or FDA.
• Breakthrough?
25
Therapeutic devices are stepping in where
pharmaceuticals have failed to provide solutions.
Venture and corporate investors have provided over
$4 billion in investment to private neurodevice
companies over the past seven years
26
Neuroprosthetics Timeline
27
Microeletrodes
28
Current status and future
29
IS-MORE Snapshot
30
31
Experimental design
32
BMBF; DFG; EU-ERC, EU-ICT; NIH
NINDS; Motorika; DGIST; MEST;
University of Tubingen, TECNALIA
Research and Innovation, DAAD,
Center of Integrative Neuroscience
Tubingen.
Prof. Christoph Braun
Prof. Andreas Luft
Prof. Leonardo Cohen
Prof. Niels Birbaumer
All the patients
Ernesto Soares (Elec. Eng.)
Jürgen Mellinger (Physics)
Sebastian Halder (Computer Sci.)
Jürgen Dax (Elec. Eng.)
Manuel Agostini (Psychol.)
Özge Yilmaz (Psychol.)
Giulia Liberati (Psychol.)
Andrea Caria (BioMed. Eng.)
Fabricio Brasil (Elec. Eng)
Marco Curado (Biology)
Eliana Garcia (BioMed. Eng.)
Massimiliano Rea (Psychology)
Woosang Cho (BioMed. Eng.)
Monika Grammer (Therapist)
Doris Broetz (Physio.)
Thomas Oesterle (Physio)
Alexandros Vizyotis (Neurosurg.)
Leonhard Läer (Neurorad.)
Acknowledgement
33
34
Acknowledgement
Core Team:
Tübingen:
Niels Birbaumer (Neuroscience/Psychology)
Andrea Sarasola (BioMed. Eng.)
Nerea Irastorza (BioMed. Eng.)
Berkeley:
Jose Carmena (Elect. Eng.)
Siddarth Dangi (BioMed. Eng.)
Suraj Gowda (BioMed. Eng.)
Hospital Donostia:
Eduardo Ramos (Neurocirugia)
Adolfo Lopez de Munain (Neurología)
Noemi Diaz (Neurología)
Patricia de la Riva (Neurología)
Juan Aycart (Rehabilitacion)
Euskal Herriko Unibertsitatea (EHU):
Ana Bengoetxea (Physiotherapy)
Funding:
University of Tubingen, TECNALIA Research and Innovation, University of
California Berkeley, Basque Country Government, DAAD.
TECNALIA:
Joe McIntyre (Mech. Eng.)
Julius Klein (BioMed. Eng.)
David Valencia (Elect. Eng.)
Aitor Belloso (Mech. Eng.)
Lorenzo Bassilucani (Mech. Eng.)
Je Huyng Jung (Mech Eng.)
Fabrice Morin (Biomed Eng.)
Thierry Keller (Elect. Eng.)
35
Thanks!
36
Thanks!
37

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Conferencia del Dr. Ander Ramos en #Perspectives2015

  • 1. 1
  • 2.
  • 3. 3 The Process of Design • Stage 1 - Identify Clinical Problem • Stage 2 - Project Proposal • Stage 3 - Conceptual Design • Stage 4 - Preliminary Design • Stage 5 - Mock-Up • Stage 6 - Preliminary Prototype • Stage 7 - Walk-Through • Stage 8 - Final Prototype • Stage 9 - Testing • Clinical Rotations • Global Health Module • Invention Innovation and Design • Business of Bioengineering Innovation and Design
  • 4. 4 Traslational Science Roadmap (Cambridge) 1st Phase: Emerging • Ideas, innovation, researchers’ visions • Spin-off’s, start-up’s 2nd Phase: Pacing • Form technical/industry associations • Work on customer education, start lobbying, consolidate • Define technological roadmaps 3rd Phase: Key • Define policy roadmaps • Interact with all stakeholders, consolidate 4th Phase: Base • Marketing strategy… (technological push) (market pull) (active push / pull) Source: Phaal, R.,Farrukh,C.J.P.,Probert,D.R. A framework for supporting the management of technological knowledge. International Journal of Technology Management 2004 , 27(1), 1–15. SCIENCE MARKET
  • 5. 5 Actual system “efficacy proven” successful clinical trials Actual system completed and “qualified”  pilot clinical trial System prototype demonstration in relevant environment System/subsystem model/prototype demonstration in a relevant environment Component/breadboard validation in relevant environment Component/breadboard validation in laboratory environment. Analytical and experimental critical function and/or characteristic  proof of concept study. Technology concept and/or application formulated Basic principles observed and reported Technology Readiness Levels (TRLs): evaluating the level of development of a technology adapted to biomedical divecies
  • 6. 6 Integrated Open Innovation supply chain TRL
  • 8. 8 Actual system “efficacy proven” successful clinical trials Actual system completed and “qualified”  pilot clinical trial System prototype demonstration in relevant environment System/subsystem model/prototype demonstration in a relevant environment Component/breadboard validation in relevant environment Component/breadboard validation in laboratory environment. Analytical and experimental critical function and/or characteristic  proof of concept study. Technology concept and/or application formulated Basic principles observed and reported Technology Readiness Levels (TRLs): evaluating the level of development of a technology adapted to biomedical divecies
  • 10. 10 GERMANY FRANCE ITALY SERBIA • TECNALIA nodes = Accelerators • Situated next to world-leading univerities in one of our strategic research lines • Facilitates the division of work, intense collaboration and rapid transfer of knowledge to the market The Node as a tool for Open Innovation
  • 13. 13 Health System Cost: 68 bill.$ and 27 bill.€ a year in US and EU: • 0.27% of gross domestic product was spent on stroke by national health systems • stroke care ∼3% of total health care expenditures • mean lifetime cost: ∼ $180.000 in US and 45.000 € EU… cost of a paralyzed patient is more than triple ($540.000). • (90%) of costs comes in the form of chronic outpatient care and rehabilitation. OUR TARGET 486.000$/patient ACTUAL STROKE COSTSTARGET PATIENTS EU national projections for the period 2006 to 2025 showed 1.5 million and 1.9 million new cases of stroke a year in men and women, respectively, at a present value of 51.5 and 57.1 billion EUR, respectively. Complete Paresis OUR TARGET 30% Stroke Patients 3.6 Million and 2 more million a year in USA+EU Impaired 35% Death 35% OUR TARGET No available Therapy Unmet Need Big Market IS-MORE Target
  • 14. 14 Neurorehabilitation case: Clinical Brain-Machine-Interfaces (BMIs) • Motor Restoration Neural Interfaces(STROKE) • Communication (ALS) Using the feedback of the closed loop neuroprothesis to induce plasticity and motor recovery via classical or operant conditioning. Stage1: Identify clinical problem (clinical rotation) Analyze the afferent pathways closing the loop of a BCI to restore communication in the completetly locked in state. N. Birbaumer, A. Ramos Murguialday and L. Cohen, Brain-Computer-Interface (BCI) in paralysis. In: Current opininon in Neurology Vol. 21(6):634-638, 2008
  • 15. 15
  • 17. 17
  • 18. 18 Chronic Severely Paralyzed Stroke Patients Inclusion criteria: 1. paralysis of one hand with no active finger extension; 2. time since stroke of at least 10 months (chronic stage); 3. age between 18 and 80 years; 4. no psychiatric or neurological condition other than stroke; 5. no cerebellar lesion or bilateral motor deficit (unilateral stroke); 6. no pregnancy; 7. no claustrophobia; 8. no epilepsy or medication for epilepsy during the last 6 months; 9. eligibility to undergo magnetic resonance imaging (MRI); 10. ability to understand and follow instructions.
  • 19. 19 Patients Groups Experimental Contingent + Control Sham (Random) Stage 7 - Walk-Through Stage 8 - Final Prototype Stage 9 - Testing
  • 20. 20 BCI in chronic Stroke patients: BCI Intervention Ramos-Murguialday et al. Annals of Neurology 2013
  • 22. 22
  • 24. 24 Conclusions of the clinical controlled pilot study • Only experimental group learned to use the BCI • Only experimental increased significantly FMA scores, EMG and Laterization Index • We proved. Efficacy of using BCI in chronic stroke rehabilitation! • However: • Low number of patients • Limited motor improvement • Limited Resources (Time, funding)  Rehab.; CE or FDA. • Breakthrough?
  • 25. 25 Therapeutic devices are stepping in where pharmaceuticals have failed to provide solutions. Venture and corporate investors have provided over $4 billion in investment to private neurodevice companies over the past seven years
  • 30. 30
  • 32. 32 BMBF; DFG; EU-ERC, EU-ICT; NIH NINDS; Motorika; DGIST; MEST; University of Tubingen, TECNALIA Research and Innovation, DAAD, Center of Integrative Neuroscience Tubingen. Prof. Christoph Braun Prof. Andreas Luft Prof. Leonardo Cohen Prof. Niels Birbaumer All the patients Ernesto Soares (Elec. Eng.) Jürgen Mellinger (Physics) Sebastian Halder (Computer Sci.) Jürgen Dax (Elec. Eng.) Manuel Agostini (Psychol.) Özge Yilmaz (Psychol.) Giulia Liberati (Psychol.) Andrea Caria (BioMed. Eng.) Fabricio Brasil (Elec. Eng) Marco Curado (Biology) Eliana Garcia (BioMed. Eng.) Massimiliano Rea (Psychology) Woosang Cho (BioMed. Eng.) Monika Grammer (Therapist) Doris Broetz (Physio.) Thomas Oesterle (Physio) Alexandros Vizyotis (Neurosurg.) Leonhard Läer (Neurorad.) Acknowledgement
  • 33. 33
  • 34. 34 Acknowledgement Core Team: Tübingen: Niels Birbaumer (Neuroscience/Psychology) Andrea Sarasola (BioMed. Eng.) Nerea Irastorza (BioMed. Eng.) Berkeley: Jose Carmena (Elect. Eng.) Siddarth Dangi (BioMed. Eng.) Suraj Gowda (BioMed. Eng.) Hospital Donostia: Eduardo Ramos (Neurocirugia) Adolfo Lopez de Munain (Neurología) Noemi Diaz (Neurología) Patricia de la Riva (Neurología) Juan Aycart (Rehabilitacion) Euskal Herriko Unibertsitatea (EHU): Ana Bengoetxea (Physiotherapy) Funding: University of Tubingen, TECNALIA Research and Innovation, University of California Berkeley, Basque Country Government, DAAD. TECNALIA: Joe McIntyre (Mech. Eng.) Julius Klein (BioMed. Eng.) David Valencia (Elect. Eng.) Aitor Belloso (Mech. Eng.) Lorenzo Bassilucani (Mech. Eng.) Je Huyng Jung (Mech Eng.) Fabrice Morin (Biomed Eng.) Thierry Keller (Elect. Eng.)
  • 37. 37