SlideShare una empresa de Scribd logo
1 de 37
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

Más contenido relacionado

Destacado

Anxiety proposal rise
Anxiety proposal riseAnxiety proposal rise
Anxiety proposal riseValerieFlo
 
Biomedical Research & Community Collaboration: Project VOGUE
Biomedical Research & Community Collaboration: Project VOGUEBiomedical Research & Community Collaboration: Project VOGUE
Biomedical Research & Community Collaboration: Project VOGUEStephaun Wallace
 
Research design proposal
Research design proposalResearch design proposal
Research design proposalmoneycarlo
 
2014 San Francisco Walk to End Alzheimer’s
2014 San Francisco Walk to End Alzheimer’s2014 San Francisco Walk to End Alzheimer’s
2014 San Francisco Walk to End Alzheimer’sScott Robarge
 
PowerpointPresentationFrench
PowerpointPresentationFrenchPowerpointPresentationFrench
PowerpointPresentationFrenchNicholas Roy
 
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013Anthony Keel
 
Ovarian Cancer Research Fund Enables Breakthroughs in Saving Lives
Ovarian Cancer Research Fund Enables Breakthroughs in Saving LivesOvarian Cancer Research Fund Enables Breakthroughs in Saving Lives
Ovarian Cancer Research Fund Enables Breakthroughs in Saving LivesHaberman Management Corp
 
PTSD campaign proposal
PTSD campaign proposalPTSD campaign proposal
PTSD campaign proposalHarvey Whatley
 
Acep%20handout gregg1
Acep%20handout gregg1Acep%20handout gregg1
Acep%20handout gregg1gregghogan
 
Tools to Expedite Your Proposal, IRB, and Results Chapter
Tools to Expedite Your Proposal, IRB, and Results ChapterTools to Expedite Your Proposal, IRB, and Results Chapter
Tools to Expedite Your Proposal, IRB, and Results ChapterStatistics Solutions
 
Targeting ovarian cancer project
Targeting ovarian cancer projectTargeting ovarian cancer project
Targeting ovarian cancer projectAleksandra Klemba
 
Research Project
Research ProjectResearch Project
Research ProjectKhalid Ak
 

Destacado (17)

Anxiety proposal rise
Anxiety proposal riseAnxiety proposal rise
Anxiety proposal rise
 
Biomedical Research & Community Collaboration: Project VOGUE
Biomedical Research & Community Collaboration: Project VOGUEBiomedical Research & Community Collaboration: Project VOGUE
Biomedical Research & Community Collaboration: Project VOGUE
 
Research design proposal
Research design proposalResearch design proposal
Research design proposal
 
2014 San Francisco Walk to End Alzheimer’s
2014 San Francisco Walk to End Alzheimer’s2014 San Francisco Walk to End Alzheimer’s
2014 San Francisco Walk to End Alzheimer’s
 
PowerpointPresentationFrench
PowerpointPresentationFrenchPowerpointPresentationFrench
PowerpointPresentationFrench
 
R proposal 1
R proposal 1R proposal 1
R proposal 1
 
Peptic ulcer (AHN)
Peptic ulcer (AHN)Peptic ulcer (AHN)
Peptic ulcer (AHN)
 
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013
ANTHONY KEEL RESEARCH PROPOSAL 17 MAY 2013
 
Ovarian Cancer Research Fund Enables Breakthroughs in Saving Lives
Ovarian Cancer Research Fund Enables Breakthroughs in Saving LivesOvarian Cancer Research Fund Enables Breakthroughs in Saving Lives
Ovarian Cancer Research Fund Enables Breakthroughs in Saving Lives
 
PTSD campaign proposal
PTSD campaign proposalPTSD campaign proposal
PTSD campaign proposal
 
Acep%20handout gregg1
Acep%20handout gregg1Acep%20handout gregg1
Acep%20handout gregg1
 
Writing Sample
Writing Sample Writing Sample
Writing Sample
 
Research Update 2012
Research Update 2012Research Update 2012
Research Update 2012
 
Tools to Expedite Your Proposal, IRB, and Results Chapter
Tools to Expedite Your Proposal, IRB, and Results ChapterTools to Expedite Your Proposal, IRB, and Results Chapter
Tools to Expedite Your Proposal, IRB, and Results Chapter
 
Final Proposal 11
Final Proposal 11Final Proposal 11
Final Proposal 11
 
Targeting ovarian cancer project
Targeting ovarian cancer projectTargeting ovarian cancer project
Targeting ovarian cancer project
 
Research Project
Research ProjectResearch Project
Research Project
 

Similar a The 8 Stages of the Clinical Design Process

Clinical development of cell-based therapies in the UK A presentation by Chie...
Clinical development of cell-based therapies in the UK A presentation by Chie...Clinical development of cell-based therapies in the UK A presentation by Chie...
Clinical development of cell-based therapies in the UK A presentation by Chie...Cell and Gene Therapy Catapult
 
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...Yole Developpement
 
EuroBioForum 2013 - Day 1 | Greame Boyle
EuroBioForum 2013 - Day 1 | Greame BoyleEuroBioForum 2013 - Day 1 | Greame Boyle
EuroBioForum 2013 - Day 1 | Greame BoyleEuroBioForum
 
Organs-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementOrgans-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementYole Developpement
 
2013-10-23 DTL Next Generation Life Sciences Event, Utrecht
2013-10-23 DTL Next Generation Life Sciences Event, Utrecht2013-10-23 DTL Next Generation Life Sciences Event, Utrecht
2013-10-23 DTL Next Generation Life Sciences Event, UtrechtAlain van Gool
 
Implanted Neural Prosthetics - an Introduction
Implanted Neural Prosthetics - an IntroductionImplanted Neural Prosthetics - an Introduction
Implanted Neural Prosthetics - an IntroductionJennifer French
 
A new generic approach for scoping HTA. Iris Pasternack.
A new generic approach for scoping HTA. Iris Pasternack.A new generic approach for scoping HTA. Iris Pasternack.
A new generic approach for scoping HTA. Iris Pasternack.HTAi Bilbao 2012
 
Dekker trog - big data for radiation oncology - 2017
Dekker   trog  - big data for radiation oncology - 2017Dekker   trog  - big data for radiation oncology - 2017
Dekker trog - big data for radiation oncology - 2017Andre Dekker
 
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...Yole Developpement
 
pHealth EU-USA Workshop
pHealth EU-USA WorkshoppHealth EU-USA Workshop
pHealth EU-USA Workshopguest76da0c
 
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...Manuel GEA - Bio-Modeling Systems
 
Real-World Evidence: The Future of Data Generation and Usage
Real-World Evidence: The Future of Data Generation and UsageReal-World Evidence: The Future of Data Generation and Usage
Real-World Evidence: The Future of Data Generation and UsageApril Bright
 
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...Life Sciences Network marcus evans
 
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...Anjani Dhrangadhariya
 
Dr. Davy Cheng
Dr. Davy ChengDr. Davy Cheng
Dr. Davy Chengichil
 
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...Anjani Dhrangadhariya
 

Similar a The 8 Stages of the Clinical Design Process (20)

Clinical development of cell-based therapies in the UK A presentation by Chie...
Clinical development of cell-based therapies in the UK A presentation by Chie...Clinical development of cell-based therapies in the UK A presentation by Chie...
Clinical development of cell-based therapies in the UK A presentation by Chie...
 
Nesher Tech I-Corps@NIH 121014
Nesher Tech I-Corps@NIH 121014Nesher Tech I-Corps@NIH 121014
Nesher Tech I-Corps@NIH 121014
 
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...
Neurotechnologies and brain computer interface 2018 Report by Yole Developpem...
 
EuroBioForum 2013 - Day 1 | Greame Boyle
EuroBioForum 2013 - Day 1 | Greame BoyleEuroBioForum 2013 - Day 1 | Greame Boyle
EuroBioForum 2013 - Day 1 | Greame Boyle
 
Organs-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole DeveloppementOrgans-On-Chips - 2017 Report by Yole Developpement
Organs-On-Chips - 2017 Report by Yole Developpement
 
2013-10-23 DTL Next Generation Life Sciences Event, Utrecht
2013-10-23 DTL Next Generation Life Sciences Event, Utrecht2013-10-23 DTL Next Generation Life Sciences Event, Utrecht
2013-10-23 DTL Next Generation Life Sciences Event, Utrecht
 
Implanted Neural Prosthetics - an Introduction
Implanted Neural Prosthetics - an IntroductionImplanted Neural Prosthetics - an Introduction
Implanted Neural Prosthetics - an Introduction
 
A new generic approach for scoping HTA. Iris Pasternack.
A new generic approach for scoping HTA. Iris Pasternack.A new generic approach for scoping HTA. Iris Pasternack.
A new generic approach for scoping HTA. Iris Pasternack.
 
Dekker trog - big data for radiation oncology - 2017
Dekker   trog  - big data for radiation oncology - 2017Dekker   trog  - big data for radiation oncology - 2017
Dekker trog - big data for radiation oncology - 2017
 
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...
Artificial Organ Technology and Market Analysis 2017 Report by Yole Developpe...
 
pHealth EU-USA Workshop
pHealth EU-USA WorkshoppHealth EU-USA Workshop
pHealth EU-USA Workshop
 
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...
Conference-The-future-will-be-digital-and-biology-but who-will-lead-watson-go...
 
Real-World Evidence: The Future of Data Generation and Usage
Real-World Evidence: The Future of Data Generation and UsageReal-World Evidence: The Future of Data Generation and Usage
Real-World Evidence: The Future of Data Generation and Usage
 
A Journey from Patient Needs to Health Solutions
A Journey from Patient Needs to Health SolutionsA Journey from Patient Needs to Health Solutions
A Journey from Patient Needs to Health Solutions
 
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...
Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data ...
 
Dr. Andy Lee
Dr. Andy LeeDr. Andy Lee
Dr. Andy Lee
 
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...
End-to-end Fine-grained Neural Entity Recognition of Patients, Interventions,...
 
Dr. Davy Cheng
Dr. Davy ChengDr. Davy Cheng
Dr. Davy Cheng
 
Identification of emerging technologies via a systematic search strategy deve...
Identification of emerging technologies via a systematic search strategy deve...Identification of emerging technologies via a systematic search strategy deve...
Identification of emerging technologies via a systematic search strategy deve...
 
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...
DISTANT-CTO: A Zero Cost, Distantly Supervised Approach to Improve Low-Resour...
 

Más de TECNALIA Research & Innovation

HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVES
HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVESHIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVES
HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVESTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesTECNALIA Research & Innovation
 

Más de TECNALIA Research & Innovation (20)

All is change. TECNALIA.
All is change. TECNALIA.All is change. TECNALIA.
All is change. TECNALIA.
 
Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.
 
Tout est changement. TECNALIA.
Tout est changement. TECNALIA.Tout est changement. TECNALIA.
Tout est changement. TECNALIA.
 
Todo es cambio. TECNALIA
Todo es cambio. TECNALIATodo es cambio. TECNALIA
Todo es cambio. TECNALIA
 
HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVES
HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVESHIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVES
HIGH TEMPERATURE AND HIGH PRESSURE CORROSION TESTING AUTOCLAVES
 
Todo es cambio. TECNALIA
Todo es cambio. TECNALIATodo es cambio. TECNALIA
Todo es cambio. TECNALIA
 
All is change. TECNALIA.
All is change. TECNALIA.All is change. TECNALIA.
All is change. TECNALIA.
 
Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.
 
Tout est changement. TECNALIA.
Tout est changement. TECNALIA.Tout est changement. TECNALIA.
Tout est changement. TECNALIA.
 
Tout est changement. TECNALIA.
Tout est changement. TECNALIA.Tout est changement. TECNALIA.
Tout est changement. TECNALIA.
 
Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.Dena da aldaketa. TECNALIA.
Dena da aldaketa. TECNALIA.
 
All is change. TECNALIA.
All is change. TECNALIA.All is change. TECNALIA.
All is change. TECNALIA.
 
Todo es cambio. TECNALIA.
Todo es cambio. TECNALIA.Todo es cambio. TECNALIA.
Todo es cambio. TECNALIA.
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 
Wearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laboralesWearables para la salud y prevención de riesgos laborales
Wearables para la salud y prevención de riesgos laborales
 

Último

Biological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfBiological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfmuntazimhurra
 
Presentation Vikram Lander by Vedansh Gupta.pptx
Presentation Vikram Lander by Vedansh Gupta.pptxPresentation Vikram Lander by Vedansh Gupta.pptx
Presentation Vikram Lander by Vedansh Gupta.pptxgindu3009
 
Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)PraveenaKalaiselvan1
 
Biopesticide (2).pptx .This slides helps to know the different types of biop...
Biopesticide (2).pptx  .This slides helps to know the different types of biop...Biopesticide (2).pptx  .This slides helps to know the different types of biop...
Biopesticide (2).pptx .This slides helps to know the different types of biop...RohitNehra6
 
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...Sérgio Sacani
 
VIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PVIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PPRINCE C P
 
fundamental of entomology all in one topics of entomology
fundamental of entomology all in one topics of entomologyfundamental of entomology all in one topics of entomology
fundamental of entomology all in one topics of entomologyDrAnita Sharma
 
GBSN - Microbiology (Unit 1)
GBSN - Microbiology (Unit 1)GBSN - Microbiology (Unit 1)
GBSN - Microbiology (Unit 1)Areesha Ahmad
 
Disentangling the origin of chemical differences using GHOST
Disentangling the origin of chemical differences using GHOSTDisentangling the origin of chemical differences using GHOST
Disentangling the origin of chemical differences using GHOSTSérgio Sacani
 
Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )aarthirajkumar25
 
Chemistry 4th semester series (krishna).pdf
Chemistry 4th semester series (krishna).pdfChemistry 4th semester series (krishna).pdf
Chemistry 4th semester series (krishna).pdfSumit Kumar yadav
 
Formation of low mass protostars and their circumstellar disks
Formation of low mass protostars and their circumstellar disksFormation of low mass protostars and their circumstellar disks
Formation of low mass protostars and their circumstellar disksSérgio Sacani
 
Physiochemical properties of nanomaterials and its nanotoxicity.pptx
Physiochemical properties of nanomaterials and its nanotoxicity.pptxPhysiochemical properties of nanomaterials and its nanotoxicity.pptx
Physiochemical properties of nanomaterials and its nanotoxicity.pptxAArockiyaNisha
 
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 60009654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000Sapana Sha
 
Chromatin Structure | EUCHROMATIN | HETEROCHROMATIN
Chromatin Structure | EUCHROMATIN | HETEROCHROMATINChromatin Structure | EUCHROMATIN | HETEROCHROMATIN
Chromatin Structure | EUCHROMATIN | HETEROCHROMATINsankalpkumarsahoo174
 
Animal Communication- Auditory and Visual.pptx
Animal Communication- Auditory and Visual.pptxAnimal Communication- Auditory and Visual.pptx
Animal Communication- Auditory and Visual.pptxUmerFayaz5
 
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral Analysis
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral AnalysisRaman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral Analysis
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral AnalysisDiwakar Mishra
 
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsHubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsSérgio Sacani
 
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Sérgio Sacani
 
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCR
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCRStunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCR
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCRDelhi Call girls
 

Último (20)

Biological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdfBiological Classification BioHack (3).pdf
Biological Classification BioHack (3).pdf
 
Presentation Vikram Lander by Vedansh Gupta.pptx
Presentation Vikram Lander by Vedansh Gupta.pptxPresentation Vikram Lander by Vedansh Gupta.pptx
Presentation Vikram Lander by Vedansh Gupta.pptx
 
Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)Recombinant DNA technology (Immunological screening)
Recombinant DNA technology (Immunological screening)
 
Biopesticide (2).pptx .This slides helps to know the different types of biop...
Biopesticide (2).pptx  .This slides helps to know the different types of biop...Biopesticide (2).pptx  .This slides helps to know the different types of biop...
Biopesticide (2).pptx .This slides helps to know the different types of biop...
 
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...
All-domain Anomaly Resolution Office U.S. Department of Defense (U) Case: “Eg...
 
VIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C PVIRUSES structure and classification ppt by Dr.Prince C P
VIRUSES structure and classification ppt by Dr.Prince C P
 
fundamental of entomology all in one topics of entomology
fundamental of entomology all in one topics of entomologyfundamental of entomology all in one topics of entomology
fundamental of entomology all in one topics of entomology
 
GBSN - Microbiology (Unit 1)
GBSN - Microbiology (Unit 1)GBSN - Microbiology (Unit 1)
GBSN - Microbiology (Unit 1)
 
Disentangling the origin of chemical differences using GHOST
Disentangling the origin of chemical differences using GHOSTDisentangling the origin of chemical differences using GHOST
Disentangling the origin of chemical differences using GHOST
 
Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )Recombination DNA Technology (Nucleic Acid Hybridization )
Recombination DNA Technology (Nucleic Acid Hybridization )
 
Chemistry 4th semester series (krishna).pdf
Chemistry 4th semester series (krishna).pdfChemistry 4th semester series (krishna).pdf
Chemistry 4th semester series (krishna).pdf
 
Formation of low mass protostars and their circumstellar disks
Formation of low mass protostars and their circumstellar disksFormation of low mass protostars and their circumstellar disks
Formation of low mass protostars and their circumstellar disks
 
Physiochemical properties of nanomaterials and its nanotoxicity.pptx
Physiochemical properties of nanomaterials and its nanotoxicity.pptxPhysiochemical properties of nanomaterials and its nanotoxicity.pptx
Physiochemical properties of nanomaterials and its nanotoxicity.pptx
 
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 60009654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
 
Chromatin Structure | EUCHROMATIN | HETEROCHROMATIN
Chromatin Structure | EUCHROMATIN | HETEROCHROMATINChromatin Structure | EUCHROMATIN | HETEROCHROMATIN
Chromatin Structure | EUCHROMATIN | HETEROCHROMATIN
 
Animal Communication- Auditory and Visual.pptx
Animal Communication- Auditory and Visual.pptxAnimal Communication- Auditory and Visual.pptx
Animal Communication- Auditory and Visual.pptx
 
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral Analysis
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral AnalysisRaman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral Analysis
Raman spectroscopy.pptx M Pharm, M Sc, Advanced Spectral Analysis
 
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroidsHubble Asteroid Hunter III. Physical properties of newly found asteroids
Hubble Asteroid Hunter III. Physical properties of newly found asteroids
 
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
Discovery of an Accretion Streamer and a Slow Wide-angle Outflow around FUOri...
 
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCR
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCRStunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCR
Stunning ➥8448380779▻ Call Girls In Panchshil Enclave Delhi NCR
 

The 8 Stages of the Clinical Design Process

  • 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