1. 1 2. 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 3. 4 Traslational Science Roadmap (Cambridge) 1st Phase: Emerging Ideas, innovation, researchers visions Spin-offs, start-ups 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), 115. SCIENCE MARKET 4. 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 5. 6 Integrated Open Innovation supply chain TRL 6. 7 Integrated Open Innovation supply chain 7. 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 8. 9 Integrated Open Innovation supply chain 9. 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 10. 11 ICTUS 11. 12 Stroke 12. 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 13. 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 14. 15 15. 16 Visuo-Motor Neural Network Stage 2: Project Proposal (Hypothesis) 16. 17 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. 18. 19 Patients Groups Experimental Contingent + Control Sham (Random) Stage 7 - Walk-Through Stage 8 - Final Prototype Stage 9 - Testing 19. 20 BCI in chronic Stroke patients: BCI Intervention Ramos-Murguialday et al. Annals of Neurology 2013 20. 21 Movement Restoration 21. 22 22. EMG improvement 23. 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? 24. 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 25. 26 Neuroprosthetics Timeline 26. 27 Microeletrodes 27. 28 Current status and future 28. 29 IS-MORE Snapshot 29. 30 30. 31 Experimental design 31. 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.) Jrgen Mellinger (Physics) Sebastian Halder (Computer Sci.) Jrgen Dax (Elec. Eng.) Manuel Agostini (Psychol.) zge 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 Ler (Neurorad.) Acknowledgement 32. 33 33. 34 Acknowledgement Core Team: Tbingen: 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 (Neurologa) Noemi Diaz (Neurologa) Patricia de la Riva (Neurologa) 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.) 34. 35 Thanks! 35. 36 Thanks! 36. 37