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Clinical Immersion for Engineers: Jumpstarting the Medtech Innovation Process Soumyadipta Acharya, MD, PhD Graduate Prog

Johns Hopkins University Department of Biomedical Engineering. Clinical Immersion for Engineers: Jumpstarting the Medtech Innovation Process Soumyadipta Acharya, MD, PhD Graduate Program Director Youseph Yazdi, PhD, MBA Executive Director BME IDEA Workshop

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Clinical Immersion for Engineers: Jumpstarting the Medtech Innovation Process Soumyadipta Acharya, MD, PhD Graduate Prog

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  1. Johns Hopkins University Department of Biomedical Engineering Clinical Immersion for Engineers: Jumpstarting the Medtech Innovation Process Soumyadipta Acharya, MD, PhD Graduate Program Director Youseph Yazdi, PhD, MBA Executive Director BME IDEA Workshop Fostering Innovation: Emerging and Best Practices in Clinical Immersion Oct 12 2011

  2. CBID’s Mission, 2 Key Elements the education and development of the next generation of leaders in healthcare innovation andthe creation and early-stage development of healthcare solutions that have a transformational impact on human health around the world. ~ Our key measure of success is the positive impact our students and our technologies have on the quality and accessibility of healthcare.

  3. Clinical Immersion Essential to our Approach notbench to bedside bedside to bench to bedside • healthcare innovation • that starts with and returns to • the clinician-patient interaction

  4. 1-Year MSE Degree Program • Starts in Summer with Three Courses: • Identification and Validation of Medical Needs • Clinical immersion, observations, interviews • Training in Ethnographic techniques • Business of Biomed Innovation and Design (1 of 3) • Assessment, value prop, markets, competition, IP • Case studies, group projects, interactions with experts from industry, VCs • Regulation of Medical Devices • 8-Lecture series on FDA mandate & process IDENTIFY INVENT IMPLEMENT

  5. Clinical Immersions ‘T’ model: Breadth then Selective Depth • Cast the net wide – Breadth first • Two core rotations (3 weeks each) from a menu of four options • Two elective rotations (2 weeks) from a menu of 20-25 options • Number of students restricted to 6-8 per department. • Focus on generating needs with high clinical impact • Direct observation, directed observation, stakeholder interviews (with supporting coursework) • First filter- Weekly clinical feedback • Dig deep into few needs that have generated the most clinical excitement. • Revisit select departments (specifically sub-specialities). • More selective observations, for needs assessment and parameterization • Multiple interactive sessions with clinicians. • Several presentations to Investors and Entrepreneurs in respective specialties • Similar models applied for global health clinical rotations • Stakeholders are somewhat different from US context

  6. Clinical Immersion:Typical Rotations At Johns Hopkins School of Medicine (June, July) • Orthopedic Surgery • Obstetrics & Gynecology • Ophthalmology • Otolaryngology • Urology • Cardiology • Gastroenterology • General Surgery • Interventional Radiology • Neurosurgery KEY: CBID Medical Director and Clinical Adv Board International Rotations (August) • India, Nepal, Tanzania, Ethiopia • 3 weeks, 1 site per team • Rural clinics and hospitals new – started 2010 Global Health Innovation Program KEY: Partnerships with Jhpiego & Local Institutions

  7. Clinical Immersion just the start… additional clinical plus commercial and technical input needed Clinician feedback/ Screening 48 Clinician Immersion Prelim Technical Feasibility Assessment 1 project per team ~900 raw needs observations 16 in-depth opportunity briefs 24 Prelim. Commercial & Market Assessments Clinical Impact Analysis & Validation June - July September

  8. Regulators • Mock 513g sessions • Mock IDE reviews • 8-wk summer course Design Team: Core + Support • Non-core Clinicans: • access to pts and labs • reviews • VoC • Prof Engineering: • design reviews • DfM • Academics • sci and tech • suppl coursework Design Team • Legal Experts: • IP legal • startup legal • Regulatory strategy • Reimbursement strat 3-5 Students 1-3 Clinicians 1-2 Faculty • Industry Experts • mentorship of team • access to corp resources (mkt data, prototyping, funds) • follow-on development • Startup Experts • mentorship on startup issues and strategy • access to prof investors • follow-on funding • Hosts teams in country • Deployment and testing

  9. CBID Clinical Immersion Program • educates both students and clinicians • generates clinical intuition in engineers • develops collaborative skills essential to successful design teams • identifies and assesses medtech innovation opportunities • launches partnerships • creates goodwill and working model for future MSE classes

  10. Selected Spinouts & Startups From MSE Classes of 2010 & 2011 Class of 2012: sinusitis, biofilm, joints, stenting

  11. Global Health Innovation Antenatal Screening Kit

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