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 Johns Hopkins University Department of Biomedical Engineering

the education and development of the next generation of leaders in healthcare innovation and the 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. CBID’s Mission, 2 Key Elements

not bench to bedside bedside to bench to bedside healthcare innovation that starts with and returns to the clinician-patient interaction Clinical Immersion Essential to our Approach

IMPLEMENT IDENTIFY INVENT 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 1-Year MSE Degree Program

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 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 Clinical Immersions ‘T’ model: Breadth then Selective Depth

 Cardiology  Gastroenterology  General Surgery  Interventional Radiology  Neurosurgery  Orthopedic Surgery  Obstetrics & Gynecology  Ophthalmology  Otolaryngology  Urology Clinical Immersion: Typical Rotations At Johns Hopkins School of Medicine (June, July) 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: CBID Medical Director and Clinical Adv Board KEY: Partnerships with Jhpiego & Local Institutions

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

Design Team: Core + Support 3-5 Students 1-3 Clinicians 1-2 Faculty Regulators  Mock 513g sessions  Mock IDE reviews  8-wk summer course Non-core Clinicans:  access to pts and labs  reviews  VoC 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 Legal Experts:  IP legal  startup legal  Regulatory strategy  Reimbursement strat Prof Engineering:  design reviews  DfM  Hosts teams in country  Deployment and testing Academics  sci and tech  suppl coursework Design Team

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

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

Global Health Innovation Antenatal Screening Kit