Johns Hopkins University Department of Biomedical Engineering Elliot McVeigh, Director Center for Bioengineering Innovation & Design Youseph Yazdi, PhD, MBA Director FacultyJHTT Soumyadipta Acharya, MD PhDAditya Polsani A. Jay Khanna, MD, MBA Robert Allen, PhDProgram Manager Lawrence Aronhime, MA, MBAMarybeth Camerer Art Shoukas PhD, Murray Sachs PhD

Hopkins CBID Design Teams Academic programs Undergrad: two semester class, required for B.S.  Teams of 6-7 students – soph, junior, senior, freshmen drafted in spring  Deliverable: working prototype device (business plan, inv disclosure) Grad: one year MSE program, 3 teams of 4 students  Deliverables: working device, design history file (DHF), device master record (DMR), provisional patent, animal testing, review paper, 513(g) meeting, mock pre-IDE meeting with FDA panel, business plan Projects: industry, JHU clinicians and faculty, outside physicians

Hopkins CBID Design Teams Key features:  Access and collaboration with world-class JHU clincians and faculty  Deep connection with clinical faculty  Multi-disciplinary review panels and mentoring teams  Entrepreneurs, VCs,  clinicians, attorneys, FDA experts  Faculty from FDA  Course on regulatory affairs  513(g) meeting (fall)  Pre-IDE meeting (spring)

 Major challenges:  Project Life Cycle: after one year, some good projects are not picked up by new teams  New course to continue product development cycle  IP and commercialization issues  Manage time and expectations: busy clinicians – what’s in it for them? Hopkins CBID Design Teams

SurgyPack Oral Thin Film Strip for Vaccine Delivery For other projects see Hopkins CBID Design Teams

The Dreams of Baltimore Children