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

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 http://cbid.bme.jhu.edu

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

Hopkins CBID Design Teams
 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 http://cbid.bme.jhu.edu

The Dreams of Baltimore
Children