Junctional Tourniquet
Source repository is private
A six-person Duke engineering team project to design a tourniquet for axillary and inguinal (“junctional”) hemorrhage — bleeding at joints where a standard limb tourniquet can’t get purchase — for pre-hospital and military use. The device uses a CO₂-inflated air bladder with a 360-degree strap adjustment system, designed to apply in under 30 seconds without restricting the patient’s mobility.
What made this a design-controls project, not just a prototype
The point of the course was running an actual Class II medical device development lifecycle end to end, across four semesters:
- Needs discovery: 10+ structured stakeholder interviews with trauma surgeons, ER nurses, paramedics, and military personnel, plus a MECE competitive landscape analysis against existing junctional tourniquets.
- Design: iterated CAD prototypes in Fusion 360, fabricated for bench testing.
- Risk analysis: a Design and Use FMECA per the ISO 14971 risk-control hierarchy.
- Regulatory strategy: classified as Class II, a 510(k) pathway identified using the SAM Junctional Tourniquet as predicate (with three other predicates also mapped: CRoC, JETT, AAJT), standards mapped across FDA/ISO/IEC/ASTM/AAMI, and an Invention Disclosure filed through Duke’s Office of Licensing and Ventures.
- Verification testing: pressure-rig characterization, strap failure testing at 100–1000 lb loads, and Doppler flow simulation, with a Design History File maintained per ISO 13485 / 21 CFR Part 820 the whole way through.
- Commercialization: a revenue model and investor pitch materials alongside the technical work.
Patented. 2nd place, Innovate Carolina 2021. Presented to the Chairman of the Joint Chiefs of Staff, General Mark Milley.