Problem Statement
Healthcare workers performing breast fine needle aspiration (FNA) biopsies at Level 6 and 7 Ugandan Health Centers need a method to obtain representative diagnostic samples in order to decrease the number of false negative results
The device removes the human error associated with traditional fine needle aspiration (FNA), the current gold standard of diagnosis in LMICs by mimicking the traditional error prone FNA techniques with robust designs taken from the automotive industry! Traditional linear needle oscillations are performed with a miniature circular eccentric, while rotary motion is accomplished with a custom syringe housing.
My role on the team revolves around developing test fixtures to gather our clinical data, validating mechanical design inputs, researching and fabricating the prototypes used in clinical studies, and navigating the 510(k) Class II pathway for an upcoming non-provisional patent.
Results
Upcoming high fidelity clinical study on rat tissue models upcoming in late November. 5 Preliminary tests performed on ex-vivo benchtop tissue models have been used in presentations and business pitches.
Developmental Timeline
6 controlled revisions across 3 year development timeline. 20+ test fixtures and "works-like" prototypes developed for testing and risk mitigation of primary mechanism efficacy.
Spring 2024 - Early prototypes focused on simulating motion without regard for form factor for mechanical testing and feasibility studies
Spring 2025 - Early prototypes integrating robust mechanisms suitable for harsh use conditions for clinical feedback from committee members (across Sub Saharan Africa/JHU)
Deliverables & QMS Experience
Work done in collaboration with 7 team members and with guidance of 12 committee members. Across 4 DHFs during our time at Johns Hopkins, I was particularly responsible for contributing towards:
- Competitive Analysis
- FMEA Risk Analysis
- V&V Testing Appendices/Protocols
- Design Master Records
- Index of Design Files
- Final Paper Manuscript
Samples of my work from my 4th DHF (Jan 2024 - May 2024) can be found in attachments
Awards & Media
- UMD MidAtlantic Regional NSF I-Corps
- JHU Pava Center Ignite Fund, Spark Accelerator, & Summer Incubator
- Venturewell E Teams Incubator, Pioneer Grant, Propel Grant
- HOUR Catalyst Award
- JHU CBID Healthcare Design Award & Student Initiatives Fund
Conferences & Presentations
- Rice360 Global Health Technologies Design Competition - 4th Place
- Johns Hopkins University - HopStart, Pava Center Incubator Spark Showcase, CBID Design Challenge (2nd place)
- ICBME at the National University of Singapore - Presentation & poster
- BMES 2024 - Presentation & poster
- JHU Design Day 2023/2024 - Presentation & poster
- Consortium of Universities for Global Health - 2025 Global Health Video Competition 1st Place