cleverCUP - Urine Collecting Device (UCD)

What it does

cleverCUP is an ergonomic, labia-separating UCD that automatically segregates First-void (FVU), Midstream (MSU), and Late-stream urine (LSU), reducing contamination and improving UTI and STI diagnostic accuracy for better antimicrobial stewardship.

Your inspiration

The idea was inspired by the widespread challenge women face in giving urine samples accurately. As a Biodesign fellow at THSTI, DBT, I observed: STIs and UTIs Are Overlapping Epidemics ~374 million new STI cases annually (Chlamydia, Gonorrhea, Trichomoniasis) – WHO, 2025 70% of Chlamydia & Trichomonas infections are asymptomatic UTIs affect 404 M people annually, with ~60% of women having ≥1 episode in their lifetime Misdiagnosis risk: Symptoms of STIs and UTIs often overlap → incorrect antibiotics → AMR We envisioned a device that makes sample collection dignified, accurate, and effortless—especially for women, children, and seniors.

How it works

cleverCUP uses a labia-separating funnel to channel urine directly into a chambered container. As urine flows, the device automatically separates the FVU, MSU, and LSU fractions into different compartments using a predefined path and locking mechanism. Because FVU is required for STI diagnosis which is often contaminated by MSU, and MSU is required for UTI screening which is often contaminated by FVU & LSU. Furthermore, the midstream sample is split into two chambers, MSU1 to ensure a viable sample even with patient's with low urine output and it will also be used for Dipstick testing, if positive then MSU2 will be used for Urine Culture & AST. Integrated with Standard Care: It aligns with India’s RMNCH+A guidelines, which mandate dipstick testing (nitrite and leukocyte esterase) at the first antenatal visit and as clinically indicated—making it easy to adopt in existing clinical protocols.

Design process

Observations: Current urine collection practices are flawed: Midstream "clean catch" rarely performed correctly STI pathogens reside in first-catch urine UTI cultures require uncontaminated midstream urine, thus our objective was to develop pre-defined compartments for effective urine segregation. Journey began with paper models, to cay models and then to initial CAD models in SolidWorks. Alpha prototypes - had test-tube detachment at the bottom - were developed using SLA 3D printing and tested with spiked lab samples and in house urine flow simulator. Based on results, we iterated the design to optimize flow control and compartment filling at the same time to make it user-friendly for both patient & lab technician. A beta prototype designed with test-tube detachment from the front and is now being vacuum-casted for pilot testing with 100 patients at ESIC Faridabad. The device has also been refined for manufacturability (DFMEA) and user comfort across different anatomies. The Gamma version will have separate slot for direct Micropipette (used to asperate urine sample) access to the tube without the need for discarding the funnel and screwing the cap on to.

How it is different

cleverCUP is a fully automatic, anatomically adaptive UCD that FVU, MSU, and late-stream urine in real time—without requiring user coordination. Unlike existing solutions like Peezy or Whiz, which still report contamination rates of 26–30% (Hayward G. et al., 2022), cleverCUP ensures <5% contamination through its patented design (https://patentscope.wipo.int/search/en/WO2025126244). The device features three distinct compartments: FVU for STI diagnosis (via NAAT/Culturing), MSU1 for point-of-care UTI screening using dipsticks, and MSU2 for confirmatory urine culture & AST if the dipstick is positive. Dual Utility: cleverCUP enables immediate dipstick analysis while also preserving a clean midstream sample for follow-up culture—minimizing diagnostic delays and the need for re-sampling. This not only improves diagnostic accuracy but also supports timely, evidence-based treatment, especially in high-risk or resource-limited settings.

Future plans

MSU 2 - 3rd compartment – along with UTI Diagnosis it can be used for Drug Abuse Testing (Workplace/Insurance) LSU - 4th compartment – underutilized in CKD diagnostics, giving opportunity to study usually discarded samples (Bober, P., et al., 2021, Zhang Z., et al., 2022). We plan to complete pilot clinical trials, optimize for scalable manufacturing, and apply for regulatory approvals (CDSCO, FDA). Next steps include a product launch by 2027 targeting (B2B) diagnostic labs and hospitals, and developing a complementary UTI & STI triage module integrated with rapid testing strips. (Post HTA we also plan for B2G and increase our social impact)

Awards

Public grants: ₹24 L (THSTI-SiB foundational investment) Awards: ₹1.48 L (Persistent Systems, BRIC-DBT, AIIMS & JNU New Delhi) In the Pre-Incubation of Women Startup Program by NSRCEL - IIM Bangalore In the finals of BIG'24 by BIRAC, awaiting results Shortlisted for TIDE 2.0, WTFund's C1/25 & BFI Biome Program 2nd edition