In-House Development and Field Validation of 3D-Printed OpenFlexure Microscope as a point-of-care cytology tool for Oral Cancer and Oral Potentially Malignant Disorders Screening in Low-Resource Settings.
All India Institute Of Medical Sciences, New Delhi
drvarunsuryamds@aiims.edu
Project Overview
The rationale for this project stems from the need of a 3D printed locally developed, low-cost microscope that can be deployed in remote field settings to improve detection of Oral Potentially Malignant Disorders (OPMDs) and early stage oral squamous cell carcinoma (OSCC) in low-resource settings. Current first-line screening relies on visual or smartphone-based examination, which, while simple, often misses subtle dysplastic changes and depends on specialist availability or AI/ML analysis. Brush cytology has emerged as a promising adjunct for early detection, demonstrating high diagnostic accuracy (pooled sensitivity ~91% and specificity ~96% in a meta-analysis of 13,249 patients, Tayebi-Hillali, N., et al). However, cytology requires microscopy and expert interpretation, resources typically scarce in rural areas. We hypothesize that an affordable, 3D-printed OpenFlexure microscope can bring laboratory-quality cytological evaluation to the point-of-care, enabling high-sensitivity screening of OPMDs and early oral cancers. To test this hypothesis, the project will develop and optimize 7 low-cost OpenFlexure microscopes (2 for the host institute and 5 for other top medical/dental institutes in India). We will specifically adapt the microscope for oral cytology and rigorously validate it in real-world field conditions. The OpenFlexure design, an open-source, 3D-printed microscope with sub-micron precision, has proven capable of resolving diagnostic features (e.g. parasites and cancerous cells) and functioning reliably in remote environments. Building on this foundation, we will develop the device in-house at the host institute’s medical device lab. The research plan includes (1) 3D printed instrument development and bench testing on oral cytology samples, (2) a pilot study comparing on-site microscope-based diagnoses with gold-standard histopathology, and (3) field validation in community screening camps. Major experiments will evaluate the microscope’s imaging quality, diagnostic concordance with conventional methods, and usability by healthcare workers. This project’s expected significance is both scientific and societal. Scientifically, it will demonstrate whether open-source 3D-printed hardware can meet clinical diagnostic needs for cancer screening, generating new knowledge on device performance, telepathology workflows, and implementation challenges. Practically, a successful outcome could provide low-resource communities with a tangible tool for early oral cancer detection, potentially improving referral timing and patient outcomes. The work aligns with World Health Organization (WHO) goals on accessible early cancer diagnosis and India’s National Cancer Control Programme priorities, by leveraging frugal innovation to bridge the urban-rural healthcare gap. In summary, this proposal integrates technical rigor with a strong translational focus, aiming to deliver an implementable solution for oral cancer screening in resource-limited settings.