ar9b00200_si_001.pdf (791.85 kB)
Engineering Steps for Mobile Point-of-Care Diagnostic Devices
journal contribution
posted on 2019-08-20, 19:37 authored by Ayden Malekjahani, Shrey Sindhwani, Abdullah Muhammad Syed, Warren C. W. ChanConspectusMobile phone technology is a perfect companion for point-of-care
diagnostics as they come equipped with advanced processors, high resolution
cameras, and network connectivity. Despite several academic pursuits,
only a few mobile phone diagnostics have been tested in the field,
commercialized or achieved regulatory approval. This review will address
the challenges associated with developing mobile diagnostics and suggest
strategies to overcome them. We aim to provide a resource for researchers
to accelerate the development of new diagnostics. Our Account includes
an overview of published mobile phone diagnostics and highlights lessons
learned from their approach to diagnostic development. Also, we have
included recommendations from regulatory and public health agencies,
such as the U.S. Food and Drug Administration and World Health Organization,
to further guide researchers.We believe that the development
of mobile phone point-of-care diagnostics
takes place in four distinct steps: (1) Needs and Value Assessment,
(2) Technology Development, (3) Preclinical Verification, and (4)
Clinical Validation and Field Trials. During each step, we outline
developmental strategies to help researchers avoid potential challenges.
(1) Researchers commonly develop devices to maximize technical parameters
such as sensitivity and time which do not necessarily translate to
increased clinical impact. Researchers must focus on assessing specific
diagnostic needs and the value which a potential device would offer.
(2) Often, researchers claim they have developed devices for feasible
implementation at the point-of-care, yet they rely on laboratory resources.
Researchers must develop equipment-free devices which are agnostic
to any mobile phone. (3) Another challenge researchers face is decreased
performance during field evaluations relative to initial laboratory
verification. Researchers must ensure that they simulate the field
conditions during laboratory verification to achieve successful translation.
(4) Finally, proper field testing of devices must be performed in
conditions which match that of the final intended use.The future
of mobile phone point-of-care diagnostic devices is
bright and has the potential to radically change how patients are
diagnosed. Before we reach this point, researchers must take a step
backward and focus on the first-principles of basic research. The
widespread adoption and rapid scaling of these devices can only be
achieved once the fundamentals have been considered. The insights
and strategies provided here will help researchers avoid pitfalls,
streamline development and make better decisions during the development
of new diagnostics. Further, we believe this Account can help push
the field of mobile diagnostics toward increased productivity, leading
to more approved devices and ultimately helping curb the burden of
disease worldwide.