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. 2016 May;8(9):905-19.
doi: 10.4155/bio-2015-0023. Epub 2016 Apr 13.

Challenges and opportunities for translating medical microdevices: insights from the programmable bio-nano-chip

Michael P McRae  1 , Glennon Simmons  2 , John T McDevitt  1   2   3
Affiliations

Challenges and opportunities for translating medical microdevices: insights from the programmable bio-nano-chip

Michael P McRae et al. Bioanalysis. 2016 May.

Abstract

This perspective highlights the major challenges for the bioanalytical community, in particular the area of lab-on-a-chip sensors, as they relate to point-of-care diagnostics. There is a strong need for general-purpose and universal biosensing platforms that can perform multiplexed and multiclass assays on real-world clinical samples. However, the adoption of novel lab-on-a-chip/microfluidic devices has been slow as several key challenges remain for the translation of these new devices to clinical practice. A pipeline of promising medical microdevice technologies will be made possible by addressing the challenges of integration, failure to compete with cost and performance of existing technologies, requisite for new content, and regulatory approval and clinical adoption.

Keywords: lab-on-a-chip; mHealth; microfluidic devices; point-of-care diagnostics; programmable bio-nano-chip (p-BNC).

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Conflict of interest statement

Financial & competing interest disclosure Principal Investigator, JT McDevitt, has an equity interest in SensoDX, LLC, and also serves on the Scientific Advisory Board. Funding was provided by NIH through the National Institute of Dental and Craniofacial Research (NIH Grant No. 3 U01 DE017793-02S1 and 5 U01 DE017793-2). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Figures

<b>Figure 1.</b>
Figure 1.. Co-evolution of the cartridge and analyzer for the programmable bio-nano-chip system.
This process shows how the programmable bio-nano-chip system evolved from ‘chip in a lab’ prototypes to point-of-care-ready lab-on-a-chip devices with each new generation of the cartridge (A–D) and instrumentation (E–H) achieving higher degrees of integration. (A) Reproduced with permission from [25]. (F) Reproduced with permission from [31] © Royal Society of Chemistry (2015). (G) Adapted with permission from [31] © Royal Society of Chemistry (2015).
<b>Figure 2.</b>
Figure 2.. The biomarker bottleneck.
Despite key scientific advancements that have unlocked insights into disease pathophysiology and promising new therapies, the approval rate of protein biomarkers for clinical use remains dismal.
<b>Figure 3.</b>
Figure 3.. The programmable bio-nano-chip mHealth ecosystem.
The mHealth ecosystem comprises a (A) cartridge/analyzer assay system, (B) data analysis and machine learning software, and (C) intuitive user interfaces. (Ai) Reproduced with permission from [45] © Elsevier (2016).
<b>Figure 4.</b>
Figure 4.. Typical development pathway for new medical devices from inception to clinical adoption.
See this image and copyright information in PMC

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