A review of Optical Point-of-Care devices to Estimate the Technology Transfer of These Cutting-Edge Technologies

Abstract

Despite the remarkable development related to Point-of-Care devices based on optical technology, their difficulties when used outside of research laboratories are notable. In this sense, it would be interesting to ask ourselves what the degree of transferability of the research work to the market is, for example, by analysing the relation between the scientific work developed and the registered one, through patent. In this work, we provide an overview of the state-of-the-art in the sector of optical Point-of-Care devices, not only in the research area but also regarding their transfer to market. To this end, we explored a methodology for searching articles and patents to obtain an indicator that relates to both. This figure of merit to estimate this transfer is based on classifying the relevant research articles in the area and the patents that have been generated from these ones. To delimit the scope of this study, we researched the results of a large enough number of publications in the period from 2015 to 2020, by using keywords "biosensor", "optic", and "device" to obtain the most representative articles from Web of Science and Scopus. Then, we classified them according to a particular classification of the optical PoC devices. Once we had this sampling frame, we defined a patent search strategy to cross-link the article with a registered patent (by surfing Google Patents) and classified them accordingly to the categories described. Finally, we proposed a relative figure called Index of Technology Transference (IoTT), which estimates to what extent our findings in science materialized in published articles are protected by patent.

Keywords: biosensor; medical device; optic; optical Point-of-Care (PoC); patent.

Figure 1

A schematic representation of the resources needed to achieve a diagnosis: PoC versus Conventional Procedure. On the top, the Conventional option shows the process until getting a diagnostic in the conventional procedure (i.e., Transfer hospital [A] + Triage [B] + Sample Collection [C] + Sample processing in the lab [D] + Results [E]) to make the diagnosis, and to indicate the treatment at home, or in the hospital (i.e., Analysis medical staff [F]). At the bottom, the PoC option confirms the reduction of the process: Sample Collection (A) + Analyze results PoC (B)+ Results (C: in a few minutes), to get a diagnostic with the use of PoC (D).

Figure 2

A schematic forecast of the Global market for PoC 2017–2025. This implies that PoC Technology can be performed in the following environments: Primary Care Clinics, Hospitals, Home Healthcare, Assisted Living Healthcare Facilities, Laboratory, and other Self Testing Areas. (Data extracted by Grand View Research´s report—See [29]).

Figure 3

PoC Diagnostics Market and its segmentation attending to the target analysis and end-use: The market is classified in 14 different products according to pathology diagnostic, and in five kinds of products attending to the end use. (Data extracted from Grand View Research´s report [29]).

Figure 4

Index of Technology Transference (IoTT): Percentage of transfer between Science and Patent between the Period: 2015–2020.

Figure 5

Structure of the used methodology, from the question to answer, to the calculation of the IoTT.

Figure 6

Schematic diagram of optical Interrogation, vertical (top) and horizontal (bottom). Depiction of the vertically characterized sensor based on an array of resonant nanopillars (top, from Casquel. R, Doctoral Thesis (2012) [35]). Depiction of the horizontally interrogated sensor (bottom). The light is coupled from the fibre to the waveguide by using a combination of a grating coupler and an inverted taper.

Figure 7

A schematic representation of the classification of PoC by optical detection method classified into four categories: Real part of RI (interference–resonance), Imaginary part of RI (absorbance), emission–fluorescence, and scattering.

Figure 8

Classification based on the monitored changes in the real part of the refractive index: A1—Broadband Based/A2—Monochromatic Based or broadband source plus a monochromator.

Figure 9

Sketch diagram of Surface plasmon resonance (SPR). Excitation of collective oscillations of electrons by the transverse magnetic polarized light at the metal interface.

Figure 10

Classification based on the monitored changes in the real part of the refractive index. A3—Turnable Detector Based by using a turnable laser; and A4—Single Detection Based by a Michelson Interferometer.

Figure 11

Classification based on the monitored changes in the imaginary part of the refractive index. B1—ELISA (top) and B2—Lateral Flow (bottom).

Figure 12

Fluorescence technique scheme to detect an antigen. The optical setup comprises a light source, a light filter and a spectrofluorometer.

Figure 13

Schematic diagram of Raman spectroscopy (SERS).

Figure 14

Inclusion–Exclusion Criteria (Web of Science and Scopus).

Figure 15

Flow diagram of the literature search illustrates the meticulous screening work in four steps, from the identification of 744 records to the study in depth of 151 scientific articles and the link to the registered patent. (Flow diagram developed from the one described in [46] and particularized for the current review).

Figure 16

Classification of articles by the categories specified: variations on the refractive index (Real part, Imaginary Part, Emission and Scattering), the optical interrogation technique (Vertical/Horizontal), the excitation monitoring (Wavelength/Angel of incidence) and detecting techniques of molecular interactions (Label-free/Labelled).

Figure 17

Classification of the linked patents.