Abstract
The term “emerging technology” (ET) is used extensively, and there are numerous definitions offered, but to our knowledge, none specifically encompass the field of laboratory medicine. An ET definition that incorporates the overarching IFCC aim of “Advancing excellence in laboratory medicine to support healthcare worldwide” would clarify discussions. We discuss key aspects of the term “emerging technology(ies)” as it applies to laboratory medicine with a view to laying the foundations for a practical definition for the profession and propose the definition of an ET as “An analytical method or device that by virtue of its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics”.
Introduction
The term “emerging technology” (ET) is used extensively, and there are numerous definitions offered including: “a new tool with promising potential” [1]; “a technology the use of which will benefit many sectors of the economy and/or society” [2]; “those that can have a significant impact on the economy” [3]; “those that have the potential to gain social validity in the next 10 to 15 years” [4]; and “the development of emerging technologies refers to technical, institutional and social change” [5]. Keywords used in definitions include “innovation”, “new”, “relatively fast-growing”, “future impact”, “socio-economic domains”, and “uncertainty” [1, 6], [7], [8]. Whilst the term ET is used freely, there is no consensus definition and therefore variations in perceived meaning can lead to confusion and uncertainty [1, 6, 7, 9].
Previously the International Federation of Clinical Chemistry and Laboratory Medicine’s Emerging Technology Division (IFCC-ETD) has used the definition developed by Rotolo and colleagues to define ET in the context of laboratory medicine [7]: “a radically novel and relatively fast-growing technology characterized by a certain degree of coherence persisting over time and potential to exert a considerable impact on the socio-economic domain(s) which is observed in terms of the composition of actors, institutions and patterns of interactions among those, along with the associated knowledge production processes. Its most prominent impact, however, lies in the future and so in the emergence phase is still somewhat uncertain and ambiguous” [7]. This definition is limited as it does not actually define technology itself and whilst useful it is not specific enough to help interpret what is an ET for the overarching IFCC aim of “Advancing excellence in laboratory medicine to support healthcare worldwide” [10].
To facilitate and provide clarity to the ongoing discussions, a clear definition of emerging technologies in the context of laboratory medicine is warranted. Whilst many definitions have been developed across a broad range of industries, to our knowledge, none specifically encompass the field of laboratory medicine. Here we discuss key aspects of the term “emerging technology(ies)” as it applies to laboratory medicine with a view to laying the foundations for the development of a practical definition for the profession and propose a candidate definition.
Key questions
We pose the following key questions to aid in the development of an appropriate definition of an ET for laboratory medicine.
1 What is the context of “emerging”?
The term emerging in “Emerging Technology” can denote a nascent technology that is progressing through the development process and is beginning to be evaluated or implemented by early adopters in laboratories. In this context Technology Readiness Levels (TRL) [11, 12] chart the progress of a technology, beginning with “Basic principles observed and reported” (Level 1) through successive levels corresponding to proof of concept, validation and prototyping, ending with “System proven in operational environment” (Level 9) (Figure 1) [11, 12]. Arguably, the technology would be considered emerging beginning with Level 2 (Technology concept and/or application formulated), and continue to be emerging through to the final Level (i.e., Level 9).
![Figure 1:
The determinants for an efficient translation of emerging technologies. Reproduced from [13].](/document/doi/10.1515/cclm-2022-0929/asset/graphic/j_cclm-2022-0929_fig_001.jpg)
The determinants for an efficient translation of emerging technologies. Reproduced from [13].
The innovation adoption curve developed by Evertt Rogers is also relevant to the context of emerging and ETs [14]; Figure 2. This curve is divided into innovators, early adopters, early majority, late majority, and laggards. There is a “chasm” described between the early adopters and the early majority that impedes the implementation of an ET, which often is associated with the high cost and uncertainty associated with the ET that can dissipate as it is adopted (network effect). Whilst there are limitations of this behavioral change theory, including that it was not specifically developed for public health, a pragmatic review of the curve may aid in developing a data driven (prescriptive) definition of ET for laboratory medicine. In our view, the first two sections (16%) of this innovation adoption curve could easily fit into an emerging technology definition [15]. Furthermore, this curve has been applied in examples from medical science including diabetes technologies [16].
![Figure 2:
Relationship of the innovation adoption curves to emerging technology implementation success. Adapted from Ref. [14] https://www.valuebasedmanagement.net/methods_rogers_innovation_adoption_curve.html.](/document/doi/10.1515/cclm-2022-0929/asset/graphic/j_cclm-2022-0929_fig_002.jpg)
Relationship of the innovation adoption curves to emerging technology implementation success. Adapted from Ref. [14] https://www.valuebasedmanagement.net/methods_rogers_innovation_adoption_curve.html.
An ET can cause change and precipitate the need to manage the change. There is a well-recognized change management curve divided into the major components of Initial Enthusiasm, the Trough of Disillusion, Cautious Optimism, and Stability of Implementation. In our opinion the development of an ET would involve the first three components. Emerging in ET can also denote a technology that is already developed and used elsewhere but only now being implemented (i.e. creating change) in a new application/discipline. In a simple description, Veletsianos states that “a technology is still emerging if it is not yet a ‘must-have’” [1].
2 Is there a country-by-country difference in ET?
The notion that an ET definition for laboratory medicine should include consideration on a country by country basis is supported by Halaweh and colleagues who looked closely at ET definitions and state that “technology can still be considered emerging in one context even though it has been considered established in another” [6]. Further to this, ET can be dichotomized into: 1) the relatively few ET creating countries have faster adoption and therefore appear to be leaders; and 2) the many ET using countries that are behind on adoption and therefore always seem to be catching up. In this regard, broadly speaking developing countries have slower adoption than developed countries.
There are many drivers for an ET (e.g., gaps in clinical care, consumer demand), but the primary driver for an ET is socioeconomic. Generally, richer countries spend more on healthcare and hence, are better placed to develop new technologies, and other size comparisons are secondary. Therefore, ET needs to be defined per country [17]. As such, socioeconomic status is a primary influencer for uptake of ET and globally, the adoption of ET varies between countries. This is also supported by Rogers change theory which describes four elements as “influencing diffusion of new ideas through cultures, these being: (i) innovations (a new idea, practice or object perceived as new), (ii) communication channels (mechanisms for messages to travel), (iii) time (influencing decision making and the rate of adoption) and (iv) social systems (groups)” [14].
Often when considering an ET, it is presumed that because the technology is commonplace in one country, such as the USA, it is no longer emerging. Therefore, to counter this fallacy a definition for laboratory medicine should recognise these global differences.
3 Can we use a published metric to define ET for laboratory medicine?
Although, various published metrics may be useful for identifying technologies that might be the basis for an ET, it is probably impracticable to set quantitative criteria (e.g., number or rate of increase of patent applications or scientific papers). More specifically focused on laboratory medicine is the use of external quality assurance program data which may reveal the emergence of new analytical technologies (e.g., testosterone measurement principles over time) [18] but once again it is likely impracticable to set quantitative criteria.
Conclusions
In conclusion, we propose that an Emerging Technology in laboratory medicine is:
An analytical method or device that by virtue of its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics.
This definition characterizes technology as both methods and devices, and emerging in terms of stage of development or translation into practice. It also caters for geographical differences in the emergence, and links the technology to value in clinical diagnostics. Furthermore, reference to this Laboratory Medicine specific definition will add clarity for future discussions.
Acknowledgments
We wish to acknowledge the foresight of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for the establishment of the Emerging Technologies Division (ETD). This functional unit is “responsible for identifying and assessing emerging technologies and for translating the emerging and disruptive diagnostic and data analysis procedures from academic laboratories to clinical laboratories and from clinical laboratories to market”. The IFCC-ETD terms of reference encompass “activities relating to the application of emerging and disruptive technologies to clinical laboratories”. The idea for a laboratory medicine-specific definition was conceived by Ronda Greaves as part of her presentation on “Emerging technologies globally: one size does not fit all” at the International Conference on Laboratory Medicine – The Ethics of Quality and Artificial Intelligence in Laboratory Medicine 23 Sep 2021 – Padova, Italy.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
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- Editorial
- A new milestone on the road to global standardization of apolipoprotein measurements
- Review
- Saliva – a new opportunity for fluid biopsy
- Opinion Papers
- Emerging technology: a definition for laboratory medicine
- The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance
- EFLM Paper
- The new, race-free, Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation to estimate glomerular filtration rate: is it applicable in Europe? A position statement by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- Guidelines and Recommendations
- Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results
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- Quantitative protein mass-spectrometry requires a standardized pre-analytical phase
- Report from the HarmoSter study: inter-laboratory comparison of LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone
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- Total serum vitamin B12 (cobalamin) LC-MS/MS assay as an arbiter of clinically discordant immunoassay results
- The preanalytical process in the emergency department, a European survey
- Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements
- Umbilical cord blood gases: probability of arterial or venous source in acidemia
- Reference Values and Biological Variations
- Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents
- Hematology and Coagulation
- Performance of digital morphology analyzer CellaVision DC-1
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- Managing the impact of inter-method bias of prostate specific antigen assays on biopsy referral: the key to move towards precision health in prostate cancer management
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- Acknowledgment
- Acknowledgment
- Letters to the Editor
- About the estimation of albuminuria based on proteinuria results
- Response to “About the estimation of albuminuria based on proteinuria results”
- Reply to Abildgaard et al.: lot variation and inter-device differences contribute to poor analytical performance of the DCA vantage™ HbA1c POCT instrument in a true clinical setting
- Reply to letter from Mayfield et al. regarding “Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting”
- High-sensitive cardiac troponin T: are turbulences coming?
- Analytical performance evaluation of bioactive adrenomedullin on point-of-care platform
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Articles in the same Issue
- Frontmatter
- Editorial
- A new milestone on the road to global standardization of apolipoprotein measurements
- Review
- Saliva – a new opportunity for fluid biopsy
- Opinion Papers
- Emerging technology: a definition for laboratory medicine
- The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance
- EFLM Paper
- The new, race-free, Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation to estimate glomerular filtration rate: is it applicable in Europe? A position statement by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- Guidelines and Recommendations
- Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results
- General Clinical Chemistry and Laboratory Medicine
- Quantitative protein mass-spectrometry requires a standardized pre-analytical phase
- Report from the HarmoSter study: inter-laboratory comparison of LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone
- The influence of proteoforms: assessing the accuracy of total vitamin D-binding protein quantification by proteolysis and LC-MS/MS
- Total serum vitamin B12 (cobalamin) LC-MS/MS assay as an arbiter of clinically discordant immunoassay results
- The preanalytical process in the emergency department, a European survey
- Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements
- Umbilical cord blood gases: probability of arterial or venous source in acidemia
- Reference Values and Biological Variations
- Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents
- Hematology and Coagulation
- Performance of digital morphology analyzer CellaVision DC-1
- Cancer Diagnostics
- Managing the impact of inter-method bias of prostate specific antigen assays on biopsy referral: the key to move towards precision health in prostate cancer management
- Cardiovascular Diseases
- Quantitation of cardiac troponin I in cancer patients treated with immune checkpoint inhibitors: a case-control study
- Infectious Diseases
- A novel scoring system combining Modified Early Warning Score with biomarkers of monocyte distribution width, white blood cell counts, and neutrophil-to-lymphocyte ratio to improve early sepsis prediction in older adults
- Technical and health governance aspects of the External Quality Assessment Scheme for the SARS-CoV-2 molecular tests: institutional experience performed in all clinical laboratories of a Regional Health Service
- Acknowledgment
- Acknowledgment
- Letters to the Editor
- About the estimation of albuminuria based on proteinuria results
- Response to “About the estimation of albuminuria based on proteinuria results”
- Reply to Abildgaard et al.: lot variation and inter-device differences contribute to poor analytical performance of the DCA vantage™ HbA1c POCT instrument in a true clinical setting
- Reply to letter from Mayfield et al. regarding “Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting”
- High-sensitive cardiac troponin T: are turbulences coming?
- Analytical performance evaluation of bioactive adrenomedullin on point-of-care platform
- Increased PD-L1 surface expression on peripheral blood granulocytes and monocytes after vaccination with SARS-CoV2 mRNA or vector vaccine
- Neopterin level can be measured by intraocular liquid biopsy
- The stability of pleural fluid pH under slushed ice and room temperature conditions