Toolkit for emerging technologies in laboratory medicine

Discussion

Central to assessing the unmet clinical needs is the role of the ET in the clinical pathway and may include questions related to the health condition/clinical management problem, target patient, current clinical practice, limitations of current practice and the prespecified desired outcomes. This may entail literature review and stakeholder engagement. Once a clinical unmet need is identified, the hypothesis can be tested by evaluating whether the current practice can be optimized to solve the problem, determining if the ET will be clinically and financially effective, and understanding potential barriers to implementation. Relevant barriers to implementation may include ethical, cultural, infrastructure, technical support, and workforce issues. These are explored further in Tool 2 forecasting methods.

To validate the intended use of the ET, it is important to consider how it may alter and improve current practice, the expected outcomes and how these outcomes compared to the prespecified desired outcome. Suitable clinical studies should be conducted to provide objective evidence such as clinical performance and clinical effectiveness to support the adoption of the ET. Finally, the factors driving the feasibility of the ET should be assessed, including commercial, economical, technical, and organizational viability.

Once it is determined that the ET adds clinical diagnostic value for improved patient care [9] and is mature for clinical deployment (e.g., as assessed by technology readiness – Tool 3), the laboratory should define the desired performance given its intended clinical use [13]. For ET that are testing methods, areas where analytical performance may be specified include method evaluation, quality control and periodic performance verification such as lot-to-lot, calibration, linearity, and between-instrument correlation. The analytical performance specification may be based on clinical outcomes, biological variation, or state-of-the-art [13]. It may be also necessary to consider performance specifications for pre- and post-analytical processes to ensure the total testing process meets the clinical need – Tool 7.

Following analytical specification, the ET should be integrated into the laboratory and clinical operational workflows. Laboratory staff training, competency evaluation, infrastructure, technical support, and logistics are essential to ensure smooth transition into routine operations. Likewise, the integration of the ET into routine clinical care requires appropriate education and communication with the relevant clinical stakeholder. Suitable laboratory comments may be employed in the pre-analytical (test selection or test ordering) and post-analytical (test interpretation) phases to improve its clinical utility and effectiveness.

Broader consideration of the impact (disruption) of the ET on the healthcare system should also be managed to optimize the potential. For example, a novel early diagnostic procedure should be accompanied by an early referral and clinical management process to allow timely intervention. The converse may be true where novel therapeutic options should motivate development of novel therapeutic or response monitoring procedures.

The financial effectiveness of an ET should ideally be assessed from a healthcare system perspective (e.g., using health technology assessment (HTA) – Tool 4) instead of narrowly focusing on the operational costs within the laboratory. This is because ET is often novel and hence may not have reached mass adoption for economies of scale to reduce the unit cost relative to precedent/existing technology. Yet, the improved performance of the ET may produce significant benefits upstream or downstream of the clinical pathway and improve patient outcome or reduce associated costs. Tools 5 and 6 respectively provide the organizational impact map and change management tools and Tools 7 and 8 respectively provide a laboratory implementation checklist and green procurement tools to support the effective and appropriate ET implementation.

Discussion

Discussion

For laboratory medicine, the starting point for an ET is an idea, perhaps motivated by a clinical diagnostic problem or an unmet clinical need [11], that is sufficiently compelling to be developed further. Further development may lead to an invention disclosure and patent application, then through various development stages (captured in the successive TRL including demonstration of proof of principle, and preliminary testing, and finally the technology matures and emerges into routine clinical laboratory medicine practice [34, 35]). The latter stages of development involve formal regulatory approval such as the FDA 510(k) clearance or FDA PMA approval in the US and the CE/IVDR approval in the European Union.

As noted in the introduction, in a public health crisis, emergency approval (e.g., FDA EUA) for an ET may be granted to expediently make available tools that can help address the threats. This brings with it a level of risk in moving through the TRLs with minimal due diligence and consideration of the benefit needs to significant outweigh the potential harm of rapid progression.

Discussion

In many developed countries, a HTA is increasingly used to inform decisions about which health technologies can be implemented, and inform the funding mechanism for the technologies [42]. For example, in Australia, as part of these reviews the guiding principles provide a framework for assessment, and “should be: sustainable; transparent; accountable and independent; consultative and reflective of Australian community values; administratively efficient; flexible and fit for purpose; and informed by robust and relevant evidence” [42]. Such assessments can be applied to device and biomarker analysis [43]. Deciding what needs translation into clinical practice depends on answering the “What? Why? Who? When? Where? And Whereby?” and this will vary based on jurisdiction and resource availability.

The need to perform local HTA for the adoption of ET is important because of regional differences and specific considerations can also include local unmet needs in clinical care; Infrastructure e.g., water quality, electricity supply, health care process and systems. Current technologies available and options for support; healthcare models (e.g., public vs. private); socioeconomic circumstances; and the ability to implement and sustain a new technology [44]. As noted earlier, HTA strategies are currently implemented by many countries and there are some differences between these strategies. It is important to consider the HTA mechanisms as the health system becomes matures (Figure 2) [37].

Figure 2:

Emerging technology Tool 4: health technology assessments, “extending the mandates of HTA mechanisms as the health system becomes stronger” [37].

Discussion

One of the main reasons for assessing organizational aspects is to identify potential challenges and barriers that may arise from the implementation of the technology. For example, introducing a new technology may require changes to existing workflows and processes, which can be disruptive and may lead to resistance from staff. Similarly, the introduction of new technology may require additional training for staff, which can be time-consuming and costly. Furthermore, assessing the organizational aspects of ET can help to identify opportunities for optimization and improvement. For example, the introduction of new technology may allow for more efficient and streamlined processes, reducing errors and improving patient outcomes. By understanding the existing organizational structure and processes, it becomes easier to identify areas for improvement and to develop strategies that can maximize the benefits of the technology.

Assessing the consequences of ET on the organizational level is also important for ensuring long-term sustainability and scalability of the technology. This involves evaluating the financial, operational, and strategic implications of the technology, and identifying ways to maximize its value and impact. For example, it may be necessary to consider the costs of maintenance and upgrades, as well as the potential for integration with other existing technologies and systems. On the other hand, the introduction of ET may displace/replace certain job functions and it is important for organisations to redesign and reassign staff responsibility to minimise the impact and optimise deployment of human resources.

Finally, it can help to increase stakeholders’ engagement and buy-in. By involving different stakeholders, such as laboratory technicians, physicians, patients and management, in the assessment process, it becomes easier to understand their needs and concerns, and to develop strategies that can address these.

Discussion

Change management is an essential component of ET implementation as it causes disruption and this precipitates the need to understand and manage it. Fundamentally, for the ET to be successfully and sustainably introduced into routine practice, it needs to be complimented by existing available technologies and support. For example, a total laboratory automation cannot be introduced into a laboratory that has poor information technology infrastructure or lack of competent technical support to troubleshoot any issues that may arise during clinical use.

1. The diffusion of innovation (DOI) theory curve was developed by Everett Rogers in the 1960s. This curve divides people into five adopter groups: (1) the innovators (2.5 %), early adaptors (13.5 %), early majority (34 %), late majority (34 %) and laggards (16 %). Whilst the percentages in this Bell-shaped-like curve may be approximate, their use provides a perspective of how the momentum for adoption can be supported or its progress hindered. This diffusion concept is often used to look at market share and acceptance of an ET. It can equally be applied to organisational change and team culture. In particular, the chasm between the early adopters and the early majority can represent the momentum to support a change initiative, and can be pivotal to the overall successful implementation of an ET. Likewise, this 16 % of the laggards is loosely related to the Pareto principle or 80/20 rule or law of the vital few, where 80 % of consequences come from 20 % of causes. Therefore, conversely if 20 % of a team (i.e., 1 in 5 people) have significant resistance to the change, then complete change will be difficult. This social science concept of innovation adoption (and the following change management curve) provide perspectives on ET adoption and the power and importance of communication and emotional intelligence [48, 49]. Examples of DOI theory have been applied broadly to public health initiatives [55], [56], [57].

2. The change curve was originally proposed by the psychiatrist Dr Elisabeth Kubler-Ross in relation to the change in emotions of terminally ill patients [50]. In the extrapolation of this original concept for laboratory medicine, the change is the loss of the current normal practice because of implementation of for example, a new test, process, or informatics. As such, the curve is useful to understand staff and team motivation and competence as an organisation looks at a new process. For staff/teams/organisations not used to change, i.e., less agile, the move from the current “norm” can cause the initial emotion of shock followed by feelings of denial, frustration and depression (often referred to as the trough of disillusionment) as staff look back and let go. This is particularly true if the staff identifies the change as a loss. With a successful change, the process of looking forward occurs were the new reality is tested, the change is accepted and over time staff/teams feel ownership of the new process and it becomes the “new norm”. It is important to note that members of an organisation can take varying amounts of time to move through the curve and take ownership of the change. Therefore, change management needs to empathise with multifaceted emotions, and the formation of habits and hence feeling comfortable with the new process will vary in time [58]. Understanding this change curve and where people may sit on this curve will help to navigate through challenges and to communicate and support change appropriately. Thus applying the concepts of the change curve and translating these into emotional intelligence can significantly help negate the negative emotions generated with the introduction of an ET.

3. The Professional plus Science (Prosci) model comprises seven best practices in change management identified that encompass: (1) “mobilize active and visible executive sponsorship”; (2) “apply a structured change management approach”; (3) “communicate frequently and openly”; (4) “engage with front-line employees”; (5) “dedicate change management resources”; (6) “engage and integrate with project management”; and (7) “engage with and support middle managers” [51]. Active and visible sponsorship of the change by organizational management is a key leader of success [51]. Ultimately success is demonstrated by projects that meet objectives, finish on time, in budget, and where forecasted return on investment is realized (Figure 3).

4. Plan Do Check/Study Act (i.e., Deming’s PDCA cycle) and associated management tools led a generational change in project management [52]. This is particularly true of the influence of Deming’s management practices on the quality of products generated in post-war Japan. The techniques were employed by many organizations and acknowledged for the contribution to their success. The implementation of any change or project management traditionally focused on “planning” and then “doing” the change and then no further action is taken. In the PDCA cycle there are the important data driven processes of checking or studying the change, often using root cause analysis, and then acting on any non-conformities. This process can be used for both small and large changes. Whatever the size of the change, the study and acting on poorer than anticipated quality indicators to implement follow-up improvements is well known to laboratory medicine professionals who seek accreditation to ISO15189:2022. Element 8.6.1 states “the laboratory shall evaluate the effectiveness of the actions taken”, “laboratory management shall ensure that the laboratory participates in continual improvement” and “communicate to personnel its improvement plans and related goals” [59].

Figure 3:

Emerging technology Tool 6: change management (ADKAR Prosci model).

Toyota Motor Corporation advanced using Deming’s management practices focusing on quality and the customer which lead them to be the number one car manufacturer in the world [53, 54]. Whilst Toyota manufactures cars, laboratory medicine manufactures results, and our main customer is the patient and their medical support teams. In addition, in both scenarios the quality of the manufactured goods underpins safety and the tools developed by Toyota equally work in the medical laboratory environment. As an example, the Kaizen model for continuous improvement focuses decisions on the customer (e.g., patient) and therefore change in practice will more readily be based on addressing clinical need [60]. The adage, if you can’t quality it you can’t change it, pertains to Toyota’s visualization of status and change management data in tools such as Kanban boards, Leadtime diagrams, and GANTT charts. The Toyota production systems now incorporate hundreds of tools underpinned by the evolution of concepts of continuous improvement, lean, agile, quality and customer focus [53, 54, 61]. Some or all these tools can be used to support and communicate data-driven change in laboratory medicine.

Whilst there are limitations of these behavioral change theories, including that they were not specifically developed for laboratory medicine, a pragmatic review and collective use of the emotive (items A to C) and logical (item D) components of the change management provide an effective tool to support ET implementation. The data-driven visual processes to manage ET implementation within laboratory medicine offer the current best practice in the logical components of change management. Active and visual sponsorship with emotional intelligence are the primary drivers for individuals and teams to take ownership of the change. In using these change management tools teams can implement ET with appropriate empathy and organization.

Discussion

The development and post-development of the checklist are usually subject to regulatory and accreditation requirements to document their clinical fitness for purpose by the performing laboratory [59, 63].

There is an increased emphasis on the appropriate rollout of ET for laboratory medicine to improve service delivery for patient care. For an ET that is novel with no existing comparator, e.g., a novel biomarker or a new class of analytical method, the clinical effectiveness (e.g., clinical sensitivity, clinical specificity) for the stated clinical utility (e.g., screening, diagnosis, monitoring, prognostication) needs to be demonstrated in appropriately designed clinical studies [64]. The components of the method validation will depend on the type of technology (e.g., biomarker, measurement procedure, algorithms), the clinical utility and relevant regulatory requirements [12]. However, this can be challenging when the laboratory professionals are considered removed from the clinical pathway or technology development, which impedes the laboratory involvement in activities in technology readiness [34]. For a novel ET, a thorough characterisation of the analytical performance is required and to validate its performance, i.e., method validation [65].

There is a potential gap between mobile health device suppliers and laboratories in relation to the requirement to perform method evaluations. Regulatory marking by, for example, the FDA is considered sufficient by manufacturers for the distribution of mobile health devices. However, for laboratories to add these mobile health applications to their testing panel requires in house method evaluation in order to meet accreditation/regulatory requirements. Mobile phone based applications for health testing provide additional challenges when the tests are assigned to a patient’s mobile phone number and the data is controlled by the application owner rather than the laboratory. Laboratory professionals have a responsibility as experts for professional oversight, hence the role should support the quality and transparency of mobile applications through engagement, development of guidance documents and education.

Discussion

The valuation of sustainability is essential in the assessment of ET and is becoming a broadly recognized requirement for implementation [66], [67], [68], [69], [70], [71], [72]. ET can have a significant impact on the environment, economy, and society, and it is crucial to evaluate their sustainability to ensure that they are developed and implemented in a way that is environmentally and socially responsible. This includes considering the entire life cycle of the technology, including its manufacture, use, and disposal. Laboratories should consider the environmental impact of the technology, including its impact on energy usage, water usage, waste generation, and the use of environmentally harmful materials.

One critical aspect of sustainability evaluation is the assessment of the environmental impact of ET. The environmental impact can be assessed through a life cycle assessment (LCA), which considers the entire life cycle of a technology from the extraction of raw materials to the disposal of waste. LCAs can help to identify potential environmental hotspots and provide insights into ways to reduce the environmental impact of the technology.

Another critical aspect of sustainability is the evaluation of economic and social sustainability. ET should be economically viable and should not have a negative impact on social and cultural values. The evaluation of economic and social sustainability can be achieved by considering the entire value chain of the technology, including its impact on local communities, social and economic factors, and cultural values. Furthermore, evaluation of sustainability is essential in meeting regulatory requirements and standards. For instance, the International Organization for Standardization (ISO) has developed ISO14001, which is a standard for environmental management [66]. Compliance with this standard can help organizations to evaluate and manage the environmental impact of their activities, products, and services, including emerging technologies in laboratory medicine.