PoCT innovators can play a major role in ensuring the successful adoption of infectious disease testing. As an example, there is a current emphasis on adapting and developing cutting edge technologies for infectious disease diagnostics without focusing on the actual clinical need for these technologies in the detection of infectious diseases and antimicrobial resistance. Therefore, innovators should establish bi-directional communication channels with end-users and other stakeholders. These groups should interact synergistically, forming a positive feedback loop, whereby the changing needs of the end-user generates adaptation in diagnostic device development. One method could include the use of online or email-based questionnaires containing targeted questions that are designed to shape the desired current and future performance characteristics and settings of the device, thereby contributing to the creation of specific target product profiles (TPP). However, ideally, a range of methods is required to comprehensively understand user participation, possibly including interviews, observational studies, and focus group meetings  For sustainability, rapid infectious disease and antimicrobial resistance PoCT innovators should obtain up-to-date information on infectious disease research and epidemiology via regular visits to scientific conferences, accessing horizon scanning reviews  or by asking for relevant information from insurance companies, professional societies, patient associations, health technology assessment bodies, regulatory bodies and global infectious disease alert systems such as Promed (https://www.promedmail.org/).
Another large problem faced by innovators is the need for strong evidence to confirm that their technologies can actually improve current clinical practice, using evidence-based rather than empirical medicine. In this context, evidence-based relates to “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”, and empirical to “based on, concerned with, or verifiable by observation or experience rather than theory or pure logic”  (https://en.oxforddictionaries.com/definition/empirical). The successful implementation of rapid infectious disease and antimicrobial resistance PoCT will rely on clinicians obtaining data from patient-centred studies that compare and contrast the new diagnostic test with current gold standard testing methods, considering inputs such as the costs of training, devices, test kits, quality control, and assurance schemes, as well as outputs such as reduced antibiotic prescribing costs, shorter hospitalisation, reduced antimicrobial resistance, and improved quality of life . To generate these data, clinical studies need to be performed and the results published in scientific journals. Further, summaries or short information leaflets could form part of sales and marketing campaigns to build user awareness. That said, it is appreciated by the JPIAMR AMR-RDT working group that establishing and conducting these studies can be very expensive, especially for innovators in small and medium-sized enterprises. However, being trustworthy and open with consumers, healthcare authorities, investors, and patients would help avoid prominent crises, such as occurred with Theranos .
For further guidance, PoCT innovators should consult regulatory frameworks such as the latest In Vitro Diagnostic Device Regulation (EU 2017/746) of the European Union which also lays the legal framework for the European database on medical devices (EUDAMED) which by 2020 will facilitate access to information on existing diagnostics (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746). To succeed with the development of viable products, innovators need to consider business-to-business implementation strategies. Ultimately, innovators need to be able to invest in manufacturing facilities, salaries, marketing, etc., and clinicians need to be able to use PoCT with confidence of an improved health economic benefit.
A lack of standardised national and international reimbursement schemes is currently reducing the potential implementation and impact of PoCT. This effect is not only restricted to traditional healthcare settings, but also involves potential new markets such as home-based care, telemedicine, and in-home testing and monitoring, where some form of reimbursement is essential . In some countries, clinicians are funded via a national healthcare service, which may be prepared to pay for in-house medical testing, for example for PoCT performed at a general practitioner’s office . However, though patient healthcare insurance may be available in some countries, not everyone can afford to pay basic healthcare insurance premiums, and a choice may have to be made between paying for a PoCT or simply buying antibiotics. In this respect, evidence of added value is essential and innovators could encourage the implementation of their diagnostics by being flexible in their pricing strategy, for example, by basing their prices on the number of tests sold. Also, cooperation with product development partnerships and/or non-governmental organisations are other possible options for promoting sales and reimbursement, including for example the establishment of ‘Diagnostic Market Stimulus Pots’ to ‘ensure a market based revenue stream for developers’ . In any case, finding funding for healthcare validation studies is one of the major challenges facing all developers of healthcare diagnostics.
Gender and cultural issues may also play a major role in preventing the implementation of PoCT due to the stigmatisation of patients found to be infected with a particular pathogen—not forgetting that stigmatisation could also be based on a false positive test result. For example, a positive human immunodeficiency virus, sexually transmitted disease, Ebola, etc., test result may be utilised to justify existing prejudices or beliefs based on gender, sexual preference, or immigration status . Further, Borg identified behaviour characteristics related to “cultures that are low in uncertainty avoidance and power distance, and high in individualism and masculinity” that could influence PoCT implementation strategies . Whilst it is not feasible for, or indeed the responsibility of, diagnostics innovators to change an individual’s or culture’s beliefs or prejudices, innovators must be sympathetic and knowledgeable about their target population. In this respect, one possible route for accessing potentially stigmatised communities would be to approach the community via a trusted intermediary, who may be a community opinion leader, local tribal elder, or a religious leader.
If we consider the future expansion of healthcare, then it is not unreasonable to assume that some form of PoCT will eventually be routinely used by members of the public, via pharmacies or at home, without the supervision of a medical professional. To prevent confusion by the pharmacist or end-user, as well as unnecessary visits to already overworked family doctors, pharmacists, and emergency departments, PoCT innovators should ideally establish telephone or internet hotlines that are available to answer the questions of pharmacists or PoCT device home-based users. These hotlines could potentially form additional arms of existing medical information hotlines, for example the UK NHS 111 service (www.nhs.uk/NHSEngland/AboutNHSservices/Emergencyandurgentcareservices/Pages/NHS-111.aspx). Further, by collecting data from such services, hotline providers could generate essential feedback to diagnostics innovators that could be used to increase device performance or improve the simplicity of instruction material supplied with the diagnostic. However, it should be noted that performing PoCT at the pharmacy or at home is a controversial issue. For example, a recent pharmacy ‘test and treat’ scheme for sore throat diagnosis in England attracted some criticism regarding poor sensitivity and lack of a full cost-effectiveness analysis . Finally, diagnostics innovators should gain a deep understanding of the context and views of potential end-users before product development progresses into a functional and marketable device, for example, using established ‘user-centred’, ‘participatory design’, or ‘person-based’ approaches. Innovators should not simply focus on the development of ‘technology for technology’s sake’. Just because a technology exists that could be adapted for PoCT, does not mean to say that the technology will ultimately be successful as a healthcare diagnostic.