Abstract
Abstract
Introduction
Point-of-care technologies (POCTs) are essential to providing clinical care for patients, with their potential for rapid and accurate results on site supporting efficient clinical decision-making.
Objectives
To understand the current key needs, barriers and challenges of POCT developers for effective development and implementation of POCTs across diverse settings particularly in the domain of cancer, nutrition and infections.
Design
A qualitative semi-structured focus group discussion (FGDs) was employed. The FGDs were guided by the needs assessment process and the Phase Gate Framework. The qualitative data were coded and analysed in NVivo and refined into various themes.
Setting
The study was conducted in person at Cornell Tech Campus in May 2024, New York, USA.
Participants
24 participants were purposively sampled from the PORTENT (Point-of-Care Technologies for Nutrition, Infection and Cancer) network. Participants included technical developers (eg, engineers, scientists, startup leads) and expert stakeholders (eg, funders, policy advisors, clinicians and academic partners) involved in POCT development, evaluation and implementation.
Results
A total of 24 participants participated in the in-person FGDs in New York (n=24). Key themes identified included gaps in stakeholder engagement, limited regulatory preparedness, insufficient market analysis, challenges in scaling and manufacturing and the need for context-specific adaptation in low- and middle-income country (LMIC) settings. Participants emphasised the importance of user-centred and context-responsive design, strategic partnerships and early planning for regulatory and implementation pathways.
Conclusions
Technical developers and expert stakeholders in the POCT landscape face various barriers to efficient and effective development and implementation of POCTs. It is important to consider their needs when adapting POCTs in LMICs and diverse settings.
Keywords: PUBLIC HEALTH, QUALITATIVE RESEARCH, Molecular diagnostics, Early Detection of Cancer, Infection control
STRENGTHS AND LIMITATIONS OF THIS STUDY
A qualitative research approach was chosen due to its humanistic and interactive focus on contexts that are emergent rather than predetermined, allowing for fundamental interpretation.
Semistructured focus group discussions were used due to their adaptive and conversational approach, which allows researchers to explore various contexts without limiting constraints.
The use of the Phase-Gate framework and Needs Assessment model provided a systematic framework for guiding both question design and thematic analysis.
The sample was limited to individuals affiliated with the PORTENT network, which may restrict the generalisability of findings to other regions or unaffiliated developer groups.
Several of our participants were well-positioned and experienced with clinical validation and product development, which may have influenced the types of needs and challenges they prioritised during discussions.
Background
Point-of-care technologies (POCTs) are medical assessments conducted at the site of care for patients, providing rapid results and supporting efficient clinical decision-making.1 These technologies are particularly crucial in low- and middle-income countries (LMICs), where healthcare infrastructure and resources may be limited, and the burden of infectious diseases, cancer and nutrition-related ailments is quite high.2 POCTs represent a paradigm shift in diagnostics by enabling rapid, decentralised and patient-centred testing, particularly in resource-limited settings.3 Their successful implementation depends on more than just technological innovation—it requires integration into health systems, sustainable business models and strategic deployment based on specific patient and provider needs.3 To develop and scale successful POCTs, it is important to understand the needs of the stakeholders and technical developers supporting and developing POCTs, respectively.
Barriers to implementing POCTs in LMICs include perceptions of end-users, economic considerations, structural issues, cultural perceptions and regulatory pathways.3,7 Although much of the previous literature recommends the involvement of end-users and stakeholders in developing health-related technologies, there is a gap in understanding POCT developers’ needs and various stakeholders’ needs, such as research experts, when developing and implementing POCTs.8
Globally, infectious diseases account for more than 52 million annual deaths.9 New infectious diseases raise significant concerns. Non-communicable diseases, such as cancer, have an estimated 20 million new cancer cases and 9.7 million deaths in 2022.10 Ideally, diagnostics (including POCTs) were made available to reduce turnaround time to test results and facilitate clinical decision-making and improve outcomes.
Research question and aims
This paper aims to explore needs, challenges and facilitators for technology developers and stakeholders (funders, advisors, academic partners) in the context of POCTs and diagnostics. Its specific aims were (1) to identify and analyse existing gaps and challenges within the currently available POCTs for the three domains (Infection, nutrition and cancer) and (2) to proactively identify potential needs and attributes where innovative next-generation POCTs developed under the PORTENT programme could be most beneficial.
The NIH-funded PORTENT (A Centre for Point of Care Technologies for the domains of Nutrition, Infection and Cancer) based at Cornell University, in partnership with McGill, Harvard, Colombia, oversees an international network focused on developing, validating, commercialising and scaling POC technologies to address challenges in nutrition, infection and cancer.
The aim of this qualitative study is to inform the development of more effective, scalable and contextually appropriate POCTs by identifying actionable gaps across the development-to-implementation pipeline. Specifically, findings are intended to guide the design of user-centred and context-responsive POCTs, strategic investment and policy decisions and the development of support frameworks (eg, within PORTENT) that facilitate successful translation from prototype to real-world impact.
Methodology
Context and setting
We conducted four semistructured focus group discussions (FGDs) with stakeholders and technical developers at the Cornell Tech Campus in New York in May 2024 to identify their needs including challenges and successes of developing and commercialising POC solutions in low and mid-resource settings. These discussions were part of the first annual PORTENT meeting and were supported by the PORTENT centre. The FGDs were conducted during the annual PORTENT in-person meeting, which convened funded project teams and stakeholders to review progress, exchange knowledge and discuss challenges related to POCT development and implementation.
The authors of this study are affiliated with the PORTENT Centre: NP (corresponding author) serves as the principal investigator and co-authors are co-investigators and trainees within the network.
Theoretical approach
Needs assessment is an ongoing process that is essential to guide product developers on attributes to help them focus on critical elements relevant to developing POCTs.11 Data gathered through this process help inform the prioritisation of attributes essential to strategic development and their envisioned deployment within various healthcare systems. These measures are vital to informing attributes like accuracy, convenience, portability, robustness, stability and time to test results—requirements that can make or break a product.11 Data on the needs assessment process focus on usability and performance measures. Due to these features, a Needs Assessment approach was used during the FGDs.
A qualitative research approach was chosen due to its humanistic and interactive focus on contexts that are emergent rather than predetermined, allowing for fundamental interpretation.12 Similarly, the semistructured FGDs were chosen due to their adaptive and conversational approach, which allows researchers to explore various contexts without limiting constraints.13 Moreover, the predetermined questions for the FGDs were created in alignment with the Phase-Gate Framework.
The Phase-gate framework is a good needs assessment framework that guides a diagnostic product from conception to commercialisation.14 This model was used to curate the predetermined FGD questions to identify the needs, challenges and successes associated with current POC technologies. The phase-gate model is generally divided into five distinct chronological phases. It allows developers and designers to make variations in its application by adding, splitting phases, reducing, collapsing or renaming phases. Each phase is supported by a series of decision gates.14 These decision gates are essential for assessing the potential, risks and progress of the diagnostic product development process against a predefined criterion. These help the product development or management team decide on the future of the product.15
Sample and data collection
All consenting participants were invited to take part in the FGDs at an in-person meeting. Attendees consisted of technical developers of POCTs and members of the External Advisory Board of the PORTENT Centre. Informed written consent was sought before the FGDs. Informed consent included providing appropriate and accurate information to participants regarding the purpose of this project, benefits, risks and their right to confidentiality and voluntary participation. Moreover, no financial incentives were provided to participants for their participation in the FGDs. Technical developers were defined as individuals directly involved in the design, engineering or early-stage development of POCTs, including engineers, scientists and startup leads. Expert stakeholders included funders, policy advisors, clinicians and academic collaborators engaged in POCT evaluation, implementation or scale-up. Participants were identified through the PORTENT network and invited to participate in FGDs during the in-person meeting.
The FGDs were led by two trained researchers and two note-takers in person at the Cornell Tech Campus in New York in May 2024. During the first FGD with technical developers, the participants were asked to talk about their POCTs about the stages outlined in the Phase-Gate Framework. The participants were also asked to describe the challenges they faced during the development or implementation of their POCTs, as well as any successes they encountered. In addition, the participants were asked about how PORTENT could support them in overcoming such challenges or needs and lastly, any needs they currently have that they have not met.
During the four FGDs with stakeholders, participants were asked questions related to current trends in POCTs, as well as what they envision as the current needs and potential opportunities to be in the field of POCTs.
All FGDs were recorded on a physical microphone and recorder and transcribed using transcribing software (Otter) to streamline the methodological process. After transcription was completed, a researcher cross-referenced the automated transcription with the audio recording file to ensure there were no errors or inconsistencies.
Data analysis
As proposed by Braun and Clarke, the process of thematic analysis includes the following steps: familiarising oneself with the data, generating initial codes, searching for themes, reviewing themes, defining and naming themes, and producing the report.16 After the completion and cross-referencing of the transcriptions by a researcher, the transcripts were imported into NVivo, a data-analysis software.
An inductive analysis of the transcripts was completed by the three researchers through the generation of codes by reading the transcripts line by line, which is aligned with guidelines by Braun and Clarke.16 Using NVivo, a preliminary coding scheme was developed. Lastly, all emergent codes and themes were reviewed and refined by three researchers to ensure inter-rater reliability.
Patient and public involvement
Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this research. This study engaged technical developers and expert stakeholders (including engineers, scientists, clinicians, funders and policy advisors) as research participants, not as patient or public partners in the research process. No patient advisors were consulted in the development of the research question, outcome measures or study design.
Results
A total of 24 participants participated in the FGDs in New York, however, only 21 participants consented to having their demographic information collected. 62% of participants were from the USA, 95% had completed either a Medical or PhD degree and most of them were cisgendered men (see table 1). Four FGDs were conducted (ranging in size from 4 to 12 participants).
Table 1. Participant demographics.
| Variable | N (%) |
|---|---|
| Country of origin | |
|
4 (19) |
|
13 (62) |
|
1 (5) |
|
1 (5) |
|
1 (5) |
|
1 (5) |
| Education | |
|
10 (48) |
|
10 (48) |
|
1 (5) |
| Age | |
|
5 (24) |
|
2 (10) |
|
8 (38) |
|
5 (24) |
|
1 (5) |
| Gender | |
|
8 (38) |
|
13 (62) |
| Occupation (participant type) | |
|
10 (48) |
|
2 (10) |
|
2 (10) |
|
2 (10) |
|
2 (10) |
|
1 (5) |
|
1 (5) |
|
1 (5) |
Thematic analysis
The thematic analysis and relationships between key domains are summarised in figure 1.
Figure 1. Thematic analysis. LMICs, low- and middle-income countries; POCTs, point-of-care technologies.
Partnerships and support
Engaging end-users and stakeholders
The need for engaging end-users and stakeholders showed the most agreement in the four FGDs, indicating a strong consensus on effective partnerships in the development and implementation of POCTs. Effective stakeholder engagement, including with end-users, was identified as a key critical need. Technical participants recognised the importance of understanding end-user requirements but acknowledged gaps in this area, such as having discussions with end-users of their technologies:
We have a good idea of what the minimum product requirement is for the technology we are developing. At the same time, we haven’ t necessarily talked to specific end-users. (Technical Developers’ Team Member).
Technical participants also described the strategic value of engaging with stakeholders in specific geographical areas, leveraging existing relationships, and consulting with companies already commercialising similar technologies:
It would be great to have some kind of consultancy that we can access. For example, a network of companies commercializing similar technologies could significantly shorten the time to … improve our development process. (Technical Developers’ Team Member)
Based on discussions related to partnerships and collaborations, engaging with policymakers can be particularly difficult for technical developers, as one technical participant explained,
Working with policymakers, especially in malaria, is a barrier… it’s not easy working with them to convince them of a technology.
It was also noted that engaging with key organisations, NGOs, and governmental bodies can facilitate the adoption and distribution of these POCTs. For example, participants highlighted that organisations like UNICEF play a crucial role in purchasing and supplying POCTs. Furthermore, establishing strategic partnerships, especially with health ministries, can significantly impact the implementation process, as highlighted by a technical participant:
In terms of strategic partnerships… a lot of times [ the ] governmental partnerships are important. Having connections with health ministries can make or break the actual implementation of the product. (Technical Developers’ Team Member).
In terms of previous engagement experiences, the technical participants have experienced varying levels of success in engaging stakeholders, including end-users and local authorities.
When we work across the northeast part of Meghalaya [ in India ] . … officers were very supportive; we were able to engage with them and get to a need finding at their level for digital health. Likewise, [ in our ] own state, we went to Gujarat as well. So, it depends on who you engage with, sometimes you can hit a firewall. (Technical Developers’ Team Member)
Overall, being able to engage with end-users and stakeholders like funders, nongovernmental, and governmental organisations through an ongoing process was seen as a key enabler to the success of developing and implementing POCTs.
Tactical partnerships
In addition to partnerships with local ministries and organisations, the discussions with technical participants revealed a need for a better understanding of the implementation of outsourcing strategies to scale the production of POCTs effectively:
All of our manufacturing is in our labs. We haven’ t outsourced to a company that can mass produce it for us. (Technical Developers’ Team Member).
Participants believed having access to infrastructure and partnerships that allow them to increase the production of their products will enable them to shift their focus to other aspects of the development pathway. Technical participants also identified the importance of finding reliable suppliers and considering the cost implications of outsourcing:
Finding a good supply and suppliers, and … cost is the major consideration. Also, ensuring we’ re not vulnerable to supply chain disruptions is critical. (Technical Developers’ Team Member)
Participants were keen to scale their technologies; however, by not having access to tactical partnerships that allowed the scale-up of their businesses, they were often left behind in the pathway of taking their POCT further down the development pathway.
Supportive environment
One way to address the challenges in the development pathway for POCTs is the benefit of a supportive environment. Technical participants highlighted the value of support frameworks, such as those provided by PORTENT, in guiding their research and development processes. In this regard, they discussed the differences between academic research and industry-driven development, including challenges:
Someone doing NIH-funded research might look at this differently. It’ s important to understand the minimum product requirements and adapt them as we progress through different phases. (Technical Developers’ Team Member).
Having access to adaptable frameworks, such as the Phase Gate framework that are applicable to diverse professionals creates a supportive environment for technical developers, enabling successful development of POCTs.
Moreover, many participants highlighted the need for support through partnerships in market understanding, research, and development, building strategic partnerships and identifying appropriate regions for product implementation and scale-up.
Additionally, participants discussed that the COVID-19 pandemic paved the way for many companies and individuals to develop solutions and technologies, encouraging innovation and highlighting the role of a supportive environment:
… All of a sudden people’ s eyes were open … some [ companies ] came up with … antibody tests and all sorts of … assays, and the government was willing to put some money [ into them ] . (Technical Developers’ Team Member).
Participants believed that a similar trend and a supportive environment is being seen in the landscape of artificial intelligence, which can enable technical professionals and experts to access new opportunities, including governmental funding.
Demand and buy-in
Another recurring theme for the successful development and implementation of POCTs was the role of local and global demand. The technical participants highlighted the cruciality of having sufficient demand and buy-in from governments. For instance, one participant highlighted the role of demand and buy-in in securing funding to scale their POCTs:
If it’s not that flashy, therapeutic kind of big technology then it limits the ability to seek financing for scaling, especially when the ROI is not that compelling (Technical Developers’ Team Member)
Similarly, it was noted that POCTs with unclear markets may limit the financing of their technology to be scaled in the future: “The scale of financing for a new product when there is an unclear market is our major barrier” (Technical Developers’ Team Member).
Additionally, participants also discussed current POCT fields that may have a higher demand. There is a demand for tests that can detect parasitic infections not visible in microscopy, as highlighted by another technical participant:
We get to understand what the needs of … testing [ is ] … Malaria falls under one of the categories of unknown fevers… there’ s a huge demand for tests which can pick up parasites which are not visible in microscopy. (Technical Developers’ Team Member).
Similarly, many technical and expert participants pointed out the crowding of infectious diseases in the POCTs landscape pointing to the demand for the development of technologies mainly for infections instead of chronic diseases. This was seen as a barrier in securing buy-in for POCTs targeting health outcomes outside the infection domain. However, POCTs measuring unique biomarkers, such as those for anaemia, are expected to dominate the market due to their differentiated approach, further highlighting the importance of innovative testing approaches in the POCTs landscape. This was highlighted by a technical participant:
We’ re measuring three different biomarkers, which have not been tested in the context of anemia … we’ re hoping it will dominate the market. (Technical Developers’ Team Member)
While the technical teams have a general understanding of the market potential for POCTs, a comprehensive market analysis, including detailed surveys and extensive stakeholder interviews, has not been fully conducted.
One team has undertaken initial needs assessments and some preliminary market analysis, but a thorough completion of these tasks across all the developmental phases is still yet to be undertaken:
For example, market analysis, we have an idea of what it could be, but [ we have ] not … done an in- depth market analysis, as in like, talk to people [ and conduct ] surveys…I wouldn’ t say we completed … everything … in every [Phase-Gate framework’ s] phase. (Technical Developers’ Team Member).
Based on discussions with technical participants, many of them have either conducted a high-level market analysis; however, many of them have not spoken to end-users nor have completed an in-depth analysis of their competitors, which highlights the need for a guiding framework that can inform them of the potential demand and buy-in for their POCT.
Regulatory pathway and policies
Participants from technical teams also stated challenges with understanding and navigating the regulatory process for their technologies. One participant mentioned the challenges of transitioning through different developmental phases without adequate data collection, which can lead to difficulties when seeking regulatory approvals in the future:
Sometimes we don’ t necessarily collect all the data, and then you go to [ the ] regulatory [ phase ] and figure [ it ] out, ‘ Oh my God, I didn’ t do that, I should have done that (Technical Developers’ Team Member).
The evolving nature of digital health regulations was also highlighted, as a challenge by technical participants noting a lack of clear regulatory guidance and the importance of developing frameworks to evaluate digital health technologies was pertinent to understanding the pathway that a digitally integrated technology may take.
Technical participants also suggested practical solutions, such as engaging a global health regulatory firm to provide teams with general regulatory insights:
One of the things that we thought would be valuable is if we can find a global health regulatory firm.
The development and understanding of policies and guidelines can facilitate the implementation of POCTs. The WHO and other international bodies are in the process of creating implementation guidance, although regulatory guidance is still evolving:
If we’ re talking about digital solutions, WHO, MTA, all of them are trying to figure it out. There is no clear-cut limitation guidance… There is no regulatory guidance because these committees were formed just two years ago. (Technical Developers’ Team Member)
As highlighted by another participant, this evolving landscape requires stakeholders to be proactive in understanding regulatory requirements and ensuring their technologies meet the necessary standards. The lack of comprehensive knowledge and industry insights is another significant challenge. It was noted that researchers and technical developers often struggle due to limited access to current best practices and technologies. As one participant noted:
A lot of times I think we end up trying to figure out things by ourselves, we don’t have access to what is the state of the art that a company is doing. (Technical Developers’ Team Member)
Moreover, one participant pointed out structural challenges with the regulatory process, such as the role of federal approvals for a POCT that may be validated to treat a specific clinical outcome just not in the specific patient population that they are looking to work with:
… in the [United States], the barrier … is definitely regulatory, right? So, you have the product there, but you just couldn't apply this in this setting or in this patient population. Right? So, [let’s] … talk about cancer. If [the POCT is] not validated for the cancer patients, I cannot use it (Technical Developers’ Team Member).
Being able to navigate the regulatory process and plan for the validation earlier on was seen as a key need for all participants.
Funding and resources
Moreover, having access to funding, resources and infrastructure was seen as a significant need for all participants. Participants appreciated having support from PORTENT and the resources in their networks. Participants discussed that “… the single biggest [barrier] … is [that] it’s expensive to develop diagnostics and if you’re trying to make them for low income [countries], [there] is zero to negative potential” (Expert Participant).
As highlighted by the participants, having access to a pool of funding is crucial to the success of POCTs but it often comes with its challenges, including being able to prove that their technology works to appropriate partners or funders.
One participant highlighted that “There are practical barriers in terms of … getting funding to our collaborators” (Technical Developers’ Team Member). There are significant financial challenges for technical teams who are building and implementing POCTs, such as “… access to that pool of people willing to pay to get [the technology] to the actual implementation stage …” (Technical Developers’ Team Member).
Additionally, logistical challenges in getting access to necessary materials for laboratory work can negatively affect development and implementation, as one technical participant shared: “A lot of those barriers are [related to] … finding the right materials… [for POCTs]”.
An expert participant also mentioned that at times it may be difficult to implement POCTs in certain contexts, where there may be cheaper alternatives, including clinical treatment for the disease or infection of interest, which may serve as competition for developing POCTs: “The thing about these tests is that it’s almost cheaper to just give the treatment …”.
Overall, funding and cost considerations for POCTs were a key need and challenge that was highlighted by all the developer teams.
LMICs settings
Adaptability
Another key identified need was the need to adapt POCTs across diverse contexts. Two participants highlighted understanding ways in which POCTs can be implemented across multiple geographically diverse contexts, including the role of resource allocation and funding:
… if we have issues … getting materials … here… how can we even fathom how this will work in LMICs … we do a lot of work and sometimes have to talk to vendors… So how does that translate to LMICs and I think some of that does come with … talking to the NGOs and that’s a really hard barrier to cross. (Technical Developers’ Team Member)
The need to tailor POCTs to the specific needs and resources of different geographical areas was highlighted as well. Technical participants discussed the challenges of implementing technologies designed for one region in another with different environmental and resource constraints:
The same technology that we are using in the United States may not be applicable to another country. It’s important to design and implement technologies that are relevant to different countries’ needs and resources. (Technical Developers’ Team Member)
Overall, there is a need to highlight that the resources and specific local needs of communities in LMICs need to be accounted for during the planning process of implementing POCTs developed in HICs to be adaptable in LMICs.
Local capacity building and awareness
A key theme was the process of developing and implementing POCTs in LMICs, including the importance of forming local partnerships and building capacity that can facilitate this process. One participant discussed the ‘invisibility’ of local expertise in low-income contexts:
…the issue with Africa is that people are there, but they’re not visible. Right? I mean, they’re not in a space where you can see them, if you’re not on the ground (Expert Participant)
In addition to this invisibility of local talent and individuals in LMICs in Africa, expert participants discussed the role of raising awareness on POCTs and ensuring that they reach the target populations in low-resource settings:
Some of these things can be addressed in the LMICs, and [be led] there in collaboration with institutions such as PORTENT… what you raised about supply chain management is one of the major issues… even [when] a diagnostic is made available. [It] is accessible, but it’s not accessible to all… if you look at people who are in most need, away from the hospital … but who [need] the diagnostic… it tends to not reach them (Expert Participant).
Overall, participants seemed to agree that there is a need to build local capacity for the development of POCTs in LMICs and ensure that there is sufficient awareness of the local developers as well as the technologies being implemented to ensure that they can support those who are in need the most.
Future of POCTs
Sustainability
Many participants also discussed what success will look like for POCTs in the future, including the need for sustainability. For POCTs to be sustainable in LMICs, they must be integrated into existing healthcare systems and policies:
Sustainability … in [the] LMICs context would be [that] whatever your technology support solution [is], it should be integrated into the healthcare system. It’s part of the policies, so people can actually have access. (Expert Participant)
In addition to creating sustainable healthcare delivery models, environmental sustainability was also a concern, especially regarding the disposal of biohazardous waste generated by POCTs:
I was also thinking about environmental sustainability, … a lot of these [POCTs] generate a lot of biohazards. So how are you [disposing of] that kind of thing? (Technical Developers’ Team Member)
Additionally, the economic sustainability of single-use devices in limited-resource settings was highlighted as a significant concern, which was noted by a technical participant:
This is a single-use device, and in a limited resource setting, they can't pay a ton. How would we get it economically sustainable and outsourced? (Expert Participant)
Furthermore, one of the participants noted the need to conduct ongoing needs-assessment activities in the landscape of POCTs:
At the end of the day, the whole point of the flow is that we do these needs assessment on a continuous basis and that feeds into a solicitation call. (Expert Participant)
Artificial intelligence
Participants discussed that artificial intelligence (AI) has the potential to revolutionise medical diagnosis in LMICs, by interpreting symptoms more accurately or reviewing a patient’s medical history to make accurate detections.
However, AI needs a large amount of quality training data to make predictions, which is often lacking in LMICs. One participant noted that machine learning (ML) models are already quite widely used in diagnostics, particularly for cancers through image processing.
The Food and Drug Administration (FDA) is already developing guidelines and a framework for using ML in diagnostics, which will shape its future use globally:
…machine learning is already pretty well established, something like 600 FDA-approved devices use machine learning, with many more to follow (Expert Participant)
Although participants highlighted ways in which AI has greater potential in the future, they also discussed some of the current limitations, such as the need for cleaner datasets which are often difficult to acquire:
Let me just give you some examples of [how] AI can be extremely disruptive. While the caveat here is you need excellent data to do your predictions and that’s the big challenge in our country. We don't have great clean data unless you're doing it a lot of data training … (Technical Developers’ Team Member)
Overall, participants welcomed the idea and incorporation of AI/ML models in POCTs but only with caution and considering the current limitations of the technologies, such as the availability of large datasets.
Discussion
This work is aimed to highlight needs and challenges faced in the POCT landscape (from conception, development to commercialisation), and has been drafted from the perspectives of technical developer teams and POCT experts, such as the External Advisory Board members at the PORTENT Centre.
The goal of this study was to conduct and describe the findings of a needs assessment process with technical and expert participants to inform the development and implementation of POCTs in both the HIC and the LMIC context.
The current study used a qualitative methodology, semistructured FGDs, which allowed the research team to identify the general experiences of developing POCTs but also the individual-level determinants of the successful development and implementation of such technologies. At the same time, this qualitative methodology may contribute to potential biases due to the relationships between the participants and the PORTENT Centre.
The reported needs and challenges were consistent with prior research on the use of POCTs in LMICs, such as a need for support in supply chain management, characteristics of the geographical location, health infrastructure and an enabling policy framework for POC diagnostics services.17 18
Prior studies have also identified regulatory challenges, funding constraints and barriers to integration within health systems as key limitations to successful scale-up.19 20 These findings are further supported by prior work examining policy and system-level barriers to POCT adoption. For instance, research in European healthcare systems has demonstrated that limitations in health technology assessment processes, a lack of robust evidence for diagnostics and fragmented pricing and procurement mechanisms may significantly hinder the uptake of rapid diagnostics.21 Our findings build on this literature by providing developer-informed and stakeholder-informed insights across the full development-to-implementation continuum, with particular emphasis on stakeholder engagement, early regulatory planning and context-specific adaptation in LMIC settings.
Concurrently, the findings also highlight additional challenges, such as the need for tactical partnerships in scaling technologies and the lack of awareness on local supports available in LMICs. One unique contribution of this research is the role of future advancements and sustainability in the development of POCTs, particularly highlighting challenges with the incorporation of AI and considering environmental sustainability due to the disposal of biohazardous materials. Moreover, one of the most common themes during the FGDs was the need for strategic partnerships, including establishing relationships with end-users, governmental organisations, outsourcing companies and specific support from the PORTENT Centre, which is currently funding POCT projects at the Cornell Tech Campus.
Additionally, the findings also highlighted the facilitators of a successful POCT implementation, such as the demand for POCTs and buy-in for specific technologies.
The limitations of this work include that the participants in the FGDs were limited to those who were affiliated with the PORTENT Centre, and the needs of other technical developers may vary by region and affiliation. It should also be noted that many of the participants from technical teams seem to be well-positioned in terms of their participation in the clinical validation of POCTs and the product development process, which may have affected the types of needs and challenges they identified.
A majority of our FGD participants were affiliated with academic institutions, which may limit representation of industry-based developers. As such, findings may be more reflective of early-stage or research-driven innovation pathways rather than fully commercialised POCT development environments. However, academic-industry hybrid models are increasingly central to early-stage POCT innovation, particularly within global health contexts, where academic labs often drive initial development prior to commercialisation.
Moreover, although four FGDs were conducted with expert stakeholders, fewer discrete themes were attributed to this group compared to technical developers. This may reflect differences in contributions, as technical developers provided detailed, experience-based accounts of operational challenges across the development pipeline, which were more readily coded into themes.
Future research and programming must support technical teams and developers of POCTs to ensure that such technologies can be accessible and adaptable in diverse environments of LMICs. If technical developers are experiencing difficulties in implementing their technology in an HIC, it may be even more important to consider the setbacks they may experience in an LMIC. Moreover, participants in the FGDs were following a non-linear path to product conceptualisation and development, such as the Phase-Gate Framework, which suggests that the development of such frameworks should include separate guidance/roadmaps for technical teams that are orientated in an academic institution rather than a business or pharmaceutical firm.
Conclusions
The needs and challenges in POCT development, scaling and advancement identified by the tech teams included: regulatory challenges, manufacturing and supply chain issues, procurement of materials to develop POCTs, early stakeholder engagement, facilitated market access, access to information, consideration of end-user needs and environmental sustainability.
The identified enablers included strategic or tactical partnerships, support networks, funding support, user-centred design enabled by needs assessment and early engagement of stakeholders to guide product development, evaluation, implementation and/or scale as needed.
In sum, by addressing the needs and integrating enablers as identified by the technical developers and the experts, POCTs can be more effectively developed, implemented and scaled across diverse settings, such as LMIC settings and the process of development made more efficient by advanced anticipation of needs and enablers of integration that will predict their success.
Footnotes
Funding: This project was funded by the National Institutes of Health (NIH) through the PORTENT Pointof-Care Technologies for Nutrition, Infection and Cancer in Global Health Center (U54EB034654)–a member of the POCTRN+ Network. Portent also received significant support from Cornell University. Dr Pant Pai acknowledges the additional support of FRSQ Merite Award #313488 for the duration of the study.
Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-109905).
Data availability free text: Deidentified qualitative data from focus group discussions are available from the corresponding author (NP) on reasonable request, subject to participant confidentiality considerations.
Patient consent for publication: Not applicable.
Ethics approval: Ethical approval was obtained from the McGill University Health Centre Research Ethics Board; REB number: 2024-10350. Participants gave informed consent to participate in the study before taking part.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Data availability statement
Data are available on reasonable request.
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