The challenges in point of care device development
What to consider when embarking on development of a point of care testing device?
By reducing the time to diagnosis and improving clinical decisions, Point Of Care Testing (POCT) has the opportunity to save lives. Such rapid decisions may be critical, for example in cases of stroke or sepsis, where precise bedside diagnosis may be vital. By removing the laboratory from the diagnostic process, the clinical outcomes for patients in developing countries may also be substantially improved.
The obvious opportunities offered by this process means that at KD we have seen substantial investment in products targeted at the POCT market, mirroring a global trend. However, there remain challenges on the road to device development. In this article we will consider a few of the hurdles that we routinely plan for.
The nature of POCT means that there is considerable diversity in the operating environment and user types that the device may encounter. Successful POCT devices add value by streamlining the process, eliminating the need for trained laboratory technicians operating with controlled processes. To do this, the POCT device must manage all aspects of sample collection, processing and result presentation to non-specialist technicians.
These variables can lead to poor definition of the target user and process steps; a problem sometimes compounded by an early rush to solve the technical challenges of the core product technology.
Our experience at KD is that during these early stages of development it is critical to maintain focus on the user needs. For example, by questioning the level of automation in sample collection, preparation and test execution, it may have a substantial effect on the preferred approach to the key technical challenges. The focus must also be on questioning where the value is really added, especially on first versions of the product.
This picture may be complicated further by the commercial objectives of the organisations involved. Is the final objective to reach commercial release of the product, or to sufficiently demonstrate the operating principals and technology to the point where the ideas may be sold or licensed?
At KD, we take steps to meet these varying challenges using our in-house research team, to assist clients in creating market and user profiles. This expertise, coupled with the understanding of our human factors and engineering teams, provides the information needed to make the correct decisions early in development. This can also have the added benefit of opening previously unforeseen commercial and technical opportunities with the product.
In addition to the wider issues of user and market understanding, there are recurring technical challenges associated with the creation of a POCT product.
Taking the example of Lab on Chip (LOC) concepts, which were first drawing attention more than two decades ago, there has been relatively limited transfer of devices to the commercial market. The challenges in this field are often found in the multidisciplinary aspects of the development process which must link the laboratory chemistry through all aspects of the final product design. At each level in this chain, there needs to be effective communication of requirements so that the intent of the design is maintained through the transfer of disciplines.
At KD, we work through a process of continual engagement with the project scientific team, with a ‘fail-early’ philosophy in the design process. By performing early stage prototyping of various aspects of the assay, demonstrating function across the technical fields, possible shortfalls in the design can be rectified at lowest possible cost and risk.
There is also the temptation to pursue device miniaturisation to open wider commercial markets and to remove the transport, storage and labelling requirements in larger remote devices. This added convenience is offset by procedural risks and greater requirements for the operational robustness of the device. There are notable exceptions to this analysis, for example the Abbott i-STAT system, however the challenges of reaching the market with a miniaturised POCT device should not be underestimated.
Beyond the technical and user challenges of the device, that is to ensure the outcome of a correct analysis, there is the ultimate economic value of the device. Here it is important to consider not just the basic cost comparison of a single POCT test with the laboratory, but the post-test analysis and outcome too.
By improving the speed of result delivery, carers and physicians may be able to improve patient outcome, leading to substantial future cost savings. Reviews of the economics of POCT testing have illustrated the complexity of ascertaining value in this approach. Therefore, to demonstrate future market application, it is incumbent on the developer to fully define the value proposition and to set the device and consumable costs accordingly.
POCT has the potential to offer substantial benefits in patient clinical outcomes. However, the development of a successful POCT product is dependent upon the design team establishing clarity of the user and product requirements. These findings should be drawn as early as possible in the development process to allow the precise targeting of project resources, minimising cost and time to market.