The development of point-of-care (POC) devices is probably one of the most challenging endeavours a medical device developer will face. This is not only because of the technical challenges that need to be overcome but also because of the disruptive nature of POC testing and the risks this poses to any commercialisation plan. However, if you disrupt the market you are targeting with a POC device – by not fitting with well-established processes – the likelihood of early adoption and commercial success diminishes.
To guarantee satisfactory adoption levels, POC device developers should accommodate the needs of their clients. In this case, I will focus on the needs of primary care providers like MinuteClinic (CVS) or Walgreens in the United States – companies which focus on the provision of walk-in healthcare, including diagnosis, and could well be a target client for POC testing device developers. What are the mistakes a POC testing developer should avoid?
A POC test cannot take more than 15-20 minutes. This constraint is dictated by the length of a typical consultation with a patient. During this 15-20-minute window, the healthcare professional must assess the need of the patient for the right test, source the test, get the sample, run the test, receive the test results and communicate any findings back to the patient. In essence, the actual test should only run for a fraction of the consultation time. It is very unlikely that tests will be adopted if they do not meet this standard. For a company like CVS and its MinuteClinic – where speed is key to its value proposition – it means any test that needs more than single-digit minutes will very likely not be selected.
One of the differentiating advantages of POC testing is that it can potentially offer an improved patient experience. The selection of the right sample type is critical for maintaining this advantage. For example, if the test requires a large volume of blood sample – and hence the use of invasive means to collect – it may put off a significant proportion of potential users. Such a test will not compete against one which only requires a finger-prick-sized blood sample.
Organisations offering tests close to the POC are less inclined to purchase and offer tests which require input/supervision from a specialist healthcare professional. This does not only cover the actual operation of the POC device but also sample collection. If a test demands a blood sample of more than 1ml, it is likely that it will require the presence of a phlebotomist. A company that does not employ phlebotomists will think twice about purchasing such a test. The requirement for a trained healthcare professional to carry out a test increases further the total cost burden of the test.
Operation and process
In an ideal scenario, the introduction of a POC test to the services of a primary care centre should have minimum impact on its current processes – for example, the processes and infrastructure for waste disposal. We only need to appreciate the difference processes and nuisances associated with disposing faecal samples vs. something like finger-prick blood samples how choosing the right sample type can define how adoptable a test can be.
Any high-street clinic, pharmacy or primary care centre which adopts POC testing is very likely to perceive any storage space as highly valuable. Tests should command as little space as possible, while at the same time ensuring reasonable levels of supply that can satisfy day-to-day demand. The need for refrigeration is even more challenging as any temperature-controlled storage space is typically occupied by drugs which are temperature sensitive.
The same applies if the sample is a ‘below-the-belt’ sample. In this case, users will require access to private rooms, bigger spaces, bigger buildings and hence more investment in real estate.
Too little information
POC testing, like pathology lab testing, should provide healthcare professionals with the confidence required to make evidence-based clinical recommendations and take action. It is therefore, important that POC tests cover a reasonably wide panel of biomarkers. If a test for STDs is only against a single candidate disease – for example, chlamydia – it is simply not good enough.
Too much information
Similarly, the test should allow access to information that is aligned with standard clinical practice and is actionable. In the case of a test which is supposed to help healthcare professionals decide whether an antibiotic is the right course of action, it is of little value to provide the full microbiome map of a patient. Any panel has to be relevant and limited to helping make informed decisions.
The commercial success of a POC device relies on far more parameters than just the core technology. Understanding the market landscape and what will drive healthcare providers to adopt such devices is a necessary first step towards a successful commercialisation plan.