The Secret to Developing a Commercially Successful Point-of-Care Device

It's critical to understand the market landscape and the factors that drive healthcare providers to adopt POC devices. 

Juan Roman

The Alere i system can provide molecular test 

results for the influenza virus within 15 minutes. 

 

The point-of-care (POC) market continues to grow, with devices such as Alere i and cobas Liat now commercially available and intended to disrupt the care pathway for influenza A & B and syndromic diagnosis. More devices and technologies for POC are in development, and there is a consensus among market analysts that the POC segment of diagnostics will dominate innovation in the medtech sector. POC devices are seen as key in transferring pathology/microbiology testing into primary care.

However, the development of POC devices is less than straightforward, and the path to commercialization is full of barriers. On one hand, there are the technical challenges that need to be overcome, and on the other hand, there is the high barrier to adoption. The latter is a point of great interest as POC devices are by nature disruptive, yet this disruption holds the key to the commercial success of the device.

POC devices can be used in multiple locations, including at home, in hospitals, and in walk-in clinics. The success of each relies heavily on how well their design satisfies the needs for use in each of these environments. Take, for example, walk-in clinics in the United States that are run by MinuteClinic (CVS) or Walgreens. A POC device intended for such clinical use must take into consideration the business model of these clinics and the processes they already have in place. This article outlines three key areas worth considering for POC device developers: patient experience, clinical value, and alignment with processes and procedures.

Patient Experience

Walk-in clinics invest heavily in providing an improved patient experience, therefore the testing they offer should take this into account. Sample type and sample volume are crucial in developing a test that is more likely to be adopted by clinics and sought after by patients. Consider a patient who has a choice between two blood tests, one consisting of a finger prick and one that requires 3 ml of blood to be drawn. The first is minimally invasive while the latter is not, so its potential to successfully compete in the walk-in clinic market is limited.

Time of testing is also related to an improved patient experience, and it should not exceed the total time of a consultation, which we can assume is 15 to 20 minutes long. During this 15 to 20 minute window, the healthcare professional must be able to assess the needs of the patient to determine the right test, source the test, get the sample, run the test, receive the 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 MinuteClinics—where speed is key to its value proposition—any test that needs 10 minutes or more will very likely not be selected.

Clinical Value

POC testing, like 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 selection of biomarkers.

This is even more evident in clinics testing for sexually transmitted diseases (STDs). An increase in STDs is being mirrored by ever more antimicrobial resistant (AMR) strains of gonorrhoea. Knowing that a patient has gonorrhoea is only part of the story. Knowing that that patient has an AMR strain allows a more targeted, personalized treatment program, potentially reducing cost, time to recovery, and importantly, reducing the pressure on AMR developing.

In situations where clinical signs and symptoms are insufficient to distinguish the cause, such as flu-like Illness, simultaneous differential diagnosis for several targets, such as the influenza A and B virus or rhino syncytial virus, is valuable. Syndromic tests such as these allow better diagnosis and improved patient management.

Procedure and Process Alignment

It is important that tests align with the business models in their respective clinics. For example, walk-in clinics are not staffed with specialist healthcare professionals, and therefore are less inclined to purchase and offer tests that require input or supervision from a specialist healthcare professional. This applies not only to the actual operation of the POC device but also to sample collection. A company that does not employ phlebotomists will think twice about purchasing and offering a test that samples more than 1 ml of blood. The requirement for a trained healthcare professional to carry out a test increases the total cost burden of the test.

Similarly, tests should have minimal impact on the processes that primary care centers have in place. One example of this is waste disposal and the processes and infrastructure surrounding it. We need to appreciate the different processes and nuisances associated with disposing fecal samples, as opposed to something like finger-prick blood samples, and how choosing the right sample type can define how likely a test is to be adopted.

Any Main Street clinic, pharmacy, or primary care center that 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 higher investment in real estate.

The commercial success of a POC device relies on far more parameters than just its core technology. Understanding the market landscape and what will drive healthcare providers to adopt such devices is a necessary first step towards a successful commercialization plan.

Juan Roman is a diagnostics specialist at Cambridge Consultants.

[image courtesy of ALERE]

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