How to re-position your point-of-care diagnostic for post-pandemic success

Rapid advancements brought about by COVID-19

The pandemic provided an intense period of investment for the diagnostics industry, with levels now returning to pre-pandemic levels. In addition, the expected reduction in emergency use authorizations and recent changes to the regulatory landscape in the EU, such as the IVDR, mean that new diagnostic technologies are being released at a slower rate than in recent years. Generally speaking, we’re getting back to a “normal” workflow for diagnostic device development.

We spoke with several organizations during the event, who found that COVID-19 was a key inflection point in the development and adoption of their diagnostic technologies. This was particularly the case for small-scale home use PCR devices, which companies were able to rapidly develop and deploy with COVID-19 tests. It is notable that many of these devices were originally intended to be platform diagnostics and that the rapid deployment of COVID-19 tests had demonstrated their use case and the effectiveness of these technology platforms. This was certainly the case for LumiraDx, a client of Team which adapted its diagnostic platform to deploy a COVID-19 test.

For lateral flow devices, a clear outcome from the pandemic is the ability of “lay” users to perform at-home testing, and their willingness to do so (for the right test). In the UK over 514 million COVID-19 tests have been reported since the start of the pandemic, with many of these being at home Lateral Flow Tests – LFTs. Even in May 2022, over 1.5 million tests were still being reported weekly.

While it’s evident that not all tests will be suitable for home use, either because the frequency of testing will be too low, or because users can’t stockpile tests for everything, the ability of lay users to perform nasal and throat swabs has facilitated the deployment of LFTs to pharmacies and decentralized healthcare settings. The COVID-19 pandemic has meant that these models can be considered more seriously than in the past. Still, it is not yet clear what form those models will ultimately take in the post-pandemic landscape.

Addressing the use case

What will the future of Point-of-Care (PoC), near-patient, pharmacy-based and at-home diagnostics look like?

It has been argued that we can still realize the vision in which every home owns a reusable reader device, with a catalog of disposable cartridges in their bathroom cabinet for all manner of diseases they may need to identify one day. Such a future would provide a number of benefits, including increased accessibility, reduced spread of infectious diseases and the potential for large scale public health data to be tracked.

However, this poses a catalog of questions too. First of all, would people actually want this set-up at home? Would it be adopted by everyone or just a small subset of the wealthy “worried-well” and not those who might need it most? Would this be appropriate for all indications, from infectious diseases, to cancer and genetic disorders? What about data privacy?

These questions must all be considered carefully if we are to realize the full potential of widespread at-home diagnostics.

The pharmacy model

Another front runner for diagnostic testing is the pharmacy model. This could be in the form of off-the-shelf pregnancy test style devices, over-the-counter self-tests or tests performed by healthcare professionals (HCPs) stationed at the pharmacy (conducting on-site laboratory tests).

Pharmacies were an integral part of the fight against COVID-19 and it would be a shame to let the infrastructure put in place during this time go to waste. This approach could take a significant amount of pressure off overworked healthcare systems, in addition to supporting the democratization of healthcare by opening up access to healthcare.

However, it must be questioned whether this model is fit for purpose in the post-pandemic diagnostic landscape. There are various regulatory and authority hurdles to overcome for this approach to reach its full potential. Allowing pharmacies to test, prescribe and dispense without intervention from general practitioners or primary care involvement will be key to the success of such a model.

Which model will be adopted?

One question that has been asked is which use-case model is most likely to work and dominate in the future? In reality, it seems unlikely that only one approach could work for all indications. Rather, all will likely play a role in different ways, for different scenarios. The real question should therefore be how to develop the right product for the use case(s).

Developing a product that addresses the use case involves building a deep understanding of who your users are for the indication(s) you are targeting, including what their needs, fears, incentives, capabilities and limitations are. You also need to consider what the use environment is, what the current clinical pathway is and much more.

It is only with these factors carefully considered that a commercially viable access model, clinical and regulatory pathway and design ambition for the diagnostic product be identified. The same applies both for new development programs and when repositioning existing platform technologies.

In addition to the use case considerations, diagnostic developers also need to consider who will be willing to pay for the product (and how much)?

Reimbursement

How do we ensure that diagnostics organizations will be appropriately paid for their devices and test consumables?

This has been a key issue for the industry for many years but has been exaggerated by the reductions in investment post COVID-19. Each summer, new reimbursement codes are published, defining the prices which Medicare and Medicaid will pay for medical and diagnostic services. Each product/service is assigned a category, with the value that is repaid to suppliers capped for each category. This poses at least two challenges for the sector:

1. The goalposts are moving frequently and products may change between categories annually
2. The reimbursement value between categories can vary dramatically

One of the major discussion streams at the NextGenDx Summit centered around reimbursement challenges for diagnostic products in the US market. Speaking with delegates, it seemed that some common challenges exist, with the goal posts moving with each Medicare summer review. Additionally, it became clear that subtle changes in the intended use and clinical pathway can have significant impacts on the level of reimbursement.

With more European and British diagnostics providers leaning on the US market whilst the challenges of the IVDR are ironed out, this challenge of commercial viability is one which manufacturers will need to understand and address early in the development cycle.

Re-positioning starts with re-imagining

In order to re-write an effective business plan and product development roadmap, developers first need to define where the road is ultimately leading to. Now that the needs of the pandemic have passed, this starts by re-imagining the end goals for future commercial success and building confidence in their feasibility with evidence.

At Team, we help our clients achieve this by using a broad range of innovative tools, which enable us to help teams challenge their preconceptions and inspire them to push the boundaries of diagnostic development. Asking the right questions to the right people can help to challenge preconceptions and provide great ‘reasons to believe’ in a new vision, ultimately helping to pave the way to achieving long-lasting commercial success.

As the diagnostic industry continues to realign itself following the pandemic, it will be exciting to see which technologies emerge to shape the future of healthcare.