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 authorisations 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 Consulting 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

The future of Point-of-Care (PoC), near-patient, pharmacy-based, and at-home diagnostics holds the potential for significant advancements and widespread accessibility. One envisioned scenario is where every household possesses a reusable reader device along with a collection of disposable cartridges for detecting various diseases. This setup could offer numerous benefits, such as increased accessibility to diagnostic tools, reduced transmission of infectious diseases, and the opportunity to gather large-scale public health data.

However, this future also raises several important questions. Firstly, there’s the consideration of whether people would indeed desire such a setup in their homes. Would it be embraced by all individuals or only a select group, potentially leaving out those who may benefit the most? Additionally, it’s crucial to assess the suitability of this approach for different medical conditions, ranging from infectious diseases to cancer and genetic disorders. Concerns about data privacy also loom large and must be addressed.

To fully realize the potential of widespread at-home diagnostics, these questions need careful consideration and thoughtful solutions. It’s essential to balance the benefits of increased accessibility and disease detection with the ethical and practical implications associated with this technology.

The pharmacy model

The pharmacy model emerges as another promising avenue for diagnostic testing, offering various formats such as off-the-shelf pregnancy test-style devices, over-the-counter self-tests, or tests administered by healthcare professionals stationed at pharmacies, including on-site laboratory tests.

During the COVID-19 pandemic, pharmacies played a vital role in the response effort, and leveraging the infrastructure developed during this time could prove invaluable. This approach has the potential to alleviate strain on overwhelmed healthcare systems and promote healthcare accessibility by democratizing access to diagnostic services.

However, it’s essential to critically assess whether this model remains viable in the post-pandemic diagnostic landscape. There are significant regulatory and logistical challenges to address for this approach to realize its full potential. Empowering pharmacies to conduct testing, prescribe medications, and dispense without direct intervention from general practitioners or primary care providers will be crucial for the success of such a model.

Which model will be adopted?

The question of which use-case model is most likely to prevail in the future prompts a nuanced perspective. It’s improbable that a single approach could cater to all diagnostic needs effectively. Instead, various models are likely to coexist, each playing a role in different scenarios. Hence, the key focus should be on developing the right product tailored to specific use cases.

Achieving this involves gaining a profound understanding of the target users for the intended indications. This includes comprehending their needs, concerns, motivations, capabilities, and limitations. Additionally, factors such as the intended usage environment, existing clinical pathways, and more must be taken into account.

Only by carefully considering these factors can developers identify a commercially viable access model, define the clinical and regulatory pathway, and establish design ambitions for the diagnostic product. This holds true for both new development initiatives and the repositioning of existing platform technologies.

Furthermore, apart from use-case considerations, developers must also contemplate who will be willing to pay for the product and at what price point. This aspect is crucial for ensuring the sustainability and market acceptance of the diagnostic solution.

Reimbursement

Ensuring appropriate payment for diagnostic devices and test consumables is a critical issue for diagnostics organizations, particularly exacerbated by the reduced investment post-COVID-19. In the United States, reimbursement codes are published annually, dictating the prices that Medicare and Medicaid will pay for medical and diagnostic services. Each product or service is categorized, with reimbursement value capped for each category. This setup presents two significant challenges for the sector:

1. Frequent Changes and Category Variation
2. Dramatic Variation in Reimbursement Values

At the NextGenDx Summit, reimbursement challenges for diagnostic products in the US market were a major topic of discussion. Delegates highlighted the challenges of navigating the Medicare summer review process, where the criteria for reimbursement are subject to change. Moreover, even subtle alterations in the intended use and clinical pathway can lead to notable impacts on reimbursement levels.
For European and British diagnostics providers, who increasingly rely on the US market amid the challenges posed by regulations like the IVDR, understanding and addressing these reimbursement challenges early in the development cycle is crucial for ensuring commercial viability.

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.