In a previous article I highlighted that >80% of antibiotics in developed nations are prescribed in primary care settings, so if we’re to improve stewardship of antibiotics and tackle antimicrobial resistance (AMR), we need to improve prescribing here.
Time-to-result is a critical requirement for any diagnostic in primary care. Antibiotic prescribing can only be improved if results are available to clinicians sufficiently quickly to guide their decision making.
In this article I’m looking at what ‘fast enough’ means. I’ll lift the lid on some well entrenched dogma and explore whether tackling AMR may require some more nuanced and considered thinking about time to result and workflows.
We’ve established that time-to-result, cost, usability and accuracy are all non-negotiables for any successful point-of-care (PoC) diagnostics test. We also know that that these requirements are often conflicting. For example, if you make a test easy to use, the cost of the consumable and/or instrument will increase. If you want your test to be fast you often need to compromise sensitivity or dynamic range. So, it’s essential to nail down what the real time-to-result requirement is.
Obviously, if a diagnostic is too slow it won’t improve workflows and will fail. Yet striving to deliver results faster than is entirely necessary will add cost and usability and/or accuracy.
The aim of this article is to help you stop and think carefully before making bold proclamations and defining user requirements and product requirements.
Don’t assume that what ‘relevant’ stakeholders tell you is the whole story
Everyone appreciates that observing and understanding the voice of the customer and the perspective of the user are valuable inputs when defining the Target Product Profile and the User Requirements. But it’s essential to gather and review this information thoughtfully and with insight when it comes to requirements for time to result.
The perspectives of different stakeholders need to be considered. A lab scientist has a very different viewpoint from a community nurse, while a practice manager will have different priorities from a GP.
You may hear people repeating the dogma that ‘any tests that takes more than 30 seconds is too slow’. While this may be true in some settings, it’s not universally true and needs to be unpacked and challenged.
Paradigm paralysis – user can struggle to imagine a world they’ve not seen
Individuals and groups are often unable to consider alternative perspectives, approaches or solutions, even when new evidence or ideas are presented. This phenomenon is a significant barrier to creativity, innovation and change. It’s a problem that is compounded by the pressures experienced by people at the coalface of primary care, where time, money and skills are often limited.
Workflow fast and slow
GP / PCP appointments are typically <5 mins in most geographies. This makes it unrealistic to perform in-vitro diagnostics in real time as part of the consultation. However, the delivery of primary healthcare is also evolving to save time and money. This has impacts on the requirements for diagnostic tests.
Patients are increasingly triaged prior to seeing the clinician – creating the opportunity to run diagnostics before clinician even interacts with the patient. In these scenarios, time-to-result can be 10-30 minutes without causing significant inconvenience to the patient.
It is also entirely feasible for tests to be requested by the GP which are performed in the surgery/office after the patient has been seen. The results of which can then be used to inform any follow-up. For example, if a GP suspects a patient may have a urinary tract infection (UTI) they can request the patient provides a sample before leaving the surgery/office.
If the urine can be tested for infection and antibiotic susceptibility within an hour, the results can be sent to the patient’s smartphone. If antibiotics are required they can be sent directly to the pharmacy for collection. In this instance the time-to-result can be as long as an hour without any significant inconvenience or delay in treatment. The patient only receives antibiotics if they are necessary and the patient receives an effective antibiotic based on test results, rather than guesswork or probability.
The implication for diagnostic test development
For diagnostic innovators, the lesson is clear: don’t just chase speed, design for clinical reality. While a 30 second test sounds like it will be a winner, make sure to fully understand workflows and care pathways. It may be that trading off absolute speed to result can yield cost, usability or accuracy benefits which are critical to adoption and improvement in outcomes.
The key is to design around real-world workflows. Speed matters, but clinical fit is what ultimately drives adoption.
At Cambridge Consultants, we help innovators navigate these trade-offs and develop diagnostic tools that can be clinically and commercially impactful. Whether your product/technology takes 30 seconds or 30 minutes, whether the system costs 30 cents or $30,000 come and talk to us. We can help you translate your technology into a product which delivers value.
専門家
Alejandra is a biomedical engineer with a PhD in Biological Sciences and over five years of experience in product development, specialising in drug delivery and diagnostic devices. She has supported projects from early concept through to regulatory submission and market launch. Passionate about strategy and innovation, Alejandra enjoys advising clients and working at the forefront of deep tech.
