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Recent years have witnessed tremendous advances in Point of Care Testing (POCT), which are a result of continuous developments in biosensors, microfluidics, assay formats, lab-on-a-chip, and other complementary technologies.
In this article, we provide you with 4 top tips to start you off on the right foot:
Depending on the type of patient sample (whole blood, saliva, urine, etc.) and patient test (blood glucose, infectious disease, drug abuse screening, etc.), the product design of the consumable (sometimes referred to as disposable, cartridge, or cassette) needs to consider numerous areas of engineering application and technology. These can be things like:
In much the same way, the product development of the instrument has to consider the same areas of engineering and technology in addition to:
In such cases, integration of the cartridge with the instrument for testing requires a high degree of coupling between the two components in the areas mentioned above. Within the cartridge and within the instrument, there may also be a high dependency on neighboring components for correct functionality.
Some of the most common reasons for developing both the consumable and instrument in parallel are:
In practice, when such POCT development projects are undertaken, small changes to the cartridge result in a need for changes to the instrument. This is especially true in cases where a contract product development firm is used alongside in-house development of chemistry used within the consumable.
Here a butterfly effect occurs, sending ripples through the rest of the design of both the cartridge and the instrument. At this point during the development (or worse, in hindsight at the end of a project), it is easy to say, ‘if only we could have designed the consumable first and then the instrument.’
The nature of development usually results in iteration to the design as a way of continuous improvement or to correct negative emergence (the occurrence of unexpected and unwanted effects that emerge from internal or external interactions inherent in complex systems) to the consumable, the instrument, or both.
We realize that timescales and funding streams won’t permit you to develop the consumable before the instrument (and in fact, taking a systems approach needs some overlap in the development of both), but there are some ways to mitigate the risks.
So, what can be done to prevent total redesign? Well, whilst each POCT system development project is different, the general points below may be useful:
Locking down the functional requirements and constraints of both the consumable and the instrument is important and needs to be done early in the project. You should also make sure that all stakeholders understand and agree on what is needed. This helps provide a direction for the design with a shared perspective.
Remember to document this in a way that allows easy verification and validation later on in the project to ensure that the criteria have been met. One effective way of doing this is to break down both the consumable and the instrument into sub-systems or modules.
It’s worth pointing out here that this can be easier said than done, especially for complex POCT systems that require multiple technologies for functionality and/or small-scale components or modules. If, for example, a requirement is changed during development, the sizes, placement, or configuration of design features may be affected, along with the choice of components.
If a changed requirement affects the design features of the consumable, this could also have a major effect on some of the sub-systems within the instrument that couple with the consumable. Other changes may occur to optimize performance, save cost or replace an obsolete part. Flexible design allows adaption to change for these uncertainties:
Having a plan in place to manage project risks is crucial. Instead of parallel development of both the consumable and instrument, you could plan the development of the instrument to slightly lag the consumable. It may also be a good idea to take a staged approach for developing the modules or sub-systems.
Ultimately, be systematic but systemic at the same time, and consider the POCT system as a whole.
If timescales are tight and investors are breathing down your neck to get the system on the market, then doing a soft launch with a version 1 product isn’t always a bad idea.
If a POCT system has been given the appropriate approvals and markings for the market, then distribution within a set of customers who understand that the product will be improved and upgraded to a version 2 later on and can start bringing in some much-needed revenue.
Although clinical trials and usability testing should have been performed during development, getting feedback from the actual market on product performance can be very useful for product success. Yes, this can result in changes to the design, but that’s why you need to do the other three things too. After all, aren’t POCT systems all about innovation and opportunity anyway?