Healthcare and Life SciencesMiniaturized Devices: How to Rightsize Your Point-of-Care System

Technology miniaturization: Is smaller always better in life sciences?

Across industries, the constant advancement of technology leads to ever-increasingly miniaturized devices and integrated systems, and the life science industry is no exception. One could look at the recent history of nuclear magnetic resonance (NMR) and mass spectrometry to see the progression of hulking instrumentation that commanded entire laboratories to benchtop and even mobile instruments — all within just a 20-year span.

Beyond the miniaturization of life science systems, increasing integration has reduced the demands on technical proficiency of the users of these same systems. What once was the realm of only PhD scientists has now moved into the hands of lab technicians.

While the trend of technology miniaturization and system integration is a natural evolution, the advancements seen between research instrumentation to that used for clinical diagnostics — as well as the omnipresence of highly integrated and sophisticated consumer electronics like modern smartphones — can at times set unrealistic expectations for the development of new life science products.

The pros and cons of miniaturized devices.

Small instruments offer many obvious benefits, such as reduced footprint in a lab and mobility. But we believe that miniaturization of life science systems should be approached with more intentionality than simply attempting to make something as small as possible.

While a highly miniaturized system may be desirable in theory, it's important to understand when technology miniaturization provides diminishing returns. For some system elements, the cost of miniaturization can be high, and its size needs to be considered in the context of the current market requirements of your life science system — how small does it need to be to be viable? When defining system size goals, the maturity of predicate systems and technologies needs to be considered as well. If it isn’t truly necessary, attempting to develop and commercialize a new technology in a highly miniaturized system can unduly complicate the schedule and budget. Further, at some point, products can be so small that they become difficult to operate, or can be perceived as a system of lower quality or complexity than desired.

The fact of the matter is, smaller is not always better. Determining the right size for life science systems and devices means understanding your market’s end users and what will create the best experience with your product.

Understanding the costs of technology miniaturization.

There are a number of factors to consider when thinking through the costs of technology miniaturization:

  • The need for more custom-engineered components. In many life science systems, you can save cost by designing in off-the-shelf components. With miniaturized devices, custom engineering is often the only option.
  • Increased difficulty of system design changes. The degree of integration in a small system means you’ll have a higher likelihood of revisions that force cascading changes.
  • Potential decrease in usability. Especially with touchscreens, there’s a size at which devices simply become harder to use. If you’ve ever tried tapping the tiny “x” to close a smartphone banner ad, you know this pain.
  • More challenging thermal management. With such tightly integrated components, it can be far more challenging to dissipate heat effectively.
  • Decreased serviceability. Miniaturized devices can be more difficult to maintain and repair, due to both size and more limited access.
  • Potential compromises to Limit of Detection. The sensitivity of a system can be reduced by smaller reaction chambers or compromises in the optical path made due to space constraints.

It’s also important to remember that, with technology miniaturization, cost often scales nonlinearly with a reduction in size. Smaller size typically means greater cost. This is particularly true for development, but can hold true for manufacturing costs as well.

How to set a “rightsized” goal for your point-of-care instrument.

So, what does Plexus recommend when establishing your product vision? A small life science system is a laudable goal, and we're proud of our track record of helping our customers meet their system size goals, including miniaturized devices. But we always strongly advocate for defining that goal though market research, user research and careful consideration of the costs of miniaturization.

Within this process, it’s wise (and often critical) to first evaluate the technical maturity of the system and underlying technology. At Plexus, we use the Technology Readiness Levels (TRL) framework to take the guesswork out of this evaluation and build alignment for the remainder of the process.

Market research should inform the definition of your minimum viable product, or MVP, including considerations of the competitive landscape, your business case and human factors. When sizing decisions are being made, they can't be made in a vacuum. These decisions should be made through analysis of the benefits of technology miniaturization compared to the costs outlined above. The value associated with a given size should be firmly rooted in a product's specific usage environment — which often means giving priority to minimizing instrument width, because width is what drives your life science system’s space claim on the lab bench.

Once an MVP is appropriately defined, we always look for opportunities for size reduction in design — but not when those reductions come at significant cost to other aspects of the system or development timeline. We are also strong believers in including considerations for manufacturability, serviceability and supply chain early in the design process. If you have to address these areas late in a development process, you’ll often find that you need to make serious compromises to meet schedule demands.

Advances in life sciences and technology can make the idea of miniaturized devices incredibly appealing. Reducing size can be a worthwhile goal, as long as it makes sense for your product goals. That’s why we recommend a slight shift in mind set — from “smaller is better” to “what’s the right size for this product?” Then you can push hard to get to market with your MVP, and give yourself the opportunity to include learnings from that process in your next-generation design — which you may want to drive to a smaller form factor (but only if it's worth it!).

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