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Putting market application up-front when developing clinical diagnostic devices

By Mike Dunkley and Mark West The field of diagnostic testing is going through a […]

By Mike Dunkley and Mark West

The field of diagnostic testing is going through a quiet revolution. Healthcare reform’s emphasis on results-driven medicine has put a greater urgency on early and accurate diagnosis. At the same time, advances in technology are leading to new breakthroughs in research almost daily, increasing the opportunities for new clinical devices.

The reality, however, is that most of these new technologies fall by the wayside before they get to market. That’s because the way they are designed has not kept up with the times in order to meet the market’s demands for fast time-to-result, ease of use, and high degree of reliability.

Too often with new clinical diagnostic devices, biological assay and instrument are developed sequentially: first the R&D group develops an effective protocol for sample prep and biomarker detection, then Product Development designs a device or system to implement it. For lack of a better solution, the design often just automates what researchers in the lab were doing by hand and the device takes the form of a huge, bulky piece of equipment employing fluid-handling robots – often, not the most optimal solution for the actual environment of use.

A researcher’s primary objective may be to advance scientific understanding or to perfect the assay performance, while engineers may be pre-occupied with automation and regulatory compliance. The knowledge-gap between the two groups may simply be too big for one group to anticipate or question the requirements of the other and the lack of alignment of goals may not steer the development effectively. In order to get scientists and engineers working towards a common objective, it is necessary to bring in a third discipline – design – to establish the vision for the ideal product early in the process.

At Continuum, we call that ideal user experience the “lighthouse” — and make it the ultimate goal when we develop a diagnostic tool for a clinical setting. It’s important to define the long-term goal so you can think through the implications of your decisions early on in the process of development of the technology—ideally after you establish ‘proof of principle’ in the lab, but before you lock in any key architectural decisions. As the scientists in the lab meet the key forks in the road where they must make decisions on how to implement their assay, they can take into account the ideal experience of users in a clinical setting.

That development requires an understanding of several key factors, including where device will be used, the skill of the users, the time necessary for results, and the cost of the test. At the same time, the ideal experience represented by the “lighthouse” must be balanced by what is technically feasible. Depending on these factors, there must be a creative give-and-take that might sacrifice accuracy, portability, or up-front cost depending on the most successful solution for usability.

For example, when we worked with Daktari to create an HIV test for use primarily in rural sub-Saharan Africa, it was clear that fluorescent detection of CD4 cells was not suitable. Sensitive optics would never be rugged enough to survive transport in a backpack to remote villages. Instead, Daktari needed a solution that could be used at point of care by a relatively inexperienced clinician in sometimes difficult environments with high heat and humidity. Daktari understood that electrical detection of CD4 cells had the inherent robustness required for its intended application. Continuum engineers and designers used this robustness “lighthouse” to make smart architectural decisions for the device early on in the development of the assay – the result was a simple hand-held instrument with a unique disposable cartridge.

A similar process took place with the OraQuick rapid HIV test, which was approved for home use last year. To create a test that could be used quickly and easily in home by unskilled users, the parent company OraSure Technologies sacrificed some technical performance. It got to market because it successfully convinced the FDA that this solution was better than the “gold standard” because it would be used by people who would ordinarily not get tested at all, therefore increasing the number of people who could be diagnosed and treated, leading to a greater benefit to public health as a whole.

On the opposite end of the spectrum, we worked with Raindance Technologies to develop the RainDrop digital PCR (polymerase chain reaction) system for use in cancer research, knowing that sensitivity at one-in-a-million levels of detection would be paramount. In this case our “lighthouse” was to produce a dramatically simpler and more reliable instrument without sacrificing performance. R&D and product development teams collaborated to simplify complex flow controls by putting more technological features into the consumable cartridge that contained the sample. This eliminated pipetting robots and tubes, creating a streamlined bench-top device that could be more accessible to cancer research labs worldwide.

As these examples show, while it may be expedient to treat R&D and product development as sequential steps, superior products can result from a collaborative approach guided by a clear view of market needs. The solutions that win are those where the technology is a good fit to the eventual application. That means establishing a “lighthouse” early in the process to guide researchers, designers and engineers toward a common vision of the ideal product.

Mark West is a principal at Continuum, a global innovation and design consultancy, where he specializes in electro-mechanical product design and development with specific expertise in robotics, precision machine design, clinical diagnostics and life-science instrumentation.

Mike Dunkley is vice president of program development for Continuum Advanced Systems, where he is responsible for building successful client engagements in the design and development of medical devices, connected health applications, clinical diagnostics and life sciences instrumentation.


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