A medical device developer in Southern California embarked on a search for help in the process of developing a diagnostic medical instrument. They visited product vendors, contract manufacturers, and integrators to develop a project approach and find a partner to help design and develop a prototype to meet their needs. They had primary ideas and goals for the medical instrument, but still needed to discuss how to implement the solution and the actual specifications.

Fig. 1 – Within each diagnostic medical prototype, Circaflex controls sensors and other components to assist in the delicate handling of patient samples.
During the initial planning phase, it was clear that even with the variety of design concepts and specifications from each contract manufacturer, one constant pattern was emerging as a large and expensive machine that might not provide the throughput desired. After narrowing down some options, a few vendors were asked to come up with a design prototype. The design team at Cyth Systems (San Diego, CA) was among the three selected. Before beginning the next design stage, the Cyth team analyzed the customer requirements and realized the most overwhelming factor affecting the design of the system was the throughput capability. Designing a smaller system with slightly lower throughput could meet the requirements just as much as a large system with high throughput, since the smaller design provided additional unanticipated benefits such as portability and less cost for production. With that design, hospitals or clinics could buy more machines and place them more conveniently, providing the patients and medical personnel with faster results.

Key Trends: Portability and Speed

Fig. 2 – Circaflex is a real-time control system that provides the portability, performance, and reliability customers need for rapid prototyping and product development.
One of the key components that made speed, size, and throughput possible was Cyth Systems' Circaflex, a real-time control system that measures about 4" × 4" in size. This system provided the flexibility to pick and choose I/O as needed, until all the necessary functions were operational. With the help of that flexibility and some late nights, the key functional subsystems were built into a benchtop demonstration and shown to the client almost one week after the project began. The design concept excited the client to the extent that they went to their executives immediately suggesting this idea would create a new unoccupied marketplace for them. The managers requested a demonstration at their next executive meeting, which was only nine days away. The proof-of-concept was rapidly assembled into a portable prototype and, after a successful demonstration, the executive team asked two questions: (1) How quickly could a fully functional prototype be made?; and (2) Could it be made even smaller?

Those two questions embody a key trend that Cyth Systems has noticed in medical OEM design cycles: a desire for smaller medical devices made on a rapid schedule. Consumer electronic devices are getting smaller and more portable even while growing more feature-rich. Medical device manufacturers are targeting products that provide the most ease, convenience, and accessibility. In fact, with growing pressure from small startups and entrepreneurs, a trend has developed that shows that the marketable lifetime of a product is dropping year after year since approximately 2005, signaling that new products with new features are entering the capital equipment buying cycle and pushing older designs off the market. At the same time, financial pressures are causing investors and business managers to be more risk-averse and drive toward results as soon as possible in an attempt to ensure that projects do not languish or fail.

The expected time to accomplish a diagnostic medical prototype is generally at least 16 months, yet the aforementioned client wanted to see a working prototype within three months. Customers often need their prototype built quickly for the following three reasons: to target an upcoming event, to quickly provide proof of concept, and to get the product to a hungry market and see financial results as soon as possible. This customer expressed the same need for those same reasons. The final product would be a medical instrument designed to identify the presence of bacteria or viruses in a fluid sample. It would be poised to replace much larger and more expensive laboratory machines up to ten times the size and five times the cost of this potential target design.