Rapid Prototyping Helps Medical OEMs Sprint to Portability

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.

Benefits of a Smaller Prototype

Fig. 3 – The real-time control system and modular design of Circaflex allowed the ease and flexibility needed to build a portable medical device prototype within the exceptional speed of just 21 days.

One benefit to the smaller prototype is that it helps doctors gain accessibility and faster lab results. For example, if a patient needs to undergo surgery, but the hospital needs test results to approve the surgery, a bedside result is preferable to sending samples to a lab elsewhere in the building or in an adjoining facility. In the case of high volumes of patients or large distance from a laboratory (like in a remote clinic or disaster situation), the portable solution provides instant results. This magnitude of improvement in speed allows patients to get treated faster, which means more lives are improved and potentially saved.

Meticulously selected sensors and control components integrated together to form a simple and reliable prototype that could perform the main requirements. The control system (designed specifically for rapid prototyping) provided the ability to read and control a wide variety of control components as they were selected and installed with no modifications to electrical circuitry and simple changes in software programming. This included advanced features such as pneumatics, transducers, buttons and safety switches, and the ability to calibrate the system or perform retests. Design verification testing exposed some improvements, and after three prototype iterations spanning a total of 12 weeks, the product was ready for pilot testing. The final design was submitted for validation in a matter of five months, after which the device had been certified for production. By initial estimates, the design plan and throughput targets will save $4 million during the first production phase of only 300 units, and has given the client access to serve customers in a better way than originally imagined.

Conclusion

Most customer projects involve a customer who has an idea of how the medical product should be or the general tasks the product will accomplish. This medical device company partnered with an integrator and dug deeper during the prototyping process to discover the best approach to not only their design but their specifications and the needs of the target marketplace. There are large benefits of having a dedicated team who can dissect the prototype requirements and envision even greater profits for its customer than planned. Being familiar with the latest trends in medical devices and being prepared to create according to those trends proved extremely successful in this example.

This article was written by Candice Garcia, Marketing Engineer for Cyth Systems (San Diego, CA). For more information, visit http://www.info.hotims.com/40431-161 .