Is it any wonder why next-generation wireless medical devices, unlike what is shown here, are providing tremendous design opportunities.

A new era of consumer-driven medical products is underway that promises to change the way healthcare is administered. The Internet has empowered patients to better understand and map their own healthcare. Wearable medical devices for cardiac pacing, pain management, drug delivery, blood chemistry monitoring, and neurostimulation are readily available for use in hospitals and at home. Wireless standards that link patients to their medical practitioners will promote greater levels of protection and independence.

The success of these smaller, more precise, and easier-to-deploy next-generation wireless medical devices will rely on strategic human-centered design efforts conducted by highly integrated, multi-disciplinary teams. An example of this is found in a newly developed patient-monitoring system, for which DD Studio, Carlsbad, CA, supported user research, industrial design, and mechanical engineering.

Studies show that hospital patients suffer preventable adverse events that could result in prolonged, costly hospitalization, injury, or death. Precursors to an adverse event typically appear in the patient’s vital signs hours before the event actually occurs – but are often not detected. Detecting early signs of patient deterioration promotes rapid response and timely intervention to help avoid adverse events. In the vast majority of cases, clinicians check vital signs manually only once or twice per shift, and patients remain unmonitored in between. This is the standard of care for lower acute areas, where vital signs monitoring has not really changed over the last century.

At the other end of the spectrum are large, sophisticated instruments that can monitor every beat. They reside only in higher acuity areas because of their high cost and lack of mobility. New technologies in healthcare must add demonstrable value to achieve widespread adoption. Advantageous products improve caregiver efficiency, allowing them more time to treat patients. And heightened patient safety eases the cost burden for hospitals.

The imminent clinical need is to create a product that allows continuous monitoring of all vital signs for patients in any acuity setting, alerting the caregiver of patient deterioration without restricting the patient’s mobility. A product that promotes patient safety is always better for the patient, the caregiver, and the hospital.

Challenges involved with designing were many. As a “first,” it has no true predicate or reference. Although the platform represents a breakthrough in monitoring technology, the system configuration was initially undefined. The program commenced with design research eliciting insights from product users to define and refine the evolving specifications. To optimize user experience, both nurse and patient were considered primary users - each presenting a unique set of requirements.

Despite a radical departure in technology, nurses demand a system that conforms to their current practices. To promote widespread adoption, it is essential to create a product tied to familiar customs and habits. Open forums and roundtable discussions put concepts and physical mock-ups into the hands of clinicians. The approach empowered product users to become part of the solution by sharing their experiences and ideas, and helped result in a product that combines rapid deployment with precision placement.

Delivering the optimal patient experience means addressing key psychological underpinnings of product use. The product must be perceived by patients as a ‘guardian angel’ rather than as a restriction. Because it may be worn for several days, patient comfort is an obvious requirement. System components must be optimally distributed, reducing concentrated mass and promoting full range of motion. The design team wore mock-ups for multiple days while performing ambulatory routines. By reaching a level of genuine empathy, comfort was addressed as a primary consideration.

Extreme performance requirements demand the utmost in usability, advanced materials, and heightened validation processes. It also requires the determined collaboration of multiple parties involved at early stages and throughout the development. The hospital environment can be relentlessly harsh and unforgiving. Products within this space are constantly abused and become repeatedly subjected to extreme conditions. Failure is completely unacceptable in any circumstance, as the slightest malfunction or inadequacy becomes a matter of life and death.

Selected materials must tolerate exposure to commonly used cleaning agents including CIDEX, hydrogen peroxide, chlorine bleach, isopropyl alcohol. Chemical resistance precludes the use of many thermoformed plastics. Commonly used plastics, including PC (polycarbonate), face difficulty on the issues of contamination and cleaning, as they cannot withstand repeated exposure to these common disinfectants.  PCT (polycyclohexylenedimethylene trephthalate) and PET (polyethylene terephthalate) lack the capacity for molding thin-to-thick wall sections.

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