Perspectives on Device Design—Part 1
How is the movement of healthcare out of the hospital and into patients’ homes impacting device design?
Vice President, Risk Management Services, Berkley Life Sciences LLC
Transitioning healthcare delivery from the hospital to home is a trend that is here to stay. It will have many implications. Some of these fall in the realm of product design. Firms will need to be more meticulous in designing products that can be easily used by lay people with no clinical background. The product design must include attention to simplifying instructions, eliminating steps and making the functioning if the device or equipment as user-friendly and “idiot proof” as possible. The design considerations must extend to the labels, warnings, package instructions and training. Since medical device firms cannot presume that the products will be used by clinically skilled individuals, the design emphasis will have to spotlight, more than ever concepts of simplicity, clarity, durability and (last but not least) safety.
VP of Vertical Markets, Avnet Electronics Marketing, Americas
Healthcare delivery in the home requires a very different approach in product design. It is important to take into account the fact that the majority of home healthcare devices will be used by non-medical professionals and to design accordingly. Equipment must be intuitive and easy-to-use right out of the box, while still providing the same levels of accuracy and reliability as those found at the doctor’s office. Recently, we have seen an increase in the rise of integrated touch sensor technology in designs, allowing for a much more user-friendly interface. This requires a sophisticated embedded operating system. Another design element that is crucial to home-use medical devices is the integrity and security of data. Results, data storage, and communications need to be automated and immune to corruption, as much as possible. To achieve this, designers have chosen to integrate reliable wireless communications protocols such as Zigbee and data protection in the form of radio-frequency identification (RFID).
Steven Dean, E.E.
Medical Market Lead, Americas, Freescale Semiconductor
Device design is now encompassing the ecosystem in support of the home environment, which enables telemedicine innovations in device interoperability, wireless connectivity, and soon, the employment of body sensor networks with certain levels of data security and data storage.
These end equipment sets include blood glucose meters, weight scales, blood pressure monitors, pulse oximeters, activity monitors, fall detectors, temperature monitors, heart rate monitors, or even electrocardiograms. All employ leading-edge semiconductor technologies, usually incorporating custom analog sensing circuits, microcontroller functions with sufficient low-power flex memory, and ultra low-power wireless communication functions, such as Zigbee wireless technology or proprietary protocols.
Connectivity is king, both wired and wireless. In moving healthcare to the home, interoperability is paramount so that patients and caregivers from afar can be assured of accurate and secure results. Freescale Semiconductor is a promoter member and leads two working groups within the Continua Health Alliance, which helps to ensure we have our finger on the pulse of appropriate interoperability standards. Common connectivity standards that are being designed for tomorrow’s consumer medical devices are USB, Bluetooth, and Zigbee wireless technologies.
Director, Product Development and Planning, Insight Product Development
This trend increases the complexity associated with device design because developers need to expand definitions of risk and solve for them successfully. Risk needs redefinition due to the increase in variety of intended users and use environments; these factors complicate existing design considerations as well as introduce new ones.
One current consideration that becomes increasingly complex is design for usability. Devices must now support users that are, relative to physicians and nurses, less skilled and experienced, and potentially less capable in physical and cognitive abilities. Interactions between device and user need to become more robust to mitigate new opportunities for human error and misuse. This challenge is exacerbated by the fact that devices will be used in environments far less regulated than traditional healthcare spaces.
Both of these factors introduce new pressures for devices to resonate with users on an emotional level; key to this is supporting personal lifestyles that vary significantly based on individual attitudes, beliefs, and preferences. In this sense, devices need to function more like consumer products in order to create strong connections with users that ultimately encourage adherence and brand loyalty, both drivers of market success.
Director for Business Development, Medical, Husky Injection Molding Systems
With ever increasing pressure on cost, the medical market is experiencing a rapid increase in self-administered healthcare. This dynamic, along with an increased pace of innovation and a convergence of minimally invasive procedures, are driving expansion in the home medical device market. These new products include everything from diagnostics to monitoring to treatment devices.
As a result of this demand, medical device manufacturers are seeing an increase in the number of new products coming to market in a wider variety of applications. Requirements of self-administered healthcare tend to drive an increase in the number of parts per application and a reduction in the overall size of the completed device. In addition to a reduction in overall device size, there is an increasing demand to reduce the time to market as competition for entry into this growing market has intensified. Many of these new devices are designed to be portable and easy to use. The final products incorporate a combination of advanced design, technical applications, and innovative packaging, which all lead to the need for very precise and repeatable manufacturing cells.