Panel discussion: Designing portable medical devices that emulate today's consumer devices - with added security

Balancing the scales of security and usability is the focus of industry experts concerned with building the next generation of portable medical devices.

2Editor’s note: Portable devices are a top focus in the small form factor embedded scene. Medical devices lead the portable design revolution, taking patient care out of traditional clinical settings and into the home and remote settings. When we asked a group of panelists about the present and future of mobile devices, medical was at the forefront of their minds. They discussed the challenges of combining the “iPhone factor” of user-friendly design with stringent security requirements and regulations, choosing platforms, and others that stand in the way of the next-generation of devices they’re trying to develop. Edited excerpts follow.

Figure 1: Portable medical device panel.
(Click graphic to zoom by 1.9x)

SFF: Portable medical devices have come a long way in the last few years. What impresses you about the current state of technology in these types of devices?

TABORN: The cell phone market, among others, is driving cost, size, power, and ease of use improvements and possibilities into all application areas, which in medical modalities are quickly being implemented to improve patient outcomes. The handheld ultrasound and its battery life is a great example. The most impressive impact on medical devices is the better focus on user experience. This will directly improve patient care by decreasing the error rate of the applications and evaluation of the data.

McCRACKEN: Out of nowhere, Android has emerged with the potential to become a dominant platform for portable embedded computing devices in the not-so-distant future. Chip-scale integration and improvements in battery technologies accompany the demand for standardized software application platforms. Finally, the performance of ARM SoCs has increased (up to Gigahertz dual core), while Intel has lowered its entry-level ultra-mobile processors to fit within size and power envelopes in order to compete for these coveted high-volume applications.

CHUNG: The projective capacitive multi-touch screen has become one of the hottest topics within this segment, but requires application software development to showcase its values. Also, energy efficiency has always been a key focal point for portable devices, and the rise of RISC-based solutions has helped to further energy savings.

Additionally, the different types of connectivity including Wi-Fi, Bluetooth, and 3.5G/4G wireless that are now readily built into portable medical devices permit easy access of electronic medical record databases or the future medical cloud in any location equipped with wireless signal reception.

MUNCH: The acceptance of x86 and Windows into a market that has traditionally relied on custom hardware and software solutions is impressive. We see Windows as the primary user interface tied to FPGAs performing data crunching in many medical applications. There is also an increasing desire to use standard building-block products like COM Express CPU modules to allow the product design to be focused on its core competency, which is increasingly software.

SFF: What design challenges are engineers currently facing in medical device development?

McCRACKEN: One key task facing engineers is platform selection. Everything from design environment and development tools to production royalties to product updating in the field hangs in the balance. Android is optimized for ARM at the moment, while other Linux platforms and Windows Embedded Compact run well on ARM and x86/Intel architectures alike. Additionally, time-to-market pressures are becoming as critical for FDA and other regulatory-based markets as they are for commercial and consumer markets where the winners take all. To that end, the richness and completeness of a product offering’s “out-of-the-box” functionality translates directly to competitive advantage. SBCs and COMs need to be ready as close as possible to the silicon launch (mass production).

MUNCH: There has been a significant increase in the speed of signals in today’s designs, resulting in the need to use expensive and complicated simulation tools to verify signal integrity. Waiting until a design is fabricated to check and catch signal integrity issues can impact launch schedules and development costs. Even when using module building blocks the design still needs to deal with high-speed interfaces such as PCI Express, SATA, and now USB 3.0 SuperSpeed.

TABORN: Of the many challenges engineers face, designers must first consider security since virtually all medical devices in the future will be connected to some type of network. Second, there are new demands for “ease of use” that are fostered by what many in the industry call the “iPhone factor.”

CHUNG: Medical customers see features like low cost, long battery life, light weight, slim design, and new technologies that are currently seen in consumer products, and expect to see these elements implemented in portable medical products, but medical devices do not yet have these features.

SFF: Where do you expect medical devices to go in the future?

CHUNG: Eventually portable medical devices will be used in the same sense that we use smartphones and tablets in our daily lives, but within a more secure network and with mechanisms to permit/deny access to sensitive patient data. Not only the patients but the physicians and healthcare administrators will benefit significantly from this development.

From a hardware perspective, lighter and thinner is always the trend. On a system level, portable medical devices have different market segments, such as general hospital/clinical administration usage that may require building a whole infrastructure, or portable diagnostic devices for ultrasound, ECG, and blood pressure monitoring that require joint system design with customers.

McCRACKEN: Someday, the portable subset of embedded devices will be nearly as ubiquitous as their consumer counterparts, relatively speaking. Whether in the form of sensors or medical patient monitors, these products will proliferate based upon consolidated, standardized ultra-mobile platforms much the way the original DOS + x86 embedded computers did. In some cases with dual- or multicore systems, the second processor core will be devoted to the deterministic and real-time aspects of the device, such as taking measurements.

TABORN: These devices will be far more flexible and extensible in the future. One of the best things to happen to medical is the advent of the iPhone. This demonstrated to the world that a small device could be intuitive and very efficient. This will cause device manufactures to address the areas of ease of use and human workflow, reducing human error and encouraging operation and use cases in non-traditional settings – improving patient care throughout the world.

SFF: What does the industry need to get to the next generation of medical portable mobile devices?

MUNCH: Continuing to drive down total power consumption would be a good start, and achieving this will just take time. This results in two benefits: an increase in battery life (or a smaller battery to reduce weight) and reduction in power that needs to be dissipated.

CHUNG: The prospect of wireless battery charging would be one technology that would help these applications realize their true potential for power-efficiency and application usage.

Additionally, comprehensive infrastructure, regulations, and mobile healthcare protocols will be key to these devices’ future. This will allow medical computing manufacturers the ability to develop portable/mobile medical-specific devices and applications that can be implemented within the same network, making the future medical cloud ecosystem possible.

TABORN: The ability to implement future security policies must be considered in today’s devices. This suggests having the “headroom” in the design shipped today to be able to implement more complex policies in the future. Unlike most devices, medical devices in clinical and hospital settings are unique in that they can be in service for 10-to-15 years. For consumer-geared medical mobile devices, we will have to ensure that the applications data acquired can be just as safe and reliable as data acquired in the clinical setting (given the various different circumstances). Multicore solutions are becoming readily available in both Intel and ARM architecture families. This topology choice will allow developers to address these unique application requirements for today with the necessary performance headroom to support the ever-changing security landscape.

McCRACKEN: Better hardware standards are needed in order to “cross the chasm.” Some existing standards like Qseven have been reasonably architecture-independent. However, there are now so many single-vendor-driven x86 and (especially) ARM module and interface standards that have been prevented from reaching critical mass in this industry. A casual stroll down the halls of Embedded World in Germany reveals that a massive shake-out will be needed; otherwise system manufacturers will be left squandering time-to-market and development budgets in taking the full custom path. Standards organizations have been portrayed as slow-moving and political, leading some suppliers to go it alone. Any standards groups that can set aside self-interests and become more responsive to customers and end users will have a major leg up in leading the consolidation that is needed to facilitate the next wave of medical portable devices.