Medical Devices Can Learn From Mobile

 January 17, 2012, Medical Electronic Device Solutions Conference, Santa Clara, CA—Alan Boucher from Care Innovations, an Intel-GE joint venture, opened the conference with the question, what can medical device technology learn form the mobile revolution? The wireless world is growing and driving the scaling of technology across all mobile platforms. These devices expose consumers to easy-to-use interfaces and apps.

Care Innovations is focused on developing devices that make it possible for people to live independently. This drives the designs to be user centered with emphasis on platforms, mobile devices, and the integration of sensors. The systems are moving down into the device level to target wellness functions.

To date, their products feature network connectivity and are platforms for various sensors. The focus is on the individual who can access devices and content where convenient to his/her lifestyle. The driver is to move people from the high-cost, institutional environment to the much lower cost home environment where users can be more comfortable and have a better quality of life.

For elderly users, the design goals are to make the technology simple to use and provide some level of comfort. We are seeing dramatic and significant changes in the makeup of the population. Now, 59 percent of seniors, the people over 65, are working people. For the prime working age groups of 30-49 it’s 84 percent and now 49 percent of those in the 50-64 age group are working.

The challenge is that seniors are a very diverse group. Some have issues with vision, others with handling novelty and complexity, and a few are very up to date. Currently, 20 percent of the seniors have wireless Internet access. As a result, designers have to consider form factors and user interfaces in product design. The latest 7-inch tablets are a good choice for an integrated medical device with mobile capabilities.

The consumer is now making more decisions about healthcare, and moving away from the traditional health organizations and insurers. As a result, product definitions have to be appropriate for a sub-class of users and adapt the interfaces and user experience to address technophobia. New devices have to connect to other platforms and apps. The industry needs to have standards to reduce proprietary formats and data types.

At the same time, people are managing more of their own health issues, but not on a tethered device. They connect everywhere and anywhere. Unfortunately, many medical wellness devices have to work on POTS (plain old telephone service) as the fallback from wireless and cellular data networks.

Medical and mobile devices have widely differing rates of change. Mobile devices are consumer electronic products with extremely high rates of change and very short product lifetimes. Consumer product expectations are driven by lifestyle, rather than absolute functionality, but the wellness market may have requirements for functionality for a decade, and health monitoring would be even longer.

To address these groups and their needs, companies need tools to translate knowledge into technical ideas. User-centered design must evaluate new usage models and evolving technology platforms. In addition, the designer needs to have ethnographic field work to validate the assumptions and use cases.

Once a concept is defined, the developer has to adapt workflows to operate in the volatile mobile space, which is very unlike the fixed embedded products. Some tools are needed to assess the existing situations. Then you have to understand the users and prioritize those mobile features that matter to the target audience. At the same time you have to minimize the function to make it simple to use.

Making a new wellness product requires starting off designing with mobile in mind. The best way to get to a useable product is to prototype, evaluate with users, revise and iterate. Repeating the loop as quickly as possible refines the product to its final configuration in the least time.

When you use the smart phone as a platform for a health and wellness device, you have to choose from a number of options. Starting at the OS level, creating a native app allows full use of all the device’s capabilities at the cost of difficulty in migrating to another platform. The native core functions are available for off-line operations under the apps and will be distributed by a third party app store. Developing an app allows direct use of integrated functions and APIs.

A hybrid approach puts a wrapper around the base code and allows fairly simple replacement of wrappers to change OSs. The loss is in not being able to use all the integrated sensors and peripherals to their full capacity. Finally, a new option is coming out. Because the smart phone and tablets are able to access content through a browser, you could write the app for the mobile web. Standard languages like HTML5, CSS3 and Javascript are OS agnostic and often provide at least partial access to the sensors and the underlying processing capabilities.

Underlying all of these partitions is the need for useful standards. The existing networks have high-speed data and additional compute and storage capacity in the cloud and through cloud services. Building on a standard platform like an iPhone exposes the subsystems for development. The built-in capabilities like WiFi, Bluetooth, and near field communications can transfer data from the sensors to an external analysis engine and also be are alarm unit when readings are out of limits.

It is best to write the appps for a standard platform, but always consider the FDA issues. Quality assurance systems and documentation are key to getting approvals in reasonably short timeframes. Also, take into account the differing rates of change in the underlying platform and the app. Clinical equipment for consumers requires design controls to address the product and the needs to fit into the rules and regulations of the industry.

The differences are not only in the base platforms, but also are regional. Adoption models and regulatory oversight differ from country to country. Designs must consider the differing product lifetimes and support of mobile versus healthcare apps. Developers have to plan for notifications and support for decades.

Because the mobile devices are changing rapidly, integrating a healthcare app into a mobile device requires careful supplier management, and systems hardware and software that is architected for validation and integrated testing. A strong quality management system is essential to long-term success as long as the product is easy to use and connects to other systems.