The Centers for Disease Control and Prevention reported that, in 2005, 133 million Americans suffered from at least one chronic disease. The magnitude of the effect of chronic diseases on society, both in terms of cost and quality of life, is often more than a statistic, affecting nearly all of us personally. The challenge to the healthcare industry is to find cost-effective ways to manage and treat chronic diseases and to deliver these solutions to all members of society by leveraging secure connected medical devices.
Medical science has excelled in the effective treatment of acute or infectious diseases, but now society must focus on the challenges associated with the management and treatment of chronic diseases, and how to leverage advanced technology to help address and simplify a complex problem.
The use of technology can overcome many of the challenges in effectively addressing chronic disease. E-readers provide current context-specific and patient-oriented information. Even patients with “Ease of Access” issues, such as poor vision or hearing, can leverage the technology already built into these devices to make communication easier. Portable, secure connected at-home medical devices allow remote monitoring and management of complex interventions without the cost of an office visit. Standardized electronic medical records allow multiple providers to share a common definition of medical information. (See Figure 1) These devices leverage secure, modern, high-speed broadband communication protocols to allow realtime updates between the patient and multiple health care providers.
Technology used for the management and care of chronic disease is intended to be a sort of surrogate for the practitioner; it is used in lieu of a direct face-toface meeting and extends the reach of the practitioner or care team. This technology must, therefore, meet the same level of trust we give to medical professionals, or it will fail in its mission to provide effective and efficient care. The trustworthiness of a medical device is the key to success, and security is essential in the implementation of a trusted device. Human lives depend on the security of medical device technology.
Software is Key
Software can make a difference by providing the connectivity middleware needed to leverage IT technology, allowing healthcare professionals to share information and lower the cost of doing business. Interoperability hinges on the ability to network medical devices, allowing for economy of scale as well as the team collaboration needed for chronic disease care. But, by connecting these devices to the Internet, we make them vulnerable to the same security threats that we see every day on our own PCs. Medical devices must be developed with a plan for managing the risk associated with connecting to modern high-speed broadband communication protocols.
The right software platform and the right development tools, along with a specific plan for addressing security risks, can deliver a solid foundation to meet these challenges—on time and on budget. Implementing functionality in software allows lower life-cycle costs as well as the re-deployment of devices to take advantage of advances in technology and address future security vulnerabilities, essentially future-proofing the device.
Medical device security is a fairly new concern and includes both securing the information on the device and authenticating the identity of the user. Faced with these new challenges, here are three specific steps medical device manufacturers can take to leverage the power of modern embedded software solutions to increase medical device security, reduce cost and complexity, and derive new sources of competitive advantage.
Consolidate Using Multi-Core and Embedded Virtualization
The latest multi-core processors significantly boost overall performance and increase performance-per-watt over single-core processors. They also improve application scalability and protect software investments by allowing processors with more cores to be substituted to meet future demand. Using the latest multi-core architectures, suppliers are now able to combine multiple operating systems on a single, secure consolidation platform.
Beyond additional processor cores, many new hardware architectures include hardware assist technologies that implement security features, such as a Trusted Platform Modules. These security features provide a high level of trust and allow for secure software updates, efficient authentication protocols, and the implementation of effective white listing schemes.
Embedded virtualization, another important concept in consolidation, provides the ability to run multiple operating environments separately from each other on the same physical device. For example, it is possible to run a real-time operating system such as Wind River’s VxWorks® and a general-purpose operating system, such as Linux, on the same device. This separation or partitioning makes resource allocation far more flexible. Embedded virtualization can also assist with implementing data separation to enforce privacy policies, allowing physical data separation of sensitive private information.
Together, multi-core processors and embedded virtualization allow medical device manufacturers to consolidate more functionality onto fewer physical systems, cut cost and complexity, and keep the focus on meeting the requirements to provide new treatment protocols for chronic diseases.
Standardize on Open Platforms
With the increased focus on embedded software, the ability to standardize hardware platforms has become a key consideration for medical device manufacturers. But, consolidation is occurring throughout system. Device manufacturers are now counting on software to provide an overall environment for security and connectivity—so although they are in a position to consolidate functionality themselves, they also need a lot of support at the software layer. Companies are looking to partner with experts in security to support them by providing embedded software solutions. By providing development tools, embedded testing infrastructure, simulation environments, operating systems, protocol stacks, services, support, and training, software companies can allow device manufacturers to adapt and integrate advances in technology on a standard platform, further lowering the cost and improving the functionality of the medical device.
Build on a Foundation that Can Support Change
It is important to build on a framework that can support comprehensive requirements and keep pace with advancements in technology. A flexible, agile software platform will make it possible to take advantage of new technologies as they emerge without sacrificing previous investments. Medical devices intended for the care of chronic diseases will likely be deployed in remote locations outside of traditional health care facilities. For the device to be cost-effective over its life cycle, it must have the flexibility to incorporate new emerging technologies and to address new security threats. Building to a standard open platform with a plan for life cycle support—including security—will meet the demand for costeffective chronic care medical devices that deliver a high level of care now and in the future.
It can be done. Today’s embedded software technologies are fully capable of cutting the cost and complexity of secure and trusted medical devices. The tools to get the job done are in front of you. Now it is up to you to get the job done.
This article was written by Jeff Fortin, a director of field engineering managing the field engineering group for medical and industrial accounts at Wind River, Alameda, CA, a wholly owned subsidiary of Intel Corporation. Wind River has pioneered computing inside embedded devices since 1981 and its technology is found in more than 1 billion products. For more information, visit http://info.hotims.com/45601-164.