Leveraging Wireless Connectivity in Medical Device Development
May 1, 2015 - Dirk Smith, Co-founder
Essential considerations for more valuable connectivity.
The world is experiencing an explosion of connected electronic devices with the term “Internet of Things” (IOT) becoming commonly recognized by businesses and consumers. An estimated 10 billion devices, including electronic equipment and more than 1 billion smart phones, can be accessed via the internet. Medical devices are no exception to the connectivity trend, rapidly joining the IOT network. In the midst of this technology expansion, perhaps the most critical challenge today for medical device manufacturers is not how to connect, but more importantly, for what purpose. While there is an undeniable “cool factor”, it is important that medical device companies consider how to best take advantage of connectivity in their products and for their patients, and then work toward efficient and effective implementation of the technology.
While wireless connectivity is relatively new, the medical device community has a long history of pursuing networked devices. The goal has been to link devices to hospital information systems (HIS) and electronic medical records (EMR) to support patient care and hospital logistics. Until recently, these efforts have arguably struggled due to challenges with standardization and technology implementation across a diverse range of health care devices, systems and environments. As wireless and connectivity technologies become more readily accessible and cost effective, medical device connectivity appears on the verge of becoming a valuable and expected component of medical devices and hospital information systems.
Often when medical device professionals think of connectivity, the applications that come to mind are EMR, connecting to HIS and mobile health and wellness aids. These applications can be quite valuable and in the long term have significant impact on patients and the health care system. However, many sometimes overlooked “workhorse” opportunities also exist for connected medical devices. A recent Forbes.com article titled 3 Ways the Internet of Things is Revolutionizing Healthcare 1 described three major impact areas for connectivity:
- Reduction in device downtime through remote monitoring and support
- Proactive fulfillment by replenishing supplies before they are needed
- Efficient scheduling by leveraging utilization to serve more patients
None of these areas involve high profile EMR, HIS or wellness monitoring applications; however, each is an example of using connectivity within medical devices to positively impact the health care system and patients.
As with any new technology or product feature, it is important to consider how connectivity can enable better outcomes at a reduced cost for patients, providers and the healthcare systems. At Minnetronix, we have developed a flexible connectivity platform that provides a framework for remote connectivity to devices in hospitals, clinics and in the home. Working with customers, we are exploring and developing systems that address a number of unique unmet needs, including some of the following examples:
- Sales force fleet management tracking
- Proactive maintenance and repair support for complex systems
- Real time inventory management for disposables
- Patient compliance tracking to support insurance reimbursement
- Location identification for capital equipment control
- Device and disposables monitoring to ensure compliant use scenarios
- Pay-per use and automated billing
- Outcomes tracking for clinical trial
- Long-term data collection for therapy optimization
Defining and vetting opportunities unique to a specific device are critical first steps in implementing connectivity solutions. Exploring opportunities that have a measurable impact on patient and provider outcomes is an important exercise, considering how access to device information can solve existing problems, improve efficiency and effectives of a therapy and/or provide long term improvements to a broader patient population. Additionally, it is important to analyze the significance of the unmet need, the financial viability of the connectivity business model and the high-level business and technical risks (security, compliance, technology evolution, etc.).
Once a valuable connectivity application and business model are defined, remaining commercialization steps involve development, scale-up and support. Developing a connectivity solution relies on the fundamentals of good design practices; from user needs definition and requirements development through design, verification and validation. It is particularly important to understand requirements and safety risks unique to medical device connectivity (e.g. cybersecurity, coexistence with other devices, compromised service, faulty data, etc.) as a foundation for an effective design. Understanding the additional licensing and compliance standards associated with wireless communications is critical. Additionally, understanding and taking advantage of available technology and expertise in wireless communications and cloud-based data storage and information processing is important. (A list of useful guidance and reference documents that can aid developers with connectivity applications is available at the end of the paper.)
Connectivity in medical devices is clearly a rapidly evolving field and will be a key component of nearly all electronic devices within the next ten years. Effective use of the technology however often remains a challenge. Device developers can benefit by seeking value generating, problem solving uses for connectivity focusing on improving patient, provider and healthcare system outcomes. With outcomes-based applications identified, effective implementation then relies on combining solid medical device development fundamentals with state-of-the-art technology and technical expertise in wireless and connectivity technology. The end goal should be to provide more than just “cool technology” by developing meaningful and valuable solutions to patient and healthcare system needs.
Guidance and Reference Documents:
- Radio Frequency Wireless Technology in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Document issued on: August 14, 2013.
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Document issued on: October 2, 2014.
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. Draft Guidance for Industry and Food and Drug Administration Staff. Document issued on: June 20, 2014.
- ISO/TR 21730:2005. Health informatics – Use of Mobile Wireless Communication and Computing Technology in Healthcare Facilities.
- IEC 62209-2 Human Exposure to Radio Frequency Fields From Hand-Held and Body Mounted Wireless Communication Devices – Human Models, Instrumentation, and Procedures. March 30, 2010.
- Isaacs, Charlie. 3 Ways the Internet of Things is Revolutionizing Healthcare; 2014. https://www.forbes.com/sites/salesforce/2014/09/03/nternet-things-revolutionizing-health-care/. Accessed December, 2014