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Internet of Things

Using the 5Ds of IoT for medical devices

January 03, 2017

I’m a fan of frameworks or techniques that help people understand our complex environment and reduce risk.

For example, there’s Michael Porter’s Five Forces model, Failure Mode and Effects Analyses, Monte Carlo simulations and many others that facilitate decision making. As the acronym IoT (Internet of Things) becomes as ubiquitous as WTF, it behooves any professional working with connected medical devices to get acquainted with an evolving landscape that can easily derail any honorable effort to improve patient outcomes.

I’ve found the 5Ds of IoT to be a useful model in classifying the myriad of topics and questions that need to be addressed to succeed in this space. They can also serve as a guidepost for smart industrial and consumer products. The 5Ds are Decision, Devices, Data, Design and Deployment.

Decision

“What outcome is my company seeking to improve with this new technology?” should be the starting block for any connected device development endeavor.

At the recent BioMEDevice conference in San Jose, Dan Pettus, BD/Carefusion VP of Connectivity and IT, discussed how his company came to embrace connectivity for their CareFusion Alaris PC pump after recognizing the enormity of issues affecting the delivery of infusion therapy. For example, it typically takes over 30 steps to get medication to a patient. Infusion-associated adverse drug events add more than $2 billion to annual healthcare costs. And 93 percent of nursing staff said they strongly agreed about the importance of having the right data in patient management. Those are pretty compelling reasons to move in a new direction. When considering connecting a medical device, you need to start with the size of the problem you’re trying to solve and weigh the trade-offs.

“Connected health is not for the faint of heart,” Pettus said.

Thanks to the interoperability of their Alaris pump with Electronic Health Records (EHR), the nurse has to only scan the bar code on the patient’s wrist then scan the Alaris pump. The pump automatically programs the settings, which saves about 30 keystrokes. More importantly, it reduces data entry errors. In addition, because insurers are demanding more accurate data for reimbursement, a 400-bed hospital that can produce evidence of when procedures start and stop can recoup about $1 million.

While figuring out the benefit may not be as straightforward, it’s imperative that organizations spend time collecting evidence — costs, time, errors, steps, etc. — so they have a benchmark to work against. In her BioMEDevice talk, Stephanie Kute, Manager of Advanced Analytics and Health Research at Batelle, offered a few standard metrics worth considering:

1) AHRQ Quality Indicators, which are provided by the Department of Health and Human Services and regularly used for reimbursement practices, include:

  • Hospital-based metrics such as inpatient mortality and utilization of procedures
  • Patient safety indicators (PSI) that focus on potentially avoidable complications and errors such as pressure ulcers or foreign objects left in patients after surgery
  • Outpatient-based metrics, such as Prevention Quality Indicators for chronic diseases like diabetes, heart failure and asthma that can help providers keep patients out of the hospital.

2) Patient Experience and Engagement Metrics

  • Patient experience is collected by a survey known as HCAHPS (Hospital Consumer Assessment of Healthcare Provider and Systems)
  • The Patient Activation Measure (PAM) measures patient engagement and education.

3) Cost of Care

  • The National Quality Forum endorses the PMPM index, which would be the total cost of care, population-based, per member per month. An example would be hospital-level, risk-standardized payment associated with a 30-day episode-of-care for heart failure.

The decision to pursue a connected device project has to be strategically supported form the top to succeed.

Devices

As mentioned above, interoperability is a critical aspect in this landscape and it refers to how your devices play with other devices. According to George Panagiotopoulos, Senior Clinical Tech Manager at Kaiser Permanente, there are about “700 different types of medical devices in a hospital used at any point in time.” Since your device is likely to depend on another to deliver data at the right time for the right patient, the synchronization of connectivity cannot fail. So what interoperability requirements should you consider? Here are some requirements offered by Pettus of BD/Carefusion:

  • Cyber-security. Security is a journey, not a one-time event. You need constantly monitor security issue to stay on top of them.
  • Fast connect and roaming. Most hospitals are in 802.11, which is “great for Starbucks,” but since these are mobile devices they have to connect during transportation — down hallways, up elevators, in different rooms, etc.
  • Store and forward. Given the above, your device may not necessarily need to be optimized for synch capability. ‘Store and forward’ may be sufficient.
  • Availability and integration. The Integrating the Healthcare Enterprise – Patient Care Device (PCD) domain addresses the integration of medical devices into the healthcare enterprise such that information from vital signs, physiological monitors, ventilators, infusion pumps, and anesthesia workstations could be exchanged and alerts could be managed. See this link for more info.

Also, let’s not forget that medical devices are heavily regulated, not only by FDA regulations but also by HIPAA and BAA requirements. This brings a host of other considerations such as encryption, hosting capabilities and patch management. So finding the right partner to help you navigate those intricacies is important.

Data

At the end of the day, it’s the data that will inform your progress toward better patient outcomes. Having a good understanding of the type, access, processing, analytics, storage, security and privacy of data is critical.

The key challenge, however, is how to effectively use data to motivate patients to adhere to their treatments when there are countless barriers — ease of use, cost, procrastination — that get in the way.

“What outcome is my company seeking to improve with this new technology?” should be the starting block for any connected device development endeavor.

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