Recognizing the Benefits of Connected Medical Devices

From aging populations to an increase in costs to a growing demand for affordable and personalized care—the list could go on, but it’s clear the healthcare industry faces a slew of challenges right now. While these may seem like negatives, they have opened the door for a few positives. New, lower-cost technology has the opportunity to replace out-of-date and problem-prone medical devices while improving quality and cost of care. In fact, it’s estimated that each year $17 billion is spent on avoidable readmissions that could be solved simply through early intervention and better at-home care.
 
While cloud-connected healthcare is capable of solving these healthcare challenges, major barriers still exist that are keeping the industry from totally adopting, such as data privacy, cybersecurity, and cost concerns.
 
Data Privacy and Cybersecurity
With connected devices comes the major concern of privacy. Cybersecurity and data privacy are the biggest barriers as to why manufacturers aren’t adopting cloud-connected medical devices. To address these concerns, the FDA and other regulatory agencies have issued guidelines to manage cybersecurity risk. Additionally, if a manufacturer has streamlined security upgrades on devices, it doesn’t have to repeat the regulatory approval process. There is a downside, however—devices will still need to be re-tested and recertified to the FDA.
 
Cost and Manpower
Cost and knowledge are other concerns when adopting a connected solution. Many companies are asking, “Where is the money going to come from?” and “Who has the knowledge to develop and support a connected solution—it’s maintenance, storage, and operations?” Connectivity infrastructure is typically an extension of the medical device, and must meet the same design and operational requirements as the medical device itself. Additionally, there aren’t many people who have the specific skill set and knowledge to develop and support a connected solution that is compliant to FDA and other regulatory requirements.
 
Opportunities with Cloud Connectivity
It’s predicted that by 2021, the IoT healthcare industry will reach $136.8 billion worldwide. Cloud connectivity and the Internet of Medical Things (IoMT) are adding opportunity to this growing trend. In the cloud, information is processed and stored, and applications deliver the user interface. These cloud-connected devices can benefit both the patient and healthcare providers by providing data insight to personalize therapy sessions, detect device failures before they become more serious, and improve overall patient compliance.
 
Connectivity can do much more than analyze and track data—it can help improve and elevate efficiency of future devices, monitor the status of current devices, and even create new devices based upon new data-driven opportunities. Further, it not only benefits the patient, but the healthcare service companies, too. For example, a connected drug delivery device can automatically refill a patient’s prescription proactively from a pharmacy, reducing the risk of medication running out while helping companies meet business goals.
 
Additionally, connected medical devices could potentially help predict device failures. If, for example, a heart pump manufacturer changes lubricant suppliers for its pump bearings and there is a slight difference in the operating temperature, it could become a serious issue. A higher wear pattern due to the change of suppliers would typically go undetected until a larger bearing failure occurred. Predictive analytics can proactively identify any potential problems in the pump output by collecting device data, and before a catastrophic incident occurs, manufacturers and physicians are notified to take action, ultimately saving a patient’s life.
 
New forms of diagnostic services may be too resource intensive for a typical standalone medical device, but connected medical devices can track these and reduce the cost and ease of manufacturing overall. They can also provide in-home collection and diagnosis through portable devices. Data is typically collected centrally, allowing engineers and researchers to improve diagnostic algorithms over time. On top of that, machine learning techniques can comb through data to find new products or services through patterns.
 
With every big venture comes a price, and many companies are wondering how they can afford these devices. For reimbursement on medical devices, Medicare requires that patients must provide evidence of them actually using the device. A connected medical device can provide this proof point by tracking and storing data from patient use, and trace specific devices and treatments to identify which ones work best based on patient needs. Last, these devices can provide ease for software updates should a critical problem spark, making this an inexpensive and strategic solution.
 
Solutions
While there are many pros to a connected medical device, they do pose risk profiles through connectivity threats. But don’t worry—these risks can still be managed.
 
When considering a connected design, ask these questions:

• If data is erased or altered, what is the potential harm to the patient or operator?
• Does the data being stored or transmitted include protected health information?
• What are the potential risks of using a connected device? What are the risks of not using one?

 
In addition, consider these strategies:

• Develop best practices for cybersecurity and train your entire workforce.
• When accessing data, use appropriate security controls and enforce password management practices such as prohibiting the reuse of passwords as well as password strength and complexity.
• Choose the right level and type of encryption.
• Only store and transmit essential data to the operation of the device or service.
• Develop a post-market surveillance program to monitor for any new cybersecurity vulnerabilities or threats.
• Cybersecurity verification and frequent reviews of security controls should be included in verification.
• Periodically review known vulnerabilities against third-party libraries or with products focused on design or operation of the medical device.
• Build a list of cybersecurity procedures and guidelines.
• Identify, prioritize secure design, secure coding, and track cybersecurity risks throughout the product development and maintenance cycle.

 
Conclusion
Connected health is the future of healthcare. It not only provides diagnostic benefits and improves patient outcomes, but it can also automate alerts, monitor remotely, and potentially lower costs. It doesn’t stop there—connected health opens doors to new opportunities for data aggregation and analysis to improve existing devices and create new ones—improving lives one patient at a time.