Matt Lavin…

Medical device manufacturers have developed a variety of cutting-edge products that do an excellent job of monitoring and collecting patient data. These devices can collect a variety of data, sometimes continuously, and oftentimes in large amounts. Despite this wealth of incoming information, medical device companies are not fully utilizing the data their devices are generating. This information offers great potential, and device manufacturers are missing out on key opportunities.

There are three main ways that medical device manufacturers can extract more value from generated data, depending on the device.

1.  Give the patient data to clinicians.

Clinicians can derive great benefits from having access to this data. The clinicians can use the data to guide better decision-making for their patients, using it to provide patients with customized care plans based on the information. Patients have a growing desire to share this information with their physicians, a Deloitte Insights report found that the number of consumers open to patient data sharing with their provider rose to 73 percent in the COVID era.

The most likely method to make device data available to clinicians is through EMRs. For remote monitoring devices, data can be pushed to doctors from the patient’s home. Without data sharing, imagine a clinician receives device data from a 24-hour blood pressure monitoring device the next morning only to realize that a critical event happened the night before. This type of information sharing would be both immediate and invaluable.

For in-hospital devices, clinicians can monitor the patient’s data without being onsite in the room. Consider the scenario of the clinician needing to physically be next to the patient in their hospital room to see the output of the device. The ability to review data elsewhere in the hospital would be immensely freeing. Additionally, clinicians could review old data from the device at a later time, whether to refer to a specific patient’s data or to compare data from multiple patients.

Perhaps a patient is simultaneously using multiple devices. Combining data from multiple devices allows for an even more advanced understanding of a patient’s health concerns. This additional data can provide a more complete picture for the clinician, giving them better decision-making capabilities.

There is also a unique opportunity for specialists to incorporate machine learning and data science to analyze the data collected from a large number of patients. This allows them to discover patterns and learn more about which treatment methods are most successful. The ability to use device data as a tool for research scientists is a newer innovation with great potential in the industry.

But what about data security? Safe storage of patient data is always a concern of utmost importance, and is even greater today in this era of cybersecurity threats. It is important that medical device companies use a cloud storage system that is Health Information Trust Alliance (HITRUST) certified. It is not enough to work with a cloud provider that only claims to be compliant with the Health Insurance Portability and Accountability Act (HIPAA). Cloud storage systems that are HITRUST certified have been certified by a third party to meet the rigorous security standards of the industry. Working with a cloud storage provider that has been HITRUST certified will give device companies the peace of mind to know they are doing their very best to keep patient data secure.

2. Give the patients their data.

Pairing the medical device with a companion mobile app allows the patient to better understand their own health data. This gives them greater control and agency over their personal health outcomes.

A patient can learn how their body behaves and make adjustments accordingly. Perhaps a patient is wearing a 24-hour ambulatory blood pressure monitoring device and has a companion app on their mobile phone. If they notice that their blood pressure spikes after they complete a certain activity, then they can avoid repeating it in the future. Companion mobile apps not only allow patients to have access to their data when they please, but also educate the patient, allowing them to better understand themselves and their care plans.

The trend of patients wanting access to larger amounts of personal data from wearable devices shows no signs of slowing down. There has been a rise in the use of Continuous Glucose Monitoring (CGM) devices in non-diabetic patients. These users can see improvement in their numbers through the choices they make and can change and adjust accordingly. This is deeply empowering. The patient can also see their numbers as compared to population averages to further motivate them to make additional changes.

Companion apps also unlock the ability to augment the raw device data with subjective feedback from the patient. For example, they can be prompted with a question such as, “How are you feeling?” This adds an additional data point of information to pair with the device data. All of this feedback circles back to the first point above, making the data available to clinicians so they can optimize care.

Once a basic companion app has been put in place, reporting data to patients and providers, even more value can be provided to patients. Device manufactures can use the app to its maximum potential by configuring it to assign educational materials to patients based on their data. Sending articles about the patients’ specific conditions or links to information that will nudge them towards behavior changes are ways that the data can be further optimized.

A recent survey conducted by Propeller Insights on behalf of Carta Healthcare found that 60% of healthcare consumers felt that their patient data access was insufficient. Ensuring patients can view and monitor their own device data is an important part of their care journey. This same survey found that 74% of respondents stated that better access to health information provided by doctors and healthcare facilities is a priority for them. Giving these patients access to their own medical device data is one step closer to meeting their needs.

3. Give manufacturers the operational device data.

The number of connected medical devices is expected to grow to 50 billion in the next decade. This is a huge market that is not without its challenges. Making the operational device data available to individual manufactures allows better understanding of the devices and better support when problems inevitably arise.

What is operational device data? It is de-identified or non-patient data. It does not convey any personal information (PHI) to the manufacturer. Operational device data can cover a wide range of data points; possibilities include everything from when the device is used to what the internal component temperature is. What can a device manufacturer learn from this data? The list is long. They could use the information to understand how many times a day a device is used, what functions are used most often, or how long each day a device is being utilized. They could learn the answers to questions such as: Is it used continuously for hours? Is it used many times per day, or just once a week or once a month?

Now that connectivity is prevalent, medical device companies should take advantage of data like other industries. Websites and applications have been tracking product usage to improve their understanding of users for a decade. The usage of de-identified data for product improvement is not a new concept, improved understanding of customers allows new products to be designed to better fit the needs of the user. The importance of this cannot be overstated. Faster learning about products leads to faster innovation.

A medical device manufacturer can monitor their devices for signs of failures and to proactively schedule maintenance on their devices. Having access to operational device data makes this process immensely easier. With lots of data, a medical device manufacturer can use data science and machine learning to detect common failure patterns, detect systemic failures, and modify their future devices to avoid those problems.

Leaving data stuck on a medical device is a missed opportunity. Medical device companies should actively explore ways to make the patient’s device data available to clinicians and to individual patients to improve care outcomes. They should also consider making the operational device data available to manufacturers themselves to improve the quality of the devices going forward into the future. Creating a better experience for everyone will result in a device that has become both essential and valuable. And that should always be the goal.