Technology Trends Continued: The Growth of Connected Devices and the Internet of Medical Things

We’ve been exploring technology as a trend in MedTech, so let’s dive deeper. The growth of Smart Connected Products (SCP) continues to drive advancement and affect the Internet of Medical Things (IoMT), such as devices and sensors. The list of applications of IoMT continues to grow including ventilators, anesthetic machines, “smart” orthopedics, “smart” wound patches (e.g. for diabetes patients), infusion pumps, pacing devices, organ support and a large array of monitoring devices.

Competitive Pressure and Seemingly Unlimited Opportunity

MedTech manufacturers are feeling the pressure to keep up and incorporate IoMT capabilities into their products or improve existing offerings. With the incorporation of AI in the medical device, considering innovations in model compression and increased access to 5G and connectivity overall, the list and complexity of applications is only likely to increase in terms of clinical application, real-life integration and, of course, business opportunity.

As we will discover in later parts of the series, market forces are also playing into this trend including shortage of clinical staff, globalization of healthcare and remote care integration into the clinical process.

Many device manufacturers have shifted or are shifting to a condition, disease or patient lifecycle service model away from a strictly product-oriented sale. This can be done in multiple ways including acquisitions and integration of telehealth services, development of apps and treatment plans or partnerships with service providers. This has further increased the appeal of IoMT-enabled devices, monetizing the relationship between the manufacturer and the patient.

Here are some examples of how these devices can be used:

• Track patient data and safety information
• Deliver remote care
• Provide software patches
• Offer patient/provider insights

Real World Evidence

As previously discussed, the FDA seeks manufacturers to generate Real-World-Evidence of Medical Devices. Here are some examples of how connected devices can provide a method to do so:

• Observe the frequency of a clinician overriding a safety setting
• Gather patient health metrics during a surgery, comparing this data to previously assumed risk/safety and efficacy assumptions
• Review device performance characteristics, such as Mean Time Between Failure (MTBF)
• Check the level of optimization applied during use (e.g. how often a device optimization command was executed based on real-time-monitoring)

Healthcare Facility Adoption Challenges

With this capability, manufacturers ideally work in concert with healthcare facilities and/or distributors to ensure supply of equipment is both uninterrupted and optimized and can monetize beyond the device. However, a chief challenge in the integration of IoMT (Internet of Medical Things) within healthcare facilities is their reluctance to adopt new technologies, often due to concerns over security, liability, privacy and costs as well as resource constraints with internal service and IT personnel.

Cybersecurity: A Real Threat to Patients

Cybersecurity is a chief concern. Ransomware attacks are increasingly common and can severely impact patient safety, liability, costs and operating margins. Per the NIH, “This exponential increase in the IoMT and the increasing wireless connectivity of anesthesia and ICU devices as well as implantable devices presents a real and present danger to patient safety.”

Not only is it essential to address cybersecurity concerns at a technological level, but it’s crucial to address as a full Total Product Life Cycle (TPLC) app in concert with new guidance on cybersecurity that mandates that medical device manufacturers embed cybersecurity throughout a device’s lifecycle.

As discussed in previous entries, TPLC integrates pre and post-market activities into a holistic view that helps ensure device safety and effectiveness from design through commercialization​. It's important to note that while the FDA strongly regulates medical devices, it does not dictate hospital policies directly, ensuring that the adoption of such technologies within hospitals remains governed by the facilities themselves and not by the FDA​.

Relevance to Digital Thread

Adopting IoMT requires a considerable technology backbone and improved digital thread.

A key component of the digital thread starts with quality engineering, system engineering and robust Software as a Medical Device (SaMD) development. Having a capable Application Lifecycle Management platform is essential, and must be integrated into up and downstream applications such as DevOps and MLOps as well as Product Lifecycle Management, labelling and Manufacturing Execution Systems.

The insights derived from IoMT data within the organization’s Product Lifecycle Management (PLM) platform/s can be used to inform product design improvements, manufacturing optimizations and post-market surveillance activities. This creates a feedback loop that helps organizations continually improve their medical devices based on real-world performance data. Therefore, it’s critical that the IoMT platform integrates tightly with PLM platforms and Quality Management Systems (if separate from PLM).

Real-World-Data can inform both product and process design and development, including cybersecurity controls. Analyzing the combined product and IoMT data can reveal trends and patterns in device performance, user behaviors and environmental factors that may impact the device's operation. These insights can help product development teams make data-driven decisions to optimize the device's operating parameters.

Further, predictive analytics can help identify potential device failures or malfunctions before they occur by analyzing patterns in the IoMT data. This allows manufacturers to build preventive measures into the device to alert of potential failure and can be a selling point to hospitals and healthcare facilities to reduce asset utilization issues.