By Harry Glorikian

The field of in vitro diagnostics is going through a period of rapid growth and innovation. Rising healthcare costs have led to a greater emphasis on evidence-based medicine and a focus on improved patient outcomes. An aging population along with the growing epidemic of chronic diseases and some infectious diseases are creating a demand for diagnostic devices for a variety of conditions. Development of these devices is challenging. Regulation of IVDs in the U.S. largely falls to the FDA, though other federal and state agencies play a role, and there are multiple development pathways to consider. And then commercialization strategies must evolve as IVDs become increasingly prescriptive. Harry Glorikian’s new book, Commercializing Novel IVDs: A Comprehensive Manual for Success, provides an overview of the major components to IVD development, from product conception through commercialization. –The Editor

February 7, 2017 | Imagine a device that enables healthcare providers to remotely monitor the well-being and vital signs of an elderly patient while that patient is at home. The device could be worn on the body or attached to a walker, cane, or wheelchair. It can tell exactly where the patient is at any given time, which is especially helpful if that person suffers from dementia and tends to wander away from home. Maybe the device is able to predict whether a fall is going to occur, or perhaps it notices caregivers if a fall has already happened. It may even be able to watch for, and report, a missed dose of medication.

Sound like something out of a science-fiction novel? It’s not. All of these tools—and many others—already exist. They’re just a few examples of remote patient monitoring (RPM), a wireless technology that makes it possible for healthcare providers to check on their patients outside the traditional hospital or doctor’s office setting. RPM devices can collect a variety of important data, including:

• Blood pressure
• Blood glucose
• Blood oxygen saturation level
• Heart rhythm/rate
• Patient movement (or prolonged periods of no movement at all)
• Skin temperature
• Pulse rate
• Breathing rate
• Sleep patterns

Once they’ve collected their data, RPM devices transmit it wirelessly to healthcare professionals, who can then access, manipulate, and analyze it using a traditional database or any number of mobile apps. RPM is quickly going from a nice-to-have to a must-have. It’s remarkable to consider that prior to the Affordable Care Act, there was no financial incentive for RPM devices. In the U.S., it’s proven to be an effective way to respond to the ACA mandate for cost-containment and outcome-based medicine.

Here’s why: RPM devices enable healthcare providers to practice preventive care as well as understanding and potentially influencing patient behavior. By keeping a virtual eye on patients and continuously monitoring their health, these devices provide advance warning. Small problems or behaviors are detected at the earliest possible stage, which prevents them from becoming even bigger, costlier ones.

This is particularly important for the elderly and the chronically ill who, as we detailed earlier, use significantly more healthcare services than other patient populations do. When doctors are able to keep patients healthy, those patients are much less likely to end up in emergency rooms. They’re also less likely to need lengthy hospitalizations. And both of these scenarios, in turn, reduce the likelihood of readmissions or hospital-acquired infections—both of which are undesirable and expensive. Everybody wins.

It’s clear that RPM will become indispensable for delivering better, less expensive, and more preventive healthcare, but there are some caveats. In order for some RPM devices to provide their value, they require patient compliance. A device might have to be worn on a patient’s wrist, for instance, or sensors might need to be fixed to a certain part of the body. If this doesn’t happen, then the technology is pretty much useless to everyone. To ensure compliance requires an understanding of patient behavior and motivations. But not all RPM devices require patient compliance. For example, so-called “smart beds” use a sensor mat that goes under a bed mattress, so the patient doesn’t need to be attached to anything. The mat records its data wirelessly, eliminating the compliance issue altogether.

All of these devices continuously delivering their readings will create a tidal wave of data on the receiving end. That means healthcare will need qualified people dedicated to processing and analyzing all of this information so that providers can use it and patients can benefit from it. These information experts will also have to ensure interoperability, so that the data from RPM devices can be poured seamlessly into EHRs, where it will add the most value if combined with predictive analytics packages.

Obviously, it can be difficult or impossible to take advantage of electronic and wireless technology like RPM and telemedicine if there’s poor IT and telecommunications infrastructure in your area. This is where emerging countries are at a distinct disadvantage. But this situation will improve as developing nations build their IT and healthcare infrastructure. In fact, you could argue that people who live in extremely remote areas stand to benefit the most from RPM.

Harry Glorikian will be signing copies of his book during the 2017 Molecular Medicine Tri Conference, which takes place in San Francisco, California from February 19-24.