Digital Conundrum

by James Cavuoto, editor

One of the most significant advances in the implanted neuromodulation device space has been the integration of digital devices such as patient controllers and handheld tablets. Of all the competitors in this market, Abbott has been at the forefront of this trend. The company’s NeuroSphere myPath digital health offering, which works with both Apple iOS and Android devices, raised the bar for connecting SCS and DRG patients with their clinicians. The app allows a user to track and report their pain relief and general well-being. In turn, it helps doctors understand how patients are responding to neuromodulation therapy.

But as is the case with any technological innovation, being out in front of competitors carries some risks as well as opportunities. And with the news that the FDA issued a Class 1 recall on Abbott’s Proclaim SCS and DRG devices, one might wonder whether the company maybe wishes they weren’t so far ahead.

(This is off the subject, but we think it’s high time the FDA changed its nomenclature regarding recalls to avoid confusion with device categories. How about first-degree, second-degree, or third-degree recalls, where—as is the case with burns—the higher number indicates greater severity?)

At any rate, the problem came about because of Abbott’s use of MRI mode, which disables delivery of stimulation until an MRI procedure is complete. This is ordinarily an important feature, since MRI compatibility has proven to be a critical requirement of implanted neuromodulation devices. Unfortunately, many Abbott patients found themselves unable to exit MRI mode because of Bluetooth communication problems or other software-related issues. This has resulted in dozens of patients needing surgical replacement of their IPG.

Most of us with cell phones and tablets have had to struggle with lost Bluetooth pairing or with apps that stop working after the device operating system has been upgraded. But for most of us, these frustrating situations don’t require surgical intervention—although there may be some hair loss involved.

Abbott’s response has been to modify its instructions for use to alert patients and clinicians not to remove a Bluetooth pairing linking the IPG and iOS device. The company also advises patients to upgrade to the latest version of the patient controller software before entering MRI mode. But they also warn clinicians not to enable automatic iOS software upgrades on their clinician programmer devices. This injection of distrust is bound to confound even the most tech-savvy users out there.

With the advent of digital health products, medical device manufacturers now find themselves at the mercy of the hardware and software platforms they use. We suspect that Abbott will not be the only neurotech firm to fall victim to hardware and software configuration issues on digital devices. The temptation to offer proprietary devices that the healthcare firm can control exclusively will be tempered by the realization that patients will continue to demand access to their digital therapies via their existing handheld devices.

How medical device manufacturers respond to this conundrum will reveal much about the future evolution of digital health. For now, we expect there to be growing demand for software professionals and beta testers in the implanted device industry.