Enemies from Without

Commercial firms and research institutions developing implanted neurostimulation systems have had years of experience dealing with challenges emanating from within the body, such as tissue encapsulation, lead migration, electrode breakage, and battery failure. But now the industry must be ready to confront two additional threats from the external world: cybersecurity intrusions and environmental influences.

Earlier this month, the U.S. Department of Homeland Security called out Medtronic for a cybersecurity weakness in its N’Vision clinician programmer, a component of the company’s neuromodulation systems. The vulnerability would allow a hacker with access to the unit’s compact flash card to access personal information, including healthcare information, about the patient. The DHS rated the vulnerability as medium severity.

The company issued a statement in response: “Medtronic was notified by an external security researcher of a potential vulnerability related to the Medtronic N’Vision 8840 Physician Programmer, a small, handheld device used solely by healthcare professionals to program certain Medtronic neuromodulation devices. The researcher’s report details that the compact flash application card used in the physician programmer may contain unencrypted patient personal health information if that information is not deleted following individual patient device programming.”

While this vulnerability is certainly not life-threatening, it should put neuromodulation vendors on notice that the government—and hackers—will be looking over their shoulders for means of compromising patients’ security by unauthorized access to digital data. As we pointed out in this pace three years ago [NBR Nov15 p2], cybersecurity issues will take on increasing importance in the neurotech industry. And vendors of implanted brain sensing and stimulation devices face particularly onerous threats from potential “brainjackers” [NBR Jun17 p2].

But cybersecurity issues aren’t the only threat looming from the outside. A recent article in the Journal of Neurosurgery reported that a patient with an implanted DBS system experienced a device failure as a result of a lightning storm that also affected electrical appliances in the patient’s home. Clinicians now recommend the use of surge protectors for rechargeable neuromodulation systems and that patients unplug their rechargers when not in use.

External challenges like these certainly add to the list of engineering factors that must be considered when designing and upgrading neurotech devices. But given the amount of talent and dedication neural engineers have demonstrated to date, we’re confident that the industry will be up to the task.

James Cavuoto
Editor and Publisher