Guest Column | January 28, 2019

4 Changes Coming To The Medical Device Market

By Kayla Matthews, Productivity Bytes

VA Changes

The medical device market is constantly evolving, and 2019 will be no different. Here are four possible changes that healthcare providers and device manufacturers should be aware of.

1. Updates To Two Device Approval Pathways

We could see changes this year to the Food and Drug Administration's De Novo approval pathway, the process for approving new, low-to-moderate-risk products that don't have a predicate to use for comparison purposes. The FDA established this pathway in 1997 but made a proposed update to it in December 2018.

If finalized, the update will provide clarity on various matters relating to the De Novo pathway, including the processes for granting, declining and withdrawing De Novo requests. The goal is to focus on patient safety while simultaneously promoting innovation.

The news about modernizing the De Novo pathway came shortly after an announcement from the FDA regarding an intention to change the 510(k) clearance process, which was established in 1976.

The 510(k)-clearance process enabled device manufacturers to get new devices approved as long as they showed substantial similarity to a device already on the market. But, in many cases, those initial devices were several decades old at the time of the new approval. The FDA plans to overhaul the process to move the market toward newer technology.

2. Increased Emphasis On Medical Device Cybersecurity

Over the last few years, cybersecurity researchers have carried out alarming demonstrations that show what hackers could do to affect insecure medical devices, including ones implanted inside patients.

The U.S. Department of Health and Human Services created a task force in 2017 to focus on cybersecurity matters in healthcare. The group included more than 150 cybersecurity experts. At the start of 2019, the task force published a set of voluntary guidelines that address the five most prevalent cybersecurity issues in healthcare.

One of the segments relates to "attacks against connected medical devices that may affect patient safety." Moreover, there is practical advice that healthcare providers and cybersecurity teams can apply in their work.

And, when assessing what the year may bring, analysts think that 2019 may bring with it federal cybersecurity laws for medical devices rather than mere voluntary best practices. Some states have already approved such rules. In 2018, California passed a cybersecurity bill for internet of Things (IoT) devices, which requires manufacturers to have "reasonable security features" on their devices and comes into effect in 2020.

One of the potential issues, though, is that any cybersecurity laws for medical devices may be too vague in these early stages. Determining what is "reasonable" concerning the security features of a gadget is open to interpretation.

3. A More Prominent Role For Telemedicine

Experts predict 2019 will be a huge year for telehealth, particularly on-demand virtual care. This year will not be the first-time patients and providers have the option, but it's likely the field will gain more dominance than ever before.

For example, TytoCare is a brand unveiled at CES 2019 that combines internet-based doctor visits with a gadget that the physician guides patients to use during an appointment. The device allows a doctor to, for example, hear heart sounds or look inside a person's ear. There's also Butterfly iQ, a handheld ultrasound wand that attaches to an iPhone.

As telemedicine continues to gain popularity, it'll still be necessary to conduct fair market value (FMV) appraisals when evaluating possible telemedicine arrangements. In those instances, it's essential to avoid common telehealth pitfalls.

For example, people should not assume telemedicine coverage is the same as call coverage or that reimbursement is the same from state to state. Another state-related specific is that the physicians assuming telemedicine roles must hold licenses in the states where their patients reside even though appointments occur online.

Another way that telemedicine may change in 2019 is increased use in treating substance use disorders. In November 2018, President Trump signed legislation to tackle the opioid crisis. The bill requires that government agencies research telehealth's potential value in this area.

4. Adjustments To New EU Laws

The European Union (EU) has historically been consistent with its medical device laws, but device manufacturers will need to ensure their devices align with the new legislation introduced in 2018 or risk going out of business.

The new Medical Device Directive (MDR) is replacing the former Medical Device Directive (MDD) and has stricter compliance regulations than its predecessor.

For example, no "grandfathering" of devices is allowed, which forces manufacturers to evaluate all their products against the new rules. Additionally, manufacturers will start seeing unannounced factory audits. The MDR also broadens the scope of regulated devices.

Device makers have until the end of May 2020 to abide by the MDR. That means they'll likely make that a priority this year to avoid playing catch up after 2019 finishes.

Manufacturers And Providers Must Evolve

The medical device market will likely see some significant changes occur in 2019. Device makers and those who recommend devices to patients need to be aware of these changes and adjust to their effects.

About The Author

Kayla Matthews is a MedTech writer whose work has appeared on HIT Consultant, Medical Economics and HITECH Answers, among other industry publications. To read more from Kayla, please connect with her on LinkedIn, or visit her personal tech blog at