A Quick Look at Wearable Medical Device Risks

The rapid transition of medical devices into the Internet of Things (IoT) space has prompted some to consider the potential risks involved and to propose ways to manage those risks. One such example is a recent white pa-per that Travelers recently published, The Wearables Revolution Has Arrived: How Technology Companies Can Manage the Risks of Wearables to Reap the Rewards.

 

As wearable medical device design and manufacturing company, we were naturally intrigued to examine the white paper and not just how we might have fit into the overall picture. Further, we reviewed it with hopes to glean some insights to share with potential customers so that they can better assess their choices when selecting a wearable medical device design and manufacturing partner. Here are some of our takeaways.

 

There are Three Categories of Companies for Wearable Device Risks

 

In sum, these categories relate to your experience with wearable device technologies and your position in the wearable device research & development, manufacturing and distribution chains. More simply, they are:

 

• Tech companies that have direct involvement
• Tech companies that are vendors or suppliers
• Non-tech companies

 

DeviceLab, of course, squarely falls into the first category, as we work directly with wireless medical device companies to bring their innovations “from concept to commercialization.”

 

For our category, the white paper provided examples of risks that are among topics in some of our recent blogs.

 

Safeguarding Wearable Medical Device Data

 

One of the them was data protection, which we discussed in our blog, Wireless Medical Device Cybersecurity: FDA Draft Guidelines. Arguably, this is perhaps one of the most pressing challenges for wearable developers, distributors and users of wearable medical devices.

 

Many of the wearable medical devices in the market are modified versions of existing medical devices that have been modified, converted or improved so that they can be worn and used away from a medical facility. Of course, the technologies that enable that freedom (which including the ability to transmit data) are just one part of the equation…another part is securing that data.

 

Safeguarding Wearable Medical Device “Use-Related Hazards”

 

The other risk was liability, which closely relates to several of the concepts we addressed in our blog, Deci-phering FDA Medical Device Design Guidance Documents, which focused on “human factors,” which we de-fined as anything that relates to how somebody interacts with a medical device.

 

The white paper suggested that a company that makes a device could be liable “if their products are blamed for highway accidents due to their customers using their products being the wheel.” This notion relates o the blog’s examination of “use-related hazards”—and more specifically to “critical tasks” (using the product normally) and “abnormal tasks” (using a product in a way that it was not intended).

 

There are Three Market Driver for Wearable Device Risks

 

After identifying the categories of companies for wearable device risks, the white paper argued that related risks are increasing of the wearable technology’s tremendous growth. This growth is due to three key drivers:

 

• Moore’s Law and the Miniaturizing of Technology
• Corporate and Workplace Productivity Applications
• Medical and Health Applications

 

It goes without saying that the last driver is the most relevant to DeviceLab. But why is that so?

 

Once again, we can look to another one of our blogs, Top Medical Device Trends: 2016 JP Morgan Healthcare Conference, in which we discussed the trends of “outpatient shift” and “personalized medicine.” Wearable med-ical devices are crucial to both of those trends, as they enable patients to access healthcare away from a medical facility, which not only is more convenient for patients, but in some ways, less expensive.

 

Ultimately, everybody wants a wearable medical devices that is safe, reliable and affordable. The advantages are tremendous, but the potential disadvantages—the risks—are real and must always be considered.

 

Arguably, the first step in leveraging the advantages and mitigating the disadvantages begins with choosing the right wearable medical device design company…which means that if you are seeking the right partner for your wearable medical device development, you should certainly ask candidates about these concepts and how they will work with you to identify and control your wearable medical device’s risks.