It’s no surprise that a large number of wellness devices are being developed to allow today’s tech-savvy patient-consumers to take charge of their own health. Wellness devices are a great way to empower people by giving them access to data. However, it’s vital to remember that unlike medical devices, they are not required to be proven to be safe or effective. The responsibility and choice to claim a device as either wellness or medical lies completely with the manufacturer. It is extremely important that manufacturers understand the rules. Mistakenly seeking FDA approval for a wellness device might be costly, but not seeking FDA approval for a medical device could be a deadly.
What’s the difference?
Medical devices require a much higher standard of design, design control, and testing than is necessary for a wellness device. This is all risk-based: a wellness device can’t be responsible for high-risk, life-saving actions. In fact, they are defined as being at low risk to cause patient harm.
Wellness and Mobile Apps
A number of wellness devices are software programs that run on smartphones and other mobile communication devices. They can also be an accessory or a combination of accessories and software. If these devices are medical devices, then they are called Mobile Medical Apps, otherwise they are simply referred to as mobile apps.
Can a Device be Both a Wellness and Medical Device?
A specific product line is typically one or the other, but a family of devices may include both. For example, a device can measure heartrate for wellness purposes, and the manufacturer could also develop a medical version with a similar architecture for acute care applications. Devices that jump between wellness and medical indications often fall into one of two categories:
- Wellness-first business model: creating a first-gen device as a low-barrier-of-entry first-step to market for companies seeking to eventually make their way to an FDA approved product. In these cases, the manufacturer (typically) releases a product as a wellness device with a clearly non-medical indication for use (e.g., “supports an active lifestyle,” or “promotes self-health”) before releasing generation-two with a more specific, medical indication for use (e.g., “used to diagnose sleep apnea”).
- FDA confidence marketing model: A marketing strategy is to create a device for improving wellness that is also FDA approved. In this case, it’s a wellness-indicated device trying to gain confidence from their consumers by getting FDA clearance, despite being technically unnecessary. Their manufacturers are simply choosing to submit to FDA to increase sales and prove they have developed a safe and effective device.
So It’s All about Medical Information?
You’ll note that in neither case is a wellness device indicated to provide medical information or treatment, which is actually the difference between the two terms. Indicating medical performance for non-medical devices is unsafe, and it’s a major risk to a manufacturer’s commercial success and to patient safety to deliver medical information via an uncontrolled, unapproved device.
Then It’s All about Indication for Use?
Indications for Use is arguably the biggest factor in differentiating between wellness and medical devices, but foreseeable use is also a factor. A manufacturer can’t create a defibrillator and then add a disclaimer for non-therapeutic use when customers will obviously use it for that very purpose—it’s too risky to patient health. In one often-cited example, FDA ordered 23andMe to stop selling its Health and Ancestry DNA product because of “potential health consequences that could result from false positive or false negative assessments for high-risk indications.”
Are There Official Examples of What Is and Is Not a Medical Device?
FDA has set mobile apps into three buckets with examples: non-medical devices, maybe medical devices, and definitely medical devices. Mobile apps are not exactly the same thing as wellness devices, but the same general logic seems to apply to both upon review of FDA’s wellness device policy guidance (which also contains examples).
A Modern Case Study
This brings us to an example I want to highlight: the iBeat, which launched this summer. The iBeat monitors your heartrate via a smartwatch and alerts its response center via your smartphone if you are having a cardiac event. In the company’s words: It’s a “Smartwatch that could save your life… [by] continually monitoring your heart rate and blood flow for potential life-threatening emergencies and can send you help.” Personally, I interpret this as posing a risk to a patient’s safety if the mobile app were not to function as intended: for one example, if a user is relying on this device to send help but it malfunctions and doesn’t, that could be a life-threatening problem.
The FDA guidances state that devices that reference a certain condition (in this case, life-threatening cardiac emergencies) without specifically expressing the relationship as “may help to reduce the risk of” or “may help living well with” the disease are not wellness devices. Specifically, cardiac monitors including rate alarms are Class II medical devices, product code 870.2300.
However, this particular device is not approved by FDA. One stand-out quote is a sort of disclaimer: “While the company is pursuing FDA approval … the product is currently a consumer wearable and is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”
In this case study, there is a real possibility that FDA will take action to have iBeat adjust its claims and its disclaimer.
What about Health Information?
Wellness devices often argue their information is not health information, and therefore is not within the bounds of HIPAA. This ups the stakes, because if devices like iBeat are found to be medical devices, their information may also be found to be Health Information.
Patient Safety is Number One
It’s important to remember that while simply writing “not to be used a lifesaving device” may be good enough for pool floaties, it is not enough (per FDA’s guidances) to transform a medical device into wellness device. If this disclaimer were enough, a lot more companies would be slapping such a disclaimer on their devices and rushing to market as fast as possible. You might argue that if these devices are being designed and tested properly, they could save more lives at lot faster by being sold as wellness devices; however, if they were really that effective and safe, then it would be simple for their manufacturers to get FDA approval.
Always carefully consider your claims and the type of information your device is collecting before deciding that it’s a wellness device—the stakes are too high, both for companies and for patient-consumers who may mistakenly rely on wellness devices.