In part 2 of this video interview, Sam Liu, VP of marketing, Vivalink discusses the key differences between consumer- and medical-grade wearables and their uses in clinical settings.
ACT: What are the differences between consumer- and medical- grade wearables and their uses in clinical settings?
Liu: The medical grade devices typically will have gone through some kind of validation verification by some organizational body like FDA or CE or some other medical body like that, so you get a certain level of minimum standards of quality. Consumer devices, it's all over the place, it depends on which one you bought and where you bought it from. So, that's the biggest difference between the two. Now, they can both be used in settings, it's just that you have to be a little more careful with the consumer devices because of the variability.
ACT: What are some of the pros and cons of allowing patients to use their own devices?
Liu: The biggest advantage is accessibility, it’s something they're already familiar with. And so, the upside of the whole consumer wearables was it started training consumers to get comfortable with these devices, and to start to use them for healthcare purposes. So that's the biggest advantage in accessibility—familiarity with their own devices.
The downside is kind of what we talked about was just that they can vary quite a bit. They may not be as accurate as you might think, but mostly, it's probably okay because most consumer-type of devices are used more for preventive measures, or generally healthy people who are proactive about their health, so they use it in that context. In that context, it’s not perfect, but it may be good enough. The medical devices are typically used because there's some situation or some condition that you're really treating, that's more serious. And so it has a higher level of expectations around that.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.