CEO and Co-Founder of Aparito
Dr Elin Haf Davies is the CEO and Co-Founder of Aparito, a digital health company that seeks to improve research and drug development in paediatrics and orphan diseases. She has over 22 years of experience as a clinician within rare diseases, regulatory and reimbursement bodies. Furthermore, she is an Associate Fellow at the UCL Centre for the Advancement of Sustainable Medical Innovation.
Section 1: The Current Uses for Wearables
1.1. What is a medical wearable?
From a regulatory standard point of view, medical-grade wearables have been approved by a regulator, such as the FDA, or a notified body, such as the BSI or MHRA. Medical grade devices have been approved according to a certain class, whether that be monitoring or diagnostic purposes. So the regulators have got with classifications of what they consider to be medical-grade wearables.
1.2. What are the different classes of wearables?
At the top-level one would be a diagnostic wearable. It would be a wearable that is used to give a diagnosis of a disease, independent of any clinical interpretation of the data. One example, from a diagnostic would be a seizure detection. So, a wearable that actually detects that a seizure is happening and gives alerts that a seizure is happening.
Monitoring devices will monitor changes over time and presents that data to a clinician, so that the clinician can interpret the data to make a clinical meaning of it. For example, a wearable that measures your stride velocity when you’re walking to show if your ambulation or your gait changes over time.
Other wearables are more of a wellness wearable, which are consumer-grade ones. They just don’t have necessarily the accuracy or the specificity, but they can still offer some value in health and wellness. For example, wearables that are calculating the number of steps that you’ve taken but, doesn’t necessarily comment on the quality of those steps.
1.3. Which therapeutic areas have you seen the most growth?
Anything consumer-facing. We know that there’s a lot of tech adoption, and we know that there’s a huge amount of growth in consumer-grade wearables. To date, this has been where the highest amount of use has been. But I would argue that we’re seeing a shift. So Apple, as an example, have invested heavily in developing their Apple Watch to be regulated as a medical device, to be a diagnostic tool for AF, atrial fibrillation. So along the same way as I was describing the wearable for detecting a seizure, the wearable for detecting an atrial fibrillation is something that the consumer-grade wearables are sort of shifting towards, to include some of these more medical uses. So I think that the needle is changing.
We noticed that the long-term buy-in for wearables at a consumer level was not sustainable. Most people were excited by it for about six to eight months, and then just got bored of tracking it; recharging it; lost it; lost the charger, and then never really reengaged. Whereas, they’re seeing the health demand for it may make it more of a long-term consideration..
1.4. To what extent do these wearables deliver better outcomes compared to traditional methods?
I think it is still early days to really know, there’s the odd example here and there, but we certainly have not seen this mass adoption, scalable healthcare benefits that have been claimed to be the panacea of wearables. There are still technical limitations that are preventing it and cost implications, because the really high-grade medical devices with the real high-grade capabilities are either ridiculously expensive or not user-friendly for long term use, both of which makes it prohibitive for really seeing the healthcare outcomes improved that we want. However, there’s certainly individual case examples where patients are made safer because they have a wearable that alerts their friends and family that they’re having a seizure, or wearables that alert them to an AF, that means that they can seek medical help, and wearables that support remote patient monitoring instead of bringing them into hospital. But we’re far from that being mainstream.
1.4.1. Do wearables improve patient engagement?
There’s a lot about gamification, nudging, rewarding. I think when you’re really talking about engaging with patients, you have to consider their capability, the opportunity and their motivation. Just having data from a wearable doesn’t necessarily immediately convert to being more motivated to manage your health. Much like if you’re a smoker, knowing that smoking kills and the information, the statistic link to that, doesn’t mean that you’ll stop smoking. There has to be more than just data from a wearable. So it could be one piece of a jigsaw to contribute to that, but it’s not the standalone answer to everything.
Section 2: Challenges for Medical Wearables
2.1. What factors affect the uptake of wearable technology into healthcare?
So at a systems level, it’s costs and logistics. First of all, they need to see the cost value, right? They need to be convinced that if they’re going to spend a hundred pounds or £10,000 per wearable for a certain group of patients, where’s the cost value in that, and what’s the outcome benefit in that? So the NHS will only be prepared when it knows that it improves patient outcome or where they know it’s a cost savings. And so until you have that data, ideally to show both improved patient outcome and cost value, then you can’t expect them to be prepared really.
Clinicians are firefighting with trawling through data and information and knowledge. So unless your wearable gives them an easier way to make decision or helps them make decision or helps them filter or helps them triage, then why would they be interested? We definitely know that you need to have data and evidence to support clinicians in saving time and making better decisions before they’re ready to adopt as it were.
2.1.1. What are the challenges for implementing wearables?
Logistical. Where does the patient get the wearable from? Who does technical support? Who replaces the money lost? The key thing, of course, is that you do not take clinical staff time away to be supplementing a tech support, logistical support issue.
2.2.What are the issues around user adoption?
Habit-forming. I think most people, if they have the same routine day in, day out, it’s kind of becomes a bit easier. But if you have a slightly erratic life schedule, if you’re working night shifts, if you’re traveling a lot. So, I think having habits and being motivated and to see the value of it.
There’s the acronym COM, so it’s capabilities, opportunities and motivation. So are they capable of using it? Do they have the opportunity to use it? And do they have the motivation to use it? And all of these factors need to play a part, so do they need to be motivated to improve their health? Are they capable of paying for it, interpreting the data from it? And are they being given the opportunity to make that happen?
I think what the problem is, people have come up with a technology and they’re now trying to find a spot to fit in, as opposed to the people have identified a problem, and they’re now identifying the solution to address the problem. I think that the healthcare system is inherently difficult to find the right solutions towards. People probably get slightly disillusioned in understanding that it’s not about, “I have a product, now everybody should use.” It’s about looking at what the process is, what the pathway is and what can be introduced into it.
I think what steps they’re trying to do versus what steps they should be doing, they’re quite two different things. I think they’re trying to carry on with the same approach that they use for sort of more consumer mass adoption, but it’s not going to penetrate into the healthcare. I think unless they start looking at how the pharmaceutical companies or diagnostic companies are bringing services to the healthcare system, I don’t think they’ll have much luck. But it’s going to require a longer-term higher strategy.
2.3. What issues do payer’s have with wearables?
Financial cost-saving, so what will your wearable save me in cost? If you’re currently paying for X amount of outpatient appointments, X amount of tests in the hospital, how many of those would you save with trust by providing them a wearable instead, as an example.
Tech manufacturers and wearable manufacturers not producing the evidence or generating the data really.
I think pharmaceutical companies, as an example, they know how to bring a drug to market. They know the regulatory steps, and then they know the reimbursement steps, and they know you had to do it. But tech providers have tried to do it differently, and they’re now understanding that it’s not how it works.
The key difference here is that when you’re developing a medicine, you have to demonstrate that your medicine is both safe and effective, or has efficacy. When you’re developing a wearable device in the lower grade, you just have to demonstrate that it’s safe. And that demonstration of efficacy is not as highly driven. So, you can demonstrated that something is safe and bring it onto the market, but you don’t have the evidence of efficacy and effectiveness.