Making Medical Wearables Clinically Relevant

Health wearables are still most commonly associated with fitness devices that are worn on a person’s wrist to count their steps or monitor some level of their body’s biometrics. The biggest problem with these is the accuracy (or better yet, inaccuracy). These devices are not clinically accurate and can lead to frustration among users who ultimately abandon them.
 
While this is less than ideal, for fitness monitoring, clinical accuracy isn’t essential. That’s not necessarily the case when seeking to offer wearable solutions for cardiovascular conditions or chronic health concerns. For these applications, clinical accuracy is paramount. With this in mind, MPO spoke with Biotricity founder and CEO, Waqaas Al-Siddiq, about the concerns with today’s health wearable offerings, what manufacturers need to do to move into the chronic care or cardiovascular space, and the challenges this leads to.
 
Sean Fenske: How will wearables make an impact on cardiac care and heart health?
Waqaas Al-Siddiq: It’s important to clearly define what we mean by “wearables” in cardiac healthcare. Where fitness bands can help measure and monitor mobility to help with fitness goals, wearables that are medical devices impact both the diagnosis and prevention of cardiac diseases. For example, Biotricity has developed a wearable medical device that reliably detects arrhythmias in patients. The data is transmitted in real-time to an ECG technician who can then analyze it and advise the patient. As we integrate medical wearables into the chronic disease healthcare space, we’ll see the biggest effect on the market coming from physicians who prescribe these wearables to patients. Integration will only happen if providers see clinical value in the data received from these devices, and if the physicians are reimbursed for their time using this data. Opportunities exist for companies who can provide clinical-grade data and easily integrate their solutions into existing billing systems.
 
Fenske: Speaking of reimbursement, is that an issue in getting a wearable to be used for a cardiovascular application?

Al-Siddiq: Absolutely. Reimbursement is an issue due to the high cost of medical wearables, both in terms of patients’ out-of-pocket costs as well as physician reimbursement for time required to read and act on the data.
 
Fitness bands are an altogether different animal. First, they aren’t set up for either medical reimbursement or medical use. If the patient prints data from a fitness wearable and takes it to his doctor, it’s unlikely that the doctor will be able to use, or even read the data in any useful way. And how will the physician be compensated for the time involved to look at data from a device not compatible with existing billing codes?
 
Physicians already have plenty of tools that they get paid to use. Unless the solution fits into existing billing codes, patients are, and will continue to be, burdened with paying the entire cost. Solutions that provide medical-grade data and fit within existing billing codes will make it much easier for providers to assimilate new, relevant products into their practice and provide both medical and cost-effective benefits to patients.
 
Fenske: You’ve already mentioned clinical grade data compared to the data gathered by the consumer level fitness device. How can device manufacturers seeking to provide a clinical-grade wearable solution ensure the accuracy of such a device for physicians?
Al-Siddiq: Clinicians want to benchmark. To gauge reliability, you need to run a clinical trial or benchmark against a device known to be reliable—that is, a device that is already FDA-cleared and clinically-tried. For example, doctors and nurses measure pulse oximetry using a probe clipped to a patient’s finger. If a new critical-grade wearable claims to be able to measure a patients’ pulse, the clinician would want that device benchmarked against the existing probe in order to prove its accuracy at a clinical level. As wearable medical technology advances, companies will start benchmarking more and more to provide clinicians with reliable data. But right now, consumer wearables aren’t necessarily clinically validated or tested against a benchmark, which can render the results suspect.
 
Fenske: So we get the clinician onboard with clinical accuracy. What about the patients? One of the main problems with consumer fitness and health wearables is that many users abandon them within a relatively short period of time. What can manufacturers do to help curb this trend?
Al-Siddiq: People abandon wearables mainly because there is no feedback mechanism and long-term clinical value to them. A user who is chiefly concerned with fitness may use it longer, but even then, it’s like a gym membership that lapses if the user doesn’t see an improvement on the weight scale.
 
It’s the same with disease management. Patients will stop using wearables if they don’t see actionable information or value. People need to see and feel a positive change in whatever they are doing to be incentivized. Manufacturers need to provide a clinically-accurate solution that includes a device coupled with software to help users achieve their goal with specific outcomes and constant feedback. For example, improving cardiac or diabetic outcomes requires daily lifestyle changes such as regular exercise, improved nutrition and smoking cessation. How do we provide feedback to the patient and measure a patient’s adherence for the physician so that the patient has incentive to continue? The first step is becoming clinically accurate so that both patient and doctor can trust the data.
 
Fenske: So clinical accuracy gets both the physician AND the patient on board with using it. If we achieve that, could wearables potentially enhance patient compliance?
Al-Siddiq: The key problem with patient non-adherence largely centers around patients who don’t take their prescribed medications or follow lifestyle-change regimens throughout the duration of their illness. Chronically ill patients generally need direct, relevant feedback as they adhere to their regimens, which fitness wearables don’t offer.
 
There are some health apps on the market today to drive adherence through software and case management. Studies are showing that these apps are helping patients stay faithful to doctors’ orders. In these instances, though, someone needs to physically call the patient for follow up, or the patient is sent a text message, which they’ll generally ignore. This approach is expensive and not ideal in extensive applications and we should really endeavor to eliminate the need for a case manager and innovate ways to cost effectively improve patient adherence on a large scale. Combining medical-grade devices with software would work. For example, incorporate wearable medical devices with current apps to automatically detect patient data, determine the data’s clinical relevance, then provide feedback and follow up to patients as they move forward with recovery and prevention.
 
Fenske: How will wearables be used for preventative care and post-incident (e.g., following heart attack) care?
Al-Siddiq: Fitness bands can track mobility in prevention and post-incident care, but they cannot detect cardiovascular (CVD) disease symptoms. While medical wearables are not yet being used for the preventive care of CVD, they certainly could be. It’s important to make the distinction between wrist- and chest- worn wearables. Comparing a wrist watch heart monitor that is LED-based to a medical grade ECG is very much like comparing apples and oranges. Chest-based wearables provide a more clinically-accurate reading. A wrist-worn watch collects data from the oxygen in your blood cells by looking at the pumping action of your heart. The heart is complex but, simply put, it can have either a plumbing or electrical issue and both need monitoring. A chest-based ECG will monitor electrical signals, among other things, but something you would never get from a wrist-worn watch is the collection of pulse-related data. At Biotricity, we are innovating within this space to create medical wearables that can detect arrhythmias in real-time and provide clinical-grade data to physicians as well as feedback to patients, including benchmarks of their conditions and information about next steps.
 
Fenske: What has the FDA’s response been to getting wearables approved? What have been the primary obstacles?
Al-Siddiq: What the market needs to understand is that the FDA clears products based on their intended use—so, do they need a safety clearance or a clinical clearance? A clinical clearance requires not only safety testing, but that many standards be met because a person’s health is in the balance. The FDA has a tri-level classification system for medical devices. The categories are determined by the harm to the consumer if something goes wrong with the device. A device in Class I could cause the least amount of harm and a device in Class III could cause the most. Medical-grade devices such as Biotricity’s Bioflux, which measure arrhythmias, are categorized as Class II. The FDA benchmarks a device for clinical accuracy when data and algorithms are required to be interpreted to make potentially life-saving clinical decisions. In these instances, the FDA is very stringent and treats the device as a clinical Class II or III device. There are almost zero wearables going through that process.
 
What will the FDA do about wearables that will be relied upon for clinical decisions? They will treat them like medical devices. For wearables that are non-clinical, the FDA will look at them only from a safety perspective.
 
Fenske: Are wearables going to stick around or will we see a continued transformation of the industry to another option, like consumables or even implantables?
Al-Siddiq: This entire sector will explode in the next five to ten years. Personally, I think we’re going to see many different products such as medical wearables, implantables, tattoo-like sensors, and consumables as well. There is so much potential. For fitness wearables, we might see some products built into fabrics, but for people with chronic conditions, we’ll likely move toward implantable options. As for internal diagnostic tests, we’ll see consumables.
 
Fenske: Beyond this explosion in the medical wearables space, what else might we expect in the next five to ten years that will have a significant impact on the industry?
Al-Siddiq: We’ll see growth in the concept of machine intelligence that will look at data and provide a feedback mechanism almost like a virtual healthcare team. We will move into a quantified self-concept of prevention in place of reactive care. We’ll be able to see how things will impact us. There will be an integration of big data, wearables, and machine intelligence that will take a holistic view of individuals to help them manage their chronic conditions or prevent their conditions from ever happening.
 
Fenske: This has been a great look at the clinically relevant medical wearables space and where you see it headed. Before we close, do you have any thoughts or comments you’d like to share?
Al-Siddiq: There is a care gap for those with chronic illnesses, where patients are not getting the long-term support they need. Medical wearables can fill this need and improve health outcomes for both doctors and patients—but only if they’re benchmarked as diagnostic and clinical, and differentiated from fitness wearables. Companies such as FitBit and Garmin make good products for their target demographic that are fitness and lifestyle oriented. However, problems arise when we think, “Hey, why don’t we use FitBit in a clinical environment?” Put simply, they’re not designed for medical use so there will be data inaccuracy problems. As a medical wearable innovator, we at Biotricity want to especially impact chronic care management and improve a patient’s experience within the healthcare system with the use of medical wearables.