Biosensing wearables. You asked, we answered.

We had an overwhelming number of questions during the session, so here’s a rundown of all the answers we covered in our Q&A session.

For more on biosensing wearables dive into the  full report and the webinar.

How are biosensing wearables being supported and who is leveraging the data from those devices? 
It’s largely a function of the platform companies that we outlined. Companies like Jiff & Redbrick are good examples of companies that are leveraging the data. They are working in the employer wellness space alongside health insurance companies and employers. Employees have their choice of device they bring with them to work and they get rewards and incentives for using them. Employers can leverage biosensing wearables in order to be able to track their incentive programs and have a viable source of truth for their employees biometric data.

Where will all of the data from these devices be aggregated?
Apple and Samsung are betting that people want to aggregate all this data for themselves and then provision its access to other companies including their healthcare professionals and clinicians. We’ve seen challenges traditionally with this as consumers don’t necessarily want to be the custodians of their own data. However, today, consumers are becoming more accustomed to the modal box asking whether you want an app to have access to things like your contacts. As we enable more passive tracking, very specific use cases, and large hardware ecosystems, we will see more personal tracking. In the meantime, there are a lot of companies that attempt to collect this data on your behalf.

How will Apple’s and Samsung’s platforms fit in with activity trackers versus single purpose devices?
If you were developing a product, and we say product very distinct from a platform, you have to face that type of trade-off. If you’re Apple and you’re launching a platform, you don’t suffer from this problem. The big issue that Apple and Samsung will face is what the core functionality of their wearable device would be if they were to launch one (for Apple, it’s a wearable device that leaves nothing to chance in terms of consumer adoption and seeds Health/HealthKit). From there, with the platform, they can enable millions of specialized use cases. That’s what we’ve seen with smartphones today. They addressed a core communication issue and now millions of special purpose apps are designed to let you reach much more niche segments.

How can physicians ensure that they prescribe a wearable device that will stick around?
The best thing to do is find the right platform, prescribe the software and let the consumer choose the device that’s going to be appropriate for them. One of the other issues that we’ve observed from clinicians to consumers is the lack of FDA clearances for many of these devices and apps. Apple and Google need to do more to flag which apps (and perhaps devices) have received FDA clearance so that consumers and clinicians can sort through all the available offerings.

What is Rock Health’s outlook on connecting patient generated data with electronic health records? How will this data becoming actionable for doctors?
We see some clinicians who are excited about the idea of patient generated data flowing into clinical workflow while others question what the utility of some of this data is. No clinician is going to want to operate on data that comes from untrusted devices. Over time we expect significant value with patient generated data for clinicians in terms of remote patient monitoring and building dashboards.

How will biosensing wearables help athletes and patients perform better and permanently improve their lifestyles?
There are a lot of parallels between the high-end sports segment and the clinical segment. Athletes demand higher reliability because they perform at a very high level and require high precision measurements. There is also very novel physiology to measure with them. The Reebok sensor, which is related to concussion impact, is a very narrow use case example but provides great value. We also think hydration and blood glucose will be important measures of performance. Collecting more data will allow companies to segment and identify interventions that might work for them.

What are some advances in technologies in the field of mental state and mood disorder diagnostics?
There are 8-12 core physiological parameters that can be linked to mood and mental state. Respiration is a good example of one, which our portfolio company Spire is using to help individuals relieve stress and increase productivity. In general, we just haven’t seen the devices. The sensors exist to track the right physiological parameters, but we haven’t seen the companies necessarily packaged or marketed in that way. Stay tuned to Spire’s launch on June 17 to see more about that.

What is the largest barrier to widespread consumer adoption of biosensing wearables?
The largest barrier for consumer adoption is that the products just aren’t good enough yet. The consumers may not directly understand that you can address a chronic disease with it or that you could in fact make your life better. The companies just don’t seem to be marketing their devices that way either for regulatory reasons or because they want to focus on being more aspirational. Though they are accessible to consumers, the adoption of biosensing wearables is low because the devices aren’t evolved enough yet along the axes of functionality, reliability and convenience.

How can entrepreneurs overcome the up-front expense associated with 510(k)’s and PMA’s but still release to general consumers?
That’s a marketing claim question. You can launch to consumers with an unregulated claim. Don’t make a medical or clinical claim with the device, so you can get it out to consumers. Test and iterate rapidly, then eventually try to move up-market which is where we see a number of the devices today.

What will need to happen for wearables to get reimbursed and gain much wider adoption? Will they need to go through clinical trials for this? What companies have overcome this hurdle?
We think you need to bridge both worlds today. You can go through a coverage and reimbursement pathway, demonstrate that you have a clinical outcome, demonstrate that you can provide it cost-effectively and that you can get yourself a code. There are companies that have done that well like Corventis, Zephyr’s Biopatch, and iRhythm. Proteus has a clearance and significant industry interest. Many of these receive reimbursement today but we don’t know if that’s necessarily the future. In terms of new business models being enabled, we see a lot of companies converting to software-based models to focus on patient management.

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