Over the years we’ve seen just about every type of sleep monitor imaginable – mattress pads, radar devices, wristbands, headbands, sleep masks, a ring – the list goes on.
The one thing in common, is that people buy and use these devices to measure, and try to better understand what’s going on when they’re asleep.
But in recent years, it’s become evident that merely having access to your sleep data doesn’t necessarily mean you’ll be able to do anything to improve your sleep.
Slowly, the sleep technology industry is recognising this disparity, and more and more sleep products are starting to offer practical help or actionable insights, rather than just passive data collection.
Beddr: Sleep tracking meets clinical insights
Beddr, a digital health startup is part of this new ‘sleep tracking 2.0’ paradigm. Their first product, Sleep Tuner hopes to narrow the gap between consumer sleep tracking and the tools and methodologies of clinical sleep medicine.
Sleep Tuner is a postage stamp-sized wearable described as like “a sleep lab that fits in your pocket”. An FDA-listed device, it attaches to your forehead and features a range of sensors that monitor your movement, heart-rate, breathing and SpO2 (blood oxygen level) with “hospital-grade accuracy”.
Whilst Sleep Tuner can give you an overall assessment of your night’s sleep, its main focus is identifying issues that can impact your sleep quality. Hence Sleep Tuner can also measure ‘stopped breathing events’, oxygen saturation levels, and your sleep position.
These kind of metrics are particularly useful in gathering insights into cases of undiagnosed sleep apnea. And indeed Beddr eventually is aiming for Sleep Tuner to become a diagnostic tool in itself, something that will require full FDA approval.
So, we talked to Beddr’s CEO, Mike Kisch ahead of last week’s launch about Sleep Tuner, and the current state of sleep technology, digital health and sleep medicine and the company’s goal to ‘democratise’ access to otherwise costly medical sleep interventions.
This interview has been edited for clarity and brevity
What exactly is Sleep Tuner?
Jeff Mann, Sleep Junkies (JM): Hi Mike thanks for agreeing to chat with Sleep Junkies. So, can you give us the elevator pitch for Sleep Tuner?
Mike Kisch, CEO, Beddr (MK) : Sure. As you probably know better than most, in the United States there’s about 100 million people who struggle with their sleep for a variety of reasons and the two avenues that are available to them today to gain insights into what the cause of their sleep issues may be are either in the form of consumer sleep trackers, which as you know generally well designed – they’re accessible and reasonably affordable but there’s questionable accuracy and there are certainly some doubts about whether or not they’re actually gathering the right set of clinically valid information.
And then on the other side, we have the traditional sleep medicine establishment, who are a group of very well-meaning, highly educated, very experienced professionals but they have, it’s almost difficult to access an overnight or home sleep test due to cost and insurance.
So the idea behind Beddr in general and the Sleep Tuner specifically was to combine the best of both of those worlds – to take the consumer friendliness of a sleep tracker with the clinical validation and the endorsement of physicians of the traditional overnight sleep test and integrate them into a single experience that guides people through the process of understanding the cause of their sleep issues but ultimately it will also help them find the right solution, which is going to lead to a more positive health outcome.
What’s the company background of Beddr?
JM: Could you tell us your background and why specifically you got involved in sleep and the emerging digital health space?
MK: Sure so there’s four founders of the company and two of us myself included come from more consumer technology, consumer internet services backgrounds.
So our perspective is thinking about this through the eyes of the individual that has a sleep problem and trying to come up with the right type of product, the right type of user experience that’s going to be engaging and motivating to them.
Tom Goff and Kirby Chang, two of our founders, have been working for the better part of several decades on medical device development particularly in interventional cardiology – devices that are actually implanted or introduced into the body for people who have heart attacks or who have irregular heartbeats and it was bringing those two worlds together and our different backgrounds that has really manifested into this overriding philosophy about combining the best of consumer and clinical.
Me specifically, I started in consumer packaged goods back in the 90s and then I went to Cisco where I was part of their emerging technologies team and so I was one of the people that really thought about which markets to enter, what was the best way to enter, what did the product need to be able to do to solve the customers problem in a way that perhaps it was not currently being solved.
And I then transitioned from Cisco to being the founding CEO of another digital health company called Sound Hawk which was focused in the hearing aid space and the goal of that business was, how do we make hearing aid technology more affordable, more accessible to more people. The core innovation there was an application that allowed people to do a self-acoustic fit of a hearing device that we made and manufactured.
The idea there was that by doing that you could bring the overall cost of the solution down and then you could help a lot more people and that same philosophy is what we’ve brought to bear with what we’re doing at Beddr.
Why did the founders decide to enter the sleep technology space?
JM: What were the initial discussions that began the journey to where you are now with Beddr?
MK: When Simon (Vining), Tom, Kirby and I came together, we knew we wanted to work on a business together, and in the course of several meetings it became clear that all of us had one thing in common which was we had relatively poor quality sleep.
There were a couple of people that had gone through the formal sleep medicine process, had been diagnosed with apnea, and then there were others of us that we had young children, we had seen the stress of startups have a very negative impact on our sleep and then we’ve seen the fact that poor sleep has on just our overall quality of life, well physically as well as psychologically.
So that was how we arrived at sleep as this real important area that is sort of misunderstood and we felt like it was an area that we all had passion in a personal connection to when we felt like we could actually do a much better job than a lot of the current products that were in the marketplace.
When we initially thought about what we were going to focus on, at first there was a lot of emphasis on treatments. But the deeper you get into looking at particularly sleep disorders, what you begin to see is that the primary issue is the large percentage of people that are either unaware or undiagnosed as having an actual sleep disorder.
And so that quickly focused the team and the organization on how do we build a product that many people can gain access to but it provides them very deep insights and understanding of what is the cause of their sleep problems.
Finding a solution for undiagnosed sleep apnea
JM: Yes, there’s a huge gap at the moment, the sheer amount of cases of sleep apnea and the numbers that have an actual diagnosis.
MK: Sleep apnea – in the US there’s 54 million people and the belief is that 85% of them are undiagnosed and, you dig deeper and you talk to people who have sleep apnea – we’ve talked to thousands of people – there are real short-term consequences and how it’s impairing the quality of their life just because they’re constantly tired and they’re lacking the physical and the mental resolve and resilience that comes with getting high-quality sleep.
And then you just look at all the research that’s been done that creates a pretty strong relationship between sleep apnea and type 2 diabetes, hypertension, depression, arrhythmias, it was an area that we gained a lot of passion around because you could see that by helping people with this, you would not only help them the next day but you could potentially help them over the remainder of their life.
So you know we’re a very mission driven group, we’ve been drawn to health care and digital health in particular because it is an opportunity not only to build companies and products that we’re proud of but the impact it goes beyond just sort of dollars and cents, it’s about seeing people actually improve quality of life and so it was one of the reasons that we got very hardcore into this being a medical device and wanting to do clinical validation because you know, it’s not a gadget, it’s a real precise instrument that’s designed to help people on their journey to improving the quality of their sleep.
Sleep ‘tuning’ compared to sleep tracking
JM: What are your general views on sleep tracking, where we are now, and how Beddr and sleep tuner fit into that?
MK: Yeah, well it’s interesting. So you know we use sleep trackers, we’ve got a variety of them and they’re generally good products made by well-intentioned companies, it’s just what you begin to see is tracking your sleep on a night by night basis actually in our view is sort of, a diminishing return exercise.
Because the reality is you’re often times more likely to overly anxious and obsessed about what is my score or what happened tonight versus last night which we think ultimately can be unhealthy, versus the more relevant approach.
We believe is this concept we call tuning and so you think about a musical instrument, think about a car engine. The idea is to get your sleep to a point where it’s as good as it can be and then just to focus on the act of sleeping not the act of constantly monitoring it.
[Then when] you begin to sense that your life has changed, your job has changed, your body has changed and your sleep has begun to degrade and then it’s an opportunity to sort of tune up again in the same way you would with a guitar or a piano.
And when we began to socialize this idea with early users of the product, what we found was the majority of people preferred this type of tuning modality that versus the tracking thing.
The tracking thing really appealed to a pretty small percentage of quantified self-ers but most people, the problem they’re trying to addresses is I would like to improve my sleep by understanding it better with as little inconvenience and as little effort as possible.
And that was really the validation for a product like ours which is used for four to five days upfront to really establish a baseline, and then to recommend some targeted actions and to quantify the impact of those actions.
We see that have a really significant impact on people’s sleep within just a few days and then we just believe they should focus on the act of sleeping until they feel that their sleep has unfortunately turned for the worse and then we see people start the process again.
Sleep scores. Are they useful?
JM: What are your general thoughts on this whole idea of a sleep score, sleep scoring?
MK: Yeah, I mean if you look at our product, we have what we call a sleep quality rating and then we’re very transparent about what are the inputs into determining that rating and what improvements to the inputs will have an impact on the rating itself.
And so I think as an educational tool, a quick way to tell a consumer hey, last night you did great, you did good, you did fair, you did poor, I think there’s some merit in sort of simplifying things to that score. I think as a means of clinical understanding or ultimately diagnosis, it’s totally irrelevant would be my take on it.
So you’re unlikely to ever find a board-certified sleep physician who would ever have a particularly positive point of view on a sleep score or would rely upon that to kind of inform their recommendation and the direction that they would give to a patient.
And so we have a great scientific advisory board led by some very well-known board-certified sleep physicians and everything we put into the product goes through that.
And the reason it goes through them is because philosophically, we’re all about being evidence-based and we’re all about following the science.
And the research that’s been put out and is endorsed and supported by the physician community. So what we want with our product, is the person uses it, and they can take that information and they can interface with a physician.
Measuring what matters
And the physician will be oh, I get it, you’re measuring the things that I really care about and that I know are critical to determining what could be the cause of your sleep issues.
And so in addition to the consumer who’s using the product, the other customer we have is the physician to make sure that we’ve captured the right data, we’ve processed it the right way to the accuracy required for them to be able to rely upon it.
Initially just to gain insight into what’s going on with the user of the product but eventually to be used as the input to a formal diagnosis and so you know I think sleep scores is coming back to it, it’s a nice way to sort of oversimplify things, I don’t think that anybody is ever going to arrive at a particularly meaningful sleep score that’s going to be truly representative or indicative of whether or not that person actually had high quality sleep.
Is Beddr disrupting the traditional sleep medicine industry?
JM: So you’re the first consumer sleep technology product to offer such a high level of clinical validation and the product is FDA listed. So do you see Beddr as a disruptive company, bypassing the traditional costly, lengthy sleep medicine alternatives?
MK: This may sound strange coming from Silicon Valley where disruptive seems to be a necessary word to describe every company that is based here but I wouldn’t necessarily term us that way and that we’re not trying to change the current industry, we’re not trying to sort of redistribute, sort of where the dollars flow, our primary goal is to focus on the undiagnosed population and to figure out how to get those people to the point where they understand what’s going on with their sleep and ultimately to get diagnosed.
What I think will happen over time is I think the traditional sleep medicine industry will evolve a little bit where they are more focused on the complex cases, where people are presenting multiple issues.
So they could have insomnia with some restless leg syndrome with some sleep apnea, where you really do need the more sort of intensive data rich polysomnography test and you need a more thorough analysis from the actual physician expert.
But I think there’s simpler cases where there’s a more streamlined approach that can be delivered faster, more cost-effectively and more conveniently with the intended goal of just helping reach those 85% of the undiagnosed.
And so you know, that’s why we just don’t see ourselves as disruptive, we see ourselves ultimately additive to what exists and that’s generally the way we’ve been received by most physicians.
The word I may use is democratizing. So I do believe that what we’re doing is we’re taking the essential elements of the existing sleep tests – whether it’s an in-home home sleep apnea test or it’s an in lab PSG – we’ve taken the essential elements and we’ve put it into a delivery model, a form factor at a price point enabled by a mobile application that inherently is more scalable and more accessible to more people.
And so that I would absolutely agree is what we’re doing here, I think does it have the potential to be disruptive? Sure but I don’t think that’s our goal, I think our goal is once again to help people really understand and solves their sleep problems and one of the best ways to do that is to give them easier, more affordable access to clinically valid tools and technology that gives them insights.
How important is FDA regulation for sleep technology companies?
JM: How important would you say is standardization, regulation and recognition by bodies outside of industry and commerce?
MK: I view sleep as fundamental critical part of a person’s health and well-being. So to me those products should be regulated, people should be required to design and develop and manufacture those products with a high degree of standards, they should be required to clinically validate the accuracy of the information that those devices capture and I believe that should be the case for one or two particular reasons.
One, we’re asleep while we’re sleeping so if people are actually going to believe the information that comes off these devices, they need some third-party endorsement and validation to have more belief, more faith that the information coming off these products are actually accurate and insightful and presented above their real sleep.
This was one of the classic issues that we saw with overnight sleep tests, was that when you have a polysomnography you know rig put on you and you try to sleep with it, invariably you’re going to have a really poor night of sleep and so right there behaviorally the individual who did that sleep test already is discounting and not fully believing the output of that test.
So what you’re seeing is that because we cannot observe ourselves when we sleep, we need a higher degree of convincing that the information is accurate and representative.
And the FDA and doing clinical validation are just one of several ways that you can really build confidence amongst consumers that this is data that they can actually rely upon to make changes to their health in their life.
I think the other part is you know, it’s easy to sort of distill sleep into like here’s 10 tips but the reality is it’s far more complex than that. You need experts to play a role if you have a real desire to understand your sleep and to improve its quality.
This is just not something at this particular point where the individual completely on their own is going to be enough of an expert to always solve their problems on their own and that’s why we work very closely with physicians and we build our products and we capture the right data and we validate the accuracy of the data so that they also will believe in it.
And what we see right now in the sleep tech space in general is there’s a lot of products, there’s a lot of people who are trying to take advantage of the momentum that we’re seeing and it’s producing a lot of noise and it’s also leading to a lot of products of questionable accuracy.
And that over time it will bring into question in the minds of the users of the products, how accurate are any of these devices and we’ve already seen that.
That was another reason that we have aggressively done validation studies at University of California, San Francisco, at a facility in Denver because it’s both in our best interest but also in the interest of the users of our product that they understand that we’ve measured and validated everything we do and that the FDA has had a chance to look at what we’ve done and be comfortable that we’re able to satisfy the claims that we make with real evidence.
Clinical validation as a commercial advantage
JM: What about the sleep startups who don’t have the resources, or decide not to pursue, let’s say, FDA approval?
MK: Yeah, look ,we’re not a large company. I mean we’re ten people you know we haven’t raised fifty million dollars of venture capital but we made a conscious decision to do things what we believe is the right way.
And we already see that it’s paying dividends both with people who are using the product but also in the way that we deal with the existing sleep medicine industry and various partners.
So my advice to anybody is to not view clinical validation or working with appropriate regulatory bodies as a burden or as a source of friction or something that’s going to slow you down but I would view it as actually it’s, has the opportunity to accelerate the trust and credibility in your business which is ultimately going to translate into you selling more product and helping more people quicker.
I’m also thinking about it as a business leader, you know anybody can make a sensor, I mean that’s not the most difficult thing in the world, but building one that’s accurate and that’s reliable and that people place faith in, that’s a huge source of competitive advantage.
And we look at clinical validation and the FDA not just as things we have to do, it’s like these are things we actually want to do.
We actually want to do more clinical studies, we want to continue to work with the FDA because we believe that they are things that are going to set us apart and ultimately make it successful.
Other companies absolutely can choose to do whatever they would like but my perspective is that they may be missing out on a really significant opportunity that would actually help their business become more successful.
How validated products can complement existing sleep therapies and devices
JM: There are so many different types of sleep technology products out there right now. Some may fall into a ‘wellness’ category, and then there are other, more validated products like Sleep Tuner. Is there room for all these different types of products to co-exist?
MK: Oh, I think so yeah. I absolutely believe that there’s room for them to exist. I hope perhaps what will happen over time is that when you have products like the Sleep Tuner which are very accurate – they’re gathering clinically valid information – that our product can actually be used to sort of measure the effectiveness of some of these consumer health and wellness therapies.
And what we may find is that while they are not formally regulated by an organization like the FDA or maybe they haven’t done formal clinical studies, they actually may be highly effective for a certain population of people back to the earlier discussion about democratization.
I mean we’ve sort of built a sleep test that now a person can buy online, a person can use multiple nights from the comfort of their own home.
We’re already being approached by people that market therapies and they want to use our product to do lower cost validation of the accuracy and effectiveness of their therapies.
So that’s sort of an unintended positive consequence of what we’ve built. We are beginning to help these companies actually quantify how effective their therapies are probably in a much less expensive way than if they had to go through a traditional formal clinical study and through a 510 K process with the FDA.
Offering more than sleep hygiene solutions
JM: How does Sleep Tuner hope to make an impact in the issue of under-diagnosing problem with sleep apnea?
MK: Well I think if we look at our primary focus, it is people who have actual sleep disorders and versus they have sort of sleep hygiene issues and you know in the US between insomnia and apnea, the two largest sleep disorders that’s you know ninety to a hundred million people.
So I think given the makeup of our team and the fact that we’ve got a lot of experience in health care and medical device development, we’re more drawn towards helping people who have a physiological or a psychological cause to their sleep issues than necessarily focusing on people who have sleep hygiene issues.
That’s one of the reasons that we went through the FDA, it’s one of the reasons that we’re on a path to become approved and cleared as a home sleep test diagnostic because there’s a huge population of people there that, there’s very few simple things they can do to improve their sleep.
It’s not about caffeine, it’s not about too much blue light, it’s not about the temperature of their room or about light coming into their room.
Those are things we can control, the physiological and psychological causes, that’s the group we feel needs our type of a product and a more dedicated focus to really making it more accessible for them to understand and ultimately solve the causes of their sleep issues.
Working with employers and the health professionals
JM: Apart from the consumer market, Beddr is very much geared up to work on a B2B basis, with existing healthcare professionals and industry as a whole.
MK: Well we have right now, we have a number of paid pilots in place with employers and so if you look in the US, the incidence rate of apnea is about 22 percent of the adult population.
So you know if you’re an employer who has 50,000 people, you have a huge population of individuals who are likely to be undiagnosed and untreated a condition like apnea and it’s the company because they’re self-insured that actually is bearing the financial cost of that but they’re also bearing the productivity cost and the liability issue related to somebody who’s excessively sleepy all the time.
So what we found early on is that one of the ways to actually help effect positive change for the individual is to work through their employer who oftentimes will provide our product at a, with a subsidy.
So it just makes it more accessible and then the employer also acts as an endorser of our product and the program which gives a lot more confidence to the employee that this is something that they can trust and that has been proven to be helpful to an individual like themselves.
And so I think what we’re going to find with sleep medicine in general is the clinical path is still going to be critically important, it’s not going away, we’ll continue to be where it is, if not more important.