Consumer Electronics Show (CES)

January 5-8, 2016; Las Vegas, NV Full Report – Draft

Executive Highlights

In this report, we bring you our full coverage of CES 2016 in Las Vegas, NV – three days of insights on digital health, fitness tech, apps, precision medicine, and more. Highlight of the meeting came from IBM CEO Ms. Ginni Rometty’s keynote address, who shared – alongside Medtronic CEO Mr. Omar Ishrak – that the first product to come out of the companies’ partnership (a predictive hypoglycemia mobile app) is slated to launch this summer. On the exhibit hall floor, Dexcom had a more spacious booth than at prior CES meetings, which focused on the recently launched G5 Mobile system (no product updates) while NeuroMetrix announced that it has received FDA 510(k) clearance for an upgraded version of Quell – it will launch in March with improved sleep tracking, battery, app-based control of the device, and other features. Other notables included an inspiring panel discussion with Fossil Group President Mr. Sonny Vu on needs in wearables and perspectives on the past, present, and future of digital health from Boston Consulting Group’s Mr. Chris Bergstrom.

Leaving CES 2016, we were disappointed that the conversation around digital health has not progressed much farther in the past year. There continues to be a TON of enthusiasm for the future, though commentary continue to harp on the same challenges we heard in 2015: patients don’t want to pay for anything, behavior change remains highly challenging, providers can’t deal with the data, payers don’t have the right incentives, and data is siloed. We’ve been hoping the conversation would turn to more actionable proposals by now and we would like to hear more of what’s working well – what are the success stories? What’s holding the field back for the different constituents? Which barrier is the biggest? Which barrier is the most addressable? And which barrier simply need time? Is technology the limiting factor? Has the medical field had trouble embracing digital health? Do we need more data and pilots to substantiate these solutions? In our view, it certainly seems time to move past the optimism – we know digital health is AWESOME for those who use it – and get to the pragmatism and really dig into the important unanswered questions. How do we convince patients to pay? How do make behavior change something people want to do? How do we show payers value? How do we consolidate our disparate data?

We share our comprehensive coverage below.

Table of Contents 

Keynote

Keynote Address

Ginni Rometty (CEO, IBM, North Castle, NY)

During her p-a-c-k-e-d keynote lecture, Ms. Ginni Rometty invited Medtronic CEO Mr. Omar Ishrak on stage to co-announce that the first product to come out of the companies’ partnership – a predictive hypoglycemia mobile app – is slated to launch this summer (2016). The software uses the Watson super computer to analyze CGM data, glucose trends, carb data, pump/insulin data, and patients’ glucose history to predict future hypoglycemic events within three hours of bolus insulin delivery.  This partnership was announced last April (pretty fast movement!) and we first saw this exploratory analysis at DTM 2015, where Dr. Rebecca Gottlieb, longtime research leader at Medtronic, said the hypoglycemic prediction has 80-90% accuracy following bolus insulin delivery. Today’s mockup of the “glycemic advisory” function that Mr. Ishrak shared was the first we’d ever seen – see an image below! The first-gen app will be compatible with both Android and iOS systems at launch and will leverage real-time data coming from MiniMed Connect (though management noted that as more connected devices come to market, they will share this capability). The app is designed to be used for those not on automated insulin delivery, where the hypoglycemia prediction could be valuable in certain circumstances – e.g., eating a meal of a given carbohydrate content and receiving a notification that “You are likely to go low” within the next few hours. We would note that the system – as it was presented – seemed reliant on accurate carb counting, which is a challenge for all patients – but we all have to walk before we can run, of course! At launch, the app will function exclusively with Medtronic CGM though we found it intriguing to hear the company’s vision for making it usable “more broadly” in the future. We do wonder what that means!? We would also love to see this kind of mobile solution work with all CGM systems and we do not know the extent to which the deal with Medtronic is exclusive, but no doubt Google and Microsoft could also jump in. This may already be in the works with Dexcom, or even done, with another manufacturer who is not IBM – it does beg the question which Big Data leader Abbott is working with since it has the device most likely to be worn by type 2 patients at least near- and medium-term. The new app from Medtronic and IBM does not yet have regulatory clearance, though presumably interaction with the FDA has been positive enough to forecast a launch this year – as we understand it, the first version will represent just the first in a cadence of releases, such that features requiring less regulatory oversight will precede those that require more stringent review. Overall, the app looks to be a very safe foray into real-time diabetes decision support – an uber CGM prediction alarm for lows – and we look forward to seeing how effective it is, how many false alarms it generates, how burdensome information entry is at the start, how frequent the notifications will be, if there are associated hassles and what they are, and how much better it is than CGM-only based hypoglycemia prediction alarms. Certainly, it’s outstanding to see Medtronic and IBM moving quickly to bring actionable software to market, and this has important potential to address a massive problem in diabetes. 

  • Notably, Mr. Ishrak characterized the app as the “tip of the iceberg” in a broader diabetes ecosystem. He shared a compelling vision for the future in which Medtronic would leverage technology adjacencies (e.g., activity trackers) and Watson’s population-level analytics (e.g., “What has happened to other patients like me when they have taken X boluses of insulin at a glucose level of Y?”) to generate even more clinically relevant insights. This is really exciting, isn’t it? More than anything else, it was clear from both his tone and passion that the hypoglcyemia app is just a starting point for Medtronic – not simply in terms of expanding to other disease areas but delving into more intricate analytics within diabetes itself. This was great to hear from Medtronic’s CEO, as the company’s Diabetes division post-Covidien acquisition is now just ~6% of company sales – but it will impact healthcare in such a big way if more patients can do meaningfully better with its tools.
  • Ms. Rometty herself shared big-time enthusiasm for the dawn of the “new cognitive era” (e.g., computers that can learn like Watson), which she believes will be the most transformative trend in the future of the internet of things (IoT). Ms. Rometty explained that cognitive IoT involves infusing connected devices with the ability to understand, reason, learn, and generate their own hypotheses and confidence levels to help people make data-driven decisions. She emphasized that technology and data are everywhere, and that the challenge is to go beyond capturing and storing data to understanding it. According to Ms. Rometty, this will require cognitive IoT like IBM’s Watson, which now has 32 different functions and 50 different technologies available via API. The company is expanding Watson to have other senses such as sight, and is opening it as a cloud platform so anyone can “build thinking into their devices.” Ms. Rometty ended her keynote with the big statement, “I believe every decision mankind makes will be better because of Watson cognitive technology.” We appreciated Ms. Rometty’s vision and clear optimism, and are eager to see Watson’s cognition translate into truly improved real-world outcomes.
  • For more on Watson’s potential capabilities in diabetes, see our coverage of the Novo Nordisk partnership from December (not mentioned today) and the original Medtronic partnership announcement.

Predictive Hypoglycemia App Mockup

NextGen Digital Health Consumers: The X Games

From Geek To Chic: Digital Health Goes Mainstream

Sonny Vu (President, Fossil Group, Richardson, TX), Preston Moxey (GM, Misfit, San Francisco, CA)

Fossil Group President Sonny Vu and Misfit GM Preston Moxey teamed up to deliver spectacular insight on how the newly partnered companies (Fossil acquired Misfit in November) are united in a quest to infuse the Misfit/Fossil brand with an emotional ingredient that has been lacking to date in the wearable space. This was one of our very favorite presentations of CES 2016, not just for what was said but HOW it was said – the passion and consumer-centered ethos guiding both panelists was absolutely inspirational. Through vivid stories and examples, they discussed the shared vision that inspired this partnership (“Why not make step counting invisible?”) and their ultimate goal of making wearables fashionable. Why has this not happened yet? Mr. Vu reprised a number of pain points in the field from a lack of wearable durability and battery life to the fact that fashion and emotional connection are not prioritized in wearable design. Healthcare was not discussed specifically, though we felt this talk had so many broader learnings for diabetes, especially glucose sensors  – whether it was how to think about any on-body device (“For wearables to work, you have to wear them and you have to wear them ALL the time”), patient adherence (“There HAS to be an emotional connection”), or listening to the consumer (Misfit shelved the concept of screens on wearables based on user feedback). Both panelists were remarkably charismatic speakers, and we include below a handful of our favorite quotes in addition to details on all the above.

  • Misfit/Fossil’s goal is to build devices that people want to wear for the brand and design, not simply for the functionality. After all, the best wearable device is useless if it sits in a drawer. Mr. Vu shared data from user studies indicating that after three months, wearable use typically drops off. Why? Because there is no emotional connection in the same way that consumers feel connected to Nike shoes or Apple laptops. As Mr. Vu shared, this I-can’t-live-without-it mantra needs to be the field’s goal.
    • Mr. Vu also shared a striking anecdote to underscore just how successful Misfit has been in identifying this emotional x-factor. “We recently found out that 10% of people wear a Misfit without a battery [e.g., without the activity tracker actually functioning]. Why would they do this? They wanted a beautiful reminder of what they wanted to accomplish that day. How amazing is that? It just tickled me that these trackers are being used for something beyond their functionality.” We thought this was very cool and an important testament to the very impressive branding and design Misfit has accomplished through its all-metal, waterproof, interchangeable activity tracker.
  • A discussion of the challenges in the wearable space came to a relatively clear conclusion about the factors holding the field back: insufficient battery life, a lack of durability, no attention to fashion, and little alert optimization.
    • Insufficient battery life: Market research indicates that battery life is one of the biggest concerns for users. Given that fact, it is unfortunate that digital health companies do not strive harder to address the inconvenience of charging devices. One of the cornerstones of Misfit products is that they are designed to last for six months on a single battery. We love this principle and were even more impressed to reflect on the way the company builds functionality around consumer priorities (as opposed to the other way around, which is all too easy in diabetes). Of course, tackling battery life is no easy task for a startup, and it comes with product design tradeoffs (e.g., longer battery life can mean a larger device).  
    • Lack of durability: Stories of consumers who buy a wearable product only to have it break after a few weeks are all too common, a result of an industry that has not always prioritized high craftsmanship and long-term durability. Part of this is a result of expectations – consumers don’t want to pay for a $500 activity tracker (though we’d point out many are willing to pay for a $300 Apple Watch!). With that in mind, Mr. Vu pointed out that activity trackers not only have to be built to last, but have to be built at low cost if they are to appeal widely.
    • Lack of attention to fashion: Wearables need to look good and be a part of the consumer. As Mr. Preston noted, “When something goes on the body, the rules change.” In other words, it’s not just about functionality anymore, though this is not the way the wearables space has traditionally been approached. This is certainly true of CGM, which are pretty far from fashionable. FreeStyle Libre has been a step forward on this front, though we think companies can do much more to make the product look more “normal.”
    • A lack of notification optimization: The ability to communicate with wearable users through lights/vibration was acknowledged as a blessing and a curse. On the negative side, Mr. Preston stressed that very little research has gone into understanding the balance between deriving benefits vs. minimizing fatigue. This is, of course, a key question in CGM optimization as well and we found many parallels to diabetes in the ensuing discussion. Mr. Preston, in particular, spoke to the fact that consumers are often overwhelmed by wearables alarm fatigue and information overload (CGM!, CGM!, CGM!), noting that alerts can very easily be seen as a nuisance. As he positioned it, the wearable field has yet to find that perfect balance – perhaps once they figure it out, they can share the secret sauce with those of us in diabetes!
  • “Wearables and fashion are two worlds and consumers are in the middle. We have to get in the middle and there are only a handful of people that can do that.” We thought it was intriguing to hear successful digital health solutions described as occupying a relatively unique niche between fashion and wellness. Apparently, this is the reason why Fossil’s fashion expertise has complemented Misfit’s tech background following the acquisition last November. “Misfit was missing everything that Fossil had … Fossil was missing everything that Misfit had,” echoed both panelists. We look forward to seeing what the companies roll out at the intersection of these two worlds.
  • Both Mr. Vu and Mr. Preston were remarkably charismatic speakers, and we’ve included some of our favorite quotes from the discussion below:
    • “Great design is sometimes about what you don’t do, what you say ‘no’ to.” – Mr. Vu
    •  “Misfit is not going away. It’s going to take over the world.” – Mr. Preston
    • “Lights and vibrations give us the ability to communicate through the wearable. It’s one of those things that socially and culturally can change the game. Intellectually, we don’t have to feel so tied to our phones. The potential to use wearables to break that dependency is really powerful. Subtle haptic feedback can be a powerful driver for change.” – Mr. Preston
    •  “To be clear, we don’t make any medical devices nor do we have plans to do that anytime soon. Will we later? I don’t know. The idea is for us to play a role in the world and affect change. If you’re talking about wearables in healthcare though, there are a number of important considerations: Will the data that is generated be taken seriously? Can you clinically validate it? Can you show efficacy? Can you connect it to outcomes? I think it will take time for the medical community to really accept digital health solutions.” – Mr. Vu
    • On implanting a fitness tracker: “I think surgically implanting watches is awesome, but you’ve got to be socially and morally mindful. Perhaps there is a time when that will be possible and when it is acceptable, I have no doubt it will be done. That said, implantable devices come with a risk right now and all the data we have suggests that consumers are not comfortable with it. Plus, technology moves so fast, why would you want to do something permanent?!” – Mr. Preston
    • “For wearables to work, you have to wear them and you have to wear them all the time. Not just for the hour you are going for a walk. It’s about the other 23 hours.” – Mr. Vu
    • On the speed of technology: “We’re going to be releasing over 100 wearable products over the next year!” – Mr. Vu

BOOM! Opportunities Explode in US and Beyond

Back to the Future: Digital Deloreans Take Flight

Chris Bergstrom (Associate Director, Digital Health, Boston Consulting Group, MA)

A lightning-quick 10-minute talk from Mr. Chris Bergstrom tackled a very tough question – where are we in the digital health lifecycle? – and offered a framework to describe the field’s trajectory. He provided a fascinating analysis of the past, present, and future of the field, echoing many of the ideas he shared with us in our October 2015 interview with him. That said, we loved the way he added to our discussion last fall and divided digital health into three eras (“The Era of the Wild West”, “The Era of Partnerships, Acquisitions, and Collaborations”, and “The Promised Land”) and, judging from the laughter he received from the audience, we certainly were not alone. We felt his summary was one of the best high-level reflections on digital health we have heard to date and have replicated that analysis below:

  • 2010-2015: “The Era of The Wild West.” Mr. Bergstrom opened by impressing upon the audience the infancy of the digital health movement. In fact, the term “mHealth” – as he noted from Google analytics data – only began to take shape five years ago and one that has developed in an appropriately chaotic and lawless manner for something so ambiguously and broadly defined. He also alluded to the way stakeholders have complained about the slow progress of innovation in digital health over the past five years and noted that this angst stems – in his view – from unrealistic expectations. Indeed, he characterized the last five years as a time of successful idea generation, during which various stakeholders (FDA, entrepreneurs, providers, patients) have had to become comfortable with the field while impressing upon the audience the five major ways in which change HAS taken place:
    • Dramatic technological progress. From flip phones to iPhones and laptops to iPads, Mr. Bergstrom noted that technology is allowing us to do things that we weren’t able to do five years ago. This has been for the better though it has also meant that the digital health movement often must follow in the wake of general technology evolution.
    • “The way we think about digital health has changed.” Few were familiar with digital health five years ago and even among those who were familiar, there was a general skepticism about the potential. Could that be further from the truth today? Mr. Bergstrom stressed that digital health is widely seen as a necessary component of the future of healthcare … a mindset that represents a 180-degree turnaround in attitude.
    • Regulatory landscape: Mr. Bergstrom implored the audience to remember how far the FDA has come on digital health. Certainly, this is a more forward-thinking, patient-centered group than the regimented organization of a few years ago and one that deserves more credit than they have received for their willingness to embrace flexibility, agility, and patient needs. We have heard lots of praise for Associate Director of Digital Health Mr. Bakul Patel. As a result, we have better guidance that removes significant risk from investing in digital health.
    • Reimbursement: The importance of the transition from fee-for-service to value-based healthcare may seem obvious, but this movement will increasingly become a wind at the back of digital health.  
    • Investment: Mr. Bergstrom contrasted – to the audience’s great amusement – the struggle WellDoc faced five years ago raising just $35 million vs. the field’s impressive $4.3 billion invested in digital health in 2015. Of course, it’s worth noting that funding was flat in 2015 vs. 2014, which could suggest any number of things: fewer startups to fund, more saturation, less investor confidence, more happening at big companies, etc. 
  • 2015-2020 – “The Era of Partnerships, Acquisitions, and IPOs.” Now that the industry is comfortable with the concept of digital health, Mr. Bergstrom noted that the next five years will be about collaboration and consolidations between large and small companies. He identified the big entrants in the digital health space (Google, Samsung, Apple) along with the large healthcare companies (biopharma, medtech) that are “on the former’s coattails,” forecasting that the diversity of players is going to bring fantastic perspective to the field in the coming years.
    • Notably, Mr. Bergstrom labeled 2015 “the year of the horizontal platform.” He highlighted the emergence of IBM’s Watson, Apple’s ResearchKit, and Walgreen’s digital health platform and predicted that with these solid horizontals in place, the field is set up to allow verticals (e.g., diabetes, orthopedics, cardiac) to proliferate. He did acknowledge that the digital health revolution is going to be a long cycle though the subtext was that the foundation for maturation is now – finally! – in place.
    • Speaking from his five months with the Boston Consulting Group, Mr. Bergstrom shared a recent trend he has observed in C-level executives. We thought his perspective was fascinating – “All of a sudden, this C-level group is saying that we have to do digital health. We HAVE to. We don’t necessarily know what that means yet, but it’s no longer a question. They want to move to where they are taking advantage of it and realize that they are going to get left behind otherwise. That sureness and attitude is something I haven’t seen before. And let me tell you, the fruits of this are going to play out in 2017 with acquisitions and roll-ups and partnerships and IPOs.”
  • 2020-2025: “The Promised Land” – Mr. Bergstrom concluded that the subsequent five years are when we will see the significant penetration of digital health technologies. Of course, this means that we are a 5-10 years from the real “promised land” – which is disappointing, to be sure – though Mr. Bergstrom was optimistic that a healthier future is on the horizon.

Company Updates

Next-Gen Quell Receives FDA 510(k) Clearance

NeuroMetrix announced that it has received FDA 510(k) clearance for an upgraded version of its widely praised Quell Wearable Pain Relief Technology; the next-gen product will launch in March 2016. The device features a number of new capabilities relative to the first-gen product: (i) extended battery life (~one day longer); (ii) the ability to control Quell through a mobile app, meaning that users can power on/off the device and increase/decrease therapy levels through their phones rather than having to physically press buttons on the side of the device; (iii) more sophisticated sleep tracking technology; (iv) more detailed therapy tracking over three months; and (v) an alternative stimulation mode that gives users a fast gentle pulse instead of constant vibration for more customizable pain relief. We assume the price will will be the same ($249 initially + $30 per month for sensors), and current Quell users will be able to upgrade for free. NeuroMetrix’s exhibit hall booth did not actually advertise the FDA clearance, though reps were more than happy to share the good news in person, stressing the big impact Quell has already had in users. As a reminder, the company reported diabetes portfolio revenue of $1.5 million in 3Q15, marking an all-time record reflecting the success of Quell’s recent launch in 2Q15. We believe Quell is a terrific, well-designed device that is helping a lot of patients with neuropathy, some to life-changing effect. We hope this product can scale widely and help many, many more people with diabetes. 

IBM + Medtronic

IBM and Medtronic executives shared the stage twice on Thursday to discuss their partnership and new hypoglycemia-prediction app (unveiled earlier in the conference, launching this summer), expressing big-time enthusiasm for the power and utility of cognitive computing; it is clear that there is a TON of internal confidence in this new diabetes platform. Indeed, we got our first in-person glimpse of the app at an IBM-hosted morning breakfast (that was quite well attended despite that it happened at 7:45 am) and heard more enthusiasm in a few minutes of afternoon discussion that brought the very impressive Medtronic President of Diabetes Service and Solutions Ms. Annette Brüls on stage with IBM Watson Health’s Chief Marketing Officer Mr. William Evans. Ms. Brüls added more color by pointing out that that the ultimate goal is to create a personal diabetes assistant that can both predict trends and provide recommendations for intervention. She drew a distinction between the closed-loop predictive analytics and the Watson-powered predictive analytics – the latter apparently being far more accurate and powerful thanks to the context brought to bear by multiple data stream interpreted via Watson. It’s excellent to see IBM and Medtronic making an announcement of this significance just nine months after partnering, and we look forward to testing the app this summer. See our more detailed coverage from yesterday of the app’s functions and our questions.

Data in Action

Validic Demo

Drew Schiller (Co-Founder and CTO, Validic, Durham, NC)

Digital health data aggregator Validic unveiled a very cool new Android/iOS app – VitalSnap – that enables patients to record data from non-connected digital health devices (such as BGMs!) via their smartphone’s camera. The app uses optical character recognition to capture numerical readings from the screen of devices (e.g., thermometers, blood pressure cuffs, glucose meters, etc.), enabling real-time data transfer to the app and shared with providers – see a very cool three-minute video here (it’s really worth a look and we strongly encourage you to watch it). Validic’s laudable aim is to help overcome the low penetration of connected devices and the barriers that limit the user experience in non-connected devices (e.g., connecting to a computer, keeping a manual log of measurements). It is our impression that the app was not subject to regulatory oversight, since it does not provide specific treatment suggestions. That said, the app does seem to sit in the grey zone of the FDA’s Mobile Medical Apps final guidance (February 2015), and we can imagine that there is some risk if data is being sent to providers who may use it for making clinical decisions. MySugr has had this exact capability for a while now for six well-known BGMs via its Importer app (see a video here), but Validic’s version seems to be brand and device agnostic. We love any effort to make data acquisition easier, and this seems like a very clever solution that could unlock a lot of traditionally inaccessible health information. We do have a number of questions: (i) The app seems to rely on taking a picture of the medical device immediately after a reading is displayed; will patients actually do this in practice? (ii) How will the data be processed and analyzed on the back end? A big point is that providers presumably won’t look at every reading, so knowing how the data will be aggregated and analyzed in some logical way is key – this may be very helpful to patients as well, depending on how it is organized. (iii) How accurate is the optical character recognition? Does it only work for certain types of screens? 

  • For context, North Carolina-based Validic is best known for its cloud-based technology platform that connects patient-recorded data from digital health applications, devices, and wearables to key healthcare companies (e.g., hospital systems, pharmaceutical companies, payers). The company aims to solve the accessibility and integration challenges for healthcare organizations by providing a “one-to-many connection” to digital health technologies.

Data: Digital Health’s Secret Weapon

Ray Lee (Head of Product Management, Proteus, Visalia, CA)

Proteus Digital Health’s Head of Product Management Mr. Ray Lee attracted our attention with a brief reference to structured glucose testing as a mechanism of patient engagement in healthcare. As a reminder, Proteus’ embedded sensor communicates with a wearable sensor patch and a medical app for measuring adherence. For context, Mr. Lee shared the commentary as a single example of connecting behavioral data (e.g., activity) with outcomes (e.g., glucose) in medicine, which he noted can be particularly valuable in diabetes management. This reinforced that diabetes remains on the ingestible sensor company’s radar, even though it hasn’t been a major public area of focus. We’ve been following Proteus for more than five years and continue to believe that addressing diabetes or obesity would be a major win for the adherence tracking company although we’re sure these therapeutic areas probably represent among the more challenging. Most recently, Otsuka and Proteus filed the first FDA application for a pill embedded with a digital sensor (the $7 billion blockbuster antidepressant Abilify) in September 2015. For more, see our 2014 coverage of the company’s $52 million round of Series G (!) financing and our coverage from SXSW 2015. We continue to hope that diabetes is a possible avenue!

Taming the Health-Tech Wild-West: It’s Just Business

How Collaboration Catalyzes Transformation

Sandra Peterson (Group Worldwide Chairman, J&J, New Brunswick, NJ), Amy Foley (VP, Product Innovation & Delivery, J&J, New Brunswick, NJ), Luisa Monge (Director of Business Development and Strategy, Microsoft, Redmond, WA), Kevin McRaith (CEO, WellDoc, Baltimore, MD)

The only Summit panel that discussed diabetes at length included Ms. Sandra Peterson (who oversees J&J’s Diabetes Solutions), Ms. Amy Foley, Ms. Luisa Monge, and Mr. Kevin McRaith. Notably, the purpose of the panel was not to discuss diabetes though the presence of both Ms. Peterson and Mr. McRaith appeared to steer the discussion in the “right” direction. Indeed we were pleasantly surprised to hear all four speakers mention diabetes in the discussion, speaking quite positively about the power of digital health to empower patients to better manage chronic conditions. We have summarized the most notable points of discussion below.

  • Mr. McRaith acknowledged that the digital health space in diabetes care (and, of course, in healthcare broadly) is still very much defined by chaos. He noted that multiple startups come into the field with a lot of audacity and the belief that they have the Holy Grail, only to experience through trial and error the great challenges of working in healthcare. Indeed, we appreciated his candor: “Nobody has yet cracked the code of how to make this work.” That isn’t to say there isn’t reason for optimism though he was clear that real systemic disruption is still years away. WellDoc’s partnership with Samsung was mentioned near the end of the panel as an example of the importance of working collaboratively across stakeholders in medicine. Mr. McRaith did not share an update on future plans though did express a great deal of enthusiasm for what has been learned through the effort. For more coverage of WellDoc and Samsung’s relationship, see our report on WellDoc’s recent $22 million round of Series B financing and answers to the question many are asking: “Why hasn’t BlueStar scaled faster?”
  • On the regulatory front, Ms. Peterson and Mr. McRaith shared heaping praise for the FDA’s forward-thinking regulatory mindset on digital health – “the FDA has evolved significantly” and “the Agency is changing its view of what a trial looks like and what an endpoint looks like.” They contrasted the regulatory environment of two years ago with the more open mindset of today, making it clear that the FDA appreciates the need not to overregulate this field. There is still much room to improve but the overriding sentiment of the panel seemed to be that things are trending in the right direction. We would agree! See our 2015 Reflections piece for examples of this theme, particularly downclassifying secondary display of CGM data, approving Dexcom G5 in just six months, and a three-month pivotal study for the MiniMed 670G. 
  • Much to our surprise, Ms. Foley delivered very patient and health-centric remarks as well: "One of the key leaernings for us is that there is a need for relevant insights in healthcare … you’ve got to keep the patient in mind at all times.” We loved hearing this attitude from the tech giant given recent speculation that the company is interested in expanding into digital health, much in the same way that other big technology companies – namely Google and Apple – have shown recent interest. These are early but exciting times in the field and Microsoft’s presence alongside J&J and Welldoc speaks wonders in and of itself. 

Skin Crawling Technology - LIVE DEMO!

Ben Hwang, PhD (CEO, Profusa), William McMillan (CSO, Profusa), and Kit Yee Au-Yeung (VP Products, Profusa, San Francisco, CA)

Three Profusa executives led a series of demoes illustrating that their implanted sensor can deliver accurate and real-time tissue oxygen data to help patients manage their health. Diabetes was mentioned, though there were no updates or accuracy data on the sensor’s potential application to glucose monitoring. The oxygen sensors were placed in the leg and arm of Mr. McMillan (and in the arm of Ms. Au-Yeung) and showed appropriate increases/decreases in oxygen concentration when presenters performed activities (e.g., inflating a blood pressure cuff) that disturbed tissue oxygen levels. It was a neat proof-of-concept of Profusa’s work to develop a tissue-integrating scaffold that can be used as a platform for fluorescent sensing of a number of different analytes, including glucose. That said, we have not seen any glucose monitoring accuracy data from the company and were hoping Dr. Hwang would provide an update or share new timing. He did discuss the potential application to glucose monitoring in depth (it was highlighted both on a slide and in a video that he presented) though it remains unclear how the company is prioritizing glucose sensing vs. other work. The Profusa team has worked for many years on fluorescent glucose sensing and we’ve watched them since we first heard of the South San Francisco-based company at DTS’ 2014 Meeting on Implanted Medical Devices. For now, the jury is still out, and we wonder whether a bigger player might consider licensing or acquiring the intellectual property once the technology moves further along.

Connectivity: The Tycoon of Health

Connecting the Dots and Closing the Loop

Richard Migliori, MD (Executive VP Medical Affairs & Chief Medical Officer, UnitedHealth Group, Hopkins, MN), Marco Peluso (CEO, Qardio, San Francisco, CA), James Mault, MD (VP & Chief Medical Officer, Qualcomm Life, San Diego, CA)

A running discussion of barriers keeping the medical community from embracing digital health resulted in a relatively clear consensus on what’s holding the field back – the need to change clinical practice. The sentiment was expressed in different ways, though we felt UnitedHealthcare’s Dr. Richard Migliori said it best: “Back in the day, as a doctor, your concern walking into your waiting room was all the patients lined up there. Today your biggest concern is the patients who are NOT there.” His words made it clear that the success of digital health solutions will not be defined by new technology, but by new ways of interacting and reaching patients who aren’t getting care. Qualcomm CMO Dr. James Mault echoed this concern, stressing that the “transition to value-based care” demands rethinking the way physicians are trained in medical schools (e.g., valuing outcomes over procedures) and rethinking the way medicine is delivered on a day-to-day basis (e.g., eliminating unnecessary and routine checkups). Simply put, what the field needs is a behavioral revolution assisted by technology – not a technological revolution in itself. In the midst of scientific discussions that characterized much of the Digital Health Summit, conversations continued to return to fundamental issues of trust and behavior, underscoring the key role psychology and social norms are going to play in scaling digital health. How do we show doctors that digital health will make them more effective? How do we show patients that it’s worth their time and expense? How can companies help change clinical practice? In a risk-averse profession that is hundreds of years old, what role can and should technology play? How do you convince patients that gathering data is worth it – the burden is high, the benefits are not immediately apparent, and making the wrong choices does not have consequences for years.

  • To illustrate the power of technology, Dr. Migliori shared the common example of logbook forging in his diabetes patients: “I used to work with many patients who had diabetes in my practice. They would all bring in their logbooks and what was interesting is that every day in the logbook was written with the same pen. So, I decided to put green pens in my exam room. Over the next few weeks, not only were the logbook readings recorded in the same color but that color was green! [Laughter.] They were filling it out in the office! They were making it up on the spot! So, this is the power of technology. We can actually see their progress. It’s eye opening. It opens the door to really meaningful conversations with our patients that we couldn’t have before!” It was one of the few diabetes examples of the day, but a valuable one for everyone to hear that hadn’t heard it before. We’d love to see, of course, not only technology used better but in a much more standardized way so that patients and clinicians are looking at the same measures.

Connectivity and its Disconnects: Breaking the Engagement Mold

Bill Evans (SVP of Innovation, Bridge Design, San Francisco, CA)

In a brief 10-minute presentation, Bridge Design SVP of Innovation Mr. Bill Evans outlined four critical areas for creating successful medical devices. We felt that many of them were valuable considerations for companies trying to innovate in the medical field, and have replicated them below.

  • Understand the broad context of the disease, and probe it where you can add value. We think this is important and often overlooked advice. Many devices come to market that don’t add real value (e.g., a connected BGM that doesn't share data), or don’t fit into the broad context of disease (e.g., apps that ask already-burdened patients to do more work for no obvious benefits), or go too narrow (e.g., targeting early adopters with type 1) or too wide (e.g., helping everyone with diabetes) to build a realistic business.
  • Cut through the “hype” of engagement and use evidence-based research to drive your product design. Mr. Evans emphasized the need to study what motivates patients and what helps them change their behaviors. The challenge, of course, is that this is different thing for different people. He also raised the important point that patient adherence isn’t the only concern; physicians also require motivation to stay engaged.
  • Choose your technology and design to make your product get used, not just be “cool” and “new”. He noted that in terms of wearables, its time to think beyond the wristband. Indeed, we’ve seen this at CES, with sensors embedded in belts, headphones, shoe insoles, and even sports bras. Mr. Evans also urged audience members to “cannibalize” their own products and expand their teams’ skill sets, and to move advances from the unregulated world to the regulated world as soon and as quickly as possible. That last piece is also often overlooked – many devices start and end in the non-regulated phase, which can brings additional business model, competitive, and engagement challenges.
  • Understand how the FDA affects your product and the way you’ll need to develop it. While this may sound like a no-brainer, it’s obviously a key consideration for new entrants into the medical field.

Harnessing the Power: Precision Medicine and Genomics

Nature vs. Nurture Debunked: The Power of our Genes

Deepak Chopra, MD (Founder, The Chopra Foundation, Carlsbad, CA), Rudolph Tanzi, PhD (Professor of Neurology, Harvard University, Cambridge, MA)

In a passionate panel discussion, NYT best selling authors Dr. Deepak Chopra and Harvard Neurology Professor Dr. Rudolph Tanzi suggested that holistic virtual reality (VR) treatment could be used to prevent and treat a variety of chronic diseases. According to both doctors, disease-causing stress and inflammation can be addressed long before disease occurs through the use of technologies that monitor stress/inflammation signals and create therapeutic experiences for patients via VR and other mental exercises. Indeed, low-tech sessions of altered consciousness have already shown promise in altering biochemical markers of inflammation and disease. Dr. Tanzi shared study results showing that after a week of meditation, participants’ markers of inflammation, Alzheimer’s, and aging were radically reduced. In fact, their gene patterns differed so much from controls that their genes alone could predict – with 96% certainty – who had meditated and who had not (!). Though still in its early stages, this kind of research illustrates the powerful role of mental experience in altering gene expression (epigenetics) and disease markers. Dr. Chopra expressed enthusiasm for these methods of personal data analysis and experiential treatment, which he believes can ultimately create behavior change and lead to a new era of prevention, reversal, and predictability. Said Dr. Chopra, “We are looking at experience; where does your experience change your biology? By changing the way you think and feel, we can ultimately change behavior.” Though their remarks tended to be a bit vague, Dr. Chopra and Dr. Tanzi were persuasive in terms of how the healthcare field could start thinking about the union of technology, physical health, and behavior. Behavior change presents a massive challenge to medicine, especially in diabetes and obesity, and technology might be the ticket to providing behavioral interventions to the masses. Will guided meditation, virtual reality, and other mental exercises be built into next-gen Fitbits, Apple watches, and other wearables? Could the power of this potential be a driver of Facebook’s Virtual Reality Oculus Rift?  We can imagine a powerful RCT designed to test the potential, particularly given that meditation is largely becoming recognized as useful but challenging to do unaided.

Look Who’s Talking: Newborn Genomic Data Enables Precision Medicine

Aaron Black (Director, Inova Translational Medicine Institute, Falls Church, VA), Andy Dé, Global Managing Director, Tableau, Seattle, WA)

A panel on the future of genetic testing put the promise of precision medicine in compelling terms – “This is the closest man has gotten to playing God” – though also contrasted this enthusiasm with much skepticism for the hype that has recently defined the field. Indeed, speakers opened by acknowledging that precision medicine research has taken big strides of late, pointing in particular to recent successes in the field such as the emergence of CRISPR technology (a gene-editing platform) in genomics. Others predicted, though, that those same successes may have unintended consequence as the triumphs have contributed to the unrealistic expectation that that precision medicine is going to pay off in the VERY near future. Is that the reality? The answer was a resounding “No” across the panel as multiple speakers were quick to paint a more modest picture, referencing a number of questions that remain unanswered in precision medicine: How do we operationalize the genome? What do we do once risks are identified? Who owns the data? What ethical concerns must we consider? What will screening cost today? In ten years? Indeed, these and other questions were batted about with no clear consensus, reminding us that for all the enthusiasm in this field, “precision” medicine ironically remains relatively ill defined.

  • How does this apply to diabetes? Over the past year, we have heard growing hype regarding the utility of precision medicine in this field. Is this warranted? We think the answer is somewhere in between “yes” and “no.” On one hand, the immense heterogeneity of the diabetes patient population and need for treatments to be compatible with a diverse range of lifestyles and levels of disease progression certainly makes precision medicine seems like a useful fit. On the other hand, we were reminded in this panel that genetic links are incredibly complex in all disease states and that understanding them is the first step towards developing targeted therapies. Are we there yet with diabetes? Certainly not. But are we getting there? Maybe. Ultimately, we felt this panel was most valuable for the questions it raised, serving as a reminder that small and many incremental steps will be more likely to drive precision medicine forward vs. major breakthroughs.

Move Over Step Counters

Connecting the Dots

Steven LeBoeuf, PhD (President, Valencell, Raleigh, NC)

In a broad discussion of what aspects of digital health generate the greatest anxiety for those in academia and industry, Valencell President Dr. Steven LeBoeuf put it well: “It’s the non-technological problems that keep us awake at night. Not the technology problems. You know what we say – if it’s a technology problem, we can solve it … unless it’s non-invasive glucose monitoring!” The remarks were right on the mark based on this field’s history, and it will be interesting to see what happens in the coming years with Google/Novartis’ contact lens, or with Dexcom/Google’s efforts to make a bandage CGM (minimally invasive). And of course, many would consider Abbott’s available FreeStyle Libre sensor to be close to non-invasive – from our own use, we think the benefits of non-invasive are basically there (two “pokes” a month that do not hurt). For context, Dr. LeBoeuf is quite the powerhouse in the wearable space and certainly a leading thinker when it comes to digital health. In 2006, he co-founded Valencell, a wearable technology company that develops physiological monitoring technology and licenses this technology to industry leading partners for integration with brand-name products. He boasts an even more impressive resume in digital health that includes dozens of patents in the wearable space and prior experience leading the optoelectronic biosensor program at GE Global Research.

CES Changing the Game through FitnessTech

Stacey Burr (GM, Digital Sports, adidas, Herzogenaurach, Germany)

Discussions during Wednesday’s FitnessTech Summit repeatedly returned to the exponential growth of the digital health movement, raising questions about whether self-monitoring and self-sensing have gone overboard. Multiple panelists suggested that data is only as useful as it is insightful. Said adidas GM Stacey Burr, “This QS [quantified self] movement is not just about collecting data. It’s about feedback and making it intuitive to make changes.” This point is probably 10+ years old at this stage, and we’re not sure the repetition is making things any better although products have certainly improved as has, at least to some extent (we need much more) public health understanding of the urgency of the two biggest public health problems of our time, type 2 diabetes and obesity. Let’s get to the real questions as well: Who is making data truly actionable right now? What is the single most outstanding example of biometric data leveraged for insight? What data and insight are really changing behavior in meaningful ways and which are poised to do that? And who can help make this happen faster?

The Evolution of Wearables: Sleeker, Smarter, Faster

Superpowers in Sensing

Jake Leach (Senior VP of R&D, Dexcom, San Diego, CA), Laurel Christensen, PhD (Chief Audiology Officer, ReSound, Ballerup, Denmark), Charles Yim (CEO & Founder, Breathometer, Burlingame, CA), Frank McGillin (Senior VP & GM, NeuroMetrix, Waltham, MA)

Dexcom Senior VP of R&D Mr. Jake Leach was featured in a panel discussion on “Superpowers in Sensing”. Though he didn’t share any product or timing updates, his remarks were certainly of value in explaining the value of CGM, given the non-diabetes audience, and stressing the peace of mind the technology brings and the recent strides Dexcom has made in connectivity. He highlighted the recently FDA approved and launched G5 Mobile system as an example of Dexcom’s leadership in the field, noting broadly that, “If you don’t have a really unique, powerful, and accurate sensor, you’re not going to be able to compete.” Dexcom certainly has that, and a major question will be how quickly it can get to factory calibration to match Abbott’s FreeStyle Libre. Dexcom has participated at CES for the past several years, and though this year hasn’t brought any product updates , we’re glad to see the company investing in a bigger exhibit hall presence – it paid off in its very busy Day #1 booth).

Exhibit Hall

Dexcom

In the exhibit hall, Dexcom featured a surprisingly spacious booth relative to previous CES meetings, which focused on the recently launched G5 Mobile system. Reps ran through the new mobile app, transmitter, and updated receiver (see diaTribe’s test drive), and reiterated that the company continues to work on many improvements: an iPhone app update (including a widget for the iPhone lock screen) and Apple Watch compatibility. Dexcom’s booth was significantly more expansive than in past years – the company’s prominent green signage was visible from across the expansive exhibit hall floor (we’ve had to search for the smaller kiosk previously) and the strategic investment seemed to be paying off – the booth was packed every time we walked by. Indeed, to a certain extent (and from listening to awed booth-goers), we wonder whether its unique presence as a diabetes technology company in the midst of back-to-back-to-back activity trackers drew attention in and of itself.

  • There was no commentary on pump partners or automated insulin delivery, though large signage at the back of the booth did remind attendees of the ever-growing list of closed-loop integration partners (Animas, Tandem, Insulet, Bigfoot) and data management platforms and apps (Diasend, Glooko, Tidepool, Training Peaks, Databetes). Non-profit Tidepool even had a tiny bit of real estate in the back of booth where the company’s logo was displayed in big block letters … a potential signal of the commitment to that partnership. We’ve been impressed with Dexcom’s own web-based Clarity software for viewing CGM data, though Tidepool adds integration with pumps and some other notes features that Clarity does not have. As a reminder, Dexcom’s plans for 2016 include Android G5, a new insertion device, a smaller transmitter, and a new receiver.

Fitbit

Fitbit’s just-announced fitness smart watch, Blaze, was the center of attention at its packed booth. We had a chance to try the device up-close, and we especially liked its onscreen workouts powered by FitStar, a fitness app that Fitbit acquired last year. Blaze has a large, square, color touchscreen face like the Apple watch, which is the product’s main competitor and a clear concern for newly public Fitbit. Other key features include connected GPS, music control, continuous heart rate monitoring, and select phone notifications (call, text, calendar – intentionally fewer than notifications on the Apple Watch, which are overwhelming for some). Blaze is available today for pre-order at $199.95, with global retail availability starting in March 2016. It is by no means a groundbreaking product, and it will be interesting to see how Fitbit does in the first two quarters of 2016. While the company should have a strong 4Q15 (holiday season), the activity tracker space is extremely competitive (one walk around the exhibit hall confirms that), and Fitbit’s dominance stems heavily from brand awareness and social features. Can it sustain its revenue and profitability momentum with a cadence of outstanding and affordable new products that appeal to a wide spectrum of consumers – from fitness geeks to sedentary folks? See our 3Q15 report for more.

iHealth

iHealth’s large booth displayed its family of sleek connected health devices, including its BG5 Wireless Bluetooth-enabled BGM, and the Align BGM that plugs directly into the headphone jack of a user’s smartphone and displays and stores results on the free iHealth Gluco-Smart app. The company has other connected health devices (blood pressure, fitness trackers, connected scales), and always has a large presence at CES. Though the strips and connected meters are very inexpensive ($8 for 50 strips, $16.95-$29.95 for the two meters), we don’t think this meter has gotten huge traction in the broader diabetes market (that said – given how big diabetes is coming, enormous traction isn’t any longer needed – just traction with some segment of some sub-population, as long as the economics are right, which we’re also not sure about in this case).

Misfit

Misfit’s booth boasted two new products: Ray, a cylindrical aluminum fitness tracker available on a sleek leather or rubber wristband, and Specter, a set of fitness-tracking smart headphones. Notably, in addition to tracking activity and sleep, Ray has a vibration feature that “nudges” users when they have been inactive for too long and vibrates for incoming calls and text messages – we’ll be interested to see user feedback on this (it will be a big win if the feedback can be seen as useful but not too annoying – presumably it’s all customizable and the great trick would be if it actually would prompt significantly greater activity than the device without the nudge – that would be a public health “win” in addition to “cool”). Like previous Misfit products, it has a replaceable battery that lasts for up to six months. Spector provides audio, while simultaneously monitoring fitness and exercise via Bluetooth. According to Misfit reps, Ray will starting shipping this spring for $100, and Spector is expected to launch sometime in 2016 for $100-$200. As a reminder, Fossil Group acquired Misfit in November for $260 million, aiming to merge fashion with connected devices. For Fossil, the move was a bold one in the context of business challenges: sales declined 14% in 3Q15, and the company expects a further 7%-16% decline in 4Q15.

Phillips

Philips’ booth featured its new diabetes platform prototype, a connected mobile app and online community for type 1 diabetes management developed in collaboration with Radboud University Medical Center and Salesforce. We had a chance to see a demo of the platform, which consists of an online community for private physician-patient messaging, and a simple blue and white mobile app display for patients. The app is built on the Philips HealthSuite digital platform and CareCatalyst, which securely collects and integrates patient data from BGMs, fitness trackers, and electronic medical records. It provides banner alerts reminding users to check their blood glucose, and users can also manually enter blood glucose levels, carbohydrate intake, insulin doses, stress level, heart rate, and other metrics – we’re skeptical that either of those strategies is sustainable or effective over time. Reps shared that the platform prototype is currently in clinical trials, with plans of FDA submission at an undisclosed date. We like the idea of integrating patient and physician data in the same platform, though it remains to be seen whether Philips will be able to overcome the many challenges of pulling data from disparate sources, making the data useful, and encouraging patients to stick with the app. In general, we’d love to see more patients be made more aware that some of the technology at hand is using “baby steps” and that personal responsibility is important in learning how patients use technology, giving feedback, and helping push it forward – we want to see way more, with all the new systems, than patient complaints – companies should try to use patients to figure out how improvements can be made. We assume they are trying to – sometimes we feel we hear too much about how “user – unfriendly” new technology is and we want to make sure patients also work to improve products, because no one, least of all patients, should be satisfied with the status quo. Diabetes data aggregation is a crowded space, and indeed, Philips will need to set itself apart with something compelling and useful for doctors and patients – and we hope that these populations try to work to improve a variety of products. 

Visiomed

This relatively new France-based medical device company displayed its FDA cleared and CE Marked BewellConnect MyGluco Bluetooth-connected BGM and paired app. According to reps, the device was FDA cleared in September, though we cannot seem to find the clearance page on the FDA website. The fairly basic meter and paired app will be made “available soon” for purchase online (~$100) though it does not sound like there are currently plans to bring it to pharmacies. Reimbursement is the name of the game in BGM, and asking patients to pay $100 for what looks like a very basic connected meter and app seems like an incredible long shot to us. (For context, LifeScan’s OneTouch VerioSync meter is at least half that price or even cheaper with far better strip reimbursement and a more robust app with pattern recognition, and a trusted, even beloved brand, and iHealth’s BG5 is a quarter of that price.) In testing the meter in the booth, it synced with both Android and Apple devices in about five seconds. The app was user-friendly and intuitive, including the usual color-coding of glucose results and documentation and graphing that has become relatively common across BGM apps – see a video here. There was really nothing special about the meter, which has a grayscale screen and cannot do much of what traditional meters do. Representatives could not speak to the accuracy, though presumably it met ISO 2013 criteria to be cleared so recently.

--by Ava Runge, Varun Iyengar, Adam Brown, and Kelly Close