Interview: Shiv Gaglani, Founder, Smartphone Physical

This post was originally featured on HIStalk. 

What is the Smartphone Physical, how did it get started, and how did you get involved?

The Smartphone Physical originated from a collaboration between Medgadget, TEDMED, and Nurture by Steelcase. As a Medgadget editor, I had been approached by TEDMED in the fall of 2012 to come up with an interactive experience for delegates. It was the perfect opportunity to implement something I had been ideating on through my dual roles. First, as a medical student at Johns Hopkins, where I’ve been learning how to perform physical exams on patients. Second, as an editor of Medgadget, for which I’ve been covering digital health apps and devices that are becoming increasingly capable of collecting clinically relevant information.

I noticed that many of the procedures I was doing as a medical student, such as taking blood pressure and visualizing ear drums and optic discs patients, were being reproduced on the digital health side with apps and peripheral devices. I combined the two perspectives into the Smartphone Physical to see how many clinically relevant exam maneuvers we could perform using smartphone-based technologies. To this end, I formed partnerships with many of the app creators and device manufacturers to develop the Smartphone Physical concept, and then recruited a team of forward-looking medical students and biomedical engineers to help perform the physical exams. In the process we’ve found some interesting use cases, ranging from telemedicine and occupational health to screening and medical education.

Can you elaborate on the reception to and next steps for the Smartphone Physical?

Overall we’ve received a lot of support from the digital health community as well as a tremendous amount of interest from the healthcare professional and patient communities. Since TEDMED we’ve performed at least 500 Smartphone Physicals and in the process have realized that there are some important obstacles to overcome if these digital health tools want to cross the chasm and evolve from toys to tools. I summarize these in what I like to call the stairway to digital health: awareness, compliance, evidence, and reimbursement (ACER). The Smartphone Physical, among other initiatives and companies, is working to tackle these issues.

With regard to awareness, we recently showcased the Smartphone Physical at the American Medical Association, where hundreds of medical students got their hands on these apps and devices. As a medical student and co-founder of the med ed tech company Osmosis, I’m particularly interested in medical education as a way to reach the next generation of clinicians. In terms of compliance, the FDA just released its finalized guidance on mHealth and many of the Smartphone Physical apps/devices will be regulated as a result. That’s to be expected because they’re tackling some hard problems, such as clinical data collection and diagnostics.

In addition to government compliance, one of the most formidable challenges – not technologically, but politically – is getting the (patient-collected and validated) data into the electronic health record so it is available on-demand. And it can’t be a simple data dump, but rather needs to be structured in a way that insight can be gleaned easily. Big data does not imply big insight.

Evidence is a third key area that we are interested in. We talk anecdotally about improved outcomes or improved engagement of patients, but these need to be proven using randomized controlled trials. To this end, we’ve heard from a number of institutions that want to run digital health studies to determine whether these devices actually enhance patient engagement, reduce costs, and improve outcomes.

Perhaps the greatest challenge is the reimbursement question. Physicians and other clinicians will not use digital health devices and apps until there’s a clear path to being reimbursed for their time in the upgrades and changes.

Can you provide an example of a device that’s succeeding along these dimensions?

In general, device manufacturers keep their adoption metrics close to their chests. In some cases, this is because adoption is fairly low. For example, as a medical student at Hopkins, I’ve met hundreds of practicing doctors and I haven’t seen one who uses a smartphone-based ophthalmoscope or stethoscope. In part this is because many devices are fairly new and just getting FDA approval; that is they still need to get ACER. One device that has succeeded along these dimensions is AliveCor’s Heart Monitor. They’ve generated tremendous awareness, were FDA approved last year, are working hard to get evidence. Recently they reported positive results on their SEARCH-AF study. They are figuring out the business model, which will involve a data play.

Sounds like most of the innovation is going on in diagnostics, not treatments. Do you have any insights as to why that might be?

That’s a good question. The relative types of apps and devices can be viewed as a funnel. At the top, the majority are simply informational or reference, for example to look up drug interactions or calculate GFR. The next layer enable data collection, and include many of the Smartphone Physical apps/devices such as the iSpO2 and blood pressure cuff. It’s a big jump though to the next layer, which moves from collecting data to actually offering a diagnosis. A number of dermatology apps have tried doing this with computer vision, though have received mix results. Smartphone Physical companies such as AliveCor and CellScope are trying to create machine learning algorithms to actually diagnose things like atrial fibrillation or ear infections, so I’d expect to see some fairly sophisticated apps coming out in the near future.

Based on?

Have you heard of Shazaam, the music-identification service?

Yes.

Shazaam is able to tell you what you’re listening to based on matching parameters extracted from the wave form of the music. Similarly, an ECG can be deconstructed into various parameters. If we create a library with millions of ECG recordings that are tagged to diagnoses, an app may eventually become good enough to go beyond simply data collection and more towards data analysis. Again the difference between Big data and big insight. Even so, there likely will be a human expert, at least for the next five, 10 years, making the final call on the diagnosis, because machines are fallible.

Similarly, algorithms may be applied to other data collection apps/devices to extract useful diagnoses. For example, continuous oxygen saturation combined with EEG data may be used to diagnose sleep apnea at home. Repeated weight and blood pressure measurements can help diagnose hypertension.

In terms of treatment, there are few if any devices that currently do that. I know of at least one group working on a smartphone-controlled biofeedback machine, which would be great for the field of physical therapy. One key issue to keep in mind is that you do not necessarily want patients self-diagnosing or self–treating based off this generation of apps and devices. Eventually that will be the Holy Grail of healthcare – the engaged and empowered patient.

How do you see funding playing out? Will these devices be crowd-funded through platforms like Kickstarter or will they go the more traditional VC route?

The Smartphone Physical is a great case study for this. We included nine devices and they could be categorized into three broad groups. The first group was very consumer-facing: weight, blood pressure, and oxygen saturation monitors. The middle group was primarily consumer-facing, but unlike the first group was primarily for specific cases as opposed to daily use. These included the ECG, spirometer, and otoscope for ear examination. The third group was primarily provider-facing and included advanced devices such as the stethoscope, ophthalmoscope, and ultrasound.

The specific end user is the first indicator I’d look at for whether an app/device would be a successful crowd-fund. For example, the Scanadu Scout was marketed as a medical tricorder for general consumer use and raised a record $1.6M on IndieGoGo. Similarly, I think if CellScope decided to do a crowd-funding for their otoscope, that would be quite popular since many parents or grandparents would want it for their young ones. This is not to say that provider-focused apps and devices won’t be successful since there are certainly a number of med tech-focused crowd-funding sites now that attract those in the industry.

Broadly speaking, digital health is well poised for crowd-funding and crowd-investing. Healthcare as a whole, as you know, has been a very capital-intensive field. If you wanted to bring a new medical device such as a stent to market, you would need a lot of capital and face significant regulatory pressure. Digital health apps and devices are much cheaper because the battery, monitor, processors, sensors, and transmitters are built into the smartphone and don’t necessarily need to be duplicated in the device itself. Indeed, the CellScope otoscope and AliveCor heart monitors are simple cases. This has reduced the amount of capital needed, and with the FDA’s final guidance the regulatory uncertainty has also decreased.

Any final thoughts?

We’ve been speaking with a lot of stakeholders who are interested in the Smartphone Physical, ranging from occupational health offices to pharmaceutical companies to hospitals and clinics. We’d be happy to forge connections with HIStalk readers who are interested in digital health and our specific application. They can contact us via our website or by sending an e-mail.

The Pristine Story: Fall Mayhem Begins

This post was originally featured on the Pristine blog.

It's showtime.

We begin testing our apps with live patients in surgery this week. After months of development, we get to test all of our assumptions. We've developed a remarkable amount of technology in a short period of time. A lot of people - investors, advisors, employees, and their significant others - have sacrificed to help us get here. I can't express enough gratitude to everyone who's helped us get this far.

Fall mayhem is here. The next few weeks are going to be wild:

Mark and Patrick are on site with our piloting surgeons and anesthesiologists.

I'm in the Bay Area for Health 2.0 and GlazedCon. At Health 2.0, I'll be interviewing Aaron Levie, Founder and CEO of Box. At GlazedCon, I'm leading a panel discussion about the future of wearable technologies in healthcare.

I'm going back to DC for the American College of Surgery Clinical Congress this coming weekend.

I pitch at Austin Startup Week October 10th to a private audience of about 100 investors.

In 2.5 weeks, I come back to the Bay Area for our public unveiling at DEMO, October 17th. I'll be removing a bullet from a John Doe live on stage in front of 500+ investors and media. After DEMO, we'll finally be able to publicly discuss what we're working on :). I'm not sure if DEMO will provide live streams. If you'd like to watch live, please check the Pristine Blog or my blog on October 17th and I'll provide links to the live stream.

I go to NYC October 21st for VC meetings.

I'm presenting at FutureMed November 3 - 6 in San Diego.

The biggest concern leading up to our first pilot has been, pathetically, lack of hardware. Up until just a few days ago, we only had 3 Google Glass units. On Thursday September 26th, we got 5 units, bringing our total to 8. It was a miracle. And we may have a couple more inbound. If you know anyone that's willing to part ways with a Glass unit, please let us know. We will always pay for more.

The team continues to grow. We dominate a full table in Capital Factory now. I'm also excited to announce that we've hired Bryan "Buzz" White as VP of Sales. He's spent the past 7 years building sales forces and selling cutting edge technologies into hospitals, physician offices and clinics. He actually founded and lead the State's largest and most successful health information exchange (HIE), the North Texas Accountable Healthcare Partnership, which is among the few HIEs in the country that's actually a sustainable, profitable entity and one of the first organizations to explore accountable care strategies in healthcare.

We're looking for a MEAN back-end web developer. MEAN = MongoDB, Express.JS, Angular.JS, Node.JS. Front end experience is a plus, but not a requirement. If you or anyone you know is qualified or interested, please reach out.

As if we weren't being secretive enough, I'll close this episode of the Pristine Story with one final teaser before DEMO. We've signed three of the most prominent medical institutions in the world to pilot our apps in surgery. You will recognize their names instantly when we unveil them at DEMO.

Understanding Control, Teamwork, and Innovation as the Value Chain Consolidates

This post was originally featured on HIStalk.

The rise of Wintel (Windows + Intel) during the 1990s was characterized by hyper modularization of computing. Apple’s integrated business model was doomed because they could never effectively compete with the modularized PC industry on cost, scale, or component quality. As the PC industry boomed, Apple simply couldn’t keep up. Apple was intrinsically structured such that it couldn’t.

Over the past 10 years, we’ve seen a massive resurgence of integrated business models in technology, led obviously by Apple, but also by Google. Google started at the end of the value chain – the application layer (search) – and has systematically worked its way down the value chain, into all layers of operating system design, device design, and even many aspects of component design and fabrication through the acquisition of Motorola.

Samsung and Amazon are also trying to expand their reach throughout the value chain; Samsung from the bottom up and Amazon from the top down. Microsoft has also made strong moves over the past few years to broaden its reach across the throughout the value chain. Steve Ballmer has repeatedly stated that Microsoft is a devices and services company.

All of the mega technology power houses have come to realize that software is a means to an end. Software alone is not enough. They must control the entire value chain. They’re all vying to become the same mega technology company.

The technology power houses are trying to integrate across the entire value chain and morph into the same mega-company as a matter of cooperation and teamwork. As technology gets exponentially more complicated and the lines separating the layers of the value chain blur, erecting artificial corporate boundaries stifles teamwork, and thusly ability to execute and innovate. That’s one of the many reasons why Microsoft missed the smartphone and tablet waves even though they started pursuing the mobile computing dream over a decade ago.

It’s clear that medicine is getting more complicated, not less. We’re still developing new specialties and subspecialties of medicine. As we develop deeper understandings of genetics, it’s clear that many prior assumptions were wrong. We still only understand a fraction of the human body and virtually nothing about the brain. As our understanding grows, our healthcare delivery system must reflect that. Patient care delivery will continue to get more complicated as we develop deeper and more nuanced understandings of medicine.

The US healthcare system is undergoing a massive shift as the value chain consolidates. Most people cynically attribute consolidation to a need to negotiate better terms with payers. That’s true, but incomplete. Consolidation is driving integrated delivery models. Healthcare must consolidate to drive control, teamwork, and accountability across the system. Doctors don’t and shouldn’t exist in the bubble of their own practice. They are an integral part of the patient care delivery and should participate in a coordinated integrated delivery system. There are a vast array of talents and skills across all of the different flavors of healthcare professionals. They need to be at least somewhat centrally coordinated as patients move through the system.

As software continues to eat the world, technology continues to perpetuate through the US healthcare industry, much of it in the name of integration, cooperation, and information exchange. Hence the rise of Epic. Despite all of its shortcomings, Epic is driving massively integrated healthcare systems. The benefits are profound and felt through the healthcare delivery enterprise. Perhaps most importantly, integrated IT systems are a form of control. They empower the mothership to enforce rules throughout the empire that were simply not feasible before. Those rules can be implemented in the name of cost savings and better coordination.

Medication orders are a simple example. Doctors may prescribe more expensive medications because they don’t know cheaper alternatives are available. The CMIO of the health system may realize this and remove the more expensive medication from CPOE. This is a simple example, but it lends itself to understanding the power of centralized control. It can take years, if not decades, to propagate practices throughout the healthcare system. With centralized IT systems, we can easily expedite propagation by multiple orders of magnitude. In a fixed-revenue, at-risk, ACO world, centralized IT will drive enormous cost savings.

There are downsides to centralized delivery and IT structures. Entrepreneurs are trying to deliver all kinds of new solutions. Selling into healthcare is becoming harder as there are by definition fewer, larger organizations to sell into. It also means that, generally speaking, startups need to raise more money to get a foot in the door.

There’s a flurry of innovation going on at the fringes. Many of those spaces are quickly becoming overcrowded as Silicon Valley entrepreneurs turn towards healthcare. There are going to be enormous opportunities for startups inside the healthcare system. Startups that can genuinely improve communications, teamwork, and process control will be positioned to do well. They can compete with the legacy players asymmetrically on dramatically lower cost structures. The opportunities inside the system are tremendous, though harder to break into.

Although the barriers to starting businesses continue to plummet, the barriers to success in healthcare are rising. It will be interesting to see which startups can really take advantage of the consolidation of the value and disrupt from the inside out.

Wasted Opportunity

I have a rule about conferences and trade shows: never attend sessions. They are garbage useless.

I just broke my rule.

I wasted precious hours of my life that could have gone into my startup, Pristine.

I suppose I should backup and explain this rule. It seems counterintuitive. After all, the primary agenda that most conferences advertise are the speakers. They justify outrageous ticket prices by arguing that you could never learn so much from industry leaders in such a short period of time.

I don't care about speakers. Any of them. I hate being lectured to. Plus, I can almost always find a speaker's writings and thoughts online anyways. If they're important enough to speak at a conference, they probably have freely available literature online.

Conferences are incredible. I love conferences. They are the ultimate cesspool of networking. They are pure entropy. Serendipity. Coincidence. Destiny. They exist to drive discovery and synergy.

My only rule at conferences is to talk to as many strangers as possible. After all, I don't know who the hell you are, who you know, how you can help me, or vice versa. The number of opportunities to be had is mind bogglingly awesome.

One of my favorite bloggers, Horace Dediu of Asymco, has written about and tried to disrupt the conference industry. It's quite difficult, but he's tried with Asymconf. Asymconf is a small conference - no more than a couple hundred people - in which everyone is expected to actively participate in a public discussion among their peer group.

This perhaps provides a reasonable middle ground between the rigid monotony of the status quo, and my free-thinking, free-wheeling anarchy-filled future.

I would like to learn about the economics of conferences. I belittle the industry on a regular basis, but admittedly know very little about the industry structure or economics. I'm convinced there's significant opportunity for improvement, I just don't know enough to provide an honest assessment of what that could look like.

At first glance, I think the problem has to do with scale. By definition, bigger conferences attract more people. But I think that's exactly the problem. Smaller, more intimate conferences are better.

Perhaps the key to amazing conferences is to limit the size, and mandate that all attendees really are qualified. Asymconf was structured this way for good reason.

Interview: Davide Vigano, Founder, CEO, Heapsylon

This interview was originally featured on HIStalk. 

What does Heapsylon do?

Heapsylon is a company focused on wearable devices and quantified sales self technology for fitness sales and healthcare. The first product that we’re building is dedicated to the human foot. A couple years ago when we first looked at the wearable device landscape out there, we would have seen Google working on Glass and Apple and Samsung working on smart watches, but there was clearly a part of the human body that is both constantly under pressure and is also underserved by technology and innovation and that’s the human foot.

Our feet are a complex system. The contain lots of muscles and ligaments, and 25 percent of the bones of our whole body are in our feet. So we thought maybe somebody should be focusing on smart socks.

What computing goes in your socks?

We’ve created our own textile sensing technology that can detect pressure and force. By weaving sensors into a sock, you can get pressure and step activity monitoring data. We also connect those sensors to an anklet that snaps directly magnetically onto the sock. By doing that, we add to our own textile sensors an accelerometer, an altimeter, a temperature monitor, and storage, plus Bluetooth 4 technology that allows us to get all this data out of the smart sock and into your favorite mobile platform.

What kinds of insights can your sensors provide that Jawbone, Fitbit, or Nike+ Fuelband can’t?

The big difference is that we can detect both how far, how fast, and how well people walk or run. We can create a real-time gait analysis. Lots of patients use a walker. All of the devices you listed can’t detect accurate data since they are limited to their accelerometer’s capabilities and they need to be worn on wrists or on the chest.  You may have seen the recent Mayo Clinic study that was recently just published and covered by Forbes. 

It’s really crucial, as an example, for every cardiac patient to be able to track activity monitoring so that the doctors are able to understand how they’re doing in terms of remission recovery after surgery, as an example. The Mayo Clinic study refers to an elderly patients coming out of cardiac surgery that use a walker. They decided to position a FitBit device at the ankle level, because if you position a monitor in any other place on the body for that kind of patient, it’s not going to provide you with a lot of meaningful data.  Their strides are slow and short. The smart sock provides an extremely accurate data feed since we have the accelerometer positioned at the ankle and our textile sensors under the patient’s foot.

Are there any types of data that you capture that those other devices don’t?

Sure, let me give you an example. Let’s assume that now we want to go running and you just transitioned to a cool, minimalist new shoe. Between 60 percent and 80 percent of the runners out there get hurt within every one year primarily because of impact forces that we generate when we run and strike the ground with our heel. There is Harvard study that talks about this. Quantifying those impact forces today is impossible. Sensoria can provide the real-time gait analysis to the runner to inform him or her of where and how well he’s landing on his foot, in real time. Is it he landing on the heel, or on the ball of the foot, or to far on the forefoot? That would be bad too if the runner has Achilles problems as an example.

How about the battery?

There’s a battery in the anklet that is rechargeable and powers the textile sensors in the garments. The anklet can be changed swapped between garments and connected to a fresh pair of socks, and depending how often you use it, can last between two weeks and up to 18 days. The garments socks themselves are of course washable.

How does the anklet bend to one’s ankle?

It has flexible PCP electronics inside. My ankle size is probably different from my daughter’s. She can bend it and adjust it to her ankle size. You can just connect it and snap it through to the sock. It’s now linked to the sock, not touching it again. It’s magnetically connected to the sock. As soon as you connect it, it turns on. And as soon as you disconnect it, turns off.

How far along is the business?

We bootstrapped the company the company for the first year and then raised some funding through angel investors. Textronics just invested in Heapsylon. Textronics It is a large $24 billion electronics and engineering and manufacturing service company. We’ve also just completed a successful crowdfunding campaign to bring our product to market. We sold about over 750 pairs of Sensoria Fitness Smart Socks and 15 developer toolkits to people that want to build their own app on Sensoria. We raised pre-sold about over $1,1550,000 of smart socks and SDKs. That is what we needed to complete the first batch of production. The first fitness Sensoria socks product will come out in Q1 of 2014.

How much does each pair of socks cost?

We sell one anklet with sensors and electronics, one pair of Smart Socks, and the app for $199. People pre-ordering can get $50 off. Customers can order an additional three pairs of smart socks for $59 and use the anklet they previously bought. The full product with the ankle, is $199. Right now we offer $50 off for those that pre-order.

That’s a bit expensive. That means you have a very focused, targeted market.

The first version is for runners. Developers can now purchase the SDK for about $1,000, which includes APIs and a fully functional prototype to build apps. We are shipping the SDK to our first 15 developers today. We’re offering an SDK as well to help people get data out.

Are you planning to license your technology to clothing manufacturers?

Absolutely. We’d love to have implement a Gore-Tex type of approach where we license our sensor, electronics, and software technology in some areas. Everyone in the world should have the choice to buy dumb socks or smart socks. We can’t get there alone.

How big is the company?

We’re based in Redmond, Washington. We have six full-time employees. We have about 20 people working on Sensoria, very close vendors that work very close to us. It’s a complex system integration project. We have textile engineering, we have electronic engineering, and then we have software engineering. There’s a lot to do.

What’s your background? How did you get into all of this?

I’ve been in software engineering product management, marketing, sales, and engineering for a long time. I worked for Microsoft for a long time. I was in charge of the product management and marketing for HealthVault and Amalga at Microsoft. I spent many years there. I started working on MacWorks and PCWorks 1.0 in 1987 before the joint venture with GE – Caradigm — came along. I left the company about three years ago and started my own thing.

How about your co-founders?

We have a materials engineer that comes from the sports industry. Mario and Maurizio, my two co-founders and partners of the company, are both from the X-Box Kinect team. We have a pretty wide spectrum of skills sets that are over here. Although it’s a small company, we are very well represented in each one of the necessary skill sets.

Any FDA or other regulations to worry about?

Sensoria Fitness is not a medical device. In the future, we will evaluate options.No FDA. It’s really hard to hurt a patient with a 3 volt battery connected to a sock, so it shouldn’t be too hard from the FDA perspective. Reimbursement is a different story, of course. We are looking for the right partners in this space.

Are you looking to be prescribed through a platform like Happtique or HealthTap?

There is a lot going on in this space and we are following it very closely. For now, we’re just focusing in on delivering our fitness product. Through the right partnerships, we may be able to enter the medical device and healthcare market. But we won’t do that unless we have the right partnership in place.

Anything else?

We’re very, very keen on protecting the privacy of the patient. We will not sell patient data. We will sell socks, but we won’t sell data. That is something that is at the core of what we believe. Privacy is important to many of us. That’s something that is woven into our DNA.