Turns out that Lifescan apparently did nothing with that concept. Anita Mathew (who gave the demo on Lifescan’s behalf in 2009) decided to take it forward on her own and founded Glooko. The company currently sells MeterSync, a cable that connects your iPhone to five popular glucometers in the market. Users can download the ‘LogBook’ app from iTunes store to document, analyze and share their data.

I’m not an investor (yet), but if I was, I’d put my money in Glooko. This is exactly what the future should start to look like for conventional consumer health devices. Instead of being isolated products that store a limit amount of quarantined information, they need to provide a service that enables longitudinal disease management. For a patient with long-standing diabetes, he/she needs to know how much insulin to inject for covering the meal they are about to have, not what their blood glucose number is. It reminds me of Theodore Levitt’s famous MBA quote “People don’t want to buy a quarter-inch drill. They want a quarter-inch hole.”

For Glooko, the long-term sustainability is directly proportional to how useful and sticky it’s users find the logbook iPhone app. The hardware (Metersync) may be critical at first, but end user experience and market differentiation will come from the software. There is competition, of course. Agamatrix  has been in the market with it’s iPhone compatible glucometer, and last year they announced partnership with Sanofi-Aventis that gives them the much-needed commercialization ability. Instead of augmenting diagnosis, another company Cellnovo takes a similar approach with therapeutic insulin pumps. Perhaps we’ll see a synchronized gluocometer-insulin pump offering or an intelligent, symbiotic ecosystem for diabetes devices in future.

I’ve talked about the ‘last-mile’ of remote patient monitoring in the past. Conventional medical devices produce digital manifestations of physiological parameters, but the information collected hardly goes beyond the device itself.  We need consumer-oriented medical devices to become monitoring services that automate/transform the last mile for consumers. The future is arriving piecemeal, and sadly enough, it’s not being delivered by the incumbent behemoths of the medical device industry. Withings BP Monitor (which I can personally validate since I use it) enhances the value proposition of a regular BP Monitor for hypertensives. Zeo does the same for people with sleep disorders. Granted these offerings are perfect yet, but all vectors are aligned in the right direction. As for Glooko, look out J&J.

Voxiva provides the technology platform, professional services and support needed for designing and deploying a mobile-based health solution for consumers. When you read that, think beyond the now-hip smartphone app market. Less than a fifth of mobile handsets out there are smartphones. So to reach the remainder, the solution has to encompass relatively simpler mechanisms like feature-phone data entry, SMS and IVR.

There are a number of unique design challenges for creating an engaging public health solution that can work across any/most devices and be delivered through multiple channels to a varied set of end-users. It needs to work synchronously across web, mobile, email. It should support data entry across all kinds of user interfaces (feature phones, smartphones, different mobile operating systems, multiple-languages, etc). It needs to deliver real-time alerts (SMS, voice, email, web portal) and provide real-time analysis for decision-makers. And obviously be scalable and dependable with near-100% uptime. What appears to be a simplistic low-end IT solution on the surface is really a huge undertaking to communicate with an end-user population that is as diverse as it can be.

Voxiva’s real impressive achievement is doing a lot of what they do in international market- specially developing countries. They have created a HIV/AIDS mHealth solution for Rwanda Ministry of Health, disease surveillance solution for Peruvian military, diabetes management program in Mexico, and plenty of others. In US, their most famous offering was Text4Baby (see Multiplyd’s previous review on it), an SMS-based maternal health education service launched in early 2010. Since then, they have diversified into Text2Quit (smoking cessation) and Care4Life (diabetes management). Simple interventions, but designed for massive implementation and adoption. Which is why Voxiva continues to stand out.

According to the National Association for Home Care, about 12 million people in this country receive care from more than 33,000 home health care providers. The market is made up of few large, publicly traded companies (see LHCG, AFAM, AMED stocks for example) and many small/mid-size players. The challenges faced by these companies are typical of those with field-based employees: scheduling the visits, then figuring out if their employee actually visited the patient, if they did then what was the real time and mileage, ensuring the data collected during visit is archived and accurate, etc.

Which brings me to CellTrak. It was founded in 2006 and delivers mobile-based automation to Home Healthcare agencies. I think it’s a brilliant application of healthcare information technology for alleviating self-reported information issues and paper-processes in a niche market. Given that everyone carries a phone today, using mobile modules to increase compliance and productivity makes a lot of sense for a field-based business. Some examples of the modules available:

• Care Plan Management
• GPS and Directions
• Time and Attendance
• Travel Time and Mileage
• Supply Management
• Alerting and Messaging
• Scheduling
• Nurse Care
• Wound Care

Solving logistical issues like location, time capture, attendance, inventory etc. is pragmatic. But providing modules around clinical care is the more interesting strategy from my perspective. Usually, software solutions that enable care documentation and collaboration are associated with either care-delivery enterprises (e.g. fixed location hospitals using EHRs) or with patients themselves (e.g. PHRs). Neither of those have a particularly critical need to be consumable in a mobile form-factor- that is just a nice-to-have functionality. CellTrak has found a special need where the inherent care delivery workflow necessitates even the clinical Healthcare IT solution to be exclusively mobile. It is a good example of the hidden corners within the complex maze of healthcare system which require thinking outside the traditional bounds.

Other examples of using exclusively mobile-based electronic health records are mostly restricted to public health context in developing countries (see ChildCount for example). That skew is mostly due to the field-based nature of public health and mobile being the primary means of connectivity in emerging economies. With CellTrak, we see the same technology paradigm tackling the problems of a conventional health industry segment in a developed country.

CellTrak partners with some EHR (Cerner, Allscripts) and wireless providers (AT&T, T-Mobile, Sprint, Verizon) currently. I expect that the future iterations of most enterprise EHRs would include incorporating a solution like CellTrak which enables running operations in the field and  seamlessly connects health information to/from a mobile workforce.

Established in 1995, the Center for Connected Health is another such example within Partners HealthCare in Boston. They’ve dabbled in a number of remote monitoring pilots- diabetes, dermatology, heart failure, etc. Healthrageous is their first spin-off. It started as a pilot project conducted in 2006 with EMC Corp. to give employees self-management tools for blood pressure. In June 2010, Healthrageous raised $6 million in a Series A funding led by North Bridge Venture Partners of Boston.

Having read enough of them, I think the marketing message around the concept of continuous care through remote monitoring has now been perfected from multiple angles. Read the descriptions from Welldoc, HealthBuddy, Telcare, iMetrikus, Hommed, Cardiocom, Gentag, BL Healthcare for example. Healthrageous also does a good job at describing the high-level value proposition.

But it seems that the transition from online paragraphs to a generally available, well-known and affordable solution has not happened. I searched for what product/service I could buy through Healthrageous to help a close friend manage her hypertension, but couldn’t find anything. There are some encouraging success stories on the website, but no explanation as to where can one sign up for becoming a success like that. I wish these websites were more transparent and lucid, maybe even at the risk of being less enchanting.

PS: Found two candidate consumer-oriented solutions for remotely managing hypertension. One is not available yet (Withings BP Monitor), and other needs an Apple iOS device to work (iHealth Lab’s BP3) and didn’t get great reviews. If anyone knows of other products/services, please share through comments below.

Companies like Cellnovo represent the key role IT is playing in the evolution of medical devices. UK-based Cellnovo began in 2002 as Starbridge Systems Ltd. to develop a novel micropump with only one moving part that made it smaller, more accurate and less expensive. Somewhere along the line, their conventional medical device transformed into a mobile health offering. It now consists of:

1. Pump: A small, waterproof device that can be easily applied, removed, and repositioned on the body. Also includes a built-in accelerometer that registers and stores user activity data.

2. Handset: A hand-held device that communicates wirelessly to control the pump and sends data to a secure website. User can manage dosage, schedule, log supplemental data like food intake, activities, emotions, etc. through this device. The look-and-feel has been compared to today’s appealing smartphones with icon-driven intuitive graphical display and touch screen ability.

3. Online: Websites customized for various participants that are usually involved in managing diabetes- provider, patient, caregivers, etc. Given the variety of people that can be involved in the care team (primary doctor, dietitian, diabetes nurse educator, eye doctor, foot doctor, endocrinologist, exercise trainer…), communication and coordination is an often under-served part of diabetes management. Seems like Cellnovo Online is an attempt to improve just that.

The overall concept is not new. OmniPod by Insulet Corporation (a public company) has a pump and handset. Big players like Medtronic, Sanofi-Aventis, J&J have shown signs of moving in similar direction. With the February 2011 series B financing round of $48.4 million, Cellnovo also seems to have enough runway in this space. As an interesting aside, combining insulin pumps with Continuous Glucose Monitoring System (CGMS) makes a terrific combo- uninterrupted sensing and coordinated, intelligent drug delivery. OmniPod does this.

Solutions like Cellnovo provide not just a way to deliver therapy, but a novel way to collect detailed data about given patient population. Analyzing aggregate data like that can lead to insights at multiple levels- clinical evidence (EBM), provider performance, population health, etc. An interesting decision fork in this evolution would be whether manufacturers leverage commercial computing hardware like smartphones or create their own (like Cellnovo). The former gives wider reach, while latter provides better, medical-grade control (something that FDA probably mandates).

But the key point in all this is about the future of traditional consumer medical devices. The next-generation devices seem to be less conspicuous, continuously connected, more personalized and come with an integrated online component that becomes the window to interaction with multiple parties (caregivers, friends, insurers…like an evolved, niche form of social networking). The new value proposition doesn’t stop at just a hardware device, but becomes a continuous service for managing chronic disease.

One can argue that managing all chronic diseases requires understanding an ever-changing constellation of information continuously generated by a whole ecosystem of participants. This ever-connected disease management approach that removes the burden of keeping journals and pushes information to healthcare professionals can to be applied to many diseases besides diabetes. I’m sure a number of those are already underway.

The underlying concept is nothing new in medical device industry, with it’s origins perhaps in holter monitoring fifty years ago. But true at-home remote monitoring began gaining traction in early 1990s; and today some major names are in the race: Honeywell Hommed, Philips, Health Hero, Cardiocom, Corventis. All of these companies have had an actual device as a part of the overall offering-  some piece of electronic hardware that enables capture and transmission of given physiological parameter(s). LifeStream, Motiva, HealthBuddy, Commander, PIIX are the respective names of the hardware from companies mentioned before. Even the recent consumer-oriented solutions like GlowCaps, Zeo, Fitbit etc. have a proprietary piece of electronics central to them.

And that, is what makes Welldoc is interesting. They have a disease management solutions that are entirely mobile and web-based. No proprietary hardware. It’s an interesting approach that points to an underlying need as well as an overall weakness of such models.

The unmet need here is for solutions that help engage patients at home and provide round-the-clock assistance in chronic disease management (e.g. what insulin dose to take, when to see your physician, etc.). That doesn’t require a device hooked to patient necessarily- it can be accomplished by manual data entry, easy-to-use software and intelligent algorithms. The value proposition is across many soft (as in, hard to quantify ROI on) aspects: enabling patient self-management, promoting health education, improving compliance, effecting positive behavior change etc. Of course, all these lead to some hard benefits that can be quantified (like improved Hb A1C values over time), but the cause-effect relationship can never be established beyond doubt.

The weakness in this approach is that all this depends on manual data entry by the patient or caregiver. It assumes that the affected individual is capable and disciplined enough to interact with the software consistently and reliably. Offering mobile applications is one way to start making that assumption partially valid. As a constant companion with computing power and internet connection, mobile phone makes it easier to use such software. But not enough to cover what I call the ‘last mile‘ of remote patient monitoring- from the patient’s body to an electronic data capture device. No matter how sophisticated the software is, it’s no good if there is not enough data to run its logic on. And our fundamental human behavior tends to revert back to lazy, undisciplined ways sooner or later. So yes, there is a role for pure disease management software but its a stretch to assume that it’ll suffice on its own.

WellDoc was founded by endocrinologist Suzanne Sysko Clough, MD in 2005. Their first solution, focused on Diabetes managment, was piloted in Baltimore in early 2006. Digging through their news it seems they have been fortunate enough to find substantial angel and grant funding, starting with $5M in 2007 and totaling nearly $17M to date. Recent years have also brought some big milestones for WellDoc: deal with Jitterbug (April 2009), FDA clearance (August 2010), deal with AT&T (October 2010), and integration with AllScripts EHR (December 2010). WellDoc website is skimpy on the actual details of their product, but there is a high-level demo. They seem to be expanding beyond diabetes into cardiovascular, wellness, medication adherence and clinical trials data management areas. That is a smart move. Also smart is their attempt at a business model. As their CEO explains in this article, they are aiming to get paid by large employers, plans and payers for making chronic disease management programs more effective.

The whole RPM industry has been praying for national direct reimbursement for decades now. Its been a tough journey so far- positive studies keep trickling out, and every year seems to be the one that will finally see payers admitting the cost-savings from RPM and starting reimbursement. WellDoc has also invested heavily in clinical trials to convince the industry. It’ll be worthwhile to see how successful a purely software-based company would be at making a living in the RPM market.

February 2011 Update: WellDoc announced that they have acquired Oncology Care Home Health, LLC, a education and consulting company helping home health providers implement specialized oncology home care programs. Probably the idea is to use that specialized knowledge to augment the logic behind their oncology offering (maybe get that FDA certified?).

Seems like there are three components of the overall offering:

1. A hardware device called “Spiroscout” – a small add-on that mounts the inhaler canister. Every time it is pushed, the location and time-stamp data is recorded.
2. Mobile app – a ‘diary’ to keep track of symptoms, triggers, medications, etc. Can also be used to view map of data received from Spiroscout, and to get sms reminders for taking medication.
3. Online website – a ‘dashboard’ of sorts. Can help summarize submitted data to figure out disease patterns and trends.

The hardware device is not out yet (website says it’ll be out this summer), and the mobile app is currently in private beta. So there is not much of real world testing that has happened. But I’m still positive about Asthmapolis, for a number of reasons.

First, it’s the right kind of ‘focused’ monitoring solution that can potentially be transformative for managing a specific disease (kinda like Regina Herzlinger‘s argument about ‘Focused Factories‘ as one of the ways to salvage the entire healthcare system). It’s better than trying to find a solution that can monitor multiple conditions (example 1, example 2). I think the mobile diary and online dashboard would be key engagement tools in this regard. The more focused and customizable, the better.

Second, it helps in medication adherence which is a big issue irrespective of the medical condition. I think that knowing whether you took your medications and getting reminders if you didn’t,  is more powerful than knowing when/where you took it. The mobile app reminders would be a great resource there (automated calls to landlines may be good too…for seniors).

Third, it helps understand the individual triggers and community impact of asthma. For successful asthma management, a patient should know his/her triggers and avoid getting exposed to them. That is not an easy task for a number of reasons. My initial reaction was that GPS may be a bit of an overkill. But with rapidly decreasing cost of location-aware technology, why not? Much better than using it to check-in to nearby McDonalds.

The Life Pebble hardware includes a single lead ECG, skin thermometer, and an accelerometer. The data collected by the system is streamed wirelessly to a USB Network Adapter over short distances. According to MobiHealthNews, the device is currently in clinical trials are few US hospitals and Toumaz has declared an intention to submit for FDA clearance in 2011. This continuous physiological monitoring capability is currently marketed for assisted living, rehabilitation and professional sports applications by the company.

If we can put aside the “who will pay for this?” question for a minute, this kind of technology has myriad applications in both consumer and provider space. What is chunky hardware today, will almost surely be a disposable, thin patch tomorrow. If we can have a reliable way to do real-time monitoring of key vitals, disease management is no longer confined to interactions in the healthcare setting.

What intrigues me is how the trend of medical-grade remote monitoring (which is moving outside of hospital setting with technologies like Sensium) will interact with the trend of consumer-oriented remote monitoring (FitBit, DirectLife, BodyMedia, Zeo, etc.). There will be a shakeout, obviously. My guess is that the winners then will be not be defined by which way and how much data they gather, but what they do with that data. Analytics and interpretation will be the differentiators.

With that background, Corventis becomes an interesting entrant to the MCOT space. Their technology platform consists of a bandaid-size wireless sensor patch called (“PiiX”) that detects, records and transmits physiological data to a portable hub (called “zLink”). zLink is a cellphone-size device that sends the data over wireless network to ‘Corventis Monitoring Center’, which is a staffed to do preliminary interpretation and urgent physician notification. They offer these capabilities in two forms: NUVANT (ECG based continuous arrhythmia monitoring) and AVIVO (non-ECG physiological paramters monitoring). Corventis has some big venture names behind it: KPCB, Mohr Davidow, DAG ventures. They recently got FDA clearance for NUVANT in January 2010.

Cardiac diseases are certainly the prime target for any wireless remote monitoring startup. Corventis is not alone. iRhythm’s Zio Patch is designed to diagnose cardiac arrhythmia by providing  up to 14 days of continuous recording. Once done, the Zio Patch can be mailed back to the company for analysis. Unfortunately, the Achilles heel for all of these companies is reimbursement. So far, private insurance companies and CMS are not convinced that such services are worth paying for. MobiHealthNews has an interesting post about this trend here.

I’ve written about a number of consumer-oriented ‘wellness’ services by startups that are using wireless sensors to detect simple metrics like activity and help you achieve a healthy lifestyle. Corventis, iRhythm are good examples of medical-grade services utilizing the same basic technical framework and abilities for managing life-threatening conditions. Once we get over the barrier for reimbursement, you can bet on the remote monitoring market for serious medical conditions exploding. We can wait for that to happen, but I’m personally convinced that as consumers take more charge in managing their conditions (and health insurance continues to spiral the drain from a cost and outcome perspective), there is a growing scope for remote monitoring services that consumers will pay for themselves.

PS: I had a discussion with Corventis founder, Darryl Drinan a few weeks ago. He had three insightful comments for anyone thinking about getting into the remote monitoring space:

• If you have a choice, focus on therapeutic service, not diagnostic
• Product alone is not enough, always tie it to a service
• Patient education is a big problem (if you need to do it for them to use your device, you are hosed)

In an effort to understand what is unique about Zumi Life, I stumbled upon this interview with its CEO. Crunchbase tells me that they started with $700k seed funding in 2007 and got a Series A infusion of $1M in April 2008. With that context, several questions come to mind. Zume Life needs manual input for all the data it needs from the user- and that assumes the user to be reliable enough to put it in. If Zuri had a sensor to automatically capture the critical vitals (like Zeo, Bodymedia, DirectLife, FitBit, LifeShirt and scores of other devices), that would make it infinitely more useful. But I understand that there is no automatic sensor for your mood or for what you just ate, so somethings need to be captured manually. Which is why there are services like RememberItNow, Reqall, Zealog, Polka etc. Still, why not get the medication list for Zuri from PHR platforms like Google Heath? If we assume that the chronically ill and overworked individual remembers to input their care regimen in one place, why wouldn’t they use a simple paper sticky note or a smartphone reminder app? Even a simple Google Calendar or 30Boxes event can be configured to deliver reminder emails that show up as audible, sms alerts on your phone. So is there really a need for a dedicated hardware device in a world that is slowly converging mobile computing platforms? Zuri reminds me of the device that is made to do twitter only.

The price tag was also a bit of surprise. Although there is no official mention of pricing on the Zume Life website, I found a PCmag article from Sept’09 that quotes $35/month or $300/year for the service, and $4.99 for the iPhone app. That sounds way too much money for a basic alerting and journal-keeping service that is 100% manual entry based.

Of course, it’s easy to criticize others idea. I don’t have the complete facts on the service, its utilization and its founder’s vision. The overall trend of using patient-oriented hardware devices integrated with web and mobile dashboard/analytics to manage chronic conditions is for real. I just think sensors are a key aspect of such devices and that pricing can be Achilles heel for adoption.

Early 2010 Update: ZumeLife has closed operations and is no longer in business.

In general, I really like the idea of using personal mobile computing devices in treating/preventing chronic conditions. As devices and sensors get smarter and cheaper, it’s logical that they start playing role in helping individuals deal with chronic, lifestyle affecting conditions like migraines, sleep disorders, allergies, dysmenorrhea, depression etc.

Proactive Sleep provides a ‘smart alarm clock’ for iPhone/iPod Touch. Some features: customize what music to fall asleep to, and to wake up with, a dynamic ‘vigilance game’ that you need to complete to turn the alarm off, and a sleep diary to note your observations and sleeping habits. Nothing earth-shattering there. The features may be simple, and its not my intention to critique Proactive Sleep per se. What I want to emphasize is that applications like these are a step in the right direction overall.

For a number of chronic disorders with no established cause (like migraines, insomnia), keeping an accurate log (diary) can be extremely useful for prevention and treatment. Integrating such ‘digital diary’ into daily lifestyle can be much more convenient and smart way of keeping track of such conditions. Proactive Sleep is a bit too manual, in my opinion (e.g. you need to document everything in your sleep diary yourself). What would be awesome is to combine it with a smart sensor (like the FitBit) to automatically record your sleep habits. That way its even more Health 2.0.

It’s not focused on healthcare issues, but I see potential for something like this in chronic conditions that affect an individual’s lifestyle. A good example is migraines. Those who have these terrible headaches would benefit from knowing exactly how many did they have this month vs. past 6 months and what were they doing when it started. So If one could log the onset/end of a migraine attack and the preceding activity conveniently, it’d be easy to spot a pattern (e.g. higher chance of migraine after cold shower).

Why not keep a simple diary bedside? or spreadsheet? Yeah, you can. But how many people do? And how many diaries can remind you to enter latest information in them and chart/graph your progress? It’d be a good idea to add some social networking features to ZeaLOG- finding comparative stats or just connecting with others in the same state as you are powerful motivators for using such tools (for example- Qwitter). ZeaLOG has twitter integration, but it’d be neat to have a mobile app too, especially one that syncs up intelligently with online data.

There is a paid service idea in this concept somewhere. I’m sure we’ll see one soon in healthcare.

Remote Patient Monitoring (RPM) is a subset of telemedicine that includes devices and software that enable healthcare providers and educators to diagnose, monitor and follow up patients remotely. There is a lot of potential in smart fabrics to enable RPM, especially for chronic diseases like Asthma, CHF, Hypertension, etc. I’m personally very excited to see companies enter this space and solutions becoming more and more mainstream.

Currently VivoMetrics is focusing on clinical research and sleep apnea study market. Their next generation product is supposed to be lighter, more comfortable and with the ability to transmit data wirelessly. Also in the works is a partnership with OBS Medical to incorporate their Visensia® software as a predictive tool.

September 2010 Update: LifeShirt and VivoMetrics websites don’t work anymore. Seems like they ran out of runway.