Eko Core, A Digital Upgrade For The Centuries-Old Stethoscope | TechCrunch

Eko Core Digital Stethoscope - product picture
Eko Core Digital Stethoscope

The Eko Core digital stethoscope is a “why didn’t I think of that?” invention.

In a few months, the stethoscope will celebrate its 200th birthday. A medical breakthrough in 1816, it’s still a part of nearly every doctor’s visit today and a symbol of medicine itself.…

Digital Stethoscope

Stripped to its essentials, the Eko Core digital stethoscope is a highly engineered Bluetooth microphone designed to fit medical stethoscopes. The device wirelessly transmits patients’ heart sounds (not EKG) to a smart phone or tablet app.

The Eko Core was invented and commercialized by a team of UC Berkeley engineering graduates (claimed to be the youngest team to secure FDA clearance for a Class II medical device).

What Eko Core did well

In developing and executing its strategy, the Eko Core team did a number of things right:

  • Targeted a huge existing market. Most doctors and many nurses carry and use stethoscopes every day.
  • Recognized and addressed a  nagging clinical problem: It can take years (even decades) to become adept at using a stethoscope to recognize heart sounds.
  • Improved the functionality of the stethoscope by enabling visualization and amplification. Benefit to the user is improved confidence in identification of heart sounds.
  • Made their device a simple, affordable ($199) add-on to the user’s existing stethoscope.
  • Employed a Bluetooth wireless connection to the user’s smart phone or tablet . Data  from the stethoscope is displayed in a custom app.
  • Enabled data sharing via “the cloud” so that users can share typical and atypical heart sounds and learn from each other.
  • Partnered with major EHR suppliers to enable the digital stethoscope data to be entered into the patient’s electronic medical record.
  • Identified the potential for use of the Eko Core to lower healthcare costs by reducing costly referrals to cardiologists for unusual heart sounds.

What Eko Core hasn’t done yet

  • Showed they can be financially successful over time. Medical device sales and marketing is expensive. Manufacturing under FDA, GMP, ISO, etc. regulations can increase costs. Maintaining healthy profit margins on low-priced medical devices can be a challenge.
  • Exhibited a competitive advantage over similar products, Thinklabs for example.
  • Fully protected their intellectual property, although the company did recently file a patent application.
  • Leveraged their technology beyond one-hit wonder status.

Takeaways

The number of medical stethoscope users in the developed world is on the order of several million. Growth rates are slow, with new graduates replacing retirees, etc.  That puts the potential market at around $500-600 million.

Not bad, but once you “pick the low-hanging fruit” and sell to the early adopters and early majority customers, selling more units gets progressively tougher and more costly. And given competition, it’s a race for market share to capture and keep customers.

I think this will be a fun and profitable business for a while. Longer term, I hope Eko Core has a big medical device company lined up as a distribution partner and has an encore product that leverages the same technology and customer base.

Source: The Eko Core Is A Digital Upgrade For The Centuries-Old Stethoscope | TechCrunch

Eko Devices website

Too good to be true…or just hype?

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image via getairo.com

In a development many were expecting, Canadian mobile health startup Airo Health backed off on its launch of the world’s first wearable device that could track caloric intake. The bold initial product announcement and aggressive commercialization timing led many to think it was too good to be true. Others dismissed the story as just hype.

 

In a story on techvibes.com, the company announced today that it was cancelling pre-orders and issuing refunds to prospective customers.

“Our early testing of AIRO shows tremendous promise, but through conversations with others in the industry, we have come to realize that it requires further testing and calibration through more extensive trials before it will be ready for general market availability,” wrote founder Abhilash Jayakumar in an email to backers this week. “The additional validation required will take us some time and, unfortunately, we no longer expect to be able to ship the first AIRO wristbands by Fall 2014 as initially indicated.”

From the Airo Health website:

NUTRITION

We all know the importance of eating right, but keeping track of what we eat takes too much effort. AIRO is able to automatically track both the calories you consume and the quality of your meals. With a built in spectrometer, AIRO uses different wavelengths of light to detect nutrients released into the bloodstream as they are broken down during and after your meals.

STRESS

AIRO helps you become proactive about stress. It measures heart rate variability, the aggregate response of your autonomic nervous system, derived from heart rate, to measure the smallest fluctuations in your stress levels. AIRO can not only warn you as your stress levels rise but can also provide recommendations as to how best to deal with it. Over time, AIRO gets smarter by learning what calms you and what doesn’t.

SLEEP

We spend a third of our lives sleeping but we know very little about it. AIRO tracks your circadian rhythm and can see distinct sleep cycles. It’ll wake you up at the optimum time and will let you know how much of your night’s sleep was restorative.

EXERCISE

It’s no secret that living an active lifestyle can lead to a long and healthy life. The best way to keep track of your daily activity is to monitor your heart rate; everything else is just a proxy. By tracking your heart rate, AIRO calculates the number of calories your body burns throughout the day.

I wrote about Airo Health and my healthy skepticism of its commercialization timing here. So did MedCityNews and mobilehealthnews.

Takeaways: Developing new medical technology is difficult, much more so than envisioning it. What works in the lab seldom works as well in humans. Unfortunately, it’s easy to get free PR for new and interesting technology without much proof. You can even generate orders without having a functional prototype.

It’s too soon to know if Airo Health actually has unique and innovative mobile health technology. It’s also too soon to know if the company has forever tarnished its reputation. I’m guessing they have “one more chance to make it right”. If they go away and perfect their technology and then try to promote it, the media will grab the story because of the company’s previous sins. If they fail again, I believe it will be virtually impossible to get press or investor attention.

Good luck, Airo.

Read more:

http://www.techvibes.com/blog/airo-health-cancels-preorders-2013-11-21

Startup unveils a wearable device it says can count calories — but it doesn’t actually exist yet – MedCity News.

Question marks, incredulity meet the announcement of Airo | mobihealthnews.

How many calories were in that cheeseburger?

CheeseburgerA Canadian startup has developed technology that may disrupt the mobile health tracking market. Airo Health is commercializing a nutrition tracker that can passively detect and inform the wearer exactly how many calories were consumed in the user’s last meal.

The nutrition tracker uses a light emitter and detector in a wristband and fairly sophisticated software in a smartphone app to measure metabolites in the bloodstream. The metabolites are released during and after the user’s meal.

The Airo device also detects the user’s heartbeat and uses that information to assess activity and fitness levels. All of this analysis starts with sensors in a small, unobtrusive wristband.

According to the company co-founder, Abhilash Jayakumar, Airo received US$81,400 in seed funding from the Canadian federal government and the University of Waterloo. The company says it is planning a commercial launch in the fall of 2014 – that’s just a year or so away. Airo has not yet built production prototypes, so their launch date is most likely optimistic.

In an interview with MobiHealthNews, Jayakumar said the sensor bracelet is detecting accurate calorie intakes about 80% of the time. That’s an exciting development, but the lead times for consumer electronics make a full commercial launch in a year improbable at best.

The fledgling startup has done impressive work with very little funding. They are taking digital health and the “quantified self” movement to a new level. Competitors are no doubt already starting development of their own passive calorie tracking technology. What would really be disruptive is an app to make you not eat that cheeseburger in the first place!

Takeaways: Mobile health sensors and applications are getting progressively more sophisticated. It remains to be seen if there is a sizeable market for these devices and apps but they are capable of measuring things in real time that were previously available only in a doctor’s office by appointment. The commercial availability of a Star Trek-like Tricorder device may be only a few years away.

Most of the personal fitness devices are targeted at healthy people. There is a large opportunity as well in monitoring people with chronic diseases or those recovering from surgery.

Read more:

AIRO ups the ante with passive nutrition tracking

 

Cheney’s Defibrillator: Life Imitates Art, or Vice Versa?

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image via nytimes.com

Former U.S. Vice President Dick Cheney revealed in an interview with the CBS news magazine program 60 Minutes that he had his implantable cardioverter defibrillator (ICD) modified after implantation to turn off the wireless remote programming feature.

 

The skeptic in me wants to believe that Mr. Cheney was just drumming up publicity on his nationwide press tour to promote his latest book. Recent events in cyberspace, however, including the news that the U.S. National Security Agency has the ability to eavesdrop on the mobile phone conversations of the leaders of other countries has caused my to revise my beliefs. There are untold numbers of hackers around the world, all looking for a way to disrupt the status quo. So there is no shortage of motives for someone to try to hack the VP’s defibrillator.

[SPOILER ALERT] In the second season of the hit Showtime cable TV series Homeland (I’m a big fan, by the way), Nicholas Brody, the ex-prisoner-of-war/Marine Sergeant/Congressman/semi-terrorist cooperates with a Bin Laden-like figure to assassinate the Cheney-like Vice President by remotely manipulating his implanted defibrillator.

After Cheney made his revelation, there was much discussion about whether such an action was technically possible. The jury seems to be divided. It’s at least plausible enough to be the major plot point of Season 2 of Homeland. And apparently the possibility of hacker bad guys doing harm was the motivation for Cheney to deactivate the function in his device.

In the Homeland episode, Brody had to find a device code unique to the Vice President, then relay that to a remote hacker. The hacker executed some code that disrupted the device. The audience was not informed as to exactly how the bad code made its way to the implanted device. In real life, experts say that a programmer device must be in close proximity to the patient in order to wirelessly access the defibrillator. Apparently, Vice President Cheney wasn’t taking any chances!

Mr. Cheney had his defibrillator modified in 2007 while he was still in office. He has since undergone a heart transplant and presumably had the defibrillator removed.

Takeaways: As medical devices become increasingly complicated, the opportunities for negative outcomes – accidental and malicious – increase proportionally. Notwithstanding the dangers to the patient, this sort of negative publicity can have devastating consequences for a company, particularly an early stage company.

An ICD with wireless remote access obviously has the power to kill but other devices can be just as deadly. Be sure to conduct a thorough Failure Mode and Effects Analysis (FMEA) during the development process. Seriously consider involving computer experts, including security consultants, as additional resources. You should also consult key opinion leader physicians and patient groups to get objective third party viewpoints about risks and mitigations.

Lastly, have a disaster plan in effect for unthinkable scenarios like the one in Homeland. And make sure the CEO reviews and approves the plan.

Read more: 

Of Fact, Fiction and Cheney’s Defibrillator | The New York Times

Homeland | Showtime

“Dick Cheney’s Heart” |60 Minutes 

 

In search of a better mousetrap…EHR system, that is

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image via mddionline.com

There has been enormous emphasis in the past few years on getting physicians to adopt electronic health records (EHRs). The HITECH Act (Health Information Technology for Economic and Clinical Health Act) part of the American Recovery and Reinvestment Act of 2008, established financial incentives for medical practices and hospitals to adopt EHRs that met specific “meaningful use” criteria. According to a recent survey, physicians are dissatisfied with their EHRs and are looking to switch.

The HITECH Act was an early effort of the Obama administration to use information technology to begin to rein in out of control healthcare costs by using data to make more informed decisions.

The Department of Health and Human Services (HHS) announced recently it has exceeded its goal of 50% of doctor offices and 80% of eligible hospitals having electronic health records (EHRs) by the end of 2013.

There are thousands of EHR products from hundreds of vendors: 3721 EHR products for ambulatory care and 1282 EHR products for inpatient care listed on the HealthIT.gov website as certified EHR solutions. Many entered the field opportunistically when it became apparent that large numbers of physicians, medical practices, and hospitals would be purchasing EHRs in response to the HITECH Act incentives.

According to research conducted by EHR software reviewer Software Advice, it appears that many physicians are unhappy with their new EHR systems: 31.2%  of medical providers are replacing their EHRs today, compared to 21.0% in 2012. That’s a 48.6 percent increase. The main reason for replacement? More than 60% of physicians reported dissatisfaction with their current system. There are multiple reasons for their unhappiness: 26% said their EHR lacks key product features while 14% said it was too cumbersome to use and 12% said their current EHR was too costly.

Adopting a new EHR is a big investment in capital and resources. The switching costs are quite high because transitioning to a new system is complicated and time-consuming.

Takeaways: There remains a significant opportunity for an EHR developer to capture revenue and market share given the high levels of dissatisfaction with current solutions. Companies already in the market should reassess their offerings and work with customers to improve usability and user interfaces, to improve connectivity with other systems, and to provide the features that users need. Startups should try to differentiate their products in the same ways.

It all starts with understanding customer requirements.

Read more:

Why Physicians are Ditching Your EHR System | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

The Impact of the HITECH Act on EHR Implementations IndustryView | 2013.

HITECH Act – the Health Information Technology Act | Policy Researchers & Implementers | HealthIT.gov.

Hyping a digital health startup

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image via NY Times digital blog

HealthTap is a digital health app and website. It’s a useful way to get health and fitness information that is tailored to your interests. You can even get your specific questions answered by medical experts. I use it myself. In an effort to attract attention and even more users, however, HealthTap appears to have hyped or at least exaggerated its success.

HealthTap works by recruiting physicians (more than 50,000 participate) to answer questions posed by subscribers for free. The subscribers do not pay for the service. I’m not quite sure what their business model is, actually. The rationale for doctors to participate is that the physicians will be recognized (“thanked” in HealthTap parlance), their online reputation will be enhanced, and real life patients will come to them as a result.

After an interaction where a user asks a question and receives a response from a doctor, HealthTap asks the user to thank the doctor or HealthTap and prompts the user for more information. The extra information apparently includes responding with a click to a question like, “This answer saved my life.”

HealthTap keeps a record of all of the positive responses to the “saved my life” prompt and issued a press release when the tally got to 10,000. Nothing wrong with any of that, except there is no way to prove if the app/website/reply really did save a particular life.

As one physician commenter in the New York times article said, “after my third “This saved my life,” I investigated. It was for recommending antifungals for jock itch. Nice pat on the back, but lifesaving? Not!”

Although some of the the lifesaving claims may be legitimate, the touting of “10,000 lives saved so far” on HealthTap’s website seems vaguely desperate and hyped – not what I expect from a serious medical app.

HealthTap also provides a disclaimer on its website and app: “HealthTap does not provide medical advice, diagnosis or treatment.” The disclaimer is obviously there to avoid being treated as an FDA-regulated medical application. Of course, the FDA (and malpractice attorneys) will have the final say on that status. I don’t know how asking a specific medical question and having an answer provided by a physician avoids becoming medical advice.

HealthTap is competing with big players in the health information field. WebMD is the 800 pound gorilla and granddaddy of health information sites. I suppose the executives at HealthTap feel they have to be aggressive in order to create awareness and get users and doctors to take notice. Unfortunately, their real utility and service has been tainted by excessive marketing, in my opinion.

HealthTap appears to be a well-funded Silicon Valley startup. Its investors include luminaries like Eric Schmidt, Chairman of Google, Vinod Khosla, Esther Dyson, and more.

Postscript:  I removed the HealthTap app from my mobile phone because I thought the notifications it provided were too frequent and intrusive. I still receive an email every few days on the subjects I told HealthTap were important to me.

Takeaways: Yes, you need to be aggressive in marketing your startup. There is a lot of competition for mind share among similar startups all over the world, no matter how unique you believe your company/product/service to be.

No, you should not make up or exaggerate claims about your product. Perhaps it can be excused as puffery or marketing hype but healthcare companies are held to a higher standard than consumer products like beer or body wash.

Read more:

An App That Saved 10,000 Lives – NYTimes.com.

HealthTap.com

Mobile Health: Red Hot Market Opportunity

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Image from Business Week

Call it mobile health, digital health, eHealth, or”Consumer Health Technology” as Forbes does. By any name the emerging market sector is expanding rapidly and attracting lots of attention, entrepreneurs, and investors.

As I’ve previously written, the time for mobile health has arrived. We carry in our pockets mobile devices with more computing power than the Apollo 11 astronauts had when they landed on the moon. The devices themselves are bristling with sensors and wireless radios. Typical smartphones have temperature sensors, accelerometers, gyros, GPS sensors, ambient light sensors, microphones, touch sensors, and high resolution still and video cameras. They can communicate via Bluetooth, NFC, WiFi, and a number of cellular communications protocols. On-board storage can hold thousands of books and dozens of movies. Connected cloud storage provides effectively infinite storage capacity.

Innovative engineers are responsible for an ongoing explosion of single and multi-purpose external, wearable sensors that communicate wirelessly with smartphones. Smartphone manufacturers are increasingly integrating fitness tracking capabilities into their devices. For example, Apple’s latest iPhone included the M7 chip that can track user activities while minimally affecting battery life.

Application developers are creating sophisticated fitness and health tracking software using the aforementioned technologies. Applications are increasingly passive rather than active, meaning the user does not need to enter data. The apps and sensors detect activities and are able to collect activity data in the background. Others are working to connect the consumer devices and sensors with electronic medical and health records “in the cloud” for a variety of purposes.

There are two main segments in mobile health, regulated and unregulated applications. In the near term, there is tremendous growth and potential in the unregulated space because it’s a quick way to get to market. The consumer markets are very large but price-sensitive.

Of course, your mobile health startup will not be alone when you get there. Big players are either already in the market or they are entering rapidly. Nike, Weight Watchers, Aetna, Garmin, Apple, Samsung, and others are already battling to be the mobile health brand of choice. There are new entrants as well. Jawbone, BodyMedia, FitLinxx, and Fitbit are relatively new companies with trendy, stylish wearable devices.

Huffington Post reported that Berg Insight said 8.3 million wearables were sold last year, up from only 3.1 million in 2011. By 2017, that number is set to reach 64 million. mobihealthnews projects 13 million fitness-related wearables will be purchased just for corporate wellness plans by 2018.

For FDA-regulated devices and applications, the initial market is smaller but the potential is just as great. Regulatory clearances and approvals provide some barriers to entry but will ultimately serve to give early market entrants a head start and not much more. These devices promise to do much more than fitness tracking. They have the potential to monitor chronic diseases and overall health, to provide alerts for significant health-related events, to collect data for clinician use, and to provide specific health-related guidance using user-specific data.

In addition to FDA scrutiny, another significant issue is compliance with HIPAA laws regarding patient privacy. With what amounts to 24×7 data collection and connectivity, there will be enormous amounts of user-specific data in devices and in cloud databases. Companies will have to address data security preemptively or risk losing user trust.

I believe the benefits to the user and to the healthcare system far outweigh the risks and costs associated with these devices and applications.

For healthy individuals, mobile health can provide real time feedback into activities, fitness levels, sleep patterns, even diet information like nutrient balance and calorie consumption.

For aging individuals or those with chronic diseases, mobile health can monitor vital signs, check disease-specific conditions, provide reminders to take medications or perform physical therapy exercises, and send updates and alerts to family members and physicians.

For physicians, mobile health can provide another way to communicate with patients and can also check compliance with recommendations and prescriptions.

For the healthcare system, mobile health can contribute to healthcare Big Data, making it easier for researchers, drug and device companies, and policy makers to track, measure, and assess the health and activities of large populations.

Takeaways: Mobile health is a once-in-a-lifetime opportunity for entrepreneurs. If you have an idea, now is the time to commercialize it. If you are a software developer, find hardware partners. Likewise, if you have developed a sensor, team up with app developers to make a complete package. If you have an unformed idea, try to shape it around mobile health. Investors have taken notice. Rock Health is soliciting applications for funding at a variety of levels.

Read more:

Thinking of Starting a Business? Check Out Consumer Health Technology | Inc.com.

13M wearables to be used in corporate wellness plans by 2018 | mobihealthnews.

How highly sensitive, wearable thermometers could change digital health | mobihealthnews.

What health startups think of Apple’s new motion tracking chip | mobihealthnews.

Moves comes to Android, not afraid of Apple’s M7 | mobihealthnews.

Healthcare Startups Can Save Lives — And Rake in Big Money | Wired Business | Wired.com.

Digital health: what’s the business model?

image via svtechtalk.com

Connecting patients with each other, with clinicians and other providers, with insurers, and with healthcare companies via mobile apps on tablets and smartphones and on the web seems like a great idea. The unanswered question is can you make money doing it?

Articles have been written about how the Internet has enabled patients with chronic diseases and their families to connect with others with the same condition. The patients share stories about symptoms, treatment successes and failures, and try to support each other in what can be emotionally draining circumstances. That ability to connect with a vast community all over the country, perhaps even the world, was virtually impossible before the advent of the World Wide Web.

Other companies are trying to connect healthcare providers with their patients. Some are offering to connect patients with providers for online visits for a fee, effectively commoditizing the doctor-patient relationship.

Google famously shut its attempt at a personal health record site, Google Health, last year. Google Health required a lot of effort to use as it didn’t automatically connect with consumers’ Electronic Medical Records. That shortcoming left a small market of people who were OK with manually entering all of their health data. And that wasn’t a big enough user base for Google.

Healthcare companies, especially those with a B2C business model, are desperate to maintain relationships with consumers.

Providing apps and cloud storage can be costly. It’s not clear who will pay for the digital services.

Doctors and other providers have been incentivized into adopting EMR technology. It’s unlikely that they will invest in additional information technology for their patients.

It seems that consumers and patients love the free stuff. A few may be willing to pay for some services but many have grown to expect that someone else will foot the bill. And most non-healthcare smartphone and tablet apps are either free or at most a few dollars. That sets a low ceiling for any new health-related apps. It’s a tough way to grow a sizable healthcare or medical device company.

People have grown accustomed to paying almost nothing for their healthcare. Sure, there are co-pays and deductibles that have increased significantly in recent years but those are a small fraction of the cost of care. It will be a challenge to change this expectation for health-related apps and services.

In-app ads are probably not the way to go. If the ads are for healthcare-related items like prescription drugs, the patients will lose trust in the service. If the ads are specifically targeted to the patient’s medical condition, the service will be accused of spying on the patient.

Perhaps healthcare companies will regard the cost of developing and providing apps as a marketing expense.

It’s an interesting dilemma. Free apps and services will draw large numbers of users. But monetizing the app via ads turns off many people. Charging for the services drastically reduces the potential market. Absorbing the expense internally places the app/service on the list of things to be cut when the company’s overall business stagnates or declines.

Takeaways: There is enormous interest in apps and services for mobile health. If you are developing products or services in this space, be sure you know how you are going to make money. It’s not a market if you can’t monetize it.

The traditional medical device business model doesn’t seem to apply here. If you procure funding, develop a product, then show economic or health benefits, who do you sell to?

Perhaps partnering with noncompeting companies interested in the same population is a creative way around the problem. If you can deliver large numbers of consumers/patients via a sponsored app to a partner like a big pharmaceutical company, you may be able to avoid some of the pitfalls and objections.

It’s prudent to put a lot of effort now into developing a viable business model. After all, when you start pitching to investors, one of the first questions asked will be, “how do you plan to make money?”

Read more:

Will Any Health App Ever Really Succeed? | MIT Technology Review

Patients share tips online for managing diseases | SFGate.

Improving Patient Engagement Equal Parts Technology, Empathy | Computerworld

Patients Eager To Access Data Including Medical Imaging Through Online Portals (infographic) | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

8 healthcare applications for Microsoft Kinect, 6 reasons not to pursue them

Microhttp://dri2.img.digitalrivercontent.net/Storefront/Company/msintl/images/English/en-INTL_Kinect_for_Windows_L6M-00001/en-INTL_L_Kinect_for_Windows_L6M-00001_mnco.jpgsoft’s Kinect is absolutely amazing technology. And Microsoft keeps improving it. Did you know that Kinect has multiple potential healthcare applications?

If you have an early teenage or “tween” kid, you probably have an Xbox gaming system. The Kinect sensor technology is perfect for all sorts of innovative interfaces for dance, exercise, and role-playing games.

The Kinect sensors and software have the ability to perform skeletal mapping on multiple people simultaneously, to detect 3D gestures and motions and facial and voice recognition. Kinect can even determine users’ heart rates! The device also has the ability to “see” in the dark with infrared camera technology.

The Microsoft Kinect is an amazing amalgam of sensor technology. I’m sure it has many useful and possibly disruptive applications in healthcare and other industries.

Here’s why you should not base your healthcare product or application on Microsoft’s Kinect:

  1. Single sourcing is risky for any startup business or new product development organization. You have no alternative way to duplicate  or replicate the Kinect functions if Kinect or its key functions are unavailable for any reason.
  2. Healthcare is not Microsoft’s core business – it could remove access at any time and/or de-emphasize it in any number of ways. In fact, Microsoft is in strategic transition right now and its long-time CEO, Steve Ballmer, announced recently that he will be retiring in 2014.
  3. You have no access to the device’s source code – access to that code might be necessary if you are developing an FDA Class II or Class III device.
  4. The Microsoft Kinect is based on a console or PC-centric world view. What about tablets and smartphones? Oh, and don’t expect to ever see an Android or iOS device with Kinect capability.
  5. Although Microsoft has made an SDK available for Kinect development on Windows operating systems, the installed base of 24 million Kinects is almost all in Xbox gaming systems. Microsoft is not interested in giving up valuable real estate on its premier gaming platform to comparatively low volume and low margin healthcare apps. If you develop a Kinect-dependent windows app, you will a). have to wait for an installed base to develop or b). take on the added risk of marketing Kinect hardware to create your own installed base.
  6. You will have little technical support from Microsoft simply because your business potential is small compared to their other ventures.

If those six reasons aren’t enough to give you pause, here are the healthcare market areas identified by MobiHealthNews that are particularly suited for Kinect-enabled applications.

  1. Fitness and Exergaming – games and exercises to get people off the couch and on their feet
  2. Physical Therapy  – conduct PT sessions, monitor recovery
  3. Surgery Support  – hands-free image manipulation
  4. Autism Screening and Therapy – not quite sure what the advantage is here. Perhaps some on the spectrum can’t relate as well to people?
  5. Virtual Visits and Virtual Nurses – automated nursing visits. I think this is a bad idea, as senior shut-ins crave human contact.
  6. Virtual Group Therapy – avatar-based online group talk sessions (I believe you can do this with Google Hangouts as well)
  7. Aging in Place and Fall Prevention – gait analysis and fall prediction
  8. Helping the Blind to Navigate and the Deaf to Communicate – using machine vision and text to speech

Takeaways: It’s incredibly risky to develop new technology that’s based on someone else’s proprietary technology. It’s even more risky if that proprietary technology is primarily focused on non-healthcare applications.

You should consider open source projects as an alternative. There are many open source projects all over the world. If it’s critically important to you, try organizing and starting an open source project to support your development work.

If you must use the proprietary technology, try to negotiate a development agreement that places key parts of the technology in escrow so it is still available to you in the event of a default to the agreement. This tactic doesn’t work with gigantic corporations like Microsoft but it may be effective with smaller partners.

Read more: Eight ways the Microsoft Kinect will change healthcare | mobihealthnews.

Wireless sensors are the missing link in mobile health applications

Scanadu Scout sensorWireless sensors are an evolving missing link and a gigantic opportunity in mobile health application development and commercialization.

Markets for mobile health are developing rapidly. Personal fitness, quantified self, chronic disease monitoring, elder health monitoring, infant monitoring, acute symptom diagnosis, physical therapy, and telemedicine are a few of the segments in mobile health.

We have fast networks that cover almost all of our population in the U. S. and most developed countries. Smartphones are powerful mobile computers with vast amounts of onboard computing power and storage. If the smartphone’s capabilities are insufficient, developers can access cloud-based storage, databases, and distributed computing that can scale to address any size problem.

Because all of this technology has been developed for mass consumer markets (and because of Moore’s law), it is inexpensive – orders of magnitude less costly than a few years ago.

So we have cheap, powerful, ubiquitous computing and connectivity mostly being used for social connectivity and YouTube video watching. This powerful computer network is also increasingly being used to improve healthcare diagnosis and delivery.

Still being developed are wireless sensors to take advantage of all of that computing power. There are a number of companies pursuing commercialization of sensors and apps to enable all sorts of mobile health capabilities and functions.

Some of the sensor technologies are wearable in clothing or on the skin, some are implantable, and others are ingestible. All use low power wireless communications technology such as Bluetooth Low Energy for continuous or periodic monitoring. The first generation of sensors, like Holter monitors, recorded data for a time period and were sent to a lab for processing so a report could be generated for a physician. The new generation of sensors records continuously and sends the data in real time where a physician or even the patient can access data that has been processed by a smart application.

Physicians are beginning to be able to monitor their patients with chronic diseases in real time. Individuals active in the “quantified self” movement have more personal data than ever with which to monitor and analyze themselves. Physicians can prescribe personal diagnostics to collect data in order to make a more accurate diagnosis.

For example, Given Imaging of Israel has developed a capsule that has video recording and radio transmission capabilities. The capsule is swallowed by the patient. It then records and transmits its journey through the patient’s digestive tract. The video is reviewed by the physician to determine a preliminary diagnosis and the need for more invasive interventions like surgery.

For the Star Trek fan, Scanadu is developing a crude “tricorder”  – a disk of sensors that is placed on the forehead to measure temperature, heart and respiration rate, blood pressure, and more. The Scanadu Scout is intended for consumers, not physicians.

According to Medical Device and Diagnostics Industry, Pathfinder Software, a mobile and wireless application developer, has created a clever infographic showing various sensors and the body functions they are intended to monitor.

The sensors shown on the infographic are a mere subset of what’s currently available and in development. For example, a startup in my home city of Redmond, Washington, Heapsylon has developed sensors for “smart socks” that can measure a variety of parameters related to running gait to improve athletic performance and prevent injury.

Takeaways: There are opportunities for novel sensors to monitor and measure all sorts of body functions and parameters. There are opportunities to develop applications that gather, process and interpret sensor data for consumers and for healthcare professionals. There are opportunities to analyze aggregated sensor data to assess population health and trends. Finally, there are opportunities to develop and deploy solutions that bring low cost healthcare to underserved populations.

Read more: How Innovations Using Sensors Can Disrupt Healthcare (infographic) | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

Mobile Health Innovations – Home Monitoring of the Elderly

What might have been science fiction a few years ago is science fact today – and one on the verge of market introduction. The Fraunhofer Institute in Germany has developed miniature sensors that continuously monitor the user’s health, communicate over a secure Bluetooth protocol to a mobile device such as a smartphone, and seamlessly transmit data to a cloud-based server.

Mobile health innovations such as this have the potential to save doctor visits, money, and lives.

The sensors can measure and monitor variables such as blood glucose, lactate, and cholesterol levels, biomarkers that may indicate presence of disease processes, and can also measure heart rate and blood oxygen level. The utility of transmitting all of the data to a cloud server is that a remote physician or family member can monitor the patient from a great distance in virtually real-time and also see trends as they develop.

Additionally, smart software could integrate the sensor data and provide diagnostic alarms for conditions like heart attack or insulin insufficiency. For people living alone and with loved ones thousands of miles away, sensors like these could literally be lifesavers.

These developments have the potential to keep elderly people independent longer and to improve the health of people working in remote locations for extended periods of time. Eventually, I expect scaled-down versions of these sensors to make their way into consumer electronics. Samsung is already marketing its S-Health suite as part of the unique software on its flagship Galaxy S4 smartphone.

I’m sure these mobile sensors will get more sophisticated over time. I also expect that clinical researchers will develop new and interesting ways to use the data for monitoring and diagnosis. From the article:

Fraunhofer FIT demonstrates the first system that integrates three different sensors in one platform. A nano potentiostat measures biochemical information in a patient’s assay, e.g. glucose, lactate or cholesterol levels. A fluorescence sensor is used to detect color-marked biomarkers. A SpO2 sensor monitors heart rate and arterial oxygen saturation. A smartphone app processes the data from the three sensors and transfers them to a server. For secure data communication, a Bluetooth connection with a specifically developed protocol is used.

Takeaways: This is a glimpse into the future of telemedicine. Fraunhofer does not commercialize or market products. They license their technologies to medical device companies and related entities. I would expect Fraunhofer to already be in licensing discussions for these technologies but you should contact Fraunhofer if you and your company are in the mobile health segment.

Read more: FIT press release, 12.9.2013 – Fraunhofer FIT.

FDA finally publishes final guidance for mobile medical apps | mobihealthnews

This has to be welcome news to any company competing in the mobile health market segment. Although the guidance is not binding in typical FDA fashion, it does remove some uncertainty about what the FDA considers mobile software that should fall under Class II (510k) device regulations.

Apparently, lobbying elected officials has some benefit. The story reports that the FDA promised to issue the guidance “in the current fiscal year” in congressional hearings last summer. We are in the last week of the fiscal year and true to the FDA’s word, the guidance is finally issued, two years after the draft guidance was issued.

As one might expect in a “land grab” environment, the absence of regulatory guidance has not been a barrier to market for a number of companies. There have been 100 510(k) marketing clearances issued for mobile medical applications in the past ten years, 40 of which occurred since the draft guidance was issued.

Some companies might have bigger concerns in that they are actively marketing apps that fall under the regulated category but have not obtained 510(k) clearance. Two acne treatment apps were removed from the Apple and Android app stores by the FTC recently.

The guidance treats mobile apps in four broad categories:

  1. Class II apps:

a. Apps that “are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.”

b. Apps that “transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.”

2.  Mobile Apps for which FDA intends to exercise “enforcement discretion” (meaning that FDA does not intend to enforce requirements under the FD&C Act).

From the Guidance:

FDA intends to exercise enforcement discretion for mobile apps that:

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions
• Provide patients with simple tools to organize and track their health information
• Provide easy access to information related to patients’ health conditions or treatments
• Help patients document, show, or communicate potential medical conditions to health care providers
• Automate simple tasks for health care providers
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.

3.  Apps that are not medical devices and thus are unregulated: Apps that provide a means of monitoring and reporting health parameters and activities but that make no claimed benefit. Examples:

a. Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities. These are not devices because these apps are intended to be used as reference materials and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.

b. Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received. These may have more functionality than providing an electronic copy of text (e.g., videos, interactive diagrams), but are not devices because they are intended generally for user education and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment.

c. Mobile apps that are intended for general patient education and facilitate patient access to commonly used reference information. These apps can be patient-specific (i.e., filters information to patient-specific characteristics), but are intended for increased patient awareness, education, and empowerment, and ultimately support patient-centered health care. These are not devices because they are intended generally for patient education, and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by aiding clinical decision-making (i.e., to facilitate a health professional’s assessment of a specific patient, replace the judgment of a health professional, or perform any clinical assessment).

d. Mobile apps that automate general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

e. Mobile apps that are generic aids or general purpose products. These apps are not considered devices because they are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

Takeaways: While the FDA appears to move at a glacial pace in many instances, it eventually responds to market activity. Mobile health is a growing segment and should grow even faster in the coming years.

The trick to escaping regulation under the “enforcement discretion” provision is to avoid making diagnoses or recommendations for treatment. If your app/device interfaces with a class II device or provides diagnostic or therapeutic information or suggestions, you are going to need a 510(k).

 Read more:

FDA finally publishes final guidance for mobile medical apps | mobihealthnews.

Get the FDA Guidance here:

 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

Experts apparently agree: Fitness wearables are now a fashion statement | mobihealthnews

I was walking through the South Lake Union area of Seattle this morning and was struck by how many people had their trusty smartphone in their hands and were reading or interacting with it as they were walking. That was not the case as recently as ten years ago, perhaps even more recently.

So smartphones have become fashion accessories as well as constant companions . You can quickly tell the iPhone devotees from the Android “big screen” fans from the Windows Phone diehards who keep insisting that their phones’ technical specs are better. And it’s almost too easy to get into an argument about which company makes the “best” mobile operating system or phone.

Nike FuelBand

Here’s one of the Next Big Things in consumer technology: fitness wearables as fashion statement. The devices themselves are distinctive in appearance and they are fairly expensive. They monitor activity and exercise levels and provide useful information to the user.

For example, a device may count your footsteps (remember, 10,000 steps a day is The Goal!), measure the distance you run or bike, monitor your sleep patterns, keep track of the number of calories you ingest and expend, and generally automate and simplify tasks that were difficult if not impossible to perform before we all had these amazing devices at our fingertips every waking hour of our day.

Every device is different in its features and functions. The manufacturers take great care in developing the look and feel of the devices since each device is a walking advertisement for the product.

I have a hunch, however, that the people who least need fitness monitoring devices are the ones who use them the most. Of course, no one really needs these devices. But trendy people like to show off their trendy toys, like the Nike Fuelband, FitBit Flex, and Jawbone Up.

One development I’m waiting for is to see if ordinary people, overweight couch potatoes and the like, start wearing and using the same devices. Perhaps they will start by emulating their favorite celebrity and then discover the utility in these devices. Perhaps people will use the devices to monitor their health and improve their fitness.

As the devices get more sophisticated and adopted by more people, I hope the manufacturers will include more ways for people to monitor and improve their health. For example, I read an article In a recent edition of Runner’s World about sitting and why it’s one of the biggest health hazards most people do voluntarily. Not even elite runners are immune from the ill effects of being a couch potato when they are not running. Just think of how beneficial a sitting monitor app would be to our increasingly sedentary population!

I expect the next generation of fitness wearables to include Smart Watches that will have a limited ability to run apps and receive input from body sensors. When you see A-list celebrities sporting those and other devices on TV shows and movies, you’ll know the next big fad is being born.

Takeaways: Popular culture is infatuated with mobile technology. Mobile device adoption is well into the 90% range in a number of demographic segments. Fitness wearables could experience the same sort of growth and adoption, especially if led by celebrities. Apps and sensors for these devices could be good businesses in which to invest. Another huge benefit could be a positive effect on public health.

Read more: Experts apparently agree: Fitness wearables are now a fashion statement | mobihealthnews.

Give Us Our Damn Lab Results!! (etc.) | The Health Care Blog

Patients are empowering themselves. We are overwhelmingly using Internet sites like WebMD and social media to research and discuss symptoms, diseases, and treatments. We are purchasing and using digital health devices and software by the millions.

Now patients are starting to demand direct delivery of lab test results instead of waiting for that call from the doctor’s office that always seems to be delayed or worse, never made.

A little-known proposed regulation issued in 2011 by the Department of Health and Human Services would allow lab test providers to send test results directly to patients. While a final regulation has not been issued, perhaps due to the current political climate in Washington, the regulation is being welcomed by patient advocates and viewed with skepticism by some physicians.

As the article states,

Increasing the ability of patients to have direct access to all their medical information allows patients to more effectively manage their own health care and organize electronic copies of their own data – a major benefit of the health care system’s ongoing transition to digital records…Most broadly, this expanded access gives patients the ability to be as engaged as they choose in their own health and care.

Some unenlightened physicians are lamenting the perceived loss of control and cite the risks involved when patients have uninformed access to clinical data. Other doctors welcome the opportunity to stay in the loop while patients take more responsibility for their own healthcare and data.

Again, from the article:

… A 2009 study published in the Archive of Internal Medicine indicated that providers failed to notify patients (or document notification) of abnormal test results more than 7 percent of the time. The National Coordinator for Health IT recently put the figure at 20 percent.  This failure rate is dangerous, as it could lead to more medical errors and missed opportunities for valuable early treatment.

How can sending lab test results directly to patients be a bad thing if the doctor still receives a copy of the results and continues the practices of alerting patients to abnormal results while offering to interpret the data?

In another empowering development, some patients are now able to skip the dreaded visit image from geekwire.comto the primary care physician, the one where they wait, wait, and wait some more while being exposed to who knows what communicable diseases in the practice’s waiting room. People in the south Puget Sound region of Washington in the Franciscan Health System service area have the ability to have a virtual visit with a physician 24 hours a day, 7 days a week for a reasonable $35 fee (not paid by insurance). The consultation may result in a referral to a physical facility or prescribing of medications. How convenient!

From the article:

“In some cases, patients just want to know if they need to go to the emergency room,” said Dr. Ben Green of Franciscan Virtual Urgent Care. “In fact, most of the time our providers are able to keep them out of the emergency room and patients are quite happy about that.”

The virtual visit with a real doctor is conducted via Skype video teleconferencing or by plain old-fashioned telephone.

The telemedicine service is actually offered by Carena, a Seattle-based company, in partnership with Franciscan. Carena started offering the service in 2010 to private companies and is now expanding to healthcare systems.

Takeaways: Empowered patients and consumers represent an enormous opportunity for medical device and digital health companies. The pharmaceutical industry proved the viability and profitability of direct-to-consumer marketing in the 1990s.

As more patients are comfortable managing their own electronic health records and in keeping their records “in the cloud,” there will be increasing demand for apps, software, and web services to facilitate and secure those transactions and records. The market niche of people who self-monitor their health, fitness, and vital signs with digital health devices and apps will steadily increase as the devices and software get more capable and easier to use.

Read more:

Give Us Our Damn Lab Results!! | The Health Care Blog.

Feeling sick? Washington health system now offers virtual doctor appointments for $35 – GeekWire.

3 things that will help hardware entrepreneurs build their startups | MedCity News

I’ve  suspected for some time that hardware, i.e., real life products, are tougher to successfully commercialize than software products.

hardware

For one thing, the cost of hardware product development is much higher. Assume that the hardware design cost is roughly equivalent to the development cost of a software product. For hardware, you then need prototype tooling, pilot tooling, and production tooling – all expensive. Real world testing and validation is time-consuming and also expensive. Animal and human clinical testing is complicated and risky. Then there are the costs of inventory and physical distribution as well as warranty and repair. Lastly, the profit margins are much lower than software!

“Starting a venture is hard — actually, if people knew how hard, they wouldn’t do it — but starting a hardware venture is three times as hard,” said angel investor and Txtr CEO Christophe Maire

The premise of this article is that there are a few things one can do to mitigate the risks inherent in hardware commercialization (these mitigations are not limited to medical technology):

  1. Launch the product online
  2. Simplify, simplify, simplify
  3. Combine hardware with a service

Starting with online sales and distribution limits your financial exposure by not having to stock a distribution channel/pipeline (assuming you can find distribution partners as a startup). You can also defer the substantial investment needed for a sales force. The upside is that you still have a global footprint. As demand and revenues grow, you can either bootstrap growth using early revenues or use the growth as evidence of demand to obtain angel or venture funding.

The big challenge with online distribution and sales is creating awareness and demand. Your online marketing skills will be put to the test. Of course, you could hire a freelancer or consultant for a short term project to “prime the pump” and get the product launched.

Creating online stores for physical products has never been easier or less costly. You can set up a store at Amazon.com for example. Amazon will take care of everything related to online sales, for a hefty percentage of the action, of course. You can even drop ship from your warehouse as the orders roll in. Companies like UPS and FedEx will physically store your inventory in strategic locations to minimize shipping time and customs delays to overseas markets.

Simplification is important, especially for a first product. You should select your most likely customer and develop a minimum viable product for that customer type. Extra features can be added later.

The prime objective is to get to market and scale up as quickly as possible. Since seed and angel funding is very difficult to obtain for early stage hardware startups, you will probably be doing a lot of bootstrapping and trying to save money everywhere possible.

Simplification can also be a competitive advantage. For every early customer you acquire, that’s one less customer for your competitors (unless you screw up the relationship with poor quality or unrealistic promises). Once you have established that early relationship, customers are more patient and more likely to wait for the enhancements you showed them on your product roadmap.

Finally, combining hardware with a service puts your startup into a different class altogether. You can create a recurring, high margin revenue stream in addition to ordinary product revenue.

There are obvious services like training, extra warranties, service and maintenance contracts, leases, short-term loaners/rentals and hardware upgrade/refresh cycles. There are new services being created every day like cloud-based storage of the data generated by your hardware. Many companies are developing mobile and desktop apps for remote viewing, control, or manipulation of their products and the data they generate. You may be able to offer data analysis or even offer access to anonymized, pooled data from all of your customers. That could be a strategic advantage for your customers!

Takeaways: Hardware commercialization is hard. Because we still live in a physical world, there will always be a need for tangible products. Because hardware development is expensive and risky, always try to limit your risk and exposure. Startups look a lot bigger online – use that to your advantage. Keep your first product simple. Ruthlessly eliminate any features or functions that are not necessary to get a sale. Lastly, look for alternate ways to generate revenue, especially recurring revenues through value-added services.

Read more: 3 things that will help hardware entrepreneurs build their startups | MedCity News.

Digital health needs more physician entrepreneurs | mobihealthnews

Are you aware of the Society of Physician Entrepreneurs (SOPE)? I was not. The CEO of SOPE, Dr. Arlen D. Meyers, a practicing ENT surgeon, says that doctors are not trained in business while in medical school or residency. That has certainly been my experience.

While many physicians have an entrepreneurial mindset, only a few I’ve met and worked with have business skills that would enable them to start and/or run a company. Some are just natural entrepreneurs although I think there are far more who believe they have business acumen but don’t have any or don’t have much business savvy. Those doctors are the toughest to work with as a medical device commercialization executive.

To address part of the problem, Dr. Meyers has created a certificate program in bioinnovation and entrepreneurship at the University of Colorado. The program is intended for postdoctoral students not interested in a career in academia.

Dr. Meyers also said, “most innovation in healthcare and medicine leaves out doctors and patients, particularly in the lucrative fields of drug and medical device development.” I’m not sure exactly what he’s driving at here. Most device companies, startups included, are happy to work with innovators or key opinion leader physicians to help create, develop, refine, and commercialize new products. They are well-compensated for commercial successes, much less so for market flops, of course. And patients are a necessary part of the process.

Medical device commercialization is not for amateurs and it’s not a part-time gig. Most physicians are incredibly busy people. It seems to me their natural role in a startup or on a new product development project in a larger company is to serve as a clinical/healthcare system resource, product endorser, and source of referrals. Of course, they are free to try their hand at business and create their own startups.

Dr. Meyers also points out that the burgeoning digital health segment is underrepresented by physicians. That may be because the technology, networking, and systems interoperability dimensions of digital health solutions and products tend to be far outside most physicians’ areas of expertise. However, there are multiple opportunities for doctors to innovate. For example, their detailed knowledge of the healthcare delivery system may have given them specific ideas about how to improve patient care delivery with apps. He also believes that non-face to face care using telehealth or digital health products and apps is going to be a substantial opportunity for entrepreneurs, whether physician or layman. Any of those ideas could be the basis of a digital health startup.

Takeaways: Medical device and digital health startups, even with their high failure rates, are attractive to at least some physicians – those with entrepreneurial mindsets. Startup founders and CEOs should identify and recruit like-minded doctors for their executive teams, boards of directors and advisory boards. If you are a digital health startup CEO with a tech/IT background, you can minimize the risk of making bad or just uninformed product decisions and enhance your commercial products by finding and engaging with an entrepreneurial physician.

Read more: Digital health needs more physician entrepreneurs | mobihealthnews.

mHealth, eHealth, Mobile Health, Connected Health: Not Fads, Not Going Away

Smartphones can be addictive. The convenience of obtaining information and maintaining social connections is a powerful benefit for just about everyone. Health-related smartphone apps have the potential to use that addictive property to inform and improve the health of smartphone owners.

Close to 60% of all adults in the U.S. use a smartphone. The proportion approaches 100% in well-educated, affluent, young-to-middle-aged, or urban/suburban demographic groups. Using “diffusion of innovation” terms, smartphone adoption has penetrated past the Early Majority and is deep into the Late Majority. That’s more than enough for a startup to base its technology platform on.

There are more than 40,000 smartphone apps focused on mobile health, growing each day. Many savvy entrepreneurs have identified mobile health as a Next Big Thing and are trying to stake out their territory during this “wild West” phase of the mobile health market.

According to an executive at Qualcomm, the exponential growth in mobile or connected health is being driven by two factors. The user experiences are getting better all the time and there is real opportunity for cost control at the provider level. App usage is growing even among clinicians: 34% of clinicians reports using apps to monitor data from medical devices now, up significantly from the 27% who reported doing so in 2012.

Of course, things like user interfaces and app features can make a huge difference in adoption and patient satisfaction. One recent study of diabetes patients showed that patients with passive monitoring and reporting apps on their smartphones to manage glucose levels had better adherence to their glucose management plans and also had better health outcomes than patients who used apps requiring manual intervention.

According to a Brookings Institution study, remote monitoring technologies could save $197 billion in the U.S. over the next 25 years. And adoption is spreading rapidly. For example, 45% of physicians report using mobile apps for data collection at the bedside compared to 30% in 2012. More than 70% of providers use mobile devices to access patient Electronic Medical Records (EMRs). Physicians are eager adopters of mobile devices with more than 66% reporting use of tablets in their professional practices.

Joseph Kvedar, MD in an article on The Health Care Blog, writes:

Mobile health offers us many transformational opportunities.  We can use smart phones as a data upload/home hub device.  We can use them as a device to engage the consumer around health content.  We can use them to display health-related information at  just the right moment in just the right context.  We can use the cameras to capture relevant health information (e.g., home test results).  We can use them to message you in the moment with contextually relevant, motivating messages.

Add to the list that we can harness the addictive properties of these devices to, perhaps, make health addictive.

Takeaways: The market opportunity for mobile health is here and now. Devices, sensors, networks, software, and connectivity have never been better, cheaper, or easier to access. Patients and providers have adopted mobile technologies in huge numbers. Yes, there is plenty of competition but there are rewards for any startup or company that can identify a market niche, develop a solution, and deploy a product that meets user expectations while maintaining a long term strategy of reducing costs and improving clinical outcomes.

Read more:

Why mHealth is not a fad but is here to stay (infographic) | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

Could Mobile Health Become Addictive? | The Health Care Blog.

The Perils of eHealth | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

Fraunhofer iPad app guides liver surgery through augmented reality | engadget.com

Here is an excellent example of the innovative use of commercially available computer technology, in this case an iPad tablet, to address a clinical problem.

The problem is that surgeons performing liver surgery to resect a tumor must identify and then avoid the extensive vascular structure in the liver when removing the tumor. They must also be sure to leave sufficient liver tissue and blood vessels for the liver to function properly after surgery or the patient will die. Currently, surgeons either memorize the patient’s vascular structure after studying 3D CT scan images or they bring printouts into the operating room or they show the images on large computer monitors.

The first option for referencing the imaging information runs the risk of the surgeon forgetting an important detail or remembering something incorrectly (it happens). The second and third options’ risks are that the surgeon must repeatedly look away from the surgical field to get the structural information that will guide his/her excision. These “lookaways” prolong the procedure, cause the surgeon to lose his/her orientation, and can even cause damage if an instrument is moved during the period of inattention.

Fraunhofer, a German research institute that develops and licenses advanced technology, created a simple iPad app that allows the 3D CT images to be brought very close to the surgical field. The iPad is placed in a sterile sleeve so it can be manipulated directly by the surgeon or assistant. That would be plenty valuable if it was all that the app did. But (as the late night infomercials say) wait, there’s more!

The app uses the iPad camera to capture a live view of the surgical field and the patient’s liver. It then superimposes the vasculature from the 3D CT imaging study on the live image from the camera. That’s the augmented reality part. The app also enables the surgeon to measure the length of a blood vessel by marking it on screen and to “erase” excised blood vessels from the display. The app can also estimate the blood flow through the remaining vessels, helping the surgeon to determine if the remaining tissue will be viable.

The researchers plan to use the app next in pancreatic surgery, another organ that requires painstaking precision and relies heavily on preoperative imaging.

This app could be further improved, in my opinion, by adapting a head-worn, see-through display with a built-in camera. The surgeon would remain focused on the task and the 3D imaging would be superimposed on his field of vision. There would be no need for the awkward manipulation of a tablet on or near the surgical field. The other members of the surgical team could have their own headsets with the surgeon’s view displayed. Of course, there are no commercially available products in this category quite yet, although Google Glass is a promising candidate.

Takeaways: This is a great example of innovation in medicine by adapting the familiar (physicians are heavy adopters of iPhones and iPads) to a serious clinical problem through the development of an easy to use software app. The lesson for entrepreneurs and startup CEOs (again) is to leverage the billions of dollars of investments made by others in consumer technology and then to add value by 1. understanding the clinical problem and 2. developing a unique solution with the leveraged technology. It’s a fast, relatively inexpensive path to the market.

Read more: Fraunhofer iPad app guides liver surgery through augmented reality.

This startup wants to help you save on medical bills by taking control of your health | GeekWire

Health 2.0“, also known as digital health – focusing on improving people’s health through a constantly evolving mix of web or mobile device apps and educational software and websites, social media, personal health records, and various forms of connected sensors – is growing and attracting much attention, from entrepreneurs, investors, the media, and public health officials.

The basic idea is that people can take charge of and improve their own health – and reduce their healthcare expenses – if they have data about what’s going on with their bodies and some basic information about what to do about it. Sometimes the data is shared with a healthcare provider.

The organization Health 2.0 estimates that there are 2540 companies in the Health 2.0 segment as of June 2013. A majority of the companies, 1465, are consumer-focused while the next largest category, professional facing, has 643 participants. There are 203 companies involved with patient-provider communications and 229 companies working on data and analytics. I’m sure the overall count increases every day.

Why is Health 2.0 such a hot segment in healthcare? For one thing, the barriers to entry are lower than in other segments like medical devices or biotech. Many of the apps are unregulated or require a 510(k) marketing clearance at most. The cost to develop and deploy an app is a fraction of what it costs to commercialize a Class II medical device.

How do these companies plan to make money? That, as the (updated) saying goes, is the $64 million question. Many of the apps and web services are free. Some use the familiar freemium model where a basic version is provided free of charge and the fully-featured version is sold for a few dollars or so. What’s lacking is a recurring revenue model, or is it?

Just as Google and other companies with large user bases do, many Health 2.0 companies aggregate and sell the data generated by their apps. It’s appropriately anonymized but it’s probably worth much more in terms of lifetime revenue per user (LRPU) than the nominal charge paid by the consumer. Plenty of researchers and marketers in Big Pharma and insurance companies as well as government would love to have large data sets with behavioral data from a target population from one of their drugs, pipeline or on the market.

The company referenced in the article, Health123, was started by ex-Microsoft and Seattle tech veterans. They plan to approach employers with the prospect of reducing their health insurance expenses by improving employee health through deployment and use of their app. It’s another revenue model. It also raises serious privacy concerns as seen in a lively discussion in the article comments.

It’s tempting to think that your company could be the one to demonstrate positive outcomes. It seems to me that there is much anticipation regarding effective health apps that can improve public health and/or “bend the cost curve” as the healthcare policy wonks like to say. Looks like there are a couple of thousand startups that are in agreement.

Takeaways: Health 2.0 presents many opportunities for medical device and healthcare IT entrepreneurs. Even hardware companies can get in on the action via development and integration of all sorts of physiologic sensors. This could turn into a “land grab” where small and nimble startups do all of the innovation and are then snapped up for outlandish valuations by big medical device and healthcare IT companies who can’t afford to miss the market opportunity.

Read more: This startup wants to help you save on medical bills by taking control of your health – GeekWire.

You Can Now Find Out What Your Doctor Is Writing Down In That File | Fast Company

This is a follow-up in a way to yesterday’s post about interoperability in healthcare IT applications. It turns out that a team of researchers has developed and deployed software called Open Notes that allows patients to see their medical records and review their doctors’ visit notes. In a trial completed in 2012 of 14,000 patients at several leading medical centers, including Harborview in Seattle, study organizers reported that the results exceeded expectations:

Patients with OpenNotes reported better care, while doctors experienced little additional work. Of the patients with access to OpenNotes, almost all opened their records, more than 60% reported they took medications more regularly and 77% said they felt more in control of their care. By the end, every single doctor opted to continue with the program, along with 99% of the patients in the program.

This is the kind of innovation that costs almost nothing to implement and has the potential to have large positive effects on healthcare costs and patient health. Last month, the organization reported that the U.S. Veterans Administration (VA) joined as a full partner and is offering OpenNotes to its >1 million patients.

My knowledge of the VA is that they are heavily data and outcomes-oriented. I’m sure they will be doing analysis to determine the actual effect on costs and patient benefits. As they are a closed system and highly computerized, they have the ability to conduct relatively fast studies with high statistical significance.

The Open Notes projects is run by Tom Delbanco, MD and Jan Walker, RN, MBA. Both are on the faculty at Harvard Medical School and Beth Israel Deaconess Medical Center. They have been working on Open Notes since 2008 and have received funding from the Robert Wood Johnson Foundation, among others.

Now we need someone to take on the problem of corporate data silos in healthcare IT.

Takeaways: Even small ideas can have large effects. A side benefit is that small ideas are easier to explain. If you are having trouble finding angel or VC investors for your startup, consider “venture philanthropy.” There are many foundations that might consider a grant if it even tangentially helps achieve one of their goals. Not sure if you have a valid business model? This team charged ahead with grant funding and now has powerful evidence that they might have a solution to a very big healthcare problem.

Read more: You Can Now Find Out What Your Doctor Is Writing Down In That File | Co.Exist: World changing ideas and innovation.