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Nominations open next week for the 2012 TripleTree I Award, our annual recognition of innovations in wireless health.  Messaging from new market entrants to physicians, payers, and most notably consumers is fueling a strong venture capital appetite, and looking back at the I Award finalists since 2009, we thought it was useful to list a few notable accomplishments.

Public Markets

  • Epocrates – The first mobile healthcare company to successfully go public in early 2011 raising $86m

Funding

  • Airstrip Technologies – Received an undisclosed amount of funding from Sequoia Capital
  • IntelliDOT – Raised $30m+ from leading investors including Psilos Group, TPG Growth, Camden Partners, Integral Capital Partners, J.F. Shea Ventures, Menlo Ventures and American River Ventures
  • Proteus Biomedical – Raised $25m from Medtronic, Novartis, and ON Semiconductor Corp
  • TelaDoc – Raised $18m from Cardinal Partners, HLM Venture Partners, Kleiner, Perkins, Caufield & Byers, New Capital Partners, and Trident Capital

FDA Approval

  • Calgary Scientific – ResolutionMDTM  after 23 months received 510(k) clearance from the FDA
  • Telcare – Wireless blood glucose meter received 510(k) clearance from the FDA for its device, Telcare BGM

Acquisition

  • CellTrak Technologies – Expanded into Canada through its acquisition of MedShare mobile technology for home health care
  • Healthagen – Patient access software to providers acquired by Aetna

Since TripleTree’s I Award inception in 2009, one company has gone public, one has been acquired, numerous rounds of funding have been raised, multiple FDA approvals granted, and some businesses have scaled nicely.  As the market continues to mature and awareness and user adoption grow, questions loom…

  • Is “connected health” on the verge of a breakout?
  • Are wireless health solutions the answer for reduced healthcare costs and improved quality of care?
  • Will innovation be driven by non-traditional healthcare vendors (ie device vendors and mobile service providers)?
  • How are the ramifications of reform influencing innovation?

As we consider these questions, a few key indicators are influencing the market:

  • Four out of five physicians use smartphones, computer tablets, and other mobile devices (Jackson & Coker industry report)
  • More than $600m has been invested in the wireless health space since January 2010
  • 89% of healthcare decision makers believe telehealth will transform healthcare in the next 10 years (Penn Schoen Berland Study)

Below is the honor roll of past I Award finalists.  Look for more information from TripleTree in the coming weeks as the nomination process commences and we plan for the WLSA Wireless Health Convergence Summit scheduled for May 22-24 in San Diego.

2011 Finalists

BodyMedia*

Wearable body monitoring device

Cambridge Temp Con*

Wireless physiological monitor for infertility

Cardiocom –

Clinical telehealth services

Cellnovo

Mobile diabetes management system

Healthagen

Patient access software to providers

Mobisante

Mobile ultrasound imaging system

Palomar Pomerado Health

Real-time mobile software patient electronic health information

Phreesia*

Touch-screen mobile tablet

TelaDoc

On-demand patient access solution to ERs and urgent care

Telcare

Wireless bloodglucose meter

Vitality

Mobile medication adherence

Wound Technology Network

Telehealth- based wound services

2010 Finalists

AirStrip Technologies

Mobile patient information

Calgary Scientific*

Medical imaging

CellTrak Technologies*

Homecare with GPS cell phones

Corticare

Critical care patient monitoring

Great Connection

Mobile imaging communications

Hopskipconnect

Motivational self management tools

InnerWireless

In-building wireless solutions

Ocutronics

Retinal camera

PerfectServe

Physician and patient care communication

PharmaSecure

Pharmacy brand protection solutions

Zeo, Inc.*

Sleep monitoring

ZMQ Software Systems

Sustainable development

2009 Finalists

BeWell Mobile

Disease management applications via text messaging on cell phone

CellTrak Technologies

Homecare automation with GPS cell phones

Diversinet

Health information transparency in partnership with AllOne Mobile

Epocrates

Rx Drug and formulary reference

GreatCall*

Jitterbug; simple cell phone with 24-hour live service

IntelliDOT*

Workflow manager connecting caregivers with information systems

MedApps

Mobile wireless health monitoring

MicroCHIPS

Continuous glucose management system

PhiloMetron

Passive weight management platform

Proteus Biomedical*

Electronically observed therapy platform

Tagnos

Patient flow management applications

Triage Wireless

Wireless telemetry/vital signs monitoring

*Denotes I Award Winner

 

Joanna Roth

Joanna Roth is a Senior Analyst at TripleTree covering the healthcare and technology industry, specializing in education solutions. Follow Joanna on Twitter or e-mail her at jroth@triple-tree.com.

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The FDA classifies a medical device as “…an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body–that could actually include some information technologies and performance technologies–but usually something that is performed on the patient, touches the patient or is performed between physician and patient.”

By this definition, an iPhone or Blackberry loaded with the proper apps or enabling a key medical service becomes a FDA-regulated device. That is an industry with over 5 billion previously unregulated potential medical devices waiting to be enabled by the 17,000 plus increasingly sophisticated wireless health applications in the market and thousands applications more in active development. Wireless and mobile health researchers at strategy consulting firm CSMG estimate industry revenues to top $4.6 billion by 2014, a stunning figure for an industry that didn’t exist just 5 years ago.

Recognizing the potential regulatory bombshell, the FDA and the FCC convened last July for a meeting on “Converged Communications and Healthcare Devices Impact on Regulation to address the current state of wireless health, innovator perspective, and investor perspective. The agencies’ stated motivation for the meeting was to “clarify and delineate the respective areas of expertise and jurisdiction between the agencies” given the increasing convergence of communications and wireless technologies and medical devices. Emerging from the meeting was a joint FDA-FCC memorandum of understanding to promote collaboration and eventually refine and improve the regulatory processes applicable to wireless-enabled medical devices (and conversely wireless devices with medical applications). While an admirable step towards normalizing government oversight over the mHealth market, neither agency has issued concrete guidance or a path to regulatory approval to date.

The FDA’s lack of clarity is causing uncertainty amongst entrepreneurs and investors. Just last month, the agency finally announced it would issue guidance on mobile medical applications later this year, settling an issue that has had many industry investors cautiously observing from the sidelines and developers nervously eying their own business plans.

Given the day’s current political environment of overregulation, it’s possible that the decision could have severe ramifications on growth in an industry in the midst of considerable upswing.

With the number of mobile subscribers worldwide passing the 5.3 billion mark at the end of the year, over 75% of the global population has a mobile device, and that number is expected to grow thanks to increasing penetration in developing countries and the growing presence of tablet computing.

We are optimistic that the FDA will adjust its need for regulation in harmony with the industry’s need for innovation, creating a set of guidelines that will attract investors and entrepreneurs while protecting the security of consumers and medical data.

Have a great week!

Marc Baudry

Marc Baudry is an analyst at TripleTree covering the healthcare industry specializing in population health management and healthcare informatics. Follow Marc on Twitter or email him at mbaudry@triple-tree.com.

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Ahead of his keynote address at the upcoming Wireless-Life Sciences Alliance Convergence Summit in San Diego next month, Bill McGuire, M.D., recently sat with mobihealthnews (MHN) editor Brian Dolan for an interview on the efficacy of technology in healthcare and the road ahead.

(MHN) How do you characterize the opportunity for wireless health? Could you also provide us with some sense of the current investment climate — a lot of activity? A lot of interest but not a lot of activity?

I like to position it as: How can we build products, services, and systems that facilitate the eventual appropriate health and wellbeing for the people in this country and elsewhere. In pursuit of that and in consideration of all that has been done — both good and bad — and all that is yet to be done, which is significant and formidable, I think the whole area of technology enabled healthcare or mHealth or any term you’d like to apply, offers significant opportunity to meet that end. It still remains to be seen obviously what the most appropriate areas and most beneficial areas will be to accomplishing that. When it comes to investments, of course, there will be a lot of investments in things that don’t make any difference or are not contributory to the kind of outcomes I am describing.

(MHN) What kind of things?

If you look at what has happened in last several years particularly with reform: These huge expenditures that have been directed at technology applications in healthcare. I’m afraid we will see that we have spent an enormous amount of money for marginal or no gain. It’s very indiscriminate. That’s classic healthcare, though and classic investing: ‘Let’s just throw money at things.’

You have the whole idea of applications on cell phones for example. Embedded among [the thousands] of health apps out there are probably a few that will make a difference in the lives of some people. Those apps should theoretically lower costs and improve outcomes, but most of these apps exist because we happen to like apps, it’s a nice story, so we chase them. Discerning what is ultimately going to make a difference and result in the kind of outcomes we are looking for, which is differentiated from just investing money, is the critical issue. The smart investors, smart developers, smart policy makers and so on will benefit from that. The land grab that is going on right now — just throwing money at it — is a little bit misguided.

Another issue is the lack of interactivity among these technology applications. The fragmentation and silos continue. Rather than determining how to piece a number of necessary components together, we have a lot of independent efforts out there to chase after something. We ask for electronic medical records (EMRs) but we don’t necessarily put out standards of performance and interactivity between them. So when someone comes along and asks to gather data or information we know that we can’t get it from each and every one of them.

(MHN) So EMR efforts are misguided?

The amount of money that is being thrown at this stuff relative to the value that it is going to return to us is ridiculous and it will not prove to offer up the kind of end gains that we are touting. Those are health outcomes gains and financial gains in terms of lowering costs. I see nothing that suggests this is going to dramatically improve outcomes, improve access to care for people who had heretofore not had access to care and certainly nothing that suggests that it is going to lower the costs of healthcare in America. People are rushing to do various EMRs simply because the government says we will pay you to install it. If you talk to people who try to extract data from various EMRs they would tell you that there is no consistency in the expectation to do it from many different systems and yet we are spending billions of dollars on this.

(MHN) Let’s switch gears back to wireless health. Are any companies on the right path? If you aren’t comfortable naming companies, what are some specific use cases that you think are promising?

I will be necessarily cautious about the specifics because I don’t want to come across as endorsing or refuting things that I know relatively little about specifically. Let’s start with a concept. What I think we are talking about in some way parallels what we are seeing from efforts in education. As we confront challenges around resource availability and the spacial relationship between the users (the someone in need) and the resource. The ability to take content out to individuals — which is what mHealth or various mobile technologies have done — becomes a substitution for asking those people to go to the content source in a different way.

It’s sort of like: If the cost of gas goes up and bus costs go up, how do we really expect kids to learn about the arts when they used to get on a bus and go on a field trip to a museum? Museums are beginning to take their content to the students where they live. The Metropolitan Opera says we can’t expect everyone to come to the Met, but opera is an important cultural element for society. So they started filming it and showing it at theaters around the country, which has been wildly successful. In these cases we are looking for ways to bring content out to touch people when we can’t in essence do it physically.

In healthcare the same principle exists. People who live in remote sites do not have access to care — primary care to say nothing of secondary or specialized care. How do we help them manage their health and wellness and help deliver services that might be beneficial to acute but relatively everyday problems? That is the kind of application opportunity that the technology provides. Whether that includes telehealth, applications, gaming… that’s the huge opportunity.

(MHN) Any closing thoughts?

I think healthcare might be unique in that it is a space where technological advance has not positively influenced efficiency or cost reduction. Just across the aboard it has not happened. Costs keep going up year after year after year. Why is that? The discussion we hope to have at the WLSA Summit is around how the companies presenting are in fact going to accomplish the needs of both enhancing efficiencies and lowering costs while achieving improved health outcomes for people. I expect it will be a lively discussion about disruption and how mobile will play into that.

Dr. McGuire is widely respected for his uncensored clarity about what has, hasn’t and can work relative to advancing the health of our nation.  This interview offers a sneak peak at the keynote remarks he will deliver during the WLSA Convergence Summit on May 11, 2011.  Click here to register.

Bill McGuire, M.D. is the former CEO of UnitedHealth Group and current Vice Chairman of TripleTree Holding Company.

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Last week, my colleague, Ryan Stewart participated as a keynote presenter for a regional Health 2.0 event.  As leading resources for innovative healthcare technology organizations, TripleTree and Health 2.0 are aligned in their belief that the growth of user-generated healthcare will foster a wave of consumerism across the industry. TripleTree has identified “consumerism” as critical for engaging consumers to take a greater degree of control in their own health and breaking down the traditional roadblocks that have caused a disconnect between payers, providers and consumers within our healthcare system.

TripleTree continues its active role in the mHealth (mobile and wireless health) arena and closely follows dozens of innovators who enable a free flow of healthcare information between various systems.  Ryan’s presentation outlines several macro-trends where mHealth is supporting this information flow and facilitating patient access to care information through greater patient participation in health-related decisions. You can view the presentation here.

Joe Long

Joe Long is an analyst at TripleTree covering the healthcare sector, with a focus on the approaches and technologies surrounding health insurance exchanges.  You can email him at jlong@triple-tree.com.

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My brother recently migrated back to India to lead a start-up in the electronics sector.  As he busily builds his business and reestablishes himself, he has introduced me to the concept of “The New India.”

The importance of his remark is wide-ranging as India competitively touches nearly every sector of the U.S. Economy. However, because of my 30+ year career in healthcare, I immediately began to consider where The New India will impact my day-to-day business realities as well.

Much has been written about the impacts of the BRICS (Brazil, Russia, India, China, South Africa) economies on innovation and consumption in many industries; but a recent New York Times article citing how the U.S. medical device sector may be losing some of its competitive edge (thanks to FDA scrutiny) underscores a viewpoint for healthcare.

Scrutiny equals delays, and delays equal costs; and while the FDA has a tough job, at some point it will need to confront (and adapt) to the realities of our globally competitive market.  The company mentioned in the article (Biosensors International) learned this the hard way, like many other emerging healthcare companies, as it was forced to shut down operations due to the lengthy FDA approval process.

The FDA’s high bar on healthcare standards in the U.S. could cloud some observers the reality that superior care also exists in BRICS economies; however healthcare access is another story.  Eighty percent of populations living in non-metro areas are often far from primary care facilities.  Thus, the expense of travelling to a doctor for even the slightest adverse health condition is usually so high that those who need the care most don’t get it.

Wireless and mobile approaches to healthcare can help alleviate this burden, and allow the impoverished consumer access to care at a central facility, freeing up monies for care that otherwise would have been spent on transportation to a distant care center.   This “redirection of discretionary spending” enables “new BRICS consumers” to have better control over their limited funds.

In India and China, 2.2 billion people actively use the web and social sites like Facebook and Xiaonei.  Are the executives of U.S. based medical device companies paying attention to the preferences of these newly empowered consumers?  A few have grasped the reality that wireless and mobile technologies are true enablers of healthcare and despite the infrastructure barriers in the BRICS countries, the pent up user demand from billions of consumers is driving meaningful innovation.

The application of wireless and mobile health solutions in traditional environments is top of mind with government and business leaders and is a central theme to the upcoming Wireless-Life Sciences Convergence Summit in San Diego. Recent research on wireless and mobile health from our friends at TripleTree is here; and we’d welcome a chance to share our latest thinking on this dynamic sector of healthcare.

Ashok Kaul

Ashok is the Vice President of Healthcare Convergence for the non-profit Wireless-Life Sciences Alliance.  You can contact him at akaul@wirelesslifesciences.org.

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As we enter 2011, the topic of wireless and mobile healthcare and its growing public acceptance should be top of mind for every healthcare professional or investor.

According to TripleTree’s most recent mHealth survey, over 43% of healthcare professionals are working with mHealth devices or applications on a daily or weekly basis.  Additionally, over 70% of healthcare professionals surveyed are knowledgeable of their applications and uses.

Physician use of mHealth applications may spur greater adoption amongst the general populace – the “if my doctor does it, it must be a good idea” phenomenon.   Many industry watchers agree that well north of 500,000 physicians are already using iPads (in the U.S.) and this number is growing by the hour!

For patients, increased tablet use may spur them to investigate health monitoring apps for for their phones. And the good news is that they will find over 7,000 apps across the Android and iPhone app markets.  Indeed, over 3 million downloads have been logged for these apps in 2010 on Android alone.

Even if every download of a mHealth app was to a separate user, the mHealth application market of over 33 million users is at most 10% penetrated.

Expect a surge of health and fitness applications in 2011 as developers (and retailers) realize that this market may be poised for a growth surge, barring any regulatory hurdles.

There may be potential roadblocks in adoption, however.  HIPPA overshadows everything health-related in the US, and the mHealth market is no different. Data leaks and the sensitivity of the data recorded may lead some consumers to doubt the security and privacy of mHealth apps. However, once large players such as Google, Microsoft, or Apple enter the market (or endorse applications) consumer doubt will ease.

These market trends are foundational as we approach our sixth annual Convergence Summit to advance the discussion of wireless and mobile innovations in healthcare.  Compliance, seniors and chronic illness and improving access to care are just a few of the topics we’ll assess and discuss.  To learn more click here.

Rob McCray

Rob is the CEO of the Wireless-Life Sciences Alliance and senior advisor to TripleTree.  Follow Rob on Twitter, or email him at rmccray@wirelesslifesciences.org.

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