Something big is being cooked up…

You realize that the world is changing when the prestigious MIT offers a course on “How to build a tricorder” (a portable, handheld, wireless device to monitor and diagnose your health anywhere, anytime), Google launches a new venture to help us live longer and the FDA lays out its long awaited regulations for mobile, medical apps. All in the same week.

The convergence of medical technology, consumer wellness devices and rapid prototyping technologies for medical devices represents an opportunity to reinvent delivery of health and wellness. Advances in fields such as wireless sensing, imaging diagnostics, lab-on-a-chip, and molecular biology are enabling a more convenient, affordable, and accessible healthcare.

In January 2012, the XPRIZE Foundation announced the Qualcomm Tricorder 10 billion dollar global competition to bring the Tricorder —Star Trek’s legendary piece of medical technology— to life. The mission is to stimulate innovation in personal healthcare and to create a wireless, handheld device capable of monitoring a patient’s vital signs and diagnosing 15 diseases ranging from sleep apnea to atrial fibrillation.

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The contest closes in 2015. On Monday, September 23, the MIT announced a new course, “Engineering Health: How to Build a Tricorder“, inspired by the prize and starting this fall, that could help succeed to some of the teams that participate in the competition. In the program, Students will learn to fabricate, remix, and design detection and monitoring devices for health following the core focus of the Tricorder. Moreover, teams will have the opportunity to travel to Bangalore, India or Detroit, Michigan to test their devices in clinical settings.

MIT’s course it is not the only innovation initiative, relevant to global societal needs and challenges, that has been made public in the last few days. On Wednesday, September 18, Google Chief Executive Larry Page announced the launch of Calico, a venture that will focus on health and well-being. In particular, in tackling the challenge of extending human life and founding cures for aging related diseases.

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Everyone would have described the idea as completely crazy if it weren´t Google. But what exactly will the company do? Google is keeping its plans secret but it is likely to use its data-processing to shed new light on age-related maladies. Sources close to the project suggested to TIME magazine that Calico will start with a small number of employees and focus initially on researching new technology. Thanks to its investment in 23andMe genetics company and having former Genentech CEO and biotech pioneer Arthur D. Levinson as Calico’s Head, Google already has access to a fast-growing genomic database but finding a cure for an intractable disease requires time, enormous amounts of human and financial capital, cooperation and research. This is what makes Google’s announcement exciting as well as mysterious.

How Calico could impact, even transform, healthcare only time will tell.

Meantime, yesterday, September 23, the U.S. FDA finally issued its final guidelines for developers of mobile medical devices. Not all smartphone and tablet apps for health, such as a program reminding patients about an appointment and fitness apps, will be regulated medical devices.

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The FDA will focus only in those apps used in diagnosis or care, apps that turn mobile phones and tablets into de facto medical devices. For example, an application that turns a smartphone into an electrocardiography machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The guidance takes effect on September 25. The FDA will also host a Twitter chat on Sept. 26 and set up an email account to answer developers’ questions.

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mHealth in a mWorld

Mobile technologies are one of the fastest growing markets in the world. The latest and greatest in mobile technology was displayed last February at Barcelona’s Mobile World Congress. Healthcare, education, urban planning and other sectors can greatly benefit from mobile technology and a recent report out from the GSMA and PricewaterhouseCoopers gives a snapshot of how mobile technology could save money, increase opportunities and enhance health and safety in the coming years.

According to it, in Sub-Saharan Africa, one million lives could be saved over the next five years with mobile health initiatives that help patients stick to their treatment plans and access information, as well as aid workers in monitoring the availability of medication and follow treatment guidelines. For example the Mobile Alliance for Maternal Action enables health care workers and pregnant women to share health information via SMS in South Africa helps HIV patients and healthcare workers comply with Antiretroviral Therapy programs, cutting missed appointment rates from 27% to 4%.

In developed countries, mobile health or mHealth could also lead to positive outcomes. In 2017, it could cut health care costs by more than $400 billion in four ways:

As telemedicine grows mobile-based services could become more common in helping with immediate care. The GSMA-PwC report estimates that mobile-based care for patients with sudden health incidents could reduce primary and emergency care visits by 10%. Already, companies like Sherpaa and Ringadoc let patients reach physicians 24/7 by phone, text or email.

In non-emergency situations, mobile technology could also play a role in helping doctors keep tabs on elderly or recently discharged patients remotely. With Sotera Wireless, for example, physicians can monitor patients’ blood pressure, heart rate and other indicators through a flip-phone-sized device worn on a patient’s wrist. GSMA-PwC’s report estimates that remote monitoring technology could lead to elderly care savings of up to 25% and improve patients’ quality of life.

As more hospitals use the electronic medical records (EMR), patient information will increasingly be captured and accessed from mobile devices. PatientSafe, for example, lets doctors and nurses log patient data and manage other workflow tasks from an iPod Touch. Mobile access to EMRs could lower the administrative burden on hospitals by 20 to 30% the report says.

Finally, the old SMS could also play a major role in saving money and improving patient care. Appointment reminder services, like that offered by Kaiser Permanente, have been shown to reduce costs and boost patient attendance. Companies like AllazoHealth and AdhereTech use SMS to remind patients to take their medication after sensors or algorithms note when a patient hasn’t taken medication or is likely to skip it.

There is a mobile healthcare revolution taking place around the world. A number of organizations and mobile technology industries are now sponsoring projects to explore new mHealth, applications.

If you are an entrepreneur already developing (or expect to develop) a mHealth app and intend to sell it in the US market you should have a look to the report FDA 101: A Digital Guide to the FDA for Digital Health Entrepreneurs. Released on March 25 by the digital health accelerator Rock Health, the report helps digital innovators to navigate the Food and Drug Agency’s regulations and premarket requirements around medical devices. It also explains when a mobile health app would be classified as a medical device by the FDA and would require a clearance.

According to the FDA 101 report, mobile health apps will be considered medical devices if they serve as implants, implements, instruments or in vitro reagents used in the diagnosis of a disease, or in the cure, mitigation, treatment or prevention of a disease or serve as an accessory in one of those functions.

The report also recommends entrepreneurs to hire an advisor to make their company’s methods more appropriate and fitted to FDA’s guidelines. Finally, it includes quotes of digital health entrepreneurs that have successfully navigated the process offering pointers and best practices to startups.

The mobile health space is booming thanks to an unstoppable flow of money into it. In 2013 first quarter 37 deals valued at $365M have been signed. That is 35% higher than the same period of last year, showing that 2013 will be another record year for the digital health industry.

Lessons Learned:

  • Over the past few years mHealth has transitioned from novel startups to a global industry.
  • Among the many factors that are affecting the transformation of the health industry, the growing ubiquity of cell phones, smartphones and mobile devices is at the top.
  • Technology is bringing change to every piece of the health industry: wellness, fitness, healthcare and medicine.
  • Many entrepreneurs and startups are seeing the opportunity in mobile health technologies and want to get in on the game, but many are not aware of how to develop their apps, devices or services so that they are in line with the FDA’s regulations. A recent report from Rock Health startup incubator provides them the guidelines to succeed.