TR Editors' blog

Seven Must-Read Stories (Week Ending November 22, 2014)

Another chance to catch the most interesting, and important, articles from the previous week on MIT Technology Review.

MIT Technology Review 21/11/2014

  1. Cities Find Rewards in Cheap Technologies
    Mobile apps, sensors, and other technologies help cities handle growing challenges.
  2. The Search for Exceptional Genomes
    They walk among us. Natural experiments, living ordinary lives, unaware that their genes may hold the clue to the next superdrug.
  3. Laser-Radio Links Upgrade the Internet
    Wireless links formed partly by lasers may offer a faster, cheaper way to improve mobile Internet.
  4. Google’s Brain-Inspired Software Describes What It Sees in Complex Images
    Experimental Google software that can describe a complex scene could lead to better image search or apps to help the visually impaired.
  5. Nanoparticle Detects the Deadliest Cancer Cells in Blood
    A novel kind of nanoparticle could lead to more effective cancer treatments.
  6. An Artificial Adhesive Outgrips the Gecko
    Gecko-inspired adhesives can help humans climb and may provide a better grip for robotic arms in factories and in space.
  7. Apple Issues Strict Rules for the First Watch Apps
    The release of Apple’s WatchKit yields more insight into how the company is tackling smart-watch issues.

Recommended from Around the Web (Week Ending November 22, 2014)

A roundup of the most interesting stories from other sites, collected by the staff at MIT Technology Review.

MIT TR Editors 20/11/2014

Virtual Reality Fails Its Way to Success
A writer revisits virtual reality and finds it as dazzling as ever, but also much less nauseating.
Will Knight, news and analysis editor

Man and Uber Man
A fascinating profile of Uber’s controversial CEO, Travis Kalanick.
Will Knight

Fitbit Data Now Being Used in the Courtroom
People making personal injury claims are starting to use their Fitbit data to illustrate the effects of an accident. Data from activity trackers is likely to become a favorite target of prosecutors, too.
Tom Simonite, San Francisco bureau chief

The FBI vs. Martin Luther King: Inside J. Edgar Hoover’s “Suicide Letter” to Civil Rights Leader
Fifty years later, how a corrupt FBI threatened MLK’s privacy rights.
—J. Juniper Friedman, associate Web producer

Why No One Can Design a Better Speculum
Every lady’s favorite medical implement is even yuckier than you thought.
—Linda Lowenthal, copy chief

The Programmer’s Price
Coders now have agents. The trend helps illuminate what makes good code.
Brian Bergstein, deputy editor

Virtual Reality Is Journalism’s Next Frontier
The Columbia Journalism Review argues that more newsrooms should be thinking about how to use virtual reality to tell stories.
Mike Orcutt, research editor

Nighttime Satellite Maps Show Increasing Flood Risks
It’s not perfect, but by mapping night lights against flood-prone areas, a new study helps illuminate a growing problem.
Nanette Byrnes, senior editor, Business Reports

The Secret Life of Passwords
Flawed and annoying, these codes nevertheless say a lot about us.
—Nanette Byrnes

The Cartoon Lounge: Technophilia
A funny visual take on the allure of gadget collecting.
—Kyanna Sutton, senior Web producer

Mobile Medical Apps: A Market on the Move

MIT Technology Review Custom 18/11/2014

No question about it: The world wants mobile medical apps (MMAs)—and demand won't slow down any time soon.

"The demand for remote patient monitoring is growing dramatically," says Jeannette Tighe, from the HealthTech Advisory practice at Sagentia, a global technology advisory and product  development company headquartered in Cambridge, U.K.

How dramatically? Let the numbers tell the story. By 2015—next year—at least 500 million smartphone users worldwide will be using health-related apps, says Tighe, who recently spoke  at MIT Technology Review’s EmTech conference in Cambridge, Massachusetts.

By 2017, the app market is projected to reach 26 billion users. Among its key drivers: the world’s aging population with its increasing need for medical care. In the United States alone, Tighe notes, almost 20 percent of Americans will be older than 65 by 2030, making them more vulnerable to Alzheimer's, cardiovascular disease, and other age-associated conditions.

This changing landscape is creating an exciting opportunity for the emerging area of connected health, and MMAs may offer particularly apt solutions to the challenges of monitoring patients remotely.

Smartphone technology is promising for use in remote patient monitoring for several reasons. David Pettigrew, Sagentia's Vice President of Connected Health, sums up the advantages:  "Benefits to medical-device manufacturers include cost savings through not having to develop a completely new device, leveraging existing platforms while adding more sophisticated sensing and data capabilities, and using an interface that consumers know and understand and is already part of their everyday life." The result: Devices are far more likely to be adopted and used correctly.

The Regulatory Pathway

The U.S. Food & Drug Administration (FDA) has created three categories of MMAs:

  • Unregulated: This lowest tier consists of wellness-focused apps such as exercise trackers and heart-rate monitors that many consumers use in their fitness regimens.
  • Enforcement discretion: This middle category includes disease-focused apps that work as simple professional calculators (for instance, measuring and calculating mean arterial pressure, or assessing a Glasgow Coma Scale score); or that provide coaching for patients with conditions such as cardiovascular disease, hypertension, diabetes, and obesity.
  • Regulated: This highest tier consists of specific patient- or disease-monitoring and treatment-responses, such as infusion pumps, which act as medical devices and could cause harm to patients if faulty.

"Of more than 43,000 health-related apps available, by 2013 only 103 were FDA-regulated," Tighe says. "But the regulatory pathway for the use of smartphones and data aggregation has recently become much clearer." In fact, the FDA has now defined the regulatory pathway for MMAs and released draft guidance proposing deregulation of medical data aggregation systems. This clarification, she says, significantly reduces the risks of these opportunities for medical technology companies.

"Currently, most FDA-regulated apps are either stand-alone or act as accessories to existing medical devices, and allow the smartphone to act as a 'dumb-user interface' or a 'data pipe' to the cloud," Pettigrew adds. "However, with the clearer regulatory pathway, emerging concepts are now starting to push the boundaries, and are moving towards using the smartphone/tablet hardware and software to perform more advanced functions."

An emerging example of this is Setpoint Medical’s implantable neurostimulation device (currently in development), configured via an iPad app. This device is aimed at treating patients with debilitating inflammatory diseases. It consists of an implantable microregulator, a wireless charger, and the iPad prescription-pad application.

Addressing Two Critical Questions

Sagentia believes there are two critical questions for medical device companies entering this space: First, how do you develop a regulated MMA and incorporate it into a medical device? And equally important, how do you make money from doing so?

In addressing the first question, Pettigrew notes that successful MMA development starts with the right mindset. "This is not just another mobile app. It's not just a software tool," he says. "MMAs should be treated like any other medical device. Risk analysis is key, and careful system design will ensure that safety critical functions are implemented appropriately."

Once companies decide to incorporate an MMA, they follow the same type of development roadmap used for any other medical device. The presence of an app doesn't fundamentally change the methodology, Pettigrew notes: "First, you need to define the intended use. This is critical for defining whether the app will be regulated by the FDA, and it identifies predicates. You then need to map your core user requirements so that you understand what information is needed, how it should be presented and when," he continues. "Next is designing the high-level system architecture to minimize patient risk and ensure that it is usable." The final step: development under the ISO 13485 medical-device standard.   

As an example of how to manage the risks of including apps in connected systems, Tighe cites the VeriHaler, which Sagentia has developed to monitor patient adherence to treatment for asthma or chronic obstructive pulmonary disease (COPD). VeriHaler uses wireless acoustic monitoring to provide valuable feedback to users, physicians, or other health-care providers, promoting correct inhaler use and rapidly detecting any deterioration in a patient’s condition.

The key to answering the question about generating revenue lies in defining the value proposition early and optimizing the business model. "In this environment, there’s the opportunity to be very creative with business models," Tighe says. "Examples include pay-per-use analytics, risk-sharing reimbursement, and patient self-payment."

She recommends defining the MMA's targeted value proposition and business model up front.  Doing that will help gauge the likely level of FDA involvement, align with the company’s business strategy, and help ensure that the app is designed as effectively as possible for its intended uses. 

Bottom line, according to the Sagentia executives: With the regulatory situation becoming clearer and the cost of technology reaching feasible levels, connected health and MMAs truly have the potential to disrupt the health-care market. With such great opportunities available, it's no surprise that many medical device companies have connected health on their agendas. It's also clear that the key to success in this emerging space is getting the business models right. 



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