Slow down, life sciences: why the industry’s not ready for consumer technologies in clinical settings

Frank Traina

Frank Traina

The life sciences industry is changing at a remarkable rate. While many companies specializing in pharmaceuticals, biotechnology, and medical products and devices have embraced consumer technologies, others stand uncertainly at the gate, weighing the price of entry. As my colleague Sameer noted, the opportunities are numerous, including improved patient care, lower TCO, greater productivity, and compliance with regulatory and consumer demands. But as many companies are learning the hard way, there are also significant barriers to adopting consumer technologies in clinical settings.

Complying with regulations

The proliferation of healthcare apps continues to rise, with more and more organizations eager to jump on the bandwagon. But before getting on board, newcomers should plan for the rocky road ahead, strewn with legal and liability issues. Those that don’t instill basic security controls and protect against data breaches or honor codes of conduct risk getting smacked down by the FDA and FTC. It’s great news for patients, but challenging for unprepared organizations.

Two companies operating under the names of “AcnePwner” and “AcneApp” with over 15,000 combined downloads experienced swift retribution from the FTC for claiming to cure acne, purportedly supported by studies in the British Journal of Dermatology. The FTC called these claims nonsense; levied fines and issued cease-and-desist letters; and ordered that the revenue from downloads be paid as settlements.

Ensuring integrity of technology

If a smartphone or other device is going to come in contact with a person in order to take biometric readings for the purpose of treating, diagnosing, preventing, or curing disease, the entire solution is open to regulation. The level and amount of regulation is proportional to the criticality of the device (e.g., Class III, defined as a high-risk device that may be life sustaining, vs. a Class II for lower risk). A device or solution with these characteristics would be subject to FDA regulations to demonstrate that the device to be marketed is safe and effective (known as 510K Premarket Notification).

For example, medically classified devices/software that run in combination with a smartphone or tablet are subject to basic safety and essential performance of electrical medical equipment standards, as defined by the International Electrotechnical Commission. In addition, some industry leaders believe common Agile software development methodologies are fundamentally incompatible with medical device software guidance issued by the FDA. The FDA wants to see a comprehensive software development plan, with formal inputs and formal outputs—not a backlog of features or a minimum viable product, common in Agile methodology.

On the clinical trial side, if the person coming into contact with a solution is a patient specimen where results are analyzed in a laboratory during research, the device and solution are open to a regulatory program known as CLIA (Clinical Laboratory Improvement Amendments). This regulation is overseen by CMS (Centers for Medicare & Medicaid Services). Its mission is to support accurate and reliable Laboratory Developed Test results.

Paying the high price of entry

The easy way

Conservatively, the costs of launching a Class II medical device can range between US $3-5MM—plus or minus a lot.  This is why we’re seeing the greatest quantity of innovation in consumer health and fitness: apps and services that are flying under the radar of regulation. The FDA announced they will not get involved in fitness apps, instead focusing on apps dedicated to diagnosis and care. This is a good thing for many developers: consider the fact that Apple has approximately 20,000 apps in the “medical” classification.Apple_medical apps

People are also opting in to services like FitBit, and the aggregated data is becoming the prize. This enables organizations to financially benefit from healthcare trends while dodging the hefty regulatory efforts and costs of classified medical devices.

There are also organizations attempting to separate the wheat from the chaff. One such organization is Happtique, which offers certification of mobile healthcare apps to improve the confidence of clinicians and consumers to download and use the ~40K medical-related apps floating in app stores in the un-regulated world.

The hard way

There are also teams of engineers, medical doctors, lawyers, and specialists working in start-ups that turn your ordinary smartphone into a classified medical device, going through the regulatory steps necessary to prove safety and efficacy. These are our pioneers, our Mount Rushmore of revolutionaries driving the industry—and bearing the high cost of entry. As mentioned in The App Will See You Now, there have been many impressive innovations to hit the market, such as the iPhone ECG (by Cardiac Designs). Currently this is cited as the only FDA-cleared, over-the-counter iPhone heart monitor.

There’s also the truly innovative, inspiring story of Oksana Masters, a 2012 Paralympic Bronze Medalist and double above-the-knee amputee who uses her smartphone to make adjustments to her prostheses so she can train—or simply wear high heels. Before this medical breakthrough, these types of adjustments required a trip to her doctor.

Rx for progress

You better believe that the brilliant creators of our mobile devices are doing all they can to lower the cost of entry. According to the FDA public calendar, a group of senior Apple executives, including former Counsel at the House of Representatives Tim Powderly, attended a meeting in the Washington DC metro area in December 2013.

The National Institutes of Health (NIH) also has a major stake in the growth of consumer technology in clinical settings. Recently, the medical research center launched a Public-Private Partnership (PPP) to address “a profound public need to better utilize mobile technologies to improve health research, health care and health prevention efforts.”

At Slalom, we’re excited to be at the table for these discussions as the revolution continues to unfold. But we have a long way to go. We recommend that companies temper expectations; continue innovating and talking about what’s working and what’s not; and engaging all members of the ecosystem to work together to advance this potential.

What do you think the pitfalls and opportunities for consumer tech in the industry are? Tell us in the comments. For those in the New Jersey area, please join us for a round table discussion taking place in Princeton, NJ in early May. Reach out to me for more details. To learn more about the work we’re doing with clients to pursue new opportunities with consumer technology, download The App Will See You Now.

About Frank Traina
Frank Traina is Slalom New York’s Mobile Practice Lead. He is a veteran in the mobile computing space and recognized thought leader with a track record of delivering innovative solutions to create revenue generating opportunities through today’s digital channels.

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