TMC PULSE

t m c » p u l s e | m a r c h 2 0 1 9 t m c » p u l s e | m a r c h 2 0 1 9 32 In 2013, a group of global medical device regulators formed the Software as a Medical Device Working Group to develop policies and a common framework for this new and nebulous application of existing technology. Chaired by Patel, the group established key definitions, framework for risk, and more. Since then, the FDA has taken steps to encourage more development and greater inno- vation in the digital health arena. In 2017, the agency launched the Digital Health Innovation Action Plan to establish policies, add expertise and implement a software precertification pilot to bring clarity and efficiency to the regulation of digital health products. Investors poured a staggering $12.5 billion into digital health ventures in 2017 and 2018—repre- senting a 230 percent increase in investments compared to 2013 when Software as a Medical Device was formally introduced, according to PricewaterhouseCoopers Health Research Institute's annual report. In many ways, this sets up 2019 as a pivotal year for digital therapeutics. While there are already several apps that have been cleared by the FDA—among them, Pear Therapeutics' opioid use disorder treatment program reSET-O and WellDoc's mobile diabetes management platform BlueStar—the massive injection of money into digital health has lit a fire under the FDA. In January 2019, the FDA announced the Digital Health Software Precertification (Pre- Cert) Program test plan, part of the Digital Health Innovation Action Plan, to establish a regulatory framework for evaluating new digital health products. "Our approach to regulating these novel, swiftly evolving prod- ucts must foster, not inhibit, inno- vation," Patel said. "This requires us to take modern, flexible, risk-based approaches to regulation in this area, which we hope will reduce the time and cost of market entry, while assuring appropriate patient safeguards are in place. " David versus Goliath Digital therapeutics tout a variety of benefits. These apps eliminate the physical barriers of accessing health care, minimize the risk of side effects from drugs and can track and generate real-world patient results and data—all while driving down health care costs. Sleepio, Big Health's CBT app to treat insomnia, costs about $400 a year, whereas Ambien, a prescrip- tion sedative often prescribed for sleeping disorders, costs $73 for six tablets, according to MIT Technology Review. And instead of paying $63 for a 30-tablet Xanax prescription, UTHealth's On to Better Health app offers anxiety treatment for free. Studies conducted by Magellan Health showed that patients who used the On to Better Health app experienced a 63 percent reduction in symptoms and a 49 percent reduc- tion in direct costs. Yet digital therapeutics start-ups must be prepared to face off against the pharmaceutical industry in a David-versus-Goliath battle. "When drug companies start to compete against things like digital therapeutics, watch out because it's a huge industry," Black said. "They not only have the money, they have the influence, the power, the downstream assets—every- thing a company that's new and up-and-coming will have difficulty struggling against." Black, who has shepherded doz- ens of start-ups through the TMCx accelerator, said digital therapeutics companies need to accept a "cold dose of reality." "What I think people oftentimes fail to see, especially in the health care industry, is that even though you're better, it doesn't mean you're going to get the lion's share of the market," Black said. "If you discover a medication, for instance, that's bet- ter than the current standard of care, it's really challenging to be able to get that market share to sustain that company. Digital therapeutics faces that same challenge. They could be better than an antidepressant medication, for instance, but they're going up against large companies that have an established base and have millions of patients." Go further. At the TWU Institute of Health Sciences – Houston Center, you can earn your graduate degree in nursing, nutrition, physical or occupational therapy, health care administration or business. Get the support you need every step of the way. 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