FDA regulates safety and accuracy, but who monitors efficacy?
"One of the challenges facing wireless health is that even if the FDA approves a wireless health device or application it only determines that the solution does A, B and C accurately," West said. "So what? How do we know that A, B and C actually improves patient care? Reduces costs? Reduces hospitalizations? All these things. Until clinical validation is done the industry will not accelerate. Many wireless health products have been invented but have not been proven beyond a reasonable doubt. And to be clear, we're not just trying to 'cut costs,' we want more value for patients at lower costs. That would be the real trick."
The Institute plans to use West's $45 million gift to conduct these clinical trials, consult with doctors and get their take on these solutions, drive development of solutions until they are ready for trials and product validation. These pilots will typically run from nine to 18 months, West said. The Institute will then work to get payers to understand the value of these services and offer reimbursement. There is also still plenty of work to be done to lobby the government and others to take a look at these technologies. Finally, when appropriate the Institute will leverage the venture funds of its partners to ensure that capitalization is not a challenge for wireless health companies that have been proven to improve care.
The search for the WWHI's CEO
West said that finding a CEO to be the leader of the Institute is the next order of business. Given the unique mandate of the Institution finding a candidate with the perfect background may prove a challenge, but West is hopeful. "There is a case to be made for both hiring a CEO out of the medical industry or hiring one out of the wireless industry. There are also a number of physicians who have tech backgrounds, not many, but some. We are not going to limit our search to just medical and wireless [industry executives] though. Ultimately, we know what we want to accomplish so we just need to sit down with each candidate, hear their story and go from there."
Which health issues will be the first to benefit from wireless medicine?
"One of the biggest health problems in this country and others is congestive heart failure. Most of the time the medical industry deals with this problem by prescribing diuretic, a 25 cent pill," West explained. "If everyone would take their medications like they were supposed to we could cut down the number of hospital admissions for congestive heart failure. People take the pill until they feel better and then they throw it away. Wireless health can connect pills to smart bandaids that allow physicians to monitor at-risk congestive heart failure patients' heart fluid levels. When the levels reach dangerous levels physicians can intervene and prevent the heart failure. This 24 hour-365 days a year monitoring is much more effective than seeing the doctor every three months and having your heart monitored for eight minutes."
That marks a "sea change" in health care, West said.