Pivot Profile

“David S Utley, MD, Founder and CEO of Pivot  I graduated from Harvard Medical School (‘ 92) and completed my surgical training in otolaryngology-head and neck surgery, as well as facial plastic and reconstructive surgery, at Stanford University Medical Center. I was subsequently appointed to the faculty as clinical assistant professor of surgery (1992–2003), and have over 25 peer-reviewed publications related to G.I., plastic and reconstructive surgery, and otolaryngology.”

“Prior to starting Pivot, I was the first employee and Chief Medical Officer for BARRX Medical from 2003 to 2014 (G.I. endoscopy, acquired by Covidien in 2012).

I have had additional roles as founder, chief medical officer, and member of the board of directors with several startup medical device companies, including Somnus Medical Technologies (ENT), Curon Medical (G.I.), Aetherworks (pulmonary), BAROnova (G.I.), Freedom-2 (plastics), and CoAlign Innovations (spine). I am the inventor of more than 65 issued U.S. patents and 100 published U.S. patents.”

“During my fellowship at Stanford, I was surrounded by surgical innovators who had invented medical devices, started companies, and changed the way we care for patients. Dick Goode, Rodney Perkins, Fred Moll, Tom Fogarty. Some of the greats. With inspiration from these innovators, I developed an idea for a surgical device, and took it to a local med-tech startup, thinking “they’ll love me, I am a Stanford surgeon, this idea is awesome, they’ll want to buy it, etc.” 

The V.P. of B.D. heard me out for 30 minutes and said, “no thanks, kid.” He then walked me to the lobby. While waiting for my ride, a guy walks in, asks me who I am, asks me about the idea, and invites me to his office. Turns out, he was the CEO of the startup. For the next 3 years, he and I worked together on a number of devices for sleep apnea and nerve ablative therapy. It was my first med tech gig. This experience totally enabled my next few companies, including BARRX in 2003.

The road to starting your own company takes a long time, no matter how good your idea and solution are. BARRX was founded in 2003. We raised $70m in venture capital and proved that the intervention worked to treat early esophageal cancer. It was a huge lift, and hundreds of moving pieces had to come together over time. BARRX was acquired by Covidien in 2012, and the earn-out was fully achieved by my team in 2014. As one of my close friends commented, “Utley, that was an 11-year overnight success.”

I founded Pivot in 2015 to engage and empower millions of people to quit all forms of tobacco. Pivot is a leading digital behavior health company on a mission to use mobile technology, behavioral science, and clinical expertise to engage and empower millions of people to quit all forms of tobacco.”

“We’re interested in human resources teams across a wide range of industries - particularly those with high rates of employees who smoke - healthcare, retail, manufacturing, transportation, and hospitality. We target human resources to encourage the implementation of smoking cessation programs in their benefits packages. Additionally, we target health plans that are looking to make a fundamental difference in the way their tobacco-using populations receive care.”

“I’m grateful for the support of my best friend and wife, Kathy. She has supported my crazy journey from thinking about quitting med school to be a ski instructor, grinding through med school, 100-hour weeks as a surgical resident, uncertainty about career paths, leaving a faculty position at Stanford for the startup world, crazy invention processes, late nights, lots of travel, 24/7 founder/CEO life, the repetitive serial quest for the next cool solution to the next big problem, and the crucible. Without this incredibly selfless support from Kathy, I wouldn’t have started any of our companies, and we wouldn’t be in a position to help millions of people with Pivot.

If you are planning to be a founder of a disruptive startup trying to change the world, like Pivot for tobacco cessation — prepare yourself for the crucible. You will be fried, burned, tested, bent, busted, and twisted beyond belief. You will think you cannot go another step, but you will. You will have hundreds of employees relying on you, and you cannot give up. You have a billion tobacco users on the globe relying on you. You will NOT give up. It’s the crucible. 

In 2020, a new investor backed out on leading a round of financing at the last minute. This put Pivot on its back foot. Our insiders came through, and we launched Pivot at one of the largest national big-box stores for their associates and spouses to quit tobacco, as well as at the largest health plan in a southern state for their members to quit tobacco. Win. This is the crucible. If it’s important, as in 8m people will die this year from tobacco use, you must survive the crucible. Few can survive, but you will.”

“Lack of experience leads a lot of founders to make mistakes that could have easily been avoided if they had mentors, board members, senior staffers, etc. who had been there and done that, and who probably made those mistakes long ago (and learned).”

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“As a leader, you have to be last in line, listen more than you speak, make sure your team is taken care of, and always put in more hours than anyone thinks is humanly possible. The buck does stop with the founder. I have filled more roles in urgent times than I ever thought possible when I first started new companies. Currently, I am running sales. Why? Because we have the need for a sales leader. I volunteered. My leadership team inspires me by doing exactly the same thing every day. My head of operations volunteered to be responsible for H.R., the coaching organization, clinical affairs, and myriad other huge roles in addition to his day job. That’s how scrappy startups succeed.”

“Tobacco use is the leading cause of preventable morbidity and mortality, health care costs, and lost productivity on the globe. The last drug approved to help people quit tobacco was in 2005 and is now off the market due to a recently discovered increased risk for cancer. And there has never been a medical device cleared by the FDA with claims to help people quit tobacco until now.

That boggles my mind. How can we NOT have invested innovative minds and capital ratably to address this huge healthcare crisis?  That’s why we started and rigorously tested Pivot in clinical trials, human factors testing, and a randomized controlled trial. We then submitted those data to the FDA — resulting in clearance of the device for tobacco cessation with claims stating that the device assists in helping tobacco users build motivation to quit, reduce their tobacco use, and make 24-hour quit attempts.

It has taken seven years, but we have built the product and then proven that we can increase enrollment at our clients by 10x (large companies offering tobacco cessation to their employees because it is the right thing to do, it’s an ACA mandate, it saves money, it improves productivity.)”