Ranica Arrowsmith, Associate Editor04.08.15
Intersect ENT ended 2014 on a very successful note, enrolling its first patient in Resolve II, its phase III study of in-office treatment for recurrent chronic sinusitis on Dec. 29. Earlier in the year, the company went public, offering almost 6 million shares of common stock.
At the helm of the Menlo Park, Calif.-based company is Lisa Earnhardt. She took the reigns in March 2008 when Intersect had only 12 employees. Today, the company has more than 200 employees with revenues of more than $38 million. Earnhardt’s bachelor’s degree from Stanford University is in industrial engineering, but she followed that up with an MBA from Northwestern University’s Kellogg School of Management. Moving into medical devices with that background felt natural to Earnhardt, as it combined healthcare with technology. Earnhardt started her career post-business school at cardiovascular medical device company Guidant Corp., where she held different roles primarily in sales and marketing. She is, in her words, a “customer-facing professional,” valuing the input of physicians and patients as the most important part of the medical device creation cycle.
MPO: How would you describe the current state of the ear, nose and throat (ENT) device market?
Earnhardt: This is a very exciting time to be in ENT. Historically you don’t think of ENT as being a medical device market per se. When people think about medical devices, they think of key markets such as cardiovascular, which is where I come from, but also orthopedics, diabetes and so on. What’s been exciting in the last decade is there has been tremendous innovation in ENT. There have been a number of both large companies such as Medtronic, as well as startup companies, focused on developing solutions for the ENT and their patients. We’ve come at the market from a unique perspective. The majority of innovation has been using balloon technology, much like in the cardiovascular world where you use a balloon to open up an artery. In this case, you’re using balloons to open up blocked or clogged sinuses. There’s been a lot of innovation in this area from companies such as Acclarent (now part of Johnson & Johnson), Entellus Medical, and Medtronic, which have all come out with new ENT balloon technology. Where we’ve focused our efforts is developing a really unique platform where we have a drug eluting implant for this patient population. I’d liken it to what happened in cardiovascular where you went from cardiac bypass with the stopped heart to off-pump bypass, to less-invasive approaches like angioplasty, then stents, and then drug-eluting stents. That similar transition is happening at ENT.
MPO: Where do you see the future of ENT devices?
Earnhardt: I believe technology like drug-eluting implants as well as balloons will go from being emerging technologies to being the standard of care in the next five to 10 years. There is also a real trend toward moving patients into the office setting. With the Affordable Care Act, there is the focus of getting the most value for the healthcare dollars that we spend. It’s important we all think about how to best deploy our resources, and whether there’s a way that we can treat these patients in a less-invasive manner in the office setting. I see that as a key trend in ENT and you’re seeing that happen already with the balloon technology. We just initiated enrollment in a phase III clinical program for an implant that’s being placed in the office setting. So instead of taking these patients back to the operating room and putting them under anesthesia, assuming all the potential risk of a hospital based procedure, now we’re treating them simply under local anesthesia in a physician’s clinic. Those are two main trends—taking today’s technology, which is truly emerging, and having it become the standard of care; and the movement into the office setting. We’re well poised on both those fronts.
MPO: Beyond funding, how do you foster innovation and/or truly creative research and development?
Earnhardt: Funding is a big part of it, so I’m glad you said that. Because, obviously, it takes both resources as well as focus. From our perspective, the most important thing we do is keep the ENT physician and patient at the center of all that we do. My R&D team, among others in the organization, is highly encouraged to spend time with physicians and patients—whether it be in the operating room or the clinic—to observe and to understand the day-to-day challenges that physicians go through to manage patients.
Relentless focus on understanding the customer and their needs really helps us in terms of driving the right innovation and moving that forward—in other words, both identifying the need and developing a solution. Physicians know what their patients’ pain points are, but sometimes it takes someone from the outside looking in to think about what a creative solution might be. We also have physicians visit our offices on a regular basis. That helps us as well because we learn from them about the trends they see and the challenges they have. Really getting in-depth with the customer is what I think is core to fostering innovation.
MPO: What is the best professional advice you have received?
Earnhardt: There are so many ways to spend your hours in a day and to dedicate your life, and those who have the biggest impact and who really enjoy their work the most are those who are really passionate about the cause. There are so many ways to spend your day—if you’re not passionate about it, find something you are passionate for and focus there.
At the helm of the Menlo Park, Calif.-based company is Lisa Earnhardt. She took the reigns in March 2008 when Intersect had only 12 employees. Today, the company has more than 200 employees with revenues of more than $38 million. Earnhardt’s bachelor’s degree from Stanford University is in industrial engineering, but she followed that up with an MBA from Northwestern University’s Kellogg School of Management. Moving into medical devices with that background felt natural to Earnhardt, as it combined healthcare with technology. Earnhardt started her career post-business school at cardiovascular medical device company Guidant Corp., where she held different roles primarily in sales and marketing. She is, in her words, a “customer-facing professional,” valuing the input of physicians and patients as the most important part of the medical device creation cycle.
MPO: How would you describe the current state of the ear, nose and throat (ENT) device market?
Earnhardt: This is a very exciting time to be in ENT. Historically you don’t think of ENT as being a medical device market per se. When people think about medical devices, they think of key markets such as cardiovascular, which is where I come from, but also orthopedics, diabetes and so on. What’s been exciting in the last decade is there has been tremendous innovation in ENT. There have been a number of both large companies such as Medtronic, as well as startup companies, focused on developing solutions for the ENT and their patients. We’ve come at the market from a unique perspective. The majority of innovation has been using balloon technology, much like in the cardiovascular world where you use a balloon to open up an artery. In this case, you’re using balloons to open up blocked or clogged sinuses. There’s been a lot of innovation in this area from companies such as Acclarent (now part of Johnson & Johnson), Entellus Medical, and Medtronic, which have all come out with new ENT balloon technology. Where we’ve focused our efforts is developing a really unique platform where we have a drug eluting implant for this patient population. I’d liken it to what happened in cardiovascular where you went from cardiac bypass with the stopped heart to off-pump bypass, to less-invasive approaches like angioplasty, then stents, and then drug-eluting stents. That similar transition is happening at ENT.
MPO: Where do you see the future of ENT devices?
Earnhardt: I believe technology like drug-eluting implants as well as balloons will go from being emerging technologies to being the standard of care in the next five to 10 years. There is also a real trend toward moving patients into the office setting. With the Affordable Care Act, there is the focus of getting the most value for the healthcare dollars that we spend. It’s important we all think about how to best deploy our resources, and whether there’s a way that we can treat these patients in a less-invasive manner in the office setting. I see that as a key trend in ENT and you’re seeing that happen already with the balloon technology. We just initiated enrollment in a phase III clinical program for an implant that’s being placed in the office setting. So instead of taking these patients back to the operating room and putting them under anesthesia, assuming all the potential risk of a hospital based procedure, now we’re treating them simply under local anesthesia in a physician’s clinic. Those are two main trends—taking today’s technology, which is truly emerging, and having it become the standard of care; and the movement into the office setting. We’re well poised on both those fronts.
MPO: Beyond funding, how do you foster innovation and/or truly creative research and development?
Earnhardt: Funding is a big part of it, so I’m glad you said that. Because, obviously, it takes both resources as well as focus. From our perspective, the most important thing we do is keep the ENT physician and patient at the center of all that we do. My R&D team, among others in the organization, is highly encouraged to spend time with physicians and patients—whether it be in the operating room or the clinic—to observe and to understand the day-to-day challenges that physicians go through to manage patients.
Relentless focus on understanding the customer and their needs really helps us in terms of driving the right innovation and moving that forward—in other words, both identifying the need and developing a solution. Physicians know what their patients’ pain points are, but sometimes it takes someone from the outside looking in to think about what a creative solution might be. We also have physicians visit our offices on a regular basis. That helps us as well because we learn from them about the trends they see and the challenges they have. Really getting in-depth with the customer is what I think is core to fostering innovation.
MPO: What is the best professional advice you have received?
Earnhardt: There are so many ways to spend your hours in a day and to dedicate your life, and those who have the biggest impact and who really enjoy their work the most are those who are really passionate about the cause. There are so many ways to spend your day—if you’re not passionate about it, find something you are passionate for and focus there.