Ranica Arrowsmith, Associate Editor01.21.15
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, per the company, it is a 200+-employee operation 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 Corporation where she held different roles primarily in sales and marketing. She is, in her words, a “customer facing professional,” valuing the input of both physicians and patients as the most important part of the medical device creation cycle.
For the first installment of MPO’s “Women in Medtech” series, Earnhardt discussed the state of the medical device industry, the ear nose and throat (ENT) device market, and the future of Intersect ENT.
MPO: How would you describe the current state of the 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. Those are some of the key medical device markets historically.
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 (which just filed for an IPO at the end of December), 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. At Intersect we’re playing a big role in that transformation.
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 ten 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 becomes the standard of care; and the movement into the office setting. We’re well poised on both those fronts.
MPO: What do you see as the greatest challenge for your organization?
Earnhardt: We are blessed with a lot of opportunities and that actually poses a bit of a challenge for us. We are actively scaling our commercial efforts in the United States. We do have a number of significant growth opportunities including expanding outside the United States and with our pipeline products.
Our challenge is to continue to focus on what really matters. As a leader one of the most challenging things to do is to say “no.” It’s really easy to say “yes.” So probably our biggest challenge is continuing to deliver on the promise and be able to “walk and chew gum at the same time,” as it were.
I believe we’re up to it, but it’s certainly a different phase for the company going from a startup with one product to now having multiple products at various stages in pipeline.
MPO: Beyond funding, how do you foster innovation and/or truly creative research and development activities?
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 these 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: That’s always a hard one because I’ve been a beneficiary of many phenomenal mentors over the years. One thing I’ve always held on to is really having an incredible passion for what you do. 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. And so that’s what I say: 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, per the company, it is a 200+-employee operation 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 Corporation where she held different roles primarily in sales and marketing. She is, in her words, a “customer facing professional,” valuing the input of both physicians and patients as the most important part of the medical device creation cycle.
For the first installment of MPO’s “Women in Medtech” series, Earnhardt discussed the state of the medical device industry, the ear nose and throat (ENT) device market, and the future of Intersect ENT.
MPO: How would you describe the current state of the 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. Those are some of the key medical device markets historically.
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 (which just filed for an IPO at the end of December), 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. At Intersect we’re playing a big role in that transformation.
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 ten 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 becomes the standard of care; and the movement into the office setting. We’re well poised on both those fronts.
MPO: What do you see as the greatest challenge for your organization?
Earnhardt: We are blessed with a lot of opportunities and that actually poses a bit of a challenge for us. We are actively scaling our commercial efforts in the United States. We do have a number of significant growth opportunities including expanding outside the United States and with our pipeline products.
Our challenge is to continue to focus on what really matters. As a leader one of the most challenging things to do is to say “no.” It’s really easy to say “yes.” So probably our biggest challenge is continuing to deliver on the promise and be able to “walk and chew gum at the same time,” as it were.
I believe we’re up to it, but it’s certainly a different phase for the company going from a startup with one product to now having multiple products at various stages in pipeline.
MPO: Beyond funding, how do you foster innovation and/or truly creative research and development activities?
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 these 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: That’s always a hard one because I’ve been a beneficiary of many phenomenal mentors over the years. One thing I’ve always held on to is really having an incredible passion for what you do. 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. And so that’s what I say: 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.