The 2.3% medical device tax is burdensome. Regulatory timelines are long (and expensive). Reimbursement is not only decreasing, but also incredibly hard to obtain. Venture capitalists are losing interest in early-stage medical device deals. Is it all downhill for medtech?
There is no doubt the current healthcare environment is challenging. But certainly not impossible!
Case in point: Intersect ENT. This startup medtech company is well-funded as evidenced by their recent series C round of financing. They were able to get regulatory approval for a “device + drug” combination product. And perhaps most impressive, they are actually expanding their sales force!
In this interview with Lisa Earnhardt, President and CEO of Intersect ENT, we learn how this medical device startup company is succeeding despite the strong headwinds within the medtech space.
Here’s What You Will Learn from Lisa Earnhardt
- Can ENT companies steal the drug-eluting stent playbook from the cardiology space?
- How is Intersect’s Propel device different than traditional balloon sinuplasty?
- Was the regulatory pathway for the Propel device more difficult because of the “device + drug” combination?
- Are otolaryngology (ENT) doctors early adopters? How do they compare to cardiologists andvascular surgeons?
- What has been the biggest challenge to increased adoption of the Propel device?
- Did Intersect ENT consider launching their medical devices with an indirect sales force?
- What are the exit strategies for Intersect ENT? Could the company actually go public?
- How important are large strategic medtech companies in terms of providing capital for start-up medical device companies?
- Lisa’s opinion of the top-line 2.3% medical device excise tax.
- How will medtech companies need to change considering the strong headwinds of longer regulatory timelines, lower reimbursement figures, and changing healthcare delivery models?
- Lisa’s advice for ambitious medtech professionals.
Lisa Earnhardt is the President and CEO of Intersect ENT. Prior to joining Intersect ENT, Lisa was the President of Boston Scientific’s Cardiac Surgery division, where she played an instrumental role in the sale of that business to the Getinge Group in January 2008 (now known as Maquet Cardiovascular). Previously, Lisa held a variety of sales and marketing positions of increasing responsibility at Guidant. She has extensive experience with global product launches and driving adoption of new technologies including implantable cardiac defibrillators, endoscopic vessel harvesting, surgical ablation and beating heart bypass surgery. Lisa holds an MBA from Northwestern’s Kellogg School of Management and a BS in Industrial Engineering from Stanford University. She serves on the boards of Intersect ENT, Kensey Nash Corporation (Nasdaq: KNSY), and the Kellogg Alumni Council and is a member of the Young Presidents’ Organization (YPO).
The 2.3% medical device tax is burdensome. Regulatory timelines are long (and expensive). Reimbursement is not only decreasing, but also incredibly hard to obtain. Venture capitalists are losing interest in early-stage medical device deals. Is it all downhill for medtech?
There is no doubt the current healthcare environment is challenging. But certainly not impossible!
Case in point: Intersect ENT. This startup medtech company is well-funded as evidenced by their recent series C round of financing. They were able to get regulatory approval for a “device + drug” combination product. And perhaps most impressive, they are actually expanding their sales force!
In this interview with Lisa Earnhardt, President and CEO of Intersect ENT, we learn how this medical device startup company is succeeding despite the strong headwinds within the medtech space.
Here’s What You Will Learn from Lisa Earnhardt
- Can ENT companies steal the drug-eluting stent playbook from the cardiology space?
- How is Intersect’s Propel device different than traditional balloon sinuplasty?
- Was the regulatory pathway for the Propel device more difficult because of the “device + drug” combination?
- Are otolaryngology (ENT) doctors early adopters? How do they compare to cardiologists andvascular surgeons?
- What has been the biggest challenge to increased adoption of the Propel device?
- Did Intersect ENT consider launching their medical devices with an indirect sales force?
- What are the exit strategies for Intersect ENT? Could the company actually go public?
- How important are large strategic medtech companies in terms of providing capital for start-up medical device companies?
- Lisa’s opinion of the top-line 2.3% medical device excise tax.
- How will medtech companies need to change considering the strong headwinds of longer regulatory timelines, lower reimbursement figures, and changing healthcare delivery models?
- Lisa’s advice for ambitious medtech professionals.
Lisa Earnhardt is the President and CEO of Intersect ENT. Prior to joining Intersect ENT, Lisa was the President of Boston Scientific’s Cardiac Surgery division, where she played an instrumental role in the sale of that business to the Getinge Group in January 2008 (now known as Maquet Cardiovascular). Previously, Lisa held a variety of sales and marketing positions of increasing responsibility at Guidant. She has extensive experience with global product launches and driving adoption of new technologies including implantable cardiac defibrillators, endoscopic vessel harvesting, surgical ablation and beating heart bypass surgery. Lisa holds an MBA from Northwestern’s Kellogg School of Management and a BS in Industrial Engineering from Stanford University. She serves on the boards of Intersect ENT, Kensey Nash Corporation (Nasdaq: KNSY), and the Kellogg Alumni Council and is a member of the Young Presidents’ Organization (YPO).
