Carol Burns is a seasoned CEO and serial entrepreneur with a passion for cardiovascular devices. Her tireless energy and proven track record have enabled Carol to accel in all phases of medical device development, from early-stage proof of concept to eventual commercialization. Carol thrives in the fast-paced startup world, leveraging her industry relationships and clinical knowledge to identify technologies with the highest potential for success.

Carol Burns, CEO of Cagent Vascular, is a serial entrepreneur with an impressive track record in the medtech industry. Throughout her career, she has played a pivotal role in all phases of medical device development, from early-stage proof of concept to successful commercialization.

Starting as a critical care nurse, she built a strong foundation of medical knowledge before transitioning into sales. Her talents were recognized by a medical device company, leading her to move to the West Coast and eventually enter the world of startups. This allowed Carol to gain invaluable experience in various aspects of running a startup and hone her expertise across the broader medical device space.

Her expertise led up to developing relationships with Dr. Peter Schneider and Robert Giasolli, who approached her with an opportunity to join their company, Intact Vascular, as CEO. With Carol taking the helm, the company achieved great success and exited to Philips. After that milestone, the trio collaborated once more to establish Cagent Vascular.

Cagent has developed an innovative angioplasty balloon called the Serenator. The device is equipped with serrated metal strips embedded into its surface. When used in peripheral artery procedures, these serrations generate point force across the lesion that push the artery open with a force that’s a thousand times greater than a conventional balloon catheter. This compelling technology offers significant benefits, including improved lumen gain with minimal dissection.

The company received 510(k) clearance from the FDA and CE Mark certification and began selling the product in January 2021, primarily focusing on the US market, with some presence in Germany.

Driven by her commitment to improving patients' lives, Carol focuses on developing devices that physicians want to use and that generate returns for investors. Her tireless energy and strategic approach have helped her navigate the fast-paced world of startups and identify technologies with the highest potential for success.

In this interview, Carol shares her insights on the importance of reducing risk early in the development process and how to effectively pitch medtech investors. She emphasizes the value of listening to clinical investigators to generate meaningful data for publication, even when faced with limited resources.  

Founders and CEOs of medtech startups need to be adept at making prompt decisions and adapting rapidly to reach the next milestone or inflection point for their company. This is especially true when it comes to assembling the right team. A diverse, capable group of people forms the bedrock of any successful venture. Carol emphasizes the importance of bringing together passionate professionals committed to the company's vision and using their varied skills and backgrounds to drive innovation.

Carol's experience has taught her the importance of constant evaluation and iteration in tackling the various challenges startups face. The team's ability to act swiftly to achieve the next milestone is crucial to a company's likelihood of success within the medtech ecosystem. 

Building the right team for your medical device startup requires a strategic approach, an understanding of when to delegate tasks, and a willingness to change direction when faced with obstacles. Selecting team members who can support and empower one another will help propel the company forward. Carol also highlights the importance of being proactive and making quick decisions when the team isn't functioning as desired. "Pivot quickly rather than keep trying to give it a little more time… Eventually, you have to say, stop, we need to move on to a different group… In our case, most of the time we have a core team, and then we outsource to another group to actually build the prototypes".

If you work with a team of professionals with deep domain expertise in your target therapeutic area, it will also be easier to overcome regulatory hurdles. For example, Carol’s company obtained CE Mark approval in 2017 and FDA clearance in 2020, following the traditional path for US-based medtech startups. However, the recent changes in the European regulatory environment, particularly in the Medical Device Regulation (MDR) certification process, have added some complexity and made it more expensive.

Fortunately, Carol was able to successfully navigate the MDR certification process with the help of her knowledgeable and experienced team. In addition to working with the right experts, Carol also believes it’s critical to develop a good working relationship with your notified body.   

Carol emphasizes the initial importance of establishing that your product is ready for clinical work. This involves conducting thorough bench and animal testing to ensure the device is safe and ready for human trials. The primary goal of your early clinical initiatives should be to understand the technical success, i.e., verifying whether the product works as intended, whether it's safe, and whether it offers efficacy endpoints valuable to physicians.

She explains, "Just do a small trial and make sure that what you have works. Because from there, undoubtedly, you will iterate on the device. Just find out first whether your device does work as intended."

Another crucial aspect Carol highlights is the selection of trial sites. To optimize enrollment, it is essential to choose sites that are technically equipped, have a sufficient procedure volume, and a track record of proper patient follow-up. Partnering with investigators who consistently deliver quality clinical trial data can significantly impact the trial's success.

Carol shares her experience, "We've worked with Andrew Holden in New Zealand and Michael Lichtenberg in Germany, Christian Wissgott, Marianne Brodmann, etc. These are several of the names we've worked with, but they deliver consistently, and provide excellent clinical trial data."

Carol also underscores the importance of engaging with regulatory bodies, such as the FDA, throughout the clinical trial process. By maintaining open communication, medtech startups can ensure they meet necessary requirements and avoid potential roadblocks in the product development journey. 

Another valuable lesson Carol's experience has taught her is the importance of listening to investors and and craft effective fundraising narratives. Engaging with the right capital partners and understanding their perspectives can provide valuable insights into the best path forward for your company.

In the competitive world of medtech, securing the necessary funding is crucial to a startup's success. Carol stresses the need to pay attention to investor feedback and tailor your fundraising approach accordingly. 

By proactively engaging with potential investors, startups can identify areas of improvement in their business plan, technology, or clinical trial design. This iterative process can help your company become more attractive and increase the likelihood of securing funding.

Carol also advises startups to be persistent and strategic. Building relationships with capital allocators and providing regular updates on the company's progress can eventually lead to fruitful connections.

While it's essential to consider feedback from industry stakeholders, Carol believes you need to strike a balance between investor expectations and the company's long-term goals. While they often bring a wealth of knowledge, experience, and connections to the table, startup leaders must maintain their vision and mission.