Dr. Steven Mickelsen was a professional musician—the frontman of two different bands with recording contracts before he decided to go to medical school when he was 28.
His interest in medicine didn’t come out of nowhere, however. He was a musician by night and worked in a hospital during the day. His involvement in cardiac electrophysiology (EP) as a member of the Heart Rhythm Society (formerly Mass B) catalyzed his underlying passion for medicine. "I knew that I loved this [space] and decided to make a career change," he reflects. He’s widely considered one of the few people who’ve ushered in the use of pulse field ablation (PFA) technology to the EP space, and is one of the leading experts in this particular domain.
When he got into medical school at the University of Iowa, Steven started working on several ideas, all of which had potential. He recalls, “If you want a good idea to make it into the market with the support of a university, you really have to lead the charge.” In a nutshell, that’s how he became a serial entrepreneur.
The first bit of inspiration struck Steven in 2010 when he realized that it was possible to use a non-thermal energy source for tissue ablation. This led to the eventual development of PFA, which is a paradigm shift for the treatment of certain cardiac arrhythmias—where the electrical signals that tell the heart to beat don't work properly.
PFA uses brief but intense electrical pulses to specifically target myocardial tissue through electroporation, altering cell membranes without heating up the tissue. The technology is on the rise, as it allows for a more predictable, faster, and safer procedural workflow. The two companies bringing it to market are Medtronic and Boston Scientific, which acquired Farapulse, a startup Steven founded in 2011.
Steven is now working on his next startup Field Medical, a company he founded in 2022. “We've made enormous progress in the first 18 months of the company,” Steven reports, largely thanks to “years of suffering and failure,” he adds with a chuckle. Field Medical is focused on the EP space as well, specifically ventricular arrhythmias—a challenging disease to treat due to the ventricle tissue's thickness and constant movement.
“There's a massive amount of patients who suffer from ventricular arrhythmias that currently go undertreated or untreated,” Steven notes, underlining the significance of Field Medical’s mission, and the market gap. “All of the technology that's been developed for catheter ablation has focused on atrial arrhythmias, and very little has been spent on the deadly and life-changing problems of the ventricle. That’s where Field Medical is coming in,” he explains.
Optimization of the electric fields is just the tip of the iceberg. “There's a whole bunch of technology that goes into enabling that vision,” Steven explains. Despite the challenging climate for raising capital, Field Medical has achieved remarkable success, securing a seed round of approximately $14 million for their Class III medical device.
Is Field Medical’s treatment of ventricular arrhythmias the next big paradigm shift? It’s certainly a possibility, especially given the success of Steven’s previous venture, Farapulse. The company’s FieldForce™ Catheter and the FieldForce™ Generator use a proprietary technology called FieldBending™ to overcome limitations of first-generation PFA technologies.
The company is now poised for early human clinical data and Steven is eagerly waiting to present the preliminary results by mid-2024.
Key Learnings From Dr. Mickelsen's Experience
- Money will always be tight at the beginning of any startup. But scarcity can breed creativity, so use that to your advantage. Build prototypes with readily available parts and focus on nailing your narrative to convince investors.
- Finding real expertise in the clinical and regulatory arenas can be challenging due to the specific requirements unique to each startup. Find a good consultant early and keep them close – their expertise will save time and boost your startup's chances for success.
- When raising capital, be honest about costs and timelines, both to yourself and investors. Be clear and concise in your communication and tailor your pitch to the specific type of investor you are targeting. Don’t stress over retaining a large equity position and aim to develop technology that meets the needs of physicians and patients.
Starting out his career as a professional musician, Dr. Steven Mickelsen made a pivotal shift in his late twenties and ventured into the world of medicine. As a practicing electrophysiology (EP) physician, he has combined his medical expertise with an entrepreneurial spirit to revolutionize cardiac care. Steven made significant strides in the development of pulse field ablation (PFA) treatment with one of his previous companies, Farapulse, which sold to Boston Scientific. A serial entrepreneur, Steven is working on his next startup, Field Medical, which is developing the next generation of PFA technology to address ventricular arrhythmias.
Limited Capital Can Breed Resourcefulness
“Despite the fact that there was a lot of innovation in the early Farapulse days, the reality is that the technical leaps that we make now are just so much bigger because we have a foundation to jump off of,” Steven reflects on his journey. Field Medical’s device marks the third human-ready pulse generator that Steven has been involved in designing. By now, he knows what it takes to get it done, but he gained this wisdom at a high price.
During the early days of a startup, money is always tight. However, Steven underscores a fundamental: limited resources foster creativity. "It's surprising how far you can get with nothing, and it's surprising how little progress you can make with all the money in the world,” he says. With Farapulse, Steven and his team had to navigate through the alpha stage on a modest budget of $40,000, which pushed him to acquire new skills. He recalls “I couldn't afford to outsource it to anybody. I literally learned how to build electronics, bought components, put them together, crossed my fingers that I was not going to kill myself, and asked for help from people at the university.”
Steven’s advice is clear: make a prototype as soon as possible and make it as simple as possible. Use off-the-shelf components and don’t be afraid if your first prototype is ugly. What’s important is to have something tangible, functional, and with a potential for scalable development. For example, Steven repurposed a laser pulsar for the insides of the original Farapulse generator. Learn to leverage a practical approach like this to test and refine your idea without a substantial initial investment. “A mock-up is so cheap to build. Build it, show it to people,” says Steven.
In fact, it doesn't even have to be a physical prototype to get your point across. You can model a photorealistic version, for example, to demonstrate where you’re headed.
While prototyping is important, keep in mind that there’s one thing you must have to get to the next level: a good business model. "Nothing moves forward without a model for making money at the end," says Steven. Having a clear path to profitability not only makes it easier to raise funds but also provides a framework for sustainable growth.
Find Real Expertise Until You Develop Your Own
The regulatory and clinical landscape can be a huge black box for anybody who doesn’t have direct experience in bringing a device to market. Steven acknowledges the difficulty in finding industry expertise, as navigating field-specific regulations is complex. "It's hard to Google-search the requirements for a pilot study or the cost of a large phase three clinical trial," he notes.
There are clinical research organizations (CROs), but their cost can be prohibitive for a startup. This is why it’s imperative to have someone on your team who understands the nuances of regulatory and clinical requirements. "You're going to need one person who really understands how to submit papers to FDA, what the regulatory environment in Europe right now is, and what European Medical Device Regulation (MDR) entails," Steven points out.
Steven's strategy with Farapulse was to conduct initial clinical trials in Europe. While this strategy made sense for Farapulse, the regulations were different a decade ago, and things have changed a lot with MDR. Now, the 510(k) path in the US is preferred by most startups. However, the recipe is never one-size-fits-all in medtech.
In the US, one of the constraints is the challenge of enrolling patients in a significant clinical trial in an economical fashion. “In the US, hospitals charge so much more and the enrollment speeds are so much slower. For a startup that’s burning money every day, that’s not good. Instead, you can go to Europe, you can fly everyone there, and you can enroll 10 patients in one week,” he explains. For a startup where every dollar counts, the faster patient enrollment in Europe is a significant advantage. He further adds, “It's really important to get that experience and be able to iterate on it. If you have to wait too long to get your data, it can be very painful.”
Knowing the ropes of these processes can define whether you succeed or fail. In Steven’s case, he learned to navigate these challenges through hard work and direct experience. He says, “Good consultants exist; they're out there. Once you find one that's really good, never let them go. Then it's not as daunting as you think.”
Master a Clear and Compelling Story
A CEO’s main job is to raise money and keep the company on track. Now that he has the experience, Steven is quite confident with finding the right resources and developing a plan for eventual commercialization. “We've had a year to put together good practice, budgets, and marketing planning. Because, when you go out to raise money, it is important to get your finances in order to understand how the money works and to be able to present that side of the business proposition confidently,” he emphasizes.
To raise funds successfully, Steven emphasizes that, “There has to be a good idea, there has to be a market opportunity, and there has to be the right team. It's crucial that you, as a CEO, can provide realistic estimates about costs and timelines, and this is easier if you've done it before.”
The business side of a startup, particularly when dealing with institutional money, is not easy. That’s why Steven chose to exit with Farapulse. He shares, “I just didn't think I had the experience to be able to pull off that leadership role. I needed more experience before I could do that. I spent the last decade getting that experience. I feel pretty confident now.”
The most important things when trying to secure funding are storytelling and clarity when you present to investors. "The reality is—it probably depends much more on the storytelling and clarifying what it is you're doing in a way that gets investors interested," he says. Diverse types of investors, whether they are angels, high-net-worth individuals, or institutional investors, have varying requirements, and your pitch must be tailored accordingly.
One nugget of wisdom that Steven shares on this topic is that due diligence and negotiations will often favor the investor. "It takes months to close a round,” he warns. That means the more homework you can get done, the better. Preparation can significantly shorten the time-consuming process of closing a round.
Finally, Steven advises having realistic expectations regarding fundraising. In medtech, unlike in some other industries, it's okay to not hold on to a large percentage of your company. "The real goal is to have a successful technology that's needed by physicians and deserved by patients. If we can bring that forward and our investors can come out on top, then it's a win-win."
He wraps up his take on developing in medtech by saying, “You have to have a personal stake in why you are working in this area. There is investment here because it's an opportunity, but there's also an interest in making the future better. And by making it better, if you can get some return on your investment, then great.” According to Steven, even investors are usually proud of their contribution, as they know they were instrumental in getting technology that benefits patients into the hands of physicians.
Dr. Steven Mickelsen was a professional musician—the frontman of two different bands with recording contracts before he decided to go to medical school when he was 28.
His interest in medicine didn’t come out of nowhere, however. He was a musician by night and worked in a hospital during the day. His involvement in cardiac electrophysiology (EP) as a member of the Heart Rhythm Society (formerly Mass B) catalyzed his underlying passion for medicine. "I knew that I loved this [space] and decided to make a career change," he reflects. He’s widely considered one of the few people who’ve ushered in the use of pulse field ablation (PFA) technology to the EP space, and is one of the leading experts in this particular domain.
When he got into medical school at the University of Iowa, Steven started working on several ideas, all of which had potential. He recalls, “If you want a good idea to make it into the market with the support of a university, you really have to lead the charge.” In a nutshell, that’s how he became a serial entrepreneur.
The first bit of inspiration struck Steven in 2010 when he realized that it was possible to use a non-thermal energy source for tissue ablation. This led to the eventual development of PFA, which is a paradigm shift for the treatment of certain cardiac arrhythmias—where the electrical signals that tell the heart to beat don't work properly.
PFA uses brief but intense electrical pulses to specifically target myocardial tissue through electroporation, altering cell membranes without heating up the tissue. The technology is on the rise, as it allows for a more predictable, faster, and safer procedural workflow. The two companies bringing it to market are Medtronic and Boston Scientific, which acquired Farapulse, a startup Steven founded in 2011.
Steven is now working on his next startup Field Medical, a company he founded in 2022. “We've made enormous progress in the first 18 months of the company,” Steven reports, largely thanks to “years of suffering and failure,” he adds with a chuckle. Field Medical is focused on the EP space as well, specifically ventricular arrhythmias—a challenging disease to treat due to the ventricle tissue's thickness and constant movement.
“There's a massive amount of patients who suffer from ventricular arrhythmias that currently go undertreated or untreated,” Steven notes, underlining the significance of Field Medical’s mission, and the market gap. “All of the technology that's been developed for catheter ablation has focused on atrial arrhythmias, and very little has been spent on the deadly and life-changing problems of the ventricle. That’s where Field Medical is coming in,” he explains.
Optimization of the electric fields is just the tip of the iceberg. “There's a whole bunch of technology that goes into enabling that vision,” Steven explains. Despite the challenging climate for raising capital, Field Medical has achieved remarkable success, securing a seed round of approximately $14 million for their Class III medical device.
Is Field Medical’s treatment of ventricular arrhythmias the next big paradigm shift? It’s certainly a possibility, especially given the success of Steven’s previous venture, Farapulse. The company’s FieldForce™ Catheter and the FieldForce™ Generator use a proprietary technology called FieldBending™ to overcome limitations of first-generation PFA technologies.
The company is now poised for early human clinical data and Steven is eagerly waiting to present the preliminary results by mid-2024.
Key Learnings From Dr. Mickelsen's Experience
- Money will always be tight at the beginning of any startup. But scarcity can breed creativity, so use that to your advantage. Build prototypes with readily available parts and focus on nailing your narrative to convince investors.
- Finding real expertise in the clinical and regulatory arenas can be challenging due to the specific requirements unique to each startup. Find a good consultant early and keep them close – their expertise will save time and boost your startup's chances for success.
- When raising capital, be honest about costs and timelines, both to yourself and investors. Be clear and concise in your communication and tailor your pitch to the specific type of investor you are targeting. Don’t stress over retaining a large equity position and aim to develop technology that meets the needs of physicians and patients.
Starting out his career as a professional musician, Dr. Steven Mickelsen made a pivotal shift in his late twenties and ventured into the world of medicine. As a practicing electrophysiology (EP) physician, he has combined his medical expertise with an entrepreneurial spirit to revolutionize cardiac care. Steven made significant strides in the development of pulse field ablation (PFA) treatment with one of his previous companies, Farapulse, which sold to Boston Scientific. A serial entrepreneur, Steven is working on his next startup, Field Medical, which is developing the next generation of PFA technology to address ventricular arrhythmias.
Limited Capital Can Breed Resourcefulness
“Despite the fact that there was a lot of innovation in the early Farapulse days, the reality is that the technical leaps that we make now are just so much bigger because we have a foundation to jump off of,” Steven reflects on his journey. Field Medical’s device marks the third human-ready pulse generator that Steven has been involved in designing. By now, he knows what it takes to get it done, but he gained this wisdom at a high price.
During the early days of a startup, money is always tight. However, Steven underscores a fundamental: limited resources foster creativity. "It's surprising how far you can get with nothing, and it's surprising how little progress you can make with all the money in the world,” he says. With Farapulse, Steven and his team had to navigate through the alpha stage on a modest budget of $40,000, which pushed him to acquire new skills. He recalls “I couldn't afford to outsource it to anybody. I literally learned how to build electronics, bought components, put them together, crossed my fingers that I was not going to kill myself, and asked for help from people at the university.”
Steven’s advice is clear: make a prototype as soon as possible and make it as simple as possible. Use off-the-shelf components and don’t be afraid if your first prototype is ugly. What’s important is to have something tangible, functional, and with a potential for scalable development. For example, Steven repurposed a laser pulsar for the insides of the original Farapulse generator. Learn to leverage a practical approach like this to test and refine your idea without a substantial initial investment. “A mock-up is so cheap to build. Build it, show it to people,” says Steven.
In fact, it doesn't even have to be a physical prototype to get your point across. You can model a photorealistic version, for example, to demonstrate where you’re headed.
While prototyping is important, keep in mind that there’s one thing you must have to get to the next level: a good business model. "Nothing moves forward without a model for making money at the end," says Steven. Having a clear path to profitability not only makes it easier to raise funds but also provides a framework for sustainable growth.
Find Real Expertise Until You Develop Your Own
The regulatory and clinical landscape can be a huge black box for anybody who doesn’t have direct experience in bringing a device to market. Steven acknowledges the difficulty in finding industry expertise, as navigating field-specific regulations is complex. "It's hard to Google-search the requirements for a pilot study or the cost of a large phase three clinical trial," he notes.
There are clinical research organizations (CROs), but their cost can be prohibitive for a startup. This is why it’s imperative to have someone on your team who understands the nuances of regulatory and clinical requirements. "You're going to need one person who really understands how to submit papers to FDA, what the regulatory environment in Europe right now is, and what European Medical Device Regulation (MDR) entails," Steven points out.
Steven's strategy with Farapulse was to conduct initial clinical trials in Europe. While this strategy made sense for Farapulse, the regulations were different a decade ago, and things have changed a lot with MDR. Now, the 510(k) path in the US is preferred by most startups. However, the recipe is never one-size-fits-all in medtech.
In the US, one of the constraints is the challenge of enrolling patients in a significant clinical trial in an economical fashion. “In the US, hospitals charge so much more and the enrollment speeds are so much slower. For a startup that’s burning money every day, that’s not good. Instead, you can go to Europe, you can fly everyone there, and you can enroll 10 patients in one week,” he explains. For a startup where every dollar counts, the faster patient enrollment in Europe is a significant advantage. He further adds, “It's really important to get that experience and be able to iterate on it. If you have to wait too long to get your data, it can be very painful.”
Knowing the ropes of these processes can define whether you succeed or fail. In Steven’s case, he learned to navigate these challenges through hard work and direct experience. He says, “Good consultants exist; they're out there. Once you find one that's really good, never let them go. Then it's not as daunting as you think.”
Master a Clear and Compelling Story
A CEO’s main job is to raise money and keep the company on track. Now that he has the experience, Steven is quite confident with finding the right resources and developing a plan for eventual commercialization. “We've had a year to put together good practice, budgets, and marketing planning. Because, when you go out to raise money, it is important to get your finances in order to understand how the money works and to be able to present that side of the business proposition confidently,” he emphasizes.
To raise funds successfully, Steven emphasizes that, “There has to be a good idea, there has to be a market opportunity, and there has to be the right team. It's crucial that you, as a CEO, can provide realistic estimates about costs and timelines, and this is easier if you've done it before.”
The business side of a startup, particularly when dealing with institutional money, is not easy. That’s why Steven chose to exit with Farapulse. He shares, “I just didn't think I had the experience to be able to pull off that leadership role. I needed more experience before I could do that. I spent the last decade getting that experience. I feel pretty confident now.”
The most important things when trying to secure funding are storytelling and clarity when you present to investors. "The reality is—it probably depends much more on the storytelling and clarifying what it is you're doing in a way that gets investors interested," he says. Diverse types of investors, whether they are angels, high-net-worth individuals, or institutional investors, have varying requirements, and your pitch must be tailored accordingly.
One nugget of wisdom that Steven shares on this topic is that due diligence and negotiations will often favor the investor. "It takes months to close a round,” he warns. That means the more homework you can get done, the better. Preparation can significantly shorten the time-consuming process of closing a round.
Finally, Steven advises having realistic expectations regarding fundraising. In medtech, unlike in some other industries, it's okay to not hold on to a large percentage of your company. "The real goal is to have a successful technology that's needed by physicians and deserved by patients. If we can bring that forward and our investors can come out on top, then it's a win-win."
He wraps up his take on developing in medtech by saying, “You have to have a personal stake in why you are working in this area. There is investment here because it's an opportunity, but there's also an interest in making the future better. And by making it better, if you can get some return on your investment, then great.” According to Steven, even investors are usually proud of their contribution, as they know they were instrumental in getting technology that benefits patients into the hands of physicians.
