Harlee Sorkin is a co-founder of Common Place Holdings, a venture studio that has given birth to eight different medtech startups, including InterShunt, which Harlee is leading as its CEO today. Prior to that, Harlee proved his business acumen by leading Traco Labs to a successful exit.
But Harlee's more than a business wiz. He was a Clinical Assistant Professor at the University of Illinois at Urbana-Champaign, dabbling in both engineering and medicine despite not being an engineer or a physician himself. There, his area of focus was translational research — marrying ideas and concepts with real-world applications.
A few years back, one of the startups Common Place was nurturing, InterShunt, reached a pivotal moment that demanded more attention from the team. So, Harlee left his seat in academia to lead the charge full-time.
InterShunt is tackling one of the most pressing issues in medicine: heart failure. When the heart muscles weaken, they struggle to pump enough blood to the body. This leads to increased pressure within the left ventricle, and if not corrected, could result in symptoms like pulmonary congestion and shortness of breath. This slow, degenerative condition affects over 6 million Americans every year.
The solution InterShunt is developing is based on a concept from over a century ago, where a French physician noticed that patients with a naturally occurring hole in their heart experienced less severe heart failure symptoms. InterShunt built upon this foundation to develop interatrial shunting.
Their flagship product is a proprietary transcatheter system aimed to replicate this natural phenomenon. There have been previous attempts to employ this same concept, however they all involved stents or tissue fixation by creating a ring of scar tissue to maintain a durable opening. InterShunt’s approach is much simpler: punching a hole in the heart that creates a pathway for blood to bypass the congested areas. The fact that it requires no implants or stents, eschewing the need for hardware in the heart, makes it a potentially safer, more compliant solution. “By creating that pathway, we leave the septum in a completely compliant state where it can respond to the hemodynamic needs of the heart,” Harlee explains.
As the idea and the concept of InterShunt grew, the team decided to move to a more conducive environment for its next phase of development, landing in Minneapolis. The pre-clinical phase included extensive animal studies and cadaver work with first-in-human studies conducted in the Republic of Georgia in early 2022. They involved 10 patients, and the follow-up results, presented at the TCT conference in October 2023, showed all patients maintaining a durable opening, an encouraging sign for the future of heart failure treatment.
Harlee is now eyeing the next big step for InterShunt. “In order to generate a heart failure claim, we do expect to have to perform a pivotal study of our own in a heart failure population,” he shares, revealing the roadmap ahead.
Key Learnings From Harlee’s Experience
- You have to prioritize ruthlessly during the capital-scarce initial phases of your startup. It’s a cycle of setting and achieving milestones that prove potential and help you secure further capital so you can move on with your next goals.
- Reframe fundraising as friend-raising. Begin cultivating these relationships well before you need the capital, as this process can be time-consuming. Align your funding requests with clear, achievable milestones and choose the right investors for each stage of your company.
- Engage openly and frequently with a diverse range of stakeholders. Don’t be afraid of people stealing your idea; it doesn’t happen as often as one might think. Treat every conversation as an opportunity to learn and refine your ideas and you’ll end up with a wealth of perspectives and insights.
Harlee Sorkin is a co-founder of Common Place Holdings, a venture studio that has spun out eight medtech startups, including InterShunt Technologies, the startup Harlee is leading today. Before Common Place, Harlee led Traco Labs, a health and nutrition ingredient manufacturer, to a successful exit. He also served as a Clinical Assistant Professor at the University of Illinois at Urbana-Champaign, where he focused on translating research ideas into commercially viable applications.
Prioritize Ruthlessly
In the world of startups, especially in medtech, the early stages are a balancing act of ambition and practicality. Harlee shares, “Capital is precious very early on. What do you need to do? The answer is everything. We all know that's not possible. So you have to prioritize, and sometimes you have to prioritize pretty ruthlessly.”
One thing that sets medical device entrepreneurship apart from other sectors is the extended timeframe required for development. In verticals like SaaS, success often comes quickly if your product finds a paying market. In contrast, medtech demands a more iterative approach. Before a medical device can even reach its users, its efficacy and safety must be thoroughly proven. It’s a cycle of ideation, securing initial capital, implementation, gathering feedback, and then seeking more capital. Harlee refers to this as 'permission-based capital' where you earn further investment by demonstrating your ability to fulfill your promises.
When you have a sharp focus on fundable milestones, some other aspects may need to be temporarily sidelined, even if they’re significant. You need to identify and hit goals that not only push the venture forward but also help you create a narrative of potential, showing what's been accomplished and what could be done with additional resources.
Harlee emphasizes three focus areas that are pivotal in the early stages. First is the team. You might not have the complete team during the first days, but securing one or two key members with unique skills and an edge in achieving set milestones is imperative. The second is intellectual property, i.e., understanding the competitive landscape and ensuring freedom to operate without legal liabilities. And lastly, proof of concept. You have to demonstrate that your solution works, no matter how rudimentary your initial models or experiments are.
Friendraising Versus Fundraising
Harlee likens the role of a CEO to the narrow waist of an hourglass. On one end are the investors and shareholders, represented by the board, and on the other, the broader organization. The CEO’s job, standing at the junction, is to communicate the company's needs and goals upward while effectively allocating resources downstream. That requires a lot of strategic communication and efficient resource management.
In Harlee’s experience, fundraising goes hand-in-hand with building relationships, or in his words, ‘friend-raising,’ and it’s by no means a short route. The time you start raising funds definitely shouldn’t be when you need them, as it can take months if not years.
Harlee’s experience with raising capital is full of moments of both triumph and frustration. The key, he believes, lies in right-sizing the ask — aligning the funding request with appropriate milestones and ensuring engagement with the right investors for each stage. “There are progressive stages to medical device development,” Harlee shares, “First you create a device that functions well in a lab setting. Then you ensure it’s effective in a live animal model. Following this, you adapt it for human use.” In InterShunt’s case, Commonplace Holdings provided the initial seed capital, but as the venture progressed, the approach to fundraising had to evolve.
Engaging with angel investors and institutional investors alike, Harlee shot two birds with one stone. Not only did he secure some immediate financial support but he also laid the groundwork for future investments. By fostering awareness and interest among potential institutional investors, he positioned InterShunt favorably, which made all the difference when the time came to showcase achieved milestones and seek larger amounts of capital.
Your Network is Your Trump Card
Harlee readily acknowledges that when he stepped into the interventional device field, it was uncharted territory for him. He candidly shares, “The first thing I did was go find a regulatory consultant to help us understand what this universe looks like”.
Engaging with domain experts helped the InterShunt team understand their operational leeway and identify the most viable regulatory pathway. This groundwork informed their strategic decisions, allowing the team to cost-effectively balance risk during the product development phase.
A key strategic move for InterShunt was conducting their initial human studies in the Republic of Georgia in early '22. It was a calculated trade-off, taking into account factors like cost, quality of care, and follow-up. While first-in-human opportunities in the US existed, they found that the cost and outcomes in Georgia were more favorable, even if it meant potentially slowing down subsequent steps.
Identifying the right teammates was another crucial step Harlee took. Making sure he was always on the lookout, he didn’t simply search for engineering expertise; he also knew he needed talent with clinical and regulatory knowledge. A key figure in this process was Maggie Wallner, whose rich experience with the Watchman device at Atritech made her an invaluable asset to the team. She transitioned to InterShunt, initially as a consultant and then as a team leader.
Harlee also emphasizes the significance of having experienced clinical individuals involved early in your project, as their expertise directly influences the device's design and usability. However, when it comes to regulatory matters, Harlee believes that while specific domain expertise is important, having strong relationships with key personnel in the specific center at FDA where you intend to move your product forward can’t be understated.
In summary, Harlee's varying approaches often intersect at relationships and collaboration. Whether it's through consultants with specific expertise or connections with experienced personnel within FDA, the value of building and maintaining strong professional relationships is vital for any medtech startup. In the world of medtech, who you know can be just as important as what you know.
Harlee Sorkin is a co-founder of Common Place Holdings, a venture studio that has given birth to eight different medtech startups, including InterShunt, which Harlee is leading as its CEO today. Prior to that, Harlee proved his business acumen by leading Traco Labs to a successful exit.
But Harlee's more than a business wiz. He was a Clinical Assistant Professor at the University of Illinois at Urbana-Champaign, dabbling in both engineering and medicine despite not being an engineer or a physician himself. There, his area of focus was translational research — marrying ideas and concepts with real-world applications.
A few years back, one of the startups Common Place was nurturing, InterShunt, reached a pivotal moment that demanded more attention from the team. So, Harlee left his seat in academia to lead the charge full-time.
InterShunt is tackling one of the most pressing issues in medicine: heart failure. When the heart muscles weaken, they struggle to pump enough blood to the body. This leads to increased pressure within the left ventricle, and if not corrected, could result in symptoms like pulmonary congestion and shortness of breath. This slow, degenerative condition affects over 6 million Americans every year.
The solution InterShunt is developing is based on a concept from over a century ago, where a French physician noticed that patients with a naturally occurring hole in their heart experienced less severe heart failure symptoms. InterShunt built upon this foundation to develop interatrial shunting.
Their flagship product is a proprietary transcatheter system aimed to replicate this natural phenomenon. There have been previous attempts to employ this same concept, however they all involved stents or tissue fixation by creating a ring of scar tissue to maintain a durable opening. InterShunt’s approach is much simpler: punching a hole in the heart that creates a pathway for blood to bypass the congested areas. The fact that it requires no implants or stents, eschewing the need for hardware in the heart, makes it a potentially safer, more compliant solution. “By creating that pathway, we leave the septum in a completely compliant state where it can respond to the hemodynamic needs of the heart,” Harlee explains.
As the idea and the concept of InterShunt grew, the team decided to move to a more conducive environment for its next phase of development, landing in Minneapolis. The pre-clinical phase included extensive animal studies and cadaver work with first-in-human studies conducted in the Republic of Georgia in early 2022. They involved 10 patients, and the follow-up results, presented at the TCT conference in October 2023, showed all patients maintaining a durable opening, an encouraging sign for the future of heart failure treatment.
Harlee is now eyeing the next big step for InterShunt. “In order to generate a heart failure claim, we do expect to have to perform a pivotal study of our own in a heart failure population,” he shares, revealing the roadmap ahead.
Key Learnings From Harlee’s Experience
- You have to prioritize ruthlessly during the capital-scarce initial phases of your startup. It’s a cycle of setting and achieving milestones that prove potential and help you secure further capital so you can move on with your next goals.
- Reframe fundraising as friend-raising. Begin cultivating these relationships well before you need the capital, as this process can be time-consuming. Align your funding requests with clear, achievable milestones and choose the right investors for each stage of your company.
- Engage openly and frequently with a diverse range of stakeholders. Don’t be afraid of people stealing your idea; it doesn’t happen as often as one might think. Treat every conversation as an opportunity to learn and refine your ideas and you’ll end up with a wealth of perspectives and insights.
Harlee Sorkin is a co-founder of Common Place Holdings, a venture studio that has spun out eight medtech startups, including InterShunt Technologies, the startup Harlee is leading today. Before Common Place, Harlee led Traco Labs, a health and nutrition ingredient manufacturer, to a successful exit. He also served as a Clinical Assistant Professor at the University of Illinois at Urbana-Champaign, where he focused on translating research ideas into commercially viable applications.
Prioritize Ruthlessly
In the world of startups, especially in medtech, the early stages are a balancing act of ambition and practicality. Harlee shares, “Capital is precious very early on. What do you need to do? The answer is everything. We all know that's not possible. So you have to prioritize, and sometimes you have to prioritize pretty ruthlessly.”
One thing that sets medical device entrepreneurship apart from other sectors is the extended timeframe required for development. In verticals like SaaS, success often comes quickly if your product finds a paying market. In contrast, medtech demands a more iterative approach. Before a medical device can even reach its users, its efficacy and safety must be thoroughly proven. It’s a cycle of ideation, securing initial capital, implementation, gathering feedback, and then seeking more capital. Harlee refers to this as 'permission-based capital' where you earn further investment by demonstrating your ability to fulfill your promises.
When you have a sharp focus on fundable milestones, some other aspects may need to be temporarily sidelined, even if they’re significant. You need to identify and hit goals that not only push the venture forward but also help you create a narrative of potential, showing what's been accomplished and what could be done with additional resources.
Harlee emphasizes three focus areas that are pivotal in the early stages. First is the team. You might not have the complete team during the first days, but securing one or two key members with unique skills and an edge in achieving set milestones is imperative. The second is intellectual property, i.e., understanding the competitive landscape and ensuring freedom to operate without legal liabilities. And lastly, proof of concept. You have to demonstrate that your solution works, no matter how rudimentary your initial models or experiments are.
Friendraising Versus Fundraising
Harlee likens the role of a CEO to the narrow waist of an hourglass. On one end are the investors and shareholders, represented by the board, and on the other, the broader organization. The CEO’s job, standing at the junction, is to communicate the company's needs and goals upward while effectively allocating resources downstream. That requires a lot of strategic communication and efficient resource management.
In Harlee’s experience, fundraising goes hand-in-hand with building relationships, or in his words, ‘friend-raising,’ and it’s by no means a short route. The time you start raising funds definitely shouldn’t be when you need them, as it can take months if not years.
Harlee’s experience with raising capital is full of moments of both triumph and frustration. The key, he believes, lies in right-sizing the ask — aligning the funding request with appropriate milestones and ensuring engagement with the right investors for each stage. “There are progressive stages to medical device development,” Harlee shares, “First you create a device that functions well in a lab setting. Then you ensure it’s effective in a live animal model. Following this, you adapt it for human use.” In InterShunt’s case, Commonplace Holdings provided the initial seed capital, but as the venture progressed, the approach to fundraising had to evolve.
Engaging with angel investors and institutional investors alike, Harlee shot two birds with one stone. Not only did he secure some immediate financial support but he also laid the groundwork for future investments. By fostering awareness and interest among potential institutional investors, he positioned InterShunt favorably, which made all the difference when the time came to showcase achieved milestones and seek larger amounts of capital.
Your Network is Your Trump Card
Harlee readily acknowledges that when he stepped into the interventional device field, it was uncharted territory for him. He candidly shares, “The first thing I did was go find a regulatory consultant to help us understand what this universe looks like”.
Engaging with domain experts helped the InterShunt team understand their operational leeway and identify the most viable regulatory pathway. This groundwork informed their strategic decisions, allowing the team to cost-effectively balance risk during the product development phase.
A key strategic move for InterShunt was conducting their initial human studies in the Republic of Georgia in early '22. It was a calculated trade-off, taking into account factors like cost, quality of care, and follow-up. While first-in-human opportunities in the US existed, they found that the cost and outcomes in Georgia were more favorable, even if it meant potentially slowing down subsequent steps.
Identifying the right teammates was another crucial step Harlee took. Making sure he was always on the lookout, he didn’t simply search for engineering expertise; he also knew he needed talent with clinical and regulatory knowledge. A key figure in this process was Maggie Wallner, whose rich experience with the Watchman device at Atritech made her an invaluable asset to the team. She transitioned to InterShunt, initially as a consultant and then as a team leader.
Harlee also emphasizes the significance of having experienced clinical individuals involved early in your project, as their expertise directly influences the device's design and usability. However, when it comes to regulatory matters, Harlee believes that while specific domain expertise is important, having strong relationships with key personnel in the specific center at FDA where you intend to move your product forward can’t be understated.
In summary, Harlee's varying approaches often intersect at relationships and collaboration. Whether it's through consultants with specific expertise or connections with experienced personnel within FDA, the value of building and maintaining strong professional relationships is vital for any medtech startup. In the world of medtech, who you know can be just as important as what you know.
