In the heart of Orange County, SinglePass, a fresh startup in medtech, is on the cusp of disrupting the way we conduct deep tissue biopsies. At its helm is Bill Colone, a serial entrepreneur with a track record of successfully leading companies like Spinal Singularity and Endomed.
Bill has been in the industry for over 40 years and holds a degree in Chemical Engineering from Arizona State University. But his true calling has always been product development and entrepreneurship. Over four decades, Bill has earned 13 U.S. patents for medical devices and has even served on the ASU Advisory Committee for Chemical and Materials Engineering.
What's more remarkable than Bill's lengthy experience is his far-reaching network. Bill explains, "When you do anything for so long, you create a lot of relationships. If you've done a reasonably good job, some folks like you, and they proactively reach out." These connections don't wait around gathering dust; they become a source of "deal flow," as Bill likes to put it. People come to find Bill for what they know he’s good at, and Bill consistently delivers. For instance, a hand surgeon he worked with 15 years ago now refers physician friends with product ideas to Bill, serving as a constant pipeline for new opportunities.
SinglePass was founded thanks to Bill’s thick Rolodex. Three years ago, Bill reconnected with Dave Ferrera, a former colleague who said: "Hey, you get deal flow for peripheral vascular, I get deal flow for neurovascular. Why don't we do something together?" Around that time, they connected with two interventionalists who had a good idea, and that was the inception of SinglePass. "We formed a company with the physicians as co-founders, raised the first batch of money, and now we believe we're close to the end, three years later," Bill shares. Although SinglePass is currently a 28-month-old company, which is relatively young compared to most startups in the medical device space, Bill and his team are already getting ready to exit.
So what is this great idea? Biopsies usually involve inserting a large, hollow needle into a patient to extract a tissue sample. Post-procedure, patients are monitored to ensure that they are not bleeding internally — an aspect that has never been guaranteed. This is where SinglePass comes in. "We simply go in after the tissue sample is removed, cauterize the tissue with this really clever new device, and the doctors can do it by ultrasound to ensure there's no bleeding before they send the patient to the recovery room and send them home," Bill elucidates. The device has already shown promising results. In case studies involving 60 patients, SinglePass effectively prevented bleeding in lung, liver, or kidney biopsies.
"There's zero downside other than the cost of the device," he adds, pointing out that the technology effectively rules out the risk of internal bleeding post-biopsy. It's a straightforward yet transformative solution that promises to increase the safety and efficiency of biopsies around the world.
On the regulatory front, SinglePass has received verbal approval for its CE mark in the EU and is close to commercialization. It has been a fast-paced journey for Bill: "We expect to be commercial in the U.S. in January 2024," he reveals. He further expects that SinglePass will be acquired before the end of next year and isn't slowing down a bit: "Company number two is already a year in the making, and company number three is already months in the making. So there's two more lined up right behind us.”
Key Learnings From Bill’s Experience
- Your network is an extension of your company. You can leverage it at every stage — from idea to development, to launch, and even to exit.
- The venture studio approach has proven to be lucrative for Bill's multiple startups. Maximizing the use of limited funds, effective outsourcing, and planning for an early strategic exit can be more profitable than the traditional venture model.
- Grounded in realism and continuous feedback, Bill has a systematic approach to being a serial entrepreneur: keeping risk at a minimum while utilizing capital extremely efficiently and strategically keeping the end goal in mind.
Bill Colone is the CEO and Chairman of SinglePass, a company developing an electrocautery device for deep tissue biopsies. He previously headed Spinal Singularity, raising over $11 million for product and clinical development. He was VP of R&D at Direct Flow Medical and the President of Endomed, which was sold in 2005. Bill also served in multiple leadership roles at Endologix and holds 13 U.S. patents with more pending. He earned his bachelor's in Chemical Engineering from Arizona State University, where he later served as an Associate Faculty Member and sits on the advisory committee for Chemical and Materials Engineering.
Connections as a Competitive Advantage
You've probably heard the saying, "Your network is your net worth." Bill is living proof of that. He has accumulated a wealth of connections throughout his career, and it provides him with a competitive edge. As Bill puts it, "When you do anything for so long, you create a lot of relationships. SinglePass actually came about from something that I did 15 years ago."
You might assume that a seasoned entrepreneur like Bill can afford to take a step back from networking at this point in his career. Not quite right. He shares: "I try to go to every single Orange County medical device meeting. Even the ones in the evening where I'm tired and have worked all day". This is undoubtedly characteristic of the best company builders in the medtech space.
In fact, this mindset is how he connects with people who provide crucial domain expertise, including the best consultants in the field. For example, with SinglePass, Bill had the privilege of choosing from a pool of consultants who had specific expertise in electronic device regulations.
Investors, as you can imagine, are another critical part of an entrepreneur's network. Bill doesn’t only proactively attend meetings to increase his contact list, but also keeps his existing investors close, by keeping them in the know. He is also quite open about his fundraising activities and the company’s progress. He regularly updates his investors on milestones and challenges. "We let everybody know what we were working on and what we think is coming," he says. Transparency with investors builds trust and can lead to further opportunities down the road. “I'm shocked at the number of investors I have that say ‘the other companies I've invested in have never sent me an update.’ So I periodically let them know where we stand with everything, and the value of that is incredible.”
When it comes to conquering complex regulatory hurdles, Bill's network again plays a significant role. For example, Bill relied on an extensive network of experienced partners and consultants to prepare for entering the European market. Notably, they had previously received EU MDR approval for other Class III devices, providing a level of confidence and expertise to navigate the process. His team had a robust relationship with their notified body and an authorized representative who was highly familiar with the kind of medical device they were bringing to market, a cautery-based device in this case. "We were able to enter the European market because of our connections and experience, and because we received great feedback from an authorized rep who essentially guided us through the process," Bill added.
Why the Venture Studio Model is Compelling
Traditional startups often have full-time employees and cumbersome overhead expenses. But Bill's venture studio framework offers an alternative pathway, cutting through complexities to deliver promising medical technologies in record time and at a fraction of the cost.
In contrast to the traditional approach of renting office space, building clean rooms, and hiring large teams, Bill’s group operates with a different approach. He describes it succinctly: "We always have a single employee, which is the CEO. Everything else is contracted out." This minimalist approach extends to every aspect of the business — no rented buildings, no full-time staff, resulting in extremely lean operations. Beyond cost-savings, Bill's model has another, less discussed advantage: agility in the face of external disruptions, such as supply chain issues. "Right now, I don't get charged unless I have the CMO doing work for me. If I had full-time employees, I'm paying them even while we're waiting six weeks for something to come in," Bill notes.
Bill is not a proponent of exorbitant funding rounds; his formula is based on capital efficiency. "What we like to do with the first round of funding is to get to human trials," Bill shares. Following this, a priced round of funding is targeted to achieve key regulatory milestones and a limited market release. According to Bill, this approach "eliminates or reduces the risk dramatically for strategics, both from a regulatory and commercial perspective."
"The seed round was a million and a half. The Series A was two and a half million.", Bill shares about his funding cycle with SinglePass. This is modest compared to the significant amount of capital raised for most medtech startups, but he also points out: "If you have less capital in, an early exit can still be a really big win for all of the founders and early investors."
The venture studio model may not be universally applicable. Bill admits this himself: "This may not apply to more complex devices, so I wouldn't say every company should start like this." However, Bill’s approach has been consistently successful for multiple startups.
A Guide to Serial Entrepreneurship
Bill is a proven startup operator and has an outline that he applies to all his businesses.
It’s his rule not to raise an enormous amount of capital, which according to Bill, increases the risk. Instead, his plan is clear: “We choose an ideal exit window. More importantly, we have a lean, but solid budget. What will it take for us to get to the first human trials? We'll close the seed round once we get those dollars.”
Once the seed money is in, the focus is on getting into human trials. According to Bill, it proves to investors and key stakeholders that the venture has legs.
Following the seed round, Bill looks to a Series A to fulfill multiple objectives. "The priced round will get us through both regulatory approvals and a limited market release," he says.
SinglePass is a great example considering it’s positioned for both acquisition and independent commercialization. Bill recommends founders strategically plan for acquisition from the onset, but he also runs his startups as if they aren’t going to be acquired. This way, the company is flexible based on the interest it generates among potential acquirers or growth-stage investors.
While you’re in the midst of it all, it’s also important to stay grounded. Bill’s overarching advice to newcomers in the field is “be realistic, understand it will take a while, and listen to feedback." For example, when it comes to your pitch deck, Bill’s take is: "Show it early and often, and you will ultimately arrive at a version that addresses what the investors are looking for.” Bill added jokingly: “I think I was on pitch deck number 42 for SinglePass before we closed the recent raise.”
Lastly, he circles back to the importance of networking — "It's a never-ending part of your job," Bill says. Even if you're tired, or you think you’ve met enough people, Bill would probably tell you to get out there and shake some more hands.
In the heart of Orange County, SinglePass, a fresh startup in medtech, is on the cusp of disrupting the way we conduct deep tissue biopsies. At its helm is Bill Colone, a serial entrepreneur with a track record of successfully leading companies like Spinal Singularity and Endomed.
Bill has been in the industry for over 40 years and holds a degree in Chemical Engineering from Arizona State University. But his true calling has always been product development and entrepreneurship. Over four decades, Bill has earned 13 U.S. patents for medical devices and has even served on the ASU Advisory Committee for Chemical and Materials Engineering.
What's more remarkable than Bill's lengthy experience is his far-reaching network. Bill explains, "When you do anything for so long, you create a lot of relationships. If you've done a reasonably good job, some folks like you, and they proactively reach out." These connections don't wait around gathering dust; they become a source of "deal flow," as Bill likes to put it. People come to find Bill for what they know he’s good at, and Bill consistently delivers. For instance, a hand surgeon he worked with 15 years ago now refers physician friends with product ideas to Bill, serving as a constant pipeline for new opportunities.
SinglePass was founded thanks to Bill’s thick Rolodex. Three years ago, Bill reconnected with Dave Ferrera, a former colleague who said: "Hey, you get deal flow for peripheral vascular, I get deal flow for neurovascular. Why don't we do something together?" Around that time, they connected with two interventionalists who had a good idea, and that was the inception of SinglePass. "We formed a company with the physicians as co-founders, raised the first batch of money, and now we believe we're close to the end, three years later," Bill shares. Although SinglePass is currently a 28-month-old company, which is relatively young compared to most startups in the medical device space, Bill and his team are already getting ready to exit.
So what is this great idea? Biopsies usually involve inserting a large, hollow needle into a patient to extract a tissue sample. Post-procedure, patients are monitored to ensure that they are not bleeding internally — an aspect that has never been guaranteed. This is where SinglePass comes in. "We simply go in after the tissue sample is removed, cauterize the tissue with this really clever new device, and the doctors can do it by ultrasound to ensure there's no bleeding before they send the patient to the recovery room and send them home," Bill elucidates. The device has already shown promising results. In case studies involving 60 patients, SinglePass effectively prevented bleeding in lung, liver, or kidney biopsies.
"There's zero downside other than the cost of the device," he adds, pointing out that the technology effectively rules out the risk of internal bleeding post-biopsy. It's a straightforward yet transformative solution that promises to increase the safety and efficiency of biopsies around the world.
On the regulatory front, SinglePass has received verbal approval for its CE mark in the EU and is close to commercialization. It has been a fast-paced journey for Bill: "We expect to be commercial in the U.S. in January 2024," he reveals. He further expects that SinglePass will be acquired before the end of next year and isn't slowing down a bit: "Company number two is already a year in the making, and company number three is already months in the making. So there's two more lined up right behind us.”
Key Learnings From Bill’s Experience
- Your network is an extension of your company. You can leverage it at every stage — from idea to development, to launch, and even to exit.
- The venture studio approach has proven to be lucrative for Bill's multiple startups. Maximizing the use of limited funds, effective outsourcing, and planning for an early strategic exit can be more profitable than the traditional venture model.
- Grounded in realism and continuous feedback, Bill has a systematic approach to being a serial entrepreneur: keeping risk at a minimum while utilizing capital extremely efficiently and strategically keeping the end goal in mind.
Bill Colone is the CEO and Chairman of SinglePass, a company developing an electrocautery device for deep tissue biopsies. He previously headed Spinal Singularity, raising over $11 million for product and clinical development. He was VP of R&D at Direct Flow Medical and the President of Endomed, which was sold in 2005. Bill also served in multiple leadership roles at Endologix and holds 13 U.S. patents with more pending. He earned his bachelor's in Chemical Engineering from Arizona State University, where he later served as an Associate Faculty Member and sits on the advisory committee for Chemical and Materials Engineering.
Connections as a Competitive Advantage
You've probably heard the saying, "Your network is your net worth." Bill is living proof of that. He has accumulated a wealth of connections throughout his career, and it provides him with a competitive edge. As Bill puts it, "When you do anything for so long, you create a lot of relationships. SinglePass actually came about from something that I did 15 years ago."
You might assume that a seasoned entrepreneur like Bill can afford to take a step back from networking at this point in his career. Not quite right. He shares: "I try to go to every single Orange County medical device meeting. Even the ones in the evening where I'm tired and have worked all day". This is undoubtedly characteristic of the best company builders in the medtech space.
In fact, this mindset is how he connects with people who provide crucial domain expertise, including the best consultants in the field. For example, with SinglePass, Bill had the privilege of choosing from a pool of consultants who had specific expertise in electronic device regulations.
Investors, as you can imagine, are another critical part of an entrepreneur's network. Bill doesn’t only proactively attend meetings to increase his contact list, but also keeps his existing investors close, by keeping them in the know. He is also quite open about his fundraising activities and the company’s progress. He regularly updates his investors on milestones and challenges. "We let everybody know what we were working on and what we think is coming," he says. Transparency with investors builds trust and can lead to further opportunities down the road. “I'm shocked at the number of investors I have that say ‘the other companies I've invested in have never sent me an update.’ So I periodically let them know where we stand with everything, and the value of that is incredible.”
When it comes to conquering complex regulatory hurdles, Bill's network again plays a significant role. For example, Bill relied on an extensive network of experienced partners and consultants to prepare for entering the European market. Notably, they had previously received EU MDR approval for other Class III devices, providing a level of confidence and expertise to navigate the process. His team had a robust relationship with their notified body and an authorized representative who was highly familiar with the kind of medical device they were bringing to market, a cautery-based device in this case. "We were able to enter the European market because of our connections and experience, and because we received great feedback from an authorized rep who essentially guided us through the process," Bill added.
Why the Venture Studio Model is Compelling
Traditional startups often have full-time employees and cumbersome overhead expenses. But Bill's venture studio framework offers an alternative pathway, cutting through complexities to deliver promising medical technologies in record time and at a fraction of the cost.
In contrast to the traditional approach of renting office space, building clean rooms, and hiring large teams, Bill’s group operates with a different approach. He describes it succinctly: "We always have a single employee, which is the CEO. Everything else is contracted out." This minimalist approach extends to every aspect of the business — no rented buildings, no full-time staff, resulting in extremely lean operations. Beyond cost-savings, Bill's model has another, less discussed advantage: agility in the face of external disruptions, such as supply chain issues. "Right now, I don't get charged unless I have the CMO doing work for me. If I had full-time employees, I'm paying them even while we're waiting six weeks for something to come in," Bill notes.
Bill is not a proponent of exorbitant funding rounds; his formula is based on capital efficiency. "What we like to do with the first round of funding is to get to human trials," Bill shares. Following this, a priced round of funding is targeted to achieve key regulatory milestones and a limited market release. According to Bill, this approach "eliminates or reduces the risk dramatically for strategics, both from a regulatory and commercial perspective."
"The seed round was a million and a half. The Series A was two and a half million.", Bill shares about his funding cycle with SinglePass. This is modest compared to the significant amount of capital raised for most medtech startups, but he also points out: "If you have less capital in, an early exit can still be a really big win for all of the founders and early investors."
The venture studio model may not be universally applicable. Bill admits this himself: "This may not apply to more complex devices, so I wouldn't say every company should start like this." However, Bill’s approach has been consistently successful for multiple startups.
A Guide to Serial Entrepreneurship
Bill is a proven startup operator and has an outline that he applies to all his businesses.
It’s his rule not to raise an enormous amount of capital, which according to Bill, increases the risk. Instead, his plan is clear: “We choose an ideal exit window. More importantly, we have a lean, but solid budget. What will it take for us to get to the first human trials? We'll close the seed round once we get those dollars.”
Once the seed money is in, the focus is on getting into human trials. According to Bill, it proves to investors and key stakeholders that the venture has legs.
Following the seed round, Bill looks to a Series A to fulfill multiple objectives. "The priced round will get us through both regulatory approvals and a limited market release," he says.
SinglePass is a great example considering it’s positioned for both acquisition and independent commercialization. Bill recommends founders strategically plan for acquisition from the onset, but he also runs his startups as if they aren’t going to be acquired. This way, the company is flexible based on the interest it generates among potential acquirers or growth-stage investors.
While you’re in the midst of it all, it’s also important to stay grounded. Bill’s overarching advice to newcomers in the field is “be realistic, understand it will take a while, and listen to feedback." For example, when it comes to your pitch deck, Bill’s take is: "Show it early and often, and you will ultimately arrive at a version that addresses what the investors are looking for.” Bill added jokingly: “I think I was on pitch deck number 42 for SinglePass before we closed the recent raise.”
Lastly, he circles back to the importance of networking — "It's a never-ending part of your job," Bill says. Even if you're tired, or you think you’ve met enough people, Bill would probably tell you to get out there and shake some more hands.
