Dan Clark is no stranger to setbacks. His medtech startup, Linear Health Sciences, spent years navigating the regulatory waters, but that didn't stop him or his team.
Like many medtech company founders, Dan was technical by training. He started out his career in the private sector at Parker Hannifin — “the biggest company nobody’s ever heard of,” he says. Although the company had a small medical device segment, the industry wasn’t on his radar.
But after diving deeper into the medtech space, he learned about the innovation cycle and eventually managed strategic relationships toward the end of his tenure.
He got antsy, though, and was itching to innovate.
“I can't stand the idea of not having a new innovative way to do things or a different perspective,” he explains. As he considered his next steps, he knew that eventually, he wanted to start something himself. The right opportunity — what would become Linear — came about in 2015 when a friend introduced him to a physician with an idea that seemed to be right up Dan’s alley.
The initial concept pitch evolved into the Orchid Safety Release Valve. Co-founded by Dan and Dr. Ryan Dennis, Linear is shifting the standard of care for medical tubing dislodgement. In this episode of Medsider, Dan explains when and how Linear raised capital, how it has navigated complex regulatory pathways, and why you need to be your own worst enemy as an innovator.
Dan Clark started his career in the private sector at Parker Hannifin, a Fortune 200 organization that he calls “the largest company you’ve never heard of.” After experiencing the medtech innovation cycle many times over, he was eager to innovate himself. In 2015, Dan teamed up with Dr. Ryan Dennis to start Linear Health Sciences, a medtech company that created the Orchid, a device designed to mitigate unwanted or accidental IV dislodgement.
Key Learnings from Dan's Experiences
- Don’t skimp on research during early-stage development. Soliciting feedback from a broad range of stakeholders before commercialization will set you up for a smoother process when it’s time to scale.
- Know your skill sets, find the right partner, and divide and conquer. Dan focused on product development, marketing, and regulatory, which freed his co-founder to tackle fundraising full-time.
- For a smoother regulatory pathway, bring the FDA into the conversation as early as possible to foster understanding. Be your own worst enemy, asking the difficult questions to ensure you’ve done all you can to be compliant.
Steps to Take Before Commercialization
Today, Linear is full-scale commercial with the Orchid safety release valve. The device is designed to mitigate unwanted or accidental IV dislodgement by creating a sterile barrier between an IV extension set and administration set.
If the IV is dislodged, an occlusion alarm sounds, and the separated valve halves can be replaced. This allows for a simple return to treatment, bypassing the need for a full replacement of medical equipment.
Linear took strategic steps before and during the early-commercialization stage to ensure success.
1. Conduct Research to Inform Product Development and Ensure Scalability
Before commercialization, Linear gathered feedback from a wide variety of stakeholders while developing the Orchid, one of the most critical aspects to address during product iteration.
In other medtech projects, Dan has seen companies experience success when gathering feedback from not just physicians, but the nurses and technicians who use the product every day. Here’s one prime example: The Orchid is purple, due to feedback from nurses who place IVs daily and need the valve to be visible against a white bedside.
Price point feedback is essential as well: Know where you fit into the market, and understand what it can bear.
Prior to commercializing, clarify that your manufacturing can be scaled exponentially. For Linear, this includes ensuring that the geometry of the valve could be replicated across a platform of products for all medical tubing. Even if there is a market need for your product, a unique design may not be scalable if it’s a nightmare to produce on a daily basis.
2. Educate Providers on the ‘Why’ of Your Product
Before and during commercialization, education has been a central part of Linear’s process. Helping users understand why a device is worth adopting is an essential part of the process that shouldn’t be discounted.
Linear had a lot to be proud of, but also a lot to explain about how its device would improve the standard of care.
Apart from the Orchid, the current process when replacing a dislodged IV is waste-intensive. The IV itself, the tubing, whatever is being infused, and the bag of treatment must all be disposed of.
What’s more, for critical treatments like chemotherapy or total parenteral nutrition (TPN), this waste is incredibly costly, and precise dosages are imperative. Additionally, introducing more needles means more trauma for the patient and redundant clinician activities.
Orchid aims to resolve those issues by replacing a simple valve set. Although the use case for the product may seem clear and feedback thus far has been positive, education is still needed.
The metrics around medical tubing dislodgement are nearly nonexistent, which means getting definitive data is challenging. For basic IVs, reported dislodgements range from 9.5 to 24%. But in reality, it is actually a much larger problem.
For devices like the Orchid — that solve largely unreported issues — founders are tasked with educating audiences not just on how the product solves the problem, but on why there is a need in the first place.
“[Medical tubing dislodgement] has been fundamentally accepted as status quo when it doesn't have to be and, quite honestly, it shouldn't be,” Dan says. “Right now, we’re in the early stages: commercialization and education, the most difficult and most exciting component of this.”
Raising Capital in the Medtech Space
Linear arrived at the commercialization stage seven years after its genesis. Like many medtech projects, it evolved from a bootstrapped, part-time project to eventually needing capital.
Although Dan and his team didn’t have to raise money for the first two years, he certainly learned valuable lessons at major inflection points of the company’s evolution. At first, the team thought that they could bootstrap Linear, but Dan now says that belief stemmed from a lack of knowledge.
Looking back with the benefit of experience, he knows that to reach a point of “liftoff,” financing is a necessity. But it’s important to start fundraising at the right time, particularly because most investors want to see a proof of concept and to know that you understand the market before they’re willing to invest.
One of Dan’s keys to success for others who are fundraising is to find people in your network that believe in what you’re doing. Linear has raised three rounds of funding for a total of $10 million. Much of the first rounds of capital came from family, friends, and physicians connected to his co-founder.
While Linear’s story of success is encouraging, Dan cautions, “It's no easy path to go raise money because you have to be the biggest proponent of what you're doing.”
He goes on to explain that while you’re focused on developing the product, you might not be as focused on the needed conversations with various investors. For that reason, many people with experience say that fundraising is a full-time job.
Dan’s focus on product development, marketing and regulatory work opened up his partner to concentrate on fundraising, a reminder of the importance of building a team with balanced skills and interests.
Lucky for Linear, the duo found dedicated investors who believed in the work and came back for multiple rounds. But to anyone raising capital, Dan advises that fundraising can feel deeply personal, so it’s critical to get comfortable with being told “no”.
Navigating Regulatory Pathway Roadblocks
While raising capital comes with its own challenges, Linear has faced a particularly uphill battle in moving through the regulatory process.
Over the course of seven years, product development at Linear was relatively straightforward. But the team has spent years locked in a difficult battle with FDA — during which time it received several Not Substantially Equivalent (NSE) Determinations — and often felt like it was going nowhere.
Finally, after a formal appeal and a three-year journey, Linear found success.
On paper, the device’s function exists in other spaces already — which some might take to mean a smooth regulatory process. But the FDA review group associated the device with a risk profile that was at odds with the market and the product’s end users.
The Orchid went through multiple rounds of enhanced testing that similar medtech companies didn’t face. Dan recalled that at the height of this ordeal, his stress hit a peak. “My exact words were, ‘This type of regulatory environment is what is killing innovation in this space,’” he says. They also called in outside resources, including well-known attorney Mark Duvall to guide the regulatory legal process.
Linear had to work hard to shape the narrative around the device throughout their dialogues with regulators. When others at the table perceived the device as removing patients from treatment, Dan and his team had to shift the perspective, explaining that the concept of IV dislodgement is what actually removes patients from treatment.
Dan’s learned a lot the hard way and encourages others to involve the agency as early as possible. Despite the challenges Linear faced, he still acknowledges that FDA’s goal is to approve safe products that don’t adversely impact the public. So the sooner they are involved, the more thoroughly they can understand your device — and the better your chances are for smooth regulatory sailing.
Dan also advises innovators to be their own worst enemy. In other words, you need to ask yourself the hard questions:
- What have I done wrong?
- What have I not done?
- What should I redo?
The exercise allows you to enter difficult conversations with more confidence in your product and your overall compliance efforts.
Admittedly, Dan says, the Linear team was afraid of the FDA at times, particularly because they didn’t want to be on its bad side. But they had to remind themselves that, as much as was within their power, they had executed the right way and were not at fault. From there, they had to trust their team, their resources, and their product.
“Pulling the right levers at the right time is absolutely critical, and you cannot be afraid to do it,” he says.
Dan Clark is no stranger to setbacks. His medtech startup, Linear Health Sciences, spent years navigating the regulatory waters, but that didn't stop him or his team.
Like many medtech company founders, Dan was technical by training. He started out his career in the private sector at Parker Hannifin — “the biggest company nobody’s ever heard of,” he says. Although the company had a small medical device segment, the industry wasn’t on his radar.
But after diving deeper into the medtech space, he learned about the innovation cycle and eventually managed strategic relationships toward the end of his tenure.
He got antsy, though, and was itching to innovate.
“I can't stand the idea of not having a new innovative way to do things or a different perspective,” he explains. As he considered his next steps, he knew that eventually, he wanted to start something himself. The right opportunity — what would become Linear — came about in 2015 when a friend introduced him to a physician with an idea that seemed to be right up Dan’s alley.
The initial concept pitch evolved into the Orchid Safety Release Valve. Co-founded by Dan and Dr. Ryan Dennis, Linear is shifting the standard of care for medical tubing dislodgement. In this episode of Medsider, Dan explains when and how Linear raised capital, how it has navigated complex regulatory pathways, and why you need to be your own worst enemy as an innovator.
Dan Clark started his career in the private sector at Parker Hannifin, a Fortune 200 organization that he calls “the largest company you’ve never heard of.” After experiencing the medtech innovation cycle many times over, he was eager to innovate himself. In 2015, Dan teamed up with Dr. Ryan Dennis to start Linear Health Sciences, a medtech company that created the Orchid, a device designed to mitigate unwanted or accidental IV dislodgement.
Key Learnings from Dan's Experiences
- Don’t skimp on research during early-stage development. Soliciting feedback from a broad range of stakeholders before commercialization will set you up for a smoother process when it’s time to scale.
- Know your skill sets, find the right partner, and divide and conquer. Dan focused on product development, marketing, and regulatory, which freed his co-founder to tackle fundraising full-time.
- For a smoother regulatory pathway, bring the FDA into the conversation as early as possible to foster understanding. Be your own worst enemy, asking the difficult questions to ensure you’ve done all you can to be compliant.
Steps to Take Before Commercialization
Today, Linear is full-scale commercial with the Orchid safety release valve. The device is designed to mitigate unwanted or accidental IV dislodgement by creating a sterile barrier between an IV extension set and administration set.
If the IV is dislodged, an occlusion alarm sounds, and the separated valve halves can be replaced. This allows for a simple return to treatment, bypassing the need for a full replacement of medical equipment.
Linear took strategic steps before and during the early-commercialization stage to ensure success.
1. Conduct Research to Inform Product Development and Ensure Scalability
Before commercialization, Linear gathered feedback from a wide variety of stakeholders while developing the Orchid, one of the most critical aspects to address during product iteration.
In other medtech projects, Dan has seen companies experience success when gathering feedback from not just physicians, but the nurses and technicians who use the product every day. Here’s one prime example: The Orchid is purple, due to feedback from nurses who place IVs daily and need the valve to be visible against a white bedside.
Price point feedback is essential as well: Know where you fit into the market, and understand what it can bear.
Prior to commercializing, clarify that your manufacturing can be scaled exponentially. For Linear, this includes ensuring that the geometry of the valve could be replicated across a platform of products for all medical tubing. Even if there is a market need for your product, a unique design may not be scalable if it’s a nightmare to produce on a daily basis.
2. Educate Providers on the ‘Why’ of Your Product
Before and during commercialization, education has been a central part of Linear’s process. Helping users understand why a device is worth adopting is an essential part of the process that shouldn’t be discounted.
Linear had a lot to be proud of, but also a lot to explain about how its device would improve the standard of care.
Apart from the Orchid, the current process when replacing a dislodged IV is waste-intensive. The IV itself, the tubing, whatever is being infused, and the bag of treatment must all be disposed of.
What’s more, for critical treatments like chemotherapy or total parenteral nutrition (TPN), this waste is incredibly costly, and precise dosages are imperative. Additionally, introducing more needles means more trauma for the patient and redundant clinician activities.
Orchid aims to resolve those issues by replacing a simple valve set. Although the use case for the product may seem clear and feedback thus far has been positive, education is still needed.
The metrics around medical tubing dislodgement are nearly nonexistent, which means getting definitive data is challenging. For basic IVs, reported dislodgements range from 9.5 to 24%. But in reality, it is actually a much larger problem.
For devices like the Orchid — that solve largely unreported issues — founders are tasked with educating audiences not just on how the product solves the problem, but on why there is a need in the first place.
“[Medical tubing dislodgement] has been fundamentally accepted as status quo when it doesn't have to be and, quite honestly, it shouldn't be,” Dan says. “Right now, we’re in the early stages: commercialization and education, the most difficult and most exciting component of this.”
Raising Capital in the Medtech Space
Linear arrived at the commercialization stage seven years after its genesis. Like many medtech projects, it evolved from a bootstrapped, part-time project to eventually needing capital.
Although Dan and his team didn’t have to raise money for the first two years, he certainly learned valuable lessons at major inflection points of the company’s evolution. At first, the team thought that they could bootstrap Linear, but Dan now says that belief stemmed from a lack of knowledge.
Looking back with the benefit of experience, he knows that to reach a point of “liftoff,” financing is a necessity. But it’s important to start fundraising at the right time, particularly because most investors want to see a proof of concept and to know that you understand the market before they’re willing to invest.
One of Dan’s keys to success for others who are fundraising is to find people in your network that believe in what you’re doing. Linear has raised three rounds of funding for a total of $10 million. Much of the first rounds of capital came from family, friends, and physicians connected to his co-founder.
While Linear’s story of success is encouraging, Dan cautions, “It's no easy path to go raise money because you have to be the biggest proponent of what you're doing.”
He goes on to explain that while you’re focused on developing the product, you might not be as focused on the needed conversations with various investors. For that reason, many people with experience say that fundraising is a full-time job.
Dan’s focus on product development, marketing and regulatory work opened up his partner to concentrate on fundraising, a reminder of the importance of building a team with balanced skills and interests.
Lucky for Linear, the duo found dedicated investors who believed in the work and came back for multiple rounds. But to anyone raising capital, Dan advises that fundraising can feel deeply personal, so it’s critical to get comfortable with being told “no”.
Navigating Regulatory Pathway Roadblocks
While raising capital comes with its own challenges, Linear has faced a particularly uphill battle in moving through the regulatory process.
Over the course of seven years, product development at Linear was relatively straightforward. But the team has spent years locked in a difficult battle with FDA — during which time it received several Not Substantially Equivalent (NSE) Determinations — and often felt like it was going nowhere.
Finally, after a formal appeal and a three-year journey, Linear found success.
On paper, the device’s function exists in other spaces already — which some might take to mean a smooth regulatory process. But the FDA review group associated the device with a risk profile that was at odds with the market and the product’s end users.
The Orchid went through multiple rounds of enhanced testing that similar medtech companies didn’t face. Dan recalled that at the height of this ordeal, his stress hit a peak. “My exact words were, ‘This type of regulatory environment is what is killing innovation in this space,’” he says. They also called in outside resources, including well-known attorney Mark Duvall to guide the regulatory legal process.
Linear had to work hard to shape the narrative around the device throughout their dialogues with regulators. When others at the table perceived the device as removing patients from treatment, Dan and his team had to shift the perspective, explaining that the concept of IV dislodgement is what actually removes patients from treatment.
Dan’s learned a lot the hard way and encourages others to involve the agency as early as possible. Despite the challenges Linear faced, he still acknowledges that FDA’s goal is to approve safe products that don’t adversely impact the public. So the sooner they are involved, the more thoroughly they can understand your device — and the better your chances are for smooth regulatory sailing.
Dan also advises innovators to be their own worst enemy. In other words, you need to ask yourself the hard questions:
- What have I done wrong?
- What have I not done?
- What should I redo?
The exercise allows you to enter difficult conversations with more confidence in your product and your overall compliance efforts.
Admittedly, Dan says, the Linear team was afraid of the FDA at times, particularly because they didn’t want to be on its bad side. But they had to remind themselves that, as much as was within their power, they had executed the right way and were not at fault. From there, they had to trust their team, their resources, and their product.
“Pulling the right levers at the right time is absolutely critical, and you cannot be afraid to do it,” he says.
