From Nurse to Medical Device Entrepreneur

Interview with Swiftsure CEO Deanne McCarthy

Before founding Swiftsure Innovations, Deanne McCarthy was a critical care nurse and caregiver dedicated to aiding patients in dire need. She held herself to high standards, always asking, “If this was my critically ill-loved one, would this be acceptable to me?”

However, her job was not without its challenges. Providing oral care to ICU patients proved to be particularly frustrating. "Nurses can't visualize the oral cavity because these patients are unconscious and sedated, and the tube is crowding the oral cavity, making it impossible to clean above or behind it," she explains.

Patients are immobilized and in a sedated state, leaving nurses to fight an uphill battle to maintain the most basic levels of hygiene. Complicating things further, the average length of mechanical ventilation is five days, during which patients cannot eat or drink, which makes the oral environment a breeding ground for bacteria. Deanne sums it up by stating, "Imagine how terrible you'd feel if you slept all night with your mouth open and then woke up in the morning with that super dry mouth and literally couldn't go rinse your mouth after."

It was one heart-breaking incident that made her determined to take action. A patient — in his late 50s and a father of two high school children — despite a good prognosis for recovery, developed ventilator-associated pneumonia (VAP) due to poor oral hygiene, ultimately leading to multi-organ failure and death. It was a tragic loss for the patient’s family and a moment that shook Deanne to her core. She found herself lying awake at night, obsessed with how to improve oral care in the ICU. That’s why she took it upon herself to come up with a solution for this overlooked part of patient care.

With the support of Creative Destruction Lab, a  non-profit accelerator for seed-stage, life science companies, Deanne assembled a team and developed a device capable of safely and effectively cleaning the oral cavity of patients on life support. The single-use mouthpiece enables nurses to reach all areas of the oral cavity, even those difficult to access because of tubes.

Deanne's background proved invaluable in this entrepreneurial endeavor. The fact that she learned the ropes of contracts, relationship management, and corporate governance early in her career helped lay a strong foundation for her venture. But Deanne also had an ally she couldn't have predicted: a sudden change in industry guidelines.

In May 2022, the Ventilator-Associated Pneumonia (VAP) prevention guidelines were updated, urging for the de-adoption of chlorhexidine — a previously common antimicrobial used for limiting bacteria in oral care. The timing couldn't have been better for Swiftsure Innovations, as the industry scrambled to find alternative solutions.

The company has made incredible progress since its inception. In less than 18 months, Swiftsure reached design freeze, transferred manufacturing, completed a positive clinical use validation study at the Cleveland Clinic, and registered with FDA. All of this on a budget of less than $1 million.

Currently, their product is available via a limited commercial release, but a full market launch is anticipated in 2024. Deanne shares, “Our work with early adopters is going to help us validate our business model, our pricing assumptions, optimize our training materials, and solidify relationships with our early customers.” 

Key Learnings From Deanne’s Experience

  • Good accelerator programs will allow you to tap into a wealth of expertise. Don’t be shy about converting your mentors into active players in your startup. 
  • Not knowing everything is perfectly okay. Harness your curiosity in every facet of your venture to ensure you find the right resources to reach your milestones. 
  • Don’t be afraid to ask for favors. And to reciprocate, approach your network with a spirit of generosity.
Guest
Deanne McCarthy
CEO of Swiftsure Innovations

Deanne McCarthy, founder and CEO of Swiftsure Innovations, was a critical care nurse before deciding to make the switch to medtech entrepreneur. With Deanne's commitment to empowering nurses and enhancing patient outcomes, Swiftsure has assembled an adept team and a robust group of advisors that has enabled the company to move incredibly quickly across key functions like product development, regulatory affairs, and commercialization.

Nurturing Ideas in Collaborative Soil

A lot of people have good ideas, but they seldom act on them because knowing where to start is not second nature to everyone. Although Deanne had no prior entrepreneurial experience, she was able to move forward with her idea extremely quickly. Deanne attributes much of her readiness to the foundational skills and network she acquired at the Creative Destruction Lab (CDL), an equity-free accelerator. 

It was there that she was able to access a cadre of seasoned advisors. But that’s not all — Deanne is a natural collaborator. Thanks to that skill set, she was able to turn these mentors into active participants in her startup's journey, shaping everything from the company’s initial funding round to forecasts and business plans. 

"The first thing that we did was outsource product development,” she explains. Swiftsure partnered with a certified Canadian medical device design company, Ironstone. There, she was able to accelerate the development process by pressure-testing each iteration with external consultants, some of whom ended up working for Swiftsure full-time.

“I'm not a quality expert. I definitely went out and learned as much as I could about all of the different work streams that are necessary,” Deanne says. During the peak of COVID, Deanne and her team adopted a hands-on approach to product testing, enlisting ICU nurses for real-time feedback. 

"We would videotape everything and then have a systematic interview with each of the end-users to unpack questions that the design team had," Deanne explains. "We did that five different times and having insights from these really experienced, smart nurses was invaluable," she adds. 

Accelerators can sometimes be a mixed bag. They demand time and energy, and not every startup walks away with a golden ticket. For Deanne, however, her experience with CDL was an invaluable opportunity to collaborate with others in the industry and find people who were interested in propelling her idea forward. 

With the non-dilutive funding she was able to garner, Deanne quickly moved on to building a regulatory plan and early prototyping. She advises, "If you're at an early stage, reach out and get to know all non-dilutive funding grant options that are out there and engage with those organizations early. It takes a lot of work and a lot of time to get non-dilutive funding, but it's well worth the effort." 

In the end, her stint at CDL proved to be a game-changer, setting the gears in motion and expanding her network in ways she never imagined. 

From Curiosity to Confidence

Deanne’s nursing background fueled her curiosity and the desire to make methodical decisions at each step.

She acknowledges that they were fortunate to progress so quickly, considering Swiftsure’s team was working remotely during the pandemic. But Deanne did what it took through regular check-ins with key consultants, always thinking about a Plan B, and keeping various options open in every area, ensuring there were alternatives in case something didn't work out.

When it came time to choose the right product development partners, Deanne was thorough: "We did interviews with four or five different product development shops, had conversations with companies they had worked with, found and talked to businesses that they didn't give us as references, etc." After deciding to partner with Ironstone, she enlisted a quality expert to attend meetings and pressure-test everything.

On the clinical side, Deanne applied an unexpectedly pragmatic lens: sales. "Your clinical sites need to think what you're doing is interesting, worthwhile, and compelling," she explains. Just like most organizations, hospitals have multiple priorities. "You need to find out who's able to move as quickly as possible and who's got the right plan in place," Deanne advises.

Deanne approached regulatory challenges with the same rigor: "I felt that was a risky area of the business, so I wanted to make sure I talked to as many people as possible." She invested in three different regulatory opinion memos and consulted with four additional experts. "Some would argue that I spent more than I should have on that aspect of the business, but I felt I needed to do it," she shares.

Building a partnership with your investors is also critically important. Deanne says, "Have investors who believe in you and who you can be candid with about what's working well, what isn't working well, and where you need support." 

She has the right partners now, but getting to this point wasn't easy for her. Deanne admits to initially feeling awkward, almost as if she was asking for a favor because her startup needed money. Her discomfort shifted over time as she gained more experience, assembled a competent team, and achieved key milestones. "I go into conversations with potential investors now, excited to tell them about this incredible investment opportunity," she adds.

How to Cultivate the Right Support

Embarking on a startup adventure is never a solitary mission. Deanne knows that all too well. Her venture was bolstered by the rich network she developed, especially through her experience at CDL. "We ended up having some really great mentors who stayed with us throughout the program. And one of our mentors ended up being the lead of our pre-seed round," she explains.

The initial step is making contact, but to truly harness the power of your network, you need to build lasting relationships. And while you might not always be in a position to give back immediately, that's perfectly fine. As Deanne puts it with a chuckle, “I find myself constantly asking for favors. I'm excited to one day be in a position to return favors for other people because, at this point, I'm always asking.” And even if you don’t have the means to reciprocate, it’s okay. Reaching out with a good question often yields good dialogue.

At the core of successful networking is a spirit of generosity, something Deanne has experienced firsthand. "People have been incredibly open and generous with their time," she recalls. This willingness to connect, share insights, and offer support has been a crucial element in her entrepreneurial journey. In Deanne’s own words, "It's overwhelming how many good people are out there that are willing to just lend an ear, hear what you're up to, and see if they can help.”

Beyond personal connections, Deanne encourages leveraging every possible network or platform. “You need to talk to a lot of people to find who they are — they’re out there and often really generous with their time."

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
Email

Before founding Swiftsure Innovations, Deanne McCarthy was a critical care nurse and caregiver dedicated to aiding patients in dire need. She held herself to high standards, always asking, “If this was my critically ill-loved one, would this be acceptable to me?”

However, her job was not without its challenges. Providing oral care to ICU patients proved to be particularly frustrating. "Nurses can't visualize the oral cavity because these patients are unconscious and sedated, and the tube is crowding the oral cavity, making it impossible to clean above or behind it," she explains.

Patients are immobilized and in a sedated state, leaving nurses to fight an uphill battle to maintain the most basic levels of hygiene. Complicating things further, the average length of mechanical ventilation is five days, during which patients cannot eat or drink, which makes the oral environment a breeding ground for bacteria. Deanne sums it up by stating, "Imagine how terrible you'd feel if you slept all night with your mouth open and then woke up in the morning with that super dry mouth and literally couldn't go rinse your mouth after."

It was one heart-breaking incident that made her determined to take action. A patient — in his late 50s and a father of two high school children — despite a good prognosis for recovery, developed ventilator-associated pneumonia (VAP) due to poor oral hygiene, ultimately leading to multi-organ failure and death. It was a tragic loss for the patient’s family and a moment that shook Deanne to her core. She found herself lying awake at night, obsessed with how to improve oral care in the ICU. That’s why she took it upon herself to come up with a solution for this overlooked part of patient care.

With the support of Creative Destruction Lab, a  non-profit accelerator for seed-stage, life science companies, Deanne assembled a team and developed a device capable of safely and effectively cleaning the oral cavity of patients on life support. The single-use mouthpiece enables nurses to reach all areas of the oral cavity, even those difficult to access because of tubes.

Deanne's background proved invaluable in this entrepreneurial endeavor. The fact that she learned the ropes of contracts, relationship management, and corporate governance early in her career helped lay a strong foundation for her venture. But Deanne also had an ally she couldn't have predicted: a sudden change in industry guidelines.

In May 2022, the Ventilator-Associated Pneumonia (VAP) prevention guidelines were updated, urging for the de-adoption of chlorhexidine — a previously common antimicrobial used for limiting bacteria in oral care. The timing couldn't have been better for Swiftsure Innovations, as the industry scrambled to find alternative solutions.

The company has made incredible progress since its inception. In less than 18 months, Swiftsure reached design freeze, transferred manufacturing, completed a positive clinical use validation study at the Cleveland Clinic, and registered with FDA. All of this on a budget of less than $1 million.

Currently, their product is available via a limited commercial release, but a full market launch is anticipated in 2024. Deanne shares, “Our work with early adopters is going to help us validate our business model, our pricing assumptions, optimize our training materials, and solidify relationships with our early customers.” 

Key Learnings From Deanne’s Experience

  • Good accelerator programs will allow you to tap into a wealth of expertise. Don’t be shy about converting your mentors into active players in your startup. 
  • Not knowing everything is perfectly okay. Harness your curiosity in every facet of your venture to ensure you find the right resources to reach your milestones. 
  • Don’t be afraid to ask for favors. And to reciprocate, approach your network with a spirit of generosity.
Guest
Deanne McCarthy
CEO of Swiftsure Innovations

Deanne McCarthy, founder and CEO of Swiftsure Innovations, was a critical care nurse before deciding to make the switch to medtech entrepreneur. With Deanne's commitment to empowering nurses and enhancing patient outcomes, Swiftsure has assembled an adept team and a robust group of advisors that has enabled the company to move incredibly quickly across key functions like product development, regulatory affairs, and commercialization.

Nurturing Ideas in Collaborative Soil

A lot of people have good ideas, but they seldom act on them because knowing where to start is not second nature to everyone. Although Deanne had no prior entrepreneurial experience, she was able to move forward with her idea extremely quickly. Deanne attributes much of her readiness to the foundational skills and network she acquired at the Creative Destruction Lab (CDL), an equity-free accelerator. 

It was there that she was able to access a cadre of seasoned advisors. But that’s not all — Deanne is a natural collaborator. Thanks to that skill set, she was able to turn these mentors into active participants in her startup's journey, shaping everything from the company’s initial funding round to forecasts and business plans. 

"The first thing that we did was outsource product development,” she explains. Swiftsure partnered with a certified Canadian medical device design company, Ironstone. There, she was able to accelerate the development process by pressure-testing each iteration with external consultants, some of whom ended up working for Swiftsure full-time.

“I'm not a quality expert. I definitely went out and learned as much as I could about all of the different work streams that are necessary,” Deanne says. During the peak of COVID, Deanne and her team adopted a hands-on approach to product testing, enlisting ICU nurses for real-time feedback. 

"We would videotape everything and then have a systematic interview with each of the end-users to unpack questions that the design team had," Deanne explains. "We did that five different times and having insights from these really experienced, smart nurses was invaluable," she adds. 

Accelerators can sometimes be a mixed bag. They demand time and energy, and not every startup walks away with a golden ticket. For Deanne, however, her experience with CDL was an invaluable opportunity to collaborate with others in the industry and find people who were interested in propelling her idea forward. 

With the non-dilutive funding she was able to garner, Deanne quickly moved on to building a regulatory plan and early prototyping. She advises, "If you're at an early stage, reach out and get to know all non-dilutive funding grant options that are out there and engage with those organizations early. It takes a lot of work and a lot of time to get non-dilutive funding, but it's well worth the effort." 

In the end, her stint at CDL proved to be a game-changer, setting the gears in motion and expanding her network in ways she never imagined. 

From Curiosity to Confidence

Deanne’s nursing background fueled her curiosity and the desire to make methodical decisions at each step.

She acknowledges that they were fortunate to progress so quickly, considering Swiftsure’s team was working remotely during the pandemic. But Deanne did what it took through regular check-ins with key consultants, always thinking about a Plan B, and keeping various options open in every area, ensuring there were alternatives in case something didn't work out.

When it came time to choose the right product development partners, Deanne was thorough: "We did interviews with four or five different product development shops, had conversations with companies they had worked with, found and talked to businesses that they didn't give us as references, etc." After deciding to partner with Ironstone, she enlisted a quality expert to attend meetings and pressure-test everything.

On the clinical side, Deanne applied an unexpectedly pragmatic lens: sales. "Your clinical sites need to think what you're doing is interesting, worthwhile, and compelling," she explains. Just like most organizations, hospitals have multiple priorities. "You need to find out who's able to move as quickly as possible and who's got the right plan in place," Deanne advises.

Deanne approached regulatory challenges with the same rigor: "I felt that was a risky area of the business, so I wanted to make sure I talked to as many people as possible." She invested in three different regulatory opinion memos and consulted with four additional experts. "Some would argue that I spent more than I should have on that aspect of the business, but I felt I needed to do it," she shares.

Building a partnership with your investors is also critically important. Deanne says, "Have investors who believe in you and who you can be candid with about what's working well, what isn't working well, and where you need support." 

She has the right partners now, but getting to this point wasn't easy for her. Deanne admits to initially feeling awkward, almost as if she was asking for a favor because her startup needed money. Her discomfort shifted over time as she gained more experience, assembled a competent team, and achieved key milestones. "I go into conversations with potential investors now, excited to tell them about this incredible investment opportunity," she adds.

How to Cultivate the Right Support

Embarking on a startup adventure is never a solitary mission. Deanne knows that all too well. Her venture was bolstered by the rich network she developed, especially through her experience at CDL. "We ended up having some really great mentors who stayed with us throughout the program. And one of our mentors ended up being the lead of our pre-seed round," she explains.

The initial step is making contact, but to truly harness the power of your network, you need to build lasting relationships. And while you might not always be in a position to give back immediately, that's perfectly fine. As Deanne puts it with a chuckle, “I find myself constantly asking for favors. I'm excited to one day be in a position to return favors for other people because, at this point, I'm always asking.” And even if you don’t have the means to reciprocate, it’s okay. Reaching out with a good question often yields good dialogue.

At the core of successful networking is a spirit of generosity, something Deanne has experienced firsthand. "People have been incredibly open and generous with their time," she recalls. This willingness to connect, share insights, and offer support has been a crucial element in her entrepreneurial journey. In Deanne’s own words, "It's overwhelming how many good people are out there that are willing to just lend an ear, hear what you're up to, and see if they can help.”

Beyond personal connections, Deanne encourages leveraging every possible network or platform. “You need to talk to a lot of people to find who they are — they’re out there and often really generous with their time."

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
Email

Join Medsider as a Free Subscriber

Subscribe to Medsider and get access to exclusive benefits for free. No spam, 100% privacy, and your email won’t be shared.