Iterating Towards Perfection in Medtech

Interview with Sonavex CEO David Narrow

David Narrow began his medical device journey at the University of Rochester as a biomedical engineering student and later attended graduate school at Johns Hopkins. During his time at Hopkins, he participated in a bio-design program, which served as a great springboard for his future medtech endeavors. There, David partnered with a physician and a professor, collaborating on an initial prototype for what would become the foundational technology for his company, Sonavex.

Before diving into his entrepreneurial path, David took a detour into healthcare strategy consulting, landing a role at Health Advances, a Boston-based firm with a global presence, and was involved in financial forecasting, market research, M&A due diligence, and health economic modeling for therapeutics, diagnostics, and device companies.

David’s experience at Health Advances proved invaluable for his career and the formation of his own company. After his stint in Boston, he returned to Baltimore to further advance the technology he and his partners initially conceptualized, leading to the founding of Sonavex.

Operating for almost a decade, Sonavex is committed to novel, automated ultrasound technology to improve healthcare. The company's flagship products, EchoMark and EchoSure, work in tandem to enhance the care of dialysis patients. 

EchoMark is a bioresorbable fiducial marker implanted at the time of arteriovenous fistula (AVF) creation, a connection made between a vein and an artery in the arm for dialysis. EchoSure, on the other hand, is an AI-powered 3D ultrasound system that automates the entire process of data collection, processing, and display in relation to the AVF. With these two technologies, Sonavex aims to expedite the maturation process of the AVF, which currently averages over six months. 

EchoMark and EchoSure have both received 510(k) clearances. Currently, Sonavex is actively involved in clinical trials to further validate the efficacy and health economics of its products, demonstrating the company’s commitment to improving patient outcomes and overall cost-effectiveness. If proven successful, this could significantly reduce hospital visits, providing an effective solution for patients, providers, and payers. 

Key Learnings From David’s Experience

  • The ultimate perfection of your product design is a result of continuous iteration. Don’t get married to your first prototype, but keep refining it. Solicit consistent feedback through every phase, especially from end users, to make this process as cost-effective and efficient as possible.
  • When navigating the regulatory landscape, leverage all of your resources and don’t be afraid to ask for help from your network. Initiate early communication with regulatory bodies like the FDA to anticipate challenges and understand their expectations.
  • There is no one-size-fits-all strategy when it comes to winning venture capital. Keep in mind that investment decisions are often driven by emotions and hinge heavily on your management team's credibility. Utilize your contacts to connect with the right capital partners and learn what drives them to invest.
Guest
David Narrow
CEO of Sonavex

Prior to co-founding Sonavex, David Narrow worked with multinational medical device companies on their commercialization and long-term business strategies as a healthcare consultant for Health Advances. David earned his B.S. in Biomedical Engineering with Highest Distinction from the University of Rochester before receiving his Masters from Johns Hopkins University. Narrow was named 30 Under 30 in Healthcare by Forbes in 2016 and 40 Under 40 by the Baltimore Business Journal in 2017.

Product Design: Iterate Your Way to Perfection

No new technology emerges from thin air; every innovation undergoes its own development cycle, completed only after countless trials and errors before it is market-ready. This is especially true in the medical device space. As an experienced medtech entrepreneur, David knows that the path to a successful device is rarely a straight line.

The initial design is not necessarily the endgame, so avoid getting too attached to your prototype in the early stages of development. Investing time and resources in refining your initial designs is a necessary part of the process. In David’s words: “You make these assumptions when you first start inventing things, but until your end-users actually try to implement the solution, it's all theoretical. And the rubber meets the road when you actually have these people put their hands on it. That's where the real learning happens."

But every iteration means more expenses, and as an entrepreneur, you’ll need to draw the line at some point so your company doesn’t bleed too much money along the way. In David’s case, their team went through 26 different designs on EchoMark before settling on one and transitioning into the rest of the development stages. He acknowledges that the process is expensive, but if you don’t iterate on your design based on stakeholder feedback, it’ll cost you more down the line.

That’s why it’s crucial to manage finances wisely during this stage, which means you must move towards your ideal device with a keen eye on every penny you spend. According to David, “It’s helpful to use an objective rubric, create scores based on different factors, and seek external input. Use surveys or other types of market research tools to make sure that you’re in a good enough place to move forward.”

David emphasizes the importance of feedback during the alpha-beta iteration phases: "Making sure that you've had the chance to get adequate user feedback is really paramount… Iterating through a device in the absence of end-user and other external feedback is a doomed mission.”

He also underscores that external input is important to maintain a clear vision towards your path as a CEO. He shares: “It's also a lot easier emotionally to have objective input because so much of entrepreneurship is emotional. The highs are great, the lows are terrible.”

Leverage Your Network to Cross the Regulatory Chasm

According to David, the trifecta of medtech entrepreneurship starts with regulatory approval, followed by quality management and clinical trials. 

Venturing into the regulatory landscape requires leveraging all the resources and wisdom of experienced mentors. David recommends tapping into the wealth of free resources, podcasts, and blog posts at your disposal. There is no shortage when it comes to educating yourself and getting comfortable with the topic. 

He also underscores the importance of experienced guides who can help decode the key areas of the regulatory arena. He shares: “Across all of these, what is most important, and this is frankly with any facet of the business, is finding a coach or a mentor who can say, ‘Here's what you have to worry about now. Here's what's coming later. Here are some of the considerations”.

However, while knowledge is power, delegation is equally critical. David strongly advises hiring specialists who can effectively steer through the often-complex regulatory requirements. As he puts it: "You've got to find a functional expert, either as an external consultant or someone that you hire internally, who’s going to be able to own a lot of these processes."

Above all, David emphasizes the importance of early and ongoing engagement with the FDA. This echoes his ‘solving the problems from the beginning’ mindset. David suggests: "Engage with the FDA as soon as possible, and get a sense of what pathway they think you're going to go down and their biggest concerns...Collect that information and touch base with them". This strategy is key to understanding regulatory expectations in a more clear fashion, and consequently, anticipating potential issues that may eventually come up down the road.

The regulatory function might seem daunting, but with proper guidance, resource utilization, strategic planning, and active engagement with the bodies, you can successfully navigate the safe shores of approval and market authorization. 

Put Yourself in the Shoes of Your Investors

David's perspective provides a fresh approach to the complex process of fundraising for medtech startups. First, it’s important to understand that venture capital is the lifeblood of any life sciences startup and a crucial phase in determining whether your ship’s going to sail or sink. To secure it, however, you need more than a compelling pitch. As David underscores: "People are going to invest emotionally versus logically." That’s why it’s more about understanding the motivations and processes of all parties involved than just laying out empirical facts.

As David asserts, raising capital isn’t a one-way street. However, he also acknowledges some guiding principles that can make the process less frustrating. The key is to realize the importance of timing, the relationships you’ve built, and the context in which you ask for money. Soft skills, thus, are as important as hard facts in this endeavor.

David shares: “The most important thing that I learned, and it was pretty early on, is the weight of the empathy element, really putting yourself in the investor’s shoes. As an engineer, I naturally had an empirical approach to laying out a set of facts...That couldn't be further from the way things actually were.”

That’s why relationships and networking are pivotal. It’s critical to target the right people, and as David points out, leverage your network to get the right introductions. Furthermore, understanding what drives different types of investors, like angels, venture funds, family offices, and strategic investors, is paramount. 

Interestingly, one of the most effective strategies time-tested by David, as counter-intuitive as it sounds, is engaging with investors even when you're not raising capital. As David puts it: “People don't want to be aggressively sold to where you're saying - Hey, I've got this company. It's a great deal! Listen to my aggressive pitch!"

Beyond strategy, timing, and networking, the human element of fundraising can’t be discounted. David posits: "So much of an investor’s bet is on the management team and the founders versus the technology."

Finally, the cornerstone of successful fundraising, according to David, is meticulous preparation. His parting advice to fundraising CEOs is to map out a detailed plan and lay out their strategies, budgets, and future milestones. Plans are subject to change, however, a sophisticated approach solidifies your credibility in the eyes of potential investors.

Download a copy of the interview transcript right here.
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David Narrow began his medical device journey at the University of Rochester as a biomedical engineering student and later attended graduate school at Johns Hopkins. During his time at Hopkins, he participated in a bio-design program, which served as a great springboard for his future medtech endeavors. There, David partnered with a physician and a professor, collaborating on an initial prototype for what would become the foundational technology for his company, Sonavex.

Before diving into his entrepreneurial path, David took a detour into healthcare strategy consulting, landing a role at Health Advances, a Boston-based firm with a global presence, and was involved in financial forecasting, market research, M&A due diligence, and health economic modeling for therapeutics, diagnostics, and device companies.

David’s experience at Health Advances proved invaluable for his career and the formation of his own company. After his stint in Boston, he returned to Baltimore to further advance the technology he and his partners initially conceptualized, leading to the founding of Sonavex.

Operating for almost a decade, Sonavex is committed to novel, automated ultrasound technology to improve healthcare. The company's flagship products, EchoMark and EchoSure, work in tandem to enhance the care of dialysis patients. 

EchoMark is a bioresorbable fiducial marker implanted at the time of arteriovenous fistula (AVF) creation, a connection made between a vein and an artery in the arm for dialysis. EchoSure, on the other hand, is an AI-powered 3D ultrasound system that automates the entire process of data collection, processing, and display in relation to the AVF. With these two technologies, Sonavex aims to expedite the maturation process of the AVF, which currently averages over six months. 

EchoMark and EchoSure have both received 510(k) clearances. Currently, Sonavex is actively involved in clinical trials to further validate the efficacy and health economics of its products, demonstrating the company’s commitment to improving patient outcomes and overall cost-effectiveness. If proven successful, this could significantly reduce hospital visits, providing an effective solution for patients, providers, and payers. 

Key Learnings From David’s Experience

  • The ultimate perfection of your product design is a result of continuous iteration. Don’t get married to your first prototype, but keep refining it. Solicit consistent feedback through every phase, especially from end users, to make this process as cost-effective and efficient as possible.
  • When navigating the regulatory landscape, leverage all of your resources and don’t be afraid to ask for help from your network. Initiate early communication with regulatory bodies like the FDA to anticipate challenges and understand their expectations.
  • There is no one-size-fits-all strategy when it comes to winning venture capital. Keep in mind that investment decisions are often driven by emotions and hinge heavily on your management team's credibility. Utilize your contacts to connect with the right capital partners and learn what drives them to invest.
Guest
David Narrow
CEO of Sonavex

Prior to co-founding Sonavex, David Narrow worked with multinational medical device companies on their commercialization and long-term business strategies as a healthcare consultant for Health Advances. David earned his B.S. in Biomedical Engineering with Highest Distinction from the University of Rochester before receiving his Masters from Johns Hopkins University. Narrow was named 30 Under 30 in Healthcare by Forbes in 2016 and 40 Under 40 by the Baltimore Business Journal in 2017.

Product Design: Iterate Your Way to Perfection

No new technology emerges from thin air; every innovation undergoes its own development cycle, completed only after countless trials and errors before it is market-ready. This is especially true in the medical device space. As an experienced medtech entrepreneur, David knows that the path to a successful device is rarely a straight line.

The initial design is not necessarily the endgame, so avoid getting too attached to your prototype in the early stages of development. Investing time and resources in refining your initial designs is a necessary part of the process. In David’s words: “You make these assumptions when you first start inventing things, but until your end-users actually try to implement the solution, it's all theoretical. And the rubber meets the road when you actually have these people put their hands on it. That's where the real learning happens."

But every iteration means more expenses, and as an entrepreneur, you’ll need to draw the line at some point so your company doesn’t bleed too much money along the way. In David’s case, their team went through 26 different designs on EchoMark before settling on one and transitioning into the rest of the development stages. He acknowledges that the process is expensive, but if you don’t iterate on your design based on stakeholder feedback, it’ll cost you more down the line.

That’s why it’s crucial to manage finances wisely during this stage, which means you must move towards your ideal device with a keen eye on every penny you spend. According to David, “It’s helpful to use an objective rubric, create scores based on different factors, and seek external input. Use surveys or other types of market research tools to make sure that you’re in a good enough place to move forward.”

David emphasizes the importance of feedback during the alpha-beta iteration phases: "Making sure that you've had the chance to get adequate user feedback is really paramount… Iterating through a device in the absence of end-user and other external feedback is a doomed mission.”

He also underscores that external input is important to maintain a clear vision towards your path as a CEO. He shares: “It's also a lot easier emotionally to have objective input because so much of entrepreneurship is emotional. The highs are great, the lows are terrible.”

Leverage Your Network to Cross the Regulatory Chasm

According to David, the trifecta of medtech entrepreneurship starts with regulatory approval, followed by quality management and clinical trials. 

Venturing into the regulatory landscape requires leveraging all the resources and wisdom of experienced mentors. David recommends tapping into the wealth of free resources, podcasts, and blog posts at your disposal. There is no shortage when it comes to educating yourself and getting comfortable with the topic. 

He also underscores the importance of experienced guides who can help decode the key areas of the regulatory arena. He shares: “Across all of these, what is most important, and this is frankly with any facet of the business, is finding a coach or a mentor who can say, ‘Here's what you have to worry about now. Here's what's coming later. Here are some of the considerations”.

However, while knowledge is power, delegation is equally critical. David strongly advises hiring specialists who can effectively steer through the often-complex regulatory requirements. As he puts it: "You've got to find a functional expert, either as an external consultant or someone that you hire internally, who’s going to be able to own a lot of these processes."

Above all, David emphasizes the importance of early and ongoing engagement with the FDA. This echoes his ‘solving the problems from the beginning’ mindset. David suggests: "Engage with the FDA as soon as possible, and get a sense of what pathway they think you're going to go down and their biggest concerns...Collect that information and touch base with them". This strategy is key to understanding regulatory expectations in a more clear fashion, and consequently, anticipating potential issues that may eventually come up down the road.

The regulatory function might seem daunting, but with proper guidance, resource utilization, strategic planning, and active engagement with the bodies, you can successfully navigate the safe shores of approval and market authorization. 

Put Yourself in the Shoes of Your Investors

David's perspective provides a fresh approach to the complex process of fundraising for medtech startups. First, it’s important to understand that venture capital is the lifeblood of any life sciences startup and a crucial phase in determining whether your ship’s going to sail or sink. To secure it, however, you need more than a compelling pitch. As David underscores: "People are going to invest emotionally versus logically." That’s why it’s more about understanding the motivations and processes of all parties involved than just laying out empirical facts.

As David asserts, raising capital isn’t a one-way street. However, he also acknowledges some guiding principles that can make the process less frustrating. The key is to realize the importance of timing, the relationships you’ve built, and the context in which you ask for money. Soft skills, thus, are as important as hard facts in this endeavor.

David shares: “The most important thing that I learned, and it was pretty early on, is the weight of the empathy element, really putting yourself in the investor’s shoes. As an engineer, I naturally had an empirical approach to laying out a set of facts...That couldn't be further from the way things actually were.”

That’s why relationships and networking are pivotal. It’s critical to target the right people, and as David points out, leverage your network to get the right introductions. Furthermore, understanding what drives different types of investors, like angels, venture funds, family offices, and strategic investors, is paramount. 

Interestingly, one of the most effective strategies time-tested by David, as counter-intuitive as it sounds, is engaging with investors even when you're not raising capital. As David puts it: “People don't want to be aggressively sold to where you're saying - Hey, I've got this company. It's a great deal! Listen to my aggressive pitch!"

Beyond strategy, timing, and networking, the human element of fundraising can’t be discounted. David posits: "So much of an investor’s bet is on the management team and the founders versus the technology."

Finally, the cornerstone of successful fundraising, according to David, is meticulous preparation. His parting advice to fundraising CEOs is to map out a detailed plan and lay out their strategies, budgets, and future milestones. Plans are subject to change, however, a sophisticated approach solidifies your credibility in the eyes of potential investors.

Download a copy of the interview transcript right here.
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