Key Learnings From Brian’s Experience
- There are three major risk factors in medtech: product-market fit, technical feasibility, and clinical validation. When assessing your idea, the first thing to do is to try to talk yourself out of it. Once you reach a point where you can’t argue any further, you may have something solid. From there, your goal should be to identify the areas with the highest risk factors and those that are quickest to mitigate.
- Pioneering innovations can be substantially rewarding, but the trade-off is they often demand longer, more complex clinical trials. Mitigate clinical risk by studying the pathways of predicate technologies to refine endpoints, patient populations, and more. True disruption requires a product that’s not just better, but significantly transformational.
- Be selective in fundraising: Consider your sector, stage, and the size of the round you’re after in order to focus your energy on your best prospects. Transparency and consistent communication build trust and enhance your brand in both fundraising and M&A processes.
"It's always a funny journey; it never takes that linear path that we all think we're going to have when we're younger," are the opening words of Brian Fahey, CEO of Adona Medical. He’s an engineer who had initially set out to build an academic career. However, during his Ph.D. at Duke University, Brian realized staying in academia permanently wasn't the right fit for him.
Instead, Brian found himself at the Stanford Biodesign Innovation Program. "In the first 10 minutes of the Stanford Biodesign introduction, I just knew, this is exactly what I want to do," he recalls.
Dedicating himself to bridging the gap between research and patient care, Brian entered the medtech arena and proceeded to found Niveus Medical in 2008, a company that developed rehabilitation solutions to accelerate patient recovery following prolonged ICU stays. Brian operated the company for a decade, during which time the Niveus technologies were used to provide more than 10,000 patient treatments before they were acquired by Stryker in 2017. He then gained further industry experience through his role at Johnson & Johnson Innovation, before landing on an idea.
Although cardiology was quite popular at the time, Brian saw an opportunity in an underserved subfield: heart failure. While early-stage therapies and life-saving end-stage interventions were available, patients in the middle stages of the disease were considerably underserved.
“Ultimately, I ended up collaborating with someone I had known about 10 years earlier, Amr Salahieh,” Brian shares. Amr is the CEO of the innovation hub, Shifamed, where Brian joined as executive-in-residence to help lead strategy for the creation of Shifamed’s new portfolio company, which later came to be Adona Medical.
Today, Adona is developing an interatrial shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter in conjunction with other common supplies. In addition, the implantable device features integrated sensors designed to remotely capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction.
"What helped me gravitate towards the ideas that became Adona is that we had an opportunity to be disruptive in what had traditionally been two separate therapy classes for heart failure," Brian reflects. Adona’s shunt combines diagnostic and therapeutic capabilities.
Recently, Adona secured a Series C funding round of $33.5 million. This capital is set to support several milestones, including the company’s first human use trials.
Brian Fahey is the CEO of Adona Medical, a Shifamed-portfolio company he co-founded with Amr Salahieh. Before Adona, Brian founded a critical care company, Niveus Medical. He also spent time at J&J Innovation, specializing in drug-device products for oncology, and contributed to the leadership team at Arrinex, a neuromodulation company in the ENT space. An alumnus of the Stanford Biodesign Innovation Program, Brian holds a Ph.D. from Duke University.
De-Risking and Assessing the Viability of an Idea
In the medtech startup world, the name of the game is risk mitigation in order to secure future capital. But choosing the right battles is a challenge in itself. “Oftentimes people try to tackle the wrong types of risks,” Brian says, and this prevents entrepreneurs from having a clear way forward. For him, technical feasibility, clinical validation, and product-market fit are the primary areas of concern.
Product-market fit is a factor you need to address during your idea stage. As an entrepreneur who has spent considerable time with the Stanford Biodesign Innovation program, Brian has been able to develop a keen sense for legitimate gaps and whether an idea is worth pursuing. He advises, “You’ve got maybe five chances to do something in your entire professional career. Ask yourself, ‘Are you going to wager 20% of your career on this idea?’”
When evaluating an idea, his strategy is to try to talk himself out of it until he runs out of counterarguments. To follow his footsteps, examine the following five carefully: clinical need, potential market size, regulatory roadmap, reimbursement landscape, and the identity of potential buyers. A holistic view will provide a clearer picture of the opportunity.
Another rule of thumb Brian shares is to think with the end in mind. He evaluates, “If we are successful, who is this a must-have product for among the big strategics?” In Adona’s case, there is a significant number of global strategic players competing for new therapies in cardiology – specifically heart failure. Competition can lead to more lucrative exits in the cardiovascular sector, as well as provide the flexibility to work with partners that align with the vision.
Once you decide on an idea, you’ll need to move on to other critical aspects. Brian admits, that as a leader with a technical background, it’s easy to hyper-focus on technical risk. For example, jumping straight to a prototype. However, “Investors often don't worry about the prototype,” says Brian, “they're worried about market risk or about pricing or reimbursement.” That’s why it’s important to shift energy to risks that could impede progress – such as securing funding or building a regulatory roadmap – because, as Brian says, “Humans, with the right funding, generally have an ability to figure the technical things out.”
To be a fundable company, you need to understand your potential investors’ sensitivities and make sure early development mitigates the risks that optimize your chances of winning them over. Engaging with potential investors early is a good starting point to get to know them and their concerns. However, you need to be thinking about product-market fit and technical risks simultaneously. “It might make more sense to jump three steps forward and then work backward,” Brian adds, if that is what it takes to address the most critical aspects early on to “unlock your path forward.”
Learn from Others When Building Your Clinical Roadmap
Developing a pioneering device requires going the extra mile. And undoubtedly, your risk-reward tolerance comes into play. Brian shares, "I would not want to be on a very long clinical and regulatory journey unless I had the ability to learn something from others along the way." This is not advice per se, but a personal preference. For example, if your project requires a PMA pathway, you shouldn't shy away from it, given that you fully understand the timeline and implications.
Novel devices can be incredibly rewarding to work on, but they require a demanding clinical validation phase. Nevertheless, they are often the ones that move the needle the most in the healthcare industry, and even if you’re not going to conduct such trials, you should always be learning from those who do.
In Adona’s case, the fact that heart failure patients are particularly diverse makes study design more nuanced and challenging relative to some other sectors. That’s why Brian champions studying successful and failed projects to refine clinical endpoints, patient populations, and data collection strategies. This is one strategy he employs to help mitigate clinical risks, by learning from others' experiences.
However, Brian points out that while following in the footsteps of the pioneers in a therapeutic area can reduce some clinical or market risks, it often transfers risk to the technical domain. To make a significant impact, you need a team of top-tier innovators and a product that’s remarkably better than existing solutions. In his words, “We have to aim to be like 500% better than everything else. Because if you're only 30% better and five years late, that's not enough to disrupt the ingrained momentum of the pioneers in the space. If you're going to be truly late, you have to be transformational.”
Fundraising and Partnerships: Time is an Asset
Contrary to the common advice of "go talk to everybody,” Brian champions a time-conservative approach to forging collaborations.
In his book, it's essential to be selective about who you talk to when raising capital. “Focus your time on being well-prepared for your best shots,” Brian advises. Your best shots depend on your sector, your stage, and the size of the round you’re after. “Narrow down your list to the people that you think are most likely to invest,” he suggests.
You should also pace what information you want to exchange at each interaction. “Your only goal on a first meeting is to get a second meeting. You're not getting a check that first day. So don’t give them 30 slides,” explains Brian. To build a strong foundation at the first meeting, it’s enough to show them you are credible, personable, relatable, receptive, and have a compelling insight into a problem that is real and have a solution that has potential.
Getting comfortable with risks and addressing them head-on is another key aspect. For Brian, it’s important to admit the risks objectively rather than trying to refute them. Being transparent about risks and discussing mitigation strategies strengthens investor confidence.
Brian also believes it can make sense to consider bringing in strategic investments if they adds value, such as access to facilities, partnerships, or physician relationships. Such investors can accelerate your company’s growth. When accepting deals, "Know what you're getting into," Brian advises. It’s crucial to be clear about any rights associated with the investment, such as board seats, observer roles, or walk-away clauses, and make sure they align with your goals and strategies.
Building credibility and trust is also paramount in M&A. A big global company will spend quite some time and effort on due diligence to see behind the curtain of your company. Still, everyone knows that they can’t surface everything. That’s why your trustworthiness is an important variable in this process.
On M&As, Brian shares, “It often feels like progress is slow until suddenly everything happens at once.” That’s why moving the needle by starting conversations as early as possible is important. Early introductions might not guarantee an acquisition, but they help in building relationships and trust. This also applies to investors. Communicating your milestones and delivering on them enhances your credibility, especially for younger entrepreneurs. Brian advises thinking about your company as a brand and engaging with your community and stakeholders with that mindset.
Key Learnings From Brian’s Experience
- There are three major risk factors in medtech: product-market fit, technical feasibility, and clinical validation. When assessing your idea, the first thing to do is to try to talk yourself out of it. Once you reach a point where you can’t argue any further, you may have something solid. From there, your goal should be to identify the areas with the highest risk factors and those that are quickest to mitigate.
- Pioneering innovations can be substantially rewarding, but the trade-off is they often demand longer, more complex clinical trials. Mitigate clinical risk by studying the pathways of predicate technologies to refine endpoints, patient populations, and more. True disruption requires a product that’s not just better, but significantly transformational.
- Be selective in fundraising: Consider your sector, stage, and the size of the round you’re after in order to focus your energy on your best prospects. Transparency and consistent communication build trust and enhance your brand in both fundraising and M&A processes.
"It's always a funny journey; it never takes that linear path that we all think we're going to have when we're younger," are the opening words of Brian Fahey, CEO of Adona Medical. He’s an engineer who had initially set out to build an academic career. However, during his Ph.D. at Duke University, Brian realized staying in academia permanently wasn't the right fit for him.
Instead, Brian found himself at the Stanford Biodesign Innovation Program. "In the first 10 minutes of the Stanford Biodesign introduction, I just knew, this is exactly what I want to do," he recalls.
Dedicating himself to bridging the gap between research and patient care, Brian entered the medtech arena and proceeded to found Niveus Medical in 2008, a company that developed rehabilitation solutions to accelerate patient recovery following prolonged ICU stays. Brian operated the company for a decade, during which time the Niveus technologies were used to provide more than 10,000 patient treatments before they were acquired by Stryker in 2017. He then gained further industry experience through his role at Johnson & Johnson Innovation, before landing on an idea.
Although cardiology was quite popular at the time, Brian saw an opportunity in an underserved subfield: heart failure. While early-stage therapies and life-saving end-stage interventions were available, patients in the middle stages of the disease were considerably underserved.
“Ultimately, I ended up collaborating with someone I had known about 10 years earlier, Amr Salahieh,” Brian shares. Amr is the CEO of the innovation hub, Shifamed, where Brian joined as executive-in-residence to help lead strategy for the creation of Shifamed’s new portfolio company, which later came to be Adona Medical.
Today, Adona is developing an interatrial shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter in conjunction with other common supplies. In addition, the implantable device features integrated sensors designed to remotely capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction.
"What helped me gravitate towards the ideas that became Adona is that we had an opportunity to be disruptive in what had traditionally been two separate therapy classes for heart failure," Brian reflects. Adona’s shunt combines diagnostic and therapeutic capabilities.
Recently, Adona secured a Series C funding round of $33.5 million. This capital is set to support several milestones, including the company’s first human use trials.
Brian Fahey is the CEO of Adona Medical, a Shifamed-portfolio company he co-founded with Amr Salahieh. Before Adona, Brian founded a critical care company, Niveus Medical. He also spent time at J&J Innovation, specializing in drug-device products for oncology, and contributed to the leadership team at Arrinex, a neuromodulation company in the ENT space. An alumnus of the Stanford Biodesign Innovation Program, Brian holds a Ph.D. from Duke University.
De-Risking and Assessing the Viability of an Idea
In the medtech startup world, the name of the game is risk mitigation in order to secure future capital. But choosing the right battles is a challenge in itself. “Oftentimes people try to tackle the wrong types of risks,” Brian says, and this prevents entrepreneurs from having a clear way forward. For him, technical feasibility, clinical validation, and product-market fit are the primary areas of concern.
Product-market fit is a factor you need to address during your idea stage. As an entrepreneur who has spent considerable time with the Stanford Biodesign Innovation program, Brian has been able to develop a keen sense for legitimate gaps and whether an idea is worth pursuing. He advises, “You’ve got maybe five chances to do something in your entire professional career. Ask yourself, ‘Are you going to wager 20% of your career on this idea?’”
When evaluating an idea, his strategy is to try to talk himself out of it until he runs out of counterarguments. To follow his footsteps, examine the following five carefully: clinical need, potential market size, regulatory roadmap, reimbursement landscape, and the identity of potential buyers. A holistic view will provide a clearer picture of the opportunity.
Another rule of thumb Brian shares is to think with the end in mind. He evaluates, “If we are successful, who is this a must-have product for among the big strategics?” In Adona’s case, there is a significant number of global strategic players competing for new therapies in cardiology – specifically heart failure. Competition can lead to more lucrative exits in the cardiovascular sector, as well as provide the flexibility to work with partners that align with the vision.
Once you decide on an idea, you’ll need to move on to other critical aspects. Brian admits, that as a leader with a technical background, it’s easy to hyper-focus on technical risk. For example, jumping straight to a prototype. However, “Investors often don't worry about the prototype,” says Brian, “they're worried about market risk or about pricing or reimbursement.” That’s why it’s important to shift energy to risks that could impede progress – such as securing funding or building a regulatory roadmap – because, as Brian says, “Humans, with the right funding, generally have an ability to figure the technical things out.”
To be a fundable company, you need to understand your potential investors’ sensitivities and make sure early development mitigates the risks that optimize your chances of winning them over. Engaging with potential investors early is a good starting point to get to know them and their concerns. However, you need to be thinking about product-market fit and technical risks simultaneously. “It might make more sense to jump three steps forward and then work backward,” Brian adds, if that is what it takes to address the most critical aspects early on to “unlock your path forward.”
Learn from Others When Building Your Clinical Roadmap
Developing a pioneering device requires going the extra mile. And undoubtedly, your risk-reward tolerance comes into play. Brian shares, "I would not want to be on a very long clinical and regulatory journey unless I had the ability to learn something from others along the way." This is not advice per se, but a personal preference. For example, if your project requires a PMA pathway, you shouldn't shy away from it, given that you fully understand the timeline and implications.
Novel devices can be incredibly rewarding to work on, but they require a demanding clinical validation phase. Nevertheless, they are often the ones that move the needle the most in the healthcare industry, and even if you’re not going to conduct such trials, you should always be learning from those who do.
In Adona’s case, the fact that heart failure patients are particularly diverse makes study design more nuanced and challenging relative to some other sectors. That’s why Brian champions studying successful and failed projects to refine clinical endpoints, patient populations, and data collection strategies. This is one strategy he employs to help mitigate clinical risks, by learning from others' experiences.
However, Brian points out that while following in the footsteps of the pioneers in a therapeutic area can reduce some clinical or market risks, it often transfers risk to the technical domain. To make a significant impact, you need a team of top-tier innovators and a product that’s remarkably better than existing solutions. In his words, “We have to aim to be like 500% better than everything else. Because if you're only 30% better and five years late, that's not enough to disrupt the ingrained momentum of the pioneers in the space. If you're going to be truly late, you have to be transformational.”
Fundraising and Partnerships: Time is an Asset
Contrary to the common advice of "go talk to everybody,” Brian champions a time-conservative approach to forging collaborations.
In his book, it's essential to be selective about who you talk to when raising capital. “Focus your time on being well-prepared for your best shots,” Brian advises. Your best shots depend on your sector, your stage, and the size of the round you’re after. “Narrow down your list to the people that you think are most likely to invest,” he suggests.
You should also pace what information you want to exchange at each interaction. “Your only goal on a first meeting is to get a second meeting. You're not getting a check that first day. So don’t give them 30 slides,” explains Brian. To build a strong foundation at the first meeting, it’s enough to show them you are credible, personable, relatable, receptive, and have a compelling insight into a problem that is real and have a solution that has potential.
Getting comfortable with risks and addressing them head-on is another key aspect. For Brian, it’s important to admit the risks objectively rather than trying to refute them. Being transparent about risks and discussing mitigation strategies strengthens investor confidence.
Brian also believes it can make sense to consider bringing in strategic investments if they adds value, such as access to facilities, partnerships, or physician relationships. Such investors can accelerate your company’s growth. When accepting deals, "Know what you're getting into," Brian advises. It’s crucial to be clear about any rights associated with the investment, such as board seats, observer roles, or walk-away clauses, and make sure they align with your goals and strategies.
Building credibility and trust is also paramount in M&A. A big global company will spend quite some time and effort on due diligence to see behind the curtain of your company. Still, everyone knows that they can’t surface everything. That’s why your trustworthiness is an important variable in this process.
On M&As, Brian shares, “It often feels like progress is slow until suddenly everything happens at once.” That’s why moving the needle by starting conversations as early as possible is important. Early introductions might not guarantee an acquisition, but they help in building relationships and trust. This also applies to investors. Communicating your milestones and delivering on them enhances your credibility, especially for younger entrepreneurs. Brian advises thinking about your company as a brand and engaging with your community and stakeholders with that mindset.
