Given his background in marketing, communications, and literature, Kelly Roman’s journey into the life sciences seems unexpected at first. But, it’s exactly what makes him an inspiration for those who want to try their hands in medtech but aren’t born into the field.
Raised as the son of a war veteran and the younger brother of renowned cell biologist Christopher Roman, Kelly grew up attuned to mental health and scientific innovation. He began his academic journey as an English major at Harvard. During this time, he established himself as a gifted marketer, notably building bridges between Bebo, a significant social network of its era, and platforms like billboard.com — which worked wonders compared to regular ads. Subsequently, his literary aspirations led him to pen a graphic novel, Sun Tzu's Art of War, about which he says: “I was living and breathing the art of war for a number of years.” This exposure to ancient strategy inspired him to sail into uncharted territory.
It was when Kelly was wondering what to do next that he met Chip Fisher, heir of an electronic legacy, Fisher Radio. While Chip had a solid foundation in technology, Kelly’s was diverse but more focused on the social sciences. Yet, their collaboration sparked something truly unexpected: Fisher Wallace, a company specializing in neuromodulation devices to treat mental health conditions. "We had very different backgrounds than a typical medical device startup. I think that's actually benefited us," shares Kelly.
Fisher Wallace’s device operates on the principle that the brain's electrical activity can be modulated to restore it to a state of equilibrium. While medications are typically designed to interact with the brain's chemical pathways, this device is designed to rebalance the brain’s functions by sending external electrical impulses. The company’s primary focus has been on treating depression, but the potential of the technology spans a plethora of neurological conditions, including Parkinson's, substance use disorders, anxiety, and insomnia.
On the regulatory side, Fisher Wallace’s first product, version 1.0, was commercialized under a 510(k) clearance. Over its lifecycle, the first version enjoyed considerable commercial success, clocking in sales of 100,000 units, accounting for a commendable $40 million in revenue.
Now the spotlight is on Oak, their newer and more refined iteration, which they’re planning to roll out in research programs before securing final approvals. With the prototype's engineering phase almost complete, Fisher Wallace is poised to introduce Oak into the world, paving the way for its official launch which is targeted for the latter half of 2025.
Key Learnings From Kelly’s Experience
- Adaptive thinking and the willingness to explore alternative approaches can yield great results. Whether you’re tackling FDA regulation or capital fundraising, leverage your resources and real-world experience to get to your goals quicker.
- Be mindful of the obstacles standing in the way of your device’s potential utilization, no matter how efficacious it is. The only way to create change and ensure long-term market success is to prioritize the needs, comforts, and desires of your end users.
- Don’t be afraid to consider remote trials for a cost-effective and expedient approach to FDA clearance or approval, particularly in the field of mental health research.
Kelly Roman is a Harvard graduate with an English major who took an unconventional path to medtech inspired by his experience co-authoring the graphic novel adaptation of Sun Tzu's "The Art of War." As co-founder and CEO of Fisher Wallace, he spearheads the development of wearable brain stimulation technology aimed at providing relief from depression, anxiety, and insomnia.
Think Outside the Box: Alternative Paths to Regulatory and Fundraising
Traditionally, the FDA’s approval processes can be notoriously rigorous and time-consuming. But, depending on your product, there might be multiple ways to reach your goals. For the wearable Fisher Wallace Labs was designing, Kelly and his team pursued an Investigational Device Exemption (IDE) path, which enabled them to introduce their device to the public earlier than expected.
Of course, they can't commercialize Oak until it’s been approved by the FDA. However, having an IDE approval allows Fisher Wallace to use their device for clinical studies or pilot research programs, as long as there's informed consent and monitoring.
This approach enabled Fisher Wallace to begin gathering data while simultaneously raising awareness in the market. A notable example of this strategy in action is their recent collaboration with the Seattle Police Department, where they enrolled 200 police officers to test the device and provide feedback.
Another unconventional approach Kelly took was crowdfunding. While typical in the realm of consumer products and SaaS, crowdfunding isn’t the go-to fundraising strategy for most medtech companies. Yet, for Kelly and Fisher Wallace, it made sense.
"When we launched crowdfunding, we already had 50,000 customers," Kelly shares. These customers were people who had already tried the device themselves in the study programs. They believed and trusted in the technology. Counter to what some investors think is “dumb money”, Kelly candidly notes, "That's very smart money in the sense that they know a lot about the technology."
However, Kelly does offer a word of caution for other medtech entrepreneurs," If we had not had all those customers, I don't think we would have been successful. Some companies are spending 70 cents on the dollar by using platforms like Facebook ads to try and get investors. That's a pretty tough thing to do."
While crowdfunding can be an effective route for some, it's not a one-size-fits-all solution. For it to work, a company needs to have an established customer base and a strong, genuine connection with its audience.
Making Mental Health More Approachable
The best products are often those designed to be simple and rooted in user feedback. The evolution of the Fisher Wallace’s device, moving from its initial design, which Kelly humorously refers to as "Radio Shack style," to the much more user-centric Oak 2.0 was in this exact spirit.
Kelly states. “Our path is as much consumer product as it is medical." By focusing on the consumer experience, Kelly and his team were able to extract invaluable feedback from their version 1.0 device users. "Even if you have the best device that addresses major problems, if users aren't comfortable or happy using it, you'll face challenges. It's essential to consider how users feel and interact with your product," he shares.
Kelly hired top-tier talent for Oak, commenting: “Eric Fields, the industrial designer behind the first Nest thermostat and various Beats products, joined our team. We also brought on Alloy Product Development, an engineering firm that has worked on all of Beat’s products.”
One significant change they made was to move away from visible wires and AA batteries. The Oak 2.0 uses a lithium-ion rechargeable battery to eliminate the need for external wires, which didn’t have as much to do with the efficacy of the product as it had with their goal to improve its user-friendliness. Kelly shares, "There's plenty of medical devices in which personalization is not as crucial. But an interesting analogy is when someone has a cast on, it becomes a whole different thing, people sign it and draw little pictures, and then it becomes a personal object."
Personalization is even more important when offering a product that tackles mental health issues. The goal for version 2.0's design was to create a stylish wearable that users would feel comfortable, even proud to be seen wearing, without the need to conceal it.
Kelly points out that the cost of manufacturing Oak 2.0 will be higher. However, he's also convinced that its improved design and functionality will not only help reduce the stigma often associated with mental health devices but will also make it easier to market. Because their users tend to be lifetime customers — some even owning multiple devices for different residences — the investment in continuous product development is justified. He anticipates that customers will likely update their devices every three years, similar to the upgrade cycles seen in consumer electronics like smartphones.
As a person who has suffered from undiagnosed ADHD for years, Kelly stresses the importance of destigmatizing mental health issues and treatments, especially in a post-pandemic world, and advocates for people to self-reflect and seek help when needed.
Tips for Executing Decentralized Trials
Clinical trials are the bedrock of advancement in medtech. How you approach and execute them can significantly influence a device's path to market. Kelly offers an intriguing perspective on decentralized clinical trials, illuminating the merits and challenges of his progressive approach.
To begin, Kelly underlines the importance of engaging with the FDA, no matter how you’re managing your trials."If you're going after an FDA indication, the first thing is you should go meet with the FDA."
Kelly shares: "Mental health is a great area to run remote clinical trials." Partnering with Climb, a company with experience in vaccine trials, and Synapse, a CRO, Fisher Wallace has been able to harness the power of simple yet efficient communication tools such as SMS, which ensures high engagement — something indispensable in remote trials.
One might wonder about the legitimacy of these trials, but Kelly's confidence stems from impressive results. "We beat placebo at every time point — week one, two, and four. We had a massive response rate by week four." However, some challenges remain, and Kelly is forthright about the roadblocks. FDA, for instance, is keen on getting more extensive data before they are fully convinced.
While remote trials can be faster and often less expensive than traditional methods, they're not exactly cheap. Kelly highlights that the costs approximated is around $4,000 a patient for their trials. And while the costs can vary based on the complexity and nature of the study, the key is to ensure value for every dollar spent. Kelly also emphasizes the comparative advantages of this type of trial: they are still faster and less expensive than working with a big institution.
Of course, it's not all about cost-efficiency. For a successful decentralized trial, you need to understand and value the participants. Kelly’s most significant feedback from their experience is simple: "Don't underpay." Compensate your participants for their time and effort fairly so that you get higher compliance and lower dropout rates.
What we can conclude from Kelly’s experience is that as medical research expands its horizons with decentralized trials, it's becoming evident that a mix of clear regulatory communication, technology that enables efficiency, and a genuine appreciation of participant contributions will shape the future of clinical trials. By placing participants at the heart of the process, not only can you streamline research but also work towards better, more inclusive medical solutions.
Given his background in marketing, communications, and literature, Kelly Roman’s journey into the life sciences seems unexpected at first. But, it’s exactly what makes him an inspiration for those who want to try their hands in medtech but aren’t born into the field.
Raised as the son of a war veteran and the younger brother of renowned cell biologist Christopher Roman, Kelly grew up attuned to mental health and scientific innovation. He began his academic journey as an English major at Harvard. During this time, he established himself as a gifted marketer, notably building bridges between Bebo, a significant social network of its era, and platforms like billboard.com — which worked wonders compared to regular ads. Subsequently, his literary aspirations led him to pen a graphic novel, Sun Tzu's Art of War, about which he says: “I was living and breathing the art of war for a number of years.” This exposure to ancient strategy inspired him to sail into uncharted territory.
It was when Kelly was wondering what to do next that he met Chip Fisher, heir of an electronic legacy, Fisher Radio. While Chip had a solid foundation in technology, Kelly’s was diverse but more focused on the social sciences. Yet, their collaboration sparked something truly unexpected: Fisher Wallace, a company specializing in neuromodulation devices to treat mental health conditions. "We had very different backgrounds than a typical medical device startup. I think that's actually benefited us," shares Kelly.
Fisher Wallace’s device operates on the principle that the brain's electrical activity can be modulated to restore it to a state of equilibrium. While medications are typically designed to interact with the brain's chemical pathways, this device is designed to rebalance the brain’s functions by sending external electrical impulses. The company’s primary focus has been on treating depression, but the potential of the technology spans a plethora of neurological conditions, including Parkinson's, substance use disorders, anxiety, and insomnia.
On the regulatory side, Fisher Wallace’s first product, version 1.0, was commercialized under a 510(k) clearance. Over its lifecycle, the first version enjoyed considerable commercial success, clocking in sales of 100,000 units, accounting for a commendable $40 million in revenue.
Now the spotlight is on Oak, their newer and more refined iteration, which they’re planning to roll out in research programs before securing final approvals. With the prototype's engineering phase almost complete, Fisher Wallace is poised to introduce Oak into the world, paving the way for its official launch which is targeted for the latter half of 2025.
Key Learnings From Kelly’s Experience
- Adaptive thinking and the willingness to explore alternative approaches can yield great results. Whether you’re tackling FDA regulation or capital fundraising, leverage your resources and real-world experience to get to your goals quicker.
- Be mindful of the obstacles standing in the way of your device’s potential utilization, no matter how efficacious it is. The only way to create change and ensure long-term market success is to prioritize the needs, comforts, and desires of your end users.
- Don’t be afraid to consider remote trials for a cost-effective and expedient approach to FDA clearance or approval, particularly in the field of mental health research.
Kelly Roman is a Harvard graduate with an English major who took an unconventional path to medtech inspired by his experience co-authoring the graphic novel adaptation of Sun Tzu's "The Art of War." As co-founder and CEO of Fisher Wallace, he spearheads the development of wearable brain stimulation technology aimed at providing relief from depression, anxiety, and insomnia.
Think Outside the Box: Alternative Paths to Regulatory and Fundraising
Traditionally, the FDA’s approval processes can be notoriously rigorous and time-consuming. But, depending on your product, there might be multiple ways to reach your goals. For the wearable Fisher Wallace Labs was designing, Kelly and his team pursued an Investigational Device Exemption (IDE) path, which enabled them to introduce their device to the public earlier than expected.
Of course, they can't commercialize Oak until it’s been approved by the FDA. However, having an IDE approval allows Fisher Wallace to use their device for clinical studies or pilot research programs, as long as there's informed consent and monitoring.
This approach enabled Fisher Wallace to begin gathering data while simultaneously raising awareness in the market. A notable example of this strategy in action is their recent collaboration with the Seattle Police Department, where they enrolled 200 police officers to test the device and provide feedback.
Another unconventional approach Kelly took was crowdfunding. While typical in the realm of consumer products and SaaS, crowdfunding isn’t the go-to fundraising strategy for most medtech companies. Yet, for Kelly and Fisher Wallace, it made sense.
"When we launched crowdfunding, we already had 50,000 customers," Kelly shares. These customers were people who had already tried the device themselves in the study programs. They believed and trusted in the technology. Counter to what some investors think is “dumb money”, Kelly candidly notes, "That's very smart money in the sense that they know a lot about the technology."
However, Kelly does offer a word of caution for other medtech entrepreneurs," If we had not had all those customers, I don't think we would have been successful. Some companies are spending 70 cents on the dollar by using platforms like Facebook ads to try and get investors. That's a pretty tough thing to do."
While crowdfunding can be an effective route for some, it's not a one-size-fits-all solution. For it to work, a company needs to have an established customer base and a strong, genuine connection with its audience.
Making Mental Health More Approachable
The best products are often those designed to be simple and rooted in user feedback. The evolution of the Fisher Wallace’s device, moving from its initial design, which Kelly humorously refers to as "Radio Shack style," to the much more user-centric Oak 2.0 was in this exact spirit.
Kelly states. “Our path is as much consumer product as it is medical." By focusing on the consumer experience, Kelly and his team were able to extract invaluable feedback from their version 1.0 device users. "Even if you have the best device that addresses major problems, if users aren't comfortable or happy using it, you'll face challenges. It's essential to consider how users feel and interact with your product," he shares.
Kelly hired top-tier talent for Oak, commenting: “Eric Fields, the industrial designer behind the first Nest thermostat and various Beats products, joined our team. We also brought on Alloy Product Development, an engineering firm that has worked on all of Beat’s products.”
One significant change they made was to move away from visible wires and AA batteries. The Oak 2.0 uses a lithium-ion rechargeable battery to eliminate the need for external wires, which didn’t have as much to do with the efficacy of the product as it had with their goal to improve its user-friendliness. Kelly shares, "There's plenty of medical devices in which personalization is not as crucial. But an interesting analogy is when someone has a cast on, it becomes a whole different thing, people sign it and draw little pictures, and then it becomes a personal object."
Personalization is even more important when offering a product that tackles mental health issues. The goal for version 2.0's design was to create a stylish wearable that users would feel comfortable, even proud to be seen wearing, without the need to conceal it.
Kelly points out that the cost of manufacturing Oak 2.0 will be higher. However, he's also convinced that its improved design and functionality will not only help reduce the stigma often associated with mental health devices but will also make it easier to market. Because their users tend to be lifetime customers — some even owning multiple devices for different residences — the investment in continuous product development is justified. He anticipates that customers will likely update their devices every three years, similar to the upgrade cycles seen in consumer electronics like smartphones.
As a person who has suffered from undiagnosed ADHD for years, Kelly stresses the importance of destigmatizing mental health issues and treatments, especially in a post-pandemic world, and advocates for people to self-reflect and seek help when needed.
Tips for Executing Decentralized Trials
Clinical trials are the bedrock of advancement in medtech. How you approach and execute them can significantly influence a device's path to market. Kelly offers an intriguing perspective on decentralized clinical trials, illuminating the merits and challenges of his progressive approach.
To begin, Kelly underlines the importance of engaging with the FDA, no matter how you’re managing your trials."If you're going after an FDA indication, the first thing is you should go meet with the FDA."
Kelly shares: "Mental health is a great area to run remote clinical trials." Partnering with Climb, a company with experience in vaccine trials, and Synapse, a CRO, Fisher Wallace has been able to harness the power of simple yet efficient communication tools such as SMS, which ensures high engagement — something indispensable in remote trials.
One might wonder about the legitimacy of these trials, but Kelly's confidence stems from impressive results. "We beat placebo at every time point — week one, two, and four. We had a massive response rate by week four." However, some challenges remain, and Kelly is forthright about the roadblocks. FDA, for instance, is keen on getting more extensive data before they are fully convinced.
While remote trials can be faster and often less expensive than traditional methods, they're not exactly cheap. Kelly highlights that the costs approximated is around $4,000 a patient for their trials. And while the costs can vary based on the complexity and nature of the study, the key is to ensure value for every dollar spent. Kelly also emphasizes the comparative advantages of this type of trial: they are still faster and less expensive than working with a big institution.
Of course, it's not all about cost-efficiency. For a successful decentralized trial, you need to understand and value the participants. Kelly’s most significant feedback from their experience is simple: "Don't underpay." Compensate your participants for their time and effort fairly so that you get higher compliance and lower dropout rates.
What we can conclude from Kelly’s experience is that as medical research expands its horizons with decentralized trials, it's becoming evident that a mix of clear regulatory communication, technology that enables efficiency, and a genuine appreciation of participant contributions will shape the future of clinical trials. By placing participants at the heart of the process, not only can you streamline research but also work towards better, more inclusive medical solutions.
