Brett Wingeier, PhD, is a biomedical engineer whose career path follows a fascinating intersection of medicine, biology, and engineering. Throughout the years, Brett has honed his skills and knowledge in these areas, with a special interest in neuromodulation. This interest led him to earn his Bachelor of Science and PhD in Biomedical Engineering from Tulane University.
Right out of grad school, Brett became a part of the first wave of employees at a startup, NeuroPace. They spent years developing a groundbreaking product – the world's first responsive implantable neurostimulator for epilepsy, which received FDA approval in 2013. The device both monitors the brain for potential seizures and provides stimulation to prevent them from occurring.
This project gave Brett invaluable experience as he went on to co-found Halo Neuroscience in 2013, where he served as Chief Technology Officer (CTO) and later CEO. At Halo, he built teams responsible for hardware and software development, led the company's applied neuroscience research program, managed IP and regulatory affairs, and more. Halo successfully commercialized non-invasive electrical brain stimulation devices with its Halo Sport, the world's first consumer neurostimulation headset for movement training.
Understanding the brain and addressing mental health issues has been a tough nut to crack, even with our current technological advancements. This challenge, coupled with the enormous need for better treatments for mental health, became the fuel that propelled Brett's journey to become the co-founder and CTO of Magnus Medical.
The founding team recognized the need for a solid dose of biology and science to effectively treat mental disorders. Their goal was to develop a groundbreaking new treatment for depression, and they did. The SAINT™ Neuromodulation System, an FDA-cleared treatment for treatment-resistant depression, stimulates specific networks in the brain in a personalized manner to treat depression symptoms effectively. Brett and his team at Magnus are striving to create a field of interventional psychiatry that will change how we perceive and treat mental health.
Key Learnings From Brett’s Experience
- You need to understand the system you’re working with and aim for a significant effect size in your clinical trials.
- When developing new technologies, try to balance consumer and provider perspectives to ensure a smoother path toward regulatory approval.
- Your product has to make financial sense to raise capital and ensure reimbursement. Once you prove the business model, you’ll enjoy greater opportunities in follow-up financing rounds.
Dr. Brett Wingeier is a prominent figure in neuromodulation, leveraging his expertise in medicine, biology, and engineering to advance the arena within medtech. He was part of the pioneering team at NeuroPace and co-founded Halo Neuroscience. Brett is also the co-founder and current CTO of Magnus Medical, whose FDA-cleared SAINT™ Neuromodulation System aims to revolutionize mental health care.
Maximizing Effect Size With Systemic Understanding
Brett's experiences have taught him that deep knowledge of the system you’re part of allows you to anticipate challenges, develop better-informed strategies, and accelerate innovation in a cost-effective manner. In his case, this includes understanding medical needs, regulations, clinical trial processes, reimbursement strategies, and the healthcare industry in general.
When you've got a handle on these core areas, you're better equipped to navigate roadblocks, design impactful clinical trials, build solid reimbursement plans, and ensure your groundbreaking tech doesn't simply end up as a fancy paperweight.
Brett places significant emphasis on the value of effect size, a term used to quantify how the effect of a treatment stands out from other sources of variation. The larger the effect size, the bigger the impact your device makes on patient care and outcomes. When you can prove your device makes a notable difference, people will start to care more about it. As he says, a large effect size provides a “real tailwind” to every aspect of business development. “If you don't have a bulletproof effect size with a wow factor, it's going to be an uphill battle," Brett reiterates. For him, this is a lesson learned the hard way in consumer markets, where the wow factor has to be immediate, not spread over weeks of careful tracking.
Reflecting on his tenure at Halo, Brett admits that he would have expedited the focus on medical applications sooner as healthcare providers are more accepting of varied patient responses; there’s less expectation that a device will work instantly for every customer. "In a medical device, if you have an effect size that is clinically meaningful and statistically significant, you can build a market around it,” he elaborates.
Although it might seem frustrating to slow down and take time to generate solid data in the lab, a deep understanding of the system you’re trying to affect – which is tough to achieve in working with the brain – is indispensable if you’re trying to design a good treatment. When there are gaps in your understanding, you can’t rely on guesses and assumptions. Instead, a clear understanding of the device's functionality, along with coherent data, is crucial for regulatory bodies and the company moving forward.
Balancing Consumer and Medical Perspectives
Regardless of the type of product you’re building, risk analysis and understanding the product’s benefits are at the core of your business. And the most essential component is the data — you have to understand what your device does and be able to show it.
Both consumer and medical devices follow the same fundamental principle of weighing risk against benefit. The difference lies in the trade-off: consumer devices necessitate a lower risk profile, and their benefit might be perceived differently compared to medical devices.
A significant lesson for Brett was understanding the balance between the consumer and provider sides of developing a new product, especially in neurotechnology. In Brett’s case, while Halo was an attempt at a consumer play, the company developed their brain stimulation devices with grounding in the world of medical-device engineering and with an eye toward medical applications, in comparison to pure consumer devices like Fitbit and Whoop. After recalling his experiences at both NeuroPace and HALO, Brett now thinks prioritizing medical applications would have been more rewarding. Although it takes a long time to prove the medical relevance of a device, this challenge eventually leads to more impactful devices and, in turn, the chance to carve out unique moats in the market.
Even though they form the foundation for eventual commercial success, a comprehensive data generation strategy and an impactful effect size alone aren’t enough. In medtech, you need to demonstrate to regulators that your device is safe and effective, which is why collaboration with regulatory bodies is a key part of the game.
As an entrepreneur, it’s important to remind yourself that regulatory bodies aren’t the enemy; on the contrary, they are there to support your efforts. Brett notes that the life sciences industry and the FDA are ultimately aligned in their goals: providing beneficial treatments to the public. To realize that, it’s important to continue to build relationships with these regulatory bodies to make sure they understand what you’re attempting to do with your device and can most effectively engage.
Twin Pillars of Reimbursement: Data and Cost-Effectiveness
For any innovative medical or health technology startup, the road to success goes beyond technical challenges and regulatory compliance. It extends into the domain of reimbursement. Brett’s experience in various healthcare companies has shown him the importance of strategic data collection and an early focus on cost-effectiveness.
He emphasizes: "Data is the foundation. Data is the fuel for reimbursement”. By data, he means robust health outcomes, utilization statistics, and cost metrics. All these form the bedrock on which a compelling case can be made for reimbursement.
Brett elaborates: “One of the most important things to do is, to the extent you can from the start, build in the ability to collect not just healthcare outcomes data, but the utilization data, cost data, and other things from the system that help build your overall case." Brett's experience across different companies has instilled in him the importance of integrated data collection from the very inception of product development.
Another core principle Brett highlights is cost-effectiveness. The healthcare reimbursement ecosystem is not just about proving efficacious outcomes but about ensuring that these are achieved cost-effectively. The pivotal part of Brett’s approach is that innovative solutions must also make financial sense for the health system. In his words: "Thinking about that from the start, how are we not just helping patients, but also ticking the boxes that make financial sense for the system? It's a key early part that everybody should be thinking about."
Brett Wingeier, PhD, is a biomedical engineer whose career path follows a fascinating intersection of medicine, biology, and engineering. Throughout the years, Brett has honed his skills and knowledge in these areas, with a special interest in neuromodulation. This interest led him to earn his Bachelor of Science and PhD in Biomedical Engineering from Tulane University.
Right out of grad school, Brett became a part of the first wave of employees at a startup, NeuroPace. They spent years developing a groundbreaking product – the world's first responsive implantable neurostimulator for epilepsy, which received FDA approval in 2013. The device both monitors the brain for potential seizures and provides stimulation to prevent them from occurring.
This project gave Brett invaluable experience as he went on to co-found Halo Neuroscience in 2013, where he served as Chief Technology Officer (CTO) and later CEO. At Halo, he built teams responsible for hardware and software development, led the company's applied neuroscience research program, managed IP and regulatory affairs, and more. Halo successfully commercialized non-invasive electrical brain stimulation devices with its Halo Sport, the world's first consumer neurostimulation headset for movement training.
Understanding the brain and addressing mental health issues has been a tough nut to crack, even with our current technological advancements. This challenge, coupled with the enormous need for better treatments for mental health, became the fuel that propelled Brett's journey to become the co-founder and CTO of Magnus Medical.
The founding team recognized the need for a solid dose of biology and science to effectively treat mental disorders. Their goal was to develop a groundbreaking new treatment for depression, and they did. The SAINT™ Neuromodulation System, an FDA-cleared treatment for treatment-resistant depression, stimulates specific networks in the brain in a personalized manner to treat depression symptoms effectively. Brett and his team at Magnus are striving to create a field of interventional psychiatry that will change how we perceive and treat mental health.
Key Learnings From Brett’s Experience
- You need to understand the system you’re working with and aim for a significant effect size in your clinical trials.
- When developing new technologies, try to balance consumer and provider perspectives to ensure a smoother path toward regulatory approval.
- Your product has to make financial sense to raise capital and ensure reimbursement. Once you prove the business model, you’ll enjoy greater opportunities in follow-up financing rounds.
Dr. Brett Wingeier is a prominent figure in neuromodulation, leveraging his expertise in medicine, biology, and engineering to advance the arena within medtech. He was part of the pioneering team at NeuroPace and co-founded Halo Neuroscience. Brett is also the co-founder and current CTO of Magnus Medical, whose FDA-cleared SAINT™ Neuromodulation System aims to revolutionize mental health care.
Maximizing Effect Size With Systemic Understanding
Brett's experiences have taught him that deep knowledge of the system you’re part of allows you to anticipate challenges, develop better-informed strategies, and accelerate innovation in a cost-effective manner. In his case, this includes understanding medical needs, regulations, clinical trial processes, reimbursement strategies, and the healthcare industry in general.
When you've got a handle on these core areas, you're better equipped to navigate roadblocks, design impactful clinical trials, build solid reimbursement plans, and ensure your groundbreaking tech doesn't simply end up as a fancy paperweight.
Brett places significant emphasis on the value of effect size, a term used to quantify how the effect of a treatment stands out from other sources of variation. The larger the effect size, the bigger the impact your device makes on patient care and outcomes. When you can prove your device makes a notable difference, people will start to care more about it. As he says, a large effect size provides a “real tailwind” to every aspect of business development. “If you don't have a bulletproof effect size with a wow factor, it's going to be an uphill battle," Brett reiterates. For him, this is a lesson learned the hard way in consumer markets, where the wow factor has to be immediate, not spread over weeks of careful tracking.
Reflecting on his tenure at Halo, Brett admits that he would have expedited the focus on medical applications sooner as healthcare providers are more accepting of varied patient responses; there’s less expectation that a device will work instantly for every customer. "In a medical device, if you have an effect size that is clinically meaningful and statistically significant, you can build a market around it,” he elaborates.
Although it might seem frustrating to slow down and take time to generate solid data in the lab, a deep understanding of the system you’re trying to affect – which is tough to achieve in working with the brain – is indispensable if you’re trying to design a good treatment. When there are gaps in your understanding, you can’t rely on guesses and assumptions. Instead, a clear understanding of the device's functionality, along with coherent data, is crucial for regulatory bodies and the company moving forward.
Balancing Consumer and Medical Perspectives
Regardless of the type of product you’re building, risk analysis and understanding the product’s benefits are at the core of your business. And the most essential component is the data — you have to understand what your device does and be able to show it.
Both consumer and medical devices follow the same fundamental principle of weighing risk against benefit. The difference lies in the trade-off: consumer devices necessitate a lower risk profile, and their benefit might be perceived differently compared to medical devices.
A significant lesson for Brett was understanding the balance between the consumer and provider sides of developing a new product, especially in neurotechnology. In Brett’s case, while Halo was an attempt at a consumer play, the company developed their brain stimulation devices with grounding in the world of medical-device engineering and with an eye toward medical applications, in comparison to pure consumer devices like Fitbit and Whoop. After recalling his experiences at both NeuroPace and HALO, Brett now thinks prioritizing medical applications would have been more rewarding. Although it takes a long time to prove the medical relevance of a device, this challenge eventually leads to more impactful devices and, in turn, the chance to carve out unique moats in the market.
Even though they form the foundation for eventual commercial success, a comprehensive data generation strategy and an impactful effect size alone aren’t enough. In medtech, you need to demonstrate to regulators that your device is safe and effective, which is why collaboration with regulatory bodies is a key part of the game.
As an entrepreneur, it’s important to remind yourself that regulatory bodies aren’t the enemy; on the contrary, they are there to support your efforts. Brett notes that the life sciences industry and the FDA are ultimately aligned in their goals: providing beneficial treatments to the public. To realize that, it’s important to continue to build relationships with these regulatory bodies to make sure they understand what you’re attempting to do with your device and can most effectively engage.
Twin Pillars of Reimbursement: Data and Cost-Effectiveness
For any innovative medical or health technology startup, the road to success goes beyond technical challenges and regulatory compliance. It extends into the domain of reimbursement. Brett’s experience in various healthcare companies has shown him the importance of strategic data collection and an early focus on cost-effectiveness.
He emphasizes: "Data is the foundation. Data is the fuel for reimbursement”. By data, he means robust health outcomes, utilization statistics, and cost metrics. All these form the bedrock on which a compelling case can be made for reimbursement.
Brett elaborates: “One of the most important things to do is, to the extent you can from the start, build in the ability to collect not just healthcare outcomes data, but the utilization data, cost data, and other things from the system that help build your overall case." Brett's experience across different companies has instilled in him the importance of integrated data collection from the very inception of product development.
Another core principle Brett highlights is cost-effectiveness. The healthcare reimbursement ecosystem is not just about proving efficacious outcomes but about ensuring that these are achieved cost-effectively. The pivotal part of Brett’s approach is that innovative solutions must also make financial sense for the health system. In his words: "Thinking about that from the start, how are we not just helping patients, but also ticking the boxes that make financial sense for the system? It's a key early part that everybody should be thinking about."
