Mike Monovoukas, CEO and Co-Founder, AcuityMD05.09.23
It can take approximately three to seven years to bring a medical device from concept to approval, and can cost upwards of $30 million for a Class II medical device. While product development is an exciting milestone, it’s just the beginning of a long journey toward commercialization. In fact, medtech companies can spend about 30% to 40% of revenue on the selling effort (SG&A).1 Even the largest companies with highly promising devices face multifaceted go-to-market hurdles.
For Synchron—a Brooklyn-based neurotechnology company developing a novel endovascular brain-computer interface (BCI) called the “Synchron Switch”—success relies as much on its technology as it does on building a network of key partners to grow this emerging field of medicine.
Synchron’s foundational technology—a motor neuroprosthesis or motor BCI—is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke but does not require open brain surgery. The system is designed for patients suffering from paralysis due to a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.
Synchron’s Stentrode with Thought-Controlled Digital Switch (SWITCH) study, a first-in-human trial, evaluated four patients in Australia implanted with Synchron’s Stentrode (motor BCI).2 Trial participants completed a 12-month follow-up with no persistent neurological deficits. Remarkably, signal quality remained stable with no evidence of significant deterioration, and each participant successfully controlled a personal computing device with the BCI.
Unlike any other company, Synchron has figured out how to deliver electronics into the wall of blood vessels, giving healthcare providers access to new data from specific areas in the brain. This might one day lead to fundamental developments in how we study, diagnose, and treat brain disorders. Synchron also received the FDA’s Breakthrough Device Designation in 2020 and became the first company to receive an Investigational Device Exemption for a permanently implanted BCI in 2021.
“We are in the precommercial phase, but it’s critical for us to understand the market and all of its dynamics shaping it now,” explained Kurt Haggstrom, chief commercial officer at Synchron. “It’s important to build relationships with the doctors and patients who our device will impact the most. Because our technology puts us on the leading edge, it’s particularly critical for us to be doing this work ahead of commercialization so we can quickly help patients when we are ready to go to market.”
Synchron is now at a major inflection point in the development of its product. After publishing the findings in JAMA Neurology earlier this year,2 Synchron enrolled patients for its COMMAND study where its device was implanted in the first patient at Mount Sinai Health System in New York City.3 This marked the first time in history an endovascular BCI has been implanted into a U.S. patient. In March 2023, the company announced the launch of a third clinical site in the U.S. with plans to start a pivotal clinical trial, an important step toward gaining FDA approval.4
Simultaneously, Synchron is focused on steps to commercialization and finding a way to make its technology widely accessible. In the U.S., there are approximately 5.4 million individuals with paralysis with limited ability to control a computer or smartphone.5 A BCI like Synchron’s could restore motor capability by using the cortical motor signal to bypass impaired limbs and directly control a computer. Fast, efficient, and broad commercialization is critical to bringing a lifeline to these patients.
“As we move to the pivotal trials, we need to expand awareness of our organization and product as well as grow our network,” Haggstrom said. “That means identifying as many people who might benefit from our product as possible, plus the doctors who are treating them.”
Synchron turned to a data-driven, medtech-specific software platform to gain insights on the market. The team developed key information about Synchron’s target patient population to help identify potential clinical trial participants who might have otherwise gone unnoticed as well as appropriate treating physicians who can serve as clinical trial sites/investigators.
“In many ways, we are building a network of medical professionals and thought leaders from scratch,” Haggstrom said. “There is so much work to be done, and it needs to be accomplished quickly and efficiently so that we can reach the patients and move the process forward.”
Identifying the right patient population to build a network of trial sites early in the development process is increasingly critical to success. In addition, technologies that enable companies to build pre-commercialization partnerships early is instrumental. This is especially important for medtech startups with novel devices that have little historical health economics data. Technologies that make it fast and easy to capture the value of product innovation compared to the standard treatment of care for their patient population all on a single platform will help democratize the path to success.
“We can look at patients with multiple sclerosis and understand the care that they are currently receiving—the types of procedures, where, and how many—as well as the total cost of care. Then, we can easily compare how our product can lower that cost and demonstrate health economic value,” Haggstrom explained.
“For us, using accurate data efficiently and for specific goals has helped us immensely as we navigate through this process,” Haggstrom concluded. “And we know that the networks we are building today will serve us down the road and enable us to help more people when our product gets to market.”
References
Michael Monovoukas is the co-founder and CEO of AcuityMD. Prior to launching AcuityMD, he was a medtech entrepreneur. He also held a leadership role at PatientPing, a leading provider of Care Coordination software. Monovoukas started his career as a management consultant at Bain & Company, where he advised leading life sciences companies on growth and commercial strategy. He received his MBA from Harvard Business School and his BA in public policy and finance from Princeton University, where he was captain of the varsity swimming and diving team. He can be reached at mike@acuitymd.com.
For Synchron—a Brooklyn-based neurotechnology company developing a novel endovascular brain-computer interface (BCI) called the “Synchron Switch”—success relies as much on its technology as it does on building a network of key partners to grow this emerging field of medicine.
Developing Synchron’s Breakthrough Technology
Synchron developed a breakthrough endovascular BCI product that can access the natural highways of the brain using blood vessels. The technology works by translating patterns of thinking into commands that control a digital device and generate digital switches under a patient’s intentional control for routine digital activities, such as texting, emailing, online shopping, and communication of care needs.Synchron’s foundational technology—a motor neuroprosthesis or motor BCI—is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke but does not require open brain surgery. The system is designed for patients suffering from paralysis due to a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.
Synchron’s Stentrode with Thought-Controlled Digital Switch (SWITCH) study, a first-in-human trial, evaluated four patients in Australia implanted with Synchron’s Stentrode (motor BCI).2 Trial participants completed a 12-month follow-up with no persistent neurological deficits. Remarkably, signal quality remained stable with no evidence of significant deterioration, and each participant successfully controlled a personal computing device with the BCI.
Unlike any other company, Synchron has figured out how to deliver electronics into the wall of blood vessels, giving healthcare providers access to new data from specific areas in the brain. This might one day lead to fundamental developments in how we study, diagnose, and treat brain disorders. Synchron also received the FDA’s Breakthrough Device Designation in 2020 and became the first company to receive an Investigational Device Exemption for a permanently implanted BCI in 2021.
The Path to Commercialization
Although Synchron is on the precipice of commercializing a technology that will revolutionize the treatment of many neurological disorders, progress depends on developing partnerships with key medical professionals, payers, and patients who will test, evaluate, implement, and eventually use the product. This is not easy, especially when establishing a new field of medicine.“We are in the precommercial phase, but it’s critical for us to understand the market and all of its dynamics shaping it now,” explained Kurt Haggstrom, chief commercial officer at Synchron. “It’s important to build relationships with the doctors and patients who our device will impact the most. Because our technology puts us on the leading edge, it’s particularly critical for us to be doing this work ahead of commercialization so we can quickly help patients when we are ready to go to market.”
Synchron is now at a major inflection point in the development of its product. After publishing the findings in JAMA Neurology earlier this year,2 Synchron enrolled patients for its COMMAND study where its device was implanted in the first patient at Mount Sinai Health System in New York City.3 This marked the first time in history an endovascular BCI has been implanted into a U.S. patient. In March 2023, the company announced the launch of a third clinical site in the U.S. with plans to start a pivotal clinical trial, an important step toward gaining FDA approval.4
Simultaneously, Synchron is focused on steps to commercialization and finding a way to make its technology widely accessible. In the U.S., there are approximately 5.4 million individuals with paralysis with limited ability to control a computer or smartphone.5 A BCI like Synchron’s could restore motor capability by using the cortical motor signal to bypass impaired limbs and directly control a computer. Fast, efficient, and broad commercialization is critical to bringing a lifeline to these patients.
“As we move to the pivotal trials, we need to expand awareness of our organization and product as well as grow our network,” Haggstrom said. “That means identifying as many people who might benefit from our product as possible, plus the doctors who are treating them.”
Insights to Understand a New Market
Synchron needed to pinpoint pertinent patient populations and investigators for clinical trial sites early to quickly target the right patients. But understanding the patient population is challenging for many medtech companies, especially in new medical fields. Since there are currently no treatments for many of these patients, they are essentially cloaked within healthcare systems. Patients are often labeled or classified inconsistently on medical records or in doctors’ notes and could have a mix of diagnostic codes associated with their disease. Combined, finding the right patients (and their doctors) is like finding a needle in a haystack.Synchron turned to a data-driven, medtech-specific software platform to gain insights on the market. The team developed key information about Synchron’s target patient population to help identify potential clinical trial participants who might have otherwise gone unnoticed as well as appropriate treating physicians who can serve as clinical trial sites/investigators.
“In many ways, we are building a network of medical professionals and thought leaders from scratch,” Haggstrom said. “There is so much work to be done, and it needs to be accomplished quickly and efficiently so that we can reach the patients and move the process forward.”
Identifying the right patient population to build a network of trial sites early in the development process is increasingly critical to success. In addition, technologies that enable companies to build pre-commercialization partnerships early is instrumental. This is especially important for medtech startups with novel devices that have little historical health economics data. Technologies that make it fast and easy to capture the value of product innovation compared to the standard treatment of care for their patient population all on a single platform will help democratize the path to success.
“We can look at patients with multiple sclerosis and understand the care that they are currently receiving—the types of procedures, where, and how many—as well as the total cost of care. Then, we can easily compare how our product can lower that cost and demonstrate health economic value,” Haggstrom explained.
“For us, using accurate data efficiently and for specific goals has helped us immensely as we navigate through this process,” Haggstrom concluded. “And we know that the networks we are building today will serve us down the road and enable us to help more people when our product gets to market.”
References
Michael Monovoukas is the co-founder and CEO of AcuityMD. Prior to launching AcuityMD, he was a medtech entrepreneur. He also held a leadership role at PatientPing, a leading provider of Care Coordination software. Monovoukas started his career as a management consultant at Bain & Company, where he advised leading life sciences companies on growth and commercial strategy. He received his MBA from Harvard Business School and his BA in public policy and finance from Princeton University, where he was captain of the varsity swimming and diving team. He can be reached at mike@acuitymd.com.
