Sepsis ranks as the primary cause of death in US hospitals and the fifth overall in the world. Standard tests used to diagnose sepsis are inaccurate on average 40% of the time in hospitals nationwide.
Unfortunately, hospitals, particularly emergency departments, often face challenges in maintaining aseptic environments for procedures. False positive sepsis tests often result from sample contamination from sources external to the patient’s bloodstream including microorganisms from the patient’s skin, a nurse’s fingertips during venipuncture, or the surrounding environment. Efforts to address this problem through nationwide medical staff training have yielded only modest, unsustainable improvement in results, as the elimination of contaminants remains unfeasible with current practices. Yet, this is not an impossible challenge to overcome.
This was the foundation for Magnolia Medical Technologies’ objective to help eliminate sepsis misdiagnosis. Greg Bullington stands at the forefront of a battle against sepsis misdiagnosis with Magnolia’s “Mission to Zero®” program: getting to zero false positives and zero patients harmed. The Magnolia team has developed a device platform (called Steripath®) that has demonstrated a groundbreaking 90%+ reduction in false positive sepsis tests in a variety of large-scale clinical studies at leading institutions (including Stanford University) published in leading peer-reviewed medical journals.
But let’s roll back the tape. Greg’s career started in strategy consulting, focusing on bringing cutting-edge healthcare technologies to market. In those early days, his broad exposure to clients, including healthcare giants in the Blue Cross Blue Shield network and revolutionary active immunotherapy technologies to treat prostate cancer informed his views of what it takes to change the standard of care. “I had an interesting mix of experience from an overall exposure to healthcare and commercializing novel technologies as well as creating completely new markets,” Greg says.
He then co-founded a software company that developed technology to improve the performance of hard drives, particularly in data center environments. After selling the technology to SanDisk, Greg realized the significant value of developing an entire portfolio of protected technologies, which shaped how he approached intellectual property in future ventures.
His path took a fortuitous turn when he was introduced to Dr. Richard Patton, a pathology expert at a University of Washington hospital, with whom he later co-founded Magnolia. “The first time I met with him, he pulled a little bag of goodies out of his drawer in his office, in the back of this huge clinical lab, and dumped a bunch of needles, tubes, and blood test equipment out on his desk and started to explain this problem around the misdiagnosis of sepsis,” Greg shares. Sepsis is the number one cause of death in hospitals and represents a huge burden on the healthcare system. Misdiagnosis of sepsis is a longstanding problem that Magnolia has now proven is totally preventable. This clinical proof is the foundation supporting Magnolia’s mission to eliminate the misdiagnosis of sepsis.
Greg and Dr. Patton tested the Initial Specimen Diversion Technique (ISDT), a conception of Dr. Patton’s earlier in his clinical practice, at several Seattle-area hospitals. They then went on to invent the Initial Specimen Diversion Device (ISDD) category and its first commercial device, known as Steripath. The Steripath system diverts and sequesters the initial couple of milliliters of blood that often contain a critical amount of contaminants. Then, the device creates a closed system between the vein and test bottle using a second, sterile flow path. The goal is to ensure that the only specimen that goes into the culture is the patient’s venous blood, excluding contaminants such as skin plugs, hair follicles, sweat glands, and adnexal structures dislodged during the process of accessing the vein. This method has allowed Steripath to demonstrate elimination of false-positive results, sustaining a contamination rate as low as 0.0%.
And that was just the beginning. Today, Magnolia helps hospitals collect samples in an aseptic manner with Steripath, preventing previously inevitable contamination risk in hospital settings and saving the lives of many through the prevention of sepsis misdiagnosis and associated mistreatment.
Nearly a decade of development and growth has brought Steripath and Magnolia to their current standing. Thanks to rigorous clinical studies and irrefutable data, Magnolia has carved out a new category and earned the bipartisan support of the U.S. Congress for a new national standard of care for sepsis testing accuracy. The company now boasts nearly 500 hospitals and hospital systems as customers nationwide and continues to expand. “We have earned bipartisan support in both the House and the Senate to accelerate the adoption of these new standards of care,” Greg reports.
Including ISDT and ISDD, Magnolia has amassed a hefty intellectual property portfolio that includes more than 150 method, apparatus, and design patents with over 50 additional patent applications pending.
Magnolia also has a software product in the pipeline that aims to make diagnostics swifter and more accurate. Greg shares his excitement, “The faster we can help more people, the faster we can be in a position to redeploy resources in driving more innovation, which will drive better outcomes.”
Key Learnings From Greg’s Experience
- You need solid data, repeatable results, and a technology that remains relevant over time when trying to shift the paradigm in healthcare. Simply demonstrating a device's functionality isn't sufficient; continuous validation and persuasion of diverse stakeholders are key to widespread acceptance.
- Effective communication strategies are crucial when introducing a novel technology. Magnolia found itself educating not only FDA but also enlightening the broader market about Steripath's significance, ultimately owning its innovative market leader role, changing the standard of care for sepsis testing accuracy.
- Positioning a device as the standard of care requires backing from government entities, which are often inundated with proposals from various parties. Knowing how to tell a compelling story with irrefutable data proving device efficacy can push your device higher up on the priority list.
Greg Bullington, co-founder and CEO of Magnolia Medical, is a leading figure in the development of Steripath, a revolutionary device that dramatically improves the accuracy of sepsis tests. Greg’s previous expertise includes leadership positions across biotech, healthcare access, and enterprise software. Over the last decade, Greg has shaped every facet of Magnolia's success, from creating their own category and navigating the regulatory landscape with FDA to collaborating with the U.S. Congress to accelerate the widespread adoption of Steripath to help avoid the preventable error of false-positive sepsis misdiagnosis.
Repeatable and Sustainable Data as the Bedrock
Concentrating on validated performance data, repeatability, and sustainability from the onset is critical to build support and gain traction in the healthcare market. Introducing new technologies in healthcare often meets skepticism – and sometimes, rightfully so. To overcome this, you need to start with solid facts. In Greg’s story, establishing a bulletproof foundation has been crucial in demonstrating the validity of Steripath to FDA, end users, and the government entities they are collaborating with today.
When Magnolia was first founded, they spent years gathering data at three major hospitals in Seattle to gain a comprehensive understanding of the efficacy of their invention to validate their core hypothesis.
Greg emphasizes, “You can't over-invest in trying to get direct end-user feedback and to have as many cycles as you can out in the field to collect that, as opposed to making decisions in a vacuum around a conference room table with a whiteboard.”
During the early periods following Magnolia’s inception, the team collected samples from tens of thousands of patients using their ISDT technique, by manually separating the initial sample from the rest. The results were clear: ISDT delivered a significant reduction in false positives, however, nearly a quarter of positive results were still false positives.
Confronted with the numbers, Greg pondered, “What if we invented a completely new device, a sterile end-to-end blood collection platform, so the only thing we test is the blood, not blood mixed with contaminants?” Today this device — Steripath — exists.
The idea was great but it had to be supported by empirical data. Steripath’s efficacy was initially tested through three major independent clinical trials that proved its superiority over common manual processes. In fact, one large-scale clinical trial at Stanford University demonstrated a 100% reduction in false positives over 11,000+ patient sepsis tests. "We have demonstrated that this is a preventable error," Greg notes.
Nevertheless, demonstrating a device's effectiveness is just the first step toward its commercialization. Success requires constant commitment. As Greg puts it, “You're going to have to convince the next segment or the next cohort of people that you're targeting, whether it's physicians, nurses, other clinicians.” He continues, "I could easily name five or ten technology platforms that have hundreds of peer-reviewed publications behind them and still struggled mightily."
Having hospitals adopt your product is not a straightforward path even with strong clinical validation. Hospitals have a long list of potential improvements to address and therefore have to pick and choose what to focus on. To have them prioritize your solution, you need more than a few peer-reviewed publications showing its efficacy. Greg shares, "Direct, significant, quantifiable data demonstrating preventable morbidity and mortality. Those are the kinds of things that should come to the top of the list."
On their mission to make Steripath the standard of care amongst U.S. hospitals, Magnolia Medical operates within multiple parallel swim lanes encompassing clinical evidence, process improvement, training, and software development for tracking and quantification. On top of all this, their team is collaborating with government organizations to accelerate the adoption of ISDD as the new standard of care.
Working With FDA to Establish a New Category
Getting FDA to recognize a new product category is no small feat. It involves not only having a robust, reliable device but also presenting rigorous data and a commitment to ongoing validation. Simply understanding, validating, and trusting your technology isn't enough; you also need to effectively demonstrate its merits to the authoritative bodies to secure their buy-in.
Magnolia pioneered the Initial Specimen Diversion Technique, followed by the invention and development of the corresponding device, the Initial Specimen Diversion Device (ISDD). Both are now individual categories, the latter having earned recognition and endorsement from CLSI, CDC, and other medical societies. The ISDT was a manual technique they developed using off-the-shelf parts. Using this technique, the Magnolia team got the false positive sepsis test results down to about one-in-four. The ISDD – Steripath – is a significant leap forward, delivering results ten times better than the manual process.
“As the pioneers in the space that we're developing and commercializing, we have the obligation and the opportunity to educate FDA on this particular challenge,” Greg shares.
The journey involved presenting robust data that highlighted the significance of Magnolia’s solution, the potential benefits it brings to patients, medical staff, and the overall healthcare system, as well as securing support from other proponents of Steripath, like bipartisan members of the U.S. Congress, which Greg has skillfully managed to get on board.
Yet, working with FDA to establish a new category for ISDD and Steripath was only the beginning for Magnolia. Regulators are not the only stakeholders that you need approval from. When you create a new medical device category, you also have to educate the entire market about its value and its impact on improving patient outcomes.
“Regardless of how simple your technology is, you've got to be creative in terms of how you illustrate and educate to get all of the various stakeholders aligned and on board with your mission. That's the communication challenge side of it,” Greg notes.
Magnolia's robust data, as well as Greg’s thoughtful and intentional targeting of the right government entities, has been critical in supporting Steripath’s widespread adoption. They achieved collaboration with key opinion leaders and authoritative bodies, including the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Quality Forum (NQF), Clinical & Laboratory Standards Institute (CLSI), and Veteran Affairs (VA) Administration.
To convince such entities to support you in your mission is a huge triumph for any medtech company. But to achieve that, you need bullet-proof scientific evidence. You need to know how to get people to pay attention to your cause. Finally, you need to educate the market and the key stakeholders in the community, demonstrating that your solution’s benefits far outweigh the costs.
Securing Widespread Support for Novel Technology
Magnolia’s strategic partnerships with diverse government entities, ranging from CMS to political leaders, have been crucial in establishing Steripath as a standard care practice in U.S. hospitals.
Greg elaborates on their approach, “It really comes back to the data and evidence as the foundation.” He acknowledges that government officials and agencies, wary of past dealings with less credible organizations, demand robust, incontrovertible data before giving their support. This need for credible evidence has led Magnolia to invest heavily in clinical research, which in turn has facilitated productive conversations and engagement.
Steripath doesn’t just offer marginal improvements; it brings a drastic reduction in false positive results for sepsis tests. Such a significant improvement in diagnosis and the subsequent outcomes can be quite a persuasive narrative for government agencies that work on healthcare quality. For example, every member of Congress has a significant number of constituents who are affected by a misdiagnosis of sepsis, for whom the congressperson serves as a representative in the government. By targeting this affected population, Magnolia has been able to establish vital communication channels and exert influence with key government representatives.
Greg summarizes, “The combination of the data, the magnitude of the solution, and the understanding that this is something preventable that’s harming folks within every district in the United States — and around the world — each and every day, has been a compelling narrative and a compelling opportunity for driving the support that we have from the Senate, the House, as well as the VA, CMS, CDC, NQF, CLSI, and all the other organizations we have worked over the time.”
Greg believes that success in the early stages of a business is about making robust connections as much as it is about having robust, reliable empirical evidence. And at the end of the day, the connections you make really come down to playing the odds — Greg calls it a “law of large numbers game,” especially in the nascent stages. He suggests treating every single interaction as a potentially game-changing moment. It’s about addressing every meeting, every conversation, and every introduction as if they could lead to a breakthrough opportunity.
The efforts the Magnolia team undertook with such big institutions to help promote Steripath’s adoption represent monumental successes towards enhancing patient care, improving the healthcare system, and of course, fulfilling Magnolia’s mission as a company to continue solving big problems in healthcare.
Sepsis ranks as the primary cause of death in US hospitals and the fifth overall in the world. Standard tests used to diagnose sepsis are inaccurate on average 40% of the time in hospitals nationwide.
Unfortunately, hospitals, particularly emergency departments, often face challenges in maintaining aseptic environments for procedures. False positive sepsis tests often result from sample contamination from sources external to the patient’s bloodstream including microorganisms from the patient’s skin, a nurse’s fingertips during venipuncture, or the surrounding environment. Efforts to address this problem through nationwide medical staff training have yielded only modest, unsustainable improvement in results, as the elimination of contaminants remains unfeasible with current practices. Yet, this is not an impossible challenge to overcome.
This was the foundation for Magnolia Medical Technologies’ objective to help eliminate sepsis misdiagnosis. Greg Bullington stands at the forefront of a battle against sepsis misdiagnosis with Magnolia’s “Mission to Zero®” program: getting to zero false positives and zero patients harmed. The Magnolia team has developed a device platform (called Steripath®) that has demonstrated a groundbreaking 90%+ reduction in false positive sepsis tests in a variety of large-scale clinical studies at leading institutions (including Stanford University) published in leading peer-reviewed medical journals.
But let’s roll back the tape. Greg’s career started in strategy consulting, focusing on bringing cutting-edge healthcare technologies to market. In those early days, his broad exposure to clients, including healthcare giants in the Blue Cross Blue Shield network and revolutionary active immunotherapy technologies to treat prostate cancer informed his views of what it takes to change the standard of care. “I had an interesting mix of experience from an overall exposure to healthcare and commercializing novel technologies as well as creating completely new markets,” Greg says.
He then co-founded a software company that developed technology to improve the performance of hard drives, particularly in data center environments. After selling the technology to SanDisk, Greg realized the significant value of developing an entire portfolio of protected technologies, which shaped how he approached intellectual property in future ventures.
His path took a fortuitous turn when he was introduced to Dr. Richard Patton, a pathology expert at a University of Washington hospital, with whom he later co-founded Magnolia. “The first time I met with him, he pulled a little bag of goodies out of his drawer in his office, in the back of this huge clinical lab, and dumped a bunch of needles, tubes, and blood test equipment out on his desk and started to explain this problem around the misdiagnosis of sepsis,” Greg shares. Sepsis is the number one cause of death in hospitals and represents a huge burden on the healthcare system. Misdiagnosis of sepsis is a longstanding problem that Magnolia has now proven is totally preventable. This clinical proof is the foundation supporting Magnolia’s mission to eliminate the misdiagnosis of sepsis.
Greg and Dr. Patton tested the Initial Specimen Diversion Technique (ISDT), a conception of Dr. Patton’s earlier in his clinical practice, at several Seattle-area hospitals. They then went on to invent the Initial Specimen Diversion Device (ISDD) category and its first commercial device, known as Steripath. The Steripath system diverts and sequesters the initial couple of milliliters of blood that often contain a critical amount of contaminants. Then, the device creates a closed system between the vein and test bottle using a second, sterile flow path. The goal is to ensure that the only specimen that goes into the culture is the patient’s venous blood, excluding contaminants such as skin plugs, hair follicles, sweat glands, and adnexal structures dislodged during the process of accessing the vein. This method has allowed Steripath to demonstrate elimination of false-positive results, sustaining a contamination rate as low as 0.0%.
And that was just the beginning. Today, Magnolia helps hospitals collect samples in an aseptic manner with Steripath, preventing previously inevitable contamination risk in hospital settings and saving the lives of many through the prevention of sepsis misdiagnosis and associated mistreatment.
Nearly a decade of development and growth has brought Steripath and Magnolia to their current standing. Thanks to rigorous clinical studies and irrefutable data, Magnolia has carved out a new category and earned the bipartisan support of the U.S. Congress for a new national standard of care for sepsis testing accuracy. The company now boasts nearly 500 hospitals and hospital systems as customers nationwide and continues to expand. “We have earned bipartisan support in both the House and the Senate to accelerate the adoption of these new standards of care,” Greg reports.
Including ISDT and ISDD, Magnolia has amassed a hefty intellectual property portfolio that includes more than 150 method, apparatus, and design patents with over 50 additional patent applications pending.
Magnolia also has a software product in the pipeline that aims to make diagnostics swifter and more accurate. Greg shares his excitement, “The faster we can help more people, the faster we can be in a position to redeploy resources in driving more innovation, which will drive better outcomes.”
Key Learnings From Greg’s Experience
- You need solid data, repeatable results, and a technology that remains relevant over time when trying to shift the paradigm in healthcare. Simply demonstrating a device's functionality isn't sufficient; continuous validation and persuasion of diverse stakeholders are key to widespread acceptance.
- Effective communication strategies are crucial when introducing a novel technology. Magnolia found itself educating not only FDA but also enlightening the broader market about Steripath's significance, ultimately owning its innovative market leader role, changing the standard of care for sepsis testing accuracy.
- Positioning a device as the standard of care requires backing from government entities, which are often inundated with proposals from various parties. Knowing how to tell a compelling story with irrefutable data proving device efficacy can push your device higher up on the priority list.
Greg Bullington, co-founder and CEO of Magnolia Medical, is a leading figure in the development of Steripath, a revolutionary device that dramatically improves the accuracy of sepsis tests. Greg’s previous expertise includes leadership positions across biotech, healthcare access, and enterprise software. Over the last decade, Greg has shaped every facet of Magnolia's success, from creating their own category and navigating the regulatory landscape with FDA to collaborating with the U.S. Congress to accelerate the widespread adoption of Steripath to help avoid the preventable error of false-positive sepsis misdiagnosis.
Repeatable and Sustainable Data as the Bedrock
Concentrating on validated performance data, repeatability, and sustainability from the onset is critical to build support and gain traction in the healthcare market. Introducing new technologies in healthcare often meets skepticism – and sometimes, rightfully so. To overcome this, you need to start with solid facts. In Greg’s story, establishing a bulletproof foundation has been crucial in demonstrating the validity of Steripath to FDA, end users, and the government entities they are collaborating with today.
When Magnolia was first founded, they spent years gathering data at three major hospitals in Seattle to gain a comprehensive understanding of the efficacy of their invention to validate their core hypothesis.
Greg emphasizes, “You can't over-invest in trying to get direct end-user feedback and to have as many cycles as you can out in the field to collect that, as opposed to making decisions in a vacuum around a conference room table with a whiteboard.”
During the early periods following Magnolia’s inception, the team collected samples from tens of thousands of patients using their ISDT technique, by manually separating the initial sample from the rest. The results were clear: ISDT delivered a significant reduction in false positives, however, nearly a quarter of positive results were still false positives.
Confronted with the numbers, Greg pondered, “What if we invented a completely new device, a sterile end-to-end blood collection platform, so the only thing we test is the blood, not blood mixed with contaminants?” Today this device — Steripath — exists.
The idea was great but it had to be supported by empirical data. Steripath’s efficacy was initially tested through three major independent clinical trials that proved its superiority over common manual processes. In fact, one large-scale clinical trial at Stanford University demonstrated a 100% reduction in false positives over 11,000+ patient sepsis tests. "We have demonstrated that this is a preventable error," Greg notes.
Nevertheless, demonstrating a device's effectiveness is just the first step toward its commercialization. Success requires constant commitment. As Greg puts it, “You're going to have to convince the next segment or the next cohort of people that you're targeting, whether it's physicians, nurses, other clinicians.” He continues, "I could easily name five or ten technology platforms that have hundreds of peer-reviewed publications behind them and still struggled mightily."
Having hospitals adopt your product is not a straightforward path even with strong clinical validation. Hospitals have a long list of potential improvements to address and therefore have to pick and choose what to focus on. To have them prioritize your solution, you need more than a few peer-reviewed publications showing its efficacy. Greg shares, "Direct, significant, quantifiable data demonstrating preventable morbidity and mortality. Those are the kinds of things that should come to the top of the list."
On their mission to make Steripath the standard of care amongst U.S. hospitals, Magnolia Medical operates within multiple parallel swim lanes encompassing clinical evidence, process improvement, training, and software development for tracking and quantification. On top of all this, their team is collaborating with government organizations to accelerate the adoption of ISDD as the new standard of care.
Working With FDA to Establish a New Category
Getting FDA to recognize a new product category is no small feat. It involves not only having a robust, reliable device but also presenting rigorous data and a commitment to ongoing validation. Simply understanding, validating, and trusting your technology isn't enough; you also need to effectively demonstrate its merits to the authoritative bodies to secure their buy-in.
Magnolia pioneered the Initial Specimen Diversion Technique, followed by the invention and development of the corresponding device, the Initial Specimen Diversion Device (ISDD). Both are now individual categories, the latter having earned recognition and endorsement from CLSI, CDC, and other medical societies. The ISDT was a manual technique they developed using off-the-shelf parts. Using this technique, the Magnolia team got the false positive sepsis test results down to about one-in-four. The ISDD – Steripath – is a significant leap forward, delivering results ten times better than the manual process.
“As the pioneers in the space that we're developing and commercializing, we have the obligation and the opportunity to educate FDA on this particular challenge,” Greg shares.
The journey involved presenting robust data that highlighted the significance of Magnolia’s solution, the potential benefits it brings to patients, medical staff, and the overall healthcare system, as well as securing support from other proponents of Steripath, like bipartisan members of the U.S. Congress, which Greg has skillfully managed to get on board.
Yet, working with FDA to establish a new category for ISDD and Steripath was only the beginning for Magnolia. Regulators are not the only stakeholders that you need approval from. When you create a new medical device category, you also have to educate the entire market about its value and its impact on improving patient outcomes.
“Regardless of how simple your technology is, you've got to be creative in terms of how you illustrate and educate to get all of the various stakeholders aligned and on board with your mission. That's the communication challenge side of it,” Greg notes.
Magnolia's robust data, as well as Greg’s thoughtful and intentional targeting of the right government entities, has been critical in supporting Steripath’s widespread adoption. They achieved collaboration with key opinion leaders and authoritative bodies, including the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Quality Forum (NQF), Clinical & Laboratory Standards Institute (CLSI), and Veteran Affairs (VA) Administration.
To convince such entities to support you in your mission is a huge triumph for any medtech company. But to achieve that, you need bullet-proof scientific evidence. You need to know how to get people to pay attention to your cause. Finally, you need to educate the market and the key stakeholders in the community, demonstrating that your solution’s benefits far outweigh the costs.
Securing Widespread Support for Novel Technology
Magnolia’s strategic partnerships with diverse government entities, ranging from CMS to political leaders, have been crucial in establishing Steripath as a standard care practice in U.S. hospitals.
Greg elaborates on their approach, “It really comes back to the data and evidence as the foundation.” He acknowledges that government officials and agencies, wary of past dealings with less credible organizations, demand robust, incontrovertible data before giving their support. This need for credible evidence has led Magnolia to invest heavily in clinical research, which in turn has facilitated productive conversations and engagement.
Steripath doesn’t just offer marginal improvements; it brings a drastic reduction in false positive results for sepsis tests. Such a significant improvement in diagnosis and the subsequent outcomes can be quite a persuasive narrative for government agencies that work on healthcare quality. For example, every member of Congress has a significant number of constituents who are affected by a misdiagnosis of sepsis, for whom the congressperson serves as a representative in the government. By targeting this affected population, Magnolia has been able to establish vital communication channels and exert influence with key government representatives.
Greg summarizes, “The combination of the data, the magnitude of the solution, and the understanding that this is something preventable that’s harming folks within every district in the United States — and around the world — each and every day, has been a compelling narrative and a compelling opportunity for driving the support that we have from the Senate, the House, as well as the VA, CMS, CDC, NQF, CLSI, and all the other organizations we have worked over the time.”
Greg believes that success in the early stages of a business is about making robust connections as much as it is about having robust, reliable empirical evidence. And at the end of the day, the connections you make really come down to playing the odds — Greg calls it a “law of large numbers game,” especially in the nascent stages. He suggests treating every single interaction as a potentially game-changing moment. It’s about addressing every meeting, every conversation, and every introduction as if they could lead to a breakthrough opportunity.
The efforts the Magnolia team undertook with such big institutions to help promote Steripath’s adoption represent monumental successes towards enhancing patient care, improving the healthcare system, and of course, fulfilling Magnolia’s mission as a company to continue solving big problems in healthcare.
