James Mault, MD, founder and CEO of BioIntelliSense, has had, in his words, “an extraordinarily rewarding personal and professional journey” both in practicing medicine as a physician, and more recently developing startup companies in the medical device space. He has spent the past 35 years innovating in digital health at a global scale as Chief Medical Officer for Qualcomm Life and Medical Director for Microsoft. In 2018, his lifelong vision of a future where continuous patient monitoring transforms healthcare delivery came to fruition with the founding of BioIntelliSense, which offers the BioButton medical-grade wearable device for continuous remote monitoring.

Mault’s original idea for BioIntelliSense came through his personal experience as a cardiothoracic surgeon, where he said it was not uncommon for a patient to come in with a cardiac event, be hospitalized, and then discharged with little direction of what to do next. The patient and caregivers were often shocked to realize that they would have to monitor the patient at home without the tools used in the hospital. This led Mault to think about a device that could track a patient’s vital signs from home and alert a healthcare professional if there is any reason for concern. 

In addition to BioIntellisense, Mault has founded five health IT and medical device companies and has earned more than 80 issued and pending patents for a variety of health IT and medical device innovations.  

MD+DI recently had the chance to ask Mault what he thinks about the future of the remote patient monitoring industry and what it will take to increase its adoption. 

MD+DI: ​​What technology advances have made the recent growth of the remote patient monitoring industry possible?

James Mault, MD, founder and CEO of BioIntelliSense: For more than a century we’ve had a service industry model in healthcare focused on one-to-one interactions, similar to the original models for travel planning, banking, and shopping, etc. Over the last 20 years, nearly every other industry has adopted technology to evolve and become more efficient. We now book airline tickets and hotels online instead of through a travel agent. People handle banking transactions and deposit paychecks through an app instead of through a teller. Even airplanes have evolved to include sophisticated sensors and data-driven automations in flight instead of being manually flown by a pilot. 

Until recently, healthcare innovation remained shackled by highly manual, labor-intensive, face-to-face care delivery, slow to adopt and scale tech-enabled transformation. The flaws in that outdated model of care were amplified by COVID-19, the subsequent nurse workforce shortage, and increased labor costs for hospitals. As a result, healthcare providers are more eager than ever to embrace technology to evolve care models, and that mindset shift was a major growth catalyst for remote patient monitoring. 

The prominence of telehealth services sparked by the pandemic was a breakthrough for remote patient monitoring. Hospitals and physicians across all industries adopted telehealth during the pandemic, normalizing these services for patients and allowing them to experience the convenience and comfort of remote patient monitoring at home. And yet, it wasn't enough because a telehealth visit is still a one-to-one synchronous versus asynchronous interaction between a patient and healthcare professional. 

That’s where our technology comes in. Developed for use across care settings, including in the hospital and at home, the BioButton multiparameter, medical-grade wearable device is easily applied and worn on the upper left chest. It continuously and passively captures trending vital sign and biometric data, including heart rate at rest, respiratory rate at rest, and skin temperature, activity levels, sleep tracking, body position, and gait analysis. Our BioCloud advanced data analytics and algorithmic-based alerting, enable actionable clinical triage and proactive intervention through potential earlier detection of adverse trends. Through the FDA-cleared AlertWatch clinical intelligence solution, healthcare professionals can intuitively view and respond to a patient’s health status based on up to 1,440 high-frequency, objective measurements per day, versus episodic manually collected vital signs 4––6 times per day in the hospital.  

MD+DI: What more needs to be done or what technology breakthroughs need to happen in order to grow the industry further?

 JM: Continuous monitoring, compared to today’s standard of care, which is intermittent or occasional measurement, is transformative for the industry. Remote patient monitoring isn’t enough. Continuous monitoring allows us to be much more certain of a person’s state based on near real-time, constant readings over a longer stretch of time that enable insights on trending vital signs, which is the holy grail of patient care. We’re then able to watch for changes that may be an early indication of deterioration or symptom progression. And the BioButton and our advanced clinical intelligence solutions do just that.

Another piece of the puzzle necessary for growth is that the technology must be interoperable and needs to seamlessly move across care settings from in-hospital to home. It has to work within existing healthcare workflows, which require simplicity, scalability, and cost-effectiveness. Creating technology that is easy-to-use for the patient and the provider, and effortlessly integrates with enterprise technologies, platforms, and tools, is critical to Improve access and weave continuous monitoring into the fabric of healthcare. 

MD+DI: What is the target audience for remote patient monitoring?

JM: Remote patient monitoring benefits everyone. Health systems are facing unprecedented nurse workforce shortages, underscoring the critical need to create a more effective and productive environment for nurses and clinicians. We’ve seen a massive uptick in interest over the past couple of years from hospitals and health systems looking for trusted, cost-effective solutions to address these operational and financial challenges, while continuing to uplevel patient care, including Houston Methodist, UC Davis Health, Renown Health, Ardent Health, and more leading programs nationally.

We’ve also seen ample opportunity to partner with other digital health companies with complementary technology to address pressing healthcare needs. One example would be our recent partnership announcement with Medtronic, which really is the beginning of a massive expansion of a new continuous care model. Medtronic is arguably one of the market leaders in in-hospital bedside patient monitoring, and now, with the BioButton, they are able to bring this capability to their customer base, which is nearly every hospital system in the United States. BioIntelliSense has formed a growing ecosystem of strategic partnerships to speed adoption of end-to-end tech enabled solutions from in-hospital to home. 

We have also recognized the need for offering an end-to-end solution to speed adoption and deployment of our acute and post-acute solutions with provider organizations. For example, we recently announced the acquisition of AlertWatch, an FDA-cleared, clinically proven patient monitoring solution with specialized product offerings for the operating room, intensive care unit, and labor and delivery unit. AlertWatch can also monitor patients in general care wards–and now, in the home. 

Last, but certainly not least, it is for patients. One of the core benefits of continuous patient monitoring is patients receive ‘peace of mind’ care anywhere, anytime. The design of the BioButton does not interfere with a person’s everyday routine and passively captures physiologic data, alerting the necessary healthcare professionals if there is any statistically meaningful change in vital sign data. Hospital stays are often shorter, saving patients on added healthcare costs, and they are able to receive medical-grade monitoring from the comfort and convenience of home.

MD+DI: Where do you see the remote patient monitoring industry going in the next 5-10 years? 

JM: Over the next few years we will see continuous patient monitoring woven into the fabric of care across care settings. We’re already seeing major players in the space making massive investments in continuous patient monitoring and amplifying opportunities to bring it into hospital systems across the United States.

As it continues to become more popularized, we will continue to see evolutions of continuous monitoring technology tracking new data and measurements. On the BioIntelliSense side, we already have quite a few new metrics and tools we’re exploring and integrating into the technology. These advancements that leverage data science (i.e., advanced algorithms, pattern recognition, machine learning) will lead to greater clinical intelligence and data-driven personalized care for patients.

I also expect we will see continuous monitoring used to expand access to care in rural communities where regular visits to the hospital and transportation options are more challenging. Offering continuous monitoring solutions will allow those patients to receive high-quality care from the comfort and convenience of their homes.

MD+DI: What new technologies are on the horizon that you are excited about?

JM: The FDA convened an advisory committee meeting last November to discuss the results of recent studies that indicate many pulse oximeters are less effective when used on patients with darker skin tones. This is an issue top of mind for many in the industry.

BioIntelliSense has acquired a groundbreaking, FDA-cleared pulse oximetry (SpO2) technology that overcomes skin pigmentation and motion monitoring challenges. We see this new sensor technology, which is a significant advancement in the field of oximetry, powering the next generation of medical-grade and consumer wearable devices. The BioIntelliSense pulse oximetry (SpO2 ) technology will enable SpO2 monitoring anywhere, anytime, whether in clinical settings, at home, or beyond and is a breakthrough in improving equity and access in healthcare. We’re really excited about this capability and powering devices with this next generation technology.  

MD+DI: What effects do you think the increase in the use of remote patient monitoring will have on the way physicians practice? Or how they are trained in medical school? In what ways?

JM: Asynchronous and exception-based care management will transform healthcare as we know it, and this new care-delivery model is only possible because of remote and continuous patient monitoring.

Healthcare has nearly always been a synchronous care model, requiring a one-on-one interaction between a healthcare professional and patient. While the human interaction element of healthcare will always remain critically important, automated remote patient monitoring enables dozens, hundreds or even thousands more patients to be simultaneously monitored, enabling providers to prioritize those patients most in need of immediate care or attention. This idea is known as exception management, and will enable physicians, nurses, and clinicians to deliver more data-driven, timely, cost-effective, and personalized care when and where it can be most impactful for the patient.

MD+DI: You mentioned in a recent press release that you have been a lifelong space enthusiast. Did you ever consider a career at NASA instead of medical school? 

JM: Growing up, I wanted to be an astronaut or a doctor. Space exploration has always been a true love and passion, right beside healthcare and I constantly waivered back and forth between “Am I going to be a doctor?” or “Am I going to be an astronaut?” Ultimately, I chose medical school, but if you look around my office you will still see space exploration is close to my heart. I have a whole row of shelves filled with model rockets. 

I’ve been fortunate to be able to marry these two passions. BioIntelliSense just recently partnered with the Translational Research Institute for Space Health (TRISH) to further understanding of human health in space. Our BioButton will be used for commercial spaceflight research programs and notably during the upcoming five-day Polaris Dawn mission, flown by SpaceX sometime after March 2023. I’m also proud to be a member of the Board of Trustees for the Astronaut Scholarship Foundation.