In this episode of the RT Now video podcast, we’re talking patient monitoring and pulse oximetry with Nonin Medical’s John Hastings and Aaron Lobbestael.
John and Aaron offer their perspectives on the necessity for fingertip pulse oximeters to provide accurate blood oxygen readings across all skin pigmentations, as well as insights into some of the innovation going on at their company.
Three Key Takeaways:
- The importance of pulse oximeter performance for all patients
- Pulse oximeter device performance on dark skin pigmentation
- A discussion of the various classifications of pulse oximeters, including FDA cleared devices, over-the-counter oximeters, and health and wellness devices
Participants:
PODCAST TRANSCRIPT
RT interview with Nonin Medical. Mike Fratantoro (00:10) Welcome everyone to the RT Now podcast. I’m Mike Fratantoro with RT Magazine. On today’s episode, we’re talking patient monitoring and pulse oximetry with Nonin Medical. I’m joined today by John Hastings and Aaron Lobbestael. John is the CEO of Nonin Medical and Aaron is the Senior Director of Advanced Technology at Nonin. Thanks, John and Aaron, for joining us. John Hastings (00:28) Yeah, thank you Mike for having us. We’re excited to be here. Aaron Lobbestael (00:31) Yeah, pleased to be here. Mike (00:31) So like I mentioned, we’re here to talk about pulse oximetry and patient monitoring. But before we get into that, if you could just tell our audience a little bit about each of you and how you got into the pulse oximetry business and healthcare in general. John (00:43) Yeah, no, thank you, Mike. And maybe where I would start is a little bit of how Nonin made its way into the pulse oximetry business. And then Aaron and I can share more on our personal pathway. So, Nonin was actually formed in 1986 with the vision of improving patient lives by expanding the capabilities of non-invasive monitoring. And at that time, at the time of founding, pulse oximeters were large and expensive pieces of equipment. They were dedicated tabletop units. And the cost and the lack of mobility really limited the accessibility for many patients. And at the time, the quality of the measurement just wasn’t where it needed to be as well. So the goal of Nonin was number one, to improve the quality of pulse oximetry, but at the same time, simplify the technology to enable devices which were accurate, easy to use, and affordable enough to reach the masses. And it was that vision which led to the invention of the world’s first handheld pulse oximeter, which was a major milestone because for the first time it introduced mobility into the field of pulse oximetry. Then five years later, we invented the world’s first fingertip pulse oximeter, which of course has now become such a staple within healthcare and a number of innovations since that point in time. So we have a very long track record of innovation in the field, which we’re very proud of. And I also think it’s important to note that the founding principles of the company are still very much in place today innovating in ways that enhance quality, reliability, accuracy, ease of use are still at the core of everything that we do as an organization. And Aaron with that maybe you can talk about your personal pathway into Nonin. Aaron (02:45) I’d be happy to. My first introduction to near-infrared spectroscopy was really during my undergraduate research days. I was working with a pediatric cardiologist doing research in patients with deep hypoplastic left heart syndrome. We were studying different ways of doing operations on these patients. And we came across a study in which near-infrared spectroscopy was used to measure the saturation of the brain during these operations. I was both fascinated and suspicious. But fast forward about five years after I’d gone through graduate school in biostatistics and done some consulting work in clinical studies, I drove by Nonin on my way to a client. Curious about who Nonin was, I looked him up and they had an open position for a statistician. I applied, interviewed, and serendipitously landed here. Fortunately, I became heavily involved in measurement of regional oximetry and developing Nonin’s first regional oximeter, really measuring something inside the body from completely outside the body has stayed fascinating to me. It’s captivated me for the last 16 years. I look forward to the time when we can continue to do that to help people know better about what to do with their bodies. John (03:56) Yeah. And then, you know, for me personally, I’ve spent almost my entire career in the medical device industry and that extends over 20 years now. And, you know, but most of that has been in the cardiovascular space. So I spent time in, in rhythm management, electrophysiology, interventional cardiology at companies like St. Jude Medical, Abbott and CSI. But I look at the healthcare space and I think it’s hard to ignore the fact that it is changing and it’s changing quite rapidly and we’ve seen this major shift towards preventative care, towards home-based care, to an environment where patients are becoming much more well-informed and also more active in managing their own care. And you know I believe that we’ll see these trends not only continue but accelerate in particular as technology advances and I think central to making all of that possible, all of these trends possible, is the ability to capture interpret and communicate accurate and reliable data to inform decision-making and that’s where the non-invasive monitoring comes in. So I really think that non-invasive monitoring is absolutely paramount to the future of medicine and that’s something that I wanted to be a part of and especially at a company with the track record and the reputation of Nonin. Mike (05:24) All right. So we’re here, like I mentioned, to talk about pulse oximetry. And obviously, since COVID-19 pandemic, pulse oximeter performance has been in the news and has been an industry issue, specifically with regarding to patients with dark skin pigmentations … So I just wondered if you could just start before we specifically talk about that. But just in general, can you talk a little bit about why accurate oximetry is impactful in clinical settings? John (05:50) Yeah, you know, maybe I’ll start by saying that we very much agree that health equity bias and pulse oximetry is a real concern. I think it’s been very well documented through a number of publications and it’s something that needs to be addressed. And so we’re very supportive of the direction that the FDA is taking on this matter, as well as groups like the Open Oximetry Project. But from a clinical standpoint, this is important because these measurements are being used to help inform important clinical judgments and decisions like whether a patient will qualify for a certain therapy, whether a patient is ready to be discharged. So if the measurement isn’t accurate, it can lead to the wrong clinical judgment, which in turn has the potential to have serious health consequences for the patient. I also think that it’s important to note that pulse oximetry bias for dark skinned patients it tends to overestimate SPO2, meaning that the reading suggests that the patient is actually healthier than they are. So these devices are not biasing on the side of caution. there was a 2020 publication in the New England Journal which showed that dangerously low levels of oxygen saturation were three times as likely to go undetected in dark skinned patients compared to light skinned patient or patients. There was then another piece that was published in JAMA in 2022, which showed that hidden hypoxemia, which is defined as low saturation levels, which go undetected by pulse oximetry, that that could lead to up to a 40 % higher mortality rate for black patients compared to white patients in certain ICU settings. So I think it’s clear that these are real issues and for clinicians choosing the right oximetry technology it just it couldn’t be more important. And Aaron maybe with that if you could say a few words on the Open Oximetry Project what that is and how we participate. Aaron (08:04) For sure. So as John mentioned, there’s a lot of interest in performing some research to understand why pulse oximetry behaves like this and what we can really do about it. So in addition to Nonin doing our own independent research on continuously improving open pulse oximetry, we’re part of an open oximetry project, which is a recognized collaborative community. It was founded at UCSF’s Center for Health Equity in Surgery and Anesthesia and the UCSF Hypoxia Lab to help address these disparities in access to accurate pulse oximetry and pulse oximetry at large. This project is led by some world-renowned clinicians and experts in the field of pulse oximetry, which include Michael Lipnick, Dr. Bickler, and Dr. Feiner, just to name a few. Their goal is to bring a whole host of stakeholders and experts in the field together to identify solutions and work to set standards to help improve that access to reliable and accurate pulse They’ve also independently and consistently demonstrated the superior performance of non-insoximetry across both a range of devices and across a range of different skin tones. Mike (09:17) So our audience is primarily respiratory therapists and pulmonary doctors, but we do have some sleep techs and sleep doctors who are part of the audience. So for their perspective, why should sleep professionals be interested in or be concerned about accurate oximetry readings? Aaron (09:30) Yeah, that’s a great question. Oxygen saturation is really a core component to the diagnosis of a number of sleep disorder breathings like obstructive sleep apnea. When an obstruction occurs, there’s often a transient drop in oxygen saturation and a change in heart rate. Both of these can be detected by an accurate pulse oximeter. But an inaccurate pulse oximeter might not catch the desaturations at their depth or could miss true changes. For example, if the change in SpO2 with a true change in underlying saturation is less than a one-to-one ratio, a true drop of 4%, which is what clinicians are looking for, might only show up as a smaller change of maybe 3 or 3.5%. And if this relationship differs for different people of different skin tones, the ability to diagnose the disease will differ for those populations. John (10:23) Yeah, I think that’s well said, And maybe the other consideration that I would point out for the sleep space is that, is with respect to monitoring patients on either CPAP or BiPAP therapy. And we’re seeing more and more physicians who are choosing to monitor their patients on therapy. Number one, to confirm that the therapy is working appropriately, but also number two, to understand if and when a patient should move on to more of a progressive therapy and this is a real emerging trend but a physician just isn’t able to make that properly informed decision if their monitoring data is not accurate. So another reason I think that this is just so important for the sleep space. Mike (11:12) So earlier, John, you mentioned a couple studies that relate to pulse oximetry with people with darker skin pigmentation. So RT wrote an article recently and included data from two studies, one’s in New England Journal of Medicine study, it found critical care patients found 11.7 % of black patients had low blood oxygen levels despite a normal pulse oximetry reading compared to 3.6 % of white patients. And a 2022 literature review concluded growing evidence that pulse oximeters are less accurate in dark skinned individuals at lower saturation, less than 80 % resulting in overestimations. So in that context, how does Nonin prioritize performance across the diverse patient groups and what evidence do you have that proves Nonin devices work well on dark skinned patients? John (12:02) Well, it’s such an important question, but let me start by talking a little bit about why we have such a challenge with bias and pulse oximetry. And I say we meaning the United States, and we have challenges both with consumer grade products as well as professional grade products. And first, many patients with chronic conditions, as you know, are required to monitor their SPO2 in the home, but their health plan or their insurance just doesn’t cover a prescription grade pulse oximeter, which means that they’re forced to turn to the retail market and buy a device either online or at a large retail chain. And nearly all of the devices that are sold through retail are classified as health and wellness devices. And the health and wellness devices are not subject to the FDA clearance process, which means there’s virtually no regulation at all for their performance. And it’s been well documented that the quality of many of these devices has been just flat out atrocious, particularly for dark skinned patients. So this is a big problem and something that consumers need to be very aware of. So that’s the retail side of it or the consumer side of it. Then with respect to the medical grade pulse oximeters, for many, many years to clear a device with the FDA, the requirement was to include only 15 % dark skinned patients in your clinical study. So what that meant, it meant that it was possible to pass your clinical study requirements with dark skinned patients being vastly underrepresented in your study population. Now, in order to ensure that your technology does work appropriately across all skin types, you need to number one, develop your hardware, number two, tune your algorithm across the patient population, which is truly diverse. But then you also need to ensure that you have that same level of appropriate diversity in your clinical protocol, which has meant going well beyond historically what the FDA requirements have been. And that’s exactly what Nonin has done. So that’s what gives us confidence in the performance of our devices across patients of all skin color. And when you see the independent comparative studies that show how we perform versus the competition, it’s not by chance. We’ve been very intentional to ensure this level of performance. With that being said, know, as confident as we are in our leadership position in health equity, we’ve always been a company who’s been focused on advancing the state of the art. So this is an area where we will continue to innovate and an area where we will continue to raise the bar. Aaron (15:08) Thanks, John. If I could add to that, think in addition to Nonin’s validation work to specify our own performance, which is required by the agency, and like you’ve said, we do it across skin tones. Earlier this year, the Open Oximetry Program published a study in which our fingertip, the 9590, was compared to 10 other fingertip devices. Nonin’s was the only device to perform well across all skin tones at all saturations. And some significant disparities of other Palsyximers were identified in that paper. In the dangerously low oxygen saturation ranges of 70 to 80 and 80 to 90 percent, the 9590 had the best performance of all devices for subjects with dark skin tone. It also had the best overall performance of all the other fingertips in the study. And more recently, this OpenOximetry group shared some data across a broader range of devices. These devices included our PalmSAT, or the 2500 handheld oximeter, the Nonin Copilot, which is another handheld oximeter, and the 95, 90 again, which is the fingertip oximeter. These three were among the top five performing devices in this study. They all performed well across a broad range of skin tones. So not only have we continued to demonstrate our own performance, but it’s been independently shown by other labs. Mike (16:28) Great, John talked a little bit about it, touched lightly on the different options that are available between FDA cleared devices, over the counter devices, health and wellness devices. So I don’t know if you guys could talk a little bit more about the differences between FDA cleared devices, health and wellness devices, and then OTC Aaron (16:45) Yeah, absolutely. It’d be good to clarify these three different categories of policy committers for users. At the highest level of regulation, we have two types of cleared devices, prescription devices and over-the-counter devices. And at the other end of regulation are the health and wellness devices. The two types of regulated cleared devices all require a 510K submission and clearance. The good thing about these devices is that they’re required by the agency to adhere to a certain set of performance standards, guidelines, and a quality management system prior to ever being prescribed to a patient. And most of Nonin’s devices fall into this category. The second regulated category are these over-the-counter devices, which have similar FDA review, performance standard, quality management, system regulations, presubmission regulatory pathways, similar product development strategies, testing and validation, labeling instructions for use. We have to have a quality management system and so on. These do not require a prescription though. Lastly, we have a health and wellness device. These don’t require that same regulatory oversight that we discussed for the two FDA cleared ones, and they’re not intended to diagnose, treat, or prevent disease. Although the health and wellness devices don’t require this regulatory oversight, they’re the ones that are most accessible to patients who are often using them to diagnose, treat, and prevent disease. And furthermore, unfortunately, these are also the devices that have some of the poorest performance across skin tones. Unfortunate that the accessible devices lack that like regulatory oversight even though they’re they’re used by patients and performed poorly. John (18:28) Yeah, I would agree with that, Aaron. You know, just, think that the predominance of health and wellness devices on the market is it’s problematic for consumers. And it’s one thing if you’re using a health and wellness grade device to track your activity and exercise. But if you’re a sick patient and you’re using one of these devices to inform real healthcare decisions, this is a risk because the accuracy of these products is just not regulated. So the unmet need that we see here is the need to have FDA OTC cleared devices on the market so that patients can have the assurance that the device that they are relying on meets a certain level of performance. And that’s why we’ve pursued this pathway with our new TruO2 OTC product line, which very excited to say we actually just received FDA clearance for this week. And so we’re very excited to have this new offering into the marketplace soon. Mike (19:30) Well, congrats on that. I just had a follow up on the idea that sick patients may be using over-the-counter, unregulated devices. Is that a primary care issue where maybe their primary care doctor isn’t sure they’re using a device like that? how do you, what’s the intervention step maybe for that? Is that something, is that just a question that the primary care doctor needs to ask about how they’re monitoring their blood oxygen? John (19:32) Yeah, thank you. It’s really, I think where it starts is the lack of reimbursement for a consumer-grade device. And so for many of these patients, they just don’t have coverage in their health plan. And so they’re forced to turn to the retail market. And we hear this from consumers quite a bit. in consumers, mean patients. They will go in and see their physician. And while they’re with their physician, they’re monitored using a Nonin device. And it works and they have confidence in the reading. They trust the reading and then they go home and they use their device that they bought in a big box retail setting and it won’t provide a reading or it won’t work if they have a cold finger, won’t work if they’re not appropriately perfused or they drop it once and it stops working. So this is a real challenge for those consumers. It creates a high degree of uncertainty in terms of the reliability of the product that they’re using and that’s the need that we really sought to address by making the same high quality measurement capability that they receive at their physician’s office or in the hospital available to them in the home. Mike (21:14) So I only have one other question to sort of get out of here on this one. So just sort of looking ahead, like what’s ahead for Nonin Medical? You just mentioned the new OTC device has just got clearance, which is great. And then just for those that are familiar with your company, they’ll know that you’ve entered some several collaborative partnerships with other partners this year, including like Tennovi, Core Science, EnsoData. So what’s in store for Nonin, either in general or vis-a-vis these partnerships? John (21:25) Yeah, thank you for the question. We’re highly focused on innovation. at the, you know, I’d say at the core of Nonin is the commitment that we have to providing the highest quality, the most durable pulse oximeters in the world. That won’t change. But what is changing, you I alluded to this in terms of what drew me into this, you know, this industry to begin with, we’re seeing these major changes in healthcare towards preventative care, towards home-based care on, you know, the, need to achieve outcomes versus just due procedures. So, you we think about those shifts and it creates a number of new unmet needs in terms of workflow, in terms of process, in terms of efficiency. And so we’re really focused on innovating in ways that help address those unmet needs. We talked about TrueO2, OTC, which will be on the market soon. A big part of solving these challenges is also related to connectivity and the ability for a clinician to access the measurement data, independent of where they are in the world and where the patient is in the world. And so we’re in the early stages of launching our new cloud-based connected data ecosystem, which is being named Nonin Health, which we’re very excited about. We’ve got a next generation ONYX platform in the works, and we’re also working on a number of new form factors. A lot of exciting innovation in the pipeline and you’ll see that being introduced into the market over the years to come here. Aaron (23:24) I’m excited about many of those same innovations as we think about the future in this world. People are trying to make more decisions at home with their physicians and if we can offer that reliable measurement across a broad range of measurement types in a range of form factors and then provide that information to both the patient and the physician together they can make well-informed decisions about care. Mike (23:53) Okay, great. Thanks guys for joining us. Thanks everyone for tuning into the RT Now podcast. For more podcast episodes and webinars, check out our website at respiratory-therapy.com. And to learn more about Nonin’s patient monitoring solutions, visit nonin.com. Thanks John, and thanks Aaron for your time. |
Unlock Exclusive Access: Watch the Full Interview Now!
Get the latest insights on pulse oximetry and patient monitoring in this expert-led discussion. Stay ahead with key industry advancements.
Sign up to watch now!