Hear how 'the data is the therapy' in the Cardiovascular Diagnostics & Services business

Septmeber 29, 2021

Julie Brewer, president of the Cardiovascular Diagnostics and Services, explains why Medtronic carved out a data-oriented business to form tighter connections with patients. Brewer also explains how advances in manufacturing and data-collection can position the business at the center of the digital health space.


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Tom Salemi (00:00):

Hey, everyone this is Tom Salemi of DeviceTalks. Welcome to our newest member of the DeviceTalks podcast family, it's called MedtronicTalks. Our constant search to find new ways to bring new insights in the MedTech industry led us to the fine, fine folks of Medtronic. They've agreed to make their senior leaders available to us and to you. In each episode, we'll discuss the opportunities and challenges facing one of med tech's clear leaders. So you'll have an inside view on what makes Medtronic go. We'll ask the questions. Medtronic will provide the answers and our great network of sponsors makes it all possible. So sit back, hop on a treadmill, take the dog for a walk, whatever you do when you listen to a great podcast and let's listen to how Medtronic is getting the job done, let's go.

Tom Salemi (00:45):

Hey everyone, this is Tom Salemi of DeviceTalks, welcome back to the MedtronicTalks podcast, it's great to have you here. Very pleased to bring you this interview with Julie Brewer. Julie is the president of the new Cardiovascular Diagnostics and Services business at Medtronic. We'll talk about the origins of the business, what it's tackling and where it's headed. Thanks again for listening to this episode, if you'd like to get future episodes sent directly to your phone, please do subscribe. You can find MedtronicTalks on all major podcasts applications, Google, Spotify, and Amazon. Before we begin this interview with a Julie Brewer I'd to bring in this episode's sponsor, Minnesota Rubber and Plastics. I'm speaking with Don Bonitati, the global director of metal device product strategy at Minnesota Rubber and Plastics. Don, tell me about Minnesota Rubber and Plastics?

Don Bonitati (01:36):

Minnesota Rubber and Plastics is a leader in material compound development, manufacturing and assembly of custom elastomeric and thermoplastic components with facilities across North America, Europe and Asia. MRP collaborates with medical device manufacturers to solve difficult ceiling and component challenges. We add measurable economic value to a wide range of product by making best in class materials, science expertise, accessible to our customers. Our intense focus on elastomer and thermoplastics is ideal for critical products that simply cannot fail.

Tom Salemi (02:16):

That's great. And how do you work with medical technology companies?

Don Bonitati (02:19):

Time is at a premium in the healthcare industry, creating highly differentiated and valuable products and bringing them to market quickly is in the best interest in the patient, but simply working fast or short cutting engineering and innovation processes is not the answer. That path opens the door to serious compromises and design quality and cost. The solution is collaboration, creating synergies between the experience and capabilities of our customers, research and development teams and our own technical teams accelerates product development and creates truly innovative solutions that will improve product performance for patients.

Tom Salemi (02:58):

Thanks, Don, we'll hear more from Minnesota Rubber and Plastics a little later in the podcast. For more information about Minnesota Rubber and Plastics go to mnrubber.com. Now let's begin this interview with Julie Brewer. Well, Julie Brewer, welcome to the podcast.

Julie Brewer (03:17):

Thank you Tom. It's great to be here.

Tom Salemi (03:18):

I'm hoping you could, we could start the podcast with just a sort of an overview of the business and sort of where you fit into the big picture. Tell us a little bit about the business you overseeing?

Julie Brewer (03:31):

Yeah, I'm happy to. So I lead the Cardiovascular Diagnostics and Services business, which actually is a new operating unit within Medtronic. It's been around. We created this space and this business over 20 years ago and was part of the Cardiac Rhythm Management business and still works very closely with the CRM business. But because of all the opportunity ahead, Geoff Martha's new structure of the operating unit model, he elevated this business as a separate operating unit. And so I'm really honored to be leading the business with all of the exciting things we have in the future.

Tom Salemi (04:05):

So what are your, let's just get kind of hit upon the two or three top products that you're selling and who are your points of contact in the industry? Who are you selling to?

Julie Brewer (04:12):

Our foundational technology is what we call the LINQ™ technology, Reveal LINQ™ and LINQ II™. We created this space again 20 years ago and it is a technology whereby the therapy of the device is the data. And so we serve many different indications and that indication list will grow as we move forward. We have a main base of business in the US, Western Europe, Australia, and Japan, with a lot of opportunity to move into other markets here as we move forward.

Tom Salemi (04:44):

All right. Well, it's a great primer. Thanks for setting us up. And I'm sure I've blown a lot of minds of listeners who know I always start every podcast asking about the guests. Now we'll get into that part of the program. How did you find your way into med tech specifically early on?

Julie Brewer (04:58):

Yeah, I just celebrated on August 1, my 15-year anniversary with Medtronic, so. Yeah, it's been a great company, a great experience. I've been in healthcare since 1992. I started in pharma and then I moved into capital equipment and then really found Medtronic 15 years ago as I made my move into medical device. So it's been a great experience and afforded me a lot of opportunities to move around the organization, primarily in the commercial space, but I've always had a thirst and a passion for business leadership in my commercial roles. I very routinely would be a part of the strategy discussions and work with the functional leaders to kind of swim outside my lane.

Julie Brewer (05:39):

And so Medtronic afforded me about two and a half years ago, the opportunity to lead this business, the diagnostic space. I was the VP of sales of this business back in 2013, 2014, when we launched the LINQ™ technology, which really revolutionized the space and continues to provide great opportunity moving forward. So been in, again in healthcare since 92, primarily commercial, and now the business leadership here for the last couple of years, and just recently an operating unit president with the new restructure. So really thrilled to have opportunity to lead this space.

Tom Salemi (06:13):

That's terrific. Well, as you said, you started with pharma and then you moved into kind capital equipment. You've stayed in med tech. So we'll take that as an indication that this is the best of the three since I was able to hold on you.

Julie Brewer (06:24):

It's fantastic. Yeah, for sure. Medtronic, as you know, great people, great company. So I'm really honored to be here.

Tom Salemi (06:29):

But you did start off, it was in Allergan, which was a company with a really strong culture as well. And McKesson also, can't dismiss that two great other companies. What did you sort of take away from all three experiences working at larger companies with strong cultures in different parts of the healthcare space? I wonder, were there any commonalities at all?

Julie Brewer (06:50):

Well, one key commonality was really that the opportunity to think broad across the business. So we had a one McKesson strategy when I was leading at McKesson of how do we work with... Between our robotics division when I was in and how do we collaborate across the broad distribution of med surge technology. So there seems to be a common element of how do you sort of, again, as Geoff Martha puts it, play big, play small, when you think about the synergy that large organizations have across different businesses. And so I think that's a really common theme, whether it's customer facing on how you present and show up in the customer eyes, or as well as a leveraging best practices across a broad organization. So certainly that was, I think, true at all the businesses that I've or companies that I've been a part of. And I think Allergan was fantastic at development as is Medtronic, but great training ground. I was young in my career at that time, a ton of great experience in training. And I think pharmaceutical in general does a great job with training their people.

Tom Salemi (07:51):

It's one of those companies that when people work there, they tend to have a very strong allegiance for it and fond memories of it when they've left. So it's a great place to start. So let's circle back again and start talking about your business. You mentioned that it's sort of carved out of CRM and you've got a lot of great tech that I think is, it looks as if you're sort of built for a sprint, they're really going to be advancing forward. Let's talk about some of your recent news. You let's hit upon artificial intelligence, because we all love to talk about AI and we'd love to say AI, you had a couple of approvals from the FDA for your algorithm, AI algorithms, which all three A's in a row, which I have a little trouble saying-

Julie Brewer (08:33):

A mouthful.

Tom Salemi (08:34):

A mouthful. Let's talk about that. This is for the LINQ II™ ICM. What do these approvals mean for Medtronic?

Julie Brewer (08:40):

Yeah, no. Really exciting, great step forward. And really the first of what will be many steps in this artificial intelligence area. As I mentioned before, the LINQ™ technology, the data is the therapy of the device. And since we've been the market leader for a number of years in this space, we've had the good fortune of collecting a lot of data. And so how we leverage that data to help our customers and ultimately help patients is what we've been focused on. So AccuRhythm AI is a step forward to go after one challenge. And that is how can we help our customers better manage the data and reduce data burden? And so these are two unique algorithms that will greatly reduce the number of false positives specifically around AF and around pause, which represents 90% of what creates all of the false positives in this space. And so huge reduction in those to be able to reduce data burden, open up capacity for physicians and their healthcare providers to better manage these patients.

Tom Salemi (09:38):

So those are large reductions, percentage wise. Is there a lot of false alarms, so to speak, not necessarily with just LINQ II™, but with this sort of technology, is this like the car alarm you hear in the street that goes off all the time, you ignore it. And one time you ignore, there's actually someone trying to break in how, how big of an issue is the false information?

Julie Brewer (10:01):

Yeah, it's a great question, Tom. So we've made a ton of progress over the years, and again, we started some time ago with the Reveal LINQ™ technology and have created new algorithms over time. So literally on our sixth algorithm in the main device where we've improved algorithms traditionally around AF or around pause detection, but you want to balance that sensitivity and specificity, so you don't want to miss those true alerts. So we've always had the objective to make sure that we're not missing any true alerts while we're minimizing false alerts. And so we've done that in a traditional algorithmic way, but AI really allows us to take that to a much greater level of accuracy because we can leverage all of these data that we've had over the years to make it even more accurate, and be able to greatly reduce false positives beyond what a traditional algorithm could do. So I hope that makes sense. It's a great step forward in AI and really just the low hanging fruit of what we can do moving forward.

Tom Salemi (11:06):

And what, and I'm sure you said this, but just to clarify for my own sake. What is the false positive signaling? Is it atrial fibrillation? Is it something milder? What is it or is it many, many different things?

Julie Brewer (11:19):

Again, the two main algorithms and they're what we call locked algorithms. So they're not continuously learning over time. We've worked closely with FDA to lock in these algorithms and then we'll be able to provide updates to those algorithms, but it's not a continuous learning algorithm. The AF algorithms specifically, again, maintaining about 99.3% of the true alerts while getting rid of about 74% reduction in false alerts. So that's probably been the most challenging, certainly for all the other companies out there in this space, they're on their first or second generation algorithms in the AF space.

Julie Brewer (11:54):

And we've been working on this for a number of years. So this makes it even more advanced than where it was before. For pause, which is typically what is the arrhythmia that they're looking for, for example, for a syncope patient or someone who's had unexplained fainting, we are able to achieve with AI a hundred percent sensitivity. So maintaining a hundred percent true rhythms while reducing about 94% of the false positives. So it will allow for just making sure the data that the physician or the healthcare provider receives is as clean as possible and limits the amount of sort of ongoing adjudication for those false positives that they need to do in the clinic.

Tom Salemi (12:33):

And is this information that's sent to clinicians or is it sent to patients? Is it someone with an app on their phone and they're getting an indication or again, it's going to the doctor's office?

Julie Brewer (12:41):

Yeah. Today it's going to the doctor's office. So most of the EP, electrophysiology and some cardiologists have device clinics that will actually manage all of this data. And so that's been one of the, as this technology's been so successful over the last few years, the amount of data has grown tremendously. And so really trying to make sure we open up the capacity of those clinics and make it easier to manage the data.

Tom Salemi (13:05):

So as it relates to AI, and as you come up with improvements like these, I'm curious if you're relying upon feedback from physicians to see that these improvements are necessary, or do you have some sort of internal process that you're identifying things that need to be improved upon?

Julie Brewer (13:21):

Yeah, I think it's a combination of both. So we certainly have great feedback from physicians rely on that partnership with our physician and our healthcare provider partners to give us feedback on where there are opportunities or pain points that we need to address. And then we can also see based upon our CareLink database, how much data is flowing through, how much of that data is productive and obviously true alerts versus what might be false alerts. And so it'll be a combination of opportunities to see how we leverage all of this valuable data that we have to provide better insights, as well as then making sure we're not doing it just for the sake of doing it. We're doing it based upon physician feedback on what the needs are to either make their life easier or to help identify patient populations that could be at risk or could benefit.

Tom Salemi (14:11):

Let's move on to another hot space. Your app-based research, you've announced, so you initiated to define AFib research study. Tell us a bit about that. What does that entail and why is it so different than other studies? We'll take a break from this conversation with Julie Brewer to bring back our episode sponsor, Minnesota Rubber and plastic. I'm here with Don Bonitati, the global director of medical device, product strategy, Don, what are some of the examples of applications that feature your medical components and assemblies?

Don Bonitati (14:43):

We collaborate with most of the major medical technology companies that are household names, for example, many of the clinical portfolio groups within Medtronic on a wide range of critical applications. We have deep expertise in these example, areas, cardiovascular, medical, surgical, diabetes, diagnostics, and drug delivery to name a few.

Tom Salemi (15:07):

And tell me Don, what expertise can you share with the engineering professionals at Medtronic?

Don Bonitati (15:11):

We have unique and specialized knowledge in material selection and development processes, because of our expertise we have been solving some of the most difficult challenges for decades. One particular challenge can be the material selection process for elastomers, which can seem daunting. To combat this, we just published a new detailed guide on elastomers material selection that walks engineers through the critical design factors to consider when selecting an elastomer for your medical components. This white paper is a guideline. We encourage our customers to partner with us directly to leverage our product design and tooling engineers early in the development process. Anyone can access this guide, at mnrubber.com/elastomerguide.

Tom Salemi (16:03):

Final question, Don. I understand you have some exciting news at Minnesota Rubber and Plastics. Please share.

Don Bonitati (16:08):

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Tom Salemi (17:43):

Excellent. Thanks Don. Once again, if you want to find out more information, you can go to mnrubber.com and you can find Don on LinkedIn. His last name is spelled B-O-N-I-T-A-T-I. Now let's get back into our conversation with Julie Brewer of Medtronic. Let's move on to another hot space, your app based research, you've announced that you to define AFib research study. Tell us a bit about that. What does that entail and why is it so different than other studies?

Julie Brewer (18:16):

Yeah, it's really exciting. And this has been a great step forward in innovation around clinical research, but also around setting a foundation for how we engage with patients. And one of those areas where in today's digital healthcare world, patients want to see their data. And that in electronic health records, they're seeing it, their data and are getting more and more access to their data. So this is a controlled way for us to be able to answer clinical questions around atrial fibrillation, how much atrial fibrillation matters also to combine other data like smart watches or whatever's in their Apple health kit. However, they're collecting data in their smartphone. We can start to aggregate that data with the high fidelity LINQ™ data and start to look at associations for how much AF is creating worse outcomes for patients or call quality of life impacts for patients.

Julie Brewer (19:12):

So it's going to really serve many, many purposes. Number one, we'll be doing research for the first time, all on the phone, everything from consent to how patients and clinicians are engaging with the study. Number two, is we'll be providing patients feedback on their AF, looking at how much AF they're having in a day and starting to ask questions and survey patients based upon the amount of AF that they're having. And then third associating all this other data that we have out there to be able to make more powerful assessments of what's happening with the patient.

Tom Salemi (19:46):

So what does this study look like when you've compiled all the data and how is this information going to be used? Is this for some regulatory submission or is it just for your internal research?

Julie Brewer (19:57):

No, it's a post-market registry of 5,000 patients that we'll be using to, again, look at associations with different levels of atrial fibrillation. We'll be looking at how patients respond on to data. We'll be aggregating other data to be able to see what the associations are. So we'll be able to apply machine learning and start to look for those high risk AF populations. Then we can further research and hopefully get to a way to help physicians be able to better identify who they need to pay more attention to. As it relates to atrial fibrillation.

Tom Salemi (20:34):

Is atrial fibrillation, especially suited for this sort of connectivity technology. It seems to be a great use of this tech and it seems like an area that really needs sort of a more regular line of communication between patients and clinicians.

Julie Brewer (20:51):

Yeah. So, well, there's certainly been a ton of awareness, especially things like the Apple Watch and wearable technologies are talking more and more about AF. AF is a worldwide problem globally, huge healthcare problem and certainly a big risk factor as we think of about stroke being a terrible healthcare problem around the globe. So atrial fibrillation is I think the first of what can be managed with these technologies and with LINQ™ specifically, we've built a foundation around atrial fibrillation, but building upon that as we move forward and incorporate other sensors and moving beyond AF is also clearly an objective moving forward.

Tom Salemi (21:35):

Yeah. What can LINQ II™, what is it in I guess, broadly, but what can it, what really, can it be? Is this really a platform for, as you indicated many things going?

Julie Brewer (21:46):

It's a platform technology. So if you think back to how we start started in this business, the technology was developed again, back in 1998, 20 years ago, plus, and was really for syncope and for patients with unexplained fainting, it was about the size of a memory stick, 10 CCs, a surgical incision, much more invasive. And then 2014 was a real pivot point where we launched the LINQ™ technology greatly, miniaturized it by over 80% and opened up the opportunity for physician acceptance, patient acceptance, didn't need to be the intimidating surgical procedure. And at the same time, landmark evidence came out in the Crystal AF study in the New England Journal of Medicine that showed the benefit of long term monitoring in the cryptogenic or stroke of unknown cause population.

Julie Brewer (22:38):

So that was sort of the first pivot point for LINQ™, really setting this new market that took people by surprise, took our competitors by surprise, even some people within Medtronic, how much opportunity and how much patient need there was for this technology. So that was sort of the first I would call, S-curve, the first growth around LINQ™ was back in 2014. And now LINQ II™ is that next sort of wave of growth that sets the foundation of moving from diagnostics technology to really a more robust disease management tool. And there's so much attention around digital healthcare and sensor technology. It's really at the forefront of all of that.

Tom Salemi (23:19):

And I assume this is all made possible with obviously miniaturization. You mentioned the advance in 2014, but Bluetooth connectivity as well, this is taking advantage of all those new tech-

Julie Brewer (23:30):

Yeah, no, it definitely is. So, LINQ II™ is foundational in that, we have invested in what we're calling the wafer scale platform, and it's the first time in medical device where we brought semiconductor manufacturing to medical device. So away from sort of traditional titanium cans to now assembling like semiconductors do where we're imprinting on Sapphire glass, we're putting the Bluetooth antenna, the circuitry, the reason that's important is because we want to be able to set a foundation where we can add sensors, we can be able to maximize longevity with the battery and really have a robust disease management tool. So you don't have to sacrifice battery longevity because of Bluetooth drain, or you don't have to sacrifice sensor capabilities, because there's no space left in the device or maybe we want to go smaller someday. So we have a platform with LINQ II™ that's going to give us many innovation options.

Tom Salemi (24:28):

Which leads me into my next question, which was about the wafer scale manufacturing. Talk a bit more about why that is so significant. I know LINQ II™ won a design award, right? MDEA, in receiving that, or at least in where that was discussed, you brought up the wafer scale manufacturing. What went it to the process to say, we need to do it this way?

Julie Brewer (24:47):

Yeah. No, thanks for the question, Tom. I think so, first of all, we've had a wafer fab available at Medtronic, which is unique in itself for a number of years. And so some very smart, R & D leaders were talking about how do we leverage this asset that we have to really help us with innovation. So a number of years ago, they started working towards wafer scale capabilities. And again, the reason it's important is because it's a platform that will allow us to have more flexibility around form factor, around sensor integration, around battery longevity and be able to give us more options that we'd be otherwise limited in a traditional titanium can. So it's been a big technological lift because of some of the unique ways and unique challenges that the team had to overcome in order to have this work in a medical device format, but it's going provide great return as we get into more and more advanced sensors in the future.

Tom Salemi (25:52):

So where do we go from here and we've talked to AI, we've talked apps, we're talking wafer scale manufacturing. This is a unique business you have here. What is this sort of, do you see yourself addressing the same sort of disease states going after just AFib or does this bring you into a lot of other other specialties?

Julie Brewer (26:13):

Certainly number one, we're still well under penetrated in all the disease states that we serve today. So today syncope is under penetrated in terms of unexplained syncope, cryptogenic stroke is a huge area of patient focus. We've made great strides in the last five years and have gotten in the US to about 25% penetration or so in the indicated population, we just though had another piece of landmark evidence on June 1 publishing in the Journal of American Medical Association called stroke AF, that looks at the amount of AF happening in the presumed known cause of stroke, small vessel, large vessel.

Julie Brewer (26:55):

And that is again, pointing to how do we manage a high risk population. We know that AF is a risk factor for stroke, and we want to prevent that next stroke. We want to prevent the first stroke, but if someone's had a stroke, we certainly want to prevent the next stroke. And so we are very focused on making sure we get these technologies in the indicated populations today, while also moving to new populations and the next population we'll move to is heart failure. And so that's a great opportunity as another big healthcare problem and using LINQ™. What we're calling LINQ™ Heart Failure is the next innovation to come.

Tom Salemi (27:32):

And in those areas where you mentioned it's under penetrated, what is the roadblock? Is it just a patients themselves don't know they need this help? What is keeping them from getting the technology they need?

Julie Brewer (27:44):

There's several barriers and much of it is. So if we take stroke, for example, there are opportunities to really bring care pathways together between neurology and cardiology, to make sure that those patients get to long term monitoring. So oftentimes a neurologist or a cardiologist will start with the short-term monitor. We know from all the evidence that it takes longer typically to identify AF in the stroke population. And so a lot of those patients, if they start with a long-term monitor versus getting a LINQ™ in the hospital, for example, they're often lost to follow up. So how we work together to say, if someone starts with a short-term monitor, how do we make sure if it's negative, they get to a long term monitor and make sure we're still looking for that AF because we know it takes over 80 days on average to identify AF in that population, so that's one barrier, getting physicians to talk to each other, between neurology and cardiology and making sure the care pathways are tight so that we're not losing these patients to follow up.

Tom Salemi (28:45):

And how much of your success going forward depends upon the, you mentioned Apple Watches and of course mobile phones, smartphones. Is a lot of your work going to be done in, a lot of your contact with the patients is going to come through that smartphone, desktop, whatever we're calling it? A smartphone.

Julie Brewer (29:06):

Yeah, there you go. The smartphone is, gosh, who would've guessed and how many years ago that we'd be using our smartphone for everything. It's amazing, right? It's become the hub for all of us. So I, certainly the Apple technology and platform, I get the question all the time is, are you concerned about the Apple Watch for example, and it's opening up awareness for atrial fibrillation and opening up the population in a way that can hopefully help us get patients to the therapy or to a LINQ™ device, for example. But patient engagement is more important than ever because we've learned in the last year with COVID how important remote monitoring is.

Julie Brewer (29:47):

The expectations that patients have moving forward around, engaging in their own health and getting their data and better engaging in the healthcare system is a great opportunity for the business that I lead. And we're sort of the tip of the spear for how we can start to share data with patients and work with this ecosystem that's been developed around us and make it even more powerful. So I'm excited about that. I think there's been a lot of fear maybe in the past about that, but we are certainly heading down the road of patients getting more and more access to their data. We need to make sure we're prepared to help enable them.

Tom Salemi (30:23):

Fantastic. Well, it's a lot of exciting stuff going on. I'm sure we'll be talking again as more news comes out. So thanks for joining us on podcast, Julie.

Julie Brewer (30:31):

Thank you, Tom. It's been a great experience. Thanks.

Tom Salemi (30:36):

Well that is a wrap. Thanks again to Julie Brewer for joining us on the podcast. Thank you Minnesota Rubber and Plastics for supporting the podcast. And of course, thanks to you, our listeners for joining us today and for tuning in to this episode of the MedtronicTalks podcast. If you'd like to hear future episodes, please do subscribe. You can find the MedtronicTalks podcast on every major podcast channel, you can also find the MedtronicTalks podcast and our DeviceTalks weekly podcasts on device talks.com. Finally, don't forget to connect with me on social media. My name is Tom Salemi, I'm editorial director of device talks. I am on Twitter @medtechtom, you can find me on LinkedIn, Tom S-A-L-E-M-I, please do tag me when you share this podcast episode on your social media channels, I'd love to be part of that conversation. Well, that is a wrap. Thanks again for tuning in to this episode of the MedtronicTalks podcast, tune in next time, we'll have another great episode of the MedtronicTalks podcast waiting for you.