Big Tech in a Small Package

Earlier this year, Hyperfine achieved an incredible milestone - CE mark for Swoop, its portable MRI system. This achievement was hot on the heels of Maria Sainz being appointed president and CEO of Hyperfine.

Sainz joins us for this episode of Let's Talk Medtech to discuss her plans for Hyperfine, how Swoop has the potential to change the way we think about MRIs; and her career. 

Swoop is an FDA-cleared portable MRI system capable of providing neuroimaging at the point of care. Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and how clinicians could apply accessible diagnostic imaging to patient care.

Season 2, Episode 6 Transcripts

Omar: Well, welcome to let's talk medtech. Maria, how are you?

Maria: I'm doing fine. Thank you for having me.

Omar: Thank you for joining us. I want to talk all about hyperfine and your vision, but first I want to talk about your career in medtech. Could you talk a little bit about your entry into the industry and what made you decide to become involved in medtech?

Maria: My entry into the industry was through sales and marketing. So, I'm one of those that carried the bag early in my career, both for pharmaceuticals and medical technology. And I found it incredibly compelling to be in a business while doing something good for patients, for health, across the variety of therapeutic areas I have been involved with. So, it bit me, and it stayed with me for the last 35 years or so.

Omar: Now, I've got to ask you this what device was hot or what device was popular or cutting edge when you began your med tech career? For me, when I started, the talk was all around drug-eluting stents.

Maria: I would say actually bare-metal stents. So, I guess I predate you.

Omar: Yeah, bare-metal stents. Cool.

Maria: It was the first time we were leaving something behind in the cat lab, and that felt like jumping out of the cliff without a parachute.

Omar: Yeah, I remember. Drug-eluting stents. I was writing about them and my editor at the time, he said, yeah, you have to talk about DES. I'm like, DES? What are drug-eluting stints. And don't forget the hyphen. Just a little journalism joke there. But yeah, that was the popular technology. I feel like people coming into the industry – now, What's going to be popular is maybe continuous glucose monitors or even artificial intelligence. Digital health.

Maria: Yeah, I think there is a lot to be said about artificial intelligence and deep learning and how that really takes what I have always thought about medical technology to a different level of just more continuous improvement and continued improved service to health providers, patients, clinicians.

Omar: Let's jump in and talk about Hyperfine for a little bit and your role there. Now, you became CEO in October of 2022, right? Can you talk about that journey?

Maria: I actually was involved with the company as an independent board member for about 10 months prior to taking on the role of president and CEO. So, I joined the board of Hyperfine right at the time of the company going public through a de-SPAC, and as I said, about ten months as a board member. And a very interesting transition into the leadership position, because I had enough knowledge of what the company was about, what the company had done, what the company could have done. Also felt really comfortable with the team in place and the things that I wanted to do. So, by nature and through my career, I think, have demonstrated to be quite action based and quick with driving change. And this felt incredibly comfortable because of my knowledge base from my tenure as a board member prior to becoming the CEO.

Omar: Now I want to get into Hyperfine’s technology, specifically Swoop, that's the world's first FDA-cleared portable MRI. Can you talk a little bit about the device and how it's so transformative?

Maria: Sure. So conventional MRI is an interesting experience. It requires a hospital or a clinic to provide a very shielded and protected room. Very often in the basement, patients actually have to go inside that tunnel. And for the most part, it's a bit of a traumatic patient experience. A lot of patients report claustrophobia, but it is a very valuable diagnostic imaging modality. In the U.S. alone, with some of the fluctuations associated with COVID I would say there's somewhere between 30 [million] and 40 million MRI scans performed every year, and of those, somewhere between six [million] and 9 million of them are in the brain. So clearly there's tremendous medical utility and diagnostic value to performing the scans. Where Swoop comes in is in totally transforming that experience for the providers, the clinicians and the patients.

In that we bring the MRI to the patient, we do not require a shielded environment. It is on wheels. It can go from one critical care unit to another, across the hallway, down an elevator, through hospital doors, and for the most part, right now, it's being used in critical care. So, it just goes right behind a critical care patient bed, and the patient's head is scooched into our unit. The scan is performed there with most of the equipment still connected to the patient without any transport, and the ability to then get clinically relevant imaging to be able to make a clinical decision right there and then. So, we transform MRI, but making it available, accessible, affordable. And we don't intend to compete with conventional MRI.

I like to say we are there when the conventional one isn't there or when it would take too long to get there. So that's really the story behind our Swoop system. The patient experience is also very different. You could hold the hand of a patient while they're having a scan and comfort them and make sure that they feel everything is okay. We hear that often when the scanned patient is a child and their parents can hold their hand.

Omar: Yes, I can imagine so. And my daughter had to have a scan one time before and it was tough. She was very afraid, she was very nervous and scared. And so, yeah, that means all the difference in the world to have someone, a parent or a loved one sitting beside you and holding your hand during this time. I wonder now if we can talk a little bit about your plans and your vision for Hyperfine.

Maria: Of course. So, as I say, we bring the MRI scan to the patient. Right now, we're focused primarily on scanning the brain, but the opportunities to scan other parts of the body over time are really endless. So, I see two ways in which the Swoop is going to evolve. First across a variety of clinical applications or indications, and then into a very wide variety of sites of care, which, as you think about taking it globally, it just multiplies. Given the infrastructure that exists in some countries around healthcare, we're talking about anywhere from a critical care unit now down to the emergency department out into community clinics that don't have a scan today, possibly on mobile care units and on and on and on. It reminds me a little bit of my experience with external defibrillators, where they used to be on a big card in a hospital just to get a patient back from a cardiac arrest. And now there is one right outside my door in a little red canvas bag strapped to the wall in case one of our employees here has an event. So, I can't wait for the day where Swoops are literally everywhere.

Omar: Yeah, and that brings up an excellent point. We're bringing care to the patient in more ways than one, and it's not taking up that much real estate. And although I know you mentioned earlier you weren't competing with MRIs, traditionally MRIs, it's important to note that you take up less space.

Maria: That is correct. We definitely take less space. We definitely take less remodeling and shielding of rooms, which is expensive, but it also requires that real state and it requires some time to fit those environments to be suitable to host an MRI machine. So, we literally can just wheel into any medical facility, or any facility for that matter, and just plug it into an outlet and be ready to scan with the help of an iPad, which is an incredibly user-friendly interface.

Omar: Yes, that's awesome. And that's pretty cool too, just to see the technology being miniaturized, so to speak, or just being put in a place where you can move it very easily. I think that's the future of medtech, taking some of these larger bulkier solutions and making them smaller so they can be with the patient, so they can be mobile. I only think that that's going to grow in the future. And it has been growing since. I want to switch gears for a second and I want to talk about now. I know you've had a lengthy career, a significant career in medtech, but I want to ask you this. When you look at the challenges that the industry faces today, layoffs, supply chain issues, inflation, a pandemic, has there ever been a time that mirrored or came close to this? And I know I'm stretching it when I say a pandemic because that probably hasn't happened [before]. But when you see the other headwinds, has there ever been a time that has just remotely been like this, challenging?

Maria: Probably. You're right. The combination of all of the above makes it uniquely challenging. But where I really think having been in this industry for as many years as I have, maybe the pandemic is one where I tend to take the tailwinds more than the headwinds. And I realize that given the challenges that has brought to healthcare, technology can rise to the occasion and actually become an ally to the transformation that healthcare needs to have so that we can't just take staffing for granted, access for granted, proximity for granted anymore. So, I have seen an emergence and a thriving of technologies that I wouldn't say replace, but really close the gap from the health care that we all took for granted pre pandemic to what we're seeing now with the challenges. I mean, think about supply chain alone. There was an opportunity to rationalize inventories and part numbers across the industry to make sure that we were really manufacturing those that were the really important products.

Think about the ability or the impossibility of having sales personnel walk into accounts. And we started seeing an avail, proximity, companies like that being able to say, well, we'll just bring you into the OR. To train a physician via a monitor or via your phone or your iPad. And in our case, I really think that not only can we just be there, but if you think about it, whether we like it or not, internet works everywhere. We have a Swoop somewhere where the physician could be 700 miles away, a medical professional could be really far away. We're making it so that someone could push the button, obtain the images, the Internet would transfer those images so that someone remotely can make a decision as to what that patient should do before the patient even goes through costly, cumbersome, complicated transformation just to see whether they should really be transported for care or not. So, the beauty of what we do is be able to bring it to the patient, but I would say bring it to the patient really anywhere, everywhere, so that then the decision can be made as to how to triage that patient for optimizing the care and the help they might need.

Omar: Yeah, I think the technology, what we've seen throughout this time since COVID hit and we've faced all these headwinds, I think we've seen that the technology is key in bringing us forward, and I do agree with you on that. We've seen so many advancements and we've seen remote patient monitoring take so many different leaps. And digital health and telemedicine, we've just seen that grow by leaps and bounds, not only advances, but acceptance as well. Telemedicine is now becoming commonplace, and I don't think we're going to call it telemedicine anymore or remote patient monitoring. I think it's going to be called patient monitoring, and I can't coin that phrase. I have to give credit Dr Jim Mault, who was on here a few months ago, of BioIntelliSense, and he was saying how the industry is changing and how these headwinds are going to make it normal for us to drop the remote patient monitoring the digital health titles and just call it patient monitoring health care. Yeah, it's a tremendous change.

Maria: As I said, I think they could be written as headwinds, but if you tend to be as positive as I like to be, they can very clearly be converted and enabled through technology to become tailwinds and to become things that increase the sense of urgency around the changes that are going to render care better again for patients, for providers and the medical professionals as well, of course.

Omar: And forgive me, I'm a journalist, so I'm always pessimistic. I'm always pessimistic. But that positivity that you have, I'm sure that that comes in handy as a leader when we're looking at all of these different, I'll say tailwinds occurring in the industry, how do you keep up morale or how do you interact with the team and how do you bring that positivity up front and foster it?

Maria: There's a few things. I mean, business wise, I operate with tremendous amount of focus. I think it is really important that we narrow down what needs to happen to be successful and bring it down to a relatively short list. But once we know what that is, there really is an impetus to make sure that there's a lot of transparency and communication, to make sure that anyone around me in the organization has a very clear understanding of what those priorities are and how we win. And with that, I think people start really feeling part of the vision, the mission, the winning ticket.

So, I like to be very present. I like to be very transparent. It is interesting in a more hybrid or virtual world, how that has proven to be somewhat more challenging. I'm actually talking to you today from Guilford, Connecticut, which is where we have most of our technical team. But I also have a very large team virtually, and I've gone out of my way to find opportunities to interact with people via zoom or face to face as appropriate, just so that people get to know me and feel like I am approachable, accessible, but also incredibly transparent about the challenges, the opportunities, the priorities, the headwinds and the tailwinds.

Omar: Exactly. Well, Maria, thanks for coming on to let's talk medtech. This has been an incredible conversation and I'm sure I'm looking forward to hearing all about the good things from Hyperfine coming up in the recent months and over the next few years.

Maria: Thank you for the interest. I am very excited about what lies ahead of us and thank you for your time today as well.