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Medical Design & OUTSOURCING

January 2024 • Vol.10 No.1 • medicaldesignandoutsourcing.com

EDITORIAL

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The medical device industry just wrapped up another year with more blockbuster mergers grabbing headlines around the world and new, innovative technologies emerging seemingly every day.

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This level of success wouldn’t be possible without the innovation, ingenuity and determination of the people who drive it: leaders. These individuals and companies are working for the growth of the entire medical device industry.

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Leadership and innovation in medtech 2.25”

reativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN). You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor. Our annual Leadership issue of Medical Design & Outsourcing features lessons from leaders at Recor and Medtronic. Both teams were propelled by faith in their technology’s ability to help tens or hundreds of millions of hypertension patients avoid strokes, heart attacks and other serious health risks linked to high blood pressure. Our cover features another device developer similarly striving to break new ground. Synchron is testing a catheter-placed brain implant in severely paralyzed patients to let them communicate via text and control smart devices. Co-founder and CEO Dr. Tom Oxley discusses this minimally invasive approach to restore function, as well as the leadership values that have brought the company to where it is now — and the unique ethical considerations of leading the way on brain-computer interface technology. This issue also features device advice and design tips from medtech leaders at Intuitive Surgical, Zimmer Biomet, Boston Scientific, Johnson & Johnson MedTech’s Cerenovus and 3D-printed orthopedic device developer Restor3d. We wrap up 2023 with a look back at the top medtech personnel moves of the year, and take a look forward with a schedule of the top device industry events of 2024 — including DeviceTalks Boston in May and October’s DeviceTalks West in Santa Clara, California. At DeviceTalks West 2023, Intuitive President Dave Rosa offered this advice (read more from Rosa in our robotics department): “Keep your head down and do the work. … Make sure you can get to a place where you can really impact the world. That’s a cultural thing.” It’s good advice for all of us with an exciting 2024 ahead. As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.

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CONTENTS

medicaldesignandoutsourcing.com • January 2024 • Vol. 10 No. 1

• • • • • THE LEADERSHIP IN MEDTECH ISSUE

DEPARTMENTS 06 HERE’S WHAT WE SEE:

Leadership and innovation in medtech

ON THE COVER OPENING THE BRAIN’S SECRET BACK DOOR

MANUFACTURING:

3D-printed orthopedic implant benefits also present challenges

ORTHOPEDICS:

REGULATORY:

ROBOTICS:

Zimmer Biomet’s Liane Teplitsky on the ‘magic’ of data integration

Synchron CEO Dr. Tom Oxley discusses advances in minimally invasive neurointervention, medtech leadership, advice for device developers, and ethics at the bleeding edge of braincomputer interface technology.

What Medtronic learned on its long road to renal denervation approval Intuitive’s Dave Rosa offers advice for perseverance and surgical robotics

38 SUSTAINABILITY:

Boston Scientific’s Kathryn Unger on how to stand up an ESG program

44 TUBING:

Cerenovus President Mark Dickinson on the future of stroke care

FEATURES

AD INDEX 58

HOW RECOR MEDICAL WON THE RENAL DENERVATION RACE FOR FDA APPROVAL

“Getting a renal denervation therapy to market is one of the biggest wins” in medtech, said Recor Medical CEO Lara Barghout.

64 MEDTECH’S BIGGEST PERSONNEL MOVES OF 2023

DEVICETALKS:

Here’s our medtech events calendar for 2024

Medical Design & Outsourcing

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From hirings and firings to promotions, resignations and surprising shake-ups, these were the medtech industry’s most important leadership changes of the year.

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MANUFACTURING

3D-printed orthopedic implant benefits also present challenges 3D-printed orthopedic implant personalization and manufacturing abilities introduce new considerations for device developers.

Jim Hammerand Managing Editor

-printed orthopedic implants are increasingly being used for patient personalization and features that improve osseointegration. Faster, better and more affordable additive manufacturing technology is driving that adoption for ortho implant developers and manufacturers like Restor3d. “The thing I’m most excited about is doubling down on this thesis that people deserve personalized implants — and that it’s actually possible now,” said Nathan Evans, SVP of product development at Restor3d. “Twenty years ago, it wasn’t possible. Ten years ago, people started doing it, but it wasn’t cost-effective. Today, it’s effective and able to be done in an extremely scalable and accessible way.” Restor3d specializes in 3D-printed spine, foot and ankle, and upper extremity ortho implants, while Conformis — which Restor3d purchased in September 2023 — makes personalized knee and hip replacement implants.

Medical Design & Outsourcing

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Restor3d uses metal and polymer 3D printing for orthopedic implants, anatomical models and surgical tools and guides.

In an interview with Medical Design & Outsourcing, Evans offered some basic know-how on 3D printing for orthopedic implants and how Restor3d and Conformis use additive manufacturing. 3D-printed orthopedic advantages Restor3D and Conformis use a kind of 3D printing called selective laser sintering (SLS) to make custom implants personalized for individual patients based on CT scans. SLS printing uses lasers to build the implants layer by layer out of powdered metal such as titanium. “Why should it be a one-size-fitsall business model where everybody gets an off-the-shelf knee?” Evans said. “… Every person is unique: their biomechanics, their body type. That deserves patient-specificity from an implant perspective. The data does show — and science helps paint the story — when you have a patientspecific implant, the outcomes are better and patients are more satisfied.”

Photo courtesy of Restor3d

SLS printing also allows for detailed surface geometry that encourages osseointegration, or bone growth into the implant for stable and secure fixation. 3D-printed, patient-specific instrumentation offers yet another advantage over non-personalized instrumentation in that it can better guide surgeons as they cut and drill. That reduces the need for assistance from surgical robotics systems, Evans said. “They don’t need a robot’s aid in placement and cutting and prep, because the instruments now do it, whereas before that wasn’t the case. The instruments were generic, and that’s why we needed assistance,” he said. (continued on page 14)

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MANUFACTURING Restor3d SVP of Product Development Nathan Evans

(continued from page 12)

“Our surgeons have given us that feedback, [saying] ‘I actually rely on navigation and robotics less than I did before because your instrumentation is so precise.”

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3D-printed orthopedic challenges While porous implant surfaces help with osseointegration, those surfaces also pose challenges. “The more porous you make something, now you have deep inside of an implant a place for particulate to possibly get trapped, and you have new considerations with regards to things like cleaning,” Evans said. “How are you going to effectively validate your cleaning process to prove that you’re able to extract any contaminants and residuals? There’s upside for sure, but then you’ve got these interesting downsides.” Another potential downside of porosity is that it could make a device weaker, so that adds another layer of complexity for engineers to test and design for. Patient customization has drawbacks as well. Because the product specifications vary from patient to patient, they can’t be inspected for quality in the same way as a mass-produced implant. “With traditional implants, it’s more linear dimensions. You can take a caliper and measure X, Y and Z,” Evans said. “But if you’ve got these highly organic, curved surfaces, how do you inspect that? It’s not easy.” Restor3d inspects its customized implants with coordinate measuring machines, microscopes and profile comparators, among other traditional methods. A part can be 3D scanned, but it’s laborious, time-intensive and costly. “The other challenge, interestingly enough, is a lot of those 3D scanners actually work best on matte surfaces,” Evans said. “A lot of our implants are extremely shiny and polished. The scanners do not work well on that. So then you’ve got to apply a coating to it [and then] take it back off.” For now, that limits 3D scanning to R&D parts because Restor3d doesn’t have a validated method to remove that spray-on coating. (continued on page 17)

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MANUFACTURING

(continued from page 14)

Materials for 3D printed ortho implants Restor3d and Conformis use traditional manufacturing techniques for certain components that can’t be 3D printed or don’t need to be, like a total knee’s polyethylene bearing. But most of what the companies make is 3D printed with titanium, cobalt chrome and — for certain accessories — resin-based polymers. “Titanium in general is for fusion applications,” Evans said. “And cobalt is generally for arthroplasty, your highly polished bearing surfaces. … We print a ton of polymers as well in-house, not for implants but for ancillary instrumentation: things like trials, cut guides and impactors.” Regulatory considerations and sterilization Regulatory standards are a massive variable that can’t be overstated, Evans said. Because 3D printing for medical devices is still relatively new, the FDA

is trying to keep up with the quickly evolving market. “We have a very collaborative relationship with the FDA,” Evans said. “But it is a continuing challenge to make sure that the devices meet quality and regulatory standards and that there are appropriate standards for these devices.” Restor3d ships most of its patientspecific implants non-sterile to hospitals, where they are sterilized with steam in autoclaves before they’re implanted. However, it uses gamma radiation to sterilize its OsseoRebar nails before shipping. Conformis sterilizes its patientspecific implants before shipping, primarily with ethylene oxide. “Part of what we’re thinking through right now is kind of understanding how we envision providing these long term. I do think it’ll be sterile, but we’re looking at even novel sterilization methods [such as vaporized hydrogen peroxide] to make sure that can be done in a timely, cost-effective way,” Evans said.

Coatings for 3D printed ortho implants Infection control is always a concern in orthopedic surgery, and porosity makes that even more challenging. Antimicrobial coatings are among the technologies that Restor3d is constantly evaluating, along with other coatings and surface treatments that could, for example, further promote osseointegration. “One of the challenges of porous structures — again, it’s the same thing with cleaning — if you’ve got porosity that is not line of sight, how do you make sure the coating effectively gets there?” Evans said. “A lot of the coating technologies are done via deposition, which is line of sight, so it can only hit what you’re spraying at. So, some of the newer methodologies are more like a dip where it would directly coat the whole thing, but this technology needs to evolve a little bit.” While Restor3d is not currently commercially pursuing any coating technologies, “we’re a technology-first company, so we’re always going to be looking at things like that.”

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ORTHOPEDICS

Zimmer Biomet’s Liane Teplitsky on the ‘magic’ of data integration Zimmer Biomet’s president of robotics, technology and data offers data integration advice, identifies opportunities beyond orthopedics and discusses tech she’s looking for.

immer Biomet is collecting more data than it knows what to do with — and that’s a great opportunity, says Liane Teplitsky. Teplitsky is the orthopedics developer’s president of global robotics and technology and data solutions. Her domain has expanded rapidly since she joined Zimmer Biomet from Abbott’s cardiac arrhythmia business in 2020. Back then, Zimmer Biomet’s ZBEdge digital and robotic technology suite consisted of the mymobility patient care app and the Rosa surgical robotics system for brain and total knee procedures. Now, ZBEdge also includes OptiVu mixed reality technology, Persona IQ smart implants, AI-powered Omni Suite operating room products and the analytics expertise of a data science team. In an interview with Medical Design & Outsourcing, Teplitsky offered data integration advice for medical device designers and engineers, highlighted data opportunities beyond orthopedics and discussed the technologies she’s looking for. “The key to the portfolio isn’t only that we have a whole bunch of products,” she said. “It’s really about the data and the interconnection of data between all of those products. We have a large quantity of data that’s coming in — basically, all the products now that we’re launching either collect data or generate data. … The real magic happens in integrating all that data together.”

Jim Hammerand Managing Editor

Data integration is the future Zimmer Biomet products are collecting more data than ever. The mymobility app collects patient data before and after a joint replacement procedure, the Rosa surgical robotics system collects data during surgeries, and sensors inside Persona IQ smart implants can track a patient’s recovery. 18

Medical Design & Outsourcing

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Zimmer Biomet’s Persona IQ smart knee implant has sensors to measure device performance and patient recovery. Image courtesy of Zimmer Biomet

Those smart implants can also sense vibration to measure the implant’s stability and how well it’s integrating into the bone, according to ZB sensor partner Canary Medical. “We’re moving further upstream in the data that we collect — so earlier on in the patient’s journey — and then further downstream as well with Persona IQ that can collect data up to 10 years post-surgery,” Teplitsky said. “If we can really understand and have all of that information, pull it all together, and now integrate it together — that’s the hard work of our data science team — [that’s] really where I think the future is going to be.” (continued on page 20)

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ORTHOPEDICS (continued from page 18)

Collecting more data before and after a patient’s surgery will help device manufacturers develop new and improved devices and procedures for better outcomes, including customized approaches for individual patients. All this data analysis will also help device developers find more efficient ways to treat patients, not only reducing surgical costs and times, for example, but also identifying when a virtual follow-up might be a better choice for a patient than an office visit. “If you can catch a patient before a complication happens or if you can improve the throughput that the surgeons and hospitals and surgery centers have, that also can help on this holistic cost of care,” Teplitsky said.

Zimmer Biomet’s Rosa robot-assisted surgery system Image courtesy of Zimmer Biomet

Keys for data integration “Objective measures of data are critically important to be able to guide data-driven decisions,” Teplitsky said. (continued on page 23)

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ORTHOPEDICS (continued from page 20)

But serious consideration of data privacy and security — how you collect patient data, store it and use it — should be the first step in that direction. “If you’re looking at building out and leveraging data, you need to make sure that you have the methodology behind that data privacy and data security really buttoned up,” she said. “We have a saying at Zimmer Biomet that the patient is always the patient and never the product.” With so many global rules and regulations around data privacy, device developers must understand the cost of compliance, which “becomes quite a heavy lift if you look at all the different countries and their own data gardens around the world,” Teplitsky said. And Teplitsky emphasized that ease of use is key for data integration. Clinical data coming your way from patients needs to be in a format that’s usable if you want to generate insights to improve care. “We’re going to be able to take all of this amazing information from a patient’s full continuum of care and we’re going to generate insights that can be really valuable to patient outcomes, to patient recovery, maybe even to patients and how we treat them — the right patient at the right time with the right intervention,” she said. Medtech’s biggest data opportunity is in the feedback loop The best opportunities for medtech to take advantage of data — even beyond orthopedics — is in the feedback loop, offering a better understanding of “a patient’s full continuum of care versus just in an OR setting,” Teplitsky said. “There’s so much more that we can do in creating that feedback loop,” she said. “Looking at the patients preoperatively, are there additional diagnostics that can be done to help them along their journey? And then postoperatively, can we really help them with their recovery? … Are there things that we can understand from a patient’s pre- and postoperative path that can be fed back in to help define what we’re actually doing in the OR?” Using an orthopedic implant as an example, she said there might be ways to optimize positioning of the implant to accelerate a patient’s recovery based on recovery data for certain patient populations. >> Medical Design & Outsourcing

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ORTHOPEDICS

Canary Medical’s Canary Health Implanted Reporting Processor (CHIRP) goes inside the tibial extension segment of Zimmer Biomet’s knee prostheses. Image courtesy of Canary Medical

Zimmer Biomet’s OptiVu mixed reality lets surgeons and patients visualize a procedure together using Microsoft HoloLens 2 headsets. Image courtesy of Zimmer Biomet

Medical Design & Outsourcing

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“Whatever technology you happen to have — advanced instrumentation, 3D-printed implants, super accurate cut positioning with a robot, an arm that makes sure that the saw is held really solidly intraoperatively — It’s the feedback loop that lends itself to what you really should be doing intraoperatively for that best outcome and leverage whatever technology is available to ensure that,” Teplitsky said. Offering another ortho example, she said data collection and analysis might help identify a patient on their way toward a total knee replacement in time to do a partial knee instead, an earlier intervention that might lead to a better outcome. “There are parallels in other areas of medtech as well where if we could better understand the trajectory of our patients in that feedback loop, we can start really being more upfront about that really idealized, personalized medicine that could give our patients the best possible outcomes,” Teplitsky said.

Technologies on Teplitsky’s radar: Smarter, faster and better Asked what technologies she’s looking for to give ZBEdge new or improved capabilities, Teplitsky said she’s looking for tech that can help in one of three ways. “For ZBEdge in general, the goal is smarter, faster, better,” she said. “Smarter meaning objective measures of data across the continuum of care for those insights. Faster is efficiency, and better is better value and improved cost of care.” That could mean taking consumergrade technology that patients, surgeons and care practitioners already use and adopting it to make Zimmer Biomet’s products easier to use. “Mixed reality is a great example of something that if it can accelerate more quickly — the technology itself — we’re going to be in great shape,” she said. “We already have products on the market in a partnership where you can actually visualize what has come across in a CT scan of the hip, look through the OptiVu mixed reality glasses and almost like a video game be helped to position the tools that you’re using intraoperatively.” As those visualization tools get more accurate and equipment in operating rooms collect and share more data, that will improve the quality and utility of information during a procedure, she said. Smart sensors — like those that Canary Medical develops for Zimmer Biomet — also have huge potential for increased data collection. “The sensor technology that we have within our Persona IQ and the information that’s coming across on it today, some of that information — because it’s brand new — we’re not totally sure how to use it,” Teplitsky said. “The insights that we’ll get as we get more and more patients across all of these different platforms and being able to interconnect those together, that’s going to build up the data analytics.”

Zimmer Biomet President of Global Robotics and Technology & Data Solutions Liane Teplitsky

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REGULATORY

What Medtronic learned on its long road to renal denervation approval

Medtronic’s Symplicity Spyral catheter has four electrodes that deliver radiofrequency energy to overactive nerves that help regulate blood pressure.

Medtronic Coronary and Renal Denervation President Jason Weidman shares advice on device design, clinical trials and regulatory hurdles.

Photo courtesy of Medtronic

t took Medtronic nearly 13 years to win FDA approval for renal denervation (RDN) since buying Ardian and its hypertension-treating technology. Jason Weidman, the Medtronic SVP who is also president of coronary and RDN, has a more personal measure of the long road to approval for the world’s largest medical device manufacturer. “The first meeting that I had with the startup Ardien, my daughter was a newborn — and she [is now in] high school,” he said in an interview with Medical Design & Outsourcing. In November, the FDA approved an RDN system developed by Recor Medical, and followed soon after with approval for Medtronic’s Symplicity Spyral RDN system. Both RDN systems treat hypertension by calming overactive nerves in the renal arteries with a minimally invasive ablation catheter procedure. Among other differences, Recor Medical’s Paradise system uses ultrasound energy, while Medtronic’s Symplicity Spyral system uses radiofrequency energy. That decade-plus offered many lessons for Medtronic and other RDN developers, including some who bowed out after clinical trials failed to show efficacy. The following conversation has been lightly edited for space and clarity.

Jim Hammerand Managing Editor

MDO: What lessons did Medtronic take away from its RDN efforts? Weidman: The No. 1 lesson when you talk about a long journey like this is one of perseverance. It’s never a straight line path to bring a new technology to market, and in particular developing 26

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a new therapy. We went along that path, and there have been a lot of other really successful medical devices in history or pharmaceutical drugs in history that have had similar paths that have not exactly been straight. We’ve had some bumps along the way, but here we are. We’re at a great spot, and I couldn’t be more thrilled. MDO: How do you keep up that perseverance? How do you keep yourself going, and how do you keep the team going? Weidman: We always center ourselves on the patients. Medtronic is a very mission-driven company, and I don’t think there’s any bigger mission than trying to help the world’s hypertension crisis. With over 1 billion people worldwide with hypertension, it’s the world’s largest contributor to death. Less than 20% of hypertensives across the globe are at target blood pressure. This is a huge problem, and to go after this problem is super motivating. When you have an approach where the science behind it is sound and we knew that we could make a big difference — sometimes that’s all you need. MDO: What did Medtronic learn about device design through its RDN efforts? Weidman: In 2014, our original pivotal trial, Hypertension 3 (HTN-3), used our original device design. While we were safe and while RDN lowered blood pressure, at that time we did not show a difference versus the control. (continued on page 28)

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REGULATORY

(continued from page 26)

And so we had to reassess our program and reassess our device design. Speaking specifically about device design, one of the things that we learned — which is typical for medical devices — is you want to make procedures as easy and repeatable as possible while still achieving your clinical objectives. So we changed our device design at that time from one where you had a single application of the therapy with a single-point device to one with multiple points of therapy application with one press of the button, so to speak. And so we just made the system more repeatable and easier to use. That was really helpful for us going forward. MDO: You’re talking about the four electrodes rather than one, correct? Weidman: We went from one electrode to this spiral pattern where we have four placed at 12, 3, 6 and 9 o’clock so you get that spacing all around that vessel to give you the maximium chance at getting effective

Medtronic’s Symplicity Spyral renal denervation ablation catheter expands inside the renal arteries and ablates nerves in the vessel wall to treat hypertension. Illustration courtesy of Medtronic

ablation. What’s also super important about the Spyral device is that it’s a one-size-fits-most device to treat virtually all patients. We don’t have multiple-size devices. We have one device that treats most patients’ vessel sizes from 3 mm to 8 mm. It’s a nitinol-based device that allows it to expand in that spiral pattern and almost fill the diameter of the vessel. In our clinical trials, we only had about 3% of patients fall out for anatomical exclusions, and that’s much different than other devices and other trials. For instance, if you look at the Recor trials, they excluded about 26% of patients due to anatomical reasons. MDO: What other clinical and regulatory lessons did Medtronic take away from its RDN efforts? Weidman: We learned a lot about the procedure, how to run those trials and the difficulty of doing trials where patients are on hypertensive medications because it’s hard to control patient behavior. With the procedure, we learned after HTN-3 — there’s been countless preclinical studies and cadaver studies — that to maximize your chances at effective ablation you need to go into the branch arteries of the kidneys. That’s what the science will tell you. And so we changed where we went with our device and ablated not only the main arteries, but we started to go into the branches. And we really think

that’s going to be critically important to get strong, sustained long-term results, which we see with our catheter. From a clinical trial perspective, the big thing we learned is how we do our best to control what’s going on with the patients so that they’re not changing their medications — which can obviously impact the results — or if they are, we know what’s going on. In our latest series of trials, we do blood and urine testing of the patients so we know exactly what is in their system. Patients will tell you that they’re taking their medications or they’re not changing their medications, but that’s not always the case, and we can actually see that in these latest versions of our trials because of those tests. MDO: Are there any other insights you’d like to share that might be helpful for other device developers? Weidman: While randomized, shamcontrolled studies had been done in the medical device space in the past, they really came into being with RDN. I believe that there are more or nearly as many sham-controlled studies in the RDN field as there are in the rest of medical devices combined. It’s a new bar, but when embarking on these types of studies, you have to be very careful and precise in your clinical trial design and be very clear in doing what you can to make sure patient behavior is consistent between your control arm and your treatment arms. MDO: Approval seemed questionable after this summer’s FDA review panel votes. How did Medtronic overcome that challenge? Weidman: We were always really hopeful. One of the real strengths of our program and one of the good parts about being on a long journey is we have a lot of positive clinical data. It’s not very often you see a brand-new device come in front of the FDA for approval that has over 4,000 patients in clinical trials across five different studies and 2,000 patients out to three years. It’s kind of difficult to get to the nuances of all of that data and the breadth of all of that data in a single-day panel with a lot of panelists that haven’t really spent much time on RDN before. (continued on page 31)

Medical Design & Outsourcing

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Go to wtwh.me/RDNafib for more from Weidman and Medtronic EVP and Cardiovascular President Sean Salmon on RDN’s potential for atrial fibrillation.

REGULATORY

Medtronic SVP and President of Coronary and Renal Denervation Jason Weidman (continued from page 28)

We have the benefit of working with FDA over a long period of time, and we were pretty confident that FDA had a good understanding of the totality of the data and really appreciated the benefits that this therapy could bring. MDO: What were conversations with the FDA like in the months before approval, and what were the key points of focus? Weidman: The conversations over the last couple of months were really a continuation of conversations from the past year or even many years. The process with FDA has been collaborative for a long time. We’ve worked with them throughout to make sure we were providing what they wanted to see. But at the end of the process, as with the end of any process for a new therapy, you’re zeroing in on things like indication, postmarket studies, final labeling tweaks and things like that. MDO: Any last thoughts to share? Weidman: There’s a tremendous unmet need with patients. And it’s not just that you have less than 20% of hypertensives with their blood pressure uncontrolled, but it’s that these patients really want other options. Studies run in countries across the globe to understand a patient’s interest and willingness to have a procedure to treat their blood pressure consistently show a pretty large percentage of patients are looking for something like this. We’re in a great spot to help a lot of patients, and we’re going to fill a void that’s desperately needed for this global epidemic of hypertension. Medical Design & Outsourcing

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Intuitive Surgical’s da Vinci system is the most popular and widely used surgical robotics system. Photo courtesy of Intuitive

Intuitive’s Dave Rosa offers advice for perseverance and surgical robotics “There’s a ton of work to be done. That’s what keeps me excited,” Intuitive President Dave Rosa said.

ou might remember the naysayers in the early days of surgical robotics development. They said surgeons would never use them and that hospitals would never pay, comparing surgical robotics systems to paperweights. “I heard it all. I’ve been called everything,” Intuitive Surgical President Dave Rosa said in a keynote interview at DeviceTalks West with DeviceTalks Editorial Director Tom Salemi. It would have been easy to give up in the face of that derision. But today, Intuitive Surgical is the leader in surgical robotics, a field that has drawn competitors ranging from startups to giants like Medtronic. Intuitive has placed more than 8,000 multi-port and single-port systems around the globe and racked up more than 12 million procedures, including approximately 1.8 million in 2022. “I do see us as the leader, as the pioneer,” said Rosa as he offered his

Jim Hammerand Managing Editor

Medical Design & Outsourcing

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perspective on perseverance and shared advice for medical device developers. “Competitors and the growing field, it’s so exciting [because] that validates the ... blood, sweat and tears that our team has put in to forge this field and show that there is benefit with robotics. We can do things better, not only bringing more minimally invasive surgery to the world, but doing it with better options than laparoscopy could. ... And now we have big and small companies coming in and saying, ‘We can make a difference too.’” He offered two bits of advice specifically for smaller surgical robotics developers. “Keep your head down and do the work. ... You think you’ve got it, then you don’t — 1,000 times, almost daily. Make sure you can get to a place where you can really impact the world. That’s a cultural thing,” Rosa said. (continued on page 34)

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ROBOTICS

(continued from page 32)

He also advised them to seek spaces that are not dominated by an industrial player or where patient outcomes are already really, really good. “Today we’re in soft tissue surgery and lung biopsies for the most part, and we’re doing a great job, in my opinion, and data show it,” Rosa said. “There are lots of other parts and lots of other places in the body that are not as well served.” “That blue ocean/red ocean aspect is an important part is to think about,” he continued, referring to market strategy terms coined by Chan Kim and Renée Mauborgne. “How do I, as a young entrepreneur, build a sustainable business? What am I trying to accomplish? Get back to that core: what problem am I trying to solve? Is it a me-too robot? Do I just want to grab some of the market share and I’m

Medical Design & Outsourcing

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happy with whatever percent of the existing market? Or am I going to do something new, and really move the needle for patient outcomes?” Rosa shared a key lesson he’s learned about scaling a business over the past two decades of his career. “It’s easy to conceive something and say, ‘OK, this is what I want to build.’ The next step is engineering that and making a prototype that works in the lab. And then the next step is in the clinical setting and doing a clinical trial, and the next step is selling that to a customer and having them be willing to pay for it and valuing the work that you put in and all of that,” he said. “It’s hard engineering work. But it’s not the really hard work of scaling the business, and to me that’s where the bar is.”

“Keep your head down and do the work. ... You think you’ve got it, then you don’t — 1,000 times, almost daily. Make sure you can get to a place where you can really impact the world. That’s a cultural thing.”

(continued on page 37)

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ROBOTICS

(continued from page 34)

“The reliability that our products have, the continuity of supply when you’re at scale, needing to supply millions of components a year to your customers every day because they count on you and your system for their patients. That gets harder as you go up that curve.” But it was those early engineering days that pulled the Intuitive team together in the face of adversity and negativity, he said. “We more or less started out in cardiac surgery. We were making inroads. We were laying our teams off at certain times, couldn’t raise money, all those same questions,” Rosa said. “When we could get the system to work as we wanted, it was magical, like you knew you had something. It would work for three minutes and then break, but we knew we had something. And so our job was, we believe we have the recipe, we just had to continue to repeat it and get the recipe so it tasted good every time. ... What helped keep us grounded through the early years was that specialness.” “What keeps us going — we still face many of those same challenges — is [that back then] it was a belief. Now, it’s provable data I can show CEOs or whoever it is questioning me or our teams about the efficacy or the economics of the system. Let me show you the data. And to me, that’s just so powerful. And we’re nowhere near done. Open surgery is so prevalent, poor outcomes are so prevalent across the globe. There’s a ton of work to be done. That’s what keeps me excited.”

Intuitive Surgical has developed and launched four generations of surgical robotics systems, including the da Vinci SP. Photo courtesy of Intuitive

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SUSTAINABILITY

Boston Scientific’s Kathryn Unger on how to stand up an ESG program and other things like that. We’re all doing this together. If we’re not asking questions, challenging, wondering what we can do to accelerate this, it’s going to take so long.”

Jim Hammerand Managing Editor

athryn Unger, VP of Environmental, Social and Governance (ESG) at Boston Scientific, joined the medical device developer and manufacturer in September 2022 to form the ESG team. “The patient is and must be at the center of everything we do,” she said on a DeviceTalks Boston 2023 panel sponsored by Canon Virgina. “We’re constantly trying to ensure that we have the absolute best patient outcome from a risk-to-the-patient perspective, period. That has to be our guiding principle, right? However, that’s not an excuse to not improve the design of our medical devices. … There has to be product stewardship that starts before you get to the manufacturing piece. And that design needs to be circular and consider the full life cycle.” Unger had advice for companies that want to launch their own ESG function or get some traction, and encouraged the industry to take a cooperative approach for everyone’s benefit. “We’re all learning together,” she said. “For example, we’re pretty far along on the E, but we’ve got a lot of work to do in product stewardship 38

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Where to start with ESG “I’m so proud to say that ESG is not new to Boston Scientific,” Unger said. “At our company, it’s actually grounded in science, in tangible action and in accountability. And we’ve been doing it for over 20 years. … More and more people are aware of what we need to be doing and getting engaged.” Even if an organization has never had a formal ESG function, there are likely already bits and pieces everywhere you look. “Find out the work that’s already happening in your organization,” Unger said. “We have people calling us, sending us emails, talking about the work they’re doing locally, whether they’re doing it in the E space trying to calculate their own carbon footprint and we tell them, ‘Hey, we’ve got members of our teams who are doing that.’” In 2017 — well before Boston Scientific hired Unger for ESG — the company pledged to go carbon neutral and has since made its science-based target commitment and had it validated. And back in 2010 when Boston Scientific set up shop in Costa Rica, the facility was designed with LEED (Leadership in Energy and Environmental Design) certification in mind. “It was important to our facilities team at that time. That wasn’t a corporate initiative, that was a facilitieslevel initiative,” she said. Engage — and reward — everyone Boston Scientific’s ESG team now includes Associate Director Jamie Mercurio and Senior Project Manager Marina Vornle von Haagenfels. (continued on page 40)

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SUSTAINABILITY

(continued from page 38) “Three people can’t do all of ESG throughout the organization,” Unger said. “It’s got to be an ESG mindset that permeates the organization.” One way to do that is to set goals and communicate results to encourage progress, even if they’re small steps in the right direction. “By setting a target, by holding yourselves accountable and measuring to that, and by communicating it companywide, you get there,” Unger said. For example, Boston Scientific publicly sets and tracks annual goals for increasing the share of leadership positions held by women and minorities. At bonus time, incentive pay is partially tied to ESG: 5% for hitting targets related to increasing women and minorities in leadership, another 5% for employee engagement, and a final 5% for hitting environmental goals.

“So 15% of our total incentive is tied to our ESG scorecard,” Unger said. “And so by doing that, it’s not just the three of us working to get this done. It’s a whole company mindset and everyone’s engaged.” Another key is to remember that ESG supports your company’s mission, and that’s a way to further engage the entire organization. “At Boston Scientific, ESG and our business value are not mutually exclusive. They’re very intertwined,” she said. “As you’re building out your own ESG functions or trying to really accelerate on the E side, making sure that it is value-driving is really important because it’ll help bring the rest of the organization along with you.” Enlist suppliers in the effort Boston Scientific is aiming to completely eliminate nonrenewable electricity sources from its operations in a bid to

eliminate greenhouse gas emissions from fossil fuel power like gas, oil and coal. The company is already at 100% renewable power in the U.S. and Europe, and 76% globally. An even greater source of greenhouse gas emissions comes from Boston Scientific’s supply chain. Those are “Scope 3” emissions by assets that Boston Scientific doesn’t own or directly control, but that are influenced by the company’s operations. “We’re looking at our suppliers from a number of different perspectives … Scope 3 actually equals more than what’s in our own house,” Unger said. “It’s the entire tail of our supply chain.” Boston Scientific is asking its suppliers to reduce their emissions, and also asking the suppliers to ask the same of their own suppliers all the way upstream. (continued on page 43)

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SUSTAINABILITY

(continued from page 40) “We’ve got some credibility in having that conversation with them because we’ve done that ourselves. … Are we there yet? No, this is the beginning of that journey for us all,” Unger said. Don’t assume opposition from investors For those who wonder how to justify ESG to investors, Unger says she sees more buy-in from stockholders than opposition.

perspective,” she said. “And by the way, U.S. medical systems are now using some of the same tenders that we saw being used in Europe in the past. Our U.S. medical systems themselves are getting on board with reducing their own environmental footprint.” An organization that has taken some of the big first steps — reducing

“As you’re building out your own ESG functions or trying to really accelerate on the E side, making sure that it is valuedriving is really important because it’ll help bring the rest of the organization along with you.” “Our investors are interested in what we’re doing in the E and the S. … We’re not exactly experiencing strong resistance,” Unger said. Investors, she said, are more interested in “what are we doing, what’s our plan, when’s the right time to start each piece of this?” “We’re having these conversations and making these choices. … It’s not having to convince investors or having to convince our leadership. It’s our customers pulling and us trying to keep up,” Unger said. Listen to customers “We are now really starting to unpack what it’s going to take to get to more sustainable design,” Unger said. “What has encouraged that? Candidly, look at everything coming out of Europe. We’ve got the EU Corporate Sustainability Reporting Directive, we’ve got Germany talking about, ‘Maybe we won’t buy singleuse devices ever.’” Customers are still driving the call for ESG more than new regulations, Unger said. “Again, ESG and business value are intertwined. We’ve got our customers demanding this. … If your customer’s demanding it, and if 40% of your sales are outside of the U.S., then that’s a strong reason to do it from an outside-of-U.S.

nonrenewable energy consumption, for example — might then turn its attention to sustainable design. That could include the use of recycled or recyclable materials, or redesigning single-use, disposable devices so they can be safely reprocessed and re-used. Hospital systems are asking Boston Scientific about standardizing the recyclability and disassembly of medical devices to streamline the process. “I am a firm believer that standardization at the end of the day reduces cost and simplifies and makes it easier to adopt change no matter what,” Unger said. She encouraged device makers to help customers manage their expectations, however. “Don’t think that happens overnight, because the design has to be vetted and properly approved and all of those things take time,” she said. “But if we don’t start now, we won’t get there. And so we are starting.”

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Boston Scientific VP of Environmental, Social and Governance Kathryn Unger

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Medical Design & Outsourcing

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TUBING

Cerenovus designed the Cereglide 71 catheter for direct aspiration and up to three stent retriever passes.

Cerenovus President Mark Dickinson on the future of stroke care

Image courtesy of Johnson & Johnson MedTech

The leader of Johnson & Johnson MedTech’s neurovascular device business forecasts the innovative technologies that will advance stroke care in the coming years.

t’s getting harder to beat aspiration systems for fast and simple thrombectomies to remove blood clots that are blocking oxygen from a stroke patient’s brain. That’s according to Cerenovus Worldwide President Mark Dickinson, who discussed the future of stroke care in an interview with Medical Design & Outsourcing. “It’s a very simple concept that the larger the tube you can get to face the blood clot, the more likely you’re going to be able to evacuate that clot just through suction,” he said. “And advances in technology have enabled us — and, candidly, others in the marketplace — to be able to design these larger bore, larger sized devices to get to destinations that they would never have been able to get to before.” While there will still be stubborn clots that call for stent retrievers, aspiration is a simpler technique that requires less skill, which could help expand access to stroke treatment in the U.S. and abroad. Great

Jim Hammerand Managing Editor

Medical Design & Outsourcing

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engineering is only partially responsible for getting thrombectomy treatment as far as it’s advanced, he said. “It’s mostly through highly skilled physicians being able to treat these patients,” he said. “But there are just so many people out there who are having a stroke. ... By 2050, almost 10 million people a year are going to die from a stroke, so we really need technologies and methodologies that the masses can use and not just be reliant upon the skills of the 100 top doctors around the world.” Cerenovus — a unit of Johnson & Johnson MedTech, the world’s secondlargest device manufacturer — recently launched the Cereglide 71 catheter for direct aspiration as well as delivery of the Cerenovus Embotrap clot retriever. This next-generation aspiration catheter is the ﬁrst aspiration device that Cerenovus has developed through the efforts of its Neuro Thromboembolic Initiative (NTI) scientiﬁc research arm. (continued on page 46)

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TUBING

“[We] put these products through the most physical tests we possibly can so when we take them to a patient, we’ve got high confidence that we’re going to be successful. ... The anatomy is so complicated. It’s so varied. And it can be challenging from one patient to the next.”

(continued from page 44) “Anybody can make a device and make it track well in one of these simple anatomical models that we traditionally would test these devices on, and then you take that device to the real world and it doesn’t perform to the level that either we would hope for or our customers are expecting,” Dickinson said. “[We] put these products through the most physical tests we possibly can so when we take them to a patient, we’ve got high confidence that we’re going to be successful. ... The anatomy is so complicated. It’s so varied. And it can be challenging from one patient to the next.” Like other neurovascular device developers, Dickinson envisions robotics and remote technology expanding access. “At J&J we’ve got massive investment going into our robotic technologies,” he said. “At the moment, it’s focused more on general surgery and orthopedics. But there’s definitely potential for crossover into the future. We’ll see that evolve. It’s going to take time for that to be a really meaningful player in terms of procedure volumes in the neurovascular space, but for sure it will come.” Until that time, Dickinson said, “our objective in the short- to medium-term is just to make sure that the device that gets to the clot can effectively remove the clot. The robotics piece — we can plug into those things in the future as needed.” Dickinson offered a taste of other potential advances in stroke care. The Cerenovus team in Galway, Ireland, has

Cerenovus Worldwide President Mark Dickinson 46

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a couple of research projects looking into whether sensors on the tip of a catheter could use light spectroscopy or impedance measurements to see into a clot and help determine the best way to treat it. However, physicians would prefer a single device that can handle any clot quickly, he said. “Ultimately, we want to design a device that can be completely agnostic to the type of clot.” There’s currently an arms race for super-bore catheters that can get into the M1 segment of the middle cerebral artery, which is the most common artery for stroke-causing blood clots. But the winning solution will likely be more of a system than just a catheter. The big differentiator after catheter design, Dickinson thinks, will be in the rest of the system with features such as cyclic aspiration, which is also called intermittent or pulsatile aspiration. Instead of binary on/off suction to remove the blood clot, cyclic aspiration rolls the vacuum through different cycles to disrupt particularly stubborn clots to make them easier to remove. “That’s where you’re going to see the most innovative changes in the space in the next five years,” he said. “There’s a lot of research and development going on in that space right now. And I know others are looking at that as well. ... We’re seeing a very strong signal in terms of our ability to remove clots that we know from our clot science work with previous techniques have been very difficult to budge, so we’re pretty excited about it.” He declined to share more details, citing a need to protect proprietary information. Asked for advice he would share with other medical device developers from his medtech career, he offered an old adage that “still remains very true.” “Fail fast,” he said. “Bring your concept quickly and find the right way to test it [with] benchtop models and test methodology to really put something through its paces. Do that early. And if you’re failing, scrap and start and move on to the next one.” “Speed to market is so important, so don’t waste time,” he continued. “If something’s not working, get on to the next thing.”

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SYNCHRON

A conversation with Synchron co-founder and CEO Dr. Tom Oxley

JIM HAMMERAND MANAGING EDITOR

Synchron co-founder and CEO Dr. Tom Oxley giving a TED Talk with an image of the Stentrode device displayed behind him. Photo courtesy of Synchron

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DR. TOM OXLEY DISCUSSES ADVANCES IN MINIMALLY INVASIVE NEUROINTERVENTION, MEDTECH LEADERSHIP, ADVICE FOR DEVICE DEVELOPERS, AND ETHICS AT THE BLEEDING EDGE OF BRAIN-COMPUTER INTERFACE TECHNOLOGY.

hat seems like a miracle today — a paralyzed patient regaining the ability to communicate with their family without open-brain surgery — may eventually seem obvious in retrospect. It already does to Dr. Tom Oxley, the interventional neurologist who's CEO and co-founder of brain-computer interface (BCI) developer Synchron. Synchron's Stentrode device is implanted inside a blood vessel in the brain to sense neural signals and relay them to another implant in the chest. Those signals are then translated into digital commands, allowing the patient to communicate electronically or control smart devices. The FDA has given breakthrough device designation to the system, which Synchron is testing in six patients through its COMMAND trial. It's the first FDA investigational device exemption (IDE) for any company assessing a permanently implanted BCI. (continued on page 51)

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SYNCHRON

(continued from page 49)

In an interview with Medical Design & Outsourcing, Oxley discussed Synchron's mission and technology, device development challenges and ethical considerations of BCI innovation. "Our vision is to build neurotechnology that solves the limitations of the human body. That's a broad scope," he said. "What we're building is an interventional, bloodvessel-based product that can sense or stimulate in all areas of the brain. We think there's a wide range of ways that can be applied, but our mission right now — the shorter-term mission — is to be the first to commercialize a braincomputer interface for motor impairment to help millions of people who are not able to access any treatment." Synchron is pushing toward FDA approval and commercialization before competitor Neuralink. Both companies are backed by billionaires: Jeff Bezos and Bill Gates are in Synchron's corner, while Neuralink is owned by Elon Musk — who reportedly tried to invest in Synchron to hedge his bets. Minimally invasive catheter delivery through the jugular vein and endothelialization of the nitinol Stentrode electrode stent are some of the biggest advantages for Synchron's system over Neuralink, which plans to place its implant with open-brain surgery. Oxley traces the idea back to his time in med school with co-founder Dr. Rahul Sharma, now director of structural interventions at Stanford Healthcare. "He loved the heart, I love the brain," Oxley said. "And I was always looking at what he was interested in like, 'Why isn't that happening in the brain yet?'" Cardiologists now use advanced catheters for cardiac mapping and ablation and to place pacemakers, replacement valves and other implants. "If that trajectory that happened in cardiology happened in the brain, imagine a world where you can have a procedure to have your brain mapped with electrophysiological data, and then some therapy [and] it's fixed — no cutting of the skull," he said. "... For me, that's inevitably going to happen in the brain. And hopefully we can deliver." He sees opportunities for minimally invasive endovascular applications for epilepsy and deep brain stimulation, >>

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SYNCHRON

and looks at the trajectory of interventional cardiology growth relative to cardiothoracic's diminution and sees a universal trend that also applies to neurointervention. "My dream was to bring neurointervention into the electronics era, and that includes sensing and stimulating. If all goes well, we will have created products that open up avenues to treatment of conditions that haven't otherwise yet been possible," Oxley said. " ... Neurointervention has a very bright future for neuroprosthetics, brain monitoring, brain mapping, ablation, and deep brain and brain stimulation. We have plans to do all of those." So why hasn't anyone done what Synchron's doing? The key to the brain's secret back door How do you get into a patient's brain without cutting a hole in their skull,

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which risks complications such as infection, stroke, seizures, brain swelling and nerve damage? The same way interventional neurologists can now mechanically remove clots blocking blood to the brains of stroke patients. The recent explosion in neurovascular catheter technology opened the door for Synchron and created ranks of neurovascular physicians primed for new technologies, particularly elective procedures and devices.

The Synchron Stentrode brain implant expands inside a blood vessel, placing its electrodes against the vessel wall to sense brain signals. Image courtesy of Synchron

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SYNCHRON

“Hardware and software that let us live our lives with just the click of a button means that you can deliver high impact to your activities of daily living from a small amount of input into a digital device.” At the same time, tech features from the likes of Amazon, Facebook, Google and Apple make it easier to communicate, shop and perform other daily tasks electronically. "Hardware and software that let us live our lives with just the click of a button means that you can deliver high impact to your activities of daily living from a small amount of input into a digital device," Oxley said. But no one's ever built a stent connecting to a lead before, presenting Synchron with a variety of novel challenges, including long-term safety. The catheter delivery challenge was a combination of three factors to be solved: the lead, the connection from the lead to the Stentrode implant, and the radial force of Stentrode itself. "We had some necessarily stiff components of our system that needed to be offset with flexible components to achieve delivery. Delivery has been a huge challenge for us. ... We're still working through it now. We're still making trade-offs," he said. Advice for other device developers "You have to take it step by step," Oxley said. "... Engineering perfection will stop you from getting to market quickly [and] learning. Maybe engineers don't like and trust physicians that much, but give physicians a chance." One example: the advent of flow-diverting stents, with Medtronic's Pipeline embolization device beating Stryker's Surpass to market. Stryker took longer "because they wanted to get the stiffness right. Pipeline came out really quick, but they had a very stiff device," Oxley said. "You know what? The physicians could handle it. And the mechanical problem that hadn't been solved pushed over to the physicians in the field, and they solved it."

tenacity and sense of urgency." That leadership style has morphed into company values as Synchron has grown to around 70 employees. Oxley said he's learned the importance of establishing and emphasizing those values to build a shared culture. "They give people a framework to fall back on for decision-making when they're not sure what to do," he said. At Synchron, common sense is an aversion to dogma in favor of pragmatism and meritocracy. "Every idea should be counted on its merits," he said. Sense of urgency — or bias for action — means empowering people to make a decision and keep moving. The company makes decisions with a personal, patient-first perspective: "Our quality policy is that our devices are good enough to be put in our loved ones," he said.

Resilience is hard to build in a culture, and it's something you often can't teach. "People are either resilient or they're not. But I certainly hire for that. I really respect it," he said. He also deploys the leadership concept of extreme ownership, which is "basically how able are you to absorb responsibility for things that are outside your obvious locus of control." "If you start to take on things that you're not actually responsible for, but you think you can impact them, everyone's circles are overlapping," Oxley said. " ... I have a bad reaction to people who have a problem absorbing responsibility, throwing blame or saying, 'That wasn't that wasn't my thing to do.' Especially in a startup, it really matters that you can reach out and try to own things that maybe you didn't necessarily need to." Another leadership tenet is what they call "respectful candor," or the ability to be upfront and open and speak one's mind without being rude, pejorative or dismissive. "If you trust and respect everyone, you can make a really direct comment. >>

Synchron's brain-computer interface (BCI) system uses the Stentrode brain implant to sense brain signals and relay them to a receiver implant in a patient's chest. Illustration courtesy of Synchron

Leadership lessons Oxley encourages speed from the corner office with a leadership style he described as "common sense, resilience, www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

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SYNCHRON

But you have to believe that the person you're speaking to was doing their best, because when you start to think that they were not doing their best, then you can lose respect for people," Oxley said. Many of these values that Oxley's prioritizes have come from his background in neurointervention, which he called "a brutal subspecialty." "You're up in the middle of the night, and when complications happen in your intervention, it's life-threatening and it's at the end of your fingertips," he said. "You have direct responsibility, and bad outcomes happen and then you have to deal with that." BCI ethics There's now a new responsibility to grapple with. Our thoughts are the only place where we are truly private, but minimally invasive BCI technology that can read brain signals might open a

door that can't be closed. "I think the reason implantable brain-computer interfaces have captured the imagination of the public is because the technology points toward a potential of overcoming a limitation in the brain's capacity to fully express itself," Oxley said. "And that limitation is the control of the muscles of the body to provide verbal and nonverbal communication, which never quite captures what's actually going on in your brain. We all have that feeling that you can never quite get across exactly what's happening. That speaks to the limitation that we have. Our brains have much greater potential than what our bodies can live up to. And so that's the principle by which — the idea that we are bypassing the human body as the mechanism of expression of the brain's state." Asked how he grapples with potential harm from more advanced

BCI technology in the wrong hands, Oxley said the benefits outweigh the risks, comparing it to the rise of artificial intelligence or the automobile. "BCI is going to progress humanity. It's going to relieve suffering and it's going to improve capability in all directions. So then how do you protect against the nefarious things? It's a serious question," Oxley said. "I think relative to the other risks that are out there right now — for example, with AI where there's zero regulation — we have very strict regulation with implantable devices going into the brain. There's a whole cybersecurity section that we're working on with the FDA. We have to be able to describe all of the possible flaws in our system. The FDA is doing an excellent job at regulating the safety of implantable medical devices, and we're keeping up with that." (continued on page 56)

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The Synchron BCI system includes the Stentrode implant, lead, and chest implant (top left) that wirelessly transmits data to a decoder to translate the signals into digital commands. Image courtesy of Synchron

(continued from page 54)

Synchron's currently only working in the motor control part of the brain, and it uses a different analytics process than might be able to measure brain signals for truthfulness or evasiveness, for example. "We're at the beginning of something brand new. ... The brain is a huge place with lots of different areas to go and we're going to have to depend on the FDA that when we start going into those areas of the brain where there is risk of [abuse], there are absolute safeguards in place," Oxley said. For now, the potential benefits are clear and keep the Synchron team moving forward. Oxley described observing a patient as their system is activated and they regain control for the first time. "They make a selection on the screen and their faces light up, they smile, they look at their wife. ... it's this most incredible moment," Oxley said. "They have restored connection with their family. We feel like we've just given them back some element of agency."

Go to wtwh.me/synchron for more, including BCI basics, the plan to beat Neuralink to FDA approval, and an interview with new CTO Riki Banerjee.

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RECOR MEDICAL

How Recor Medical won the renal denervation race for FDA approval JIM HAMMERAND MANAGING EDITOR

Recor Medical CEO and President Lara Barghout

"GETTING A RENAL DENERVATION THERAPY TO MARKET IS ONE OF THE BIGGEST WINS" IN MEDTECH, SAID RECOR MEDICAL CEO LARA BARGHOUT.

t’s been a long wait to see the FDA approve renal denervation for treating hypertension. Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN (uRDN) system. While they were celebrating, the team learned that the very first commercial procedure had just been completed. “After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done 58

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— they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotional moment for the team to be talking together at a townhall and then getting the news about the patient.” In an interview with Medical Design & Outsourcing, Barghout discussed the long road to approval, the technology that made it possible, and how Recor accomplished what medtech giants could not over the past decade.

“It’s incredible to have the first renal denervation therapy launched through a company with this passion and technology. … We also want to get it to as many patients as we can,” she said. “And it was great to see that we were able to do that so quickly after approval.” Dueling RDN technologies Recor won a race that Medtronic — now the largest medical device manufacturer in the world — has been running since buying RDN developer Ardien in 2011. (continued on page 60)

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Boston Scientific was a contender with its Vessix RDN technology, but bowed out after a failed trial in 2018. The stakes are huge. More than 1.2 billion people have hypertension worldwide, but most don’t have it under control, causing heart attacks, strokes, kidney damage and premature deaths. Medtronic estimates renal denervation could be a multibillion-dollar business. “Getting a renal denervation therapy to market is one of the biggest wins that the world of devices has seen in a really long time,” Barghout said. Medtronic and Recor designed their competing systems to ablate overactive nerves between the brain and the kidneys that help regulate blood pressure. RDN therapy uses minimally invasive catheters inside the renal arteries to apply energy and calm those nerves in the artery walls, lowering a patient’s blood pressure. Recor seemed lined up for approval in August when medical and statistical experts on the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee determined the Paradise Ultrasound RDN system was safe and effective. One day later, those experts voted that the risks of Medtronic’s technology outweighed its benefits. Recor’s first-of-its-kind uRDN system hit all of its primary endpoints in clinical trials. While Medtronic’s trials hit their safety targets in 2014 and 2022, they missed their primary endpoints on efficacy. Medtronic’s Symplicity Spyral RDN system uses a self-expanding radiofrequency catheter with four electrodes to apply that energy. Recor’s Paradise system delivers two to three seven-second sonications to heat a controlled ablation zone of up to 6 mm. At the same time, water circulates inside the balloon catheter to protect the blood vessel’s endothelium from the heat. “The most important thing as the denervation procedure is being done is to be able to reach the nerves in the renal artery to make sure there’s been denervation and that the therapy is actually effective,” Barghout said. “Having 360-degree sonication is one of the biggest differentiators besides the fact that it’s an ultrasound wave.” 60

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RECOR MEDICAL

Medtronic congratulated Recor for its FDA approval, calling it “a significant milestone in the field of RDN and for patients and physicians.” The FDA approved Medtronic’s RDN system less than two weeks later. Recor’s believers Barghout joined Recor in January 2023 after four years at Siemens Healthineers, where she was SVP and head of advanced therapies for North America. Before that, she spent nearly 19 years at Terumo, ultimately becoming SVP of global commercial operations at Terumo Cardiovascular. One of the things she’s learned about Recor’s employees in her first year at the helm is how passionate they are about the technology they’ve been developing for so long. “They are big believers that it actually is effective. One of the things that

continue to drive them is the confidence they have in the fact that this technology is actually going to yield phenomenal results for patients,” she said. “It’s simple because the theory behind the therapy — and if you look at how our product is designed — it’s extremely natural to know that this is going to be effective.” That kept them pushing toward the finish line and lifted them over their biggest hurdle: designing the clinical trials to demonstrate the system’s value. “Creativity, being able to be consistent, be rigorous, and be patient about recruiting the right patients and continuing to support the protocol that they all aligned on with our physician partners is what really continued to drive them,” Barghout said. “There were three randomized, sham-controlled studies that we did and the minute that the first study resulted in positive outcomes — our Solo trial — that’s when they knew they just

had to finish it off.” Each small milestone and continued confidence in the therapy gave them “the breath to continue on,” she said. In 2018, venture capital firm Sofinnova Partners sold Recor to Otsuka Medical Devices, which provided financial stability to keep device development and clinical trials on track even through COVID-19 pandemic disruptions. “The continuous breath that they had from the Otsuka side to continue to support the team was also a pretty significant portion of how the team continued to keep going,” Barghout said. Trial design Because Recor’s Paradise system hit its endpoints in all three trials, “the potential of not having an FDA approval was extremely low in our books,” Barghout said. >>

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info@qosinaeurope.com

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1/9/24 11:07 PM

RECOR MEDICAL

The Recor Medical Paradise uRDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. Illustration courtesy of Recor Medical

“Our goal was to continue to drive until we got to an FDA approval,” she said. “There was no backup plan, and if we were not able to meet that goal in those three clinical trials, we probably would have run more — but it was not necessary.” She credited the Recor team with developing “solid” trial protocols and for their specific patient selection criteria. The involvement of medication was a challenge for Recor’s trials and hypertension device trials more broadly. “Mainly what really is needed is for patients to adhere to the medication protocol, whether it’s an onmed or an offmed trial, and to adhere to the follow-up that’s needed after the procedure is done,” Barghout said. To improve patient compliance, clinical trial subjects received a single pill combining three common antihypertensive medications. Intake observation and urine sampling ensured patients consistently took their meds, ensuring clean data to compare Paradise uRDN against the sham. And it can be a challenge to find patients willing to participate in a shamcontrolled trial because they might not want to be part of the control arm that doesn’t get the treatment. “The protocol was rigorous, and the patient selection was rigorous, and the team continued to drive according to the plan,” Barghout said. 62

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What’s next Recor is planning for growth to get more doctors on board and more patients treated. Some of the first procedures were conducted by cardiologists who participated in the clinical trials. Others had been waiting for FDA approval to use the system for the first time. Barghout said Recor has between 300 and 500 employees. They’ll be joined by new colleagues not only on the commercial side, but also new hires in innovation and R&D, for the clinical team, and infrastructure. “The first thing is we continue to drive for commercialization, but also we have a huge passion for innovation,” Barghout said. “We’re going to continue to innovate in the world of hypertension therapy, we’re going to continue to innovate

in creating and developing data to prove that this therapy is an important part of the world of healthcare and that it can help patients live a healthier life.” She also sees potential for more innovation in the sympathetic nervous system and treating other chronic diseases with denervation. “I’m always inspired when I talk to physicians after they treat their patients to understand how the patient’s journey was and how would they be after the procedure,” Barghout said. “That, for me, is what Recor is all about. We are a mission-driven organization. We think about patients first, and we think about everything else after that. I’m really excited to see the team with all the hard work that they’ve done, that we are able to hit all the goals that are in front of us.”

This illustration depicts three sonications delivered by the Recor Medical Paradise uRDN to ablate the nerves that run alongside the renal arteries. Illustration courtesy of Recor Medical

Read more from our interview with Barghout at wtwh.me/barghout, including leadership lessons and what she’s looking for in job candidates as the company expands.

www.medicaldesignandoutsourcing.com

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PERSONNEL MOVES

SEAN WHOOLEY ASSOCIATE EDITOR

JIM HAMMERAND MANAGING EDITOR

Medtech’s biggest Johnson & Johnson MedTech Worldwide Chair Tim Schmid

of 2023 FROM HIRINGS AND FIRINGS TO PROMOTIONS, RESIGNATIONS AND SURPRISING SHAKE-UPS, THESE WERE THE MEDTECH INDUSTRY’S MOST IMPORTANT LEADERSHIP CHANGES OF THE YEAR.

he leadership change at Johnson & Johnson MedTech was a surprising shift that ended up as the year's biggest personnel move in the medtech industry. In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world's second-largest device manufacturer. She's staying on into the first quarter of 2024 while her successor, Tim Schmid, gets settled into his new role. Schmid, a 30-year J&J vet who was most recently company group chair of J&J MedTech Asia Pacific, said he's "committed to building even further on the progress we’ve already made.” “While I recognize that we have more work to do, I’m focused on

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further advancing our impact and our competitiveness," he said in the final weeks of 2023. "Our goal is clear. It is to be No. 1 or No. 2 in every market that we compete.” Here are more of the top medtech personnel moves of 2023, starting with the world’s largest device manufacturer. Movement in and out of Medtronic There has been plenty of change at Medtronic. Sometime around the beginning of 2023, Medtronic promoted Surgical Robotics President Mike Marinaro to EVP and president of the new Surgical operating unit. Medtronic declined to say when, exactly, the change took effect, as it made the change without a public announcement while consolidating its

Former Johnson & Johnson MedTech Worldwide Chair Ashley McEvoy

surgical robotics and more traditional surgical devices into a single operating unit. In the C-suite, Medtronic hired Scott Cundy as chief quality officer. Cundy returned to Medtronic after nearly 13 years at Danaher. Medtronic also created the new role of chief technology officer and hired Ken Washington to fill it. Formerly chief technology officer at Ford, Washington most recently served as VP and GM of consumer robotics at Amazon. Medtronic also hired Paolo Di Vincenzo as the president of its neuromodulation business. Di Vincenzo joined from Smith+Nephew, where he served as SVP and GM of U.S. advanced wound management. (continued on page 66)

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PERSONNEL MOVES

(continued from page 64)

Medtronic departures included EVP and Chief Human Resources Officer Carol Surface, who was recruited by Apple to serve as its first chief people officer. Cardiovascular Diagnostics and Services President Julie Brewer left to become Baxter’s president of patient support systems, global surgical solutions and care communications. And Medtronic Spine & Biologics VP and GM Carlton Weatherby joined Inspire Medical as chief strategy officer.

Solventum CEO Bryan Hanson

Zimmer Biomet CEO leaves to lead 3M HealthCare spinoff Bryan Hanson resigned as Zimmer Biomet’s president and CEO to become CEO at Solventum, 3M's soon-to-becompleted healthcare business spinoff. This move set in motion a series of executive changes at both companies and across medtech.

Zimmer Biomet President and CEO Ivan Tornos

Zimmer Biomet promoted Chief Operating Officer Ivan Tornos to president and CEO and made other leadership changes. 3M, meanwhile, hired Insulet CFO Wayde McMillan to lead the spinoff's financial operations, while 3M HealthCare President Jim Lavers departed to make way for Hanson. Intuitive Surgical’s new president Intuitive Surgical promoted Dave Rosa to president, leading the product, digital, quality, regulatory, supply chain, manufacturing and commercial teams as the surgical robotics developer expands globally. Intuitive also named Bob DeSantis to the new role of EVP and chief strategy and corporate operations officer. Recor Medical switches gears Recor Medical — which became the first renal denervation developer to win FDA approval for treating hypertension — (continued on page 69)

to healthcare’s biggest challenges M AY 1 - 2 , 2 0 2 4 66

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PERSONNEL MOVES

(continued from page 66)

started its monumental year by naming Lara Barghout as its new CEO and president to lead global commercialization. The former Siemens Healthineers and Terumo executive succeeded Andrew Weiss, who as CEO since 2013 led the technology’s development, clinical trials and FDA submission. New CEO at Silk Road Medical Silk Road Medical hired Chas McKhann as CEO to replace retired CEO Erica Rogers. McKhann was formerly CEO of Apollo Endosurgery, which Boston Scientific acquired for $615 million in April. Cordis board chair becomes CEO Former Spectranetics CEO Scott Drake became executive board chair at Cordis and then took over as CEO, replacing Shar Matin when he stepped down as CEO in November.

GE HealthCare hires from Baxter and Amazon GE HealthCare hired former Amazon executive Dr. Taha Kass-Hout as its first chief technology officer. GE HealthCare also hired Jay Saccaro as SVP and CFO after a 21-year career at Baxter, most recently as CFO. Baxter hired Sysco vet Joel Grade to replace Saccaro as EVP and CFO.

GE HealthCare Chief Technology Officer Dr. Taha Kass-Hout

Abbott promotes finance execs Abbott promoted CFO Robert Funck to EVP of finance and named Philip Boudreau as CFO and SVP of finance.

Boston Scientific Chief Medical Officer Dr. Ken Stein

Boston Scientific replaces chief medical officer Dr. Ken Stein became Boston Scientific’s chief medical officer, taking over for Dr. Ian Meredith, who retired from the role he held since 2017. Stein joined Boston Scientific in 2009 as SVP and chief medical officer of its Rhythm Management business. >>

Orthofix picks new CEO after terminating trio of execs After merging with SeaSpine, Orthofix ousted CEO Keith Valentine, CFO John Bostjancic and chief legal officer Patrick Keran, terminating them with cause after an investigation found “repeated inappropriate and offensive conduct.” Orthofix later announced Massimo Calafiore as its new CEO. Calafiore, the former CEO of LimaCorporate, started as Orthofix CEO and president in January 2024 after Enovis completed its acquisition of LimaCorporate. Distalmotion selects former Zimmer Biomet exec as CEO Switzerland-based Distalmotion appointed Greg Roche as its CEO as the company continues commercial expansion of its surgical robot. Roche most recently served as CEO of soft tissue robotics company AvateraMedical, and before that was global president of robotics and technology at Zimmer Biomet. Shockwave Medical hires Abbott exec as CMO Intravascular lithotripsy technology developer Shockwave Medical named Dr. Nick West as its CMO-in-waiting. The former CMO and divisional VP of global medical affairs at Abbott Vascular will take over for Dr. Keith Dawkins in mid-2024. www.medicaldesignandoutsourcing.com

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PERSONNEL MOVES

Biosense Webster’s new president Johnson & Johnson's Biosense Webster chose Jasmina Brooks as its next president. She succeeds Michael Bodner, who is now the global head of heart recovery for J&J MedTech.

Biosense Webster President Jasmina Brooks

BD elevates Brooke Story Becton, Dickinson & Co. (BD) promoted Brooke Story to president of its Surgery unit. She previously served as president of the Integrated Diagnostic Solutions unit. Story joined BD in 2021 after 15 years at Medtronic, where she led the Pelvic Health and Gastric Therapies business.

BD Surgery President Brooke Story

Insulet restructures executive team Insulet shuffled its leadership team to accelerate innovation and commercialization, splitting the role of chief commercial officer into two new

leadership positions for the automated insulin delivery technology developer. Eric Benjamin, who served as EVP of innovation and strategy, became chief product and consumer experience officer (CPXO). Mark Field, previously the group VP of software engineering, took over as chief technology officer. Insulet EVP and Chief Commercial Officer Bret Christensen left the company and later became CEO and president of DermTech, a noninvasive skin genomics platform developer. Dexcom hires first chief commercial officer Dexcom appointed medtech veteran Teri Lawver to the newly created role of chief commercial officer. Lawver spent two decades in leadership roles at Johnson & Johnson, spanning the medical device, consumer medtech and pharmaceutical sectors. LivaNova searches for a new CEO LivaNova CEO Damien McDonald resigned following several pipeline disappointments, including its Caisson transcatheter mitral valve replacement and a heart failure indication for vagal nerve stimulation. LivaNova Chair William Kozy has served as interim CEO since then. As of press time, LivaNova had not named a permanent CEO. iRhythm's COO resigns iRhythm Chief Operating Officer Douglas Devine resigned in a move that the company said was related to its ongoing “business transformation.” Devine — who previously served as CFO — will remain an executive advisor through July 3, 2024. CFO leaves Integra Lifesciences Integra Lifesciences CFO Carrie Anderson left medtech to serve as EVP and CFO of Campbell Soup Co. Go to medicaldesignandoutsourcing. com and massdevice.com for the latest personnel moves at medtech developers, manufacturers, suppliers and other partners.

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www.medicaldesignandoutsourcing.com

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AD INDEX Able Electropolishing......................................65 Actuonix Motion Devices, Inc.........................70 Additive Manufacturing Users Group............68 Aerotech...........................................................60 AllMotion............................................................6 Altech Corporation........................................8, 9 Argon Medical.................................................56 AVNA formerly Okay Ind.................................67 BMP Medical....................................................30 Cadence...........................................................17 Canon U.S.A. Inc..............................................21 Carl Stahl Sava Industries................................52 Cinch Connectivity.............................................1 Clippard............................................................11 COMSOL..........................................................25 Confluent Medical Technologies.............47, 71 Del-tron............................................................15 Eagle Stainless Tube & Fabrication, Inc.........31 Filmecc USA, Inc, subsidiary of Asahi Intecc USA..................20 Freudenberg Medical......................................57 HEIDENHAIN CORPORATION......................19 Hobson & Motzer..............................................7 Integer..............................................................42 Interpower........................................................36 John Evans' Sons, Inc......................................34 Kahle Automation............................................33

Keystone Electronics Corp................................5 KNF Neuberger...............................................35 Lee Spring Company.......................................55 LEMO USA, Inc................................................41 Master Bond.....................................................69 maxon................................................Back Cover Medbio iNC.....................................................54 MICRO Medical...............................................51 New England Wire & Tubing Technologies..... 45 Nitto Kohki U.S.A. Inc......................................23 Onanan.............................................................40 P-DUKE Technology Co., Ltd..........................59 Paragon Medical................................................2 ProMed Molded Products, Inc.......................29 PSN Labs..........................................................27 PTI Engineered Plastics...................................63 Qosina..............................................................61 Resonetics............................ Inside Front Cover Rohm GmbH....................................................50 Rotor Clip.........................................................16 SigmaTron........................................................13 Smalley.............................................................22 Solar Atmospheres..........................................14 Sorbothane......................................................37 Steute Meditech, Inc..................cover/corner, 3 Stock Drive Products/Sterling Instrument......... 39 Tegra Medical....................... Inside Back Cover

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Medical Design & Outsourcing

1/10/24 12:13 AM

DEVICETALKS

Here’s our medtech events calendar for 2024

Medtech events have a new energy to them after the COVID-19 pandemic as industry insiders once again seek opportunities for inperson networking and learning. Here are medtech events that we'll be following and attending in 2024, including our own DeviceTalks conferences and expos.

American Heart Association Scientific Sessions McCormick Place Convention Center Chicago sessions.hub.heart.org/home/ promotion/22877679/2024-aha-conferences

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Radiological Society of North America Annual Meeting (RSNA) McCormick Place Convention Center Chicago www.rsna.org/annual-meeting/ future-and-past-meetings

MARCH 5-7 APRIL 8-10 MAY 16-19

Heart Rhythm 2024 Boston Convention and Exhibition Center heartrhythm.com

JUNE 21-24

DeviceTalks West Santa Clara Convention Center Santa Clara, California west.devicetalks.com

Design of Medical Devices Conference University of Minnesota Minneapolis dmd.umn.edu

American Diabetes Association Scientific Sessions Orange County Convention Center Orlando, Florida professional.diabetes.org/ scientific-sessions

SEPT. 29 OCT. 2

JAN. 9-12

North American Spine Society Annual Meeting (NASS 2024) McCormick Place Convention Center Chicago www.spine.org/am

RAPS Global Regulatory Strategy Conference 2024 Hilton Baltimore BWI Airport Linthicum Heights, Maryland www.raps.org/events/raps-globalregulatory-strategy-conference-2024

American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting Walter E. Washington Convention Center Washington, D.C. www.astro.org/Meetings-and-Education/ Micro-Sites/2024/Annual-Meeting

OCT. 27-30

The MedTech Conference Metro Toronto Convention Centre Toronto themedtechconference.com

American Association of Neurological Surgeons Annual Meeting (AANS 2024) McCormick Place Convention Center – North Building; Chicago annualmeeting.aans.org

JUNE 20-23

RAPS Convergence Long Beach Convention & Entertainment Center Long Beach, California www.raps.org/convergence2023/2024-call-for-proposals

American College of Cardiology Scientific Session (ACC.24) Georgia World Congress Center Atlanta accscientificsession.acc.org

Society of Robotic Surgery Annual Meeting Conrad Orlando Orlando, Florida srobotics.org

OCT. 16-17

Medical Alley Association Annual Dinner Location TBD Minneapolis-St. Paul area medicalalley.org/events

AAOS 2024 Annual Meeting Moscone Center San Francisco www.aaos.org/annual

SEPT. 25-28

MAY 3-6

DeviceTalks Boston Boston Convention and Exhibition Center boston.devicetalks.com

CES 2024 Las Vegas www.ces.tech

TCT 2024 Walter E. Washington Convention Center Washington, D.C. www.crf.org/crf/news-andevents/events-calendar

DEC. 10-13

HIMSS Orange County Convention Center Orlando, Florida www.himssconference.com

FEB. 12-16

MD&M West Anaheim Convention Center Anaheim, California www.imengineeringwest.com

APRIL 6-8

JPM Annual Healthcare Conference (JPM 2024) The Westin St. Francis San Francisco 2024.jpmhealthcareconference.org

DEC. 1-5

NOV. 16-18

OCT. 15-17

SEPT. 17-19

MID-MAY

MAY 1-2

MARCH 11-15

FEB. 6-8

JAN. 8-11

Chris Newmarker Executive Editor

NextMed Health Hotel del Coronado San Diego www.nextmed.health

www.medicaldesignandoutsourcing.com

1/10/24 12:14 AM

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