Key Trends and Challenges Shaping the Future of Medical Device Innovation

Technological advancements and digital health integration

Technological advancements and digital health integration are pivotal in the medical device sector. Companies like Avant Technologies and Stryker are leveraging AI and digital tools to enhance patient care and decision-making. Intuitive Surgical reports significant growth in digital product adoption, underscoring the trend towards integrated healthcare solutions.

""Our mission is to utilize the latest advancements in AI, including the massive potential of future quantum computing, to create a healthcare ecosystem where healthcare applications can naturally incorporate smart features for patient care, ensuring that every patient receives the best possible care," said Kenneth L. Waggoner, CEO of Avant Technologies." --- (MDT, press release, 2024/08/14)

""care.ai will help Stryker significantly accelerate our healthcare IT and digital vision to provide customers with real-time, smart and connected decision-making tools that enhance the lives of caregivers and their patients."" --- (SYK, press release, 2024/08/12)

"We expect our measured rollout to continue through the first half of 2025. Adoption of our digital products and services grew nicely in the quarter, with routine use of My Intuitive App expanding to nearly 14,000 surgeons and surgeons using Intuitive Hub more than doubling versus a year ago." --- (ISRG, earning call, 2024/Q2)

"Our development efforts and diagnostics focus on developing new systems and creating new tests that play an important role in making healthcare decisions, expand the accessibility of testing and deliver a result as fast as possible." --- (ABT, earning call, 2024/Q1)

""This acknowledgement from MedTech Breakthrough inspires us to accelerate our vision to serve more patients in more places. The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data & Privacy, and many more."" --- (MDT, press release, 2024/05/09)

Shifts in market demand for medical devices

Market demand for medical devices is shifting towards heart-assist devices, automated insulin delivery, and capital products, as evidenced by growth in these segments. Companies like Abbott, Medtronic, and Stryker report strong demand and strategic positioning, while also facing challenges in meeting growth expectations in certain areas.

"In heart failure, growth of 9% was driven by our market-leading portfolio of heart-assist devices that offer treatment for both chronic and temporary conditions.In neuromodulation, growth of 8% was driven by strong demand in international markets for our Eterna rechargeable spinal cord stimulation device, which obtained CE mark in Europe last year.In vascular, we received FDA approval in late April for our Esprit dissolvable stent, a breakthrough innovation for people who suffer from blocked arteries located below the knee." --- (ABT, earning call, 2024/Q2)

"We believe this strategy positions us well and will drive our growth as the market continues to shift to Automated Insulin Delivery and Smart Dosing." --- (MDT, earning call, 2024/Q4)

"Demand for our capital products remained healthy in the quarter with continued elevated backlog across our Endoscopy and Medical divisions." --- (SYK, earning call, 2024/Q1)

"We have strong momentum with key end-market products and continue to advance our pipeline with significant clinical and regulatory milestones being attained. Our MedTech business delivered growth that fell below our expectations of growing in the upper range of our markets, which as you recall correlates to a weighted-average market growth rate of 5% to 7% from 2022 through 2027." --- (JNJ, earning call, 2024/Q2)

"The 5.1 percent increase in total net sales during the first three months of 2024, excluding the impact of foreign exchange, reflected higher sales primarily in the Medical Devices and Established Pharmaceuticals segments, partially offset by a decrease in demand for Abbott’s rapid diagnostic tests to detect COVID-19." --- (ABT, sec filing, 2024/Q1)

Regulatory challenges affecting medical device innovation

Regulatory challenges in medical device innovation are significant, as highlighted by Abbott's recent FDA approval process, which underscores the complexities of regulatory compliance. Additionally, Baxter faces hurdles due to raw material shortages, impacting their ability to meet demand and innovate effectively.

"This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks." --- (ABT, press release, 2024/04/02)

"These challenges, including the unavailability of certain raw materials and component parts, have also had a negative impact on our sales for certain product categories (including those acquired in our December 2021 acquisition of Hill-Rom Holdings, Inc. (Hillrom)) due to our inability to fully satisfy demand and may continue to have a negative impact on our sales in the future." --- (BAX, sec filing, 2024/Q1)

""Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization of two leadless pacemakers has been a significant challenge – one that Abbott engineers sought to solve," said Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer at Abbott's cardiac rhythm management business." --- (ABT, press release, 2024/08/15)

"Our new operating model has been vital in helping us isolate underlying challenges affecting this segment." --- (BAX, earning call, 2024/Q1)

"I think it’s going to be important to generate data, even if it’s not to communicate to payors to get reimbursement, but even if it’s to communicate to physicians, the primary care and the direct consumers, that there’s a value here of doing that.I think the key thing here is personalization and how do you personalize information and the data and the coaching, so the strategy here is, yes, you’re doing to have to use TV to be able to communicate, but I don’t think it’s--I don’t think given our experience here that you could just go on TV and blast." --- (ABT, earning call, 2024/Q2)

Funding and competitive landscape in medical devices

The funding and competitive landscape in medical devices is increasingly challenging, with longer selling cycles and pricing pressures noted by Intuitive Surgical. Companies like Abbott are focusing on innovative products to gain market share, while Stryker highlights difficulties in displacing established competitors.

"In addition, as overall competition for medical technologies, including robotic-assisted devices and treatment options, progresses in various markets, we will likely experience longer selling cycles and pricing pressures." --- (ISRG, sec filing, 2024/Q1)

"You know, we had patient registry data come out where we showed that 95% closure rates were achieved post implant and sustained after 45 days, 90% of closure success rate using Amulet, for patients that actually fail to achieve proper closure rate with a competitive product, so I think that there’s an opportunity here for our value proposition, and then we’ve got to continue to invest." --- (ABT, earning call, 2024/Q2)

"So I don't want to speak on behalf of all ASCs, right? If it's already an ASC, that's an orthopedic ASC, and there's entrenched surgeons that are using competitive products, that's a little harder for us to displace." --- (SYK, earning call, 2024/Q2)

"And you can see that grew by 52%. And this is where we see many of our customers moving from their operationalizing their robotics program to their standardizing now on robotics in surgery. And it's a function of their understanding of the clinical benefit and the fact that it's economically attractive because you get low complication rates, because you have lower length of step." --- (ISRG, event transcript, 2024/04/25)

""By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy. The LIFE-BTK trial, which evaluated Abbott's Esprit BTK System, was presented in October 2023 as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco and simultaneously published in the New England Journal of Medicine."" --- (ABT, press release, 2024/04/29)

Emerging trends in patient-centered design

Emerging trends in patient-centered design emphasize innovative solutions that prioritize patient outcomes. Companies like Spineology and Medtronic are developing technologies that enhance patient experiences, while Zimmer Biomet's data-driven platforms and Intuitive Surgical's robotic-assisted surgeries reflect a shift towards more personalized and effective care.

"With a strong commitment to patient-centered care, Spineology aspires to provide every spine patient the freedom from pain through the creation and delivery of ultra-MIS solutions." --- (SYK, press release, 2024/04/04)

"This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient. The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death." --- (MDT, press release, 2024/05/17)

"This is a platform that only Persona IQ has. It interconnects the data of the stem with a dashboard that, in a very objective way, can quantify how patients are doing in comparison to other patients with similar dynamics." --- (ZBH, earning call, 2024/Q1)

"Over 1 million urgent or emergent procedures were identified. During the study period, the use of robotic assisted surgery for all procedures experienced a 3.5-fold increase in cholecystectomy, a 6-fold increase for colectomy, and 38-fold increase in inguinal hernia repairs. Notably, increases in the robotic assisted approach corresponded to" --- (ISRG, earning call, 2024/Q1)

"across the globe. We had, a total of 716 patients came in 1 to 1 randomization and was focused on those patients that had smaller annuli where we thought the benefit might be the biggest. And then, of course, we did a very meticulous follow-up, and you'll consider see this data now, for the next 5 years." --- (MDT, event transcript, 2024/04/07)

Impact of artificial intelligence on medical devices

Artificial intelligence is poised to revolutionize medical devices, with the AI in healthcare market projected to grow at a 36.83% CAGR, reaching $613.81 billion by 2034. Innovations in robotic surgery, such as enhanced force feedback and 3D model manipulation, are set to improve clinical outcomes and surgeon proficiency.

"According to analysts at Precedence Research, the Artificial Intelligence (AI) in Healthcare Market is set for explosive growth, with a 36.83% CAGR between 2024 and 2034 to hit US$613.81 billion." --- (MDT, press release, 2024/08/14)

"We believe that force feedback and looking at force feedback through case insights, can improve their time to proficiency on the robot. When it comes to kind of longer term clinical outcomes and what force feedback and the data surrounding it, it's what Gary described." --- (ISRG, earning call, 2024/Q2)

"And then from the surgeon having this head end experience, when they're in the console, they'll be able to start accessing and controlling Intuitive 3D models, being able to manipulate them from the console with the controls there. And also, they'll have the ability to access and replay intraoperative video." --- (ISRG, earning call, 2024/Q2)

"I'm just curious how you see the impact on robotic surgery adoption and driving better outcomes from some of those dV 5 training capabilities that's going to roll out and how long some of this stuff actually is going to take?" --- (ISRG, earning call, 2024/Q1)

"Just a reminder for everyone, they have very sensitive sensors that are built into the distal end, in the body end of the instruments that are sterilizable and cleanable, and they report back contact forces with tissue which at a sensitive way, which has been a goal for us and for surgery for a long time." --- (ISRG, earning call, 2024/Q1)

Future outlook for medical device innovation

The future outlook for medical device innovation is promising, with companies like Johnson & Johnson and Abbott emphasizing their commitment to advancing health technology through strategic product development and robust pipelines. However, some uncertainty remains regarding specific surgical innovations, indicating a cautious approach to future advancements.

"As I said earlier, we are confident in the cultural fit between our organizations, and we believe that our shared patient centric missions, the strength of Shockwave's current and future portfolio and Johnson's and Johnson's capabilities will enable us to make a significant impact on cardiovascular disease." --- (JNJ, M&A Announcement, 2024/04/05)

"Our new product pipeline is helping us sustain top-tier growth as we create the future of health tech." --- (ABT, Twitter announcement, 2024/07/18)

"What that means for future surgery, I think there's a range of opinions and I would not hang a lot of confidence on any of them just yet." --- (ISRG, earning call, 2024/Q1)

"We consistently evaluate new business opportunities through a strategic and scientific lens to deliver value for patients and for Our preference is to be in areas in which we have internal capabilities and know how and also to pursue products that represent progress in improving the current standard of care." --- (JNJ, AGM, 2024/04/25)

"As you know, Johnson & Johnson is laser-focused on advancing the next wave of medical innovation." --- (JNJ, earning call, 2024/Q2)

Global market dynamics in medical devices

The global medical device market is shaped by strong relationships and strategic partnerships, as highlighted by companies like Johnson & Johnson and Abbott Laboratories. Their confidence in navigating market dynamics, including innovation and growth, underscores the importance of both developed and emerging markets in driving future opportunities.

"We are confident Johnson and Johnson's global footprint, professional education capabilities, deep regulatory and market access expertise and well established health system and physician relationships will enable the Shockwave business to achieve the full potential of its differentiated platform." --- (JNJ, M&A Announcement, 2024/04/05)

"Kevin, there's some easier comps. Can you just comment maybe on seasonal dynamics a little bit, and expectations around the health of the orthopedic market, the ability to see kind of that sustained growth rate through the back half of the year and then potentially into 2025?" --- (SYK, earning call, 2024/Q2)

"It fits right into our wheelhouse, where we’ve got relationships with governments, we have relationships with physicians, and we’ve got relationships with the distribution area. The question is how can you do it in--how can you execute that strategy that’s capital efficient and doesn’t erode gross margin of that business, and I give a lot of kudos to the team because they’ve really been able to position our presence in these markets as an advantage to these players that really aren’t focusing on emerging markets, they’re focusing more on the opportunity that exists in developed." --- (ABT, earning call, 2024/Q2)

"Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications." --- (MDT, press release, 2024/05/13)

"And so we think regardless of any pricing dynamics in the other markets and changes in political parties and things like that, we think that we're in a very good position to be able to continue to advance our innovation and to continue to grow our business, at above market rates." --- (JNJ, conference, 2024/06/12)