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Recall Aftermath Who is Gaining Share in the Sleep Apnea Devices by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Recall Aftermath: Who is Gaining Share in the Sleep Apnea Devices and Ventilators Market?

In recent years, the number of ventilator recalls has increased considerably, primarily due to product quality issues, software malfunction, and manufacturing defects. This affected manufacturers such as Philips, Medtronic, and Vyaire Medical, leading to brand damage, financial losses, and a shift in the market competition. Existing players and new entrants such as Getinge and Nihon Kohden are stepping in to fill the gap with innovative and non-invasive products. The recalls caused challenges for manufacturers and patients, highlighting the need for strong quality control and regulatory oversight.

Recalls of its sleep apnea devices and ventilators hit Philips the hardest

The medical device industry has recently experienced many product recalls, particularly in the ventilators segment, impacting major market players such as Philips, Medtronic, Baxter, GE Healthcare, Hamilton Medical, and Vyaire Medical.

Philips (Philips Respironics) faced a series of class I respiratory product recalls, including CPAP and BiPAP machines, and ventilators, due to health risks caused by the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown in the devices. Industry experts consider Philips’ sleep apnea devices and ventilator recalls among the most significant since 2021. As of January 2024, the company experienced a recall of over 15 million sleep apnea devices and ventilators, and reportedly hundreds of deaths. The recall seriously hurt the company’s reputation, weakened its position in the market, and caused significant financial problems.

The recalls led to a decline in the company’s share price by 60-70% in 2021, and it is still about 50% lower than its peak in April 2021 (US$ 53.45). Comparable sales of the connected care segment, including sleep apnea devices and ventilators, declined by about 19% in 2021 in comparison to 2020. This happened primarily due to sleep apnea devices and ventilators recalls, and the normalization of demand for hospital ventilators and monitoring systems following the COVID-19 surge. Recalls continued to drive down ventilator and sleep apnea device sales in 2022 and 2023.

The considerable impact on sleep apnea devices and ventilator sales resulted in a decline in Philip’s share in the sleep apnea device market, dropping to an estimated 20% between 2021-2023 from over 30% before the recall. The company also experienced a notable decline in market share in the ventilators market. Despite the decline in market share, Philips maintained its position as one of the leading players in both the sleep apnea devices and ventilators market.

However, in January 2024, Philips agreed to halt the sales of 19 sleep and respiratory products in the USA as a part of the consent decree with the US Department of Justice (DOJ). These products included hospital ventilation, certain home ventilation, sleep diagnostic devices, and portable and stationary oxygen concentrators. This affected the company’s brand image greatly and resulted in a further loss of market share in both ventilators and sleep apnea devices markets. Since the company will continue to sell consumables and accessories, including masks, it is anticipated to maintain a portion of its market share in both segments.

In April 2024, the company agreed to pay US$1.1 billion in legal settlement to resolve injury-related cases caused by sleep apnea devices and ventilators in the USA. Overall, sleep apnea device recalls cost the company over US$5 billion, likely including charges such as provisions for Philips Respironics-related litigation, consent decree, remediation costs, legal settlements, workforce restructuring, and quality remediation action. In addition, Philips cut 6,600 jobs by 2023 and is likely to reduce its workforce by a total of 10,000 by 2025.

Several companies bore the brunt of their own ventilator recall setbacks

Other prominent manufacturers such as Drägerwerk (Draeger), Medtronic, Vyaire Medical, Hamilton Medical, and Baxter also experienced various ventilator recalls due to manufacturing and quality defects. Although the FDA classified these recalls as serious, these companies did not face the same severe consequences as Philips, as these recalls did not result in major injuries.

All these manufacturers also witnessed a drop in ventilator sales largely due to the stabilization of demand for ventilators following the COVID-19 surge, with product recalls also contributing to the downturn.

In February 2024, Medtronic completely exited the ventilator market due to unprofitability. Similarly, in June 2024, Vyaire Medical filed for bankruptcy and was subsequently acquired in October 2024 by Zoll, an Asahi Kasei company engaged in the manufacturing of medical devices and related software solutions. This caused a profound impact on the ventilators market.

Market players are introducing products with advanced features to gain market share

The ventilator market encountered a radical shift in competition due to numerous product recalls. The suspension of sleep and respiratory product sales cost Philips its leading market position in sleep apnea devices and ventilators (except for certain home ventilators). It remains unclear when or if Philips will be able to resume sales of these devices. However, the company is unlikely to leave its presence in the sleep apnea devices and ventilators market entirely due to its commitment to service and supply of parts of ventilators in use, as well as its decision to continue the sale of consumables and accessories.

Existing market players such as Getinge, Hamilton Medical, Drägerwerk (Draeger), ResMed, and GE Healthcare, and newer entrants such as Nihon Kohden, are likely to fill in the gap left by Philips, Medtronic, and Vyaire Medical in the USA.

Market players such as Getinge, Drägerwerk (Draeger), and Nihon Kohden are focusing on introducing technologically advanced ventilators with features such as enhanced patient comfort, advanced monitoring capabilities, portability, and adaptive ventilation modes, to grab a slice of the pie. They are also increasingly focusing on expanding their portfolio of non-invasive ventilators with different interfaces, including face masks, nasal masks, helmets, and mouthpieces.

For instance, in October 2024, Nihon Kohden introduced a new ventilator system that combines invasive and non-invasive ventilation and high-flow oxygen therapy in one device, offering adaptability and eliminating the need to switch between machines. It also features a customizable, app-based touchscreen interface with advanced monitoring capabilities. Similarly, in January 2024, Getinge introduced ‘Servo-air Lite’, a non-invasive ventilator with high-flow therapy that offers optimal respiratory support, enhanced patient comfort, and ease of use for clinicians.

ResMed, a leading player in both the sleep apnea devices and ventilators market, is estimated to have grabbed over 10% of Philips’ market share in the sleep apnea devices market in the USA. ResMed witnessed a substantial increase in demand for its sleep and respiratory care products, including sleep apnea devices and ventilators, for various reasons, including Philips’ product recalls. The demand for its sleep and respiratory care products in the USA, Canada, and Latin America increased by 16%, 25%, and 10% in 2022, 2023, and 2024, respectively.

Companies engaging in sleep apnea devices and ventilator rentals, sales, and distribution, such as Trace Medical, also started adding brands from different companies to their product mix to meet the demand for these devices.

Patients experience delays in treatment and struggle to switch to other brands

Philips’ foam degradation issue has exposed patients to severe health risks, leading to respiratory complications and even cancer. Recalls of many ventilators and sleep apnea devices have left hospitals struggling to replace them, causing delays in patient treatment.

Patients relying on a specific brand faced reduced treatment options. Many patients found it difficult to switch to other brands due to cost and differences in machine settings or interfaces. With Philips halting sales of various sleep apnea devices and ventilators, patients have no choice but to switch to other brands.

The recall of various products from different companies has created significant demand and supply chain pressures for existing companies. These pressures will likely drive up ventilator and sleep apnea device prices, further burdening patients.

EOS Perspective

Product recalls in the sleep apnea devices and ventilator segment brought quality issues to the limelight. This highlights the need for stronger quality control processes and technologically advanced sleep apnea devices and ventilators incorporating virtual monitoring and AI integration, which can help detect defects earlier.

While the FDA received complaints about Philips’ degradation of the sound abatement foam in the sleep apnea devices and ventilators before the recall initiation, decisive action to force correction was not taken immediately. Also, despite knowing that Philips had been aware of the foam degradation issue for many years, the FDA did not take stronger enforcement measures against the company sooner. This situation highlights the importance of assessing and enhancing the FDA’s oversight process to ensure timely response to medical device complaints.

Philips suffered lasting brand damage due to the recalls. Although the company is trying to regain shareholder and consumer trust after settling US claims for an amount much lower than anticipated (US$2-5 billion) by analysts and the public, it faces a long road ahead.

Regarding market competition, ResMed is estimated to continue to lead and strengthen its dominant position in the sleep apnea devices market. The exit of well-established players from the ventilator market will intensify competition among existing companies and new entrants seeking to capture market share. However, it will be a gradual process as customers slowly transition from existing products to new brand ones. On top of that, the new entrants are likely to face stricter regulatory norms and product approval processes aimed at reducing the number of product recalls and enhancing patients’ safety.

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Continuous Glucose Monitoring Devices: Overcoming Barriers in LMICs

The rising prevalence of diabetes in low- and middle-income countries (LMICs) underscores the need for advanced diabetes management solutions. Continuous glucose monitoring (CGM) systems are highly valuable but face limited adoption in LMICs due to high costs, infrastructure inadequacies, issues with accessibility, affordability, and limited insurance coverage. On the other hand, these countries offer opportunities to develop scalable CGM solutions tailored to the needs of LMICs and to penetrate these markets.

Over the past decade, the global prevalence of diabetes has surged, with a notable concentration in LMICs, particularly across India, China, the Middle East, and Southeast Asia. The LMICs now host the majority of nearly 540 million people living with diabetes.

Read our related Perspective:
  The Future of Diabetes Care: Key Innovations in Continuous Glucose Monitoring

Effectively managing diabetes in LMICs is crucial and requires advanced solutions for precise and consistent monitoring of blood glucose levels. However, the CGM adoption rate remains low in developing and underdeveloped countries. As LMICs seek to incorporate these advanced solutions into their healthcare systems, they face numerous challenges.

Why is CGM adoption and acceptance lagging in emerging economies?

CGM systems are a revolutionary diabetes management tool. Despite the critical role it plays in advancing diabetes care, the high cost, uneven distribution, and inadequate infrastructure severely restrict their access, particularly in LMICs.

High costs hinder CGM adoption

A substantial barrier to adopting CGM systems in LMICs is their prohibitive cost. The average cost of CGM systems can be between US$120 and US$300 per month, placing them predominantly within the realm of those who can pay out of pocket.

For instance, the Dexcom G6 system, which includes sensors and transmitters, costs approximately US$300-US$350 per month. This price makes it out of reach for most individuals in LMICs, where average incomes are significantly lower.

As highlighted by a 2023 report by FIND, while an estimated 55,000 individuals live with type 1 diabetes in Kenya and South Africa, only about 10% are currently utilizing CGM systems. Many LMICs do not have subsidized healthcare or insurance coverage systems, which makes the situation worse. Consequently, the high cost of these devices creates a significant affordability gap, further entrenching healthcare inequalities.

In countries such as Iran, Lebanon, and Pakistan, the absence of governmental support and the unavailability of CGM technology highlight a broader issue. In many of these countries, private sector’s efforts are underway to bring diabetes-related innovations to the market, but the high costs associated with these technologies are a major obstacle.

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence

Limited availability of CGM systems impedes diabetes management

In addition to high costs, the availability of CGM systems is another pressing issue. In many LMICs, including countries such as Turkey, Uganda, and Malawi, CGM solutions are either scarce or completely unavailable. This lack of availability limits access to advanced diabetes management technologies, crucial to improving health outcomes.

Similarly, In Egypt, where diabetes prevalence is notably high at 18.4% of the total adult population, the situation is equally challenging. The country lacks access to the latest innovations, while healthcare professionals need training in using CGM.

In LMICs, inadequate infrastructure poses a significant barrier to the widespread adoption of CGM devices. These tools rely on consistent power and internet connectivity to function optimally. However, frequent power outages, a common issue in many LMICs, can disrupt the continuous monitoring process, leading to data gaps and potential risks for patients who depend on CGM alerts for their health management.

Moreover, limited internet access, especially in rural areas, can severely impact the real-time data-sharing capabilities of CGM systems. This is particularly evident in African nations such as Niger, Nigeria, Chad, and South Africa, where infrastructure challenges are more pronounced.

For instance, South Sudan, with one of the lowest Infrastructure Index ratings in the region, faces critical limitations in accessing reliable power and internet services. These infrastructural deficits highlight the urgent need for targeted investments and solutions to bridge the infrastructure gap and enhance diabetes care in these regions.

Insurance coverage gaps stifle CGM access

The accessibility of diabetes management technologies, particularly CGM systems, is significantly hindered by inadequate insurance coverage and reimbursement policies.

This gap is especially noticeable in Asian LMICs such as the Philippines, where the healthcare system often does not include comprehensive coverage for these critical tools, placing a substantial financial burden on patients. In Vietnam, the National Health Insurance (NHI) scheme covers essential treatments such as oral antidiabetic medicines and insulin. However, it does not extend to glucose monitoring products. This lack of coverage forces patients to pay out-of-pocket for CGM, making it challenging for many to access.

What lies ahead for CGM in LMICs?

As diabetes increasingly poses a global health challenge, LMICs are ramping up efforts to enhance diabetes care. Progressive government policies, innovative programs, and manufacturers expanding reach across LMICs support this shift.

Government policies facilitating CGM integration with diabetes management

In many LMICs, government agencies and organizations are slowly working towards integrating advanced diabetes management solutions into healthcare infrastructure. This is visible through various initiatives undertaken that highlight the growing importance of CGM technologies.

For instance, the Chinese government demonstrated its commitment to standardizing CGM practices by issuing the Chinese Clinical Guidelines for CGM in 2009, with subsequent updates in 2012 and 2017. These guidelines establish clear protocols for device operation, data interpretation, and patient management. The guidelines also support training of healthcare professionals, improving quality assurance, and facilitating CGM integration into the national healthcare system. In several Chinese hospitals, the implantation, operation, and daily management of CGM systems are already handled by trained nurses and head nurses within the endocrinology departments.

India has also made significant strides, particularly in 2021, with the establishment of guidelines for optimizing diabetes management through CGM. The Indian government has introduced several initiatives to foster digital health advancements, including the National Digital Health Mission.

Advancing diabetes care, the ‘Access to CGMs for Equity in Diabetes Management’ initiative, a collaboration between the International Diabetes Federation and FIND, aims to integrate CGM solutions into African healthcare systems. This initiative seeks to double the number of CGM users in Kenya and South Africa by 2025, potentially impacting 21.5 million individuals with type 2 diabetes and 213,000 individuals with type 1 diabetes in Southern and Eastern Africa.

Government support for such initiatives is pivotal, as it can significantly enhance market access and ensure that CGM technologies reach underserved populations. These collaborative efforts and governmental actions are likely to drive extensive market reach and foster a more effective response to the global diabetes epidemic.

Manufacturers driving adoption by introducing affordable CGM solutions

Customizing CGM to meet the needs of LMICs offers manufacturers an opportunity to expand device access and adoption within these markets.

Medtronic is taking the lead by customizing its CGM solutions to reduce production and distribution costs specifically for LMIC markets. By optimizing its technology to be more cost-effective, Medtronic aims to increase the accessibility of its CGM systems in regions where diabetes management tools are often limited.

Similarly, emerging startups such as Diabetes Cloud (Aidex) and Meiqi are making strides in expanding CGM availability in South Africa. These companies are introducing more affordable CGM devices designed to meet the needs of local populations, thereby broadening access to critical diabetes management tools.

Manufacturers’ strategic initiatives accelerating CGM access

Manufacturers recognize the urgent need for effective diabetes care solutions in LMICs and the significant growth potential in the underpenetrated CGM market. To capitalize on this opportunity, they are focusing on expanding their product portfolios in these regions.

Additionally, Dexcom is planning to introduce the Dexcom ONE+ across the Middle East and Africa in the near future. This advanced CGM system can be worn in three locations on the body, enhancing comfort and usability. By accommodating individual preferences and needs, Dexcom aims to improve user experience. This strategic launch underscores Dexcom’s commitment to broadening its market presence and advancing its footprint in emerging regions.

Manufacturers are also supporting research initiatives across Africa. For instance, Abbott has donated its FreeStyle Libre Pro CGM devices for research in Uganda. The research’s favorable reviews and positive outcomes reflect a notable interest in and demand for sophisticated diabetes management technologies in these regions.

Moreover, strategic partnerships amongst manufacturers highlight a broader commitment to enhance the accessibility of CGM systems by leveraging combined expertise and innovative technologies. In January 2024, Trinity Biotech and Bayer partnered to introduce a CGM biosensor device in China and India. The collaboration is poised to leverage Bayer’s expertise and Trinity Biotech’s technological advancements to enhance diabetes care in these rapidly growing markets.

These strategic initiatives will likely impact the CGM market positively in emerging economies. Increased availability of CGM systems in LMICs will to drive higher adoption of glucose monitoring technologies and stimulate further investment in diabetes care.

EOS Perspective

Despite the challenges, the CGM market in LMICs presents a compelling growth opportunity for manufacturers. With diabetes cases on the rise, there is an increasing demand for CGM systems that offer real-time glucose data to improve patient outcomes. This demand, combined with progressive government initiatives and heightened awareness of diabetes care, creates a fertile ground for market development.

Manufacturers have a significant opportunity to capitalize on this emerging market by addressing the distinct regional needs. One of the primary challenges is the high cost of CGM systems, which limits their adoption. Hence, there’s a need to develop more affordable, scalable solutions tailored to the economic realities of LMICs. By focusing on local manufacturing and distribution strategies, healthcare companies can provide cost-effective solutions that meet the needs of underserved populations.

The shortage of trained healthcare professionals further complicates the widespread use of CGM. Manufacturers can address this by implementing comprehensive training programs for healthcare providers, equipping them with the skills needed to support patients in using CGM systems effectively.

This investment could foster greater acceptance of the technology. Non-profit organizations such as Medtronic LABS have made significant contributions, impacting over 1 million individuals with diabetes and training more than 3,000 healthcare workers across Kenya, Tanzania, Rwanda, Ghana, Sierra Leone, and India since 2013. The organization educates on diabetes management, equipping healthcare workers with skills to utilize CGM systems effectively. By enhancing the knowledge and capabilities of these health workers, Medtronic LABS ensures that communities receive better support in managing diabetes, ultimately leading to improved patient outcomes and CGM adoption.

Strategic partnerships with local entities, governments, NGOs, and international organizations can further enhance market reach. Collaborations can help manufacturers navigate the complexities of the market, overcome logistical challenges, and strengthen distribution networks. Partnering with organizations with established connections and regional expertise can facilitate more effective market entry and expansion.

For instance, organizations such as FIND, the International Diabetes Federation, and the Helmsley Charitable Trust are working to create business opportunities for CGM manufacturers. They specifically target manufacturers whose CGM products are unavailable in markets such as Kenya and South Africa to improve access in these regions.

Further, programs such as the Access to CGMs for Equity in Diabetes Management and national health guidelines in countries such as China and India are laying the groundwork for improved diabetes care. By integrating CGM solutions into national healthcare plans and providing necessary training to healthcare professionals, these initiatives aim to establish a sustainable model for diabetes management. Other developing regions should replicate this approach.

In the future, sustained emphasis on innovation, affordability, and strategic collaborations are poised to transform the CGM landscape in LMICs, ensuring that these advancements are more accessible to all. As this gains traction, access to advanced diabetes management technologies is expected to improve, offering a promising outlook for millions of individuals living with diabetes.

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

The Future of Diabetes Care: Key Innovations in the Continuous Glucose Monitoring

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Continuous glucose monitors (CGM) represent a disruptive innovation that has transformed the diabetes management landscape. In recent years, the CGM market has seen remarkable growth, becoming an integral part of diabetes care with the potential to supplement or even replace traditional blood glucose monitoring methods. Opportunities in the CGM sector are endless, as the market remains under-penetrated. Market leaders such as Dexcom and Abbott leverage this potential to establish their foothold while continuously innovating their offerings.

CGMs provide accurate readings that can be used for insulin dosing decisions, eliminating the need for traditional fingerstick tests. The devices offer high ease of use and convenience, with many integrating seamlessly with smart devices. Additionally, the increasing use of AI and machine learning has led to the development of algorithms that customize health-related data for users.

Read our related Perspective:
Continuous Glucose Monitoring Devices: Overcoming Barriers in LMICs 

As we expect the next generation of CGMs, revolutionary advancements promise to transform diabetes management with these devices. The ongoing innovations aim to enhance precision and accuracy, offer predictive analytics, provide continuous monitoring beyond glucose, and enable the integration of other health parameters into the CGMs.

Precision and accuracy

Building on the success of current CGMs, the next-generation devices are likely to offer unprecedented precision and accuracy. Upcoming CGMs will use next-generation sensor technologies, including advanced nanomaterials and multi-enzymatic systems, to detect glucose levels with higher sensitivity and specificity.

Sophisticated AI and machine learning will support the prediction of glucose trends and real-time data processing to increase accuracy. To further improve accuracy across diverse populations and glucose ranges, emerging CGMs will leverage personalized calibration algorithms that adapt to individual metabolic variations.

Integration with broader health ecosystems and cloud-based analytics will be industry players’ key focus, ensuring improvement through real-world data feedback. Clinical validation and regulatory supervision will ascertain that CGMs adhere to all safety and health standards.

Overall, players will aim to provide reliable glucose data to empower users with actionable insights for effective diabetes management. Leading industry players, such as Abbott and Dexcom, prioritize data accuracy and ensure that their devices track glucose trends accurately with minimal error. For instance, Abbott’s Freestyle Libre uses advanced sensor technology to maintain accurate glucose readings over a 14-day wear period. On the other hand, Dexcom’s G7 utilizes advanced algorithms to continuously calibrate and refine glucose readings based on real-time data and historical trends, eliminating the need for fingerstick calibrations. Both devices provide real-time alerts on glucose levels to help users take action.

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring Market by EOS Intelligence

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring Market by EOS Intelligence

Integration with smart devices

Anticipated advancements include seamless connection with smartphones, smartwatches, and other wearable devices for uninterrupted glucose monitoring. Such integration will not only elevate user experience but also allow real-time updates, such as alerts for glucose fluctuations, viewing historical trends, and sharing data with healthcare providers, thus facilitating proactive management of user’s condition.

In advanced CGMs linked with mobile applications, predictive algorithms will be able to foresee glucose levels, offering tailored suggestions and insights based on individual patterns. Recently, in June 2024, Dexcom enabled a direct-to-watch feature, allowing its G7 users to monitor real-time blood sugar data from an Apple watch, regardless of whether they are carrying their phone.

In the future, this synergy between CGMs and smart devices will not only improve the accuracy and accessibility of glucose monitoring but also empower users to make quick, informed decisions regarding their health and improve overall well-being.

Predictive analytics

The real-time and historical analysis of glucose data equips CGMs to predict blood glucose levels several hours ahead, notifying users about impending hypoglycemia or hyperglycemia before they occur. This proactive approach allows for timely interventions, such as regulating insulin dosage or dietary modifications to maintain optimal glucose level.

Predictive analytics integrated with CGMs is revolutionizing the diabetes care market, and key market players are increasingly prioritizing its incorporation into their devices to gain a competitive edge. Roche is gearing up to compete with Abbott and Dexcom with its Accu-Chek Smartguide, which will soon be launched in the European market following its approval in July 2024. The company is betting on robust predictive analytics to differentiate its product from competitors. The device aims to enhance glucose monitoring by employing predictive AI to forecast glucose levels up to two hours ahead, identify the risk of low blood glucose within 30 minutes, and detect nocturnal hypoglycemia.

Over the years, as predictive algorithms improve, CGMs will become increasingly suitable for mitigating risks, reducing glucose spikes in patients, and equipping patients to manage diabetes better and improve quality of life. In the future, enhanced personalization and seamless integration of CGMs with broader health ecosystems can transform diabetes management by providing more precise and accessible real-time insights and recommendations tailored to individual metabolic responses, lifestyle patterns, and environmental influences. It is likely that the next generation of CGMs will also predict and adapt to potential disruptions caused by stress, illness, or diet changes.

Product diversification

The evolution of CGMs is expected to go beyond glucose monitoring, embracing a holistic approach focused on personalized and preventive healthcare. Companies are conducting research to integrate CGM readings with health metrics such as ketone levels, hydration status, and early indicators of other health conditions.

Industry players are also developing targeted solutions for various customer segments. For instance, they are focusing on pediatric and geriatric populations by creating CGMs customized to meet these segments’ unique physiological and lifestyle needs. Another area of focus is developing CGMs to support gestational diabetes, helping pregnant women better manage maternal and fetal health.

Currently, companies such as Medtronic and Abbott have partnered to integrate Medtronic’s automated insulin delivery systems with Abbott’s CGM to create closed-loop systems. This system automatically adjusts insulin delivery based on real-time glucose readings, which helps patients improve glycemic index.

EOS Perspective

The next generation of CGMs is poised to help manage chronic diseases beyond diabetes. With key players such as Dexcom and Abbott maneuvering the industry, the future promises unprecedented advancements through the fusion of technology and healthcare. The impact on patient outcomes and the broader healthcare landscape will lead to a more personalized, proactive, and interconnected approach to care.

There is a significant opportunity for industry players across major markets such as the USA, where CGM adoption remains low, with about 90% of people with diabetes still not using these devices. To penetrate key markets including the USA and Europe, CGM companies need to develop effective go-to-market strategies to increase adoption rates. They should focus on patient segmentation, exploring multiple distribution channels, and forming alliances with key stakeholders.

Patient segmentation

Sales strategy and product offerings could be tailored around specific patient groups, i.e., Type 1 versus Type 2 diabetes or various income levels. For example, Abbott has strategically developed different CGMs to target varied patient groups. Its FreeStyle Libre is designed for users with Type 2 diabetes, while Lingo, a consumer wearable, is ideal for consumers trying to improve overall health and well-being.

Diversifying distribution channels

The CGM players must diversify their distribution channels, particularly by utilizing digital marketing and social media to reach a broader audience and increase awareness. Digital marketing can also serve as a crucial tool for connecting with diabetes online communities and educating patients.

Abbott and Dexcom are looking to explore new distribution avenues. In H2 2024, both companies rolled out their competing products (Abbott’s Lingo and Dexcom’s Stelo) over-the-counter in the USA, selling through their websites, with an aim to expand the reach and enhance market penetration. Expanding sales through the online channel also makes it simpler for consumers to purchase CGMs directly from producers simpler for consumers.

Partnerships

Forging strong alliances with key stakeholders can create improved and integrated diabetes management systems. Strategic partnerships with technology companies can help CGM players enhance products, expand market reach, and improve patient outcomes. On the other hand, partnering with insulin pump and insulin pen companies can streamline diabetes care by combining real-time glucose monitoring with automated insulin delivery.

Both Abbott and Dexcom have partnered with Tandem Diabetes Care to integrate FreeStyle Libre CGM and G6 CGM, respectively, with Tandem insulin pumps. These systems use real-time glucose readings to automatically adjust insulin dosing, improving diabetes management.

The opportunities in the CGM market are vast and continually expanding. As technology advances, CGMs will become more accurate, user-friendly, and integrated with other health management tools. Moreover, with the growing prevalence of diabetes worldwide, the demand for efficient and effective glucose monitoring solutions will only grow in the future, making the CGM market an attractive segment for continued investment and development.

Prescribing Security Diagnosing and Treating the IoT Universe in Healthcare by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Prescribing Security: Diagnosing and Treating the IoT Universe in Healthcare

The integration of the Internet of Things (IoT) into the healthcare industry has significantly transformed the delivery of medical services, enhanced patient experiences, and revolutionized medical practices. While the benefits of IoT are undeniable, there are challenges that come with its adoption. Issues such as device hacking and data breaches pose significant obstacles that must be addressed. Therefore, it is essential for device manufacturers to design medical devices with caution. By taking a proactive approach and investing in robust cybersecurity measures during the design and development phases, manufacturers can create devices that are more secure and less vulnerable to hacking.

IoT has revolutionized the healthcare industry by enabling medical devices to connect and communicate with each other, as well as with healthcare providers and patients. These devices utilize cloud computing and collect valuable data in real time, allowing for remote monitoring, timely interventions, and personalized care.

The average hospital room worldwide has an estimated 15 to 20 interconnected medical devices. This number is steadily increasing due to the rising adoption of internet-connected devices. The market for IoT medical devices is close to US$40 billion as of 2023. With exponential growth, it is likely to cross US$150 billion over the next five years. This upward trajectory is geared towards reducing healthcare systems’ costs, enhancing patient care, and streamlining clinician workflows.

Healthcare organizations are not immune to cybersecurity breaches

Amid this inevitable growth in adoption, it is crucial to prioritize the security of medical devices to protect patients’ lives, safety, and privacy. While these devices have the potential to streamline and improve treatment, they also pose significant risks due to their susceptibility to cyberattacks.

According to a 2019 report by Fierce Healthcare, 82% of healthcare organizations experienced cyberattacks targeting IoT devices. Moreover, about 53% of medical and IoT devices in hospitals had vulnerabilities. Cybercriminals have honed in on the healthcare industry as a prime target, capitalizing on its perceived lack of robust cybersecurity protocols.

Healthcare bleeds out money without a cybersecurity cure

According to IBM’s Cost of a Data Breach 2023 report, the average cost of a cyberattack in the healthcare industry is US$4.45 million per breach, marking a 2.3% increase from the previous year’s average cost of US$4.35 million.

This significant uptick in costs since 2020, when the average overall cost of a data breach was US$3.86 million, represents a substantial 15.3% increase over three years. This growth underscores the importance of prioritizing cybersecurity measures to protect sensitive patient data and ensure the safety and integrity of medical devices in healthcare settings.

Unaddressed IoT challenges in medical devices lead to unauthorized access

Despite the many potential benefits of IoT medical devices in healthcare, the lack of adequate security measures continues to be one of their main challenges. Many devices do not have robust encryption protocols or authentication mechanisms, making them easy targets for hackers.

These vulnerabilities could potentially be exploited to gain unauthorized access to patient information or manipulate the device to deliver harmful treatments. As these devices become more interconnected with other healthcare systems, the potential cyberattacks only increase, posing a serious threat to patient safety.

Prescribing Security Diagnosing and Treating the IoT Universe in Healthcare by EOS Intelligence

Prescribing Security Diagnosing and Treating the IoT Universe in Healthcare by EOS Intelligence

Hackers endanger patients’ health and lives

Hackers can exploit vulnerabilities in IoT medical devices to gain access to sensitive patient information, alter treatment settings, or sabotage critical systems. This poses a grave threat to patient safety and privacy, as well as the overall integrity of healthcare infrastructure. Furthermore, since IoT devices are interconnected, a breach in one device could potentially compromise the entire network, leading to widespread disruptions and chaos in healthcare delivery.

One example of such a breach occurred in 2019 at a Springhill Medical Centre in the USA involving a ransomware attack. This attack disabled patient monitors for several days, leading to a substantial impact on patient care. A lawsuit has been filed, alleging that the disabled monitoring devices led to infant death during delivery at the center.

IoT medical devices need improved security to match technological advancements

The rapid pace of technological advancements in IoT medical devices often outpaces the development of security protocols. New features and functionalities are constantly added to these devices to improve patient care.

However, these updates may also introduce additional security vulnerabilities that cybercriminals can exploit. Many healthcare providers struggle to keep up with these evolving threats and may not have the resources or expertise to effectively secure their IoT devices on an ongoing basis.

Diversity of IoT devices complicates securing healthcare environments

The healthcare environment is characterized by a diverse range of interconnected devices, often developed by various manufacturers with varying security protocols, making it difficult to implement a cohesive security strategy across all devices. This diversity complicates efforts to achieve comprehensive visibility and security, as each device may require distinct monitoring and protection strategies.

Additionally, the sheer number of devices in use within a healthcare facility can overwhelm IT teams responsible for monitoring and securing them, increasing the likelihood of overlooking potential security risks.

Limited downtime poses cybersecurity challenges

IoT medical devices are used continuously in real time, leaving little room for downtime. This lack of downtime poses a challenge for security teams, as they have limited time to analyze the devices and implement necessary patches to ensure their security.

The constant use of these devices in healthcare settings highlights the importance of finding a balance between security and functionality in order to safeguard sensitive patient data and uphold the integrity of the healthcare system.

Devices’ size and continuous connection result in insufficient battery support

Another challenge in the realm of IoT devices is related to their powering. Many of these devices use batteries and their compact size restricts the capacity for large, durable batteries. They need to be constantly connected to transmit data, which continually drains power.

These devices’ limited power and memory make it difficult to incorporate encryption, continuous software updates, and authentication protocols that can protect sensitive patient information from hackers.

Durability of IoT medical devices poses a security risk

Additionally, IoT medical devices are engineered to have a long lifespan. Their durability can pose a security risk. Once a vendor ceases production or stops releasing updates for these devices, hospitals may continue to rely on outdated technology, making them vulnerable to cyberattacks.

Hospitals must play a role in safeguarding their IoT device systems

Securing healthcare IoT devices can be a complex task, but it is essential to implement a variety of solutions to guarantee their security.

Part of this responsibility lies on the healthcare institutions themselves. Hospitals must ensure regular software updates, avoid default settings, and provide comprehensive training to staff members. Healthcare providers must implement unique and multilayered login structures for every device, such as two-step logins, hard-coded passwords, firewalls, and fingerprint checks to ensure that patient information is securely stored.

Leading players’ solutions increase devices’ resilience to breaches

Advanced and complex security solutions

Prominent vendors, such as Medigate, Medcrypt, and Cynerio, provide advanced platforms designed to assist healthcare organizations in safeguarding their networks and connected medical devices.

These security vendors offer complex security solutions, including real-time threat detection, device monitoring, network activity visibility to medical device manufacturers, and vulnerability management solutions to enable healthcare providers to effectively identify and mitigate potential risks associated with their connected medical devices.

Detection and recovery plan

Cybersecurity providers are generally vigilant in offering detection and recovery services to safeguard medical assets and systems around the clock. In the event of a security breach, they must be able to swiftly implement response and recovery plans to mitigate the impact. With a focus on healthcare, they must be able to identify issues efficiently without overwhelming users with excessive information. They need to aim at taking instant action to restore normalcy as quickly as possible.

Network segmentation

Another important solution players should provide is network segmentation, which involves dividing devices into separate, private wireless networks to protect data in the event of a cyberattack. Firewalls and multi-factor authentication can achieve this. By segmenting the network into distinct zones, healthcare providers can isolate medical devices from other parts of the network, reducing the risk of a cyberattack spreading across the entire network. This segmentation also allows for more granular control over medical devices, limiting the potential for unauthorized access or tampering.

Modern network segmentation for medical devices now relies on technologies such as virtual LANs and subnets to keep up with advanced cyber threats. For instance, Cisco Systems, a multinational technology conglomerate, offers medical device security solutions whose key aspect is network segmentation. Cisco also provides specialized monitoring and analytics tools to assist healthcare organizations in detecting and responding to security incidents in real time. These tools can identify abnormal behavior on the network, alerting security teams to potential threats before they can cause harm.

AI technology and machine learning

IoT device security providers, such as IBM Corporation, Cylera, CyberMDX, Sternum, ClearDATA, and Palo Alto Networks, place emphasis on conducting comprehensive risk assessments during software validation to guarantee devices’ security. In the event of new cyberattacks, these providers inform stakeholders and offer solutions, such as security updates. They have integrated programs that utilize AI technology and machine learning to proactively manage risks and stay ahead of cybersecurity threats.

Security vendors contribute to IoT device safety protocols transformation

The cybersecurity industry is currently experiencing a surge of new companies that are transforming security protocols. Armis, a leading US-based asset intelligence cybersecurity company and provider of agentless device security solutions, is spearheading this movement.

Notably, Medtronic and Zimmer Biomet have incorporated Armis’ security platform into their products, such as insulin pumps and orthopedic devices. Armis offers the Armis Centrix platform, powered by the Armis AI-driven Asset Intelligence Engine. The platform has the capability to detect breaches, run routine security scans or updates, maintain asset visibility, identify blind spots, optimize resource allocation, and perform essential maintenance. Armis’ solutions encompass advanced threat intelligence and machine learning features, enabling the system to adapt to new and emerging threats. This proactive cybersecurity approach is essential in the healthcare sector, where any disruption or compromising of medical devices could have severe repercussions.

Collaboration is key to effectively managing cyberattacks

Collaborations between medical device manufacturers and cybersecurity vendors to combat IoT medical device hacking have great potential. It also facilitates the sharing of threat intelligence and best practices, enabling vendors and manufacturers to proactively address emerging threats and vulnerabilities. Their collaborative efforts center on safeguarding critical devices from cyber risks by implementing protective measures for both the devices and the data they collect.

Philips partnered with CyberMDX to create a vendor-neutral cybersecurity service

In November 2020, Philips, a prominent player in healthcare technology, partnered with CyberMDX, a cybersecurity expert specializing in medical devices. This partnership focused on enhancing the security of connected medical devices and systems, essential for protecting patient data and for the smooth operation of healthcare facilities.

Drawing from Philips’ industry expertise and CyberMDX’s cybersecurity solutions, together they provide vendor-neutral options to protect IoT medical devices. They focus on managing connected devices in hospital settings, whether they are managed or unmanaged, by utilizing a combination of risk assessment, detection, threat intelligence, and prevention capabilities in the constantly evolving healthcare technology landscape.

Medcrypt collaborated with NetRise to address cybersecurity issues

In August 2023, Medcrypt, a US-based proactive cybersecurity provider, partnered with NetRise, another US-based cybersecurity company. By combining Medcrypt’s experience in identifying and managing vulnerabilities with NetRise’s ability to develop Mobile Device Management software featuring a Software Bill of Materials (SBOM) for embedded devices and firmware, medical device manufacturers now have access to a comprehensive solution to protect their devices from potential cyber threats throughout their lifecycle.

Medcrypt integrated NetRise’s SBOM generation capabilities into the Helm tool, enabling continuous integration, analysis, and transparency of the ever-changing state of medical device software. This integration facilitates the proactive identification and mitigation of the most exploitable vulnerabilities, extending support for SBOMs across the entire lifecycle of medical devices. The resulting solution empowers medical device manufacturers to create, ingest, enhance, manage, and monitor SBOMs, providing invaluable insights into the vulnerabilities present in their embedded devices and firmware. This collaboration represents a significant advancement in bolstering cybersecurity measures within the healthcare industry.

The industry is moving towards Trojan-free devices to safeguard against cyberattacks

Among the various cybersecurity threats faced by IoT medical devices, hardware Trojans are emerging as a grave concern. Hardware Trojans involve the deliberate manipulation of an integrated circuit or electronic device to compromise its security features or functionality.

Hardware Trojans are typically small in size, consist of only a few gates, and alter the device chip’s functionality. Due to their small size, hardware Trojans are challenging to detect using traditional offline methods such as side-channel analysis or digital systems testing. As a result, the healthcare industry is increasingly prioritizing the development of Trojan-free medical devices to enhance the security of IoT medical devices.

Unlike other medical devices, Trojan-free devices are highly secure and challenging to breach. Attackers would need a high level of expertise to understand the device’s design blueprint through reverse engineering and then create a manipulation that can only be triggered under specific conditions.

Moreover, the development of Trojan-free medical devices presents a unique opportunity for manufacturers to drive innovation, improve patient care, advance cybersecurity solutions, and shape regulatory standards.

One example of a Trojan-free medical device is the Philips IntelliVue patient monitor, which tracks patients’ vital signs and provide real-time data. This device works with advanced network security measures, including firewalls, encryption, and intrusion detection/prevention systems, to safeguard against unauthorized access and malware infiltration. Its cybersecurity features are specifically designed to protect against potential threats such as unauthorized access and data breaches.

Boston Scientific’s S-ICD implantable cardioverter-defibrillator is another Trojan-free medical device. It treats patients at risk of sudden cardiac arrest by delivering an electric shock to restore normal heart rhythm. This device employs encryption to secure communication between the device and the programmer and authentication protocols to ensure that only authorized healthcare professionals can access and control it.

EOS Perspective

IoT has transformed numerous industries, with healthcare being no exception. In the realm of healthcare, IoT medical devices utilized in virtual wards, such as remote monitoring devices and wearable sensors, are susceptible to cyberattacks. These attacks can result in unauthorized access, data tampering, and disruption of patient care. Detecting and responding to cyber threats targeting medical devices is crucial.

To combat these threats, security vendors employed prevention systems, anomaly detection algorithms, and advanced analytics to identify potential cyberattacks and abnormal device behavior. Implementing robust incident response plans, conducting simulated exercises, and utilizing strong device security measures is imperative to safeguard against device-level cyber risks.

The field of cybersecurity in healthcare is intricate and constantly evolving. Addressing cybersecurity risks necessitates a comprehensive approach that encompasses technology, policies, regulations, and education. Continuous collaboration, vigilance, and adaptation to emerging threats are essential to ensure the security and safety of medical devices in the future.

Moreover, healthcare facilities must prioritize the implementation of robust device security risk management practices. This involves establishing standard protocols, automating device isolation, utilizing asset intelligence to minimize security breaches, and ensuring compliance with regulatory frameworks such as HIPAA, FDA, ISO 13485, and HITRUST when acquiring and managing connected medical devices.

In addition, healthcare facilities must provide comprehensive training to professionals who work with these devices on cybersecurity best practices and identifying potential security threats.

Collaboration between healthcare providers, device manufacturers, cybersecurity experts, and regulatory bodies is essential for enhancing the security of medical IoT devices. By sharing knowledge, resources, and best practices, stakeholders can collectively address vulnerabilities and safeguard healthcare systems.

Their collaborative efforts facilitate the adoption of SBOM formats, threat modeling processes, Secure Product Development Framework, encryption technologies, AI-based anomaly detection, regulatory frameworks, and secure hardware modules. This approach ensures a more secure environment for medical IoT devices and ultimately protects patient data and healthcare systems from potential cyber threats.

Innovations such as blockchain technology, biometric authentication, predictive analytics, regular patching or updates, and Trojan-free medical devices offer promising opportunities to enhance security measures in the healthcare sector. Trojan-free medical devices, in particular, show great potential in safeguarding patient data, ensuring device integrity, and maintaining the trustworthiness of healthcare technology. This not only improves device reliability but also reduces downtime, benefiting both patients and healthcare providers. This is likely the direction the industry will take in the long run.

By prioritizing proactive cybersecurity measures and compliance with regulations, healthcare security providers can offer potential solutions to enhance the security and integrity of medical devices and the data they handle.

Commentary PFA A Potential Paradigm Shift in Atrial Fibrillation Ablation Landscape by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

PFA – A Potential Paradigm Shift in Atrial Fibrillation Ablation Landscape

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Pulsed Field Ablation (PFA) is an emerging technology for treating atrial fibrillation (AFib), a form of irregular heartbeat affecting 40 million heart patients worldwide as of 2023. As the prevalence of AFib is increasing, all eyes are on this novel, minimally invasive technology that offers improved effectiveness, safety, and shorter procedure and recovery time compared to the existing thermal ablation procedures.

PFA applies short, high-voltage pulses of energy to cardiac tissue and is proven to be more precise and safe than the thermal ablation methods, which come with the risk of damaging collateral tissues.

A clinical trial conducted by Medtronic across North America, Europe, Australia, and Japan during 2022-2023 revealed that the efficacy performance of its PFA system PulseSelect stood at 66% in paroxysmal and 55% in persistent AFib patients against the pre-specified performance goals of >50% (paroxysmal) and >40% (persistent). Performance goals were set based on multiple studies conducted on thermal ablation procedures that evaluated efficacy based on the freedom from acute procedural failure and arrhythmia recurrence in one year.

Despite promising results, the first-generation PFA technology still needs improvement in targeting the tissue of interest, and players in the field are developing supportive systems such as mapping systems to improve performance.

PFA emerges as a better alternative to conventional ablation methods

PFA is viewed as the best evolution within the electrophysiology (EP) space (comprises ablation catheters, diagnostic catheters, laboratory devices, and access systems used to treat arrhythmia). The tissue-targeting approach of PFA overcomes the drawbacks of thermal ablation methods, such as extensive scarring and the risks of injuring nearby organs. Along with improving clinical outcomes, this transformative technology will significantly improve patient experience and reduce the cost of care by lowering procedure and recovery time.

Being safer than other ablation methods, PFA is set to become the preferred modality

Only about 2% of the eligible patients with AFib globally and 15% of the eligible patients in the USA were treated with ablation as of February 2023, according to a MedTech analyst at Bank of America. This is because thermal ablation comes with the risk of damaging nearby issues, which can lead to damage to the esophagus, phrenic nerve, and pulmonary veins.

A study published by the European Heart Rhythm Association in January 2024 comparing the outcomes of PFA and thermal ablations stated that the risk of injury from PFA was 3.4% compared to 5.5% in thermal ablation. PFA, being safer than thermal ablation, can be expected to reach many more eligible patients. After the launch of Boston Scientific’s Farapulse in Europe in January 2021, 38,000 AFib patients were treated there with the Farapulse PFA system during 2022-2023, compared to 2,000 patients Farapulse treated in 2021. Moreover, Boston Scientific predicts the global AFib ablation market will grow from US$5 billion in 2023 to US$11 billion in 2028, driven by the increase in the number of PFA procedures.

The growing adoption indicates that PFA has the potential to become the preferred method for treating AFib over the existing treatments, such as thermal catheter ablation and surgical ablation procedures.

Initial clinical trials indicate PFA results in better patient outcomes

With this new technology, patients will experience an improved quality of life with a significantly lower risk of complications and post-procedural discomfort.

This finds evidence in some of the studies performed by the industry. In January 2024, the European Heart Rhythm Association published a study comparing the performance of Boston Scientific’s Farapulse PFA system against thermal ablation systems in 1,572 patients across Europe. The study showed that 85% of patients who underwent PFA experienced overall freedom from AFib after one year, compared to 77% of patients who underwent thermal ablation procedures.

Reduced time of post-procedure care is PFA’s major advantage

With a duration of about 2 hours, the PFA procedure is shorter than thermal ablation, which takes 3-4 hours. More importantly, PFA requires a few hours of hospitalization post the procedure, while thermal ablation is typically associated with one day of hospitalization after the procedure.

Shorter hospital stays improve patient experience by minimizing stress and discomfort from longer hospitalization hours. They also enable faster scheduling, as hospitals can perform more procedures and minimize scheduling delays.

As PFA does not require in-patient admissions, PFA procedures will not be disrupted by hospital bed shortages. This is a considerable advantage, as many developed countries such as the USA and the UK lack adequate hospital bed capacity. As of 2021, there were 2.8 hospital beds per 1,000 population in the USA and 2.4 in the UK, below the WHO’s recommendation of 3.4 beds per 1,000 population.

Moreover, reducing the length of hospital stays yields significant cost savings for patients as well as the payers. Reducing a hospital stay by a day or several hours translates to savings that cannot be ignored. For instance, in the USA, the average cost of per-hour hospital observation is US$600 in 2024, as per the healthcare pricing transparency platform Turquoise Health. The average cost of per-day hospitalization was US$2,883 in 2021, as per a study by the Kaiser Family Foundation (Medicare patients are eligible for $1,632 reimbursement). In the UK, the average cost of per-hour hospital observation is US$100, and the cost of per-day hospitalization is US$442 as of 2022, according to the National Health Service.

Short learning curve and procedure time facilitate performing more procedures

A short learning curve equips more cardiologists and trainees with the skills required to perform and support the procedure faster. Cardiologists typically get comfortable with PFA procedures after 5-10 cases, which allows to expand the pool of specialists performing this treatment relatively quickly and easily. This, in turn, can significantly improve PFA accessibility.

As the shortage of physicians continues to worsen globally, particularly in the USA, which represented 50% of the ablation market in 2023, PFA can play a crucial role in facilitating an increase in the number of procedures performed at a hospital within the same timeframe. With an expected shortage of 120,000 cardiologists in the USA by 2030, according to a 2021 report by the Association of American Medical Colleges, performing quicker procedures can help to partially offset the lack of specialists. Since PFA takes 30-50% less time than conventional ablation methods, it has the potential to significantly increase the number of procedures performed.

MedTech companies grow their ablation market share by offering PFA devices

With increased health screening efforts that detect more patients with arrhythmias, the number of cardiac ablation procedures performed globally doubled between 2013 and 2023 to reach about 650,000 procedures in 2023.

Boston Scientific expects the global AFib ablation market to more than double to US$11 billion during 2023-2028, with PFA predicted to grow to more than 80% of procedures (from under 5% in 2023). PFA technology is expected to be adopted quickly. As seen in Europe, PFA devices were launched in 2021, and already about 12% of the ablation procedures in the region in 2023 were done using PFA technology.

J&J, Medtronic, and Boston Scientific take the lead in the PFA field

Eyeing the potential of this emerging market, MedTech giants such as Johnson&Johnson (J&J), Medtronic, and Boston Scientific (accounting for 55%, 10%, and 5% share of the global thermal ablation market in 2023, respectively) have entered the market with their newly developed PFA devices. Being early entrants, these companies have the potential to expand their market shares in the cardiac ablation market by grabbing shares from thermal ablation procedures.

Boston Scientific was the first company to commercialize PFA devices with the launch of the Farapulse PFA system in Europe in January 2021. Boston Scientific enjoyed a two-year monopoly in the European market until Medtronic launched an integrated mapping and PFA system called Affera in March 2023. Later, the company launched another PFA system, PulseSelect, in December 2023. In February 2024, J&J’s Varipulse PFA system also received approval in Europe.

In the USA, Medtronic was the first company to receive FDA approval for its PFA system PulseSelect in December 2023, followed by Boston Scientific in January 2024. Medtronic also received FDA approval for Affera in March 2024.

J&J is the only company with a presence in Asia, as the company received approval for its PFA system in Japan in January 2024. Abbott is currently conducting clinical trials for its PFA system Volt in Australia and expects to start clinical trials in the USA this year.

The companies work to enhance and improve their systems. For instance, Medtronic’s integrated mapping and PFA system Affera offers enhanced procedure performance supported by real-time mapping. The integrated system includes an ablation catheter Sphere-9 and mapping software to facilitate real-time mapping. Sphere-9 catheter can perform high-density mapping and ablation simultaneously to allow cardiologists to deliver wide-area focal ablation lesions quickly. Affera can also work with the PulseSelect PFA system to provide real-time mapping. Similarly, J&J has a 3D mapping system called Carto 3 (in the market since 2009), which integrates well with its PFA system and generates real-time 3D mapping that aids in better cell targeting. Boston Scientific has not developed an exclusive mapping system for its PFA system, however, the company claims that any catheter mapping system will work well with Farapulse.

Comparing the PFA systems’ performance in the clinical trials, all systems, including Boston Scientific’s Farapulse, Medtronic’s PulseSelect, Medtronic’s Affera, and J&J’s Varipulse proved to be effective in over 70% of patients in terms of freedom from arrhythmia recurrence in one year.

Currently, PFA devices are only available in the USA, Europe, and Japan, with Boston Scientific dominating in Europe. Boston Scientific has witnessed high adoption rates in Europe so far, and the company has been able to serve 40,000 patients in three years since its entry into the European market in 2021. The company expects an overall organic sales growth of 8-10% during 2024-2026, driven by its PFA devices. Medtronic and J&J have just launched their PFA systems in the USA and Europe, and how these companies perform has yet to be seen. Analysts from BTIG financial services firm predict that Medtronic’s PulseSelect will secure 9% and Boston Scientific’s Farapulse will secure 14% of the cardiac ablation market (which comprises PFA and two other forms of thermal ablation procedures – radiofrequency and cryoablation) in the USA by 2025.

With competent technologies, the market is expected to witness stiff competition from these companies. Analysts from BTIG financial services firm predict that by 2027, PFA will grab 48% of the US cardiac ablation market, while the radiofrequency ablation market will have a 42% share and cryoablation a 10% share. The expected PFA’s 48% market share is likely to be split amongst the leading PFA systems – Boston Scientific’s Farapulse, J&J’s Varipulse, Medtronic’s PulseSelect, and Medtronic’s Affera, at 16%, 13%, 10%,7%, respectively, followed by others with 2% share.

While these companies have already entered the PFA space, Abbott’s wait-and-see approach to PFA may backfire on its performance in the EP market. The company aims to commercialize its PFA system Volt in the USA by 2027 or 2028. However, PFA’s fast adoption threatens Abbott’s US$1.9 billion EP business and its 15% global thermal ablation market share (as of 2023). Growing PFA adoption could also threaten Abbott’s diagnostic catheter and mapping systems, as healthcare providers using PFA systems would prefer buying mapping systems linked to PFA.

New entrants to drive innovation and further improve PFA technology

Apart from the large players, there are a few smaller players, such as Canada-based Kardium, US-based Adagio Medical, and US-based Pulse Biosciences, that are developing PFA systems. These companies are investing in improving the PFA using nanotechnology and supportive systems such as 3D mapping systems. For instance, Pulse Biosciences developed Nanosecond PFA (nsPFA) technology that uses superfast nanosecond pulses of electrical energy that can regulate cell death, which spares adjacent noncellular tissue. The company expects FDA approval for this system in 2024.

EOS Perspective

Over the years, MedTech companies have been actively pursuing the development of minimally invasive procedures that have shorter recovery periods, offer improved patient outcomes and reduced post-procedure discomfort. As the limitations of the existing ablation methods became apparent, PFA poses a vast growth potential, as it is a safer, more convenient, and more effective alternative.

On the other hand, the pulsed-field waveform is significantly more complex than the energy modalities that preceded it, with numerous variables determining the dose targeted at the tissues and the quality of the resulting lesion. While a variety of PFA systems have demonstrated effective ablation procedures, these systems have yet to advance in overcoming all limitations of targeting the tissue of interest and rare but potentially serious complications.

In the coming years, we can expect companies to develop multiple catheter configurations that allow cardiologists to configure the energy delivery to achieve the desired energy dose and lesions. This includes the development of multi-configurable ablation catheters that can shift shapes to create circular, linear, or focal ablation lesions without performing catheter exchanges.

As the technology advances, we can expect PFA to dominate the AFib ablation market and democratize AFib ablation procedures by improving accessibility to all eligible patients.

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