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China-based Comen was the most recent vendor to announce it has received MDR approval for its respiratory fleet. Its V2, V5, V6, V8, NV10, NV50, NV60, and NV70 ventilators have now received CE-marking through the MDR approval process.
How is the new MDR approval process affecting medical devices?
The MDR approval process continues to be stumbling block to healthcare innovation, particularly in the European region. The rigorous process requires a substantial amount of clinical data to support safety claims, in addition to ongoing surveillance of approved products. Signify Research has been assessing the impact of the updated MDR process. Vendors have expressed frustration toward the lengthy processes involved. This is exacerbated by the volume of clinical evidence that is required to support submissions. Despite the extension to the deadline for re-certifying Class IIa and Class I devices shifting from May 2024 to May 2028, vendors are still concerned about the wider impact the process will have on innovation within the medical industry. However, slowly but surely the number of vendors announcing that they have been able to achieve approval is starting to ‚Äòtot up’.
Comen has stepped up its game
The recent approval from Comen for its ventilator fleet is not its only CE certification for a medical device that has passed through the MDR process. Earlier in the year it received one of the first MDR approvals for its patient monitoring fleet. Comen outlined its approval in April, highlighting the necessary measures it had taken to push its patient monitoring portfolio through the approval process. It also identified its commitment to ensuring the highest levels of safety for its solutions, utilizing its 20 years of experience to enhance the portfolio with solutions that are focused on specialized monitoring including neonatal, cardiovascular and obstetrics.
Comen has fast become a recognizable name within the patient monitoring market, especially with the increased demand for monitoring solutions seen during the height of the pandemic. Signify Research assessed the impact of the COVID-19 pandemic on the monitoring market in its 2023 edition of the Patient Monitor report. As highlighted in the report, Comen gained share of the Patient Monitor market year on year from 2020 through to 2022 within the Emerging Asia Pacific region. It has also been able to take advantage of the recent developments within China in which local-made manufacturers are prioritized. As such, its brand is slowly building within the region, with sales expanding globally. Although Comen was not ranked as a core player within other regions in Signify Research’s market analysis, its recent developments in the patient monitoring industry have not gone unnoticed. Its expansion into Europe is expected continue as a result of its recent MDR approval.
Specifically for the ventilator market, Comen has also gained share in recent years, taking advantage of local-made policies and affordable options it offers to healthcare providers, that are increasingly facing purchasing constraints. In Signify Research’s most recent ventilator report, Comen also showed revenue share gains in the Mid-Range Critical Care ventilator market within the Emerging Asia Pacific region. It increased its share of the Mid-Range Critical Care ventilator market from a share below 2% in 2020, to 2.6% in 2021 and 3.3% in 2022.
Advantages of the approval over competitors
Although the time to gain approval for Class IIa and Class I devices has been extended through to May 2028, gaining approval prior to other vendors will no doubt free up additional resources for Comen to continue to evolve its product offering, whilst others grapple with the nuances. This may offer Comen a leap forward in the competitive stakes in Europe if others take significantly longer. Having gained MDR approval for both the patient monitor and ventilator portfolios, Comen will also be able to maximize on larger bundles of solutions, through its ability to offer a comprehensive portfolio of clinical devices. Many healthcare providers are also seeking solutions that offer similar user interfaces to combat the rising healthcare shortage, by helping to simplify training on solutions from one vendor and streamline training processes. Mindray has managed to secure itself as a leading brand internationally, and Comen has already advanced its product offering across a very similar number of device markets. Although it has taken Mindray several years to build up its reputation, it is often cited as the vendor to watch and has been gaining share on a global basis. Mindray has also been able to gain recertification for its flagship solutions also highlighting the efforts China-based vendors have made to focus on their accessibility to the European market.
Future Outlook
Many European vendors were expecting some smaller players to fall to the wayside, being unable to fund the significant efforts to meet the specific requirements for the creation and maintenance of MDR technical documentation. Some leading vendors have also reduced their own portfolios to reduce the burden of ongoing surveillance of the safety of their solutions and associated costs to ensure medical safety and compatibility of their MDR approval. Despite its lower current footprint in the European market, it is clear that Comen has seen the benefit of persevering with the approval process, dedicating the necessary resources. As more vendors come to terms with the expectations for the MDR approval process, new approval announcements will become more frequent in upcoming months. Signify Research expects to see newer vendors in niche segments that are currently dominated by market leaders. However, we still envision product innovation will be somewhat stifled, as smaller start-ups assess the likely profit margins they would expect for regulating their solutions in the European Union. Although patient safety is of utmost importance, it seems that it will come at some cost to innovation from European vendors.
Related Research
Signify Research has published its Ventilators – World – 2023 report and Patient Monitors – Interim Report – World – 2023 The reports build on our 2022 and 2021 editions of the research and provides a data-centric and global outlook of the market. The reports blend primary data collected from in-depth interviews with healthcare professionals and technology vendors to provide a balanced and objective view of the market.
About Kelly Patrick
Kelly joined Signify Research in 2020 as a Principal Analyst. She has over 15 years’ experience covering a range of healthcare technology research at IHS Markit/Omdia. Kelly’s core focus has been on the clinical care sector, including patient monitoring, diagnostic cardiology, respiratory care, and infusion and associated IT solutions. Kelly holds a BSc degree with honours in Pharmacology from the University of Leeds. In her spare time, Kelly has a passion for running and outings with her husband and three children.
About the Clinical Care Team
The clinical care team provides market intelligence and detailed insights on the clinical care equipment and IT markets. Our areas of coverage include patient monitoring, diagnostic cardiology, infusion pumps, ventilators, anaesthesia devices, and high-acuity IT. Our reports provide a data-centric and global outlook of each market with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
About Signify Research
Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.
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