ICU Medical Receives FDA Approval for Duo Pump

Publication Date: 11/10/2023

Back in August 2023, ICU Medical announced that it received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its new Plum Duo infusion pump with LifeShield infusion safety software. It also announced that the Plum Duo pump and LifeShield software will be available to customers in the U.S. in early 2024.

So what’s new?

The new infusion solution combines advanced large volume infusion technology with a large colour screen, promising an intuitive and easy to use interface, and is capable of infusing up to four compatible IV medications. The LifeShield software incorporated into the Plum Duo pump is a cloud-based solution, offering advanced tools and a comprehensive drug library. ICU Medical is also in the process of expanding the integration of the LifeShield software into its next generation CAAD and Medfusion infusion solutions, which it integrated into its portfolio through the Smiths Medical acquisition in January 2022.

History of ICU Medical

ICU Medical acquired the Hospira Infusion Systems business from Pfizer in February 2017, which previously acquired the Hospira business in September 2015. Hospira Inc., was a leading vendor within the large volume, electronic ambulatory and PCA infusion pump segments. Like many infusion vendors, it had been plagued by pump recalls including several battery issues across its product offering. Hospira Inc., was also at the centre of an investigation into the Symbiq and LifeCare PCA infusion systems due to vulnerabilities that were identified. Subsequently a new release of the LifeCare PCA pump was approved, whilst the Symbiq Infusion System was removed from the market.

In its 2022 edition of its Infusion Pump report, Signify Research estimated ICU Medical to hold a 15.3% share of North American market revenue for large volume infusion pumps in 2021, a slight fall from its 2020 share (15.7%). It was also ranked second on a global basis for the provision of associated infusion software accounting for 18.5% of global revenues in 2021. Signify Research is currently updating its analysis of the infusion market and will be publishing its new Infusion Pumps – 2023 report in November.

What are the advantages for ICU Medical?

Since acquiring the infusion systems from Hospira, ICU Medical has also expanded its offering through its acquisition of Smiths Medical enabling a breadth of infusion solutions within its portfolio. It is now one of the vendors with the most comprehensive offering, including a wide number of infusion types and only missing an enteral feeding product line. The roll out of the LifeShield software across the wider infusion portfolio will reduce the burden of product integration into supporting information systems, and the EHR. By standardising on one platform the ‚Äòheavy lifting’ of device integration will be reduced. This will not only enable smoother data transition, but will also simplify processes, utilising one standard interface across its offering. With many hospitals placed under increasing strain due to the fall in the number of healthcare staff, the need to provide training on just one platform and associated interface that can be utilised across an infusion portfolio will be welcomed with open arms.

What are the pros and cons to infusion software?

ICU Medical will also need to be on top of software glitches which have been the thorn in the side of many infusion vendors in recent years. BD was quite publicly at the shortfall of issues it faced with its Alrais system. However, it recently made its comeback with the new 510k approval for the revitalised Alaris infusion platform, which took several years and a significant amount of renumeration to remediate software errors it had faced previously. ICU Medical hopes that its cloud-based offering will enable a streamlined approach to software updates in real-time, to ensure customers are utilising the newest version immediately. Its SaaS business model will also enable ongoing support and implementation scaled to the number of pumps supplied within the healthcare providers facilities.

ICU Medical is also eager to take its position and newer solution offering and maximise the opportunity it has within the market. Its closest competitors BD and Baxter have been limited in terms of market presence in recent years due to product recalls. The pandemic highlighted the need for digital solutions that helped to support clinical decisions, and this will continue to drive growth for digital large volume pumps in the North American region. Despite a relatively saturated market in the U.S, demand for newer digital solutions that improve patient safety and clinical efficiency is at an all-time high.

With more connected devices available, greater emphasis has also been placed on both software robustness and cybersecurity. The FDA has now provided both pre-market and post-market guidance for manufacturers of interconnected and interoperable devices.

Future Outlook

The new developments from ICU Medical will no doubt improve its chances of increasing its market share both in the North American region and wider to its global customer base. Although official roll out of the Plum Duo solution is not expected until early next year, it will be going head-to-head with BD who will be determined to revitalise its positioning in the market after achieving its 510k approval earlier this year. As such, the full impact on market share is not expected to be felt until 2024. Signify Research expects ICU Medical to gain share, maximising its advantage by offering a comprehensive platform and an intuitive software solution that will hopefully meet the increasing demands of the healthcare workforce. ICU Medical took just over eight months to undergo the FDA approval process for its Plum Duo and LifeShield software offering, highlighting its preparedness in the level of clinical data required for FDA submission. The team has clearly learnt from the issues that have arisen in Hospira’s past. As long as it continues to keep on top of any software issues that may arise, its reputation as a safe infusion vendor will support its efforts to continue to rise in the infusion market rankings.

Related Research

Signify Research is due to publish its Infusion Pump – World – 2023 report. The report builds on our 2022 edition of the research and provides a data-centric and global outlook of the market. The report 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 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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