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Getinge: The Swedish Medtech Roll-Up That Faced the FDA
An Acquired.fm-Style Deep Dive Into a Century of Medical Innovation, Aggressive M&A, and the Decade-Long Regulatory Reckoning
I. Introduction & Episode Roadmap
Picture the operating room of the future: surgeons working under precision lighting on state-of-the-art tables, patients kept alive by sophisticated ventilators and ECMO machines, every instrument meticulously sterilized to prevent infection. Now imagine that much of this critical infrastructure—from the table to the ventilator to the sterilization equipment—comes from a single company that started out making horseshoe calks in a small Swedish farming village.
That company is Getinge.
Getinge AB is a global medical technology company headquartered in Gothenburg, Sweden, that develops and manufactures products and solutions for hospitals and life science institutions to enhance clinical outcomes and streamline workflows. With operations in 40 countries and sales reaching over 135 markets, Getinge employs approximately 12,000 people worldwide and reported net sales of 34.8 billion Swedish kronor in 2024.
The hook of this story is irresistible: How did a small Swedish agricultural equipment maker from a town of the same name become a medtech leader—and then nearly lose it all to FDA consent decrees that have haunted it for a decade?
With a sales share of around 40%, the United States is by far the most important market for the company due to significantly higher prices and margins there. This makes Getinge's ongoing regulatory troubles in the US not just an operational headache, but an existential strategic challenge that has shaped every major decision the company has made since 2015.
The Getinge story contains multitudes: In 1989, Swedish entrepreneurs Rune Andersson and Carl Bennet acquired Getinge from Electrolux. This was the beginning of an era of expansion and development. In the decades to come, Getinge acquired over 15 different infection control and sterilization companies across Europe and the United States. But what followed the acquisition spree tells us something deeper about the medtech industry—how quality management systems can either be a moat or a millstone, how regulatory relationships can take years to build and moments to destroy, and how a company's most important market can become its greatest vulnerability.
This article traces Getinge's journey from farm tools to sterilizers, through its transformation into an M&A machine, into the depths of its regulatory crisis, and examines where the company stands today in its ongoing turnaround.
II. Founding & Early History (1904–1989)
Origins in Rural Sweden
In the spring of 1904, in the small rural town of Getinge in southern Sweden, Getinge was founded in 1904 in Sweden as an agricultural company by Olander Larrsson in the town of Getinge. Larsson was a practical entrepreneur, and the Swedish entrepreneur Olander Larsson started manufacturing agricultural equipment in the community of Getinge. He decided to name his company after the small town in southern Sweden.
The early years were marked by the unglamorous work of serving Swedish farms. The company produced horseshoe calks and wind engines—essential tools for an agricultural economy that still relied heavily on horse power. During the 1920s, under new leadership, the company began diversifying into thermal technology apparatus, including steam cookers for commercial kitchens and early laundry equipment tailored for hospitals. This shift reflected broader industrialization trends in Sweden, where agricultural firms adapted to urban demands for efficient processing and hygiene solutions.
The Pivot to Medical Technology
The decisive pivot came in 1932, when Getinge made its first move into medical technology by starting to produce sterilizers for medical equipment. This was no coincidence—the early 20th century had seen a revolution in understanding of infectious disease, and hospitals were desperate for reliable ways to sterilize surgical instruments. Joseph Lister's antiseptic principles had transformed surgery, but the sterilization equipment to implement them was still primitive.
Getinge's background in steam technology—developed for those commercial kitchen cookers—translated directly into autoclave sterilizers. The company had the engineering expertise to build reliable pressure vessels, and the manufacturing capability to produce them at scale. This is a pattern we'll see repeatedly in the Getinge story: capabilities developed in one domain transferring unexpectedly to another.
The Electrolux Era
The company was acquired by Electrolux in 1964 and strengthened through a series of acquisitions. In the 1960s, Getinge was acquired by Electrolux, a move that provided access to a vast international network. This facilitated the company's global expansion, marking a pivotal moment in its early growth. The acquisition by Electrolux was a crucial step in establishing Getinge's presence in the medical technology market.
Electrolux—the Swedish appliance giant known for vacuum cleaners and refrigerators—might seem an odd parent for a medical equipment company. But the logic was sound: Electrolux understood manufacturing at scale, distribution networks, and the professional equipment market. Under Electrolux's ownership, Getinge gained access to capital, management expertise, and most importantly, Electrolux's international sales network.
The Electrolux years taught Getinge how to think globally. The company expanded beyond Scandinavia into broader European markets, learning how to navigate different regulatory environments and healthcare purchasing systems. It was an invaluable education—and it attracted the attention of two former Electrolux managers who saw far more potential in the sterilization business than its parent company did.
III. The Entrepreneurial Buyout & IPO (1989–1993)
The Carl Bennet Era Begins
During his time there, he met Rune Andersson, who would later become his business partner. In 1989, the duo departed the company and acquired Getinge Group, a struggling medical equipment subsidiary of Electrolux. Over the next two years, they managed to turn its fortunes around.
Carl Bennet, together with Rune Andersson, acquires the company Getinge from Electrolux for 320 MSEK. Carl takes over as CEO and Rune as the chairman of the board. Within six months the company had turned a profit.
That last detail deserves emphasis: within six months, a company that Electrolux had been willing to sell was profitable. This tells us something important about both the quality of the underlying business and the inefficiency of corporate ownership. As a small subsidiary of an appliance conglomerate, Getinge had likely suffered from benign neglect—not enough investment, not enough strategic focus, layers of corporate bureaucracy. Under focused ownership with aligned incentives, the same business could flourish.
Carl Bennet himself is a fascinating figure. Carl Bennet is a member of the Swedish noble family Bennet and holds the title of baron (friherre). Born in 1951 in Helsingborg, he earned an MBA from the University of Gothenburg in 1976. His early career included roles at Kockums and Electrolux, where he served as CEO of Electrolux's AlingsĂĄs unit from 1982 to 1988.
The partnership with Rune Andersson was a study in complementary skills. Andersson was already a prominent Swedish industrialist—his name would later become synonymous with Trelleborg AB. Together, they brought operational excellence, financial discipline, and an acquisitive mindset that would define Getinge for the next three decades.
Going Public
Growing a financially strong and prosperous company is a core part of the Getinge story. The company went public in 1993 by listing its shares on the Stockholm Stock Exchange (NASDAQ OMX). At the time, Getinge had a revenue of 600 million SEK and employed 750 people.
The IPO was transformative. It provided currency for acquisitions, liquidity for shareholders, and visibility in the capital markets. They took the company public in 1993 for 600 million SEK, where it is listed on the Stockholm Stock Exchange and has been part of the OMXS30 index from July 2009 to June 2025.
Ownership & Control Structure
By 1997, Andersson & Bennet, their joint holding company, was dissolved in what Swedish media referred to as a friendly separation. Bennet rebranded the company under his own name, Carl Bennet AB, becoming its sole owner. He retained an 18 per cent share in Getinge and secured nearly half of the voting control. At that point, he stepped down as CEO and assumed the role of chairman.
With a 20% stake in the capital and 50.19% of the voting rights, Carl Bennet remains the main owner of the company through his holding company Carl Bennet AB. Other notable owners include two Swedish pension funds and American asset managers such as Vanguard and Blackrock.
This dual-class share structure—common in Sweden but often controversial in other markets—has enabled a remarkably long-term approach to ownership. Carl Bennet has controlled Getinge for over 35 years, through multiple market cycles, management teams, and industry transformations. The structure provides stability but also concentrates decision-making power, for better or worse.
As of July 2025, Forbes estimated his net worth at US$11.4 billion. The value creation at Getinge—despite all its challenges—has been substantial for patient shareholders.
IV. The Acquisition Machine (1995–2014)
Building Three Business Pillars Through M&A
The Getinge that emerged from the 1989 buyout and 1993 IPO was focused on sterilization equipment—a solid but narrow niche. What followed over the next two decades was one of the most aggressive acquisition campaigns in European medtech history, transforming Getinge into a diversified medical technology conglomerate organized around three business pillars.
Extended Care – The Arjo Acquisition (1995)
The first major diversification came in 1995 with the acquisition of Arjo. Arjo was first listed on the Stockholm and London stock exchanges in 1993. At that time, Arjo had about 1,100 employees and generated sales of approximately SEK 1,300 M. In 1995, Arjo was acquired by Getinge which then expanded its product offering to include medical beds, patient lifts and bathing systems. Arjo thus became the foundation of Getinge's Extended Care business area.
Arjo was a different business from sterilization—it focused on patient handling, mobility aids, and therapeutic surfaces for long-term care facilities and hospitals. The acquisition logic was twofold: first, it gave Getinge access to a broader set of hospital decision-makers; second, it diversified revenue streams into a more stable, less capital-equipment-dependent business model.
The Maquet Acquisition – Entering the Operating Room (2000)
The acquisition that truly transformed Getinge was the 2000 purchase of Maquet from German energy conglomerate RWE AG. Maquet's sales for 1999/2000 were EUR 156 million. Maquet is the world leader in surgical tables with a 30% share of the world market and with a well established brand name synonymous with innovative strength and quality for more than a century.
Maquet will be part of the Getinge Group from 1 January 2001. The cost of the shares will be EUR 91 million.
Maquet brought more than market share—it brought heritage. The foundation for MAQUET was laid in 1838 by Johann Friedrich Fischer in Heidelberg. The company manufactured and sold patient chairs and other health care equipment. In 1876 it was a takeover of the company by Curt Maquet. In 1933 the company relocated to Rastatt, Germany.
Founded in 1838, Maquet has a rich heritage in creating groundbreaking products, including the first motorized operating table and the table used for the world's first heart transplant. The connection to Christiaan Barnard's 1967 breakthrough gave Maquet—and by extension, Getinge—a powerful marketing narrative and genuine clinical credibility.
Expanding Into Critical Care (2003)
The acquisition of Jostra (heart-lung machines) and Siemens LSS (ventilators) in 2003 made the offer within Acute Care Therapies even more competitive and patient-centric.
The Siemens LSS acquisition was particularly significant because it brought the Servo ventilator franchise—a brand that would prove crucial during COVID-19 nearly two decades later. Siemens had developed world-class ventilator technology but viewed it as non-core to its broader healthcare imaging strategy. Getinge saw an opportunity to build a leadership position in critical care.
The Huntleigh Deal – Consolidating Extended Care (2007)
The significant acquisition of Huntleigh Technology PLC took place in 2007 after which the ArjoHuntleigh brand was established. In 2007, Getinge Group made another significant acquisition: Huntleigh Technology PLC, combining it with Arjo to create the ArjoHuntleigh brand and globally leading player with a comprehensive portfolio.
The Huntleigh acquisition demonstrated the roll-up playbook at its finest: acquire competitors, consolidate operations, eliminate duplicative costs, and emerge with a stronger market position. The combined ArjoHuntleigh entity had critical mass in patient handling and extended care that neither company could have achieved independently.
Cardiovascular Expansion – Datascope & Beyond (2008–2014)
The cardiovascular push culminated in the 2008 acquisition of Datascope Corporation. Under a merger agreement dated September 15, 2008, Getinge proposed to acquire all outstanding shares of Datascope for approximately $865 million.
Datascope is the world's leading supplier of intra-aortic balloon pump counter pulsation devices, and is a diversified medical device company that develops, manufactures, and sells products used in critical care, interventional cardiology, and other cardiovascular procedures.
The Datascope deal required regulatory navigation. Getinge AB has settled Federal Trade Commission charges that its proposed $865 million acquisition of rival Datascope Corporation would be anticompetitive. Under the settlement with the Commission, Datascope is required to divest its endoscopic vessel harvesting (EVH) product line to an FTC-approved buyer.
In addition to the Atrium acquisition, MAQUET's parent company, the Getinge Group, also completed a $750 million acquisition of Boston Scientific's cardiac surgery and vascular divisions in 2007, and the $841 million purchase of intra-aortic balloon pump devices from Datascope.
In 2011, Getinge acquired the US company Atrium Medical, and in 2014, it acquired the German company Pulsion Medical Systems. The Atrium acquisition would prove fateful—it was one of the facilities later included in the FDA consent decree.
Since its listing in 1993, Getinge sales have grown continuously, achieved through a combination of organic growth and acquisitions. By 2014, Getinge had transformed from a 600 million SEK sterilization company to a diversified medtech conglomerate with revenues measured in billions. The M&A machine had worked brilliantly—but the integration challenges were about to become apparent.
V. The FDA Crisis & Regulatory Reckoning (2015–Present)
KEY INFLECTION POINT #1: The 2015 Consent Decree
A federal judge from the US District Court for the District of New Hampshire has entered a Consent Decree of permanent injunction against Maquet Holding B.V. & Co. KG and two of the company's officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies: Atrium Medical Corporation in Hudson, New Hampshire; Maquet Cardiovascular, LLC, in Wayne, New Jersey; and Maquet Cardiopulmonary AG in Rastatt and Hechingen, Germany. Maquet Holding is subsidiary of the Getinge Group, based in Getinge, Sweden. According to the FDA, between 2009 and 2013, investigators from the agency conducted ten inspections across the three Maquet facilities and uncovered major violations of the Quality System (QS) regulation, Medical Device Reporting (MDR) regulation, and Correction and Removal (CR) regulation.
The consent decree was devastating in its scope. It didn't target a single product or facility—it named multiple sites across two continents and alleged systematic failures in quality management. Additionally, between 2009 and 2014, the FDA is aware of 45 recalls of Maquet-manufactured devices, five of which were classified as Class 1—representing the most significant risk to patients.
"We have learned from this experience, and this agreement with the FDA provides us with a clear path forward," said Johan Malmquist, CEO Getinge Group. "We have taken this situation very seriously and have committed substantial investments into the quality management system. The remediation work is well underway and has already led to significant improvements." The overall financial impact, excluding the remediation costs, is estimated to amount to $60.4 million and will have a negative impact on the operating profit for 2015.
Getinge Group announced that the overall financial impact, excluding the remediation costs, related to the Consent Decree is estimated to amount to Swedish kronor (SEK) 500 million (approximately $59.52 million) and will have a negative impact on the operating profit for 2015.
The Long Shadow of Regulatory Issues
What makes the Getinge regulatory saga so instructive is its duration. A decade after the initial consent decree, the issues remain unresolved.
The issues identified in 2015 had not been resolved by 2019, which led the FDA to sent a warning letter to Getinge. Inspections of its facilities between November 2021 and January 2022 found they were still not in compliance. The company said its costs for the IABP improvement activities from 2018 to 2022 amounted to about $470 million.
The remediation spending has been staggering. By one estimate, Getinge spent approximately SEK 2 billion on remediation and restructuring related to the 2015 consent decree, plus approximately SEK 1.8 billion in provisions for surgical mesh liability costs. In 2023, the company spent approximately SEK 800 million in quality spending related to its cardiopulmonary and cardiac assist businesses.
KEY INFLECTION POINT #2: Consent Decree Expanded (2022)
U.S. Food & Drug Administration (FDA) will include Getinge's subsidiary Datascope as an additional facility in the company's existing consent decree with the U.S Government. This is due to findings from previous FDA inspections and a warning letter related to operational compliance with the company's quality management system and processes. Getinge has today responded to FDA and accepted that Datascope will be included in the existing Consent Decree. FDA's conclusion relates to a previously communicated warning letter in 2019 and subsequent inspections at the Datascope site in Wayne, NJ, US, between November 1, 2021 and January 21, 2022. According to FDA, Getinge's subsidiary Datascope has failed to fully comply with the Quality Management System and related processes.
The FDA worked with the U.S. Department of Justice to place Getinge manufacturing sites under consent decree in 2015 and added the IABP manufacturing site in 2022. This action allows additional FDA oversight, an independent auditor, inspections, and updates on progress made toward addressing quality and safety concerns. At this time, the cardiopulmonary bypass and IABP facilities have not met the requirements to have the consent decree lifted.
The Quality Challenges Continue (2023-2024)
The US FDA alone ordered the recall of two Getinge products in 2023 due to significant risks. Additionally, the company agreed to pay around 200 million SEK in the US to settle a class-action lawsuit over defects in surgical products. For a further 360 million SEK, the company agreed to settle with Brazilian authorities after allegations of unfair competition between 2004 and 2017.
Getinge initiated 12 voluntary recalls for the Cardiosave IABP From Jan. 1, 2023, through April 11, 2024, including eight classified by the FDA as Class I recalls, the most serious type. The FDA said it has received 2,964 MDRs related to Cardiosave IABPs in the last 12 months, including 15 that reported serious injury or death.
In May 2024, the FDA took the extraordinary step of recommending that healthcare facilities transition away from Getinge devices. "The FDA recommends that health care facilities transition away from use of these devices and seek alternatives, if possible. These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices."
The European regulatory picture has been similarly troubled. Getinge has seen its CE certificate suspended over similar concerns. In July 2023, the EU reinstated the company's CE mark but has now withdrawn it for a second time due to gaps identified in compliance with applicable regulations.
VI. Strategic Restructuring: The Arjo Spin-Off & Refocus (2016–2017)
KEY INFLECTION POINT #3: Shedding Extended Care
By 2016, the regulatory crisis had forced a strategic reckoning. The company was overstretched—trying to manage quality remediation across multiple facilities while running three diverse business units. Something had to give.
The Board of Directors of Getinge AB has today proposed that the shareholders of Getinge shall decide, at an Extraordinary General Meeting in Getinge, to distribute the Patient & Post-Acute Care business area through a distribution of all shares in the wholly-owned subsidiary Arjo AB.
The Extraordinary General Meeting will be held on December 4, 2017. Provided that the shareholders resolve in accordance with the proposal, the distribution will be executed and Arjo's shares of series B will be listed on Nasdaq Stockholm on December 12, 2017.
For the year ended 2016, Arjo AB reported revenues of SEK 7.8 billion, total assets of SEK 14.7 billion, EBIT of SEK 781 million, EBITDA of SEK 1.5 billion, net profit of SEK 490 million and shareholders' equity of SEK 10.6 billion.
The rationale was compelling. "The board of directors believes the proposal to split the group into two separate listed companies, Getinge and Arjo, will enhance the prerequisites to successfully develop the respective businesses which will increase the value for customers as well as shareholders," chairman Carl Bennet said.
At that time, a spin-off decision with Arjo had already been made; my first priority was to execute the complex carve-out process. At the end of the day, I believe it has been to the benefit of both companies. It allowed Getinge to be more focused within the hospital setting.
In 2016 Getinge AB unified all former brands under the Getinge name, generating a new master brand identity, Maquet was included within the rebrand as a product family name.
The spin-off was the right call. Extended Care operated in fundamentally different markets—long-term care facilities, rehabilitation centers, nursing homes—with different customers, different sales cycles, and different competitive dynamics than Getinge's core hospital-focused businesses. Trying to manage both while navigating a regulatory crisis was a recipe for mediocrity in both.
The separation also improved Getinge's financial profile. From Getinge's point of view the spin-off improves everything, margins, leverage ratio and growth. The Extended Care business had lower margins and slower growth than Acute Care Therapies—shedding it made Getinge look better on every metric that mattered to investors.
VII. The Modern Era: Turnaround & New Growth Vectors (2017–2025)
New CEO, New Strategy
Mattias Perjos has been named as the new President and CEO of Getinge. He will take up his new role on 1 May 2017 at the latest. Perjos joins Getinge from the Coesia Group, a privately owned Italian group of companies, where he holds the position as CEO of the IPS Division and a member of Group management since 2012. In addition, He is Managing Director of Coesia International which includes the subsidiaries in China, Japan, South Korea, South-East Asia, India, the Americas, Russia, Africa and the Middle East. Born in 1972 and holding a Master of Science in Industrial Engineering and Management from Lulea University of Technology, Perjos began his career at Sandvik and shortly thereafter joined FlexLink.
Mattias Perjos has held senior positions at Coesia 2012–2017, including CEO of Coesia IPS Division and Coesia International. Previously he was CEO of Flexlink 2006–2016 where he started his career in 1998.
Perjos arrived with a mandate to fix quality and refocus the portfolio. His background was in industrial automation, not medical devices—but that may have been exactly what Getinge needed. The company's problems were fundamentally operational: process discipline, quality management systems, regulatory compliance. These are engineering problems as much as medical problems.
COVID-19: Temporary Tailwind
The pandemic created unprecedented demand for exactly the products Getinge made. The quarter was dominated by the COVID-19 pandemic and the huge need for advanced ventilators and ECMO therapy at intensive care units around the world. Our leading global positions in these fields contributed to a 47% organic order growth. We expect to see continuing strong demand in both areas since demand is far outstripping supply.
Getinge plans to ramp up ventilator production capacity to 160% of last year's output levels or 26,000 units, as hospitals around the globe scramble for ventilators to treat critically ill COVID-19 patients.
In addition to a huge demand for advanced ventilators, the fight against the new coronavirus COVID-19 has also increased the need for Extracorporeal Membrane Oxygenation (ECMO), an approach that provides the body with oxygen when the lungs fail to perform this task. Getinge's ECMO devices are designed to help keep critically ill patients alive while giving their damaged lungs time to recover.
The Servo ventilator franchise—acquired from Siemens back in 2003—proved its worth. Getinge found itself in an enviable position: world-leading technology in the exact product category that every hospital in the world suddenly needed.
But the tailwind was temporary. The order intake for ventilators increased in the third quarter, but at a less spectacular level and the capacity will be adjusted accordingly. The strong sales of ECMO therapy products for hospitals and Sterile Transfer products for the pharmaceutical industry continued.
KEY INFLECTION POINT #4: Exiting Surgical Perfusion (2025)
Getinge CEO Mattias Perjos said surgical perfusion has "been a struggling category" since an FDA consent decree forced the company off the U.S. market in 2015. CEO Mattias Perjos said on an earnings call that surgical perfusion has "been a struggling category" since a consent decree forced Getinge off the U.S. surgical perfusion market in 2015.
"The rationale behind withdrawing from surgical perfusion is the low market share that we continue to have, really in the wake of the consent decree 10 years ago. It's a loss-making category for us as well. So, we don't feel that we're good owners of this anymore. The effect of withdrawing from this segment is that we actually free up competency and resources for transplant care and for ECMO." Getinge's market share outside of the U.S. has fallen from 15% in 2018 to 7% in 2023.
The company plans to end production of its HL 40 Heart-Lung Machine and HCU 40 HCU 40 heater-cooler unit and related disposable products. One of the main reasons for ending production is the fact that these products were not included in the lucrative U.S. market since 2015, when Getinge signed a consent decree with the U.S. Food and Drug Administration (FDA) to temporarily suspend production of the devices at its manufacturing site in New Hampshire because of quality production management issues.
The exit of Getinge from the cardiopulmonary bypass equipment (CBPE) sector will likely benefit dominant players such as LivaNova, which already had about 50.3% of the market share as of 2024, according to GlobalData. But GlobalData said Getinge only accounted for about 1.9% of the market share.
New Growth Vectors: ECMO & Transplant Care
At the time the letter was sent, Getinge said it had over 60% of the U.S. market share for these types of products. So despite the letter, Perjos said there was no impact on its sales in 2024.
With the acquisition of Paragonix Technologies – a pioneer and innovator in organ transport and preservation – Getinge marks its entry into a rapidly advancing field driven by rising transplant volumes, technological innovations and evolving clinical practices. The acquisition aligns with Getinge's broader strategy to expand its portfolio into high growth markets that complement and enhance its acute heart and lung support offering.
Getinge announced that it had entered into an agreement to acquire Paragonix Technologies, Inc., a leading U.S. company in organ transport products and services, for a total purchase price estimated at USD 477 million, including upfront and currently estimated earn-outs. All conditions for the transaction have now been fulfilled. Getinge paid approximately USD 253 million in cash upon completion of the acquisition. The earn-out payments are expected to be paid between 2024 and 2026 if agreed upon regulatory and financial performance milestones are achieved.
The total market for transplants has been growing rapidly in recent years and is expected to continue to grow double digit and exceed USD 10 billion in 2033. Growth is driven by volume increase due to demand and the transition from traditional methods (ice) towards new technologies as the average cost of transplant cases increases. This trend is already established for the Heart and Lung segments, and similar development is expected for the Abdominal segment. Paragonix Technologies outgrows the market significantly (136% growth in 2023) – seizing a substantial market share.
The Paragonix product portfolio now encompasses all major organ categories, which includes about 50% off the market share for heart transplant.
Paragonix Technologies, a leading organ preservation company recently acquired by Getinge, receives FDA clearance for the innovative transportable perfusion device KidneyVault, to optimize standard of care in kidney preservation. Getinge's most recent acquisition, Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, has received US Food and Drug Administration (FDA) 510(k) clearance for its donor kidney preservation system, KidneyVault.
In 2025, Getinge expanded its Servo-c ventilator offerings to neonatal patients; the new design can support preterm birth babies weighing as little as 500 grams.
VIII. Current Business & Financial Performance
Three Business Areas Today
The company is divided into three business areas: Life Science, Acute Care Therapies, and Surgical Workflows.
Revenue is geographically diversified, with the Americas contributing 45% (SEK 15,516 million), EMEA 35% (SEK 12,182 million), and APAC 20% (SEK 7,061 million); the United States represents the largest single market at around 40% of total sales. Major revenue drivers include the Acute Care Therapies segment at 52%.
2024: A Record Year
Net sales increased organically by 4.9% (6.4) and the order intake rose by 6.3% organically (-1.6). Adjusted gross profit amounted to SEK 17,409 M (15,533) and the margin was 50.1% (48.8). Adjusted EBITA amounted to SEK 4,869 M (3,887).
Adjusted EBITA amounted to SEK 4,869 M (3,887) and the margin was 14.0% (12.2). Adjusted earnings per share amounted to SEK 11.73 (9.19). Free cash flow amounted to SEK 3,284 M (1,623). A dividend per share of SEK 4.60 (4.40) is proposed.
"2024 was a record year for Getinge. We have grown significantly, maintained high customer loyalty, and launched highly demanded products across all business areas," says Mattias Perjos, President & CEO at Getinge.
Both order intake and net sales increased significantly, also organically, with positive performance in all regions. Growth was particularly strong in ventilators, where Getinge is benefiting from the consolidation in the market. Furthermore, consumables in ECLS in Acute Care Therapies and Sterile Transfer in Life Science, showed solid performance.
Q2 2025 Performance
Net sales increased organically by 4.1% (8.9) and order intake rose by 4.4% organically (7.8). Adjusted gross profit amounted to SEK 4,183 M (4,151) and the margin was 50.8% (50.0). Adjusted EBITA amounted to SEK 989 M (981) and the margin was 12.0%.
Paragonix, acquired in the autumn of 2024, continues to impress, with another sales record in the quarter. The operations also made a positive contribution to Getinge's EBITA margin, slightly earlier than expected.
2025 Outlook
In 2024, we have demonstrated that we are well positioned in prioritized product categories for our customers. This means that we have a positive outlook on 2025 and expect organic sales growth of 2-5% for the full year.
IX. Competitive Landscape & Market Position
Sterilization & Surgical Workflows
Steris' competitors include 3M, Getinge Group, and Belimed (Metall Zug). STERIS operates in the highly competitive infection prevention and control market, facing competition from both large diversified medical technology companies and specialized players. In the healthcare sterilization equipment segment, STERIS's primary competitors include Getinge AB, a Swedish medical technology company that offers sterilization equipment, surgical tables, and other infection control products.
In the surgical products market, STERIS competes with Hillrom (acquired by Baxter International in 2021), Stryker Corporation (SYK), and Getinge for surgical tables, lights, and equipment management systems.
The Sterilization Equipment industry is moderately concentrated on a global scale. Major players such as STERIS Corporation, Getinge AB, 3M, and Belimed AG hold significant market shares due to their extensive resources, broad product portfolios, and global distribution networks. These companies dominate the market through continuous innovation, strategic acquisitions, and the ability to meet diverse sterilization needs worldwide.
ECMO Market
Key companies, such as Getinge AB, Terumo Corporation, and Medtronic plc, accounted for most of the Extracorporeal Membrane Oxygenation machine market share in 2024. Getinge AB, Terumo Corporation, and Medtronic plc are the major players in the market.
Getinge AB has positioned itself as a global leader in the ECMO machines market by leveraging its strong portfolio of advanced life support and critical care solutions.
Major players like Medtronic, Getinge, and Maquet dominate the market with established brands, extensive distribution networks, and significant market share.
Transplant Care
The Paragonix acquisition has catapulted Getinge into a leadership position in organ preservation. Today, Paragonix is the leading US cardiothoracic organ preservation technology provider and is rapidly expanding in abdominal transplantation.
X. Bull Case, Bear Case & Strategic Assessment
The Bull Case
The bull case for Getinge rests on three pillars:
1. Market Leadership in Attractive Segments: Getinge holds dominant positions in ventilators, ECMO, and now organ preservation through Paragonix. These are structurally attractive markets with high barriers to entry, sticky customer relationships, and meaningful switching costs. The aging population and rising burden of cardiovascular and respiratory disease create durable tailwinds.
2. Turnaround Progress: The financial results speak for themselves. Adjusted EBITA margin improved from 12.2% to 14.0%. Free cash flow more than doubled. The Arjo spin-off, surgical perfusion exit, and Paragonix acquisition represent disciplined portfolio management—shedding underperforming assets and adding high-growth ones.
3. Owner-Operator Alignment: Carl Bennet's 35-year involvement and 50% voting control enable long-term thinking that publicly traded companies with dispersed ownership often lack. The company can make unpopular decisions—like exiting surgical perfusion—without fear of activist pressure.
The Bear Case
1. Regulatory Overhang: The FDA consent decree, now approaching its tenth anniversary, shows no signs of resolution. At this time, the cardiopulmonary bypass and IABP facilities have not met the requirements to have the consent decree lifted. The ongoing FDA warnings create headline risk, customer uncertainty, and continuous remediation costs.
2. US Market Risk: With 40% of sales from the US, any deterioration in US market access—whether from regulatory action, reimbursement changes, or competitive displacement—would be material. The FDA's May 2024 recommendation that hospitals transition away from Getinge devices is an existential threat to certain product lines.
3. Quality Culture Questions: Ten years of ongoing quality issues raise questions about whether the problems are solvable. Is this a management execution issue, a cultural issue, or something structural about how the business was assembled through M&A? The repeated failure to satisfy regulators suggests deeper problems than any single remediation program can address.
Porter's Five Forces Analysis
| Force | Assessment |
|---|---|
| Supplier Power | LOW. Getinge manufactures most components in-house and has multiple sourcing options for raw materials. |
| Buyer Power | MODERATE. Hospital customers have some negotiating leverage, but switching costs for critical equipment are high. Group purchasing organizations increase buyer concentration. |
| Competitive Rivalry | HIGH. Well-funded competitors like Medtronic, STERIS, and Stryker compete aggressively across multiple product categories. |
| Threat of Substitutes | LOW to MODERATE. No substitutes exist for ECMO or ventilators. Some sterilization can move to outsourced services. |
| Threat of New Entrants | LOW. Regulatory barriers, capital requirements, and established customer relationships create significant moats. |
Hamilton Helmer's 7 Powers Framework
| Power | Getinge Assessment |
|---|---|
| Scale Economies | WEAK. Manufacturing is not highly scale-sensitive; competitors can match production economics. |
| Network Effects | NONE. Medical devices don't exhibit network effects. |
| Counter-Positioning | NONE. Competitors can and do replicate Getinge's strategy. |
| Switching Costs | MODERATE TO STRONG. Hospital integration, staff training, and service contracts create meaningful switching costs for capital equipment. |
| Branding | MODERATE. The Maquet and Servo brands have clinical credibility, but regulatory issues have damaged reputation. |
| Cornered Resource | WEAK. No proprietary technology that competitors cannot replicate. |
| Process Power | DAMAGED. The regulatory failures suggest the opposite of process power—systematic operational weaknesses. |
Myth vs. Reality
| Consensus Narrative | Reality Check |
|---|---|
| "Getinge is a quality turnaround story" | Mixed. Financial metrics improved, but regulatory issues persist. The consent decree remains unresolved after a decade. |
| "COVID demonstrated the strength of the franchise" | True but misleading. The pandemic was a one-time tailwind that has normalized. It didn't fix structural quality issues. |
| "The Paragonix acquisition positions Getinge for growth" | Promising but unproven. Paragonix is growing rapidly, but integration with a company with quality management challenges carries execution risk. |
| "US market share proves customer loyalty" | Complicated. 60% ECMO market share despite FDA warnings suggests either genuine loyalty or lack of alternatives. The latter is not sustainable. |
XI. Key KPIs for Investors
For long-term fundamental investors tracking Getinge, three KPIs matter more than others:
1. Organic Sales Growth (Target: 2-5%)
This is the single best indicator of underlying business health. Organic growth strips out M&A and currency effects to show whether customers are buying more Getinge products. The company has guided to 2-5% organic growth for 2025. Sustained performance at the high end of this range would suggest the turnaround is working; slippage below 2% would raise concerns.
2. Adjusted EBITA Margin (2024: 14.0%)
Margin expansion demonstrates operating leverage and quality remediation progress. The company has improved from 12.2% to 14.0%—meaningful progress but still below medtech industry leaders like STERIS (20%+ margins) and Stryker (25%+ margins). Continued margin expansion toward 18-20% would indicate successful portfolio optimization and quality cost normalization.
3. Consent Decree Status (Currently: Unresolved)
This is the qualitative KPI that doesn't appear on financial statements but dominates the investment thesis. Any update from the FDA—whether positive (partial lifting of consent decree) or negative (expanded scope, new warning letters)—is material. Investors should monitor FDA inspection reports, warning letters, and quarterly management commentary on regulatory progress.
XII. The Road Ahead: What Comes Next
Getinge stands at a critical juncture. The company has made meaningful strategic progress—spinning off Extended Care, exiting surgical perfusion, acquiring Paragonix, improving margins. But the fundamental question remains unresolved: Can a company built through aggressive M&A develop the operational excellence and quality culture required to satisfy regulators and maintain market leadership?
The next two to three years will likely be decisive. Several scenarios are possible:
Scenario 1: Regulatory Resolution. Getinge finally satisfies FDA requirements, the consent decree is lifted or narrowed, and the company returns to normal operations in the US. This would be transformative—removing the overhang that has weighed on the stock for a decade and enabling full commercial efforts in its most important market.
Scenario 2: Continued Stasis. The regulatory situation neither improves nor deteriorates dramatically. Getinge continues to operate under consent decree, spending significant resources on remediation while losing market share in affected categories. This is essentially the status quo extended.
Scenario 3: Regulatory Escalation. Additional products or facilities are added to the consent decree, or the FDA takes more aggressive enforcement action. This could force further portfolio divestitures and create existential risk for certain business units.
What's certain is that Getinge cannot be evaluated purely on financial metrics. The regulatory dimension is not a sidebar to the investment thesis—it is the investment thesis. A company can have world-leading technology, loyal customers, and strong market positions, but none of it matters if regulators prevent it from selling products.
The Getinge story is ultimately a cautionary tale about the dangers of growth without integration, acquisition without assimilation, and scale without systems. The company that Bennet and Andersson bought in 1989 was small but functional. The empire they built through M&A became too large and too complex to manage with adequate quality controls. The resulting regulatory crisis has cost billions in remediation, untold amounts in lost revenue, and incalculable damage to reputation.
Yet the story isn't over. Getinge remains a global leader in critical medical technologies. Its products save lives every day. Under Perjos' leadership, the company has shown it can make hard decisions—shedding businesses, acquiring strategically, and improving operations. The question is whether those efforts will be enough to finally close the chapter on a decade of regulatory purgatory.
For investors willing to accept regulatory risk in exchange for exposure to attractive medtech end markets, Getinge offers a potentially compelling opportunity. But this is not a set-and-forget investment. It requires ongoing monitoring of FDA actions, quality metrics, and management's credibility on regulatory timelines. The difference between a successful turnaround and an extended value trap may depend on developments that no financial model can predict.
Getinge AB (GETI-B.ST) trades on Nasdaq Stockholm. Carl Bennet AB controls approximately 50.19% of voting rights through its ownership of Class A shares.
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