Getinge 2022 Annual Report slide image

Getinge 2022 Annual Report

Getinge 2022 Annual Report Introduction Strategy Corporate Governance Annual Report Sustainability Report Other information Contents Financial impact of COVID-19 At different occasions during the year, parts of the Chinese market went into lockdown as a result of new outbreaks of COVID-19, which caused certain delivery disruptions. Whistle-blower investigation Five current and former Getinge employees are being investigated by the prosecution authority in Baden-Baden, Germany. The inves- tigation was initiated following accusations by a whistle-blower (Medizin-produktegesetz) and is related to potential violations of the German medical device law based on a potential deficiency in the sterile HLS SET packaging for use in ECMO treatment. Getinge was informed of the German prosecutor's investigation in January 2022 and is fully cooperating with the public prosecutor. The company has carried out an internal investigation, led by an German lawyer, that was completed in the second quarter of 2022. Getinge's internal investigation identified shortcomings related to individual interpretations of quality and regulatory processes. As a consequence, corrective measures have been carried out, such as an analysis of the fundamental reasons, structural changes and intensified measures to strengthen a culture of quality at all levels of the organization. The potential impact on Getinge of the final outcome of the public investigation cannot be estimated at this stage of this process. Adjustments to EU Medical Device Regulation (EU MDR) Work on meeting the requirements of the new EU Medical Device Regulation (EU MDR) started in 2019 by upgrading all of Getinge's manufacturing sites. In February 2020, the unit in Solna was the first of Getinge's manufacturing sites and the Servo-u and Servo-n ventilators the unit's first products to be certified under the EU MDR. Work on upgrading the remaining manufacturing sites and products to meet the new requirements continued in 2021 and 2022. At the end of 2022, 67% (42) of the manufacturing sites had received their EU MDR certificates. All of Getinge's manufacturing sites are expected to be verified under the final implementation period of the new regulations in 2024. New products IN2 was launched in the first quarter - a modular system of wall and ceiling elements. The product comprises an intelligent solution for creating interconnected, sustainable and efficient workplaces in hospital departments around the world. In the same quarter, Aquadis 56 was launched, which is Getinge's new product family of innovative mid-sized premium washer-disinfectors; high-perfor- mance devices that help meet long-term efficiency and sustainabil- ity goals for infection prevention across healthcare institutions. An updated version of the ED-Flow automated endoscope reprocessor was launched in the second quarter. The new features bring a higher level of digital connectivity and data management to Getinge's endoscope reprocessing customers, which can result in improved uptime and increased productivity. Getinge launched Vac-a-Scope in the same quarter; a patented benchtop packaging system that prepares and stores endoscopes, preserving instru- ment integrity from reprocessing through to the procedure room. A new alpha port DPTE®-EXO with sleeveless DPTEⓇ-BetaBag was also launched at the end of the second quarter. It is a first of its kind alpha port, with external opening and integrated funnel, securing automated aseptic transfer and improving operational efficiency for Life Science customers worldwide. Getinge launched Livit Flex in the fourth quarter - an intuitive system for bioprocess control that will enable pharmaceuticals and biotech products to reach the market faster. New Experience Center In January, Getinge opened a new Experience Center in Wayne, USA and in May in Frankfurt, Germany, as part of the company's contin- uous strive to interact with, and support, customers and partners. The new centers allow visitors to explore Getinge's solutions in a real life setting and learn more about new and advanced technolo- gies that can help improve healthcare and life science. Changes to Getinge Executive Team On April 1, 2022, Getinge welcomed two new Executive Vice Presi- dents and members of the Getinge Executive Team, Elin Frostehav and Eric Honroth. Elin Frostehav was appointed President Acute Care Therapies and a member of the Getinge Executive Team. Elin previously served as Vice President Critical Care, part of Getinge's Acute Care Therapies business area. Elin joined Getinge in 2019 and previously held leading global positions within Semcon, an international technology company. Prior to Semcon, Elin held various positions at FlexLink, a global factory automation company. Elin succeeded Jens Viebke who took on a new role in Getinge as Executive Vice President Research & Business Development, focus- ing on Getinge's Research Programs and M&A activities. In this role, Jens Viebke will continue to report to Mattias Perjos, President & CEO, but no longer be a member of the Getinge Executive Team. Eric Honroth was appointed President Life Science and a mem- ber of the Getinge Executive Team. Eric was previously President for Getinge's sales region North America and has been with the company since 2018. He has more than 20 years of extensive experience in global leadership roles in the medical devices indus- try, including roles at Becton Dickinson, Care Fusion and Abbott Vascular. Eric succeeded Harald Castler who retired after a long and successful career at Getinge. On September 15, 2022, Agneta Palmér was appointed Executive Vice President Operational Services and a member of the Getinge Executive Team. The newly established function covers Group Purchasing, Logistics, IT and Academy and has been established to further strengthen Group synergies. Agneta joined Getinge in 2018 and most recently held the position as Vice President Corporate Control. Prior to Getinge, she held similar positions at AB Volvo within the area of Business Controlling and Management Consulting. On October 6, 2022, Joanna Engelke was appointed new Executive Vice President Quality Compliance, Regulatory & Medical Affairs and a member of the Getinge Executive Team. Joanna Engelke most recently held the position as Head of New Ventures and Chief Quality Officer for JUUL Labs. Prior to JUUL Labs, she held leading positions as Senior Vice President Global Quality & Regulatory Affairs at Boston Scientific Corporation, Managing Director at Holloran Consulting Group and Portfolio CEO, Biospecific at PureTech Ventures among others. Joanna succeeded Lena Hagman who decided to leave Getinge. 59
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