Hemostasis
Giovanni Russi
COO, Hemostasis and Acute Care Diagnostics
As we reflect on 2020, the first word that comes to mind is resiliency. Nowhere was this more evident than in the clinicians, laboratorians, and healthcare systems we serve. And with them, throughout our entire organization, from manufacturing and logistics to service and support, Werfen, too, has persevered. We have all faced—and overcome—tremendous challenges, while continuing to pursue the highest quality patient care, every day.
The global pandemic elevated the importance of specialized diagnostic solutions as never before, with Hemostasis, Blood Gas and Viscoelastic testing, key for COVID-19 management. Automation, ease of use, quality management and connectivity became even more essential for healthcare systems as they responded to organizational and workflow changes. And, the reliability of healthcare manufacturers to ensure minimal disruption to the supply chain was vital.
Fortunately, we were able to meet the challenges of the pandemic head on. First and foremost, we successfully maintained operations for all functions, addressing the increased demand for products and services from our customers worldwide, with virtually no interruption. More than 450 million patient samples were tested on our Hemostasis and Acute Care Diagnostic systems in hospitals and labs around the world, and we consistently met quality and reliability goals for more than 65,000 Hemostasis and Acute Care Diagnostic systems in clinical use.
In addition to maintaining continuity for our customers, we initiated or expanded the commercial release of key new products, including the GEM® Premier™, ChemSTAT™ and GEM Hemochron™ 100 systems. And, we received de novo marketing authorization from the US Food and Drug Administration (FDA) for the HemosIL® Liquid Anti-Xa test kit to measure apixaban.
2020 was also a record year for shipments of GEM Premier 5000, ACL TOP® Family 50 Series and ROTEM® systems, as well as our HemoCell™ Specialized Automation workcell. Adoption of our data management solutions, G GEMweb® Plus Custom Connectivity and HemoHub™ Intelligent Data Manager set new records.
Our commitment to, and investment in, R&D continued, increasing resources by more than 10% and entering feasibility and/or proceeding with the development of next-generation systems and parameters.
A transformative year for our training, education, and support, we engaged in myriad virtual initiatives, including trainings, demos, educational webinars, congresses and events. We expanded our digital educational and training platform, Werfen Academy, for healthcare providers around the world; and, we leveraged it to facilitate customer operator training. We also increased our emphasis on remote support through ProDx™ Remote Support Suite systems, and other connectivity tools.
Though uncertainty remains high in 2021, we will continue to focus on innovation, quality management, connectivity, advanced service and support and personnel training. Our diversified portfolio of Hemostasis and Acute Care Diagnostics will be critical, for COVID-19 management and beyond, as clinicians and their patients return to routine care.
Through it all, as always, we prioritize continuous quality improvement and innovation, to address the needs of our customers and their patients. We appreciate the trust placed in us and remain dedicated to providing the very best specialized diagnostics.
Industry-leading systems, reagents and data management solutions.
Full commercial release of HemosIL AcuStar ADAMTS13 Activity assay and launch of Ac Accutrak™ 2.0 quality control program.
De novo approval from the US FDA for the HemosIL Liquid Anti-Xa test kit to measure apixaban and release of HemosIL Fibrin Monomer in Japan.
Record number of HemoCell workcell and HemoHub Intelligent Data Management placements and record sales for HemosIL D-Dimer, HIT and Anti-Xa assays.
