Sarah Howard

Sarah Howard has been in the MedTech industry for 15 years, focusing on In-vitro biocompatibility testing of medical devices. She is now the Senior Manager of Laboratory Services overseeing four departments: the In-vitro lab, Sample Preparation lab, Clinical Pathology lab, and the Lab Service Specialists.

Sarah began her biocompatibility career as an In-vitro technologist at WuXi App Tec, later transitioning into a Study Director role. The experience working in the lab and with clients proved invaluable when she helped launch the In-vitro testing lab for American Preclinical Services (APS) 12 years ago. Sarah, along with several other talented individuals, successfully validated hemocompatibility, genotoxicity, and cytotoxicity testing, achieving ISO 17025 accreditation in the process. Sarah became a NAMSA Associate 3 years ago after APS was acquired, continuing to expand NAMSA’s impressive offerings. Included in these offerings are industry-leading hemocompatibility tests such as the In-vitro Blood Loop Assay, Platelet and Leukocyte Assay, Thrombin Anti-Thrombin Assay, and Beta-Thromboglobulin Assay. Additionally, NAMSA has increased focus on offering custom mechanical hemolysis assays to meet ever-evolving FDA requirements.

Sarah earned her B.A. at Macalester College in St. Paul, MN with a degree in Biology. She is a voting member for the Association for the Advancement of Medical Instrumentation (AAMI) BE-WG 09: Effects on Blood Working Group.

CORE COMPETENCIES

• Working knowledge of ISO 10993 part 3 (genotoxicity), part 4 (hemocompatibility), part 5 (cytotoxicity) and part 12 (sample preparation)
• Routinely participates in technical discussion with Sponsors regarding In-vitro blood loop and custom mechanical hemolysis
• Technical expert responsible for updating all applicable In-vitro assay protocols and documents whenever guidelines (such as ISO, ASTM, USP) are revised
• Participating in several In-vitro round robin programs including the In-vitro blood loop, cytotoxicity, and In-vitro skin irritation
• Providing technical and benchtop support to the In-vitro lab staff; routinely assisting with the Mouse Lymphoma assay
• Providing technical reviews of Sponsor biocompatibility test submissions, ensuring test requests are achievable
• Ensuring labs maintain GLP compliance and are prepared for audits and inspections

RECENT PROJECTS

• Assay validation completed for two new hemocompatibility tests utilizing freshly collected human blood and now available as routine hemocompatibility assays
  • Thrombin Anti-thrombin assay, which evaluates coagulation
  • Beta-Thromboglobulin assay, which evaluates platelet activation
• Provided initial support to clients to discuss design and capabilities of several complex mechanical hemolysis studies
  • IVT successfully completed several studies that included several additional blood parameters with different ELISA tests, such as platelet activation, white blood cell activation, and coagulation)

PUBLICATIONS

• Deline, S; Schatz, T; Grove, K; Howard, S; Smith, M “Development of a Novel Positive Control for the Standard Test Method for the Platelet Leukocyte Assay: An In Vitro Hemocompatibility Assessment of Blood-Contacting Medical Devices.” Journal of Medical Devices June 2016, Vol. 10
• Grove, K; Deline, S; Schatz, T; Howard, S; Smith, M “Thrombogenicity Testing for Blood-Contacting Medical Devices in an In Vitro Ovine Blood-Loop.” Journal of Medical Devices June 2016, Vol. 10
• Grove, K; Deline, S; Schatz, T; Howard, S; Porter, D; Smith, M “Thrombogenicity Testing of Medical Devices in a Minimally Heparinized Ovine Blood-Loop” Journal of Medical Devices (2017), doi:10.1115-1.4035724
• Cunningham, M; Deline, S; Schatz, T; Beltrame, A; Steinmetz, E; Howard, S; Smith, M “Thrombogenicity Testing for Blood-Contacting Medical Devices in an in vitro Ovine Blood Loop: Design Improvements and Continuing Validation.” Journal of Medical Devices (2017) doi:10.1115/DMD2017-3385
• Schatz, T; Beltrame, A; Howard, S; Smith, M “Modification of the ASTM Platelet and Leukocyte Assay – Use of an Alternative and Clinically Relevant Anticoagulant: An In-vitro Hemocompatibility Assessment of Blood Contacting Medical Devices.” Journal of Medical Devices (2017) doi:10.1115/DMD2017-3345
• Schatz, T; Howard, S; Porter, D; Grove, K; Smith, M; Chen, Y “Improved Method for the ASTM Platelet and Leukocyte Assay; Use of Minimal Heparinization in a Screening Test for Hemocompatibility of Blood-Contacting Medical Devices” Journal of Medical Devices MED-18-1077 (2018) doi:10.1115/1.4041805