“Leadership Tools to Operationalize Equity in the Medical Device Design Control Process”
The severity of health inequity in the United States has recently been highlighted by the COVID-19 pandemic. This was seen, for example, through racial biases exposed in pulse oximeters, which are integral to diagnosing and treating respiratory conditions such as hypoxemia (often linked with COVID-19). Research has shown that occult hypoxemia is more prevalent in patients with darker skin colors due to the inaccuracy of current over-the counterand hospital grade pulse oximeters. Currently there are no regulatory requirements to prevent bias in the design of medical devices with the exception of a few scattered guidance documents that address clinical trial requirements based upon demographics. This presentation will walk through all stages of medical device design control (per 21 CFR 820 andISO 13485:2016) and propose tools to build equity into the development process. An example of a design history file traceability matrix used for the MelanOxi Pulse Oximeter developed by the Cornell University Biomedical (CUBMD) team will be presented to show how bias can be prevented during the development process. This real-world example will open engagementand dialogue with the participants. The presentation will present specific tools on how equity can be built into the quality management system and the following stages of development:-Design and Development Planning-Participant interaction: Example of CUBMD's MelanOxi Pulse Oximeter Traceability Matrix for Design And Development Inputs, Outputs, Verifications & Validation using equity-based users needs requirements-Design Reviews -Design Changes -Design Transfer & DHF (Recommendations on post market maintenance)The presenters' goal is that current and future leaders use the proposed tools which can be applied to any future biomedical device to ensure medical devices are designed to diagnose and meet the needs of people in our diverse nation. We want to make a major impact to encourage fairness in health and wellness for everyone and recognize that change starts withthe influence of leadership teams in medical device development and manufacturing companies. A link to the White Paper written by Lori-Ann Archer and CUBMD will be referenced throughout the presentation and a link will be provided for free downloads.
Please see attached pdf for Speaker Biographies and more details about the webinar.
ASQ_0713_invitation_082124_Lori-Ann_Archer_Jenna_Ceraso_Building_Equity_Medical_Device_Design_Control-072324.pdf