We are happy to announce that the paper is finally released for the public!!!
Here are two ways to access the paper:
Summary: Evidence reveals that bias is a prominent issue in the systematic design of biomedical devices. An example of this are the FDA cleared faulty oximeters that mis-diagnosed patients during the COVID-19 pandemic which ended up have fatal consequences for many. Biased devices result in unjust health disparities, especially for individuals of marginalized communities. The current scope of the regulatory landscape does not include a holistic solution to build equity into all stages of the medical device development process.
Our White Paper proposes regulatory guidance on how to build equity into ALL stages of the medical device design control process of the US and international regulatory requirements. The proposed quality system improvements will provide tools for medical device leaders to be socially responsible in building equitable products to ensure medical devices are designed to diagnose and meet the needs of people in our diverse nation, not just a select few.
A case study of Cornell University Biomedical Device (CUBMD) team's MelanOxi Pulse Oximeter is presented as a real-world example on how to select and trace equity-based requirements.
I look forward to taking a deep dive to release a series of articles on the proposed concepts of the paper. In the meanwhile, many thanks to the CUBMD co-authors and collaborators, along with Gary Henniger, my mentor, who performed the peer review and provided us excellent feedback.
Stay tuned!
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