If the US FDA has approved or cleared a medical device as safe and effective, you would expect it to be equally effective across the entire patient population within the scope of its intended use.
Well, you may be surprised to learn that current industry practices in design, development, and testing of medical devices inadvertently introduce many inherent biases in these devices that can lead to preventable harm in some patients.
In this episode, Lori-Ann Archer highlights that inherent bias in medical devices is a serious issue. She emphasizes the need to formalize a requirement for building equity in medical device design control as part of the Quality System Regulation (QSR).
She inspires all of us to, first be aware of inherent bias in medical devices, and second, to do our part in improving our design control processes. A good place to start is to update the Quality Policy to be intentional about building equity across our key processes.
About Lori-Ann Archer
Lori-Ann Archer is currently the founder and CEO of Qafe, the Quality Academy for Excellence, where she offers comprehensive quality insights and consulting services for the cosmetics, medical device and combination product industries. An alumni of the Cornell University alumni of the Electrical Engineering department, she has over 25 years of experience in medical device and combination products as a quality systems subject matter expert and executive leader. She has been involved in building outstanding quality systems at top companies like Google, Teva Pharmaceuticals, Medtronic and multiple startups. She has now dedicated herself to be an advocate and thought leader for equitable development of medical devices, and collaborated with with the Cornell Biomedical Engineering Medical Devices (CUBMD) team to release a white paper on this critical issue (see link below).
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 28: It is time to build equity in medical device design control