It is time to build equity in medical device design control
Insights from a Let's Talk Risk! conversation with Lori-Ann Archer
Note: this article highlights key insights gained from a conversation with Lori-Ann Archer as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
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.
As an example, pulse oximeters were found to routinely miss low blood oxygen saturation levels among patients with darker skin during the COVID-19 years. Even when a patient should have been triaged as experiencing occult hypoxemia (blood saturation, SaO2 of <88%), thus needing prompt oxygen therapy, the pulse oximeter readings (SpO2) were inaccurately higher in the 92-96% range. As a result, patients with black or brown skin were much more likely to not receive timely oxygen therapy compared to those with light or white skin1.
Lori-Ann Archer shares in this Let’s Talk Risk! conversation that inherent bias in medical devices is a serious issue. In a recent white paper2, she proposes an intentional and structured approach to build equity in medical device design control so that design, development and testing plans can be developed to eliminate different sources of bias.
A good design and development plan needs to establish equity principles in the beginning. Unless different sources of bias are adequately addressed from the start, there is a high chance their unintended effect will not be detected during design validation. In her white paper, she points out that medical devices are predominantly tested on the White, male demographic, yet Latino and Black communities comprise 30% of the US population.
The US Census Bureau predicts that within 30 years, the non-white proportion of the American population will shift to more than 50%. However, these communities make up a mere 6% of all participants in the federally funded clinical trials.
Risk practitioners need to be aware of the user needs of a rapidly changing demographic, and the uncontrolled risk in a medical device due to bias that is not addressed during design, development and testing. The issue of bias is now more important than ever, as we see increasing application of AI/ML in medical devices.
Lori-Ann emphasizes the need to formalize a requirement for building equity in medical device design control as part of the Quality System Regulation (QSR). There are encouraging signs that the issue of health equity is being broadly recognized as needing urgent action by the US FDA. California Attorney General Rob Bonta, leading a multistate coalition of 25 attorney generals, recently sent a letter to the FDA Commissioner urging more guidance, updated label warnings and outreach to healthcare providers regarding inherent bias in pulse oximeters3. Lori-Ann also sent her own letter to the FDA Commissioner as a follow up to encourage collaboration in developing additional guidance/regulation for pulse oximeters4.
In this Let’s Talk Risk! conversation, Lori-Ann 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. By and large, most medical device companies recognize diversity and inclusion as core values. An explicit focus on building equity should be seen to be in prefect alignment with these core values.
She encourages practitioners in the medical device industry, no matter what position they are in, whether just starting out or seasoned professionals, to open their hearts and to focus on the patient. When there is bias in our medical device, it directly affects people in a negative way. When we are aware of this issue and how it affects our patients, we can strive to build equity in our devices for the welfare of all.
Listen to the full recording of our Let’s Talk Risk! conversation above.
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 article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Lori-Ann Archer: Building Equity in Medical Device Design Control
Attorney General Rob Bonta letter to the FDA Commissioner.
Lori-Ann Archer: Letter to FDA Commissioner.