Medtronic is actively working to mitigate health disparities in medical device accuracy, particularly in pulse oximetry. The company has commenced clinical trials focused on ensuring equitable performance across diverse skin tones and perfusion levels. These trials are a direct response to studies highlighting inaccuracies in pulse oximeters for patients with darker skin, which can lead to missed or delayed diagnoses of hypoxemia.
Addressing Technology Bias
Studies during the pandemic revealed that patients of color were disproportionately affected by inaccurate pulse oximetry readings. Factors such as low perfusion, skin pigmentation, and user error contribute to what Medtronic refers to as "technology bias." While their Nellcor™ pulse oximeters meet current FDA standards, Medtronic aims to eliminate disparities and improve outcomes for all patients.
"We saw all the studies coming out of the pandemic around equity and pulse oximetry and delivering safe care," said Dr. Sam Ajizian, Chief Medical Officer for Medtronic's Acute Care & Monitoring (ACM) business. "We accelerated our work. In doing so, we aim to do the right thing for the patient."
Inclusive Clinical Trials
To facilitate inclusive research, Medtronic has established a clinical physiology lab in a racially diverse neighborhood of Denver, Colorado. This location ensures convenient access for community members to participate in clinical trials. The lab enables Medtronic to conduct trials more rapidly and frequently, accelerating innovation and device improvements.
"We decided to locate this lab in Denver, away from the central offices of Medtronic, and it has proven to be the right choice," said Roger Martin-Pressman, Lab Manager. "To make it convenient for people from diverse backgrounds to access these research opportunities was really important to me."
Data-Driven Improvements
The diverse data set collected at the Denver lab is crucial for Medtronic's research and development efforts. It ensures that equity is considered from the outset of the innovation process. The lab has already enrolled over 130 participants and continues to recruit, reflecting a strong community response.
Jason Case, Vice President of Research & Development for ACM, noted that in a recent study, one of Medtronic's competitor's devices missed 30% of hypoxemic events, while Nellcor™ pulse oximeters missed 7.9%. "The goal isn't to be better than everyone else," Case said. "The goal is to provide a solution that works for everybody. How do we get that 7.9% to zero, independent of if you have thick skin, dark skin, or low perfusion?"
Building Community Trust
Medtronic is actively engaging with the Denver community to build trust and raise awareness about clinical trials. Obioma Nwankwo, a clinical studies coordinator, leads engagement events and educates the community about the importance of diverse representation in research.
Zahra Abdullahi, a trial participant and engineering student, emphasized the importance of this work: "As a minority in the healthcare system, a lot of things are overlooked. I'm doing this not only for my safety, but for others' as well. I have siblings and friends who are also minorities and making sure they have accurate representation in healthcare is very important."
Medtronic's commitment extends beyond meeting current FDA standards. The company aims to drive lasting change by ensuring equitable outcomes for all patients, regardless of their background.
