This past summer, I found myself teaching a classroom full of fourth through eighth graders. When I asked them, “What do engineers do?” Their answers were spot on: “Engineers make things to help people.” This answer is not too different from the one I heard throughout my K-12 education; however, as I get further into my education as a biomedical engineer, I find myself circling back to this definition with more and more questions. Do we help folks who need it? How do we help them? These questions are even more critical in the medical field where people’s health and wellbeing are on the line. This is where the concepts of Verification and Validation (V&V) come in. Every medical device goes through a rigorous process involving regulatory oversight, review, and iteration before it gets released; this process is ongoing even after a product is released!
Outside agencies like the FDA regulate medical products to ensure health, safety, and compliance with the agency’s regulations, which leads to a better quality product. The FDA is the regulatory body for medical devices in the United States; many other nations use the International Organization for Standardization (ISO) standards. Notably, the FDA has its own standards, rules, and regulations, and, while some overlap with ISO standards, many do not. Companies manufacturing medical devices in the United States only have to follow FDA standards. However, many opt to follow the additional standards ISO sets, allowing them to market their product internationally. Sometimes, the FDA will adopt a specific ISO standard.
Ultimately, these standards aim to protect the general public and ensure medical products are safe and effective.
During the verification process, an engineering team checks whether its design meets the requirements established at the beginning of the project. Did they design what they said they would? Verification is often thought of as “Did we design the device right?” In this step, testing is typically conducted through bench testing, which involves engineers using instruments to verify that their design achieves a specific, measurable goal.
Let’s use the pulse oximeter (the thing a nurse always puts on your finger) as an example for the V&V process. A pulse oximeter uses light absorption to measure the amount of oxygen in a person’s blood. Pulse oximeters are used by medical staff to determine if someone needs to be “put on oxygen” if they have a low reading. The first fingertip pulse oximeter was created in 1977 in Japan. When pulse oximeters were first introduced, there were no ISO standards for this type of device. Today, because pulse oximeters have already been around for a while, they do not have to go through the most rigorous verification process.
During the validation process, an engineering team checks whether the device they designed meets the needs of its users. Validation is commonly thought of as asking, “Did we design the right device?” In this step, some devices may require a clinical trial, where a sample of people will try out the product. Other low-risk devices or devices that do not require premarket approval may undergo other testing.
In the case of the pulse oximeter, when the device was first invented in Japan, it was validated on a population that was not as racially diverse as the United States (U.S.). Additionally, the same technology was validated in the U.S. at a time where it was standard for medicine to see “light-skinned individuals” as the “default baseline for assessing medical devices”. However, because the pulse oximeter was validated and put on the market it did not have to go through the same process of validation with a more diverse group of patients, this is due to the FDA’s 510(k) process which allows products to be put on the market faster by proving they are similar enough to other devices currently on the market. The 510(k) process also means that if an initial device has a flaw other technologies will have the same flaw.
Even with the process of Verification and Validation and the oversight of regulatory agencies like the FDA, disparities continue to exist in the efficacy of medical devices.
Now, let’s revisit the pulse oximeter. These devices are the “go-to” way to get an accurate measurement. However, these devices are three times more likely to not accurately detect low oxygen levels for black patients compared to white patients! This is because these devices are based on light absorption through the skin. Due to the inaccuracy of pulse oximeters for patients of color, these patients may not be given oxygen when they need it, leading to poorer health outcomes.
This brings up a few questions:
Diversity in clinical trials is essential to ensure sufficient data on the effectiveness of a device across various populations. With accurate data, the manufacturer can provide transparent labeling about the device’s efficacy and clinical trial population. The FDA is beginning to consider gaps in representation in clinical trial participants and the people who will be using the device. The FDA released a discussion paper last October to address this topic and ask for public input (check out the Learn More section).
Overall, transparency could be a significant step toward achieving equity in medical devices, as it requires researchers to consider and disclose who they are serving. Community-Based Participatory Research (CBPR) also has potential within engineering because it encourages engineers to build a healthy, intentional relationship with the community they aim to serve, thereby better understanding its needs. CBPR could benefit numerous communities that have been overlooked by science and engineering during design, including communities of color and the Disabled community.
Ultimately, while medical devices undergo a rigorous review process to ensure safety and efficacy, they still fail to serve diverse communities. To address the needs of these users, engineers must be transparent about clinical trial participants and foster healthy working relationships with communities.
Figure 1 A
Figure 1 B
Figure 1. This figure, created by the author, illustrates the process suggested by the FDA in its 2024 discussion paper.
About this Figure:
In Panel A: If Wider Research Shows a Difference
In Panel B: If Wider Research Does Not Show a Difference
“Design Verification and Validation versus Human Factors Validation.” Emergo by UL, 2022, www.emergobyul.com/news/design-verification-and-validation-versus-human-factors-validation. Accessed 29 Sept. 2025.
FDA. “Premarket Approval (PMA).” FDA, 30 Nov. 2021, www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma.
Ferryman, Kadija, et al. “Adherence to FDA Guidance on Pulse Oximetry Testing among Diverse Individuals, 1996-2024.” JAMA, American Medical Association (AMA), Dec. 2024, https://doi.org/10.1001/jama.2024.26473.
Gill, Carol. “Understanding Disability Identity, Community, and Culture | University of Massachusetts Office of the President.” Www.umassp.edu, 2024, www.umassp.edu/inclusive-by-design/who-before-how/understanding-disabilities.
Jin, Jill. “FDA Authorization of Medical Devices.” JAMA, vol. 311, no. 4, Jan. 2014, p. 435, https://doi.org/10.1001/jama.2013.286274.
Lanier, Olivia, et al. “Ten Simple Rules in Biomedical Engineering to Improve Healthcare Equity.” Nih.gov, edited by Elizabeth Cosgriff-Hernandez, 13 Oct. 2022, pmc.ncbi.nlm.nih.gov/articles/PMC9560067/#pcbi.1010525.ref084. Accessed 6 Oct. 2025.
“Pulse Oximeters Infrequently Tested by Manufacturers on Diverse Sets of Subjects | Johns Hopkins Bloomberg School of Public Health.” Johns Hopkins Bloomberg School of Public Health, 9 Jan. 2025, publichealth.jhu.edu/2025/pulse-oximeters-infrequently-tested-by-manufacturers-on-diverse-sets-of-subjects.
Quaresima, Valentina, et al. “Ninety Years of Pulse Oximetry: History, Current Status, and Outlook.” Journal of Biomedical Optics, vol. 29, no. S3, SPIE, Aug. 2024, https://doi.org/10.1117/1.jbo.29.s3.s33307.
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Winny, Annalies, and Nicole Jurmo. “Pulse Oximeters’ Racial Bias | Johns Hopkins | Bloomberg School of Public Health.” Publichealth.jhu.edu, 8 July 2024, publichealth.jhu.edu/2024/pulse-oximeters-racial-bias.
Wong, Alice. “Ep 91: Disabled Engineers.” Disability Visibility Project, 29 Nov. 2020, disabilityvisibilityproject.com/2020/11/29/ep-91-disabled-engineers/.
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