Diversity Challenges in the MedTech Industry

by | Aug 19, 2021 | CDRH, Compliance, Data, FDA, GMP, MedTech, Quality Systems

The lack of representation in the medical device industry is not a new topic of discussion. The lack of representation of minorities in C-Suites is alarming, with the executive ranks of the medical device companies predominantly being predominantly white.

Everett Cunningham, who is only one of a handful of minority leaders in the medical device industry, was questioned about the color of the faces across the industry and remarked that none of the leaders look like him. Cunningham continued to mention that “…only 3% of black leaders in place in Medtech demonstrates that we have a long ways to go” when asked about the diversity challenge.

The medical device and technology field must be as diverse as the patients that the medical industry serves and treats. AdvaMed’s CEO Scott Whitaker believes that the industry ought to be as diverse as the patients if the medical industry is trying to meet the needs of all who enter the system, just not the majority, but the minority as well.

To help increase the diversity of the medical device industry, Cunningham and Whitaker both believe that companies need to open up the candidate pools for senior-level positions to individuals from more diverse backgrounds. Organizations should also have a diverse interview panel to screen potential candidates to help make important hiring decisions.

Mentoring programs are also a way to help guide the development of people of color inside the industry already. These programs also help foster people of color’s growth leading to promotions. Companies, like GE Healthcare, have already implemented a mentor-mentee program as a requirement so diverse mid-level and high-level managers can climb the ladder in the medical device and technology field. 1

Diversity is something EMMA International is passionate about. If you need help with any quality, regulatory, or compliance aspect of your product, EMMA International’s team of experts has you covered. Contact us at 248-987-4497, or email info@emmainternational.com today!

1Slabodkin, G. (2021, August 12). Medtech industry starts to face lack of diversity, execs of color. MedTech Dive. https://www.medtechdive.com/news/medtech-industry-starts-to-face-lack-of-diversity-execs-of-color/604681/

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Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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