The Importance of Women in MedTech

by | Aug 9, 2021 | Blog, Healthcare, HIV, MedTech, Women's Health

Since at least the early 1800s, women have played an integral part in advancing the MedTech industry along. Many groundbreaking technologies such as the radioimmunoassay, the syringe, and stem-cell isolation technique, and many more are the results of hard-working female scientists.

One of the greatest discoveries in the world of modern medicine was the discovery of HIV and the mapping of its genes. This medical marvel was accomplished by Flossie Wong-Staal, a Chinese American virologist and molecular biologist. In 1985, Wong-Staal was the first person to clone HIV, which subsequently led to the development of its genetic map. This accomplishment laid the foundation for the development of HIV detecting blood tests and other related treatments and diagnostic devices.[1]

Up until the 1980s, cataracts were a debilitating condition with therapies that were not highly accurate nor comfortable. In 1986, Dr. Patricia Bath invented the Laserphaco Probe system, a first-of-its-kind cataracts treatment. Using this system, Bath was able to help patients who had been blind for decades recover their sight. In addition to her groundbreaking innovation, Bath was also the first African American female doctor to win a medical patent in 1988.[2]

Despite the incredible accomplishments of women in MedTech, there is still a lack of women representation in the industry. According to an October 2020 study, only 20% of executives at the 100 largest medical device companies in the world are women.[3] Despite this less than perfect statistic, it seems like the industry is actually starting to trend towards more diverse representation. The number of women in executive leadership positions is up 4% from the year prior, with more and more companies committing to diversity and inclusion.

As a women-owned business, EMMA International recognizes the hard work of women in the MedTech industry every day. We work with incredible women pioneers, some running their own start-ups, and some working with industry giants. EMMA International provides full-circle solutions for the MedTech industry; call us at 248-987-4497 or email to learn more today.

[1] NIH Center for Cancer Research (July 2020) In Memoriam: Flossie Wong-Staal, Ph.D. retrieved on 08/08/2021 from:

[2] US National Library of Medicine (n.d.) Dr. Patricia E. Bath Biography retrieved on 08/08/2021 from:

[3] Danielle Kirsh (Oct 2020) Diversity in medtech: Just 20% of executives roles held by women retrieved on 08/08/2021 from:


Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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.

Ready to learn more about working with us?

Pin It on Pinterest

Share This