Diversity Toolkit for Medical Device Researchers

This toolkit is intended to empower medical device researchers to design and implement studies with diverse participants that can advance medical science and improved health equity.

Get Started

How to use this toolkit?

Use this toolkit by leveraging the resources to learn, identify targets for improvement, and applying a health equity lens to your work.

Top 10 Resources

This section will provide the basic foundation for diversifying study participation through guidance on the historical context, importance and benefits, outlining barriers and providing tangible steps for improvement.

Frequently Asked Questions

We've collected some common questions and answers from health equity literature and our resource library

Key Terms

This section defines commonly encountered terms for those in the clinical research and medical device development space aiming to learn more about diversity, recruitment, and retention

Skin Color Quantification Protocols

Ensuring diversity of skin pigments in a medical device study has become recognized as increasingly important yet challenging.

Lack of a standardized approach to skin color quantification is problematic.

According to FDA regulations, manufacturers of pulse oximeters should validate device performance on “a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.”

While ‘darkly pigmented’ is not formally defined, it is routinely defined by testing labs as Fitzpatrick skin phototype groups V-VI. The Fitzpatrick scale is a widely used method for classifying skin pigment, from I (pale white) to VI (darkest brown). However, it was originally developed for skin photosensitivity typing, which is not the same as skin color, and should not be conflated with race or ethnicity

Studies have shown inaccuracies in self-reported values, especially in darker skin types. There are other similar visual skin color classification systems, but as with the Fitzpatrick scale, they are all subjective.

Full Protocol

If you would like to know more about Skin Color Protocols click on the button below.

Read more

Research Diversity Best Practices

We have compiled a checklist of best practices to improve diversity in research cohorts.

Audience: Medical device researchers and developers engaging in clinical trials and validation studies

How to Use: These best practices can be consulted at any time during the development of a research study, but ideally during the early phases, and should be used to aid the planning, implementation and write-up of research by helping avoid inappropriate use of terminology, communication and engagement practices with diverse populations.

The checklist includes best practices for collaboration, communications, recruitment, study design, funding, resource allocation, and organizational structure and hiring practices.

Checklist

If you would like to view the checklist, click on the button below.

View Checklist

Acknowledgements

This page is a collaborative effort from many individuals across many institutions including: Olubunmi Okunlola, Fekir Negussie, Ashlee Osborne, Casey Norlin, Odinakachukwu Ehie, Jana Lyn Fernandez, Michael Lipnick, Maryn Kanter, Gregory Leeb, Lily Ortiz, Galen Joseph, Consuelo Wilkins and team at Vanderbilt, Brianna Carreno, Leonid Shmuylovich, Jenna Lester, and Ellis Monk. This project was made possible through funding from the Robert Wood Johnson Foundation.