Melissa R. Lemke is the founder and principal of Human Ability Designs.
Human Ability Designs’ Mission is to help manufacturers design safer, more accessible, usable, and effective medical technologies for end users, including healthcare professionals, users with disabilities, untrained healthcare providers (lay users), and self-care recipients.
Melissa’s passion for improving medical device design began as a personal endeavor in 1999, as she became a lay caregiver and untrained user of complex medical devices and products in the home. She has personally witnessed the numerous existing hurdles related to using and adapting medical devices for patients and healthcare recipients with disabilities, in both clinical and home healthcare settings. Melissa is determined to help optimize the safety, efficacy, and accessibility of medical devices and product designs.
Sharing her family’s never-give-up attitude and unwavering quest for maintaining a quality of health and independence for her brother with complex healthcare needs due to a C4-5 spinal cord injury, Melissa is dedicated to applying her human factors and accessibility expertise in the field of medical device design. Melissa’s passion for this area continues to grow as she works to ensure that medical devices, products, and daily living aids are safe and effective for end users, including people with temporary and permanent disabilities who often depend on devices for maintaining their overall health and quality of life.
Melissa’s education in human factors and accessibility began during her undergraduate studies at North Carolina State University (Raleigh, NC). She received degrees in both biomedical engineering and biological engineering; she also worked for the Center for Universal Design, College of Design, and as a Researcher within the Department of Biomedical Engineering. Melissa pursued a master’s degree at Marquette University (Milwaukee, WI) in biomedical engineering with an emphasis on accessible medical device design. With the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation, Melissa helped develop human factors based accessibility assessment methods and investigated the accessibility of various types of medical devices. Part of her master’s thesis, entitled The Evaluation of Three Alternative Methods for Understanding Biomechanical Aspects of Medical Device Accessibility, included a comparative analysis of 7 different medical devices operated by users with diverse disabilities. Melissa continues to conduct research with the University of Wisconsin – Milwaukee’s Rehabilitation Research Design and Disability Center and other affiliates, and she has published multiple works on the topic of human factors and accessibility applied to medical device design.
Melissa’s standards development experience began as she sought out opportunities to apply the findings of her master’s research. Melissa joined the efforts of the Human Factors Committee of the Association for the Advancement of Medical Instrumentation (AAMI) in 2005, and she contributed to the development of the ANSI/AAMI standard, HE75: 2009, Human factors engineering – Design of medical devices. The FDA recognized HE75 guidance includes a section that Melissa was lead co-author of, entitled “Accessibility Considerations.” This accessibility guidance is currently being used to drive the development of other federally mandated technical accessibility criteria intended to improve the access to medical diagnostic equipment in the United States, under the Patient Protection and Affordable Care Act of 2010.
Melissa’s expertise comes from over 10 years in the field of medical device design and engineering, as well as over 14 years as an untrained lay caregiver. Melissa worked with Marquette University’s Rehabilitation Engineering Research Center on Accessible Medical Instrumentation (2003-2008), including as Manager of the Accessibility and Usability Laboratory, Rehabilitation Engineer, and Director of Operations. She currently holds an appointment with the University of Wisconsin – Milwaukee, conducting research and teaching the graduate level Design and Disability.
Melissa has extensive experience developing and conducting quality research protocols. She has helped numerous clients conduct formative evaluations as well as successful validation studies for a broad spectrum of medical devices. Melissa is committed to helping medical device manufacturers achieve their goals of producing high quality, safe, effective, and accessible designs for end users; she is also committed to helping her clients receive FDA approval with our sound human factors investigations and reporting for the submission process.
Melissa is an active member of HFES, AAMI, and RESNA.