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Presenter

Melissa R. Lemke
Biography
Melissa Lemke is the founder and Principal Human Factors Engineering and Accessibility Advisor with Human Ability Designs, which is a human factors engineering (HFE) consultancy that helps medical and combination product developers design and apply sound HFE methods to achieve regulatory clearance. Human Ability Designs focuses all its HFE advising and training on use-related safety, efficacy, usability and accessibility of medical products, instructional materials, and training as part of the product user interface and product design and development process.

Since 2003, Melissa has focused her career on the assessment and design of medical and combination products. Her consulting services are always driven by her passions for good design, meeting the needs of patients and end users of all abilities, as well as innovating and applying strategies, methods, and solutions to help stakeholders solve complex regulatory HFE challenges.

Melissa is a Biomedical Engineer and also a lay caregiver for her brother with spinal cord injury, which is what initiated her passion for good design and love of HFE applied to medical device design. With Human Ability Designs, Melissa provides expert advising and training for HFE professionals, teams, and organizations seeking practical and applied scientific skills, knowledge, and methods.

Melissa is an active member of the Human Factors and Ergonomics Society (HFES) as well as the Association for the Advancement of Medical Instrumentation (AAMI). She is a faculty member for AAMI's Human Factors for Medical Devices and serves on AAMI’s Human Factors Engineering and Home Care and EMS Environments Committees. She is a contributing author to the original HE75 (2009): Human Factors Engineering - Design of Medical Devices, including lead co-author of the accessibility considerations section. More recently, Melissa led the committee updates of the revised HE75 for the sections on Accessibility and Devices Used in Non-clinical Environments by Laypersons. She also has authored numerous HFE publications including chapters within the recently published Applied Human Factors in Medical Device Design (2019) and Development of Biopharmaceutical Drug-Device Products (2020).