Human Ability Designs is passionate about improving the quality and safety of healthcare through good medical device design. As leaders in the field of human factors and accessibility, we are committed to ensuring safety and effectiveness in all medical device and product designs. We want to apply our expertise to help you meet the needs of diverse end users and customers, and we will help you navigate the potential challenges of evolving FDA human factors regulatory expectations.
Our comprehensive consulting services will provide you with the support, resources, and guidance you need throughout the design process, from the early conceptual phases through final validation testing. Together we will implement a sound human factors plan to meet the overarching demand for safe, effective, and accessible medical devices for a wide variety of end users operating devices in dynamic clinical and home healthcare environments.
Since 2003 Human Ability Designs founder, Melissa R. Lemke, has been committed to designing safer, more accessible, and usable medical devices for end users, including people with disabilities. She has over 10 years of experience as a human factors and accessibility focused biomedical engineer, researcher, and instructor. Melissa has been working in the fields of medical device design, human factors, and accessibility since her undergraduate training at North Carolina State University (1998-2003) and the Center for Universal Design (1999-2003). Melissa received her masters in biomedical engineering from Marquette University (2005), with an emphasis on accessible medical instrumentation. She has conducted research with the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation, where she also managed the Accessibility and Usability Testing Laboratory. Melissa currently has an appointment with the University of Wisconsin – Milwaukee and the Rehabilitation Research Design and Disability Center. She is an active member of HFES, AAMI, and RESNA. Ultimately, Melissa brings a passion for design excellence, with a special interest in medical device accessibility that launched when she became an untrained lay caregiver in 1999.
Human Ability Designs wants to help you understand and apply the burgeoning field of human factors and accessibility applied to medical device design. Melissa R. Lemke is a key thought leader in this field, and clients consistently call upon her to utilize the breadth and depth of her human factors and accessibility knowledge. Melissa is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and serves on two AAMI standards development committees related to human factors and home healthcare: AAMI Human Factors Engineering Committee (since 2005) and AAMI Medical Devices and Systems in Home Care Applications Committee (since 2012). Melissa is a contributing author to HE75 (2009): Human factors engineering – Design of medical devices, and she is a primary co-author of the HE75 section on Accessibility Considerations. She knows that because more than half of home healthcare device users are operating with some form of functional or environmental limitation, it is critical to design for the needs of this growing user population in order to assure safer and more effective user-device interactions. Human Ability Designs has the expertise to help medical device manufacturers apply human factors and accessibility processes.
Working with Human Ability Designs can help your team reduce overall costs by applying the human factors process as a design control. We can help you understand and mitigate risks related to end users interacting with device interfaces, so you can more efficiently produce safe, effective, and accessible medical devices that will help you gain a competitive advantage in the marketplace. We have extensive experience in developing FDA compliant risk and accessibility based human factors analyses. We design and conduct early formative studies such as simulated use testing, user surveys, interviews, and focus groups, both large and small scale. We also design and conduct FDA compliant human factors validation protocols, per 2011 FDA Draft Guidance – Applying Human Factors and Usability Engineering to Optimize Medical Device Design. Our experience includes devices and products designed for both professional and lay users and caregivers, as well as devices used in clinical and non-clinical home healthcare environments. We have unique expertise and experience in evaluations that involve users with diagnosed or temporary disabilities (e.g., due to the environment or illness) as well as devices intended for use in home healthcare.