Melissa Lemke is a biomedical engineer with mastery in regulatory medical device Human Factors Engineering gained through over 15 years of experience in the industry. She is the founder and principal of Human Ability Designs as well as an experienced consultant, advisor, educator, and innovator.
Melissa leads Human Ability Designs' mission to help individuals, teams, and organizations apply regulatory Human Factors Engineering strategies and processes to produce first time human factors regulatory approvals with safe, effective, accessible, and usable medical products for end users.
"We have a passion for good design, high quality, accessible user interfaces, and scientific processes. We enjoy helping our clients achieve efficient regulatory success through customized solutions to meet unique client needs. Human Ability Designs believes in working with your team to solve complex Human Factors Engineering challenges throughout the lifecycle of product design, development and commercialization."
Pam brings over 30 years of experience in client support services where she’s worked with diverse clients, teams and individuals, including those with disabilities. Pam has experience in planning and coordination services and has become a disability expert through working with and advocating for clients over the years. Pam supports assessments, project management, task analysis, training, coaching, as well as team communication. She is a valuable member of our team, and when Pam is away from HAD she loves spending time with family (including her 2 dogs) and friends, or in her garden.
Melissa first became interested in Human Factors Engineering after her brother sustained a spinal cord injury in 1999 while serving in the U.S. Army. Once Matt was discharged from rehabilitation and started working towards living independently, Melissa observed how challenging it can be for end users to interact with seemingly simple to very complex medical products.
Because of the challenges she saw her brother facing when designs required users to interact with confusing information or sustain impossible motions, Melissa pursued accessible design that led to human factors engineering through Universal Design. Melissa's journey is through her brother's journey.
Human Ability Designs is led by our founder who has over 15 years in the industry, including accessible design and human factors engineering standards. We are focused on in-depth understanding of regulatory human factors engineering challenges and potential solutions. We have contributed to helping hundreds of human factors professionals, teams, and clients who all were able to obtain 100% success with their human factors regulatory submissions.