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Scientific. Rigorous. Professional. Regulatory ready quality.

Human Ability Designs brings extensive experience, commitment to safety, scalable solutions, and regulatory ready deliverables to help you improve the success of your human factors regulatory submissions, processes, in house team expertise, and medical device user interfaces. Led by a biomedical engineer expertly trained in human factors engineering, we join each client team to help your organization develop and bring to market medical products that are safe, effective, usable, and accessible for end users of all abilities.

Industry-recognized expertise

We provide regulatory-ready solutions led by an experienced biomedical engineer with extensive leadership and engineering expertise who has reviewed the human factors work of hundreds of teams to help produce optimized user interfaces (product, labeling, training) as well as first time successful regulatory human factors engineering submissions.

Long-term safe and effective user interfaces

Human Ability Designs is led by a qualified professional, industry thought leader and seasoned expert who is passionately invested in helping you optimize the use-related safety, efficacy, usability and accessibility of your medical devices and combination products. Our scalable approach ensures your design meets user needs and your submission achieves human factors regulatory approval.

Accessibility with empathy

The number of users with conditions that cause temporary or permanent physical, sensory, and cognitive limitations is continually increasing, and these limitations often influence the safe and effective use of medical devices. Human Ability Designs has extensive experience planning, executing and analyzing studies with diverse users with disabilities, including building strategies and rationales for surrogates.

Experience Matters

Human Ability Designs is led by a seasoned human factors engineering expert and thought leader with over 15 years in the industry, including 10 years of helping clients achieve regulatory approvals with FDA and within the EU. When you are a client, we remain invested in helping to generate a successful human factors regulatory submission by optimizing your user interface related to safety, efficacy, usability and accessibility. We collaborate with client teams, individuals, and organizations to optimize medical device designs for end users and prepare submission ready results for regulatory approval.

17

years in the industry

10

years as HFE consultant and director
for medical device and combination products

240

+

pre-FDA HFE/UE protocol &
validation report reviews

100

%

regulatory HFE/UE
client submission success

Our Human Factors Services

HFE/UE Protocol, Report, and Submission reviews
HFE Training for Teams and Organizations
Threshold Analysis
Task and Use-related Risk Analyses
Heuristic and Expert Reviews
Strategic planning and development of HFE processes
What We Do

Through authentic and systematic human factors engineering methods, we help our clients optimize user interfaces and meet human factors regulatory requirements to obtain human factors regulatory approvals and minimize post-market issues.