Human Factors MD helps pharmaceutical and medical device companies create safe, effective, usable, and innovative products. We support our global clientele through the product development lifecycle using a custom process refined by more than a decade of experience.
Our Services:
User Research
- User needs exploration, analysis, and documentation
- Task analyses, cognitive walkthroughs, and contextual inquiries
Risk Management
- Use error analysis development and review
- Analysis of use error trends identified during post-market surveillance
- Design audits of concepts, prototypes, and working devices
- Compliance with human factors regulations, standards, and guidance documents
Human Factors Testing
- Formative usability studies of concept, prototype, and working designs
- Summative usability testing (human factors validation testing) of final products and labeling
Device Labeling
- On-product labels, carton labeling, and instructions for use (IFU)
- Design, development, and testing
- Rapid Iterative IFU Development
Trainings and Workshops
- Human Factors for Medical Devices
- Human Factors and Design Controls
- Labeling for Combination Products
User Interface Design
- Use specification development and review
- UI facelift (addresses usability defects and enhancement requests)
- Conceptual blueprint (high-level design for new product or point release)
Our Experiences:
- Regulatory: Premarket Notification 510(k), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and CE Mark
- Areas: injection devices, inhalers, pumps, patches; diagnostics, health information, imaging, patient monitoring, pharmacy, surgical devices, therapy devices
- End Users: physicians, surgeons, nurses, technicians, paramedics, adult and juvenile patients, caregivers
- Settings: emergency departments, operating rooms, intensive care units, imaging departments, pharmacies, doctor’s offices, labs, patients homes
Contact us at 1.800.639.7941 to learn how we can develop a custom solution fitting the needs of your organization.