Our Experience
Our clients depend on our more than 20 years of focused experience, our intimate relationship with FDA and other regulatory agencies, and our diverse team that’s always ready to take on any challenge. Every day we assist to successfully navigate the human factors engineering design process.
Home health care devices and drug delivery product
Wearable devices
Over-the-counter (OTC)
Pre-filled syringes, pens and auto-injectors
Wound care and negative pressure therapy systems
Manual and computer-controlled anesthesia machines
CT injectors
Infusion pumps
Chemical and blood analyzers
Clinical support software
Autograft and burn care devices
Mobile and handheld devices
Reprocessed/reusable devices
IVDs
Packaging
Feminine hygiene products
Liquid dosing cups
Robotic devices
Inhalers, patches, drops and sprays
Implantable devices
Hospital equipment
Android and iPhone medical applications
Ultrasound and imaging equipment
Ventricular assist and cardiac devices
Our Work
Our overall approach aims to mitigate risk we do this using a collaborative approach to ensure consistency, efficiency and unparalleled access to SMEs, with the ultimate goal of right-first-time execution. See our full breath of experience in work due with biologics, combination products, cell & gene therapy, modeling and prototyping.
IVD Labeling
Medical Device: In Vitro Diagnostic
Evaluate User Interface: 2 Formatives and a Validation
Lay user: Including Low Health Literacy
510(k) Submission
Medical Device: Insulin pump manufacturer
Evaluate User Interface: Summative
End result: Successful 510(k) submission
Patient Information Leaflet
Problem: Patient Information Leaflet not effective
Solution: Redesign PIL and test
End Result: 100% effective
User Guides
Problem: User guide not effective
Solution: We redesigned the user guide and labeling
Results: Success! results improved in HF test by over 90%