Worked on a diverse array of medical products for 50+ clients, across a variety of disease states and user populations
Conducted approximately 300 explorative and formative studies and 75 summative validation studies
Had no FDA rejections of our HF validation studies since our founding
Recent Projects
Pen injectors, Autoinjectors, & On-Body Injectors
Combination Products; multiple device formats for therapies including rare conditions (e.g. hemophilia, HGH, PAH, etc.)
Digital Health Apps & Mobile Connectivity
Mobile app development integrated with state of the art devices, legacy devices, enterprise systems and cloud-based data analysis
Glucose Sensors (CGM)
UX requirements, complete UI design, prototype down-selection, life-cycle HF research
Mechanical Ventilators
Validation for updates to legacy devices and next generation touchscreen ventilators
Hemodialysis Machines
Formative and Summative testing for regulatory filing
Hospital Monitoring Devices
System Design: from user requirements through design verification
Smart Infusion Pumps for Hospital Use
Requirements definition, UI development, controllers and durables, V&V testing
HCP Informatics & Dynamic Displays
System design: from concept development through final validation testing
Some Recent Clients
Amgen
Breathe Technologies
Carefusion
DEKA
Dexcom
eVent Medical
Genentech
iCare USA
ICU Medical
IMT Medical
Medtronic Diabetes
Medtronic Cardiac & Vascular
Novo Nordisk
Owlet
Roche
RxSight
SetPoint Medical
Stuart Karten Design
Targus
Timpel
United Therapeutics
We go to the user population! Our projects have taken us all over the world; across the United States, throughout Europe, as well as Asia and Australia.