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OUR EXPERIENCE

Since our inception in 2006, HFCSI has:

  • Worked on a diverse array of medical products for 50+ clients, across a variety of disease states and user populations
  • Conducted over 250 explorative and formative studies and 50 summative validation studies
  • Had no FDA rejections of our HF validation studies since our founding

Recent Projects

Pen injectors, Autoinjectors,
& On-Body Injectors

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

HCP Informatics
& Dynamic Displays

System design: from concept development through final validation testing

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

Multi-Format
Viewing Stations

New product development, field evaluation in complex clinical environments

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

Recent User Populations

Anemia
Ankylosing Spondylitis
Cancer and chemo complications
Cardiovascular Diseases
COPD
Crohn’s Disease
Diabetes
Glaucoma
High Cholesterol
ITP
Juvenile Idiopathic Arthritis
Migraine
Neurological conditions
Noonan Syndrome
Plaque Psoriasis
Psoriatic Arthritis
Pulmonary Arterial Hypertension
Respiratory conditions
Rheumatoid Arthritis
SGA
Turner Syndrome
Ulcerative Colitis

Where We've Worked

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.