Issue:
Our customer’s protocol called for blind infusion of drugs to all patients enrolled in its clinical trial for oncology. Specifications for the blind infusion included a product constructed of vinyl material in dark color, clear viewing strip for clinical to inspect as transfusion occurs, easy insertion of multi-sized IV bags, one-time use product, and for global distribution. The APT researched the market and discovered that no such product existed that would meet all required specifications.
The Solution:
The APT managed an engineering team that designed a product that met and exceeded all customer specifications. A prototype was developed and delivered to our customers’ clinical team. The prototype was tested in the field by site clinicians for a two month period and cleared for mass production. Ancillare designed, produced, and delivered over 100,000 covers to the field before the FPI time schedule. The product is currently produced in a variety of colors to meet protocol demands and is in use throughout the world.
