Client Background

A Southern California company had a vision to design, develop, manufacture, and market minimally invasive devices for the diagnosis and treatment of breast cancer.

Client Challenge

Since this group was a true start-up, it possessed no internal manufacturing capabilities and sought an FDA registered contract manufacturer with Class 10,000 cleanroom near its facility.

LSO’s Role

Life Science Outsourcing served as a one-stop shop for this start-up. It fine-tuned the manufacturing procedure for the marker delivery system by developing fixtures and streamlining the assembly process. Life Science Outsourcing oversaw both sterilization and packaging validation. Once the product began to gain substantial market penetration, the company made a strategic decision to set up its own internal manufacturing operation, including a cleanroom.

Client Results

The company continued to gain market share in both the US and international markets. In 2010, it was acquired by a multinational company involved in multitude of clinical spaces.