Case Studies

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.

Client Background

An early-stage company based in Southern California developed a powerful new minimally invasive technology for heart valve replacement.

Client Challenge

This company needed an FDA registered, ISO 13485 certified contract manufacturer to assist with the assembly and packaging of their endovascular system.

LSO’s Role

LSO provided the company with process and development guidance and a range of services including ordering and inspection of raw materials, ultrasonic cleaning, final assembly, and labelling development for primary and secondary packaging.

Client Results

This novel technology proved to be a clinical success by providing the patient with dramatically shorter recovery time, as compared to traditional open heart procedures. This cardiovascular company was acquired by a multinational company in 2008.

Client Background

Millions of people around the world take daily oral medication to relieve acid reflux. This Bay Area medical device start-up acquired a novel technology from a vascular company to treat Gastroesophageal Reflux Disease (GERD) with an endovascular approach.

Client Challenge

The product offering involved a unique catheter delivery system, used to deliver an embolic agent to bulk the esophageal sphincter muscle.

LSO’s Role

LSO provided packaging development services, packaging, and sterilization validation.

Client Results

The company had successful clinical results, received their FDA approval, and were acquired by a multinational company within four years.

Client Background

Shoulder rotator cuff repair was an open procedure that required lengthy rehabilitation. This company developed a product that enabled the surgeon “arthroscopic” access to the shoulder and acquired intellectual property for a unique system of access and repair with trocar access.

Client Challenge

The company needed a complete turnkey solution to execute the development and build plan for product clinical trials and commercial launch.

LSO’s Role

Life Science Outsourcing provided completed services included packaging development, sterilization validation, and packaging validation.

Client Results

The unique rotator cuff technology was acquired by for approximately $130 million.

Client Background

A Southern California medical device start-up company developed an intravascular temperature management system that enabled the clinician to raise or lower the patient’s core temperature depending on the clinical situation.

Client Challenge

This technology involved a piece of capital equipment and a disposable catheter. One of the critical components was the accessory kit used to facilitate the transfer of temperature to the patient’s body.

LSO’s Role

Life Science Outsourcing was selected to manufacture the kit utilized with this system. The key components of the kit included a complex bonding process requiring the development of a customized bonding process to properly secure plastic to metal. Life Science Outsourcing successfully fabricated these custom components, which became an integral part of the operating system.

Client Results

This organization has placed units worldwide and is the market leader in endovascular cooling. It was acquired in 2009 by a large organization with the objective of adding this new technology to their suite of products.