Our Capabilities

LSO (Life Science Outsourcing, Inc.) customers are offered a comprehensive suite of solutions for all their medical device manufacturing needs. An intentional strategy of horizontal and vertical expansion has allowed us to build robust capabilities that can stand changes in industry policies, corporate strategies and market cycles. Our production staff is trained, cross trained and retrained in these skills, to ensure the continuity of their strength. LSO currently comprises of six divisions and a broad service portfolio that allows customers to focus on getting their product market-ready.

These are a few examples of what our capabilities allow us to do for our clients.

Cardiovascular Market

Client Background An early stage company based in Sourthern California developed a minimally invasive technology for heart valve replacement.
Client Needs This company needed an FDA registered, ISO 13485 certified contract manufacturer to assist with the assembly and packaging of their endovascular system.
LSO Activities LSO provided the company with Process Development assistance, and a range of services including ordering and inspection of raw materials, Ultrasonic Cleaning, final assembly and labeling 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.

Breast Biopsy Market

Client Background A Southern California company was founded in 1998 to design, develop, manufacture and market minimally invasive devices for the diagnosis and treatment of breast cancer.
Client Needs Since this group was a true start up, they posssessed no internal manufacturing capabilities and sought an FDA registered contract manufacturer with Class 10,000 clean room, in a close proximity to their facility, that had additional capabilities. The primary objective of this start up company was to identify a “one stop shop” contract manufacturer.
LSO Activities LSO fine tuned the manufacturing procedure the marker delivery system by developing fixtures and streamlining the the assembly process. Both sterilization and Packaging Validation were performed at LSO. Once the product began to gain substantial market penetration, the company made a strategic decision to set up their own internal manufacturing operation, including a cleanroom.
Client Results The company continued to gain market share in both the US and OUS markets. In 2010, they were acquired by a multinational company involved in multitude of clinical spaces.

Gastro Market

Client Background In 1999, this Bay Area, CA medical device start up acquired a novel technology from a vascular company, to treat Gastro Esophageal Reflux Disease (GERD) from an endovascular standpoint. Millions of people around the world take daily oral medication to relieve acid reflux.
Client Needs The product offering involved a unique catheter delivery system, used to deliver an embolic agent to bulk the esophageal sphincter muscle.
LSO Activities 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 from the start of the company.

Orthopedic Market

Client Background Shoulder rotator cuff repair was an open procedure that required lenghthy rehabilitation.. Our client developed a product that enabled the surgeon “arthoscopic” access to the shoulder.This Orange County, CA start up company acquired intellectual property for a unique system of access and repair with trocar access.
Client Needs This company needed a complete turnkey solution to execute their development and build plan for product clinicals and eventual commercial launch.
LSO Activities LSO provided completed services included packaging development, sterilization validation and packaging validation.
Client Results The unique rotator cuff technology was acquired by for approximately $ 130,000,000 in 2004.

Vascular Market

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 Needs 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 temperture to the patients body.
LSO Activities LSO was selected to manufacture the start up kit used with this system. The key components of the kit required a complex bonding process that required the development of a customized bonding process to properly secure plastic to metal. LSO successfully fabricated these custom components that became an integral part of the operating system.
Client Results This organization has placed units worldwide and is the market leader in endovascular cooling. They were acquired in 2009 by a large organization with the objective of adding this new technology to their armentarium of products.

We are here to help

If you’re ready to begin your project or if you need more information; send us an email or give us a call at (714) 672-1090. We have a highly knowledgeable team ready to assist you and answer all of your questions.