Insight Shanghai Offering Manufacturing Supervision of Chinese Suppliers

December 7, 2009 - Insight Shanghai opened in 2007 as a small research office with the goal of offering clients a trusted resource that would effectively conduct user research in Asia. While research remains an integral part of the office, it is now offering manufacturing support of Chinese suppliers for FDA regulated devices.

"Many U.S. and European companies turn to China for low-cost manufacturing or other services," said Mark Slaven, partner and managing director of Insight Shanghai. "There are many benefits to this; however, there are also many risks, especially when dealing with heavily regulated devices."

Simply hiring a supplier and taking their word that "everything is fine" is risky and placing U.S staff at the factory for long periods of time is expensive and sometimes difficult on the employees. Working with Insight will allow clients to have access to product development and support in Asia for manufacturing. Insight's staff in Shanghai is composed of bilingual Chinese nationals and Americans who will be able to communicate with the manufacturer and the client so there are no surprises during production.

Only 6% of registered foreign manufacturers are inspected in a given year, according to the U.S. Government Accountability Office (GAO), so it is imperative that overseas manufacturing is closely supervised. Insight has worked closely with medical manufacturers in China to ensure device manufacturing conforms to FDA requirements.

Insight experience includes:

  • First Article Inspection (FAI's): Evaluation and qualification of production tooling
  • In Process Controls (IPC's): Planning and coordinating quality and production departments to define appropriate measurement techniques
  • Work Instructions (WI's): Creation of English and Chinese documentation including photos and detailed instructions for each work station
  • Process Failure Mode and Effects Analysis (pFMEA): Leading cross functional teams to identify and assign Risk Priority Numbers (RPN's) for any items that could lead to process failures from incoming inspection, injection molding and assembly
  • Design of automated test fixtures: Design and creation of test fixtures to conduct in process testing
  • Traceability: Creation of documentation to trace incoming materials and components to subassemblies and work in process to final assemblies and to specific lot numbers
  • Inspection Procedures (IP's): Creation of step by step procedures and Acceptable Quality Levels (AQL's) for both incoming and injection molded parts

Insight is currently helping a U.S. based client supervise manufacturing in China. "Our vast medical manufacturing experience means we know the protocols to follow during production, which allows us to catch any problems before it is too late," said Slaven.

Medical production in China requires constant monitoring to ensure products are developed correctly and on time. Insight's support services give clients who are thousands of miles away timely updates and peace of mind.

Press Contact

Tara Prasad
Manager, Marketing and PR

773.907.0100 x255
tprasad(at)insightpd.com