Before technology makes its way to the clinic, biochemistry and engineering come together to form Life Science instruments. New lifesaving and healthcare delivery ideas are perfected and tested in the demanding laboratories of leading research institutions around the world. Even though it’s not a clinical environment, the rigor for excellent design, robust software and reliable hardware are absolutely critical for medical breakthroughs.
KMC has had a long standing relationship with the Life Science industry and it continues today. Whether working on a new concept or perfecting an established product, we apply the same level of excellence to your Life Science tools as we do to our Clinical Instruments.
If you’re trying to market a bench top instrument for rapid PCR, improve optical properties within your existing product, or are looking for a quality instrument manufacturer that you can depend on year over year, partner with KMC.
A customer was successfully selling a life sciences analytical instrument for several years and began seeing an increase in field failures. These failures resulted in a number of product returns for investigation, repair or replacement. It was disrupting their customer’s research efforts, causing significant customer satisfaction issues and was demotivating their sales force. After considerable internal discussions, the customer determined that a contract manufacturer with a proven quality system, skilled assemblers and access to full service engineering support would mitigate their problem. KMC was asked to assess their failures and propose a solution.
After quickly assessing their product history, KMC determined that build quality and mechanical design was the root cause of many failures. Variability in their manufacturing process, along with supply chain non-conformities, had increased over the years causing many of the field failures. A proposal was submitted and accepted to address some of the mechanical issues in their current design. In addition, we proposed outsourcing the assembly and testing of the instruments to KMC’s ISO 13485 environment, where proper manufacturing and supply chain controls could be applied. After successfully transferring the product to KMC, field failures decreased by 50% and customer satisfaction scores began to improve. In addition, KMC was hired to provide sustaining engineering support and assist the company with implementation of Engineering Change Orders (ECOs) to further improve usability and reliability.