Value Stream Mapping Leads to Medical Device FDA Success
Ivy Biomedical Systems is an industry leading medical device manufacturer focused on cardiac and respiratory gating solutions. Located in Branford, Connecticut, all of its products are designed, developed and manufactured here.
The privately-held company has sold over 60,000 trigger monitors and modules since its inception in 1984. They are the market leader for precision gating monitors used for synchronization of radiographic image acquisition across all major modalities.
Their primary OEM partners include GE Healthcare, Hitachi Medical Corporation, Philips Healthcare, Siemens Medical Systems, and Toshiba Medical Systems. Assistance is provided to these OEM partners with product registrations in over 180 countries worldwide.
Ivy Biomedical was facing a Food and Drug Administration (FDA) mandate to implement the UDI Rule which establishes a unique device identification system for medical devices. Under the rule, the healthcare community and the public will be able to identify a device through a Unique Device Identifier (UDI) that will appear on the label and package of a device. The UDI will provide a standardized way to identify medical devices across all information sources and systems, including electronic health records and devices registries.
In order to meet the UDI requirements mandated by the FDA, Ivy Biomedical needed a uniform system that would standardize their methods and provide alignment of the build structure to implement the system. An efficient process was necessary to avoid adversely affecting the company as they prepared to design and develop UDI labels universally across all products.
Having worked with Connecticut’s MEP center CONNSTEP in the past, the executive leadership at Ivy Biomedical turned to them again for recommendations to clarify and optimize the process to meet UDI requirement of the FDA mandate.
Implementing appropriate continuous improvement tools can help establish a Lean culture throughout an entire organization and deliver transformative results.
Waste is plentiful in the manufacturing world, although much of it goes unnoticed, or at least unaddressed. If you’re thinking of waste purely in a physical capacity, you’re catching only a small glimpse of the bigger picture.
“After evaluating our mold making process and identifying improvement opportunities, we’ve significantly reduced our overall lead time and improved first pass yield. With our improved workflow, we’re able to get jobs out quicker.”