Ivy Biomedical

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.

CONNSTEP opened up our eyes to see where we can assign the UDI in the manufacturing process and get it to the finished level. The Value Stream Mapping clarified the process for us to help meet UDI requirements mandated by the FDA. It all resulted in being able to make appropriate investments and implement a successful UDI system.

Project Impact

$ 0 K
New Investments
$ 0 M
Retained Sales
Retained Jobs

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