How Value Stream Mapping Secured FDA Approval for Ivy Biomedical’s Medical Devices

Ivy Biomedical Systems is an industry leading medical device manufacturer focused on cardiac and respiratory gating solutions. All of its products are designed, developed, and manufactured in Branford, Connecticut. They produce precision gating monitors used for synchronization of radiographic image acquisition across all major imaging techniques.

Ivy Biomedical faced a Food and Drug Administration (FDA) mandate to implement the Unique Device Identifier (UDI) Rule, for medical devices. Under the rule, the healthcare community and the public will be able to identify a device through a UDI that will appear on the label and the 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.

CONNSTEP opened up our eyes to see where we can assign the UDI in the manufacturing process. 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.  —Zack Curello, Vice President/General Manager

In order to meet the UDI requirements mandated by the FDA, Ivy Biomedical needed a uniform system that would standardize their methods and achieve successful system implementation. An efficient process was necessary to avoid adversely affecting the company as they prepared to design and develop UDI labels across all products. 

To help Ivy Biomedical meet FDA requirements, CONNSTEP, part of the MEP National Network^TM, recommended a PRIME (Process Reengineering for Improved Manufacturing Efficiency) project. A key component of the PRIME project involved value stream mapping of their manufacturing and service department areas to improve the flow of information and materials in producing their products. In the manufacturing area, the mapping helped Ivy structure the “U” in UDI, which is the point in which a cardiac or respiratory monitor becomes unique, or customer-specific, such as for GE or Siemens. The mapping process also allowed Ivy Biomedical to understand how to handle field returns for those devices, both with new UDI requirements and those with pre-UDI requirements.

In mapping out its value stream, Ivy Biomedical brainstormed ways to identify where to implement UDI – at which stage in the process it would be most efficient. It also helped them to pinpoint weaknesses in the label generating process. The PRIME project recommended by CONNSTEP allowed Ivy Biomedical to successfully implement the FDA mandated UDI Rule.

Results

• Increased or retained sales $11,000,000
• Increased or retained 12 jobs
• $100,000 in new products
• $12,000 in new investments

Could your company benefit from assistance with value stream mapping? Connect with your local MEP Center for more information.

 

The Connecticut State Technology Extension Program (CONNSTEP) is the official representative of the MEP National Network in Connecticut. The MEP National Network is a unique public-private partnership that helps small and medium-sized manufacturers generate business results and thrive in today’s technology-driven economy. The MEP National Network comprises the National Institute of Standards and Technology’s Manufacturing Extension Partnership (NIST MEP), the 51 MEP Centers located in all 50 states and Puerto Rico.