Manufacturing in the medical device field comes with a unique set of regulatory requirements that Lean Flow Methodologies can not only work with but can help drive and maintain compliance with these requirements. Compounding the issues, as with all high technology products, medical devices are often at risk of product obsolescence, new product introduction, technology shifts and shelf life. Issues like these that can lead to obsolescence risk and significant financial risk if inventory turns are low.
How to Implement Lean Flow
For Medical Device Companies
Often the manufacturing process for medical devices requires cleanrooms for certain processes and strict adherence to design tolerances for most, if not all, of the processes. These challenges play into the strengths of Lean Flow Methodology. FlowVision creates Process Flow Charts of all the current manufacturing processes, links processes together and identifies areas where improvements can be made, taking into account both regulatory compliance or environmental requirements.
Working within known parameters, FlowVision uses a patented mathematical approach to identify areas of waste within the current process, paying special attention to minimizing wasted time around processes that impact quality, reliability and compliance. Because medical device manufacturers typically rely on batch processes, work-in-process grows throughout the cleanrooms. By applying Lean Flow Principles to this part of the manufacturing process, we can yield significant improvements in lead times and work-in-process inventories.
As FlowVision works with manufacturers to implement Lean Flow Principles throughout the facility, we focus on designing quality checks into the process. This helps medical device companies more easily comply with Current Good Manufacturing Processes (CGMP) and Quality Systems (QS) regulations. Inspections at the end of a line (inspecting in quality) add significant costs and contribute to delays. FlowVision will design quality into the process.
Lean facilities by design are able to carry significantly less inventory (raw materials, work-in-process, and finished goods) and FlowVision’s ION software gives medical device manufacturers a powerful solution to better optimize inventory levels and fill rates. Optimizing finished goods inventory is especially important in industries where obsolescence is a significant risk. The moment a new device is released to the market, the older version of the product will at best be significantly discounted or at worst need to be scrapped. ION optimizes inventory so that manufacturers can reduce their inventories by up to 40%, greatly reducing obsolesce and scrap while simultaneously improving service levels.
FlowVision helps Biosense Webster Reduce Inventory and Lead Times
The first useful deflectable tip catheter was pioneered by Will Webster more than three decades ago. Ever since then, the Webster name has been synonymous with industry-leading design and craftsmanship in diagnostic and therapeutic cardiac catheters.