Part 1 of a two-part series
Applying its lean manufacturing practices to medical devices and instrumentation, KMC Systems Inc. is achieving significant time-to-market, cost and quality improvements for its customers. “Lean manufacturing helps us trace, create and maintain efficiencies with regards to labor and material expenses,” David Burns, KMC’s assembly manager, explained. “Using lean principles, we are better able to show the customer more accurately what it costs to build and test the device and deliver on that.”
KMC developed, and now assembles and tests instruments that are fully automated random access chemilumninescent analyzer. It performs a variety of autoimmune diagnostic, clotting and infectious diseases tests with a throughput of up to 450 results in a single shift.
“Lean manufacturing helps us trace, create and maintain efficiencies with regards to labor and material expenses,” Burns explained.
The results from using KMC’s lean tools for the chemilumninescent analyzer have been dramatic:
- on-time delivery performance has improved to 100 percent
- labor hours per unit have been reduced by over 10 percent
- product quality goals attained (there have been no defects found and zero warranty claims filed for the past four to five months)
“Lean tools and philosophy help make abnormal situations and defects stand out,” Burns noted. “You don’t want to hide what’s wrong. You want it to surface and make it visual so it can be fixed immediately.”
Lean manufacturing focuses on efficiency, accuracy and continual improvement. A key element in that is the practice of poka-yoke. Poka-yoke, the Japanese term meaning "mistake-proofing" focuses on avoiding operator (yokeru) error (poka) to eliminate product defects through preventing or identifying and correcting issues as they occur.
When lean practices are used in medical device manufacturing, quality improvements are made in real time as opposed to being built to yield. “If you have to build a robot to test and you need one a day, you don’t build two in case one fails,” Burns explained. “Addressing problems in real time forces the manufacturing process to troubleshoot failure immediately versus later, after the product is manufactured and placed on a shelf.”
KMC follows the “5S” (Sort, Set in Order, Shine, Standardize, and Sustain) methodology on the manufacturing floor to create an organized workspace and higher efficiencies for its own company and its customers, like Biokit.
INVENTORY and MATERIAL BENEFITS
By partnering with key suppliers, KMC also creates several “lean” materials benefits, passing on volume-purchased savings on parts used in minimal quantities. Additionally, using the Japanese-named Kanban scheduling system of signal and pull, KMC closely monitors the volume of inventory needed, saving additional costs in storage or transporting of unnecessary stock. Cost savings are achieved by having the supplier ship in smaller quantities more frequently.
Specifically, KMC uses the two-bin Kanban system, whereby suppliers do not send any additional materials, until a signal based on a pre-determined amount for a “pull” is given, showing that the existing supply in the first bin is depleted.
|Dave Burns - KMC Assembly Manager|
“The whole idea behind lean in medical device manufacturing is reducing the amount of time it takes between payment of received materials and getting paid for the shipment of finished goods,” Burns said. “By reducing defects, inventory, and getting a ‘pull’ in two weeks, we shorten the manufacturing cycle.”
Customers also benefit from a shortened manufacturing cycle with KMC’s spare-parts program. Employing the lean philosophy and a FIFO (first in, first out) materials control process enables KMC to reduce long lead times and assure the most current version of the spare items are available without the wait.
Working together, KMC’s lean processes in medical device manufacturing:
- increase customer flexibility and responsiveness
- provide better inventory turns
- identify product issues in real time
- improve quality by reducing defects with both component and production challenges by reacting to solve problems immediately and preventing recurrence. Better controls yield better quality.
- lowers cost by producing in small batches providing only what is needed at the time
“With lean manufacturing, we bring budget to mind up front for greater efficiencies,” Burns said. “Lean is about philosophy and culture change in how you do business every day. Customers like Biokit benefit directly with reduced labor and material expenses, and improved quality of product.”