By Sean Fenske, Editor-in-Chief
 
The pandemic revealed many problems within a company’s supply chain. In some cases, the “warts” on a supplier were unveiled when challenges occurred or shortages began. Having a trusted partner perhaps never meant as much as it did during the last two-plus years.
 
A significant part of that is working with a company that constantly seeks to improve at every level associated with the business. When a supplier practices continuous improvement, they are demonstrating just how much quality is a concern to them. The constant search to better every aspect of a firm within the medical device manufacturing industry means the opportunity for cost cutting, enhanced communication, less waste, and greater output.
 
Sharing his perspective on why continuous improvement is so important, Tim Steele, founder and CEO of Microspec Corporation, made time to address a number of questions on the topic. He speaks as a supplier who seeks continuous improvement at his own firm as well as those within his company’s supply chain.
 
Sean Fenske: Can you explain what continuous improvement means?
 
Tim Steele: Always striving to improve upon the status quo is what continuous improvement is all about. When considering continuous improvement at a manufacturing facility, one naturally thinks of the products produced by the firm and the quality level of those products developed for customers. The scope of continuous improvement, however, goes far beyond the quality of the product shipped. Continuous improvement is incorporated into every aspect of the manufacturer’s operation, with a specific focus on the quality of these elements: customer service/communication, raw materials received, the tools used to make the product, the training of all personnel at the company, the machines used to produce the product, meetings; preventative maintenance; on-time delivery; packaging; inspection; planning to avoid defects (not just in the product, but everywhere in the company). Ultimately, the list of activities affected by continuous improvement includes every activity at the company, regardless of how small.
 
Fenske: Why is it important for a company to strive for continuous improvement?
 
Steele: The importance of continuous improvement cannot be overstated. Without continuous improvement, a company will, over time, fail as others innovate and produce a superior product. Therefore, it is necessary to have a continuous improvement program established for all the activities involved in producing a product so every aspect of the product is always getting better.
 
Fenske: How does continuous improvement affect the processes and procedures at a company like Microspec?
 
Steele: Continuous improvement is a responsibility of management; however, implementation of continuous improvement needs to be a task undertaken by every employee at the entire company as it affects every step of every process of parts production. Constantly improving processes and procedures, as is the case with all ISO 13485 programs, is verified through documentation. At a company like Microspec, continuous improvement raises everyone’s awareness of documentation of everything we do in making product, avoiding defects, intuitively understanding what is being accomplished, and offering recommendations for how a process may be improved. In this sense, everyone is a process improvement engineer.
 
Fenske: Why should your customers care if you are consistently striving for continuous improvement?
 
Steele: Customers care when suppliers strive to constantly improve because, without that effort being made, the materials supplier would eventually disappear as competitors innovate and displace those firms satisfied with the status quo. At Microspec, we count on our suppliers to constantly improve. Sadly, we have been burdened with a major supplier of raw material that has not been continually improving, making it difficult for us to manage our supply chain. This has led to a disruption of our production and the on-time delivery of products, resulting in a frustrating situation. Had our supplier been effectively maintaining a continuous improvement program, no disruption would have occurred and they would have a very satisfied customer in us.
 
Fenske: Do you have a way to measure continuous improvement? Are there parameters?
 
Steele: Measuring continuous improvement at Microspec manifests itself in our management review process. We track key performance indicators (KPIs) that define trends in our business. Although each KPI is a measurement of an activity at a given point in time, it is compared to a previous point, and we can then see if our plan to improve is effective or not and assess the existing plan accordingly. For instance, is our preventative maintenance program working? Has downtime of machinery improved since the last review? That said, what else can we do to improve efficacy? An improved plan is forthcoming.
 
Fenske: Do you expect your suppliers to also be striving for continuous improvement?
 
Steele: We do expect our suppliers to constantly improve for the same reason we practice constant improvement. Strong suppliers help maintain a strong supply chain, which is good for business.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Steele: In the past couple of years, we (as an industry) have seen significant challenges within the supply chain. The pandemic has disrupted manufacturing from raw materials through to OEMs, and those problems do not appear to be improving substantially anytime soon. Further, weather issues in Texas from a year ago has contributed to raw material shortages across the industry. Meanwhile, the labor market is causing manufacturers to scramble to try to fill positions. Inflation is rampant and economic issues show no signs of improvement. This collection of challenges has made continuous improvement difficult, to say the least. Our resources to improve have been in a state of constant change; unfortunately, it appears we are still a year or two away from what we may consider normal.
 
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