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Reducing Cost in Medical Disposable Manufacturing

Wed, 12/02/2009 - 4:25am
Tom Ferris and Pawel Wasniowski
The Project: Reduce costs in the production process of medical disposables without requiring a redesign of the device.
The Solution: Move the product to a lower cost labor market and upgrade the production line while implementing principles of Lean and Six Sigma.


Tom Ferris is a Kimball Electronics Group Medical Solutions business manager and can be reached at tom.ferris@kimball.com. Pawel Wasniowski is Kimball Electronics Group Poland's medical operations manager and can be reached at pawel.wasniowski@kimball.com.

Cost reduction is just as strong a focus in the medical industry as any other industry. But, a key difference is that cost reduction efforts often have to be far more creative, since redesign efforts, which drive a product requalification process, may ultimately generate more cost than is saved. Kimball Electronics Group faced one such challenge with a medical disposables product. The customer was a manufacturer of disposable test strips used by hospitals, doctors' offices, and consumers. A decision was made to both move the product to a lower cost labor market and to upgrade the production line as part of that process. This article presents overall project goals, design constraints, cost reductions achieved through a redesigned production process, the transition to a different facility and the qualification process.

Project Goals
Figure 1: Maciej Karwat, Medical Engineering technician, sets up the cartoner for tests.
The existing production equipment had been in service for over 30 years. The process consisted of two stages. In the first stage, cards are laminated, slit into 50 individual strips, placed in a bottle, capped, and inserted in a semi-finished tray. Once orders are received, the semi-finished trays are put into the second stage of the process where the bottles are labeled, put in cartons, and palletized. The first stage was customized to the specific product, but the packaging stage supported a range of products.

In terms of possible cost reduction opportunities, the customer did not want to redesign the product or product packaging. Instead, Kimball focused on the combination of entry into a lower cost labor market and application of Lean and Six Sigma principles in redesigning production processes. Areas of cost reduction opportunity included:

•  Reduced labor headcount through increased automation.
•  Reduced overall footprint of the production line.
•  Minimized variation in production processes to reduce probability of operator-induced defects.
•  Improved line throughput by teaming with equipment suppliers to improve overall production layout.
•  Enhanced product security by increasing use of automated labeling and scanning of product traceability bar codes.

There were no off-the-shelf automated solutions so it was important to team with an equipment vendor who could not only supply the equipment, but also provide a range of options and work with both Kimball and its client to develop an optimum solution.

The Process
The new project was not simply a re-automation, but a re-automation at a new site. This added complexity, but also drove significant efficiency improvements. The Wales facility, where the product was originally built, had a production team that was highly experienced with the current automation strategy and its efficiencies and inefficiencies. They were also experienced with the regulatory constraints associated with the product and manufacturing process. The project was being transferred to Poland. The Poland facility's engineering team had previously been focused predominately on automotive electronics production rather than medical disposables. However, they had significant experience in Kimball's Transfer of Work (TOW) process, applying Lean and Six Sigma principles in achieving continuous improvement, and working in an industry with very precise customer product acceptance testing and configuration management requirements. Although many on the Wales team would lose their jobs once the project transferred, they took a highly professional approach in sharing their expertise during the TOW process. It is significant to note that the Welsh team was committed to putting quality of the end product and process first, even if success translated to loss of work. The Polish team was equally committed to the success of the project. The end result was a very robust analysis. The Polish team questioned why the new production process couldn't perform at the efficiency levels they saw in electronics manufacturing. The Welsh team provided excellent input on what could feasibly be changed and where industry constraints should be more carefully considered. Customer input on past issues and new desires was also considered. The final product and process was better than either team would likely have achieved entirely on its own.

Figure 2: Installing new equipment in Poland enables the Wales line to remain in full production during the project transfer and new line validation process.
The supply chain was also integrated into the design process. Initial analysis identified suppliers with the right mix of equipment offerings and expertise to support the re-automation effort. There was a bidding process which asked for both pricing and efficiency improvement recommendations and the supplier with the most cost effective solution was selected. During the project, vendors were also asked to answer the question: "If there were no constraints, what could change to increase efficiency?" The test strip line was customized to the current product configuration so there were no real opportunities for improvement if the product configuration changed. However, the packaging line can run multiple product types and the "no constraints" question did generate ideas for future improvements related to changes in bottle configuration that could generate future cost reductions.

Preliminary Failure Mode Effects and Analysis (PFMEA) studies were run on the product and the new equipment design to test assumptions on the new process. There was a multidisciplinary team put in place which consisted of Welsh and Polish engineers and managers. The analyses were performed right after the kick-off meeting took place and before design was frozen. Previous lessons learned by the Welsh team over many years of experience in manufacturing the product and solving process issues were taken into consideration during the PFMEA studies (Figure 1).

The TOW was planned with redundancy in mind to ensure that the customer would see continuity in terms of project interface regardless of the build site. The old lines in Wales continued to operate as the new line in Poland was fully validated and ramped up to 100% full production capability (Figure 2).

Since the product was a cross between a pharmaceutical and medical device, it had a limited shelf life. The storage process required accelerated shelf life stability testing. Inventory levels were adjusted to ensure continuity of supply during the changeover, as well as sufficient inventory to support testing/validation requirements.

The Poland facility had previously been certified to ISO 9001:2000 and ISO/TS16949. This project resulted in a strong focus being put on the Quality Management System (QMS) to ensure it would facilitate the ISO 13485 registration and compliance with FDA QSR requirements already in place in Kimball's other facilities manufacturing medical products. Since the project includes both manufacturing and fulfillment to end customers, the QMS must support the regulatory requirements of all end markets to which product is shipped.

Lessons Learned
Improvements in the test strips manufacturing line included:

•  Inserting strips into the bottle horizontally vs. dropping them into the bottle eliminated the need for a bottle shaking device on the line.
•  The new line increased traceability and security by UV printing part and lot number on every semi-finished bottle.
•  Bottle color and size verification is now automatically performed on the line.
•  Desiccant in the low humidity-controlled area of the machine reduces exposure of product to humidity.
•  The capper device includes 100% automatic torque check for each bottle and will automatically reject any that fall outside of specification.

On the packaging line, improvements included:

•  Improved quality due to automated scanning of the UV printed data matrix that is applied at the semi-finished level.
•  Gives assurance of lot, expiration date, and product compatibility to finished product code.
•  Links semi-finished bottle with market specific packaging materials including label, leaflet, and carton.
•  Single data entry point for lot expiry information and OCV which removes the potential for human error that could occur when the expiration date is added manually at multiple points in the process. This also reduced changeover time significantly.
•  Line is fully automated from labeling through pallet packaging.

Results
The overall results of the project included:

•  Five lines in Wales were replaced with a single balanced production line in Poland.
•  Two unwind and lamination stations reduced changeover time for restart of production after reel with polyflex and/or a reagent change.
•  Production staff for lamination and bottling was reduced from 47 people on the old line to 22 people in the new line.


The synergy between the project teams in Wales and Poland resulted in several excellent improvements to the original redesign assumptions. These included:

•  Design of a single multi-operational line for packing and test strips, rather than the two lines originally considered.
•  Adding two unwind and lamination stations on the lamination machine to better balance the line.
•  Reduction of materials for line development.
•  Optimized equipment layout on the production floor.

Online
For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com or Kimball Electronics Group at www.kegroup.com.
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