Implementing Lean Six Sigma in the Medical Device Industry

Pelham Plastics, Pelham, NH

Lean Six Sigma (LSS can reduce variability and wasteful activities within a company’s processes. (Credit: Cagkan/AdobeStock)

A continuous effort to improve reliability and efficiency of processes is at the forefront of any successful business. One methodology that can have a crucial impact in this effort is Lean Six Sigma (LSS), which aims to reduce variability and wasteful activities within a company’s processes, in turn leading to improvements in areas such as customer satisfaction, employee morale, regulatory compliance, and profitability. In the medical device industry, where a seemingly minor error could be life-threatening, LSS can play a pivotal role in patient safety. This article presents a case study illustrating the benefits of LSS for a medical device manufacturing company, as well as one of its key customers.

Room for Improvement

Tristan Belanger, a project development engineer at Pelham Plastics, has made significant progress in applying LSS to the revision of a particularly difficult process: the formation of a tip on a urinary placement catheter (UPC) that begins as a raw extrusion. Over the past year, the customer for which Pelham Plastics supplies the UPC had raised numerous field complaints, most of which were due to the customer’s drug-administering device meeting resistance while exiting the port at the UPC tip. Ensuing discussions between Pelham Plastics and the customer identified a need for improvement to the UPC design in order to increase its manufacturability (e.g., efficiency and effectiveness of production) and functionality (e.g., ability of the device to easily exit the UPC tip port). The question of how best to achieve these goals became the driving force behind Belanger’s LSS project.

LSS in Action

This video demonstrates different manufacturing options that can be used in medical device design and development.

A key strategy in executing an LSS project is to utilize a variety of models to break down elements of the process being revised. For instance, Belanger created a SIPOC model, listing the suppliers, input, process, output, and customers for each manufacturing step, while also noting the process times, wait times, and potential defects for each. The current UPC tip process consists of eight steps, most of which are highly manual, and all of which carry the possibility of producing dimensional and/or cosmetic defects. These steps form the geometry of the UPC tip, both inside and out, and include three radio-frequency (RF) thermoforming steps, a skiving step, and an angle-forming step. Belanger determined that an ideal solution would streamline this process, addressing two major components of the LSS framework: reducing process variability (fewer steps means fewer opportunities for error), and increasing customer satisfaction (resolving the chronic field complaints through design change).

Because Pelham Plastics specializes in injection molding, Belanger chose to focus on the possibility of molding a UPC tip that contains all the required design features that, in the current process, are created through eight complex steps, as noted above. The mold would be designed to manufacture a tip with improved functionality, as determined through clinician feedback and continued discussions between Pelham Plastics and the customer. Upon being molded, the tip would be welded to the extrusion through two RF processes, prior to being cleaned for printing. Belanger illustrated this potential process flow in another LSS model, a Future State Value Stream Map. When compared to a Current State Value Stream Map that he created earlier in the project, the data showed a 50 percent reduction in total process steps, a 67 percent reduction in process time, and a 57 percent reduction in wait time.

With an ideal solution in mind, Belanger created a Rolling Action Item List (RAIL). This model identifies all action items required to achieve a solution, as well as an Action Owner and Target Date for each item. In this case, the initial tasks were to design the molded tip and to build the injection mold and RF tooling. From there, the tasks would be to establish the manufacturing processes needed to bring the tip design to fruition in a repeatable and reproducible manner.

As personnel began their respective tasks, Belanger performed a Cost Analysis (another crucial element of LSS) to ensure that the effort would be financially feasible for the company. Initially, he determined that the savings (labor time and effort, etc.) would outweigh the costs (tooling, engineering, etc.) in just under a year. The customer, however, has agreed to pay for all tooling and development costs up front; thus, the return on investment is immediate. As the process moves toward production, both parties will continue to monitor key metrics such as reprocess/rework time, throughput yield, and on-time delivery, ensuring the financial benefits of the revamped process are sustained for years to come.

Conclusion

Through universal models of self-evaluation and data analysis, the LSS methodology has proven to be an excellent tool in fostering major improvements within a business. In the medical device industry, it is particularly important that manufacturers maintain a mindset of continuous improvement and are willing to collaborate in the pursuit of common goals. Pelham Plastics is still undergoing testing on its revised UPC tip process, but it has manufactured samples that meet both dimensional and cosmetic requirements. As a result, Pelham Plastics and its customer are on track to see increases in process efficiency, profitability, and most importantly, patient safety.

This article was written by Kevin Crowell, Technical Writer, Pelham Plastics, Pelham, NH. For more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it. or visit here .