Lake Region Medical
 
 
 
EXPERTISE: CASE STUDIES
line blend
Subintimal
Angioplasty Device
Molded Acetabular
Linar Trials
Endoscopic Tubing
Assembly
Nitinol Stent Development and
Process Transfer Program
Leads Connector for
Cardiac Rhythm Management Program
Flexible Scissors
Project

Subintimal Angioplasty Device

Challenge: Lake Region was challenged with accelerating the development and production ramp of a complex catheter for subintimal angioplasty procedures. This product was based on an existing device but significant cost and functional improvements in the design were required to realize the potential of this product. In conjunction with the cost reductions, the product required improvements in design, process yields and a reduction in field complaints. Specific functional improvements included a smaller profile and improved needle deployment.

The Lake Region Advantage: Lake Region leveraged the process expertise and manufacturing capabilities of eight facilities to support the design for manufacturing and process development for the components and assemblies. Specifically, Lake Region was able to leverage our expertise in Nitinol needle forming, grinding and EP/Finishing, as well as our polymer and assembly expertise, to produce the catheter shaft components, molded handle components and device assembly, testing and packaging. Our structured product development process guided the design for manufacturing analysis, quality planning, risk analysis, tooling and process development, component level and assembly process validations and on-going post launch cost and quality improvements.

The Result: The device has been well received by the marketplace and Lake Region continues to ramp and support the growth of this product.

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Molded Acetabular Liner Trials

Challenge: Quickly bring to market a new kit of acetabular trial liners that provided substantial cost reduction over the existing machined products. The existing acetabular liner design had to be completely revamped to accommodate the injection molding process and 108 unique SKUs needed to be tooled and manufactured at low to moderate volumes.

The Lake Region Advantage: Lake Region supported multiple design iterations to overcome ongoing discoveries and evolving design specification targets while assuring specification compliance and safety and efficacy of part designs. Part designs incorporated multiple requirements including, flex arm stiffness, tab interlock configuration, insertion and removal force constraints, mold-in part identification, stress analysis, new packaging and label design. Subsequent to design freeze, Lake Region qualified, validated and manufactured 108 individual part numbers for market release including sterile barrier packaging.

The Result: The customer explicitly acknowledged the Lake Region project team and leadership for making the program a success and for the design for manufacturing expertise that enabled the conversion to low cost molded product.

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Endoscopic Tubing Assembly

Challenge: Lake Region was asked to provide a substantial cost savings over an existing supplier and minimize our customer's investment in equipment and process development and validation resources.

The Lake Region Advantage: Lake Region launched the manufacturing process in a location close to our customer's manufacturing site in an effort to further optimize the value stream. This was accomplished by a core team of tube fabrication, machining, marking, welding, finishing experts and logistics professionals. Lake Region made the necessary equipment investments and engineering resources to develop the process parameters and component level specifications to achieve the required level of quality at the lowest unit price. Based on our extensive experience and preferred level supplier status with our customer we were able to quickly and effectively validate the process.

The Result: Lake Region is continuing to supply our customer with on-time deliveries at a lower cost than previous suppliers. Shipments regularly exceed 20,000 units per week over the past year.

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Nitinol Stent Development and Process Transfer Program

Challenge: Lake Region was challenged with developing technology and processes to manufacture a new line of Nitinol components for endovascular stents. Upon completion of the development work, and the stabilization of the manufacturing processes, Lake Region was challenged with establishing a second equivalent manufacturing line to provide a low cost solution.

The Lake Region Advantage: The Development Process A project team was assembled from three of Lake Region's United States facilities, consisting of process and technology experts, to develop robust and proprietary manufacturing processes and equipment. Some of the special processes Lake Region developed for this product included raw material qualification, shape setting, chemical etching and electropolishing of the Nitinol wire, and precision trimming and assembly of the components.

The Transfer Process Lake Region's transfer procedure was utilized to ensure all manufacturing process inputs, documentation, equipment, training and qualification/validation requirements were satisfied. The transfer procedure also outlined the responsibilities for each facility to streamline the transfer process. A cross functional team, consisting of program management, manufacturing and quality engineering, microbiology, regulatory, operations and supply chain experts met on a weekly basis to manage and update the transfer. Extensive training for the engineering, quality, and operations team from the receiving facility was executed by the transfer team, and all qualification activities and pre-production runs were supported by process experts from Lake Region's United States facilities.

The Result: Production in Lake Region's low cost manufacturing facility commenced on-time, with no gaps in the delivery of the product to the customer. After completion of the manufacturing transfer, the customer commented that they will use this project as an example, and a success story, for future projects. They had never experienced similar performance and success with other suppliers.

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Leads Connector for Cardiac Rhythm Management Program

Challenge: Lake Region was challenged with improving a currently-marketed cardiac rhythm management lead device by optimizing a subassembly sourced from a competing supplier. Significant improvements in design, cost and quality were desired. The development timeline was tight, and the tolerances even tighter.

The Lake Region Advantage: Lake Region utilized their comprehensive supply chain solution approach to capitalize on the expertise, and synchronize the efforts, of five separate Lake Region facilities. A modular tooling approach, in which many design paths were simultaneously developed, was employed to compress the timeline and accelerate the path to a design solution.

The Result: The customer showed their satisfaction in Lake Region's execution of this program by embarking on another significant development effort with us even before this program was complete.

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Flexible Scissors Project

Challenge: Lake Region was challenged with developing a new flexible scissors device for use in several new minimally invasive endoscopic procedures. These procedures require a new generation of surgical devices with greater functionality, including longer and more maneuverable designs and unparalleled cutting performance. In addition to the enhanced functionality, more efficient design concepts and highly capable manufacturing processes were required to meet the customer cost targets.

The Lake Region Advantage: The program began with a detailed review of existing prototype devices and the development of comprehensive design for manufacturing analysis. Lake Region leveraged manufacturing, material and design experts from five facilities to identify and evaluate the concepts to achieve the challenging goals. A methodical review of the design and product specifications along with an understanding of the measurement aspects of the device were required to develop the more efficient design and capable manufacturing processes. Multiple prototype builds were started early in the redesign phase to prove the performance of the cost effective designs and evaluate the capabilities of the new manufacturing processes. Based on the early prototype efforts, Lake Region quickly transitioned to the verification and validation, builds developing and implementing a semi-automated assembly line in our U.S. assembly facility.

The Result: The low cost and capable manufacturing processes position this product line for success in the market as these new endoscopic procedures are adopted.

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