6. ANGIOPLASTY CATHETERS

A. Problem/Issue

A Medical Catheter Company needed assistance with a new product they wanted to introduce. A doctor had patented a new balloon angioplasty device that needed NiTi (nitinol) wires on the end of a catheter system. They were in their third year of development and their fifth set of engineers without success. The forming/fusing method was not dependable and the assembly procedures were much too complex to validate.

B. Analysis

We began to work on-site two days a week and off-site on CAD and processes. Twelve different cross-sections of NiTi wire were tested and five different materials were evaluated. To further complicate the project, the design was changed two times in the middle of the process to enhance the sales potential of the product. A long hands-on R&D program was what the project needed. An extensive log book with digital images was kept on the project for their design files.

C. Solution/Results

After more than 14 months of hands-on development, the product was ready for prototype evaluations. The surgeon was satisfied that the product as modified would satisfy the need for this unique product. The product is in the last stages of development and is being changed no more. Process validation is underway as of print date. We continue to support this project today.