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Case Study 6: Medical Device Nano Technology Process Design

A Senior Manager of a San Diego medical device startup company contacted MDS in regards to providing guidance on the company's nano technology genetics screening device. Several process issues had stymied forward progress in the development schedule. The company signed a contract with MDS to add MDS personnel experience and talents to overcome these obstacles.

The customer's technical staff provided MDS personnel with background information on the product design and process needs. While the product concept was proven, the initial materials selected were not suitable for mass production. Due to potential product variability, the initial assembly process could not be successful on a large scale. Both the materials and process needed revisions to move the development forward. Materials needed to be selected for a new assembly process that mimicked the original materials, but which did not have the original material's inherent problems.

In this project, MDS personnel worked independently, but attended project review meetings with the customer's engineers. MDS personnel selected and ordered new candidate materials. MDS devised a new process to use these materials. MDS created CAD designs of prototype tooling that could be used for high volume manufacturing. The new materials, process details, and tooling CAD models were then provided to the customer's engineering staff during the periodic review meetings. The internal staff maintained project control of the work and integrated MDS's contributions in to the overall project.

MDS's role was to facilitate a new pathway and to enhance the initial efforts of the design team. The design team was a very talented group of engineers, but a group that had reached a progress block. MDS participated in the project for a total of three months. During that time, a new path was structured that opened the door for the company's success.