Guidance and assistance to the medical device industry since 1999
CASE STUDY: Design & Implementation of Production Facility Plan
A leading manufacturer of consumer diagnostics had a POC instrument whose development had been halted and “moth-balled” just prior to production release several years previously. In order to explore the feasibility of reviving the project, the company needed a limited number of devices for Marketing Evaluation purposes.
BMG was hired to develop a plan to construct a pre-production facility to assemble & test these Evaluation Devices and to oversee the implementation of the plan, independent of the company’s ongoing manufacturing operations.
BMG made a detailed evaluation of the existing manufacturing data package and an accounting of existing inventory, fixtures and tooling. Manufacturing documentation revisions were reconciled against design control records; missing materials, tooling and test equipment were identified.
Once the baseline was defined, we developed a comprehensive Production Plan for the pre-production build effort, and a Project Plan to have the necessary facilities ready within a pre-defined three-month window.
BMG managed implementation of this plan, coordinating activities with Purchasing, Facilities, Engineering, Quality Assurance, and a third-party Test Equipment contractor. Hands-on Product Engineering tasks were handled by BMG directly, including workstation flow, facility layouts and development of detailed work instructions.
The pre-production facility was ready for the Evaluation Device build on schedule, within the desired three-month window.