Utilizing an Expanded Design for Manufacturing Analysis in the Design Decision-Making Process for Implantable Medical Devices

摘要

The benefits of applying a Design for Manufacturing (DFM) philosophy to the electronics industry have been demonstrated in numerous papers and articles. While general guidelines leading to a manufacturable design are present, no all-encompassing method exists that can be used to compare various design options and determine a "most manufacturable" - low cost solution meeting market demands. This paper will present one such methodology and the tools for implementation. The method can be used across multiple levels of build and for internally built or supplied product. The method takes the basic penalty points concept developed to estimate operator work content for mechanical processes (Boothroyd Dewhurst, Inc.) and expands it to include throughput and process capability. An easy to use database tool was developed to create a virtual process map of a given design, including: necessary manufacturing operations part/operator interactions, manufacturing tools, process capabilities, and processing times. By coupling material and historical cost data with the information captured through the use of the database tool, Cost of Product Sold can be projected and used in the design decision-making process. With a more thorough understanding of both manufacturing processes and financial impact, the business can make design decisions based on objective comparisons of costs such as capital, startup, development resource, and manufacturing processing costs.