Engineering Expert Witness Blog

     The Preproduction aspect is instrumental to nipping potential problems in the bud before the medical devices go into actual production.  In the initial Preproduction stages, systems engineers coordinate with the manufacturing and purchasing departments within the company as well as outside suppliers.  The goal is to acquire all parts and equipment necessary to build a limited number of medical devices on the assembly line.  Subjects such as preference in molded plastic components, motors, gears, pumps, springs, electronic components, circuit boards, wire, and tubing are discussed and agreed upon.  Vendors are assessed with regard to their ability to produce parts when they are needed and that meet design specifications, satisfy quality requirements, and have costs that fall within budgetary constraints.

     The assembly of Preproduction devices provides an opportunity for systems engineers to validate manufacturing and quality control instructions and assess the device design with regard to manufacturability, meaning, the extent to which devices can be manufactured with relative ease, at minimal cost, while maintaining maximum reliability.  Devices manufactured during this aspect of the Development stage serve as a test.  Are instructions clearly written?  Do the device parts fit together as they should?  Are parts strong enough to withstand the assembly process?  Can the devices be assembled as quickly and easily as expected?

     If the answer is “no” to any of these questions, then the device design and instructions must be returned to the design engineers and technical writers.  Heads come together to rehash things and work out the bugs.

     Next time we’ll continue with the Preproduction aspect of the Development stage to see how laboratory and field testing enables systems engineers to shake out any more bugs from the medical device design, operating instructions, and maintenance instructions.

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