| Last time we began our discussion on Preproduction, the final aspect of the Development stage of our systems engineering approach to medical device design. This is the point at which a small amount of devices are put into actual production, then evaluated for full production possibility. It is also the final juncture at which problems will be evaluated and corrected before full commercial production can begin.
Once the medical devices produced during Preproduction are assembled, they’re subjected to rigorous testing in both a laboratory and the field. This testing is necessary to see if stakeholder requirements are satisfied. At this stage devices constructed en masse on the factory assembly line are compared to prototypes built by hand by design engineers earlier in the Development stage. During Preproduction laboratory test data is gathered and analyzed by engineers to assess how the device will hold up during actual use. Real-life conditions are simulated in the lab environment to facilitate this process. For example, lab testing of a Preproduction kidney dialysis machine can determine whether its blood pump flow rate falls within acceptable range during hundreds of hours of operation. Other factors, such as durability of materials are evaluated during lab testing. In the case of the dialysis machine, there is a component called a dialyzer that filters toxic waste from blood. Over the duration of the lab test, the material used in the dialyzer filter membranes would be inspected and evaluated for durability. Next week we’ll conclude our discussion on Preproduction to see what happens when testing is moved outside the lab environment into the field. ___________________________________________
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Posts Tagged ‘systems engineering in medical device design’
Systems Engineering In Medical Device Design – Preproduction, Part I
Monday, February 4th, 2013| If you’ve been following along with our blog discussion on the systems engineering approach to medical device design, you should by now be convinced that instructions are important. In fact, the meticulous instructions produced during the manufacturing, operating, and maintenance phases of the Development stage are also crucial to later stages, that of Production and Utilization. Let’s finish up our discussion on the Development stage by taking a look at its final aspect, Preproduction.
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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