| 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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Archive for February 11th, 2013
Systems Engineering In Medical Device Design – Preproduction, Part 2
Monday, February 11th, 2013
Tags: design engineer, design revision, Development Stage, durability of materials, engineering expert witness, factory assembly line, field testing, filter, filter membrane, flow rate, forensic engineer, lab testing, machine, maintenance instructions, manufacturing, medical device design, operating instructions, preproduction medical device, Production Stage, project stakeholder, pump, systems engineering in medical device design, test data, Utilization Stage
Posted in Engineering and Science, Expert Witness, Forensic Engineering, Innovation and Intellectual Property, Personal Injury, Product Liability | Comments Off on Systems Engineering In Medical Device Design – Preproduction, Part 2
