Transfer to Manufacturing
Just prior to Transfer to Manufacturing, the System Engineer assists the Manufacturing Lead Engineer or Manager with identifying the product variables (such as pass/fail criteria, min-max attributes, nominal range or deviation, etc.) that will need to be tested during manufacturing. The goal is to pin down probability, confidence, and reliability or repeatability through adequate sampling, and then to designate the characteristics of representative (often called Golden) units or samples. This work is used to identify pain points or challenges likely to be faced during manufacturing and to inform the design of individual manufacturing stations. The Systems Engineer is a key contributor for determining the methodology, variable identification and manufacturing process, and needed resources (equipment, for example) that will optimize manufacturing.
Next, The Systems Engineer builds directly on that work to define Acceptance Test Criteria within the manufacturing flow and to produce an artifact that qualifies each manufacturing test’s methodology. He or she must also review the proposed Installation Qualification, Operator Qualification, and Process Qualification (IQ, OQ, and PQ) for each manufacturing station as well as the overall manufacturing line.
Finally, the Systems Engineer oversees the sufficiency and integrity of the Design History File (DHF) content that must be transferred to the manufacturer. Manufacturers don’t need (and in many cases, should not have) the entire design history of the device; it is the System Engineer’s job to ensure that the manufacturer gets the correct subset of DHF artifacts and no more.
Before main production can begin, the first-run production must furnish a sufficient quantity of verified products for use in Formal Design Validation. (As a quick reminder, Design Verification ensures “yes, we designed the thing right” while Design Validation ensures “yes, we designed the right thing.”) Validation encompasses several different tests – Usability and Safety Tests, also known as Human Factors Validation, as well as Clinical and Formative Tests, which confirm the device’s anticipated therapeutic or diagnostic efficacy. The Systems Engineer may assist with technical input for validation test design, and serves as the central coordinator for receipt and dissemination of validation test results and findings.
Deployment, Maintenance, Support, and Decommissioning
As the project progresses toward deployment, the System Engineer’s role begins to diminish. He or she is now providing technical oversight on project labeling, including instructions for use, product descriptions, warnings, and package inclusions required by Standards and Regulations, as well as training programs and materials.
Support for products in the field will be handled generally by a Continuation Engineering group, which the Systems Engineer will help to brief. He or she will ensure they are adequately familiarized with the technical details of the product and have access to all the resources they need to provide adequate field support. He or she may also assist with their documentation, including advising on procedures for troubleshooting and routine maintenance.
During these phases, the Systems Engineer will also remain accessible to the postmarket surveillance team to help investigate any field issues that might result in a technical CAPA (Corrective and Preventative Action). He or she also advises the postmarket product analysis team, helping them parse technical feedback when individual products are decommissioned, or the entire product line retired. Finally, the Systems Engineer may be tapped for assistance with next-generation design, particularly if postmarket feedback exposes any NUDs – anything New, Unique, or Difficult – that will need to be addressed in the next release or next version of the product.
That concludes our overview series on Systems Engineering. We hope we’ve made clear how vital this position is for ensuring wholistic oversight, technical completion and consistency, and cost-effective compliance in medical device development. Please contact us with any specific questions you have regarding Systems Engineering as a discipline or how our Systems Engineers can be of service, getting your next medical device designed, built, and ready to market.
