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Improve Medical Device Development by Expanding Systems Engineering
Author(s) -
Black Carissa J.
Publication year - 2016
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2016.00247.x
Subject(s) - traceability , documentation , scope (computer science) , deliverable , function (biology) , risk analysis (engineering) , process management , engineering management , process (computing) , computer science , key (lock) , systems engineering , engineering , business , software engineering , computer security , evolutionary biology , biology , programming language , operating system
Most members of the medical device design community are familiar with the term systems engineering, but their definition is often too narrow in scope. To maximize value, each team should have a systems engineer that serves as technical lead for the project and has overall ownership of the design and its full traceability. When a systems engineer has ownership of all traceability, it will lead to stronger regulatory submissions. When they have responsibility for identifying requirements issues or gaps throughout the design process, design changes will be identified earlier. By understanding the big picture of how all of the medical device deliverables relate (trace) to each other, the systems engineer will empower each function to consistently focus effort in high‐impact areas. When a systems engineer is the technical lead, they ensure that decisions and changes are communicated and reflected in the design documentation. It also means that they can remain neutral with stakeholders on key decisions, and allow the project manager to maintain the team balance by advocating for cost and time to market control.