Where: ALTEN Technology

For: Medtronic

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ALTEN Technology provided systems support to Medtronic to develop content and drive completion of various design input sources for the Medtronic TTVR system. My role on the project was to identify relevant technical standards and regulations, support requirements development, identify gaps between standards needs and requirements, and compose the preliminary Verification Master Plan.

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To identify relevant technical standards and regulations, I utilized the FDA database of recognized consensus standards for medical devices and leveraged data from similar products' 510(k) submissions. I then compared my findings against Medtronic's first revision of the Tricuspid Product Standards List to propose updates. For packaging standards, I connected with Medtronic packaging SMEs to request their input on which are typically used by Medtronic. These technical/design standards were decomposed into individual clauses in JAMA (a centralized web application for handling requirements, trace relationships, and testing) and tagged by whether they were applicable to the Tricuspid system. I then made traces from applicable standards clauses to requirements, and the results from the gap analysis I conducted fed into refinement or initialization of existing requirements. 

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For this project, I was additionally responsible for the preliminary design verification planning. This was intended to supplement requirements development and assumed Medtronic SMEs and testing group would refine later in the project once requirements were out of their preliminary state. A few of the verification strategies I proposed were based on methodology given in standards, some leveraged preexisting Medtronic testing documentation for a similar product, and others I devised based on my research on general bioprosthetic heart valve test methods. There were between 150-200 requirements; likewise, there were at least that many verification strategies which I proposed. In general, it was 1-1 requirement to verification but for some, multiple strategies were proposed to fully verify (or validate) a single requirement.

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I absolutely loved this project for so many reasons. I learned so much and was really excited about the product itself. I am looking forward to seeing this go to market!