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Abstract. Whether it is a small company hoping to start using systems engineering with a Model Based Systems Engineering (MBSE) approach, or a larger, established company interested in converting existing document-based practices to MBSE, the challenges can be daunting. These can include unfamiliarity with the MBSE tool, complex default schemas, and understanding what is worth tracking in MBSE (or not). This paper will address the practical aspects for building and using a simplified MBSE schema. The schema details a selection of diagrams and items to be used for each phase of the product development process. The practical aspects for what information to include, how to trace items to each other, and what to include in each output document are described and demonstrated with examples.  

Syncroness, Inc.  © 2016

Nichole Kass
Systems Engineer

Abstract. Statistical techniques are required for medical devices and can be used to make verification more meaningful in any industry. Sometimes, a company needs to predict how their total population of devices will perform. Other times, teams simply need stronger justifications than ‘that’s how many we had’ or ‘we always test 5’ for test plans and sample sizes. However, there are an overwhelming number of statistical methods and references available. We have identified three tests that can be used to verify many types of device requirements: pass/fail (binomial), tests on the population (tolerance interval), and tests on the mean (t-tests). This paper provides the information needed to choose a test, pick the right statistical claim and related parameters, determine the sample size needed to pass, and write acceptance criteria that makes it easy to determine a pass or fail.

Abstract. 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.

James Kolozs
Staff Systems Engineer

Carissa Black
Systems Engineer