Developing in HandcuffsData management in a regulated environment

Jeff LemmermanB.S. Physics, B.S. Astrophysics

University of MinnesotaMS Software Engineering

University of MinnesotaSr. Software Engineer – Medtronic (2006-

Present)

Matt ChimentoB.S. Computer Engineering

Kettering UniversityMaster of Business Administration (2014)

University of Minnesota Carlson School of Management

Prin. Test Engineer – Medtronic (2006-Present)

What are the “handcuffs” ?Every application requires verification and validation

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What if you make a change?Every change requires re-validation

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Are all changes equal?Critical changes may even require FDA approval

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What does it all mean?

High cost of collecting, curating, and maintaining data

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Why MongoDB?Strong user community10gen enterprise supportC# driverPerformanceFlexibility, but…noSQL doesn’t mean no schemaHere’s why:

Where does the data come from?

What data?

Influences…

Where stored?

How does it get there?

How does it get there?

How does it get there?

Repository.Add()

Repository.Get()

GapsEnterprise acceptance of “new” approachIntegration with off-the-shelf reporting and

analyticsUser interface for managing the database

clusterDeveloper familiarity with JSON and

MongoDBLabVIEW to JSON

Released to open-source community21 CFR Part 11 Compliance

Thank YouQuestions

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