Leveraging Reusability and Traceability in Medical Device Development

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Leveraging Reusability & Traceability in Product Development

David A. Vogel, Ph.D. – President - Intertech Engineering Associates, Inc.

Larry Nicholson – Life Sciences Business Development – Seapine Software, Inc.

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More detail …

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Much of the content of this webinar is covered in more detail in this text book.

For more information, see www.validationtext.com

• This webinar will:– Introduce you to some basic concepts– Point out examples of benefits of traceability– Stimulate thinking about how more focus on

traceability would benefit your organization

• Unfortunately, too little time to dig into specific solutions

• Getting traceability right in your organization will take time

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Setting Expectations

Traceability Mentioned in GPSV*

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Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

• General Principles of Software Validation, FDA Guidance Document

• Regulatory position … a soft “requirement”

• Little guidance on how or why

• Project Metrics• Are we designing the device right? (verification)

– Are all requirements implemented?– Are all requirements verified?– Are we meeting requirements of standards?

• Are we designing the right device? (validation)

– Are we meeting “stakeholder” needs?• Clinical, Marketing, Legal, Service, Manufacturing,

Risk Control, Usability• … and, yes, Regulatory

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Benefits of Traceability

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Sample Benefits - I

Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

A

B

SOFTWAREREQUIREMENTS

DESIGNREQUIREMENT

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Sample Benefits - II

Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

A

B

SYSTEM LEVEL SOFTWARE

VERIFICATIONTESTS

SOFTWAREREQUIREMENTS

TRACE ORGANIZATION

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Top Down

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Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

• Note top level design input sources

• Logical, predictable

Modified Top Down

10© 2012 – Intertech Engineering Associates, Inc.

Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

• Design inputs often have “requirements” from variety of levels

• Efficiencies from reuse

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Traceability/Reusability Ties Quality System to Project Specific Artifacts

SW Design & Dev. Policies(QSM)

62304 – SW

Lifecycle Standard

FDA – QSR820.30

FDA – G.P.S.V.

GuidelineSoftware

Development Process

Software Testing Process

Software Requirements

Software Design

Specifications

System Level Software Testing

Integration Level

Software Testing

Software Development

Plan

Software V & V

Plan

Difficult to Change Quality System General

Easier to Change Project Specific

Software Design

Specifications

Unit Level Software Testing

Decomposition of DHF Artifacts

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System Level Software Test

Plan

System Level Test Plan Master uP - Functional

System Level Test Plan Master

uP - GUI

System Level Test Plan Safety uP - Functional

• Yes

• Ask yourself:– Why do I need this trace?– What benefit do we get from it?

• Document these answers

• If no benefit, why do it? (tracing can get “addictive”)

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Is There Such a Thing As Too Much?

TRACE MORPHOLOGIES

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Morphology Do’s and Don’ts

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Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA

METRICS AND TRACEABILITY

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• How many requirements have been designed?

• How many requirements have verification tests written?

• How many tests have unresolved defects written against them?

• What is the average fan-out of requirements to design elements … requirements to verification tests?

17© 2012 – Intertech Engineering Associates, Inc.

Properly Designed Traces AllowSome Metrics

• Analyze current processes and tools

• Consider Intertech for helping to develop and improve processes and methods

• Consider Seapine Software for an integrated framework to support good processes and product development artifacts

18© 2012 – Intertech Engineering Associates, Inc.

Future Considerations

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Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290

Questions & Answers

Please submit your questions via the Q&A panel

at the bottom right of your screen

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