1 / 7

Radiotherapy System Software Development

Presented by Peter J Coronado 16 November 2004 at the Planning Meeting for the High Confidence Medical Device Software and Systems (HCMDSS) Workshop Arlington, Virginia. Radiotherapy System Software Development. Thesis and Guiding Principles.

may
Download Presentation

Radiotherapy System Software Development

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Presented by Peter J Coronado 16 November 2004 at the Planning Meeting for the High Confidence Medical Device Software and Systems (HCMDSS) Workshop Arlington, Virginia Radiotherapy System Software Development

  2. Thesis and Guiding Principles • Because patient and user safety depend upon it, software development tools need to be validated against intended use; however, this is nearly impossible to accomplish. • Some guiding principles – • Good documents ≠ Quality software • From FDA on Design Controls • “… a system of checks and balances” • “… make systematic assessment of the design an integral part of development” • “… deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier…” • “… increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use” • From the MDD • “If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices.”

  3. Radiotherapy Process • Every step requires reliable software • Diverse application technology • Databases • Image processing • Physics algorithms • Embedded systems • Motion control • Beam control • Real-time • Information must be reliably shared between workflow steps

  4. Though shown like a waterfall, iterative development has become the primary model Multiple development teams build components in parallel Hardware / software integration in most devices (level 1) Nearest neighbors in radiotherapy workflow integrated next (level 2) Finally, end-to-end through the entire system (level 3) Medical device / software / system workflow Risk Management

  5. Process Validation / Artifacts • Tool chain • MRD/SRD – Requisite Pro or MS Word • SDD – MS Word / Visio / Rhapsody • Compilers/Linkers – MSVC++, gcc • Run-time libraries • Operating systems – Windows, DOS, VxWorks • Bug tracker – Rational Clearquest • SCM – MS Sourcesafe • DBMS – Sybase or MS SQL Server

  6. Contact Information • Peter J Coronado • E-mail – peter.coronado@varian.com • Phone – 650.424.6320 • Mail • 3140 Hansen Way, MS F-055 • Palo Alto, CA 94304

  7. BIO Peter Coronado has over 25 years of experience in software engineering having worked in numerous areas of technology, including control systems for medical linear accelerators and defense communications systems. He has developed, managed, and deployed complex systems built to the requirements of 21CFR820.30, DoD-STD-1703(NS), and DoD-STD-2167A. He has designed and deployed corporate development procedures in both defense and medical device companies. He is the designer and co-instructor of Varian Medical Systems’ design control procedures course. Most recently, he led the development team for the Trilogy linear accelerator that adapted Varian’s device for stereo tactic radio surgery applications. He is presently working on implementation of ISO14971 compliant processes throughout Varian. Peter holds a Masters Degree in Computer Science from Southern Methodist University and a Bachelors Degree in Engineering Mathematics from the Colorado School of Mines.

More Related