Radiotherapy System Software Development VARIAN Medical Systems n

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

Thesis and Guiding Principles n 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. n Some guiding principles – n Good documents ≠ Quality software n From FDA on Design Controls n n “… a system of checks and balances” n “… make systematic assessment of the design an integral part of development” n “… deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier…” n “… increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use” From the MDD n “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. ” VARIAN Medical Systems

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

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

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

Contact Information n Peter J Coronado n E-mail – peter. coronado@varian. com n Phone – 650. 424. 6320 n Mail n 3140 Hansen Way, MS F-055 n Palo Alto, CA 94304 VARIAN Medical Systems

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 21 CFR 820. 30, Do. D-STD -1703(NS), and Do. D-STD-2167 A. 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 ISO 14971 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. VARIAN Medical Systems