Radiotherapy System Software Development

1
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

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
Medical device / software / system workflow

• 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)

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_at_varian.com
• Phone [phone]
• Mail
• 3140 Hansen Way, MS F-055
• Palo Alto, CA 94304

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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 Varians 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.