Transcript OBI Org readiness

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
VARIAN Medical Systems
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
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From FDA on Design Controls
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“… a system of checks and balances”
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“… make systematic assessment of the design an integral part of development”
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“… deficiencies in design input requirements, and discrepancies between the
proposed designs and requirements, are made evident and corrected earlier…”
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“… 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.”
VARIAN Medical Systems
Radiotherapy Process

Every step requires reliable
software
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Diverse application technology

Databases

Image processing
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Physics algorithms
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Embedded systems
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Motion control
Diagnosis
Referral

Beam control

Real-time
Information must be reliably
shared between workflow steps
VARIAN Medical Systems
Detailed
Planning
30
Scheduling

Evaluate Tx Simulation
Options
/ CT
Pre-Tx
Checks
Clinical QA
Treatment
Medical device / software / system workflow

Though shown like a waterfall,
iterative development has
become the primary model

Nearest neighbors in
radiotherapy workflow
integrated next (level 2)

Multiple development teams
build components in parallel

Finally, end-to-end through the
entire system (level 3)

Hardware / software integration
in most devices (level 1)
Establish
MRD
Establish
SRS
Architectural
Design
Detailed
Design
Code &
Unit Test
.EXE
Integration
Risk Management
Device
VARIAN
Medical Systems Device
Integration
Verification
Device
Validation
Nearest
Neighbor
Integration
End-to-end
Integration
Process Validation / Artifacts

Tool chain


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
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MRD/SRD – Requisite Pro or
MS Word
MRD
Validate
Medical
Device
SRS
Verify
Exe
SDD
Verify
Source
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
VARIAN Medical Systems
Contact Information

Peter J Coronado

E-mail – [email protected]

Phone – 650.424.6320

Mail

3140 Hansen Way, MS F-055

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 21CFR820.30, DoDSTD-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.
VARIAN Medical Systems