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Selection Phase

• Propose several candidate biomarkers
• Define briefly the workflow for each biomarker and how it would be used
• Identify issues that would need to be addressed to deploy the biomarker
• Sketch/Analyze mitigation strategies for each significant issue
• Defer any candidates with intractable issues
• Select a candidate for development

Development Phase

Develop detailed mitigation strategies

• may involve systems documenting certain operating/performance details
• may involve systems supporting certain operating modes
• may involve systems supporting certain calibrations
• may involve specific software features/algorithms

Write a Profile document

• implementation guide for the mitigation strategies
• nail down the details
• list of compliance requirements

Note: These mandate that the system be able to operate in a way that meets the requirements. It doesn't prohibit the system from being able to operate in other ways also. (Think of the list of formats under Save As..., e.g. you shall be able to Save As DICOM. You may provide as many other formats as you like. Users trying to follow the profile will use the DICOM format)

Deployment Phase

• Solicit vendors to implement, test and/or demo the profile
• Organize a Connectathon-equivalent testing event
• Tweak the Profile based on testing experience
• Organize a public demonstration to show the biomarker works and is deployable and develop user interest in systems that support the profile
• Take a deep breath, pat ourselves on the back
• Do it all again for another biomarker