- CorticoMetrics is working to bring FreeSurfer to the clinic
- To be used in the clinic, it needs to be FDA approved as a "Class II medical device"
- A Medical device must be developed under a QMS (Quality Management System)
- A QMS is a set of business processes and records that must be adhered to
- "Design Review"
- "Validation"
- "Risk Management"
- "CyberSecurity"
- etc
- Code of Federal Regulations, Title 21, part 820 specifies what a QMS for a Medical Device must implement
- Establishing a QMS has been the single greatest challenge encountered at cmet
- There's a small industry of companies providing "QMS solutions"
- Industry largely runs on the "software and service provider" model
- Model does not empower the user
- Can we build an open source QMS?
- Potential impact for translational science is huge
- Gets people "up and running"
- Benefit to sharing audit results/best practices is huge
Essentially a record of:
- things that need to be done
- who did what and when
- Some parallels to new MGH record keeping(?)
- 3 parts
- SOPs (Standard Operating Procedures)
- WIs (Work Instructions)
- Infrastructure (record managment)
A QMS consists of 3 parts:
- SOPs (Standard Operating Procedures)
- WIs (Work Instructions)
- Infrastructure (record managment)
- "The what": Describes what needs to be done to comply with 21cfr820
- Mostly boilerplate derived from ISO 13485
- Can be pruned substantially for "non-interactive software-only medical devices"
- No manufacturing/supply chain
- No interaction with the software while it's running
- Implemented as a set of markdown files in a git repo
- "The how": Describes how the SOPs are to be implemented
- Gitlab does the heavy lifting here
- Tools useful for any open source QMS
- Git/Gitlab
- Latex for project documentation (not QMS documentation)
- diff'able
- more expressive than markdown (linking across docs)
- Tools useful for "non-interactive software-only medical devices" - Docker - CWL
- Implemented as a set of markdown files in a git repo
- Git does a better job at keeping records than any other solution I've seen
- Empowers the user.
- Can 'walk away with everything' at anytime
git clone/forkare fundamental operators- Ever try forking an SAP instance?
- The web front ends to git (github/gitlab) do a better job performing "reviews" than any other solution I've seen
- Developers are already familiar with git
- IaC + Cloud resources present interesting new possibilities here
- Imagine cloning a repo, entering your AWS credentials, pushing a button and having a QMS automatically deployed for you!
Would be very neat expressing all this in an Iac languange (helm?)
- Gitlab
- Gitlab is much more compliance focused than github
- Can also perform reviews (Design, Risk, Management, etc)
- "git, but for data"
- Examples:
- LCN could potentially benefit from one of these tools
- Manages users/permissions
- Keycloak
- For 21cfr11 (electronic records) compliance
- Lambda scripts to perform backups?
- Phase I SBIR submitted to NIH-NCATS (National Center for Advancing Translational Sciences) to pursue this
- Happy to chat to anyone interested in this or translational science in general! - [email protected]