Detailed Clinical Models for Medical Devices Lessons Learned

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Lessons Learned

Based on a VA meeting on 19 August 2010, after submitting the first release of the DAM to the HL7 ballot


  • Project Management
    • Ioana- the minute we had milestones lined up it helped. We need PM introduced early on. By the time we go to the HL7 workgroup meeting in Cambridge, MA we should have a schedule of the milestones. We will do it sooner. We will work back from this to get the ballot in on time. We need ballot reconciliation to be added in.
    • Jay- Followed-up on Ioana’s point. The milestones are important. There were misunderstandings of timings for what was needed and the deadlines for work products. We need more formal PM processes. A list of 5 bullets is not going to do it. We need a detailed WBS. We need detailed articulation of what the work products are and what are contained in them. We need more PM formalisms.
    • Greg asked if Jay would recommend using MS Project. You could use a tool to help to do this. The meetings should be on the calendar. Need more detail. The details can be in Excel as well.
    • Jay- If we did create the milestone ballot now we could start now then there could be issues. There is looseness in the project objective. The charter was not formalized and there were different perspectives.
    • Project planning is needed. Adequately resourcing the project is key.
    • Greg—suggested that there is a master calendar of identified resources and it would include the external groups. We could post that on the shared workspace.
  • Outreach
    • We need to keep the workgroups within HL7 more involved.
    • We didn’t have the outreach with the SME’s that was sufficient. We should show the clinicians the clinical workflows. The clinicians are helpful when we show them the steps. Validate the clinical workflow with the SMEs versus the DCMs.
    • We didn’t get the external stakeholder’s involved as much as we would have liked.
  • Timing
    • Timing was in Jan and everything was crammed into one month and there was not enough time to work with SMEs. They can only spend a small amount of time on this work.
    • Other work with the VA has been a very iterative process and there has been more feedback loops. SMEs feedback is critical.
    • Some resources had a limited number of hours and there was a compromise of the other projects to get the work done on time for this project.
  • Approach
    • We need better definition of our work products, e.g. samples, a metamodel
    • We can’t tell when a DCM is complete
    • We don’t know how to refer to an externally defined DCM
  • Clarity
    • There was a great deal of new territory with this project. There seemed to be changing targets. Industry does not have a set way of handling DCMs. Even the DAM documentation is new. It was challenging and the newness needs to be worked into the plan.
  • Workspaces
    • There are too many workspaces. Which workspace will we use consistently? We need folks to have permissions to access the workspace that we do use.
    • (GFORGE should have what we want others to see and comment on the information published in this location.)
    • HL7 has a project management tool that is on the HL7 website that Ioana/Greg will send. It is web based. We could take advantage of this tool. There is one login per team. We need to ask the PMO for that. It is not limited to the co-chairs.
    • VA VPN access is needed to access SharePoint. We will follow-up with Leah.


  • Success
    • We can report on success that the pilot process for DCMS for Medical Devices was submitted for the comment only ballot.
  • Learning
    • There was evidence that we learned things as we went through the process and it works.
  • Tactics
    • Milestones were helpful. What would be useful milestones? Could this help the Project insight work for other projects?
  • Direction
    • We are going to get new stakeholders in this process. Dr. Goldman is interested in what we are doing.
  • Collaboration
    • Collaboration with General Standards & Terminology Standards teams was successful.
  • Process
    • When we have an artifact that we are getting input from others then we are leveraging the opportunity to get the involvement of external partners and other industries. The ballot process happens to be a good process to get everyone’s comments from the industry.
    • We should get more support on the calls going forward from other stakeholders in the industry.
    • If you put out content in a ballot then you can get input on it but if you wait until perfect then you will not progress as fast.
    • Ioana- we have overcome the newness of the project. Now if we get comments back from the reviewers they will tell us if they want changes in the structure. We want to get all of our thoughts on the table. We want rigorous PM but we need a team and interaction with the workgroup.
  • We have talented people