Detailed Clinical Models for Medical Devices Lessons Learned

As we are inventing things as we proceed, we thought it would be useful to document the problems we encountered and, where we were able to come up with solutions to those problems, the assumptions we had to make in order to make the solutions work.

The dcm methodology needs to be documented before it can be efficiently married to the DAM methodology The dcm methodology needs a way to document scope so that you can tell when a dcm is complete The dcm methodology needs a way to manage change control, assuming that scope definition won't be clairvoyant The dcm methodology needs a way to include models by reference, preferably with versioning The dcm methodology and the DAM methodology have different approaches to vocabulary binding, indicating different assumptions about the variability of the places where they will be used. Any project marrying DCM and DAM methods must develop a detailed plan to ensure participants understand exactly what is expected when