Next week I will begin planning a major new product development project of a Medical Device. Should I plan all the clinical and validation activities next week or should I wait for a couple of years when I have the actual team members present?
Eager in Mansfield, MA
While I'm sure your management would love to have you predict the future perfectly and come back to them in a month with every activity planned for this seven year project, and with the cost calculated to the penny and the end date carved in stone, we both know that this is unrealistic.
Every new product development project I worked on in the Medical Device Industry involved people coming on and off the project as their careers progressed and the companies restructured. Clinical studies changed locations and validation activities changed with new FDA regulations and new regulatory interpretations. This kind of uncertainty calls for Rolling Wave project planning.
The way this works is pretty simple. Plan the project the same way you would plan any other project. Determine the Objective, Scope, and the Deliverables level of the Work Breakdown Structure(WBS) in the usual way. Then sequence the deliverables in the WBS so that you isolate those deliverables that will be worked on during the first year of the project. Continue planning these deliverables, determining the activities, responsibilities, schedule, budget and risk for all of them.
What you are left with is a project planned to meticulous detail in the first year and a lot of deliverables that remain unplanned. You will need to go to people who know these deliverables fairly well and ask for a parametric estimate of the cost and duration of these deliverables. You will receive a range. Clinical studies for a new medical device can vary tremendously based on location, number of tests, amount of follow-up, etc. That's OK. Get the range and place that in your project plan.
Your project budget will now have a range that is made up of a bottom-up estimate of the detailed activities, plus parametric estimates of the long-range future deliverables. You quote your budget as $20 +/- $3 Million.
Your schedule will look like a partially rolled up Gantt chart with all the near-term activities opened up and the future deliverables showing up as long deliverable lines with a worst-case duration shown. If you want to get fancy you can display the duration range in MS-Project but that is a discussion for another time.
But your work is not done. One of the most stringent rules in Rolling Wave project planning is that the next six months of work must be planned to the high level of detail. So, every six months to a year, you need to reconvene the current team, (the membership will change depending on team member changes and deliverables ahead) and plan out the next few deliverables in high detail. Always try to have the next year's worth of work planned out so that you can work for six months before reconvening.
Finally getting to your answer, plan out the clinical and validation activities about a year before you are ready to do them. That way you should have your correct team and location and regulations in hand and you will be successful.