I think its difficult to pinpoint a single portion of a DDP to be as the most crucial as all portions are critical to a project's success. To answer your question, a gantt chart is a very important in terms of outlining the tasks related to the project, the responsible party for each portion as well as the expected timeline to completion. The critical path of the project can be determined from this tool very effectively and relayed to the entire team.

-Tarek

Thank you very much for your interesting question. I would agree with Tarek that it is difficult to choose which area of the DDP is most important, but the Gantt Chart is extremely useful. As Tarek mentioned, it really outlines all the details that need to be completed by each member.

I would also say that the outlining of project meetings is just as important. This allows for all team members to stay up to date on the project. They will also know how each portion of the project is going and know how their portion will fit into the project. It also keeps each member accountable as they will be informed into each part of the project and its goals.

-Andrew Nashed

Design development plan(DDP) is a plan written by project manager, and it defines and describes all important aspects needed for the project. I think final scope statement is the most important part of DDP to provide understanding of project strategy, justification, deliverable, and scope of a project. I agree communication management plan is important as well for a project to be successful. The risk of insufficient planning or lack of communication may result in failure to accomplish project objectives because it contains contact information and rules for people involved in the project as described above.

As I may have mentioned in the lecture, the DDP for most companies is just a boiler plate document that gets filled in, and pretty much remains the same throughout the project. What I am trying to teach here and in the Project Management for Medical Devices course is that the document has much more importance than just being a boiler plate placeholder in the DHF. It is a marker and charter for the entire project that can change to accommodate the project over time.

Including all of these other Project Management items in the DDP is not normal practice. It is a best practice, however.

A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people working on the project know exactly what is needed to get done they can begin to work on it. Once the scope is clearly defined in a scope management plan, it can always be referred back to. Months down the line when multiple people are working on the project, everyone will be able to refer back to the scope management plan and determine wether or not they are advancing the project. This can also help with scope creep so that people do not become too ambitious when working on the project. Always having a defined scope will help people to keep the ultimate goal of the project in mind.

I agree as well with the comment above, that if to choose a certain aspect that is important in the design development plan, the scope management plan is quite important. This details the ideas of the medical device and each milestone that should occur throughout the research and development of the product. The scope management creates a timeline of when certain aspects of the device should be completed, what date features should be implemented, or when the target date for FDA submission occurs. The scope also details the requirements of the device the must be met.

I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsibilities. It is basically a good mixture of activities listed. Some of the important aspects about design development plan are,
• Identify all stages and activities.
• Define responsibilities.
• Define resources required.
It needs to be revised, revisited and updated throughout the project.

-Hetal

I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most important part of the DDP. Not that there is more important part, but my reasoning is that without any of the other parts, the project will fail, and I can't see the communication being more important than the say the scope. If you don't know what you are suppose to design, how can you communication to workers or stakeholders about schedule, progress, etc.

Thanks
Adrian

As Dr. Simon said, the DDP is often just used as a boiler plate placeholder in the DHF but it should be used as an underlying plan for the project. Therefore, all of the 5 parts you mentioned are important. If I had to pick which was the most important I would narrow it down to quality management plan and team member lists/responsibilities. Quality management is vital because it establishes the standard that needs to be met such as customer needs and also shows how the project will accomplish it. Without quality management the project could easily drift from accomplishing its main purpose. Team member lists/responsibilities is equally crucial as it helps get the project done efficiently. Team members are going to be unique, possessing different characteristics and traits. It is essential that the project manager delegates the responsibilities accordingly to each team member's strengths. Team member responsibilities are not only important for efficiency but for holding someone accountable if something goes wrong.

I’m not sure which part would be more important because all phases are needed to have a successful project. It is very crucial that DDP is followed thoroughly. I feel planning and scheduling is very important. Making sure all deliverable for every week or month is accomplished. By schedule I mean all the work on a certain design or part of a project is going to finish by the deadline, even if there is certain setbacks.

I agree with Andrew, Gantt Chart is one of the most important factors in any project to keep the whole team informed about all the activities that take place. Every member is undated about others roles and responsibilities in the project for the specific time frame. The chart is a good way to keep track of daily goals, if they were achieved or not. In the DDP, all the plans from risk to communication are needed to be well described. It is important to determine the communication management plan via various sources for the team to more effectively share and discuss project information. Both the phases stated product quality and communication plan are important for successful final result of the project.

I completely agree with you! All components of the DDP are very important, however if I had to choose one, it would most likely be the quality management plan. Quality management and control act as checkpoints as the device is being developed in order to make sure that all regulations are being met and the product is on track to meeting its requirements. Further, because medical devices take a long time to develop and involves many moving parts, delegation via the roles and responsibilities is also crucial. Each member of the team needs to have very specific and detailed responsibilities so that they can take ownership of that one specific part and contribute to the project as a whole

- Saad Ali

Hello,

Though I agree with your thought that a Gantt Chart is important, there is much more that goes into the scheduling process. It is extremely important to keep up with this schedule as it should be a living one that is constantly updated based on the progress made. Other aspects that play into the schedule may also include milestones that need to be monitored as well as regular meeting for the in depth reporting of progress beyond the scope of the chart.

Thanks,
Romany

Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to complete an efficient project. There's nothing worse than having a project with a deadline, getting distracted and working on something out of the scope and as the deadline approaches, little progress is being made because the team is not totally aware of what needs to be done. As long as everyone knows what he or she is supposed to be doing, and provided the person is not lazy, the work will get done.