I don't think it is fair to assign one part of the DDP as the most important. One could argue that quality management(or any other part) is the most important, even if the most important part is done correctly, if another part is not being handled well the project can fail. If the quality management is well done, but team and responsibilities are not defined well, then project will struggle. To have a good quality product you need a define what the product is, the plan/schedule to make it happen, who makes what happen etc.

It's very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It's certainly not a requirement. I can't say the same for the project scope. This is the backbone of the project and without it there simply is no project. There was mention of Gantt charts helping to simplify the planning process. There's also the Work Breakdown Structure which helps to subdivide the project scope.

Hey Saad,

Although I agree that quality management is important, I believe that the team member list/responsibilities is the most important. Even though I am only an undergraduate student and I have not worked in industry, from my research experience I can say that knowing what to do is imperative for the success of a project. In my most recent project that I was working on, the slightest miscommunication between members of the research team in terms of what roles they would have turned out to be problematic. A lot of time was wasted when multiple people were doing the same work! I believe that this can also cause delays in industry when working on a long-term project or when developing a device. If multiple team members end up working on the same thing, a lot of time, money, and energy would have been wasted. It is important from the beginning to clearly establish roles and responsibilities.

-Murad

Design Development Plan is the foremost important aspect in starting a medical device project. According to FDA regulations on Design & Development Planning (820.30(b)), "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."

Hello, I also agree with you that quality is the most important. The whole project ( roles/responsibilities, gant chart) is based on this product and if the product doesn't work well everything will get delayed or worst people will fired. It is important to make sure there are checks along the way to ensure the products functionality.

I would have to disagree that I don't think there is any one aspect of the Design Development plan that is more important than the other. In order to produce a high quality product there needs to be good communication and the team members have to make sure they work within the scope of the project.

Although I agree with you Murad on clearly establishing roles and responsibilities, I think that the scope is also important to acknowledge early on in order to make sure the team stays on track and doesn't veer off course. Working out of scope can also cost the company a lot of money and resources by missing deadlines of the DDP. As someone else mentioned below, the Gantt Chart is useful for keeping track of the schedule in order to prevent delays. Therefore, I think the best is to initiate a kick off meeting where roles/ responsibilities and scope are determined first as well as discussing the Gantt Chart in order to make sure everyone on the team is on the same page and approves.

I would like to mention about EAP program, which stands for EXPEDITED ACCESS PATHWAY. It basically to aid and benefit patients who have not met their medical need, due to criteria issues. This program provides the following:
1. It's main purpose is to treat irreversible disease ad life threatening conditions.
2.It clears way to new upcoming technologies.
3. Increase in availability to provide patient care.
4. Formulating a solid draft of DDP.
These four items will be key considerations in determining whether or not a designation is assigned and is the reason to bring in FDA in early. The FDA then has 30 days, once the Pre-Sub is received, to provide a designation, request more information or issue a denial on the device or drug.

I have to disagree with you little bit, yes the communication management plan is important but I believe that every part of the design development is necessary. So I believe each have their own importance in the document and it should not be ignored because you think is not so important. Each give a piece of information that is necessary for the medical device to be able to be produce, since the DDP is check by the FDA and since we all know FDA have regulation that need to be follow and it should not be ignore.

I am also on the side that all of the parts of the DDP are equally important. Everyone needs to know the scope of the project like the back of their hand, as well as what their duties are as their respective department members. Communication is crucial as you cannot work as a team if you are not constructively communicating with each other. As for the Gantt chart, even if you ignore deadlines, it is just as important and each team member can visualized how their respective portions of the project intertwine with other members responsibilities.

In my opinion, it is very difficult to claim one portion of the DDP as the “most important.” However, if I had to choose a certain aspect that is important in the plan, the scope management plan stands out immensely. The scope of the project must be clearly defined in order to help the project move forward successfully. Undoubtedly, it is the backbone of the entire project. Each team member must be able to know exactly what needs to get done before they begin working on their tasks. A defined scope will help employees keep the product requirements and final goal in mind. The best way to complete a project is to understand what needs to be done in a given amount of time. In the future, members can refer back to the scope and be able to determine whether or not the project is being completing thoroughly and efficiently.

That is a tough choice because all of those are very important to DDP! If I had to choose one it would be scope management plan; the reason behind that is that having a general scope of how I am going to execute my DDP it will make it a lot easier for me. Everyone is making some valid points! If there were four other major components that could be the main topics what would you they be? Or could it be more than just four? I think no matter what the development of a device is a team work effect and there are several different responsibilities/duties that have to be done.

In my opinion, the most important phase is scope management plan. scope management plan is the collection of processes used to ensure that the project includes all the tasks required to complete the project while excluding all work which is out of scope. The Scope Management Plan details how the project scope will be defined, developed, and verified. This phase is the most important one because it would decide how is the design of the product looks like. A good scope management plan would make the products to match with the requirement of the customers. So it is very significant to decide to what kind of tasks should be included for satisfying requirements of the consumers for the product.

I feel that communication management plan is the most important because only if the people are discussing properly then they can find the flaws of a project and can be rectified in a constructive way. If there is not proper friendly approach between the team members the members will be ignorant towards each other work and the project would be not positively taken ahead. So professional discussions of the people would initiate a technical improvement in the design plan which leads to the success of the project

From a professionalism stand point, I think the gantt chart and team expectations are important, but I believe the risk management deliverables and the combined effort to identify input requirements. In my opinion these two things really get the ball rolling and essentially gate all other downstream activities until this is well defined. They set the scope for the project and define what activities will need to be completed for verification and validation. In the event that the risk management and input requirements are not well define, I believe there will be major gaps in the device design, they will have trouble proving the safety and efficacy of the device, and they might blow the project time line because of repeating work to close those gaps.