The planning phase is the phase where the project solution is further developed in much detail. Its the phase where the steps necessary to meet the project's objective are planned. In this step, the team identifies all of the work to be done. The project’s tasks and resource requirements are identified, along with the strategy for producing them. This is also referred to as “scope management.” A project plan is created outlining the activities, tasks, dependencies, and timeframes. The project manager coordinates the preparation of a project budget by providing cost estimates for the labor, equipment, and materials costs. The budget is used to monitor and control cost expenditures during project implementation.

Once the project team has identified the work, prepared the schedule, and estimated the costs, the three fundamental components of the planning process are complete. This is an excellent time to identify and try to deal with anything that might pose a threat to the successful completion of the project. This is called risk management. In risk management, “high-threat” potential problems are identified along with the action that is to be taken on each high-threat potential problem, either to reduce the probability that the problem will occur or to reduce the impact on the project if it does occur. This is also a good time to identify all project stakeholders and establish a communication plan describing the information needed and the delivery method to be used to keep the stakeholders informed.

Finally, the team will want to document a quality plan, providing quality targets, assurance, and control measures, along with an acceptance plan, listing the criteria to be met to gain customer acceptance. At this point, the project would have been planned in detail and is ready to be executed.

Going back to Devarshi's original point, I think it is actually good that sometimes a user's needs are a bit vague. This allows the engineer to be a bit more creative catering to the needs of the user.
For example, if a user is especially specific "I need a blank stent of blank length made of blank material coated in blank" then that narrows down what the engineer can create.
However, some of the best devices are those that can cater to a variety of people, such as the smart phone. A large population majority of the world uses them because they are applicable to multiple needs. I understand that this is not always the case for medical devices but I believe that this might be more lucrative for companies in the long run.

With the planning phase the communication management group as well as the project manager share in the same phase. The project manager has to reach out to the various stakeholders that will actually be using this medical device. It is important to get the perspective from them and to be implemented into the designing of the device. Like Devarshi stated customer needs can be vague. The project manager can speak to the communication manager to get word back from the various phases to understand if the various needs are plausible. The take-home message is to have communication between the project manager and communications manager, however, the PM can speak to various Phase groups to get clear and concise answers.

The Project Planning Phase includes creating a set of plans to help direct the team through the execution and conclusion periods of the project. The designs made during this stage will enable to oversee time, to cost, quality, change, risk, and issues. It helps to manage staff and external providers, to guarantee that one conveys the project on time and inside spending plan. The Planning Phase starts when the project has been formally endorsed and financed, and the Project Charter is approved. This Phase requires study and examination finishing in the full Project Management Plan and that may prompt framework improvement activities.

User’s needs is indeed an important topic to be discussed in the planning phase of a medical device project. A question that should be answered is: what questions should be considered when talking about user’s needs? I will list three main questions. The first one is who will use the medical device? The next one is how will users/patients interact with the product? The third is what kind of clinical procedures are involved? These are some questions that should be asked to determine user’s needs. Once the user’s needs has been finalized, the next step would be design input which is followed by design process. Then design output which will lead back to verification of the design input. And finally you have the medical device and the validation process.

When looking at the Planning Phase user needs are extremely important as they are the ones who will be buying the product but you also have to look at the investors needs. Without backing from the investors it will be impossible to get a project up and running. Therefore the planning phase should address how they will take care of their investors, what their investors are looking for in terms of return, and we should take into consideration their input as how to carry out the project. In all phases of the project it is also important to look at risk factors. The planning phase should go over potential risks factors that could occur, how severe each risk can be, what risk would you address first, and then a plan on how you will overcome a problem if this risk happens. Also, it would be ideal to set up some milestones for the project team to work forward too. Milestones keep the project team on track and will keep them up to date so they know how close they are to finishing the project.

Where as it is obviously important for everyone involved to know the users needs, I also think it is important to consider what the user does not want. If we are given a list of things to include and given some creative liberty, then there may come a product that includes something undesired by the user, but never expressed to the designer. For example, and I'm just making something up here, If they tell us that they need a new scaffold with certain qualities, but don't mention it has to be entirely synthetic and cannot include animal collagen, then theres a potential for error. As easy as it is to include "unwanted qualities" in the initial requirements; if left unsaid, anything could set back the entire project.

It is very important to get input from all of the stakeholders involved in a project. I agree with some of the statements above that when the inputs you get are vague it isn't really a bad thing. The engineer has more wiggle room as to what they can do. It is the engineers job to take user wants and needs and turn them into measurable constraints and specifications. Not everyone you talk to will be an expert or be able to be as specific as you might like. As for the comment above, if there were no indicators that the scaffold would need to be entirely synthetic then that would be an error of the user. I think that it would not be the engineer providing unwanted qualities but the user failing to provide needed information or possibly the engineer was not as thorough as they should have been when going over user needs. The scaffold could have met every aspect that was provided but one detail was added at the end.

I agree with the discussion above . Each phase is important. Planning has have to determine the real problem , identify stakeholders, define project objectives. There are many problem that a project fall into they are . The problems they seek to address are critical and don't have known solution, project teams lack experience, Available technologies are unfamiliar. So should address all this issue at the time of planning phase.

I agree with all the points that everyone in this thread has mentioned so far. The planning phase will down the foundation of how you will tackle the project. A poorly executed planning phase may cause the project to fail, face issues such as delays, or will downright not be profitable at all for the company which cause layoff or much more. So another aspect that should be important is to determine based on what the team is given (budget, resources, previous experience) if the product will be profitable based on what the team can design and develop. There is no point in continuing a project if it will not be worth it for a company, even though it sounds like a great idea.

As we learned, in the planning phase its important to do:
1- Scope Statement:
the statement thoroughly describes the project, and objectives of the project . The statement also describes the project's context. When everyone agrees with the statement, the project can proceed.
2- Schedule/WBS/Gantt chart
3- Quality Management Plan
Describes how the project will ensure this level of quality in its deliverables and work processes
4- Risk Management Plan
5- Communication Management Plan
6- Finance Management Plan

As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gaps that can implicate the success of the project. The PM would ensure the planning phase of a project is composed of processes performed to establish the total scope of the effort, define and refine objectives, and develop the course of action required to attain those objectives. This includes gathering user needs for the project. In my experience the better the user needs are defined more change of the right product will be development. Often when gathering Voice of Customer (VOC), users tend to overstate what the need, which could be a problem if not defined correctly by the project team. Take for example the famous “tree swing development” diagram, which depicts difference on how each department interprets and implement a design requirement based on what the user wants. Despite the diagram also alludes to communication and project development issues, the issues could be avoided if all departments understood the user needs correctly.
https://www.zentao.pm/share/treeswingpm-97.html

Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be planned that gives a clear view of what has to be done in a project. The Planning phase should include all the aspect such as execution, risks, design and flaws that helps to avoid any problems.

The planning phase is the foundation for all other phases of the project to come. A strong and detailed planning phase is essential to the success of the project. As mentioned, customer needs are a large and important role of the planning phase as they are the key to assessing what your product, in the end, needs to require. However, as was mentioned, vague customer needs can lead to large problems down the road. With important customer needs, if they are vague, it can easily cause a very slowed down design process as decisions that should have been made in the planning phase come up later. For this reason, I think it is imperative that in the planning phase, these vague customer needs are ironed out into a finite set of design requirements for the product in order to drastically increase the efficiency of the design process. Does anyone have experience working on a project with a very vague set of customer needs that caused problems down the line?