Other aspects to consider during the planning phase include the meeting stakeholders' expectations, incorporating inputs from customer surveys, and allotting time for any changes that may be made to the original design. The planning team should outline how they can meet the requirements of the stakeholders within their desired time frame. Projected revenue (benefits) that greatly outweigh the risk of financial failure will also lead to more stakeholder buy-in and engagement. The customer surveys will offer suggestions for improving certain aspects of existing products, which will help the new product stand out and increase sales. New customer feedback may contradict older reviews, and stakeholders may want to include more specifications after the documents(DDP,DID) from the planning process has already been completed. The team will need to account for the time spent making those adjustments to the initial design, by including that buffer when negotiating the project boundary.
Another important measure that is important when considering the medical device is how frequently the device will be used by the user or how long the device will last. For instance, if the device is an electronic device, important questions to ask would be: 1) how long will the battery last? 2) Is the device expected to be used daily or weekly? These questions are important because it gives the company or rather the project team an idea of what aspects of the medical device should be optimized so that customers will buy the product rather than a similar one from a competitor. If your device is similar to one that is already on the market, one should ask how the device that you are proposing will be an improvement or stand out to consumers. This is especially important because you can have a medical device that works and complies with regulations but it may not make enough money for the company/business simply because there are plenty of competent products that consumers can choose. Moreover, another measure would be the cost to build the product and how much it will cost the consumer to buy it. If consumers feel that the product is not worth the money or if it is too expensive, then they will choose another product, and that can be detrimental because you are technically encouraging them to buy from someone else if the price is too high. These are other important measures about the medical device that should be considered during the planning phase. The earlier you think about this, the more likely you will be able to solve them because you have more time to do so.
While sometimes the user needs are vague, it is important to define them as quick as possible so that you can exit the planning phase and continue with the bulk of the executing phase. After the first round of defining the user needs, the customer should be contacted and together, the designers and customer will hopefully finalize those needs. Following that, another round of addressing and solving the user needs should be conducted and again followed up with a discussion with the customer. In some cases, the customer will not want to partake in such meetings, and that will allow you the freedom to design your device whichever way you want. But at least you are doing your due diligence to reach out to the customer and go over your design. Working hand-in-hand with the customer will reduce the amount of time spent on planning and will remove the uncertainty of the user needs.
In the planning phase of a medical device, some more aspects that should be discussed are: stakeholders, roles and responsibilities, scope, schedule and cost, management plan, staffing plan, quality and risk. These are some very important terms to discuss in the planning phase. Roles and responsibilities include project sponsors, project team, managers and business experts. Each of these play key roles in the initiation of a project. A scope helps define the project plan and clearly portrays how large or small of a project this will be. It also helps identify "all the deliverables produced on the project, and therefore, identifies all the work to be done." Schedules help keep the project on a timeline and cost helps verify that there's enough funding for the kickoff and maintenance of a project. Quality and risks include putting forth acceptance criteria that will help define checkpoints for the project.
One thing that needs to be considered by the engineer more often then I realized is the cost of the product. You could have an amazing idea for a device that the user will love and but if it is fiscally out of bounds to what you can produce then you need to adapt to that while also fulfilling the needs of the user. This may sometime mean removing features that would be great and have made the device that much better
The Project Planning Phase is the second phase in the project life cycle. It involves creating of a set of plans to help guide team members through the execution and closure phases of the project. The plans created during this phase will help the team to manage time, cost, quality, change, risk and issues. They will also help in managing staff and external suppliers, to ensure that the project is delivered on time and within budget. Planning may not be the most enjoyable component of managing projects, but it is the most vital part for reducing risk and failure rates. Time spent on planning will reduce risk and increase project success. On the other hand, inadequate analysis and planning will lead to a failed project. One important aspect that most be considered by engineers during the planning phase it the ability of the breakdown of works to be conducted limit the allotted timeframe and ressources provided.
The planning phase is when the project plans are documented, the project deliverables and requirements are defined, and the project schedule is created. It involves creating a set of plans to help the project team through the implementation and closure phases of the project. The planning phase is very important, as it establishes the tasks, deliverables, schedule, staffing and budget for carrying out the project. The project plan is very important to the project success. The planning phase is the most critical step in completing development, acquisition, and maintenance projects.
A very important aspect in the planning phase would be creating the Project Team. The project manager would have to be chosen as well. This is a very important step because you need to make sure the members you pick fit the project. You do not want to put a software engineer in charge of a hip implant. Deciding which team members would be most efficient for this project I think is one of the the most important aspects of the planning phase. It would also be ideal that these team members have worked with each other before or have very good communication skills. Picking members for a project team could be very difficult and take some planning.
If we talk about planning phase in a project of medical devices, according to me one of the important aspect is to find out user needs. Sometimes user needs are bit vague and ambigious but that is considerable. In planning phase some points that are needed to look are who is going to use that device, how will the user interact with that product, the clinical procedures involved, the environment where it will be used in, and other products that is going to interface with medical device.
So what other measures are important and how would this help?
I think one other thing to consider is who are your competitors, and what do they have to offer that is similar to what you're planning on offering? When you are in the medical device field, you will often have at least one, if not several competitors that are fighting to offer the best products to the users. Since that is the case, it is important to consider if your competitors currently offer something similar to what you are planning on offering. If they do, it is important to figure out how you are going to make your product different (and hopefully better) than theirs since ultimately, you want the users to be using your product instead of theirs. However, it is important to do your research and see if any patents currently exist related to this product, because that may limit what modifications and improvements you are planning on making. If they do not have something similar and no patents exist, you have much more freedom to come up with a great product! In this case, it is extremely important to manage expectations and set realistic goals. Often, users and upper management will want a ton of features to be incorporated into the device, so as someone who is managing the project, you want to make sure you're setting your project team up for success and you aren't overcomitting on what they can actually deliver.
In the planning phase, sufficient details are required for the desired project development plan and permit to work under validation of the deliverable. User’s needs is one of the important one to discuss in the planning phase. Planning phase consists of establishing the scope of the effort, designing it and refining the objectives and developing the course of action to attain those objectives.
The project management plan and project documents developed as outputs from the planning process group will explore the aspects of scope, time, cost, quality, communications, human resources and stakeholder agreement.
Mintzberg (1994) describes planning as the effort to formalizing decision-making activities through decomposition, articulation, and rationalization. The purpose of project planning includes establishing business requirements, cost, schedule, list of deliverables, delivery dates, resources plans, obtain management approval and proceed to the next phase
The planning phase refines the project’s objectives, which were gathered during the initiation phase. It includes planning the steps necessary to meet those objectives by further identifying the specific activities and resources required to complete the project
Project planning is a tool to build a pre-conception of the stages of project implementation and visualize the expected risks that the project will face when implementing it, and what are the mechanisms necessary to address these expected problems. Therefore, the success of the project planning is related to the ability of the planners and their experiences in predicting the problems and difficulties that the project will face in the implementation phase.
When conceiving the idea of a product, it usually is made to fix one kind of need in the market. During the planning phase of a project, there should be a discussion of what other consumers can this product attract and how can we get this product to still have its integrity while reaching out to more kinds of consumers. This way you still have a product solving a problem but in this way more people will buy it and maybe itll fix more problems than the original product that was conceived.
Being a customer in the first place will give a better idea of what people needs are. Having a time to do research on people feed back about other competitors devices which are similar to the one we are offering can help in planning for a device that is more capable and helped resolving the main issues that the customers had faced.
During the planning phase of the project, I do agree that the user needs should be considered in a vague aspect. The customers are the ones who are going to be using the device/product so that should be one of the main things to consider. Other things to consider during the planning phase is what teams are needed to create this product and how much time it will need. Figuring out a timeline of how long the project will take to great the product is important. By using a Gantt Chart, you can tell how long the project will take and the resources that will be needed as well as what parts of the project depend on other parts of the project. Figuring out what kind of clinical or animal trials is also important because trials cant take up a lot of time.
