I agree that customer needs are important in the planning phase, since ultimately the customers will use the product. However, I would like to add that a more efficient way of assessing customer needs or concerns is through customer service representatives, who have a great deal of expertise on what customers want and don't want, in addition to being able to compile a comprehensive list from many customers. Additionally, in the planning phase of the project, the input of the whole team should be considered (in addition to the customer service representative being on the team), since the team will be working on the project. By assessing all team members' ideas and concerns, one is better able to plan a project. Therefore, it is important to not only make sure that all the documents are completed in an organized manner, but also to make sure all team members are on board with the plan of the project.
It is important as a project engineer to understand that the end users are not only the patients and healthcare professionals utilizing the equipment, but also the technicians who are responsible for calibrating, validating, and repairing the devices. Working as a biomedical technician, I have noticed that some devices are easier to work on than others. Some devices have a counterintuitive disassembly/assembly process which complicates and extends the work done as a technician. On the contrary, other manufacturers of the same technology have products with intuitive and sequential assembly/disassembly processes. It is clear that some manufacturers have a better grasp at who their end users may extend to, looking further than just the patient and healthcare professional.
The planning phase is crucial to make sure that the user's requirements and design inputs are compatible and can be executed. People should take into account of different protocols/ tests are going to take place during the project. Unless a protocol hasn't been considered for the project, someone will have to write it and make sure that it is appropriate for the tests it goes through. The planning phase is when all scenarios should be considered to make sure that the project can be completed in a feasible amount of time and with the resources available.
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?
Other measure that occur during the planning phase is what class is the medical devices?
Are pre clinical or clinical trials required
Are what is the market size expected for the product
What is the expected amount of unit that can be sold.
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?
There are several other measures that are important to consider during the planning phase in a project of medical devices. One factor to consider would be the safety of the device. Does the device have pricks or needles that need to be covered? If so how will it be packaged? Is the product heavy? Does the device have wheels? If so, how can it used the reduce the risk of harming the patient? The cost of the device is also something to consider. Although the device may fulfill its purpose, is it affordable? Will your target audience be able to pay for it? If not, will certain or any insurance be able to cover it? Some devices are made to be used for home care, in hospital facilities or both which will play a financial role in production along with accessibility. How easy or difficult will patients be able to acquire the device according to their setting? Lastly it is important to consider the significance of the device. What percent of people compared to the average health condition would need your device? How does it stand out from a similar product? You don't want to invest time and money into a useless device, even if it is successful.
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.
I completely agree. Planning phase is the most important because it is the basis for the project essentially. If the planning phase is not well thought out and vague the project will not a falter. Another part of the planning phase that needs to be addressed is the project manager and the team. The team size and structure needs to be considered because the team is important for the execution of the project. If a team is not in place, and does not a have a solid structure and project manager, the project cannot be executed properly and efficiently.
