This is a good point. Before one invests time and money into a project, they need to make sure there is a need for their idea/project and it will bring in money. As much as bme is about helping people and improving healthcare, it is ultimately a business. The initiation phase is very much about seeing the project through the lens of a business.

One important question that I would ask is: who should I involve in the project? Which departments within the company should be involved? This is especially important in project management because this helps determine the scope of the project, addresses the issue of who would be a stakeholder. It's difficult to determine the minimum number of people and which people within the company should be involved in the project. Another important question would be: how do I convince management or leadership to fund my project and approve my project over all of the others? In other words, what makes my project stand out compared to the others? There's always going to be competition in gaining the attention of leadership and making a difference as resources and time are limited. This is a great question that should be asked because it addresses the significance of your project. It may be a way to decide if you're project is worth pursuing and maybe you could get involved in another person's project as you may have skills that are required. Another important question to ask if there are potential improvements that could be made later on regarding the new product and capability? Can I improve my product or capability later on or is it a dead end after it's completed? This is important because companies constantly innovate and therefore their products and services always get improved. It's important to assess the full potential of your concept as it may be help you gain the attention of leadership.

I agree with you manolo in terms of asking questions that are critical when initiating the start of a project. The important question to ask is the following: Whatever the project we are doing is there a market for the end product being made? Are there needs for it. Will this product create revenue for a company? This brings to point rv347 point about health care being a business. If there is no return on the product then company whomever that is will be at finical lose. While project progress there will always be questions that arise that were not of thought when in the executing the executing phase. An example could be what happens if their rejected parts what do we do with them. Another question is do we have enough time to complete a project when certain items were not on time to be assembly because of a hurricane that went through a suppliers building that was associated with the project etc…

Questions that I would ask fall under subdivisions of the four main questions asked:

1) To further expand on the business need, I would ask how profitable/lucrative the medical device is when taking into account the patient demographic along with how effectively it provides a solution to a medical complication. If the device treats a condition that only a few dozen patients in the world suffer from, then unfortunately it will not likely initiate into a project let alone even be discussed. And if the condition is abundant in the human population, then it can also be assumed that many other companies are attempting to find a treatment as well, in which case the challenge becomes making your device perform better than theirs.

2) A question on the project's objectives would be to reiterate what was mentioned in lecture, and that is whether or not the device is affordable, understandable, and achievable with the provided budget/resources. A product can have plenty of promise, but if it cannot be made understandable to your investors/stakeholders, it will arouse skepticism which can only harm your project's outcome.

3) The complication of the project can be determined by asking individuals with prior experience, or anyone you can get your hands on about their success and experiences so the project at-hand can be reassessed if need be. This includes asking everyone involved in a project including those who get their hands dirty rather than just those who overlook the project from afar. My current job requires manufacturers to work 7-8 hours straight in a cleanroom (sometimes without break) because managers did not take into consideration the possibility of being understaffed and having team members quit on projects in pursuit of other opportunities.

4) The stakeholders are essentially everyone involved with and affected by the project's outcome/deliverable. An essential question to ponder is what is the overall expectation of a project, and can I get all the stakeholders on the same page with regards to their provisions and expected outcomes.

Some other questions that would definitely need to be asked in the initiation phase of the project are:
1. Do I have the necessary resources to do this? If not, how feasible is it to obtain those resources.
While there may be a business need for your project, sometimes it is not financially feasible to get the resources you need to make it happen.

2. Which group of people am I going to have as my team?
This is extremely important because you would want people who have the proper skills and training to complete this project. You'd would want there to be as little room for error as possible and so you'd want to make sure your team can handle that and work in a timely fashion.

Coming from a person who is always asking questions to ensure I understand what it required of a project, I feel that the more questions you ask yourself during the initiation phase of a project, the more you will know how feasible the project is during the Planning and Execution phase.
Some other questions I would ask are:
After asking myself if there is a need for this project, I would question how in demand this project would be? As in, how many people would be interested/need the end result of the project. As a project manager, this would help me sort out the order in which projects are completed.
After asking myself how complicated this project would be, I would begin listing all the tasks that would have be done to complete this project, to visually see how complex it is. From there I will have a proper understanding of what my project requires, along with the other questions that have been mentioned by my classmates.

I agree that these questions are so important to the development of the project. Before making a device we need to make sure that we can sell it. Why waste money on a project that we will not make money from. Also need to understand the objectives of the device because if they are not realistic we will put ourselves in a situation where the project will never finish. I think the most important question would be "how realistic is the project" we need to make sure the project can be completed and solve a problem. We do not want to make a device that causes more problems than it solves.

I agree that an important part of the project is who should be involved. The project manager needs to involve the right people who understand the specifications of the project and can accomplish them. I also agree with the continuation of the project. If you start a project that cannot be improved on and it does not do much maybe making it is not a good idea. But if it can be improved on later it will be worth it to make it. Also with the ability of being improved the company can have more products produced which can lead to more money. With these two questions the project manager can have an easier path to making sure the project gets accomplished to create the best possible product.

I would agree that one of the most important questions to answer during this period is how valuable this project will be in a business perspective to the company. Aside from answering questions pertaining to the objectives or complexity of the project, it is here where a team will determine whether the project is worth spending time, money and resources on in comparison to another project. Therefore one valuable question to ask is whether there are competitors on the market with products similar to the one that will result from this project. The importance provided by this question is that by doing market research, the project team can better determine the angle they hope to pursue to separate their product from the competitors. For instance, if the project team determines that the competitor products are very expensive, they can tailor their project to create a more affordable version. Another question to ask during “Due Diligence” is what the current market need for this product is and how long this demand will be prevalent. For instance, it would be more valuable to spend resources on a project for a market that has an increasing demand and will be needed for a longer period of time. Overall, it is important for the company to do the required research to determine whether their project will be successful on the market after the completion of its development.

Before I initiate with a project I would think about the product and how helpful it would be in real world from a business point of view since my time, money and energy all would be utilized hence i would definitely expect to have returns on it. I should also have a rough idea about how I would go about marketing it and my other competitors in the market and be able to explain the customers why they should consider my product over pre-existing product. You need to have a clear vision before initiating such a project and have a solid plan to make it work

Revenue for a company is like air for a human being. When it comes to a medical device company, there are a few questions to ask in order to make sure they not only come out of the project breathing, but breathing better. First, I would ask what's the best case scenario of the project? What's the increase in revenue? How many people do we have to allocate to work on this and what will each person do? I'd break down the project step by step and see where anything could go wrong; manufacturing, clinical trials and FDA approval? There are so many hurdles with any medical device, but what are those going to be for this project? How long will the project take and what are the monthly/yearly costs? What kind of liability are we taking on, financially and ethically, to complete this project from start to finish? It's hard to say what exact questions are the ones you need without knowing what the project is, but I think looking at financials and ethics are the best start to seeing what could be the hurdles ahead of you.

I would like to suggests that one more group of people should be invited/added to the kick-off meetings: the end-users or patients. Ultimately the end-users are the individuals who are going to use the medical products developed, therefore, they should be in the loop starting from the initial phase. In addition, the group of end-users may provide extremely useful information since they are the ones who have been using the device daily. When you use a medical device daily for more than a year, you can easily tell a company the problems one face and what should be improved in the next design. It may be hard for engineers or designers since they are not necessarily the ones who have physically used the device before. Would you guys agree with this statement or do you think the end-users should be invited in a later stage of the project?

I would like to suggests that one more group of people should be invited/added to the kick-off meetings: the end-users or patients. Ultimately the end-users are the individuals who are going to use the medical products developed, therefore, they should be in the loop starting from the initial phase. In addition, the group of end-users may provide extremely useful information since they are the ones who have been using the device daily. When you use a medical device daily for more than a year, you can easily tell a company the problems one face and what should be improved in the next design. It may be hard for engineers or designers since they are not necessarily the ones who have physically used the device before. Would you guys agree with this statement or do you think the end-users should be invited in a later stage of the project?

I would ask my self if people don't really need the device that is going to be developed then how can it be marketed to let people know that they need this device. Because if there is no need for the device then you have to create a need just like what people who make smartphones do. It is mostly marketing when it comes to this kind of projects, whose end product will make peoples life easier but they don't really need it.

Secondly I would ask how much will it cost to manufacture it because you can create the device while you are working on a project but if you think about manufacturing those devices they can be pretty expensive unless you chose to change the material of the device and geometry of the device so it can be easily manufactured so it saves time.