How much information is needed in order to begin a formal project is solely dependent on what is already known about the the technologies surrounding the prospective project. Like in the above example you provided, the biomaterial that's been in development for nearly a decade will probably not need as much research regarding the pros and cons of its application. What is probably to be provided would be whether or not if it's feasible given all the previous research done in the past decade. Additionally, the market or business case/business assessment model is needed, otherwise there is no knowledge on whether or not this project will have some reward for the company.

In the real world, there needs to be enough information and feasibility from gathered research that this would pass the Go/Kill decision of the Stage Gate. Absolutely no design controls should even start until there is enough evidence/feasibility otherwise this poses problems and risks later on when it comes to the inputs and outputs of the project in the DID, DSD, etc. Sometimes it's even a good idea to have a prototype and see if it's fully functional before the formal project is even initiated.

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I agree with jvv6, it completely depends on the project if someone has previous experience with similar project can start with minimal information about new project with confident. However, if the project is new then required lot of research and risk analyses before initiating a project. In my opinion, first, you need to start gathering data about the project, aligning the project with organizational goals, and defining the boundaries of the project. Furthermore, if your project defines such questions as ‘what, why, who, when, where, and how’ and when you are able to answer those questions, then I think you are ready to begin your project formally.

I agree with all of the above however I would like to add that in certain cases where similar products exist in the market, if the project team spends so much time in that phase it might take longer than needed. By the time the project is ready to initiate, the market gap it had to fill might be taken over by some other company or a project. A market gap depends on market research and the need for that specific product in the market. The gap can vary in terms of affordability of the project, or a feature it may add that others don't have.

To answer how much information is needed to begin a formal project it is important to outline what information is needed. You sort of answered this in your question, enough preliminary details to plan or propose. These preliminary details (most already explained in previous posts) would include . . .

1. Description of the project. What will the device do?

2. Why is such a device needed? What is its market niche? What does it offer to the consumer? Perform a competitive analysis and reflect on any market constraints.

3. Management plan and design approach. How/why are you qualified to undertake such a project? What technical skills do you need to hire? Any technological restraints? Consider legal, safety, and environmental realities. Even a general schedule of completion; milestones.

Once these details have been satisfied, the project development phase could begin. This opinion is formulated from my experiences working on Capstone as an undergraduate.

Within our company a project we started last year needed a good amount of information before we introduced the idea for a formal project. First off we had an R&D phase for the product in which we tested it's effectiveness and after about 5-6 months of testing against various conditions we developed an animal trial. During the time of R&D we also did research on similar products and literature research on if the material was able to be patented. The animal trials took another 2-3 months of development and implementation as there were many regulations we needed to adhere to in order to conduct the trial. At the end of all this we received a provisional patent on the material and put together a presentation on why this product would be useful to the company and the monetary benefits. All in all the process took a little over a year before we were even able to properly present it. Overall my opinion is that it is an extensive process and rightfully so since medical devices have many risks associated with them for both patients and the companies creating them, therefore all this research and due diligence should be done prior to taking the step towards a formal project because if not done properly there can be a lot of sunk cost for the company. Moreover, if the proper R&D is not done it can affect the consumer as well, if the project makes it to market and a defect is discovered afterwards.

Based on the information give, since the material has been in the development phase for a decade, the potential of the material should by now be known or at least have a pretty good idea on what it could do with a possible set of pro's and cons. One major decisive factor is the potential market the material has or in other words how it can effect or enhance the ability of other devices and how much money is needed to initiate a project. In my opinion, I would want to know, what they material can offer to my device, what can it improve on and what are the potential risks involved with this addition. Of course the benefits have to outweight the risks in order to be convinced to initiate a project that would incoporate that material. Lastly, I would want to know how this material compares to current standards.

Chris

It really does come down to the project manager's premarket research. They should not jump into a project using new materials just to be at the forefront. If too little is known about the material then the project it is being applied to might turn out to be a bad fit. Unless the project manager can see the potential for a material in a certain market, sufficient testing on the product must be done to know it's capabilities. Another thing a project manager should consider with timing is, will the product being created even be relevant in a few years or will it be a niche product that will be overshadowed given enough time as someone may find a better way to do what your device does.

I agree with all the participants that the project timeline and the scope depend on the type of the project. For example, if it’s the same project the company has already done in the past, then it will require minimal research. However, if it’s a new project, then there will be time spent in training and then SME will assist the project manager in finishing the project. In the new project case, there will be lot of pre planning required especially if it’s a medical device as the company needs to get the FDA approval before launching the product in the market. In the example in the discussion, I agree that the project manager shouldn’t agree on any kind of material without a certification given by the vendor. All in all, the project manager and the team should always pre plan and acquire all the necessary testing results of the materials before using for production of medical parts.

How much information is needed to begin a formal project can vary from company to company, even smaller companies do not all operate the same way. Also, it depends on what device or technology that is been developed or modified. There is no “one size fits all” answer to that question.

Prior to gathering or developing project documentation, take time to understand why the project is happening and what type of governance the project may require. This is when you start to put together the scope of the project, expectations, requirements, resources, and risks should be obvious to all from the outset. All this information is needed as least the basics before having a formal prophecy proposal or formal project initiation because without this information, you find yourselves and your team going round the project trying to figure things out and at this point scope creep can begin to slide in because the team do not either understand what the project is all about or not much information was derived. 

In place where a small company do not make use of the stage gate, which currently is not the case as it was back then, because presently there are software or system that small companies can use with easy to map out their project. What is needed is a method that focuses on the essential steps and does not waste time on overkill.

In place of a stage gate, a project charter can be used, this formally outlines a project in an organization. It covers the scope of what the project will achieve, as well as the people involved, milestones, budget, and possible risks.

I think that the proper time for a project to be initiated is if and when a team can agree on an idea that they think they have the resources to explore. If this  is the case then the next step of the project development process would be to start planning, then the executing portion would follow and finally the closing process would occur.  

A project should be initiated once a team has produced a feasible design of a product that can be realistically manufactured and be brought to market with a large return on investment. Sometimes, the discovery phase can last for years due to resourcing on teams or the project being shelved until enough human capital is within the company. Sometimes, a line extension of a project needs to have a project chartered to fill in a gap that was identified after an initial launch. What this boils down for a project to be initiated is: a project need, human capital, and feasibility of the product. Project needs can either be what was listed before or a technology that has emerged as the next hot commodity for that division. If the senior leadership sees a gap produced by the new product on the market by a competitor, they know that the product is feasible if a competitor was able to launch a similar product and will move different personnel to fit the team to have this product expedited. That project will be on a fast track where the discovery phase should go on from 3 months to 1 year (at least at my company) where there should be a good outline of products in scope. The discovery phase can go onto a few years if any bumps in the road occur that can be company related or team related. More organic projects will have an initial idea float around for a few months with one or two engineers working through to see if the idea is feasible. If it is, then the product discovery phase will take a few months and the project will start as there is usually already a prototype and scope by the time the product has reached its discovery phase. 

Posted by: @jvv6

How much information is needed in order to begin a formal project is solely dependent on what is already known about the the technologies surrounding the prospective project. Like in the above example you provided, the biomaterial that's been in development for nearly a decade will probably not need as much research regarding the pros and cons of its application. What is probably to be provided would be whether or not if it's feasible given all the previous research done in the past decade. Additionally, the market or business case/business assessment model is needed, otherwise there is no knowledge on whether or not this project will have some reward for the company.

In the real world, there needs to be enough information and feasibility from gathered research that this would pass the Go/Kill decision of the Stage Gate. Absolutely no design controls should even start until there is enough evidence/feasibility otherwise this poses problems and risks later on when it comes to the inputs and outputs of the project in the DID, DSD, etc. Sometimes it's even a good idea to have a prototype and see if it's fully functional before the formal project is even initiated.

When would a fully functional prototype be a good idea to have before the formal project is even initiated? In the limited number of product development projects I have been involved in, it was advised not to start prototyping until further down the project line. Why would prototyping even occur if design controls arent even in place?

I believe the proper time for project initiation is when you can prove a need for a project, a market, and that the project is feasible. I think the project being feasible is the most important part to initiate a project. Not only do you need to show why you are initiating, but you also have to show how. Whether that means using pre-clinical or clinical studies to prove the theories of the project would work, or showing a functional prototype. In order to initiate a project, you should be able to show that it is possible and reasonable to complete the project.