This week's discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that we had to turn in: business requirements document and the test plan document. The business requirements document was a direct representation of the customer needs. We met with our customer, asked what he wanted his device to have and the constraints, and then we determined how to create a device that fulfilled all these requirements. This document was long and was to specifically list every single aspect of the device and be so detailed that if carrying out and following every requirement, the device can be made perfectly every time.
The test plan document is a supplement to the business requirement document. The test plan is meant to take all the requirements and introduce a test architecture to determine whether all the values in the requirements represent the device.
It is common for a device to go through all these steps before it can be mass produced and sold. Everything has to be perfect because of that and the constant trial and error of making it is difficult and takes a decent amount of time.
I didn't do my undergraduate at NJIT ,but I believe it's common for a medical device to go through common steps. Those steps may just have a different name and ask for specific information. I think it's good that they require the students in that course to have to do a test plan document. It often seems as though we think a product has to be perfect before it goes on the market , but it seems that it is not true; Due to the quality of different products. even though a company goes through all that paper work for a product. Is it really worth it in the end ? If the product does not perform at its best ability ? A medical device document will be even longer as we had seen in the sample documents that Dr. Simon has given us.
I also had to do a business requirement document in capstone here at NJIT and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure we fulfilled them. This is similar in that validation checks that the inputs are the user needs or intended use and then validates whether the needs are met. As mentioned, it is common that devices go through these processes, as it is a good way to make sure the product fulfills the costumer needs so it will be useful to the market.
You bring up a good point. More often than not, products aren't perfect by the time they make it onto the market. There are always improvements that can be made. Even for products that have been used for decades, there is always an evolution of the product to make it as efficient as possible. Take Band Aids (adhesive bandages) for example. They were invented in 1920. In 2020 it will be the 100th anniversary of the invention. In those 100 years, countless changes have been made. Different materials, adhesives, and sizes have been experimented with. I believe that any good medical device should be dynamic and willing to change. The good features can be kept, while any limitations of the device can be altered to improve the device. Having the necessary documents and being organized help keep track of these changes. Furthermore, as mentioned in the original post, speaking to the customer to find out the specific needs is also important. Below is a link of all of the changes that have been made to Band Aids since they were created.
In my R and D work experience, I worked a lot with new product development and just as our senior design projects, customer needs/design requirements and test plans are huge deliverables. Once the customer told us their needs (in my case a perfusionist), we were able to write the design requirements for a particular heart lung machine. We then had to make sure our test plans were comprehensive and tested every aspect of our design requirements.
I understand how frustrating sometimes it can be to refer to a small parameter in these test documents or the product documents. But, when a product is not functioning to it's ability, one factor could one or more specifications listed could be a failure. Though tiring, it's always preferred to go back and refer the document and then modify the device/product accordingly.
I work in Sustaining Engineering and though we don't usually come up with new products and develop them, we do put a lot of work into getting and documenting VOC (voice of customer), and testing our solutions against the documented VOC. There are also a lot of failed projects that don't work becasue the engineer failed to get proper VOC or didn't listen to it. While it may get annoying at times, the VOC can make or break the device/ solution.
In my company, the customer needs, business requirements, and test plan are all housed within one document, called the DIOVV (Design Input, Output, Verification, Validation). the customer needs are listed as user needs in this document, which the product development then translates into design outputs (business requirements) with acceptance criteria that must be met via verification testing. The test plan is covered by the verification and validation sections. Verification testing is performed to ensure that all design outputs meet the specified design inputs, while design validation is performed by the final user evaluating the device to ensure it meets all the user needs.
I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete because of the major details that are involved. However, these documents are definitely necessary when it comes to producing new products especially. For my capstone project, we had to design an apparatus that tested the permeability of drugs through the blood brain barrier. This isn't a very common device, and my team and I had a very tough time trying to make these documents as comprehensive as possible. However, looking at it from an outside perspective, these very detailed descriptions are very necessary, so that any one can be able to look at it and use it.
I completed my undergrad at NJIT and within the senior design course (capstone) I developed a better understanding of what a requirement and test plan document contains. It was grilled into my head that every time you write a document it must be clear and concise enough that anyone can understand it. The requirements document was specific to the customer needs while the test plan goes into detail of testing each requirement. I’m realizing right now at work how vital it is to write everything down. My coworker had to go out for surgery and his projects were transferred to me. It took me two weeks just to understand what he has completed because he did not have clear documentation of anything. It was so frustrating, but it supported all the scrutiny that I got while in my capstone course over documentation. While following procedures at work to complete an inflate and deflate tests I realized that the test methods had to be “dummy proof.” All documentation has to be this way because when an auditor comes in, they are unaware of everything besides the documents in front of them.
From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were required to submit a lengthy and extremely detailed requirements document and a test plan. My professor for capstone described that the requirements document should cover every customer need given to us by our customer and that it should be detailed enough that "you could give this to any average joe in the hall and he or she can make the device just based off the document". The test plan was simply a document containing a test architecture to assure that our device is compliant with our customer needs and regulations from the FDA, ISO, etc. Our professor stressed that these types of documents are what is used in industry today and most likely will continue to be this way forever. He even provided evidence by showing us emails from former students who landed jobs because of their knowledge with handling these documents. Overall, these types of documents are prevalent and are very necessary in order to create a medical or any other type of device/ product.
I am currently also in the BME Capstone class, as I am in my senior year. I also had to make an extensive list for the design requirements and customer needs. We met with our customer and they told us exactly what they wanted and we worked towards building the device in a specific way. We also had to meet with their design requirements, and they would often reject any design that they seemed would not work in the setting of the body. I cannot give much away about this project, since it works with an outside company, but I can tell you that explaining our design to the customer vs someone on the street has to be totally different. Our design should be easy to understand and visualize. It should make sense for why we need this product on the market and why the other products have failed. It should also follow any FDA regulations as well as the company's regulations in testing the product and utilizing their resources to make a product that they will be proud to use in the future.
I am in capstone 2 right now and I will say it is the best class in the entire curriculum we have at NJIT it gives you the idea that how you will be working in the Industry, it teaches you how to write these documents as an engineer and why it has to be idiot proof, can't be vague and most important think DEVILS IS IN THE DETAILS. Design Requirement is the most important document because you will write your test plan based on that and you will test all the requirement you wrote in the design requirement document. Our demo is in two weeks and we feel like our requirement should have been in to more details because we are face the problems which we did not even thought off( Devil is in the details)
Being part of the BME capstone class this semester, many of the criteria and aspects detailed above are something I have encountered and worked on. For my particular project we are working with an outside company, not just a professor at NJIT. This adds to the challenges we face because our advisor is not always readily available to speak to. Thus, when discussing our customer needs there had to be several back and forth discussions in order to ensure we have covered everything our customer needs. Taking this capstone class has made me realize the strenuous task of bringing forth a medical device. There are several requirements that need to be met on top of the tedious documentation. But all this this is necessary in order to obtain the best final product.
Having completed Capstone I and II, the requirements and test plan documents are the most important documentation you have for your product. These documents describe the product's mechanical properties, electrical properties, biocompatibility and the likes. These documents are also considered living documents because if there are any additions to the product, the person adding a new feature will look at these documents and add the necessary additions accordingly. It is important that these documents describe each feature as concise as possible to ensure that the product does what its intended to do based on customer needs.
