In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification and gives a very specific description(ex, "red knob 3cm in diameter dyed with red #5 from Vendor x with a tolerance of 0.001cm"). What do you think the advantages and disadvantages are of each document and why are they both necessary?
There are pros and cons to everything. The advantage of Design Input Document is that it gives a general idea of the product or project. DID lists the consumers wants and needs then formulates it into a device. The main disadvantage of DID can be a little too broad or general. The advantage of Design Specification Document is that it gives intricate details of every step in creating that particular device. The disadvantage of DSD that it could be time consuming, confusing, and you still can miss the mark of the purpose of the device. DID and DSD are necessary in the process of developing the device because they serve its purpose in communicating to the right people in charge.
When designing a medical device, customer needs and deign output are both important factors. Design controls ensure that the device meets the user’s needs, intended uses and specified requirements. Design controls are also put in place to see what can be improved and to prevent future issues from occurring. Design inputs however are the physical and performance characteristics of a device that are used as a basis for device design. Design inputs address user needs and intended uses in measurable terms. It is important that both that the design input, customer needs and design controls coincide with one another to create the best device for the user.
In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification and gives a very specific description(ex, "red knob 3cm in diameter dyed with red #5 from Vendor x with a tolerance of 0.001cm"). What do you think the advantages and disadvantages are of each document and why are they both necessary?
An advantage to a DID is that input of the product is given by a team and customers, and it gives a basic description of the product. This is beneficial because it takes the market and the customer’s desire into account, and the description is minimal. A disadvantage to this is that a DID is that it’s big picture, and doesn’t provide an in-depth description of a product. An advantage to a DSD is that it’s very detailed, and is backed by research. It also can contain drawings and blue prints. However, a downside to this is that all the specifications have to be verified and accurate. Also, the FDA has access to these documents, which could cause problems if they are incorrect.
Both a DID and DSD are important and necessary documents when it comes to product development and management over this process. While a DID isn't as thorough (a disadvantage), that's made up with a DSD and creates the needed balance around product design specifications and features. I agree with one of the comments above regarding one being necessary for the other and both being important rather than having pros and cons. The DID does give a general picture of what the product is to look like and how it should function, while the DSD is more in-depth around what the product will entail down to the most minor of details.
Both documents are necessary for the project design because they are the basic description for different readers. The advantage of DID document is that the reader can quickly understand the product's purpose and what the desire will fulfill. Most opinions and design input will be concluded in this document to provide a primary direction. The disadvantage of DID is this document lack of detail contact for designing and drawing. And this is the purpose of the DSD document exist. The advantage of DSD is that it gives a detailed description of all input or opinions that should be in the output. It offers everything about how to produce the product and when to do that. But the disadvantage is that the DSD is full of instructions to give a clear vision for the reader.
I am not sure I would use that one of these documents are better than the other as they both have two different uses as some have mentioned before me. The DID is great for anyone to add in what they think the product would need to have and can be read by all members of the team without jargon or very specific measurements. The DSD goes into the specifics of how engineers, scientists, or other team members building the device will meet all these inputs and gives the test engineers what they need to accomplish to have a successful product. I think there could be disconnects between what the customer or other team members have asked for in the DID and what was possible to make and that was put in the DSD. Has anyone ever worked on a project where the customer needs or inputs could not all be realistically made?
The DID and the DSD are both very important documents and as stated in the initial question, they both describe the design in a different ways. It is very important that both are present with any design as they each help paint the picture of how the final product is supposed to appear visually. The advantage of having a DID is that it helps describe the design in a way that does not get too technical. IT can help create an initial image of the device or object without having to get into the dimensions and other specifics. This is also the disadvantage of this document as wanting to know anything further than the basic broad description would require the DSD. Much similar to the DID, the advantage of the DSD is it helps go into the specifics of the design but the disadvantage is that it is not very useful if just trying to get a basic initial idea of the design.
I believe that there are not any disadvantages to the DSD and DID documents. Both complement each other and are necessary for design control compliance. Although, when designing a new product, the specifics within each document could inherently hold the design in such high regard that can't be reached. While ceramic hip implants can be highly resistant to compressive loads, it's not able to rebuild themselves after minor fractures so that should be kept in mind when making those documents.
The Design Input Document (DID) provides the physical appearance and basic performance of a device. The Design Specification Document (DSD) is a detailed document that provides the exact specifications of the product. Both documents are crucial in medical device development for their own reasons. The DID is necessary because it gives the basic desires for the product and takes the market, consumers, and project team opinions into consideration during the design process. The DSD is necessary because it gives the detailed specifications of the product depending on the engineering design limitations. As the DID and the DSD complement each other in many ways, there are disadvantages to the DSD due to restrictions on modifying the specifications. By modifying the specifications, the entire design of the product changes which may cause a delay in the development of the product.
Both the DID and DSD are important because one relies on the other. Design input is broad, so it will be easier to pertain and summarize the scope of your project: just form reading the inputs, you as either a manufacturers, designer, or provider will have an understating of what materials you might need in general for the development of your device. However, the disadvantage of this will be, you will not have the specifications, such as how much of the materials you might need. Design specifications will go into specifics, so now you can understand the quantities of the materials you might need, but additionally what they do and how they contribute to the functionality for the device. This will again go into specifics, and as a result there will most likely be wording that will be in general difficult to understand for someone not familiar with the device. As a result, if you did not understand the DID you will most likely have a hard time understanding the project through the DSD. Hence why both documents are equally as important.
The Design Specification Document (DSD) gives the numerical details of the product and explains every individual piece with the size and tolerance. The DSD can contain all the drawings and blueprints of the device; also, it is essential to include tolerances because the FDA can look into your product and measure each piece, and if the numbers don't line up, then your product can be recalled. The Design Input Document (DID) gives the product's overall desires, like the color. The whole team and customers provide input on the DID, and the team considers the desires for the device. I don't think the DID should have its own document; I believe it should be within the DSD since it is not that major of a component.
In my opinion, the DID is helpful in creating something appealing to the customer visually and allows for the customers needs to be heard in a general sense. This document gives the engineers a general idea of how the device should look and what general features the customer would want to make it easier for their use. The DSD is more for the engineers. The DSD provides more detailed specifications to the generic wants and needs that the customers wanted for the device. The details are extremely important for the creation of the device because you don't want a device that is too large or too small for a customer to use and we want to make sure that the device is also easy to use for the customers. Both documents are extremely important is design creation and you need to do both to create your product. The DID is more a generic start for your design and the DSD gives you more specific details. These devices both play off each other in order to develop the device.
Although we cannot say that these two documents are the same, we can say that they are similar to each other. While DID is a document prepared by marketing and contributed by other departments, DSD is filled by the technical department. While DID is about needs, DSD can be considered as a document that enables needs to come to fruition. another important thing is, DID helps to prepare DSD.
Both are important to have since the DID is more overarching and lets you trace inputs to outputs and requirements. It is also easier to read since it does not include all of the specifics which may be unnecessary for what you need. The DSD is very important in its own right since manufacturing needs the exact specifications to be able to make the product correctly.
DID is the rough sketch of requirement whereas DSD is the specification of those requirements so both are needed. It's simple.
