My perspective is that the various artifacts such as Design input Document, Design Specification Document and/or Design Output Document are important to document the robust process of gathering information, analysis and decision making. As the Professor indicated each organization may have slightly different approaches with the documents but what really is important is to show traceability from customer needs all the way to providing the right medical device. I have seen organizations become totally immersed with documents and forget the real point of them. Need to keep your eye on what you are trying to do, then create and maintain documents to support the process. Yes, you need good document practices also but if those documents do not support the processes of the organization (marketing, engineering, manufacturing and quality), they could be looked as disadvantages.
Turn the documents into value added artifacts!!!
A design specification document (DSD)is a detailed document that provides information about a designed product or process. The design specification must include all necessary drawings, dimensions, environmental factors, ergonomic factors, aesthetic factors, required maintenance, details on performing the work, etc. The purpose of the design input document is to define each user's need as an objective and measurable design input. While developing the product each of these inputs must be addressed and included in the design specification document. When completing design verification, the DID is used to verify that the device meets the requirements set by the customer. Verification ensures that all the customer needs are addressed through checking if the inputs have an output. If the device fails verification, then the DSD must be reviewed, investigating the specifics of the device. Once the verification and validation report is completed, the results are documented in the DSD. Verifying and validating a medical device definitely requires both these documents.
As this week material showing, the design input document (DID) is an overview and short description, and the design specification document (DSD) illustrates a specific technical design data, the selected material data, and dimension information. Both are important for group of people, for example, people whom are unconcerned about the technical term do not need to read or know DSD even if they work at the company. On another hand, the DID is kind of unaided data for engineers and technicians like whom work at manufacturing area.
The design input document and design specification document each play an important role in design controls as they are the documents that proclaim official descriptions of the design. After gathering a list of user needs and requirements, the design team can begin developing the product around this list. In order to ensure that every detail on this list is met, documents such as the design input document and the design specification document are used. The design input document provides a brief description of each requirement, which allows the project team to focus less on product specifications and more on general design. As this general design is developed, the design specification document can be used to sharpen the specifications of the design.
The DID and DSD tie in very nicely when developing Verification and Validation procedures. The Design Input Document should be used for Validation, where the resultant function of the product is assured to meet consumer needs. The Design Specification Document is used to assure the physical design of the product meets the engineering specifications provided by the engineers, company, or regulating bodies. This document is used to develop Validation plans.
Both of these documents help set goals for the design of the product, and are respectively tested in verification and validation.
When first trying to brainstorm an idea, you would want to think broadly. You want to get an idea for a product that would be useful for patients or customers. More specifically, you would want to know what specifically customers are looking for in a product. This is where you would want to create a DID. It is a general overview, or blueprint, of what you want to create, and it is typically in accordance with what a customer would want. The DID can verify if a creation ultimately satisfies the needs that the customer had required. A DSD is much more technically specific. It outlines the exact specifications required to create the product. A DSD can be used to verify that a product was created correctly. Overall, both are useful as they each help in unique instances and serve different purposes.
As it have been stated by the others, DID is a document that contain the inputs data from the customer (users) but it also have different inputs such as Functional, environmental, physical , labeling and regulatory input. During the project DID is one of the first documents to creat, it works as the base for other Documents and one of them is DSD.
DSD gives specific information about DID inputs especially the user and physical inputs. DID says " what i need" but DSD says " How i want what i need to be.
While both documents are extremely important and I don't think either has any major cons. However, I will point out some flaws with both documents.
The design input document is important because it gives the broad idea and basic desire for the product. It is the simplest form of documentation that just about anyone can read and understand. It complies all of the information from all the parties so it serves as a great foundation for the proposed project. While extremely necessary, it can be slightly frustrating for the whole team to give their input and to deal with a large number of opinions and especially conflicting opinions.
The design specification document is perhaps one of the most important as it takes the DID and creates specifications and tolerances. This is used to verify all the outputs and use specific ranges while also referencing other documents such as drawing and blueprints. This document is extremely useful because I remember having to refer back to it many times throughout the duration of completing my capstone project. However, it was extremely frustrating to have to go back and make changes and add details because of failed ranges and tolerances. Updating this document was very time consuming as it involved other team members as well, and one change usually created many changes.
Pro and Cons might be little out of character this as one if necessary for the other. For the instance given, one needs a basic understanding of the door knob example, if one doesnt know that a door knob is needed (DID), then its not possible for one to know what type of door knob to get (DSD). By just focusing on the DSD, it may constrain one too quickly as the specifics are required.
@mattie718 I would have to agree with you in the sense that the Design Input Document (DID) and Design Specification Document (DSD) are similar documents. But I do think that the DID is most vital because the writer who composed it is able to describe assets and features of the actual product. This is in attempt to make the user have a easier way to be immersed in getting the potential out of the device's use, not to mention it being intuitive. It essentially gives the reader a unique point of view.
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?
I think both documents are incredibly important. The documents you are describing detail the differences between verification and validation. Verification, similar to the DSD, gives specific and detailed engineering understanding of what comprises the product and how it performs. This document delves into the nitty-gritty of how things perform, appear, and assemble. Regulatory and Marketing might require this information for submission purposes or marketing claims.
The validation portion, similar to DID, is understanding in general terms how a product meets criteria and how a product works in practice. This gives important information about the practicality of a product that isn't necessarily captured within the DSD.
Both documents are necessary for capturing the whole picture of a product. The sections that are incredibly detailed and the portions that are harder to quantify but are important for the practicality of a product.
Thanks,
Matt
One of the benefits of the DID document is that it gives you a broad idea of how the finished product will look. This is essentially a mental image of what you and the department think the design will be. This is more precisely what the notion will become with a DSD. You may choose what sort of red you want the knob to be and what size is ideal for the product using design specs. One of the drawbacks of a DID is that it isn't precise enough, so when one person thinks about the broad notion, it might imply something completely different in someone else's view. One of the downsides of a DSD is that it might be more difficult to manufacture the product with detailed descriptions. I think they go hand in hand, where you start with a broad concept and then flesh it out with detailed details. Both of these papers will serve various purposes for the product and will be useful at different phases of its development.
The underlying purpose of the DSD and DID is to ensure the customer's needs are satisfied. To develop a product effectively, the company must meet the overall perspective of the product and the detailed functions as well. The DSD ensures that details are satisfied. Product development involves several perspectives working towards one common goal. Having a DSD ensures that the DID perspective, which varies by department, is specified.
I think design input is great for giving the team a general idea of the specs of the device. It is advantageous for times when the general idea is needed but the specifics need to reman safe guarded. The DSD would be most useful for when the general idea of what is needed in the device has already been confirmed. Then next step would be building the device, so that's when the DSD is most needed. It will have the specifications that are needed for the completion of the device.
The DID and DSD documents are essential to any medical device design project. The DID is essentially like the rough draft. It has the basic desires for the project but no specifics are included. It is generally composed by the marketing team and the entire team gives input as well as the customers. On the other hand the DSD is the master plan. This document contains the detailed specs of the product. Every input has specifications that will ultimately produced a very specific output.This document is compiled by the research and the engineering teams and may include the drawings and/or blueprints for the product design. Spec ranges must be carefully set and adhered to because if verification failures occur it could be costly to the company. Both of these documents are necessary so that the entire team gives their input to get the best quality output.
