All of the components associated with design controls serve a necessary purpose. However, the design verification process and design validation processes are the most important. Both the verification and validation procedures, in addition, to the DID and DSD, allow companies to complete product development. If product development were to proceed without design verification, users would identify product errors before companies.
I believe the most important part of design control is the design verification phase. I chose this part of the process because the verification of the design is crucial to being a "good" product in my opinion. I think it makes or breaks how well a product will do on market. Nowadays everyone is going with what is the most accessible and if your design is not that, it will not flourish. I do believe that customer input is also very important in this aspect as well.
I think that the design verification is the most important aspect of design control. Design verification checks that the inputs match the outputs. It consists of coming up with a verification protocol that includes test for each output. I think testing to make sure something works properly is very important. Safety is number one! Also design verification protocols includes what to do when something fails a test. How else can things be checked or verified, if not for design verifications?
I think that the customer’s input and specifications are important as well. But after knowing their input, it is important to make sure the product matches their request, or else, it won’t be bought. Design verification makes sure of that.
All nine parts of design controls are necessary and play an important role in designing an effective product. I believe the most important part is the design input. Input is the first key part of a successful product because it will provide context to user needs and allow you to frame and design the product toward fulfilling the needs of users. Without input, there would essentially be no truly successful output and therefore throw all of the other steps off target and the true end goal won't be met, which is to design a product that serves the customers' needs. Useful design input creates a solid foundation for the rest of the design control process and helps to determine what the functionality of the product will be.
The verification aspect is the most important part of the design control process. This process is a crucial part of the design control process because without the verification process you cannot ensure this is safe for the person using it. Design verification checks that all parts of the design controls including if your design outputs match your design inputs. Design verification is confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Verification is a theoretical exercise designed to make sure that no requirements are missed in the design. Without design verification it would be impossible to put any medical devices on the market.
Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do YOU feel is most important to the process?
I think that the design verification process is the most important to the design process. I this because this is the part of the process that ensures that the product has a meaningful purpose for use by the public, the product has the components to make it functional, and that the product has the ability to be lucrative. Without the design verification process there could be a potential for creating a product where it may not be needed or there could be missing components of the device they are trying to develop. Taking the time in the beginning to verify the design of the device allows for all those involved to create this "checks and balance" system that exposes the benefits and risks involved and that the intended purpose of the device is able to be carried out.
@ayomide-o Hi Ayomide! I do agree that there is importance in each of the 9 steps of the design process. I do think that while each part has its own value, what would be one that without it, a device would never reach public use? I thought that the design verification process was one that is vital to getting a device through the design process and into the hands of the public. So, with the understanding that all steps are important, which step do you think would be the most vital to the success of a product?
In my opinion, I believe the planning portion is the most important. How you start can determine the how the outcome of your project will. If you have poor planning for the very beginning, the process never stood a chance to be successful in the first place. Strategic and well though out planning can set off the right necessities to make a medical device what it is intended to be in the end. Planning gives the project the initial structure it needs quite literally get the ball rolling, and I personally think you cannot start a project without a solid plan in place.
I feel the design verification is the most important part. Verification of design output is the process of confirming that the output matches the input specifications, including risk analysis. As opposed to design validation, design verification involves tests across all layers of the design process, rather than at the system level. It is important that test equipment is calibrated and controlled in accordance with the quality system requirements for the best results and data accuracy during the design verification process.
Design verification, in my opinion, is the phase that needs the most significant attention after reading and evaluating. It entails developing a verification protocol with tests for each output. It's crucial because, for instance, you might need to do a design verification test if a client keeps complaining to you about your project. It is a fantastic technique to serve your consumers' needs better. This form of quality control is a significant bonus whether you work in the industrial sector or with medical products.
All components within the design control process serve a vital role to the overall product design and delivery. Of all the components involved, I would place the most importance to design verification and customer input. Design verification is where all the magic happens with planning and execution. This is the trial and error process that ultimately leads to the final design protocol and success of the product. Customer input is also an essential piece to this process because it is their opinion and needs that lead the direction of the project. Input from the customer helps the design and development move in a cohesive way to produce what's being asked. I think both the verification tests and customer input work hand-in-hand to create a successful outcome in the pipeline.
I agree that the customer input is the most important part of design controls. This is because to be successful you need the customer to buy the product. To ensure sales it is in the best interest of the company to talk to potential customers and get their opinion. What is a product that you need right now? What features do you like? What features do you not like? With this information, you can create a device that is more likely to be well received in the community you are trying to serve.
@leilani_johnson I agree with you, the verification process is like the rate limiting step of a biochemical reaction. Essentially production can only proceed once this step is passed. If the verification fails often times it could mean starting back over completely which will set the team back months. It could also mean the project gets scrapped all together if it costs enough money.
@ljatta Great observation, I would have to agree with you that customer input is just as important as the verification process. It would be a disaster to spend a ton of money on a perfectly made medical device that no one wants to buy. Customer input tells the team what the need is and the output creates it to see if it indeed works the way it is intended to work.
I'm sure many of you chose the validation process, which is extremely important in design control; however, I think the most important step is customer input. Listening to the customer's wants and needs then use it to create a product for them is one of the reasons why design control is created. How are we supposed to know what to create if we don't know what our customers wants and needs? Consumer input is the reason why we're all in this business in the first place.
