Hi,
Your suggestion that input is the most important part of design control is spot on. This can be conducted before or after the product has been launched in order to have a grasp on user commonalities amongst users. Also, this serves as a method of introducing new concepts to the public on potential products. Without this level of product development, a product's capability to please users will be limited. My question for my classmates is if you believe that consumer input is more valuable beforehand or after a product has been launched?
If I had to choose one, the user's needs would be the most important part of design control. It's why the process is even in place, to prove the device does what it intends to do or solve the user's need. All the other components of the design control are in place to ensure the product is produced correctly, efficiently, safely, and to meet standards.
Every component of design control is significant, and each one relates to others. I believe opinion input and verification are the most important of the nine components of design control. The opinion input represents the idea and the purpose of designing this product. The opinion of the customer is the central theme of the development process. And the verification means the final test of the design control. This will be the last check before producing the product. The company will take this step carefully to avoid the callback after marketing. The FDA will also examine all documents, drawings, and records for public safety.
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 believe the design history file (DHF) of the nine design controls is the most important because it contains all the documents for the whole project. The DHF includes everything about the project, which the FDA can assess to see if everything is correct. Also, all the protocols, notes, research, and minutes worked on the project are included in the DHF; however, the regulatory documents are not included, like the PMAs or 510k's, since the DHF is included in the regulatory documents. So the DHF is the most critical document throughout the design control process since it includes everything. For example, if the product does not work as it is supposed to, one would go to the DHF and see where everything went wrong in creating the device.
I am conflicted between the two most important design controls of customer input/ verification and validation. This is because if the product being made has no customer input and will not be successful on the market, then creating the device and all the steps after it will be useless and a waste of money and time. The other make-or-break design control is verification/validation. If the product need is there but there are problems with the verification and validation, the product could fail when being used or not live up to the claims that the company is making about it. In biomedical engineering especially this puts lives in danger and is morally and ethically wrong. I feel like if these two controls are present and working when the product makes it to the market place, the company can have high confidence that the product will be successful because there is a need and it was tested correctly meeting the expected standards.
I definitely think that Planning is one of the most important aspects in design control. Without making a proper plan for the creation of your device, it can be very easy to miss deadlines and fall behind in your device production. Planning also includes an estimate for the cost of materials, the creation of the prototype and the cost to maintain the animal and clinical trials. Planning is what helps keep the team in check while making sure that the project doesn't go over budget, which could be detrimental to a team depending on if they work in the industry or academics.
As most things we’ve discussed in class, each part of the process is important. But in the case of Design Controls, I feel the most important parts to the process is verification and validation. This feels important because it verifies that the design put into place does what it is intended to do. In a way it proves that the device was built up to standards. Each component would need to be tested to ensure that it is giving the sufficient output for each input. Also by having the different tests to check each specific part, it allows for a better understanding of if something goes wrong it can be easier to pinpoint what conditions could be affecting it.
As we discussed, there are nine design controls listed in 21 CFR 820.30 which include planning, input, output, review, verification, validation, transfer, design changes, and the design history file. As per the prompt, although all nine controls are essential for the development process as well as all phases of the PDCA cycle and other projects such as packaging, production, and distribution, I would say design inputs are the most important step in creating a safe and effective medical device. Design inputs are where the manufacturers establish design requirements that conform to user needs and it is important to do so as clearly as possible to avoid ambiguity or conflicting requirements. Therefore, design inputs serve as a crucial starting point in medical device development since they set the scope and provide a preliminary roadmap for the development process.
While its a tough choice to decide one specific part of the design control process, I think that Design Verification would be the most vital part overall. If we think about it, customer inputs and needs are something that are validated as outputs in this stage, so that is incorporated within this stage although some have seemed that the most important part. Similarly, the verification process also includes the verification report which includes other smaller documents like test results within it, this means documentation, which some have claimed to be the most important part, is also included within the verification stage. Along with meeting customer, regulatory and clinical requirements, this stage also focuses on checking that the full list of inputs is met, this is why I believe verification is the most important part of the design control process.
Like some others have said in this thread, the design control aspect that I feel is the most important is the review/verification portion. This is the part where the design goes under extensive checks to make sure that the inputs are equal to the outputs and it is tested to make sure that it passe whatever you are testing for. Depending on the product, the verification and review tests may look different but they will always have the same end result. It is crucial that these steps are done correctly as they will affect the final outcome of the design and will decide if further changes will need to be made. Certain verification reports and additional testing may still need to be done but those are to ensure that the design is fully ready to be taken to the next step. Any of the results will be added to the DSD and this will allow others to see what happened in the verification process.
I believe that design validation would be the most important part of design controls. While one can be very precise in detailing the design and components of the device, the validation is where the product would be verified. Problems can arise during the production of the device and if those were overlooked, the product could potentially harm the customer. That would therefore put the company in a less than favorable light and would affect the incoming profit.
Design input is the starting point for product design. The requirements which form the design input establish a basis for performing subsequent design tasks and validating the design. Therefore, development of a solid foundation of requirements is the most important design control quality.
The entire product design and delivery depend on each step in the design control process. I'd like to assume that design verification is the most significant of the design controls. The product can be rushed into production without design verification. If a component of the gadget or product has the wrong specs, this could come at a high cost to the product being created. They would have to start the procedure over from scratch, which would be expensive and cost them the product.
I believe the user/customer feedback is the most important aspect in design controls. When companies consider the needs of the customer, it displays the company's willingness to build and maintain their clientele. Oftentimes, the feedback from existing customers may address faults in the product that would possibly be issues for future consumers. By addressing these issues during the design controls, the companies are guaranteed to satisfy their current customers and draw in future consumers.
As stated in the topic, all nine design controls components are integral to the eventual manufacturing and production of a device. That being said, the design development plan (DDP) is one of the most important components as it is the underlying plan for the project and is a living document and thus can be expanded upon and revised as needed. It contains all the information found in the project proposal with more detail and sets the tone and pace for the project going forward. While the verification and validation aspects are very important and the next important components of design controls, they would not be applicable without a well crafted and followed DDP as it is required by the FDA and ISO 13485 to prove a well planned project design.
