Design controls are in their simplest form a way to make sure that the product developed and released is going to meet the user needs and also be safe for the user. The process makes sure that those who are using it are doing each step of the design of the product with the necessary amount of checks in place to ensure that the final product they release will be what they set out to make. Design controls will also allow those using them to prove that their product meets whatever requirements of the country or countries they are releasing the product in. They can be used in the event of an issue to prove that the device was designed in such a way that the risks were mitigated and that the issue is not in the design of the device. These documents are a safety protocol of sorts as they make sure that internal development is done in the proper way and can be checked if needed.
Design control is a key role because it allows us to set a standard of product that you want to be made throughout the process. Also, it helps to bring out in the product development process is risk management. This is a way to take the policies, procedures, and practices to the responsibilities of identifying, analyzing, controlling and monitoring risk. It will monitor the steps that you take in designing and creating your device to ensure that no necessary steps are skipped, that enough time is taken on each step to ensure completeness and accuracy and that everyone is following the same procedure to keep everything regulated. Design control requires medical device manufacturer to keep documents and records during the development phase to make sure design is safe.So, . Without these controls, it is extremely difficult for products to be safe and effective.
As mentioned in other discussions, ensuring an adequate design control would lower the risk of a product failure at any point.
Design Controls, in general, were explained a lot in this discussion, thus I wanted to discuss in particular the Design validation section.
Each medical device would go through a validation process (examination tests) to ensure the design output, results, efficiency, accuracy, etc. This would also check whether the device specifications does meet the intended use needs. FDA has its requirement in the design validation (820.30 (g)).
The main requirements include the following:
"-Each manufacturer shall establish and maintain procedures for validating the device design.
- Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
- Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
- Design validation shall include software validation and risk analysis, where appropriate.
- The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File"
According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Each of these nine parts has their own documentation to go along with it. Each document includes the importance of the project and details related to it. The purpose of the design control is to allow the company to make sure and provide all necessary requirements before launching the product in the market.
Design controls are implemented by the FDA in order to build quality, safety and ethical medical devices. Voluntary recalls in the 80's may have presented if the adequate design system were in place to ensure production of a regulated standard. The most common form of recall performed are due to the nonconforming material/components. Ensuring quality of designs in the beginning steps of designs are maintained generally leads to successful projects.
Design control are intended to demonstrate that a medical device has been designed to address the needs of users and patients. Design input : This define the performance criteria and feature requirement of medical device. Design input are the most time consuming aspect of design control. Design input are directly informed by user needs. Design output: Design output are like a recipe of the device , consisting of all the pares, component, and testing protocols that are needed to create the device.
Design controls are required by the FDA pretty much to ensure the developed device is safe for public use. While the company has to spend resources to create design controls, it also structures the development process and gives the company reduced liability in the case of anyone getting hurt using their product. The validation part of the process is establishing that the device would work for its intended use, while the verification process is the clearance a company needs in court to prove that their device should not be the cause of some accidental injury.
Design controls are mandated by FDA in the year 1996 and defined in FDR 21 CFR 820.30. It monitors the steps in designing and creating the medical device. It demonstrate the medical devices are safe, effective and meet the indications for use. There are nine parts in design controls namely planning, input, output, review, verification, validation, transfer, design changes, design history file. Design controls expects to keep documentation and records throughout the product development process.
Design Controls are a part of 21 CFR part 820.30 which are presently adopted into the ISO 13485:2016 standard to ensure that the device or the even a component that you are making follows the design control process as it is a good coherent design practice. It is a good way to put out a product that does not hurt the people as mentioned in this week's lectures because it is a system consisting of checks and analysis. It is a design built in a way to cut out designs that will fail. The main objective is that you/your company should be the one finding any problem and not your customers bringing up an issue about your product after it's use.
In my opinion, I believe the importance and usefulness of standardized design controls is that it necessitates the project team to question every detail of the project as well as document every aspect of it. In relation to questioning every detail related to the project, I think its added importance is that it requires the project team to thoroughly analyze why each individual aspect of a project has been included. For example, if the project requires the inclusion of a part with certain dimensions, the design controls will require the team to assess how important it is for those specific dimensions to be near a designated value. This will allow the team to assign appropriate tolerance levels to dimensions for testing. Therefore such assessments will help increase the quality level of the end product produced from the project. Furthermore, the requirement to follow design controls also assures that important details related to the project are documented and available to be referenced. Using the prior example again, the design controls will help make sure that if the measured dimension of a part fails that the team cannot just simply change its specifications to make it pass the test. Correspondingly, the ability to reference all important aspects of the project can be useful in finding faults if the product were to fail. Overall, the usefulness of design controls is that it helps ensure the creation of a safe and high quality product for consumers to use.
“Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development.
Open up the discussion about Design Control and also how useful these are?
Design controls are hugely important for several reasons. In the new product development world, many times the design inputs and performance requirements of legacy devices are leveraged when designing new devices. If a legacy device was designed to withstand X amount of load prior to failure, the new device being designed can leverage that performance requirement and the new performance requirement will be that the new device has to withstand at least X amount of load prior to failure. Design controls are also very important in the sustaining world. If non-conformances occur, the design controls ideally would have identified the failure mode and defined the performance requirements associated with it, so no new failure mode would need to be added to the DIOVV/DFMECA/Risk Table which was previously unidentified. Also, often times features are over-defined and over-engineered, so if there are manufacturing issues, you can use the design controls to rationalize the device is still within the FDA-required limits, even if the device doesn't match the engineering drawing.
Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During the planning phase, the project proposal gives management a broad idea of the project scope, demand for the product, timeline, and any testing required. Inputs will be listed in the DID, and the outputs from the DID (such as prototypes and drawings) are part of the DSD. It is crucial to define a spec that has reasonable tolerance in the DID, to prevent failure during the verification protocol. The verification stage consists of the verification protocol and verification report. Tests will be designed in the protocol and performed to ensure that the inputs match the outputs. The results will then be recorded in the report, which will determine if the DSD and product needs to be altered. Even if a product passes verification, it may also need to undergo validation. Since validation can involve clinical testing and physician use to ensure the inputs match user needs, any detrimental risks must be minimized before pursuing this stage. This phase involves validation testing, change request if required, and a validation report detailing any successes and failures encountered during the testing. Design controls are important for ensuring the safety of potential clients, by urging the company to carefully design and thoroughly test the product before releasing it to the market.
Design controls are FDA guideline which you need to follow when you begin creating your device. This guidelines help you understand weather your device is safe to release into the market. It is way easier to follow this guidelines while developing the device because if you don't follow this guidelines then it will be difficult to get approval from FDA and it will cost you time and money to go back.
For any new device, it should be good practice to always have a way to test and minimize errors or risks before the product is sold to customers. It is extremely important to do this before and well. Since once it is in the hands of customers it is extremely to recall the product or to change the functions of the products. For example, the recent news regarding how potentially dangerous vape products has been recently emerging. And I believe, this could have been minimized substantially if each company's had better-outlined design control especially the clinical trials as well. Exspoeiccally scientists and engineers do not necessarily enjoy this task. However, it is extremely important for the customers and also for the future of the engineers developing devices.
Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc which are essential in bringing a device in the market which is safe for use.
Design controls are like a test that a product has to pass to sustain in the market.
