There has been much offered so far to answer the question "What are Design Controls".
Working at a medical device company fory several years i would like to offer what i observed from my experience. Not necessarily a definitive answer but more of an attempt to share how i encountered it in my work.
To understand what are Design Controls it may helpful if we ask a related question: "What problem are design controls meant to solve?" This question may bring us a step closer in answer the question "What are Design Controls". Since it puts us in a position to consider what problem arises in the process of design. It is the process of creation that really causes a problem.
To be clear but risk redundancy, when designing a thing it follows that the thing does not already exist. Also the path to the things creation is not clearly known. Design controls are a way of documenting design from its inception to its realization. Because design is inherently a creative endeavor, it often lacks a specified order, and boundary. Design control seeks to add order and definitive form to the fluid process of creation so as to provide a benchmark. A benchmark permits design activities to be measured.
Its like the old scientific method which had specific steps: 1 hypothesis, 2 experiment 3 observation etc.
Do design controls is a way to formalize creation activities.
Formalization then permits many of other activities to be performed on the created thing, the design output. Such as reproducibility, verification, appropriate modification, accountability etc.
Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries. One of the aspects that I think design controls help to bring out in the product development process is risk management. By keeping track the risks, it is easier for the project team to work on risk mitigation and adjust accordingly to minimize any change cost.
Design controls were made so that companies have documentation for every step of their design process, and so that these documents can be reviewed to consistently find any design and technical errors. This saves companies from any flaws in their products. The FDA was actually the group which forced these documents to be produced by companies for the purpose of ensuring that companies collect substantial clinical data before releasing a device, and also confirms the safety of that device within the design itself.
Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. A high-level overview of these design control requirements is provided to increase awareness of the device development process and provide a basis for mutual understanding for continued dialogue with end users. Design control requirements were established by the US Food and Drug Administration (FDA) as an element of the QSR in 1996. Device manufacturers are required to have a quality management system (QMS) to ensure their devices are safe and effective. The QMS is established by writing operating procedures to achieve consistent application of the methods used to control quality and comply with regulatory requirements. The FDA has the responsibility to audit device manufacturers for compliance with the regulation. The requirements of the QSR and the resulting device design control procedures lend themselves to what is commonly known as the waterfall development process. This iterative process results in documented evidence that is defined in the QSR as the Design History File. This record of development is essential for managing the product life cycle. The elements and purpose of the design control process will be presented to illuminate today's development environment.
Design controls will have all the nine parts mentioned in the lecture, planning, input, output, review, verification, validation, transfer, design changes, design history file. Design controls help companies release harmless and useful device because as you follow through all the nine parts of design controls you will be making changes to your designs, tests, inputs, output, and ect. so you release good product. After you are done with design controls you will have everything you will need in order to manufacture your product after design transfer stage is completed. Design controls documents allows you to go back and track what you did for your project so if someone has problem with your device then you will have all the files from PDF to design transfer.
Design controls are a set of quality practices and procedures required by the FDA during the design process. They are established per 21 CFR 820.30. These processes are in place to make sure user needs are met, the product functions as it is intended to, and that the product meets specific requirements for safety. This process can catch issues and improve on them before a product is released on the market. This prevents putting users at risk and reduces the number of recalls for products. The Safe Medical Devices Act required design controls to be a part of common good manufacturing practices.
Design controls consist of design planning, design input, design output, design review, design verification, design validation, risk analysis, and design transfer. Design controls also have a role in premarket and postmarket device development. These include design changes that would improve a product or are necessary due to defects identified by quality testing. Following the production of a product, a design history file (DHF) containing all documents relating to the product.
The design control regulations implemented by the Food & Drug Administration (FDA) provide a cogent process for the myriad of components that go into medical device development. It is a godsend to both novice and experienced entrepreneur. The steps involved in design controls (Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, Design History) and the implementation of the Design Development Plan (DDP) mimic the project management (PMP) guidelines in many ways.
Moreover, the principles of design controls are effective that they are being adopted universally worldwide. Design controls add clarity and simplicity to a very complex enterprise. What also cannot be overlooked is how these regulations contribute to consumer safety by facilitating the development of products that have been thoroughly vetted and tested for reliability. Their manufacturing processes have been refined and the final product also meets certain standards.
Design controls are an elemental piece of getting a well-thought out idea on a piece of paper to a manufactured reality. Design controls include nine parts: planning, input, output, review, verification, validation, transfer, design changes and the design history file. Although legal requirements in terms of FDA regulation allow these to be a fairly general, if used to their best ability, can be a useful tool in determining if your current design fulfills its intended use, how to test for this, and eventually how to produce a final product that is sustaining. And of course, most importantly in my opinion, how to document everything associated with this project. Documentation is key in practice because it will be what is presented to regulatory bodies that come in to do an audit, and if not done correctly, could such down production and sales all together. Design controls can additionally be useful in updating current design methods to improve the product, and continue to be functionally efficient compared to competitors on the market.
My view of design controls is to provide a complete product lifecycle to medical devices. In the early stages of project definition to the ultimate regulatory approval and post market surveillance, we need to fully understand reasons for change and how the project team which members will change over time got to that point. During the lifecycle many decisions are made based upon information and the sequence of documentation helps everyone understand the logic. Wokring on several older drug products with little documentation, it is hard in some cases why the formulation was made. Retrospective evaluation is limited so applying this to medical devices having design controls really helps all functional groups to support the product lifecycle.
Design Controls are pre-marketing assaying methods, which were created by FDA in 1996. The design controls duration starts with the project initiation until the final product is tested properly. Design Controls areas involve design of planning, input, output, review, verification, validation, and transfer. In my opinion, the design output and verification play a significant role in design controls because I think that ensuring of output match the design requirement is most important function in design controls.
There are many constraints in the development of medical products and devices. Identification of these constraints is important, and there is a procedure to follow named design controls. For medical devices, design control is needed from the Food and Drug Administration (FDA) for class 1 and all class 2 and class 3 medical devices. Basically it explains what the device does, its intended uses and, specific requirements for the device. Medical device manufacturers mostly need this procedure to create new or alternative devices and products to be used within the health industry.
To make this simple, design control makes sure that there's a plan set by the company or manufacturer that has to be implemented and makes sure all requirements are met during development. By doing so, design control protects patients from all possible flaws which could lead to patient risks. It basically ensures that the device or product has a blueprint for safety etc. It will definitely improve efficiency and productivity of the product through all the necessary steps that need to be taken.
Design controls are the means a medical device developer uses to prove that a product is safe, it works, and it is suited to the needs of the market. The following are points that justified by design control that the medical device meets a valid user need, is this medical device is safe and is the medical device and its production process meet regulatory requirements.
Design Controls are a set of quality practices and procedures
Control the design process to assure that the
the device meets: User needs, Intended uses, Specified requirements
They can improve and prevent future issues.
Design controls apply to:
– All Class II and Class III medical devices
– Only these Class I medical devices:
- Devices automated with computer software
- Tracheobronchial suction catheters
- Surgeon's gloves
- Protective restraints
- A manual radionuclide applicator system
- Radionuclide teletherapy source
Design control is a systematic process with a range of activities that will guarantee the product development and meets the regulation requirements with a number of key elements. It is about planning, design execution, testing against the specifications and requirements, and uncovering and fixing problems at an early stage to reduce the risk. It is very important for any organization to plan and organize team action and documentation for all the activities. For every project it is good practice to have a planning, review and approval system with proper documentation in place for the whole team.
