What are Design Controls?
“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 control is required by FDA to check the medical device you design and develop is safe to use before you bring the product to market. Design Control is a procedure while developing a medical device to meet with specification requirements as includes
Intended use and design inputs
A design plan
Reviews design throughout the process
Design outputs meet to the design inputs
Entire process must be documented in a DHF.
An interesting standpoint on design control is that they protect against product liability of design defect. Design defect is concerned with claiming the safety of the product is in doubt and that the route taken to design said product, neglected to account for product safety or make a safer design. With the use of design control, specifically design verification and validation, this can be a powerful tool against litigation of claims of product safety.
Design control are interrelated set of practices and procedures that are incorporated into the design and development process.A design control provides a systematic assessment of the design an integral part of development. As a result ,deficiencies in design input requirements, and discrepancies between the proposed design and requirements, are made evident and corrected earlier in the development process. In particle this procedure can save a lot of money .
Design controls are very essential and useful as others have mentioned. They have listed what they are and their benefits, to avoid repetition, I would like to shift the discussion to a key challenge to design control. The process of implementing the design takes a great deal of time. This fact makes companies feel the frustration of the process which sometimes lead to discourage. Some companies when the process becomes heavy, they start following the regulation instead of understanding its intent and main purpose. Therefore, their rush and concentration on following the process makes them oversee the benefits mentioned earlier in this discussion.
Design controls are a component of a comprehensive quality system that covers the life of a device.Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes. Design control does not end with the transfer of a design to production. Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market.
You make an interesting point Lamiaa. It definitely becomes a problem when a company strays away from adhering to their design controls. I am not quite sure what you mean when you say that "when the process becomes heavy, they start following the regulation instead of understanding its intent and main purpose". I hope you can clarify what regulation you are referring to here. Apart from this, I would like to add that this goes hand-in-hand with having a mission statement for the company. If the company deters from the original goal, it starts to become unclear as to what their purpose is. This is why design controls are implemented to make sure companies are keeping track of the products they are putting out in the market and that they are consistent with their original product claims.
It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. If that were the case then they would never create an end product.There must be a point where they decide that the device is safe enough or the most optimal parameters have been chosen where they do not notice that many changes within the medical device. They should be creating a device that can withstand subtle changes without causing other major issues.
It's important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices require that everything be documented or else it didn't happen. Furthermore, change controls require valid justification and cannot just be executed for any purpose.
Medical device regulations are complex, but design controls are the most complex process in any quality system. The reason for this is that each of the seven sub-clauses (Clause 7.3) represents a mini-process In fact, many companies choose to create a separate work instruction for each sub-clause.
Design controls are required by the FDA and are implemented to ensure traceability on released products. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history is traced from raw materials used in the construction of the device to the manufacturing of it. If there is an adjustment within a procedure or process; the adjustment should be noted within the revision of the document. In addition, one of the most important design controls in my opinion are verification and validation, these procedures, although independent, are used together to ensure that a product meets requirements and specification, while fulfilling its intended purpose. Validation incorporates the concept of qualification to establish quality assurance and scientific evidence that the overall process is capable of consistently delivering quality product or performance. Verification, on the other hand, can be a considered a form of quality control in which processes, services or documents conform to specified requirements or regulations, which may also be attributed within Installation qualification, which ensures that equipment that is installed meets all specifications, and is installed correctly, this can be a day to day task, while validation is looked upon as the overall process.
I agree with the responses so far. One of the aspects that I think design controls help 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. Also, with framework is helpful to managing risk and how it is effected in the design process. It all begins during the development process with the design input and as it evolves, new risks arise and are more evident. By keeping track of risk, it is easier for the project team to work on risk mitigation and adjust accordingly to minimize any change cost. An example of this is an exposure control system for a general purpose x-ray system. The control function was allocated to software. Late in the development process, risk analysis of the system uncovered several failure modes that could result in overexposure to the patient. Because the problem was not identified until the design was near completion, an expensive, independent, back-up timer had to be added to monitor exposure times.
thank you for your reply! To clear my statement, I meant that with the long process and amount of time the company needs to invest in the process of design controls and abiding by it, they mostly use it as a set of paperwork to finish and not actually take the benefit of it toward their product. They use it as another step that needs to be done to approve their product. On the other hand, if they really take the time to use every step of it to improve the quality the process won't be as hectic and their product will avoid recalls. Again I am only speaking of some companies that fail to realize the benefit of it.
With my background of mechanical engineering, the process of Design controls for medical device development is very similar to our product design process. The process steps are as follows: define the problem, brainstorm, research and generate ideas, identify criteria, select an approach, model/prototype, test and evaluate, refine, and communicate results. Following this type of process greatly eliminates inefficiencies in the design process. By consistently documenting all steps made, it's very easy to refer back to work and indicate where errors or changes need to be made.
Design Controls to me are basically risk management and safety checks for a company. These allow a company to run through a list of checkpoints before their product is put out on the market to ensure that they have done everything on their part to make sure the device isn't dangerous. As Dr. Simon mentioned in lecture, regulations and bureaucracy can be very tedious and annoying at times, however in this case it is very helpful for all parties involved. It may take some extra time, but to have a procedure to go through to ensure a safe product and limit liability of the company is something that is very valuable
- Saad Ali