Design Control is a set of methods used during the development and production of medical devices to ensure that device designs are safe and effective. Design control includes design planning, verification, validation, and many other steps that continue through production. These processes ensure that any flaws in the design are corrected before they reach the hands of the consumer. Among many other benefits, design control ensures safety for the consumer and reduces liability issues for the producer. Many countries use design control to ensure their products. Although specific regulations and standards vary from country to country and even company to company, there are many similarities found in the methods used.
@delany using the concept of checks and balances in the legal system to explain design control is great! It's even more interesting when you consider the cons that sometimes come from checks and balances in the legal system. Do you think that there are cons of design control? If so, what are they?
@naglaa-hemida Wow! This is information that I haven't found while researching design control. Thank you for sharing. Considering that flaws with the process of the procedure could make the product falsely appear to be flawed, how did you differentiate between flaws with the actual product versus flaws in the process of the procedure?
“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 designate the application of a formal methodology to the conduct of product development activities. Essentially, design controls are guidelines set by the FDA that the manufacturers have to follow when making a medical product or device. Design controls are useful because they assure that a plan has been made and will be implemented by the company or manufacturer, and that ensures that all the final requirements for this design will be met.
Proper design controls are needed due to the most frequent causes of recalls being from issues related to design. Design controls are a set of qualities and procedures set forth by the FDA to ensure the medical device meets user needs, intended uses, and specified requirements. Also, having these set of qualities and procedures can improve the product and prevent future issues. The FDA's CFR 820.30 applies to all Class II and Class III medical devices and only specific medical devices in Class I like protective restraints, surgeon's gloves, and devices automated with computer software among others.
The purpose of design control is to make sure that a plan has been made to be implemented by the company and manufacturer that ensures that all final requirements of the design are met during the process and development. Design control includes: General, Planning for design and development, Design input, Design output, Design review, Design verification, Design validation, Design transfer, Design Changes, Design history file (DHF).
Design controls gives a precise idea to FDA as it has to go through the process of controlling over the development, review and documentation which could lead to patient risk if lacking
In this week's lecture, Dr. Simon explained how design controls are regulations that talk about how a medical device company needs to go through a specific way of planning and executing a medical device project. These regulations were introduced in 1996 a part of 21 CFR Part 820. As such, 21 CFR Part 820.30 is important to ensure medical device companies are design projects in a safe and efficacious way. Later on the International Standards Organization adopted these same regulations and medical device companies all around the world began following the same standards. As a result it became easier to understand how medical device companies create projects around the world. What are some benefits of global harmonization of standards?
Design control means a specific way of planning and executing medical devices or projects. It's a combination or sum of laws. There are different parts of the design process. Each part can have detailed documentation or multiple portions can be combined into a single document. It really varies from company to company. Basically to output a quality device through a coherent process design control is necessary. Since standards are pretty much the same all over the world nowadays, maintaining design control documents is a must for multinational medical device companies.
The FDA mandates design controls, which are used to assure traceability of issued products. The notion is that if a released product has a flaw that interferes with its operation and has an impact on the consumer, the entire history of the gadget can be traced from the raw materials used in its creation through its production. If a method or process is changed, the change should be acknowledged in the document's revision. In addition, verification and validation are, in my opinion, two of the most critical design controls. These procedures, while separate, are utilized together to ensure that a product meets requirements and specifications while also performing its intended function. Validation combines the notion of qualification with scientific evidence to establish quality assurance and scientific proof that the overall process is capable of consistently delivering high-quality products or services. Verification, on the other hand, is a type of quality control in which processes, services, or documents comply with specified requirements or regulations; this can also be attributed to Installation qualification, which ensures that equipment is installed correctly and meets all specifications; this can be a day-to-day task, whereas validation is considered the overall process.
Design Controls are required to improve product quality and help companies avoid manufacturing defects that can lead to recalls or other significant issues. Complying with the requirements fully can prevent recalls and other regulatory enforcement actions. In order to avoid recalls and warning letters a strong design control system is needed. Design Controls provide a structure for ensuring that device design and development is completed in a highly controlled manner, and each design step is planned before being executed and that the execution is verified. Design Controls also ensure that a cross-functional approach is taken to the design process so that additional viewpoints are considered and potential roadblocks are realized early (Kelderman 2022).
Kelderman, E. (2022, March 30). Everything you need to know about design controls for medical devices. #1 Cloud-based Quality Management Software for MedDevice & Pharma. Retrieved April 7, 2023, from https://www.qualio.com/blog/design-controls
The FDA requires design controls to facilitate a structured design and development process for medical devices. There are numerous checkpoints in place to ensure that the device is safe and effective when it is released to the public. Compliance with Design Controls is required if you manufacture medical devices. Design Controls help organizations achieve five critical goals in the world of medical devices and SaMD solutions: Produce high-quality goods, ensure the safety of the user, ensure regulatory compliance, reduce your expenses, and reduce time to market. Design controls provide a framework for ensuring that device design and development are carried out in a highly controlled manner. This means that each design step is planned before it is carried out, and the execution is verified. Design controls also ensure that the design process is approached cross-functionally, so that additional perspectives are considered and potential roadblocks are identified early. Finally, organizations use these controls to ensure that their design processes deliver safe and effective products to market.
I work at a medical device company and it is interesting to see design controls being used in the real world. I had to read a multitude of SOPs to better understand the importance of design controls when it came to creating protocols for verification of assays and softwares. That is where I see the importance, it creates a streamline process to better execute the expected results. It makes sure all avenues are covered and whatever is being tested is safe for public use
The design control subsystem's goal is to regulate the design process so that devices are created to fulfill user wants, planned purposes, and predetermined specifications. Understanding design control requirements is essential, especially when selling to the US, where design control requirements are a legal requirement for medical products. It is equally true to suggest that market access is impossible without design control.
In other areas where design control standards are not required, you would still find businesses adhering to these principles because they understand the ideals behind them. The design control criteria also represent best practices in producing new products. Whatever business you work in, it's critical to comprehend the lingo, and medical device product development is no exception. Even while many concepts are similar across other product development industries and the world of medical devices, there are two aspects that are fundamentally different. The first is that things have distinct names and definitions, and the second is that risk management and safety are obsessions.
Design controls are practices required by the FDA to facilitate a structure design and development process for medical devices. There are many checkpoints put in place to ensure the device is safe and effective when its taken in the market. It is listed in an FDA document ISO 13485 it helps companies establish a QMS where they can prove that they are designing a product according to plan and that they have controls over the R&D and manufacturing processes. They are the formal processes mandated by the US medical device regulation FDA 21 CFR 820 and the Quality standard ISO 13485:2016.
So many great points on why Design Control is important to have been shared. Simply put, Design Control assists with the assurance of the safety and effectiveness of medical devices. When there are issues concerning the quality system, investigators look specifically at the design controls. Many countries/regions take design control very seriously, for example, the U.S. commands a strong design control system that expects human factors analysis in the design input, verification, and validation. They also want to see summary reports, certificates, and protocols included in the technical documentation.
