Design controls are an integral component of a comprehensive quality system that covers the life of a device. The assurance process includes a total systems approach from the development of device requirements through design, production, distribution, use, maintenance, and, eventually, obsolescence. Design control starts with the development and approval of design inputs and includes designing a device and the associated manufacturing processes. Design control focuses on all aspects of designing a product and the implementation of the design. Some of the tools and techniques that can be used are described in the guidance. Although aspects of their utility are sometimes described, they are only included in the guidance for illustrative purposes.
Design control for medical devices are focused on:
- Addressing the needs of users and patients
- Meeting design inputs and requirements
- Meeting necessary applicable standards
- Performance criteria
Overview on Design Control for Medical Devices
The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is considered relevant for all devices which can be automated using a software. The purpose of design control for medical devices is to keep patient and user risk low without compromising the integrity of the product manufactured. FDA marked three classes of medical devices, namely Classes I, II, and III, based on product’s use, use indications, and level of risk. This process includes layers of documentation that show the FDA how manufacturers have provided for the new device’s safety and efficacy.
Some of the medical devices listed under Class I include
- Devices that are automated with computer software
- Medical devices such as tracheobronchial suction catheter
- Medical gears such as surgeon’s gloves, protective restraints
While focusing on design control for medical devices, design input plays a significant role. Some examples of design input include human factors, environmental limits, device functions, safety, reliability, sterilization, regulatory requirements, performance, labelling and packaging, maintenance, and device compatibility. The design control process helps medical device manufacturers follow a set of practices and procedure to
- Meet and manage quality
- Every product meets quality and safety requirements
- Prevent recalls in the future
Benefits of Design Control
The focus of design control is predominantly centered around the type of device, software used, materials required, and manufacturing process. Simply put, design control is focused on design input and output.
The purpose of design control is to ensure that a design plan laid out is met by the manufacturer during the process and development. The guidance applies to the design of medical devices and the design of its associated manufacturing processes. The design control guidance is applicable to both new designs and improvements or modifications to existing device designs. Design control allows the FDA to have better control over development, and review to prevent patient risk. The elements of design control includes:
- Design and development plan
- Design input
- Design output
- Design review
- Design verification
- Design validation
- Design transfer
- Design Changes
- Design history file (DHF)
DHF is a critical document for the device manufacturer. Some of the points to consider while maintaining DHF mentioned below.
- Keep DHF as a standalone file from main project file
- Keep DHF organized and accessible
- Ensure links between all design controls are recorded accurately
By establishing a proper design control structure, manufacturers can reap the following benefits –
Helps review the quality of a design
Ensures that the product is built to its requirements
Guarantees the customer that the product is safe, effective, and suitable for the intended use
Improves time-to-market by minimizing the time spent on rework and corrective actions
Creates traceability between design inputs and output
Facilitates a path for further development by creating the need to maintain a set of comprehensive documentation and records
What are the two types of design control models?
FDA 21 CFR 820.30 stipulates the guidelines for design control for medical devices. Applicable to medical device manufacturers, design controls are used in the medical device development process. There are two main types of design controls that can be used as elaborated below –
The waterfall model follows a logical sequence of phases or stages. The model follows a traditional or linear approach that begins with requirements and moves to design implementation. In this method, the requirements are developed and a device is designed to meet those requirements. Upon completion, the design is then evaluated, transferred to production, and the device is finally manufactured. In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development. The waterfall method is considered a useful tool to introduce design control. It is applicable to manufacturers focused on developing simpler devices.
A concurrent engineering model involves both production and service personnel throughout the design process, assuring the mutual optimization of a device’s characteristics and its related processes. It helps organisations focused on simultaneous development and promotes changes. This model takes a more evolutionary approach to design. While concurrent engineering’s primary motivations are shorter development time and reduced production cost, the practical result is often improved product quality.
CQ for Design Control
A robust quality management software (QMS) allows medical device manufacturers to create documentary evidence supporting the defined, controlled product design and medical device development process. ComplianceQuest’s Key Solutions take cognizance of the regulatory and competitive environment where quality, cost, compliance, and customer relationship are the key determinants of success. The key components are also modular, allowing the business to choose to implement any based on their business goals and priorities. CQ’s EQMS supports design control with a range of features.
The CQ Risk Management Software offers unique AI and analytics capabilities to spot potential risks based on history and trending data along with key metrics. With embedded intelligence, quality and risk management leaders can proactively start their risk mitigation efforts before it becomes a major challenge. Drive strategic decisions on potential threats with the solution that is aligned with the latest standards (ISO 31000, ISO 14971, ICH Q9 and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001 and ISO 14001) to help accelerate assessments, identify and analyze risk trends and drive risk mitigation activities. Identify the right approaches that contribute to process efficiency, improved risk management and internal controls with our risk framework.
Create, schedule, and manage audit programs using the calendar view available in the CQ Audit Management Software. The software also facilitates collaboration between stakeholders during the different stages of an audit and helps the enterprise build a QMS workflow that is data-driven and enables Continuous Improvement (CI). CQ’s Audit Checklist feature helps quality leaders “know their gaps,” take preventive action and, overall, stay compliant with all regulations.
With CQ Document Management, organizations can manage their entire document lifecycle, gain complete visibility and rely on a single source across all locations for more effective decision making. The solution offers an electronic approach to document management across the enterprise. Organisations will have a central repository to create, modify, review, approve, store, organize, access and share documents globally in a controlled manner.
CQ CAPA management solution uses predictive analytics and intelligence to identify the right issues to solve. With CQ CAPA Management Software, manufacturers can identify and initiate a corrective and/or preventive action process, detect trends, conduct or link to an existing investigation and root cause analysis (RCA), define action plans to change or improve, and ensure effectiveness checks with a structured verification and closure. The solution supports various methodologies like 8D, 5W-2H, and World Class Manufacturing (WCM).
Design Control Guidelines
Design controls are applicable for the development process of all products. As changes are part of a continuous, ongoing effort to design and develop a device, design control does not end with transferring a design to production. To that end, design control has a continued role through both premarket and postmarket development. It applies to all changes, including those occurring long after a device has been introduced to the market, such as
Evolutionary changes, including performance enhancements
Revolutionary changes such as corrective actions resulting from the analysis of failed product
Some tools and techniques for design control are described in the guidance. As a manufacturer applies design controls to a particular task, the appropriate tools and techniques can be used by competent personnel to meet the needs of the unique product or process specific to the manufacturer.
Frequently Asked Questions
What are the areas which should be focused on while introducing design control?
Design controls provide improved visibility on the design process to both managers and designers through improved communications and coordination among all participants. As a result, managers are empowered to direct the design process more effectively as there is a better chance to recognize problems, make necessary corrections, or adjust resource allocations as needed. Designers also benefit as there is enhanced understanding of the degree of conformance of a design to user and patient needs. Senior management should ensure that internal policies are established for design issues such as:
- evaluation of the design process
- assessing new product ideas
- training and retraining of design managers and design staff
- use of consultants
- patenting or other means of design protection
- product evaluation, including third-party product certification and approvals
The senior management must ensure that the necessary resources are available to carry out the design within the required time. This involves reinforcing the skills and equipment available internally and/or obtaining external resources.
How can CQ’s Document Management Solution help with traceability?
What are some of the best practices for implementing design control?
Design controls are a set of interrelated procedures incorporated into the design and development process. It is a systematic way to track the process of medical device development. To effectively improve the chances of moving a design from planning to pro stage, follow these simple design control practices.
- Meet all design control regulatory requirements as regulated by FDA 21 CFR 820.30
- Incorporate cross functional teams to help design devices
- Ensure all design control addresses the stipulated user needs, meets the use of the device, and has all appropriate specifications defined
- Leverage design control to manufacture medical devices that are cost effective, highest quality, safe for use, and effective to meet the needs of the user