Author: Anne Holland, CEO and Founder
In 2022, 14% of all medical device FDA 483s were attributed to design control delinquencies.
The purpose of medical device design controls is to assure that only safe and effective products reach the market and to reduce the occurrence of FDA 483 observations.
In this article, we will discuss the fundamentals of design controls, medical device company benefits of early implementation and provide tips for getting your design control process started.
What are Design Controls?
Design controls are guidelines and validated practices that medical device manufacturers must adhere to during the planning and development of their products in order to guarantee their suitability for the intended use. In the United States, the Food and Drug Administration (FDA) requires Class II and III medical device manufacturers to prove their product is safe and effective for use.
Design control guidance for medical device manufacturers is outlined in the FDA’s Quality System Regulation (QSR). You can also find an updated overview of FDA design control requirements — published by the agency in March 2023.
The QSR design control guidelines help to ensure that the phases and activities throughout the design control process are appropriately controlled and documented throughout your product’s lifecycle.
Phases of the Medical Device Design Lifecycle
Understanding the various activities of the design control lifecycle is the first step to ensuring compliance and reducing the risk of (or responding to) FDA 483 observations.
Design Planning: Establishment of the Product Requirement Specifications (PRS) and the manufacturing processes that will be used to create the product.
- The PRS, also known as the Product Requirements Document (PRD), is a formal document that typically includes detailed information regarding the product’s features, design specifications, usability criteria, and technical constraints, to name a few.
Design Input: Establishment of the user requirements specification (URS). If you’ve ever purchased an over-the-counter medication, then you’ve opened an insert containing directions for use – this user guidance was written at the URS development stage.
- The URS is a formal document that discusses how the product will be utilized by the end-user.
Design Output: Generation of final design blueprints and acceptance criteria.
Design Review: Does the product design meet the product requirement specifications?
Design Verification: Is the product design functional and does it adhere to user requirement specifications?
Design Validation: Does the final product design meet the minimum QSR design control requirements?
Design Transfer: This involves translating the product design into the manufacturing process in a manner that is reproducible and meets quality specifications.
Generally, the outputs from one stage become the inputs to the next stage however this is not an all-inclusive list of action items. The deliverables for each stage depends on the nature of your product. For example, some devices contain software that require additional verification and validation activities. No matter the product, QSR design controls must be considered throughout the medical device development process.
Insights from our experts:
Some medical device developers may want to substitute testing performed during preliminary research for verification or validation of design requirements so that additional testing is not needed in later stages. However, use of preliminary data is not an accepted practice because it generally lacks traceability and is not representative of the final device.
At a glance, design controls require:
- Testing to a pre-approved protocol with acceptance criteria
- Approval of protocol deviations and/or additions
- Use of validated test methods and qualified test equipment
- Test samples to be equivalent to final design
- A statistically valid sample size
Five Key Indicators of When to Start Design Controls
Research and development of a medical device often takes years of preliminary feasibility studies and false starts before an official project team is formed. It can be confusing to know when to start design controls.
The FDA did not intend design controls to apply to ideation or feasibility studies when the requirements were introduced into the Quality System Regulation (QSR) in 1996. Instead, design controls should begin once it is decided that a design will be developed. Below are five key indicators for when design controls should commence:
- Project charter approval
- Obtaining product development funding
- Formation of a product development team
- Completion of product feasibility studies
- Initial generation of design inputs
Starting the Design Control Process
You’ve determined it is time to start the design control process based on the five indicators above. How can you implement procedures that conform to FDA design control standards? We’ve got you covered:
Start with a comprehensive risk and gap assessment: Develop strategies to mitigate the risks associated with the device’s intended use.
Document everything from start to “finish”: Record all tests, results, and design control actions. This ensures that the product was developed in a systematic and predictable way such that potential issues can be identified and addressed early in development.
Test early and often: Throughout the development process, conduct testing and validation and use the results to inform downstream design control decisions.
Partner with a design control consultant: New medical device companies or those struggling to meet QSR design control regulations should consider working with experienced consultants. Look for partners with expertise and a track record of success in related device technologies to yours, international regulations, human factors engineering, quality management systems, and microbiology assessment.
Establish a Design History File (DHF): This vital document houses your product’s design and development history in its entirety. This includes all stages discussed above and their associated reviews. Having all the necessary documentation and processes in place makes it easier for regulators to assess your device and approve it for commercial use.
By following these actions, developers can assess risk and address potential issues before they become more difficult and costly to fix. The activities above also demonstrate to regulatory agencies that you have taken steps to ensure product safety and efficacy and also help you gain a greater understanding of the device’s intended use, user needs, and user behaviors.
Assign Value to Design Control Review
By now, it should be clear that implementing design controls for your medical device is a sequential process with certain stages having prerequisites. For example, before validation testing occurs, developers must perform verification testing first to ensure that the device design is feasible for use.
Each QSR design control stage should conclude with a detailed review of events conducted by a cross-functional team represented by engineering, quality assurance, regulatory affairs, and other product support departments, such as research and development. Conducting reviews throughout the product development cycle allows you to address issues before proceeding with the next stage of the design process.
Consider using this decision flow chart from the FDA to determine if and when you should move into new stages of the design process:
Source: FDA Inspections Guides – Design Controls
Looking for more expertise to guide you through the stages of the design process? Connect with QA Consulting. Having helped hundreds of medical device companies accelerate product development, remain compliant with regulatory guidelines, and mitigate risk at each stage of the product lifecycle, our experts are ready to help your team.
Things to Consider Beyond Design
We understand that implementing design controls for your novel product can be a daunting task, and although regulatory agencies provide design control guidance for medical device manufacturers, there is still a significant amount of work that goes beyond establishing your official design.
Design transfer, or the transfer of a developed product to a manufactured product, is often not immediately successful, especially for devices with complex designs. An even greater challenge is the design of a complex device that also needs to be sterile. This would involve designing manufacturing processes that are conducted under clean environments (which have their own set of FDA regulations). At the design transfer phase, there is significant potential for nonconformances, especially if your company lacks experienced personnel.
Ready to kick off a design project? Learn how to excel by avoiding common mistakes and consider partnering with an industry expert today! Our consultants have extensive experience in bridging the gap between design blueprints and production. Already have design controls in place, but need to update them to respond to a 483 observation? Lean into our know-how. We can help your team make the necessary adjustments to ensure compliance.
If you need assistance implementing, managing, or updating design controls, please call 512-328-9404 or contact us at info@qaconsultinginc.com.
