By David Jensen, Master Control
The U.S. Food and Drug Administration (FDA) continues to create avenues for medical device companies to get products approved and on the market at a faster pace. Some of the agency’s initiatives include:
- New 510(k) pathway – Regulatory pathway where medical devices get their own final guidances based on device safety and performance criteria.1
- 21st Century Cures Act – Passed in 2016, the Act is designed to help accelerate medical product development and bring new innovations and advances to patients.2
- Breakthrough Devices Program – Voluntary program for medical devices and device-led combination products designed for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.3
While the FDA is making an effort to reduce the regulatory burden on sponsors, devices still need to make the trek through the regulatory pathway to achieve market approval. The road from concept to product release can be long and arduous. Success depends on not only understanding the new product development process but also the FDA submission process.
Effective product development involves coordinating multiple complex systems and processes, including:
- Design control.
- Compliance management.
- Risk analysis and assessment.
- Process validation.
Design approval is more challenging with software-based medical devices because there is a higher risk of defects or functionality discrepancies occurring later in the production process. It’s critical that the delivered software code is capable of enabling the device to meet its intended use requirements.
So, how can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? First, it’s helpful to understand how regulators expect you to develop and implement design controls. Eventually, you need to transfer the product design to manufacturing while continuing to follow regulatory guidelines. In short, you must design for compliance.
Design Control Includes Closer Scrutiny of R&D Data
According to the FDA’s “Design Control Guidance for Medical Device Manufacturers,” medical device design begins with the development and approval of design inputs along with the associated manufacturing processes.
“Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process.”4
Getting a medical device approved and on the market calls for a sustainable process design that is comprehensive and efficient. It should also be based on the complexity and risk-level of the product. Using the 21 CFR Part 820.30 guidelines as a benchmark, the sections below highlight the design control regulations.
Medical device design control requirements specify that all information regarding device design, development, testing, and production needs to be recorded and traceable. Essentially, every syllable of research data, design concepts, storyboards, functional specifications, emails, meeting minutes, and notes scrawled on a whiteboard must be captured in system records that are available to all the stakeholders and inspectors.
Design Development and Planning
Manufacturers should create and document plans that describe or reference the design and development activities and define the responsibility for implementation. During this phase, plan on frequently reviewing, updating, and having stakeholders approve the plans to ensure compliance as the product’s design and development evolves.
Design verification needs to confirm that the design output meets the design input requirements. Design verification results are documented in the design history file (DHF), which includes the design identification, methods, date, and name(s) of the person(s) performing the verification.
The purpose of design validation is to ensure that a device conforms to defined user needs and intended uses. It also includes testing of production units under actual or simulated use conditions. To keep the device’s functionality on track with its initial design requirements, design control needs to involve defensible validation of research and development (R&D) data.
Production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. This means manufacturers need to establish procedures to make sure the device design is correctly translated into production specifications.
A well-known fact of medical-device-design life is that designs will change. Proper change management processes are essential to companies in regulated environments. According to the guidelines, manufacturers need to establish procedures for identifying, documenting, validating, verifying, reviewing, and approving design changes before they are implemented.
What Inspectors Look For
Design control is one of the subsystems of the Quality System Inspection Technique (QSIT), which is a technique implemented by the FDA to improve the efficiency of inspection processes.5
In reviewing product designs, the investigator’s goal is to assess whether the medical device is designed, verified, and validated to meet the users’ requirements, and to find if design changes were developed and evaluated prior to implementation. When evaluating design controls, below are some of the items inspectors need access to:
- DHF, including inputs, outputs, verification, validation, and transfer.
- Design matrix, risk analysis, failure mode and effects analysis (FMEA), design reviews.
- Design changes.
The FDA’s “Guide to Inspections of Quality Systems” serves as a guidance for FDA staff when performing inspections. To get an idea of what to prepare for, below are excerpts from the guide that apply to design control:6
- Use the firm's design plan as a road map for the selected design project.
- If the project involves a device that contains software, consider reviewing the software's validation while proceeding through the assessment of the firm's design control system.
- Evaluate the firm's risk analysis while proceeding through the assessment of the firm's design control system. Risk analysis should be addressed in the design plan and risk should be considered throughout the design process.
- Verification and validation activities should be predictive. Acceptance criteria must be stated up front. Review the documentation associated with samples of both verification and validation activities.
- Determine if design reviews were conducted. Design reviews should provide feedback to designers on existing or emerging problems, assess the progress of the design, and confirm the design is ready to move to the next phase of development. Reviews should focus on the ability to produce the design and whether the design meets the input requirements.
- Determine if the design was correctly transferred. The transfer process must be a part of the design and implementation plan. Production specifications typically consist of written documents such as assembly drawings, inspection and test specifications, and manufacturing instructions. It is not uncommon for the design to be transferred in phases.
Common Design Control Violations
Structured and well-documented design controls, as well as process automation, foster good design and engineering practices that result in producing high-quality products. This is important when navigating the pathway to regulatory compliance because design issues can overlap into other areas. To help avoid potential obstacles in product development, below are a few violations observed during design control inspections:7
- Design changes lack or have inadequate procedures.
- Design validation risk analysis is inadequate or not performed.
- Not using a risk-based approach with design reviews.
- Lack of adequate procedures or documentation proving that the design outputs meet the design inputs.
Developing a product design strategy that aligns with regulatory compliance guidelines yields many benefits and competitive advantages. The assurance of a quality product from the beginning results in faster cycle times and a more streamlined, successful submission process. Ultimately, it improves your chances for compliance and a successful product release.
- “FDA Issues First Final Guidances on New 510(k) Pathway,” FDA News, Aug. 19, 2020.
- “21st Century Cures Act: Implementation Update,” Thomas Sullivan, Policy & Medicine, Feb. 17, 2019.
- “Breakthrough Devices Program,” U.S. Food and Drug Administration, Jan. 5, 2021.
- “Design Control Guidance for Medical Device Manufacturers,” U.S. Food and Drug Administration Guidance Document, Mar. 1997.
- “QSIT: The New Quality System Inspection Technique,” Timothy R. Wells, Medical Device and Diagnostic Industry (MD+DI), Oct. 1, 1999.
- “Guide to Inspections of Quality Systems,” U.S. Food and Drug Administration, Aug. 1999.
- “Top 10 Findings from a Warning Letter Analysis,” Linda Braddon, Orthopedic Design & Technology, Nov. 30, 2018.
David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.