Untangle Medical Device Development with Design Control Software
May 21, 2024
Medical device creators and manufacturers have a lot on their plate. Not only are they creating potentially life-altering equipment, they are working in an industry where safety and attention to detail are paramount.
In 2023, one of the greatest number of U.S. Food and Drug Administration (FDA) warning letters issued for medical devices related to deficiencies in design controls. Design control software can help you avoid potentially costly mistakes that result from inadequate design controls, incorporating all the elements you need to not only successfully meet design control requirements, but create efficiencies that save time and money.
This article provides an overview of design control software and the best practices for creating an effective and value-added design control environment.
Design control and design control software
Design controls are quality and regulatory requirements that are incorporated into the product design and development process to ensure that a medical device is safe, effective and appropriate for its intended use. Medical device manufacturers must demonstrate functional design control to be able to bring their product to market.
Design control software provides an automated framework for organizing the series of tasks and documentation needed to satisfy design control requirements. Design control software creates efficiencies in the process and facilitates collaboration among the cross-functional teams involved in device development. Design control software serves as the central hub for coordinating and documenting every phase of the design process, from initial concept to final product release.
Regulatory requirements and design control software
The FDA regulation 21 CFR Part 820 mandates that medical device manufacturers adhere to a methodical, comprehensive design control process. The International Organization for Standardization’s ISO 13485: 2016 standard, closely reflects the FDA’s requirements, emphasizing the importance of implementing design controls and addressing potential risks throughout a device’s lifecycle.
Both FDA 21 CFR 820 and ISO 13485 require manufacturers to establish a systematic process that includes detailed planning, testing, reviewing and documentation. Design inputs must reflect user needs, and each step in the design process must be continually measured against design requirements.
The design control process
Once user needs are defined and documented, the design control process can be broken down into the following steps:
- Design and development planning
- Design input
- Design output
- Design review
- Design verification
- Design validation
- Design transfer
- Design changes
- Design History File (DHF)
Planning
During this phase, detailed plans for how you will design and develop your device are created. This involves outlining the steps to be taken and in what order, and assigning responsible parties to each step. Design plans must be documented and documentation made readily available, with a system in place for tracking changes and ensuring use of the most up-to-date documentation.
Design Inputs
Design inputs is one of the most important phases of design control and should be given thorough attention. Medical device designers must define what the device will do for the end user and how it will work, including how it might integrate with other systems. Input requirements must be documented, reviewed and signed off on by a designated authority.
Design Outputs
Design outputs are the result of the planning and inputs phases, usually in the form of a model or related documentation, such as drawings or engineering plans. Outputs must be specific enough for a manufacturer to use in production. Output documentation is also subject to review and approval with signature by a designated authority necessary.
Design Review
This is a formal review of the device’s design that involves “representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility,” plus any necessary specialists. The goal is to ensure that the design and design plan are viable. All data from the design review, including results and participants, must be documented and included in the DHF.
Verification
Design verification involves testing device components to ensure design output meets design input requirements. Results, dates and reviewers identification are documented and included in the DHF.
Validation
The design validation phase ensures that produced devices conform to defined user needs and intended uses. Validation involves testing of initial devices under actual or simulated conditions, and include packaging, transportation and storage. Any problems are evaluated and addressed.
Design Transfer
The design transfer phase requires device manufacturers to develop and then maintain procedures to ensure that appropriate specifications are provided to all parties involved in producing the device.
Design Changes
Procedures must be established for tracking any changes that are necessary to make to the design, including documentation, validation, review and approval of changes prior to implementation.
Design History File
A Design History File must be established for each type of device a company manufactures. The DHF contains all of the documentation from each design phase or an index describing where those files can be found. The DHF is proof that the device was developed in accordance with the approved design plans.
How does design control software assist with the design process?
Design control software provides a structured framework that can address the more tedious aspects of medical device design, helping ensure compliance and freeing up engineers and manufacturers to focus on more productive activities.
Integrating design controls with quality management functions affords a host of features that help manage the intricate processes of design control. Some of the major features of design control software within a QMS include:
Automated Document Management
Automated document control is by far the most useful feature of design control software. Documents are centralized and can be easily shared for review and approval, with revision-level controls and built-in electronic signatures. DHFs are easily maintained and updated. Reviewers can be pre-assigned and electronically notified when documents change or training is required. QT9 QMS’s document control module offers read-only links that can be shared with customers, suppliers and employees that enable them to view documents securely.
Change Control
Change control applications provide a system for initiating, managing and tracking the change process and offer simplified transparency. Change control and design control applications can be integrated so that actions created and addressed in the change control process are automatically captured and documented for your DHF.
Risk Management
Structured risk management systems can easily link with design control applications for verifiable proof that a manufacturer has appropriately evaluated and taken steps to mitigate any potential or unforeseen risks in the product design and development plan.
Identifying and mitigating risks early in the design process can be critical to preventing costly errors and ensuring patient safety. Design control software facilitates comprehensive risk management by providing tools for risk assessment, analysis and mitigation.
Supplier Management
Supplier management applications assist in ensuring suppliers are appropriately qualified for their role in the manufacturing process and provide a traceable system for tracking supplier inputs and activities.
Benefits of design control software
Utilizing design control software in your medical device development offers an array of transformative benefits that pave the way to bringing your device to market.
Save Time and Money
Design control software streamlines the entire product development lifecycle, from conception to release. By automating documentation tasks, facilitating reviews and collaboration, and providing real-time visibility into project status, device manufacturers can gain efficiencies that significantly reduce the amount of time and effort required to bring a medical device to market.
Enhance Traceability
Automating documentation and integrating quality applications into your design controls establishes and simplifies traceability among the various phases of the design process. This ensures that changes, revisions and updates are documented and tracked systematically, and provides a clear path for regulatory submissions and audits.
Collaborate More Easily
With a regulatory mandate to involve diverse teams in the product design process, effective collaboration between these teams is important. Design control software acts as a centralized platform where engineers, quality and regulatory experts and other stakeholders can share insights and align efforts. Features such as document sharing, task assignment and real-time communication tools, foster efficiency, synergy and drive innovation.
Regulatory Readiness
Design control software alleviates the burden of regulatory compliance by integrating built-in templates, workflows and audit trails aligned with FDA and ISO regulations. By automating compliance processes and documentation, it ensures that companies adhere to regulatory requirements throughout the design and development phases. This proactive approach not only minimizes the risk of regulatory setbacks but also instills confidence among stakeholders and customers in the safety and quality of the final product.
Real-Time Data
Design control software empowers companies through access to real-time data, analytics and insights that enable informed decision-making at every stage of the design process. By aggregating and analyzing data from various sources, including design inputs, test results and customer feedback, design control software can provide stakeholders with valuable insights into product performance, market trends and customer preferences. Armed with this actionable intelligence, companies can make data-driven decisions that optimize product design, mitigate risks and maximize market success.
Summary
Adopting design control software, especially as part of a total QMS, will help you improve efficiency, ensure compliance and bring innovative products to market more quickly. Automating and streamlining the intricate processes involved in design control, enables you to more easily meet FDA and ISO requirements, while fostering a culture of quality and collaboration. More than ever, success in the medical device industry requires the ability to maintain high quality and regulatory standards in the most efficient and cost-effective way possible. Investing in design control and quality management software makes it considerably easier to reach these goals.
