Design Controls across the Product Development Lifecycle
The product development lifecycle typically covers:
A Design Controls traceability matrix becomes crucial for the product development teams to understand the relationship and linkages between all these aspects of the development cycle.
The design control traceability matrix is an industry best practice that provides a high-level view of the flow of medical device product development from start to finish. It is also a requirement in ISO 13485:2016.
While in the initial stages, a traceability matrix might be maintained in manual tools such as Excel. But as the complexity increases, it can become impossible to track. Using an automated, cloud-based solution such as ComplianceQuest can improve speed, efficiency, and reduce risk.
#1 - Capturing User Needs
Before the development of a medical device, it is essential to define two key factors:
The intended use or function of the product – this should be specific.
Indications for use describing the disease or condition for which the device will be used. It could be to diagnose, treat, prevent, cure, or mitigate the disease. The target patient population should also be established.
This requires an understanding of the User Needs, which should be documented along with how the medical device under development is going to be used. To help you better understand User Needs, you need to answer questions such as:
What is the intended purpose of the device?
Who are the target audience?
When will it be used?
The important features and attributes it should have to meet the objectives
The possible interaction between the users and the device
The procedures for which the device will be used, and so on.
The answers form the foundation for development of the product as they help understand User Needs and are part of Design Controls. Once the User Needs are documented, the next step is to formalize the Design Inputs.
#2 - Design Inputs
Design Inputs can be understood as the specifications that establish the features and the performance criteria of the device. Design Inputs are derived from User Needs, which can be subjective and abstract. So Design Inputs must be drawn out and converted into be objective and measurable specifications. They should also take into account industry standards, competitive products, and regulations and take into consideration factors such as:
Is there a team that should help with defining the Design Inputs?
Should there be a hierarchy of Design Inputs?
What is the complexity of the medical device being developed?
Is it a SaMD or also includes mechanical and hardware components?
The clarity emerging from these questions will improve the process of establishing the design inputs.
#3 - Design Output
Design Outputs determine what the product will eventually be, containing granular details about all the components and subsystems that will go into the making of the product. Drawings, specifications, and instructions are the components that make up the design output. This should demonstrably link back to design inputs and is the Device Master Record for the product.
#4 - Design Verification
Design Verification helps to verify whether the medical device meets design inputs. Design Verification is a vital step in the process, but it can be expensive and time consuming. Therefore, having a clear-cut plan with specified budgets for time and cost is crucial. So it is important to:
Create a plan for design verification.
Identify the process to establish the link between Design Outputs and Design Inputs.
Document the results after completing Design Verification
Update the traceability matrix.
#5 - Design Validation
While Design Verification establishes the correctness of the design of the medical device, Design Validation proves that the correct medical device has been designed. In other words, it establishes that the medical device meets user inputs and that it will meet intended uses and indications of use.
#6 - Design Reviews
Design Reviews should be conducted periodically throughout the design process. These meetings help in identifying gaps and correcting them in a timely manner to prevent more costly corrections later. Design controls should also be a part of the Design Review. While the number of design reviews may vary from product to product, a final design review must be conducted before moving on to the next phase of the design and development process. Once the design has been finalized after the design validation stage, the design transfer to production happens. At this stage, the traceability matrix can be closed too.
To ensure that the design process deliverables are performing as expected, the following should be reviewed periodically:
Design Inputs are comprehensive and measurable
Verification and validation testing is thorough (all Design Inputs verified and all user needs validated) and statistically sufficient
Risks have been identified and sufficiently mitigated
Design Development Plans are updated, sufficient, and realistic
Prior to manufacturing ramp-up (Design Transfer), specifications are finalized and manufacturing processes are properly validated.
Regulatory clearances are received prior to clinical or commercial human use.
#7 - Design History File
FDA Design Controls regulations and ISO 13485:2016 require a Design History File to be maintained. It is a record of all the Design Controls, made accessible to the project team. It establishes the linkages and relationships between all the Design Controls and demonstrates the traceability of all the Design Controls throughout the product development process. It should be readily available for regulatory inspection as well and should be kept up to date and current.
Common Challenges in the Design Controls Process
Implementing Design Controls poses several challenges. Some of these include:
From 1983 to 2017: The number of pages in design files for a 510(k) submission increased by >2,000%
Extensive documentation can inhibit efficiency, leading to delays, mistakes, and non-compliances
For teams using paper systems, or spreadsheets - maintaining proper documentation including signatures and revisions can become a nightmare
Collaboration Across Departments
All involved departments (engineering, quality, regulatory) must be able to access documents easily
Collaboration between different members for critical tasks such as revisions or validations can be a challenge, especially if done through spreadsheets
Numerous Changes & Updates
All changes and updates must be tracked, documented and approved according to regulatory standards
A minor change in one component can lead to a series of changes, tests, reviews, validations, and verifications
From human errors to complex workflows, a multitude of components and many stakeholders are involved, increasing the inherent risks in product development
It is a real challenge for teams to assess, identify and mitigate all risks, especially if relying on spreadsheets or papers.
Cloud-based Design Controls Solution from ComplianceQuest
A cloud-based Product Design Management Solution from ComplianceQuest can help businesses manage design controls better and overcome the challenges. The solution is integrated with the CQ EQMS, thereby providing instant access to risk management and documentation solutions, among others.
The 5 key features of the CQ Design Controls software include:
Meeting Management: Allowing easier collaboration, as well as design review and detailed documentation
Gantt View: Weekly or monthly view of tasks completed for better project management
Project Deliverables: The ability to add deliverables for each stage of design (plan, development…) and track progress for each one
Project Records: To assign deliverables, facilitate project management and simplify collaboration for product design teams
Team Collaboration: An easy-to-use platform with integration with Microsoft Office and Google Docs for document collaboration
Integrated: Can bring in data (ex for parts) from ERP or other systems
Product Design Files (Design Control): A living record across a product’s lifecycle that documents all design-related activities and serves as one source of truth for the design process (RTM, Parts, Documents…)
Configurable Queues: Customers can configure the workflow and approval matrix queue to fit their needs and processes
References & History: Effortless and always up to date documentation
Requirements Traceability Matrix
Formatted Printouts: Customers can print RTMs and design files as needed – with built-in numbering and revision control
Change Orders: To compliantly implement minor changes to products with all required steps and documentation
Single View: An always up-to-date living document that allows you to link and track all requirements, inputs, outputs validations, and verifications
Change Alerts: Automatic change alerts in RTMs for records to ensure all changes are reviewed and implemented appropriately
Requirements per Part: Define and track design controls per product part
Easy Edit: allowing for seamless updates to requirements as needed
Design History File
Product Assessment: Document all product-related risks, with risk assessment and classification
Product Risk Control: Document risk control measures, control verifications, and residual risk analysis
With CQ’s Product Design Management Solution, customers can bring their products to market quicker by gaining 100% visibility and traceability of the product development process. CQ makes collaboration easier, offering design teams better control over design inputs, requirements and risks to improve product quality while ensuring compliant documentation.
The benefits include:
Collaboration Simplified: For all members with meeting minutes, action items, and more
Single View: A unified view of all requirements, inputs, outputs validations, and verifications
Compliance: Ensure proper documentation in compliance with ISO 14971 and FDA CFR 820
Efficient: Decrease the time and labor needed for design projects
100% Traceability: Track and access records of changes, reviews, validations, and verifications
Embedded Risk Management: For all product-related risks along with proper risk control
Unified Repository: For all design documentation easily accessible to all members
Always Up-To-Date: Design files with change alerts to ensure proper change implementation
Easy Publish: Print design data, documents, and records with one-click at any time during development
These features closely align with the design and development process and are fully compliant with FDA and ISO requirements. In addition to enabling designers to automate design controls, they can also leverage the CQ EQMS features such as document, change, CAPA, and management review. This further ensures the quality and safety of the design and helps to meet user and indications of use requirements.