What is a Design and Development (D&D) plan?
A design and development (D&D) plan outlines a structured and systematic approach to developing a medical device.
A D&D plan ensures that all aspects of the device’s lifecycle are considered, from initial concept to production and post-market activities. It is important to ensure that all requirements are addressed and fulfilled. A good D&D plan also aims to efficiently manage human resources, equipment, and supplies. D&D planning is critical to meeting regulatory requirements, ensuring product safety, and managing an organisation’s exposure to liability and reputational damage.
The D&D plan fits the broader project management activities accompanying the device’s development lifecycle.
What is in a design and development plan?
All medical device developers must implement a defined plan for design and development activities that comply with the regulatory requirements. Design and development processes must be covered within the organisation’s Quality Management System (QMS). The requirements ensure that the design and development processes document:
- Design and development stages with
- Review(s) conducted at each design and development stage
- Verification, validation and design transfer activities that are appropriate at each design and development stage
- Methods to ensure traceability between design controls
- Resources required, including time, financial, human resources, equipment and supplies
- Responsibilities and authorities for design and development
The key components of a design and development plan should include the following:
Roles and Responsibilities: Identify the key team members and their roles in the project. This includes project managers, engineers, quality assurance personnel, regulatory affairs specialists, and other stakeholders. Provide an organisational chart showing the relationships and reporting lines among team members.
Suppliers: Document suppliers or third parties participating in the device development activities.
Activities: List all development activities conducted for each design control, including user requirements, design inputs, design outputs, verification, and validation. Specify any design activities, drawings, prototypes, code, tests, and studies conducted at each stage.
Acceptance Criteria: Define the technical and functional specifications that the device must meet for each activity.
Deliverables: List the documents created from these activities.
Review Plan: Schedule for formal design reviews at various project stages.
Review Criteria: Define the criteria for conducting design reviews and the objectives for each review stage
Documentation: Record each design review’s outcomes, action items, and decisions.
Challenges in managing medical device development projects
Despite its benefits, project management in design and development is not without challenges. Expectations will always differ between stakeholders and customers. Balancing the needs and interests of diverse stakeholders can be challenging, especially in large and complex projects. Ineffective communication can lead to misunderstandings, misaligned expectations, and conflicts among team members and stakeholders.
Implementing a well-thought-out design and development plan will help mitigate some challenges. The plan is an excellent communication tool for internal R&D teams and external parties (suppliers, development partners, and regulators). The plan can help control scope creep, leading to delays and budget overruns due to uncontrolled changes or continuous growth in project scope. Limited availability of resources, including skilled personnel, can hinder project progress. D&D planning ensures that resource capacity is mapped before starting development work, minimising the chance of delays. It is also an essential tool for risk management, ensuring that continual risk identification, assessment and mitigation measures are built into the design and development process. Failure to identify and manage risks proactively can result in significant setbacks.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
United State of America (USA):
Food and Drug Administration (FDA) guidance document:
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(9)(g)
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(8)(g)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- Technical documentation requirements are specified in the QMS requirements PART 820.30 Quality System Regulation Procedures: Design Controls
International Standards:
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes, Section 7.3. Design and Development
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems. This is also known as Change Management.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Design Control: A systematic process that ensures a device is designed to meet user needs and intended uses.
Design and Development Plan: A comprehensive document outlining the systematic process and stages, including timelines, responsibilities, and resources, required to bring a medical device from concept to market-ready product, ensuring compliance with regulatory standards.
Design Freeze: The point in the medical device development process where the design is finalised and no further changes are allowed, ensuring a stable basis for validation, regulatory submission, and production.
Design Inputs: The physical and performance requirements of a device that are used as a basis for device design. Also known as Technical Specifications.
Design Outputs: The results of a design effort at each design phase and at the end of the total design effort used to evaluate conformance to design input requirements.
Design Review: A formal evaluation process to assess the completeness, feasibility, and compliance of a device’s design with specified requirements (design inputs).
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Design Verification: The process of ensuring that design outputs meet design inputs.
Design Validation: The process of ensuring that devices conform to defined user needs and intended uses.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Technical Specifications: Detailed descriptions of the requirements, characteristics, and standards that a product, service, or system must meet or adhere to, ensuring clarity and consistency in its design, production, or implementation. Also see Design Inputs.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
Traceability Matrix: A document that maps and links requirements throughout the development lifecycle, ensuring that each requirement is tested and validated, thereby demonstrating compliance with regulatory standards.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.