Key Strategies for Successfully Executing the Design Transfer Process

Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such as, transitioning from internal development to contract manufacturing for increased volume, moving from R&D to formal production, changing manufacturing locations, outsourcing to global facilities, and shifting from manual to automated production processes.

The medical device design transfer process is essential as it ensures validated devices can be consistently manufactured at scale, meeting regulatory standards and maintaining safety. It facilitates seamless integration between R&D and manufacturing, ensuring efficient production and timely market entry of innovative medical products.

Design Transfer – Regulations

Design Transfer in 21 CFR 820

Design Transfer is a critical component outlined under the Design Control Section of 21 CFR 820.30, which mandates that manufacturers establish procedures ensuring accurate translation of device design into production specifications. Design Transfer involves extensive documentation and addresses potential modifications. Furthermore, it intersects with the Design Change process, detailed in Section (i) of the regulation, which necessitates manufacturers to establish procedures for identifying, documenting, validating (or verifying where applicable), reviewing, and approving design changes prior to implementation. These regulatory requirements ensure that medical device designs are effectively transferred to production and that any subsequent changes are carefully managed to maintain product quality and compliance.

Design Transfer in ISO 13485:2016

Section 7.3.8 on Design and Development Transfer mandates that organizations document procedures for transferring design and development outputs to manufacturing. These procedures must verify that outputs are suitable for manufacturing before finalizing them as production specifications, ensuring that production capabilities align with product requirements. The outcomes and findings of this transfer process must be documented comprehensively, capturing results and conclusions to maintain transparency and accountability throughout the design and development stages.

Design Transfer in MDSAP

The MDSAP Companion Audit document provides additional guidelines on auditing the design transfer process concerning ISO, FDA, and other MDSAP regulations. The audit team is tasked with reviewing how a selected project’s design was transferred into production specifications. This review includes assessing key aspects of manufacturing processes, such as supplier products and established process tolerances, against approved design outputs documented in design records. These evaluations verify the accuracy of the design transfer. Design transfer isn’t solely initiated at the conclusion of design and development phases but can also begin just before validation stages and continue throughout the evolution of design and development. This early initiation ensures that production processes and device validations proceed smoothly, allowing for corrections as needed. Ultimately, the design and development process concludes with a “final design transfer,” marking its finalization. Moreover, MDSAP integrates the design transfer process with Production and Purchasing functions to encompass risk management, validations, incoming inspections, and other critical areas within the design transfer process.

When To Begin Design Transfer

Determining when to begin the design transfer process depends on the current status of your development and manufacturing. Typically, a product is developed, and a pilot or prototype batch is created, often used for testing or trials. Once the design has been thoroughly evaluated and deemed ready for manufacturing, several steps in design control need to be completed before transferring the design:

1. Document initial design outputs.
2. Conduct a design review.
3. Perform design verification.
4. Identify the destination for the design transfer.
5. Establish a timeline for the transfer process.

These steps ensure that the design is well-documented, reviewed, verified, and strategically prepared for successful transfer into production.

How to Prepare – Design Transfer Plan

A Design Transfer Plan (DTP) is crucial to ensure clarity among all stakeholders regarding their roles, responsibilities, and the timeline for transferring the design. This plan should clearly outline the scope, specifically identifying the product undergoing design transfer and whether the scope involves one or multiple suppliers.

The DTP should establish the process for Design Change Orders/Change Orders (DCO/CO) and define how design changes are updated and approved. Key personnel involved in the design transfer process should be identified by their roles. Tools such as Gantt charts, project timelines, or task tracking systems can be referenced or integrated within the DTP.

Additionally, the DTP must include a comprehensive list of key items involved in the Design Transfer process, specifying responsibilities for each item. This includes ownership and due dates for documents, whether for internal stakeholders or suppliers. The plan should clearly designate responsibilities for each process and record, encompassing:

• Bill of Materials (BoM)
• Purchase Order Process
• Failure Mode and Effects Analysis (FMEA) Records (both design and process)
• Incoming Inspection Requirements
• Sampling Plans
• Work Instructions
• Custom Test Equipment
• Test Method and Production Equipment Validation
• Process Validation
• Verification and Validation (V&V) Requirements
• Quality Control (QC) Requirements
• Labeling Specifications
• Packaging Specifications
• Product quantity needs for testing
• Training Requirements (if applicable)
• Other special considerations (i.e. biocompatibility requirements, cleanliness requirements, environmental controls, etc.)

By documenting these responsibilities and processes in the DTP and related documents, all parties involved can ensure alignment and accountability throughout the Design Transfer process.

How To Prepare – Time to Transfer

Once the plan is in place, the focus shifts to implementing the design transfer process. The DTP outlines responsibilities for initiating Change Orders, details the collaboration process, and specifies record storage in the eQMS. According to FDA and ISO standards, it’s crucial to thoroughly evaluate changes and complete V&V as needed. Even seemingly minor adjustments to suppliers, molding processes, or components can have significant repercussions if not properly tested and documented, potentially leading to CAPA or recalls later on.

Internal Preparation

During development, companies gather valuable insights about their devices. This information ideally resides within the Design History File (DHF) or Device Master Record (DMR) from development, though gaps may exist, particularly for startups. Prior to Design Transfer, it’s crucial to review internal DHF, DMR, and Approved Supplier List (ASL) to ensure all necessary documents are ready for sharing. Work instructions should be prepared to transfer knowledge to the new manufacturing facility, while material specifications and testing practices, including any custom test equipment, should be reviewed and updated for potential new material sourcing or equipment transfer.

Transfer Index / Plan

The Design Transfer process requires ongoing effort to ensure thorough documentation tracking and maintenance throughout the project. Utilizing the DTP facilitates updates to documents, or alternatively, creating a Design Transfer Index helps monitor progress. This index should be regularly updated with new versions of Work Instructions, Drawings, Risk Analysis Records, Validations and Qualifications, Calibration records, Training materials, and other Design Transfer documents.

Testing

As the design transfer process begins delivering new products, a verification testing plan must be promptly established, potentially involving internal or external testing depending on the changes made. Testing should be integrated into the design change process to assess modifications against key device attributes specified in ISO 13485, such as function, performance, usability, safety, and compliance with regulatory requirements.

Results from internal testing should be documented in formal protocols. Often, the testing plan used for initial regulatory clearance can be adapted for Design Transfer verification.

Completing Design Transfer

After successful verification/validation testing, the finalization process begins. The Design Transfer plan or index, or both, should incorporate the conclusive V&V reports. A comprehensive review is necessary to confirm the accurate publication and proper referencing of all files, records, and work instructions. The Design Transfer documentation must undergo a final review as a complete package and be approved by relevant stakeholders. These records should be securely stored in the electronic Quality Management System (eQMS) for future reference and audit compliance.

Look To Rook

Rook Quality Systems offers robust support throughout the design transfer process, ensuring seamless transitions from development to production. Our expertise includes creating detailed DTPs, updating documentation with final V&V reports, conducting thorough reviews for accuracy and compliance, and securely storing records in our advanced electronic Quality Management System. We collaborate closely with clients to streamline operations, mitigate risks, and ensure regulatory adherence throughout every stage of design transfer.