Preparing for Successful Design Transfer

Planning ahead for design transfer and using it as a management tool results in a smoother, less costly transition from development to production.
Terry Zenner

It has become popular to say that all medical products, from small point-of-care devices to large high-volume analyzers, go through a life cycle. The metaphor is apt. Not only are there distinct stages in each product's life, such as proof of principle, engineering prototype, and commercial product, there are also distinct and critical transitions between each stage that determine the ultimate success of the product. Of these transitions, design transfer, the introduction of a design to production, may be the most important. Effective design transfer requires a thorough assessment of the product's design documentation, selection of components, and careful definition of production methods. Failure to transfer a design effectively can lead to situations in which specified parts are either unavailable or higher in cost than expected, production workflow is interrupted, and product quality suffers. Conversely, the rewards of effective design transfer are great: it can lower material and production costs, decrease product time to market, increase product quality, and generate customer enthusiasm. Medical device developers often transfer their product designs to an in-house production facility. There is a growing trend, however, to transfer them to an outside contract manufacturer. Given the amount of design and process information that typically needs to be transferred, a sound design transfer process can make or break an outsourcing relationship. This article is written from the perspective of a medical product developer working with an outside contract manufacturer. The information presented will help both parties establish and manage an efficient design transfer process to transform engineering designs into manufactured products successfully and consistently. THE DESIGN TRANSFER PROCESS Design transfer is an integral process in the early life of a product. It must be well executed, especially for complex medical devices. FDA's quality system regulation requires the manufacturer to complete the following steps in order to satisfactorily complete the design transfer process: Establish and maintain procedures to ensure that the device designits components and configurationis correctly translated into production specifications. Transfer the product design into production methods and procedures. Create a production environment that ensures the product complies with regulatory requirements and industry standards.

The transfer of a product design into a manufacturing environment requires a comprehensive set of processes to coordinate many tasks simultaneously. Experience, well-executed procedures, and careful review are the keys to a successful transition. This is especially true when a product design is transferred to an outsource manufacturer because of the greater potential for miscommunication. Differences in corporate cultures, business styles, quality systems, and perceptions of what constitutes design transfer can contribute to problems.

Consider the example of a product developer contracting the manufacture of a handheld point-ofcare diagnostic device. From the developer's point of view, the scope of design transfer was to deliver a prototype and electrical schematics. To reduce costs, the developer insisted on using an off-the-shelf enclosure to package the electronics. Although the prototypes function in most respects, the enclosures did not consistently pass the fluids-resistance test required for use in a clinical environment. As a result, the design and procurement of a custom gasket and rework of the enclosure parts was required. It was then discovered that the required EMI coating applied to the inside of the case softened the parts, requiring additional drying time before final assembly. Thus, failure to fully consider regulatory requirements during design transfer resulted in increases in the total number of parts, the total cost of parts, and the cost and time for parts rework; workflow modifications; and, ultimately, a delay in the planned product introduction to the market. POTENTIAL CHALLENGES AND CONSEQUENCES The effectiveness of the best-conceived design transfer process will be diminished if it is not properly supported and carried out. Some of the more common problems that arise include the following: Product developers do not have a finalized design. Business managers and technical experts do not grasp the scope of the design transfer effort and underestimate the amount of time and effort required. Manufacturing processes have not been developed, documented, or validated. Developers have not created a vendor supply chain based on an approved-vendor list. Developers bring unresolved cost, reliability, or safety issues to the manufacturer. The design transfer process is well understood by both parties, but the inability to plan the transition of a product design into a controlled manufacturing environment results in slow starts and unacceptable delays. The purchasing department does not have enough time to identify and approve new vendors, verify component specifications, and update the manufacturing planning system. The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures. Delays occur even after all the documentation is approved, because manufacturing must receive, inspect, and finally release parts for production. Failure to appreciate these challenges inevitably leads to unnecessary project delays, frustration, and misunderstandings between the developer and manufacturer. It is a reason some firms have not taken full advantage of the benefits that an outsourcing relationship can provide. DESIGN TRANSFER QUESTIONNAIRE A design transfer questionnaire (see sidebar) can help a developer and manufacturer ascertain the former's readiness to transfer a device design into manufacturing. The use of this document, or one similar to it, can result in a better understanding of the device from a technical, business, and regulatory perspective. The questions are useful in evaluating the status of the project, identifying shortcomings that could put the project at risk, estimating unit costs of the product, and determining what resources will be required to prepare the product for formal design transfer.

DESIGN TRANSFER QUESTIONNAIRE

Are the test plan, procedures, and test fixture documentation complete and validated? Is there evidence of design verification and validation? Is the process validation report complete? Is a completed hazard analysis available?

Is the bill of materials complete and fully costed? Are all part drawings and schematics complete and ready for production?

Are complete assembly procedures available?

Are assembly fixtures required?

Has a product-failure mode and effects analysis been performed and documented? Is a final acceptance test report available? What regulatory approvals are required (FDA, UL, CE, etc.)? How many off-the-shelf parts are in the device? Are standard components specifications available for all off-the-shelf parts? How many custom parts are used in the device? Are specifications and drawings available for all custom parts?

What is the estimated time required to manufacture the device? Are there vendor requirements that must be met, e.g., audits, first-article inspection, supplier survey? Is the incoming materials inspection plan complete? How may parts will require first-article inspection? Are the in-process and final inspection plans complete and validated? How much time will testing the device take? How much time will testing the device take? Have safety, compliance, and packaging tests been performed and passed? How many devices will be produced and according to what schedule?

Have all parts been assigned part numbers? Does an approved-vendor list exist?

Is the device designated Class I, Class II, or Class III? Does the product have FDA market approval? If not, how does the product developer intend to submit? o 510(k) o PMA

REGULATORY CONSIDERATIONS It is important to determine whether a product will be submitted for 510(k) or premarket approval. Preparation for each of these reviews requires considerable time and effort; delays can be avoided through planning and allocating resources. In some cases, a device that uses new technology or that is designed for a new intended use may not be immediately assigned a class designation by FDA, thus causing another possible delay in design transfer. Class III device manufacture requires significant documentation and administrative cost. To mitigate regulatory and scheduling risk, the product may need to be treated by the designer and manufacturer as a Class III device until FDA makes its final determination. COMPLIANCE FACILITATES DESIGN TRANSFER SUCCESS First and foremost, successful design transfer requires planning for and assessing compliance with regulatory requirements. Compliance is essential to meeting the developer's product, business, and financial objectives. It also leads to improved quality and savings in cost and time throughout the manufacture and support of the product. Regulatory compliance will help ensure that each device includes all the quality features established during the design phase. It will also assist the device developer and the contract manufacturer in coordinating their methods for

managing the volumes of documentation associated with design control, design transfer, and the engineering change process. Additionally, complying with regulations aids both the developer and manufacturer in verifying that each device is built to approved specifications using the same materials and components; assembly, inspection, and test methods; and quality procedures as the approved design. Concurrent planning for production, sustaining, and value engineering is facilitated by regulatorycompliance efforts, as is assuring that the final product design meets quality, reliability, budget, and schedule goals. Finally, maintaining regulatory compliance aids both parties in verifying component and subassembly lead times, identifying manufacturing process constraints and production bottlenecks, and determining spare parts and support requirements. OTHER KEYS TO SUCCESS To coordinate a comprehensive design transfer effort, the following guidelines are recommended. Start Early. Device designers should begin thinking in terms of manufacturing the product early in the design stage. Create a Cross-Functional Design Transfer Team. This team should include representatives from the engineering, manufacturing, materials management, quality, and business development departments. Plan the Design Transfer. The developer should use a checklist (see sidebar for an example) to see that all requirements are being met on schedule. Merge Process and Design Expertise. Manufacturing engineers should actively participate in the initial product design process. Focus on Quality. The developer must create solid design documentation, including a quality plan, product-failure mode and effects analysis, and a product validation plan. Time to market is critical to a developer's seeing a return on its investment. The following precautionary measures can help reduce delays in a product's transition to manufacturing. Identify Obsolete or End-of-Life Parts. Take, for example, the case of a product developer who outsources the manufacture of a medical imaging device. The device includes commercial, offthe-shelf components such as a computer, display, printer, and other electronics with short life cycles of 12 to 18 months. If the developer is knowledgeable about the end-of-life issues, then both the designer and the manufacturer can help the engineering and business principals work with key supply-chain partners to resolve technical, documentation, and purchasing issues early on. This shared knowledge not only strengthens the relationship between the parties, it also creates a better working relationship among all the supply-chain partners. Identifying obsolete or end-of-life parts allows adequate time to consider any needs for revalidation, document the appropriate changes, and introduce them into the manufacturing system in a controlled manner, thereby avoiding production delays. Secure Parts through Approved Vendors. A developer planning to manufacture an electronic monitoring device that attaches to a patient's belt, for example, requires several passive components and integrated circuits commonly used in cellular telephones, PDAs, and pagers. Because of their performance characteristics and small size, these components are popular with medical device designers. Obtaining these electrical components in the relatively low volumes needed for clinical units and early production is a challenge to even the most experienced and

savvy buyers. A setback in locating these parts can extend the scheduled production start date for the device. Requesting quotes from a number of bidders to secure a supplier and a good price is a beneficial use of time and reduces the possibility of manufacturing delays. Four additional guidelines for successful design transfer include: Use off-the-shelf components whenever possible. Identify manufacturing process constraints and potential bottlenecks. Determine spare parts and product requirements. Validate parts in advance of release to production.

RESPONSIBILITIES OF THE DESIGNER BEFORE DESIGN TRANSFER Prior to production, a manufacturer must obtain a complete documentation package that accurately reflects the product design and the required manufacturing processes. This package should include all product and process documentation listed in the design transfer checklist. DESIGN TRANSFER CHECKLIST A product development quality plan has been established. Design verification and validation results are up-to-date. A detailed risk analysis is complete and available. Documents outlining product requirements are created. These include: Software requirements documents. Custom parts specifications. A manufacturing quality plan, including: o Critical process control points. o Process flow. o Process validation. o Process control. o Environmental requirements of the production equipment. o Materials handling and control. o Materials receiving inspection. A device master record, including complete and accurate: o Bill of materials. o Component, subassembly, and finished product specifications. o Assembly drawings and schematics. o Manufacturing and assembly procedures. o Component incoming inspection procedures. o Manufacturing in-process inspection and test procedures. o Finished product test and inspection procedures. o Labeling and packaging specifications and procedures, and acceptance criteria. o Product servicing procedures. Device history record forms. Manufacturing final-acceptance test report. Copies of labeling including service and operation

manuals.

In many cases, product developers are surprised to discover that their project is not ready to transfer to manufacturing. Lack of resources, limited experience, or the inability of the developer to freeze the product design may render a product unready for production. Regardless of a developer's enthusiasm or determination to bring the product to market, all design transfer activities must be complete and documented for regulatory and business requirements to be met. Using a design transfer checklist will help the developer in the preparation of complete and accurate documentation. Transfer of an engineering design into production will typically require a formal review and approval of the product specifications and manufacturing procedures. Transfer may also require the product developer to provide evidence of the adequacy of specifications, methods, and procedures through documented process validationincluding the testing of the finished product in actual or simulated conditions. Important elements of the checklist that are often missing or incomplete, and can therefore cause delays, include: The bill of materials. It may not reflect the current, complete configuration of the product. The manufacturing in-process inspection and test procedures. In particular, the validation of the procedures and the inclusion of test-fixture calibration and preventive maintenance may be overlooked. These should all be addressed in the manufacturing quality plan. The finished product test and inspection procedures. Like the bill of materials, these procedures may not reflect the final configuration of the product. These tests need to be validated, also. Labeling and packaging specifications. Design changes may not be tracked or may not reflect the current configuration of the product. DESIGN TRANSFER REVIEW FDA generally requires developers to conduct a design review to confirm that all aspects of the design transfer have been executed. Results of clinical tests and design verification and validation are reviewed. This measure determines whether established processes yield finished devices that meet the project requirements. At the time of the design transfer review, the manufacturing quality plan must be made available for review. The manufacturing procedures and test methods are drafted and controlled through an engineering change order management process. When procedures and other documents reach their final form, the developer releases them to production. The minutes of the design transfer review should include open issues, assigned responsibilities, necessary follow-up activities, and the scheduled date of design transfer completion. The sidebar on this page lists the documents that the developer should have available for release at the time of the review. REFERENCE DOCUMENTS FOR DESIGN TRANSFER REVIEW FDA market approval. Any agency approvals other than FDA. Employee training program.

Clinical field trial report, if available. First-article inspection reports. Device history records for: Prototypes. Clinical test units. Product development audit report including action item resolution. Process validation plan, if required. Automated test equipment. Equipment software validation. Calibration documents. Process and test equipment validation and qualification reports. Index for transferred design history file. Vendor master maintenance form (for new suppliers). Manufacturing proposal, contract, and any amendments.

The design transfer checklist provides the agenda for the design transfer review. A copy of the completed and approved checklist is added to the design history file and attached to the design review minutes. The review minutes and checklist are published and distributed to the transition team members and the device developer. Any issues identified in the review minutes must be resolved prior to transfer to manufacturing. CONCLUSION The process of design transfer involves more than simply negotiating a maze of tasks as a product undergoes its metamorphosis from engineering prototype to commercial product. In addition to the help it provides in ensuring product requirements are met, the design transfer process serves as a valuable project management tool for meeting regulatory, technical, business, and financial goals. Regulatory requirements are clearly articulated at design transfer, and plans for achieving, monitoring, and validating them are established. Technical hurdles are identified early in the process, providing time for solutions to be implemented. The business issues of forming supplier relationships and freeing production bottlenecks are managed at their inception, and, finally, financial goals are met as time to market is minimized and quality, service, and customer enthusiasm are maximized.
Copyright 2001 Medical Device & Diagnostic Industry