FDA medical device design controls – meet the PMBOK® guide
Businesses are challenged by rapid changes and increasing complexity due to global markets, evolving technologies and a mobile workforce. Projects undertaken to develop innovative products, services, and solutions provide an effective competitive and growth response in this volatile business environment. Project management processes are valuable management tools for successful definition, design, development, and deployment of unique products, services, and innovative solutions (PMSI-PM 2000).As organizations have recognized the criticality of projects to their success, project management has become a focal point of improvement efforts. More and more organizations have embraced project management as a key strategy for remaining competitive in today’s business environment. Some organizations are just getting started with project management, while others have reached a level of maturity where project management is a way of life (Kerzner 2000). In medical device development organizations, integrating project management best practices with required FDA design controls, and device development processes will produce an effective formula for project success.How can this integration be efficiently accomplished? Enter the PMBOK® Guide and a systematic approach called OPUS® Operating Procedures for Universal Standards (PMSI-PM 2000).
Scope and Objective
OPUS® Operating Procedures for Universal Standards is a deliverables- oriented approach to project management that ensures consistency in project management functions and outputs, and complies with concepts and principles established by the Project Management Institute (PMI®). The goal of this approach is to establish standard methods and procedures for project management, that can be used over and over again, and that will increase the likelihood of achieving the project objectives. The deliverables- oriented approach can be applied to not only enhance and integrate design controls, and medical device development processes, but also can be applied throughout other industry sectors. This paper targets medical device development organizations, but is not a technical guide on how to comply with FDA design controls requirements, nor does it define the device development process. Its intent is to be used as a framework guide for the integration of the processes to enhance the collaboration and communication between cross-functional project teams and ensure organizational success in the management of medical device development projects. Exhibit 1 displays the process integration framework within a medical device development environment on which this paper is based.
FDA Design Controls
The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act. The regulations require that domestic and foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States. Under the guidance of the Center for Devices and Radiological Health (CDRH), design controls are a component of a comprehensive quality system that covers the life of a medical device (CDRH 1997).Within the medical device development and commercialization process, design controls formally begin when the decision is made to go from the concept/feasibility phase to the device development phase.
Design controls are an interrelated set of practices and procedures, i.e., a system of checks and balances, in order to increase the likelihood that the design transferred to production is appropriate for its intended use, consisting of the following stages as outlined in the Code of Federal Regulations (CFR): Design and Development Planning; Design Input; Design Output; Design Verification; Design Validation; and Design Transfer. Design Review, Design Change Control, Document Control, and establishment of a Design History File are required activities performed throughout these stages (CDRH 1997).As with the project management process phases, the design controls stages are not always discrete, one-time events. Exhibit 2 displays a graphical version of the design controls stages showing the overlapping and varying degrees of activity throughout the medical device development phase of the project. Each of the individual design controls stages are linked by their inputs and outputs. Design input, and design and development planning begin early on in the device development phase. Design and development planning activities are iterative and occur throughout most of the phase. Design output, design verification, and design validation activities begin with design input approval and continue through to design transfer. These activities are subject to design change control, design review, and document control procedures. Design transfer is the final stage competed prior to device development phase closeout.
Design Development and Planning
During the design and development planning stage, a high-level plan is established that defines the design and development activities and deliverables, and identifies who is responsible for performing the activities, including interfaces between different internal and external groups. Design and development planning is required to ensure that the design process is appropriately controlled and that device quality objectives are met (CDRH 1997).
The design input stage results in the development of the preliminary requirements for the medical device, which describe the essential elements of the product. The final version of the design input requirements become the basis for evaluating when the product’s design and development is complete (Olivier 1996). Procedures must be established to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient (CDRH 1997).
Design output includes the documents, design descriptions, analyses, test procedures, and test results produced during actual design activities.Typically an item is considered to be design output if it is a work product, deliverable, or design task.At the end of this stage, it is essential to determine if all of the outputs have been produced, and there is associated documentation to support and justify the output. Design output procedures contain or make reference to acceptance criteria and ensure that those outputs that are essential for the proper functioning of the device are identified (CDRH 1997).
Design Verification and Design Validation
Design verification and design validation activities include procedures for verifying that the design output meets the design input requirements and that the medical device conforms to defined user needs and intended uses. Planning for verification and validation activities begin early in the design process. These activities are performed at all stages and levels of device design and produce outputs such as testing, inspection, and analysis documents (CDRH 1997).
Design Change Control
Design change control includes formal procedures for the identification, documentation, review, and approval of design changes before their implementation. These activities encompass both document control, and design change control (CDRH 1997). Design change control procedures are required, but not limited to requests that involve significant changes to form, fit, or function of the device, and changes to design validation and verification activities.
Design transfer includes activities that ensure the device produced by manufacturing is the same as envisioned by the design and development engineers. A significant part of design transfer specifications are produced when design output is created. These specifications ensure that the device can be repeatedly and reliably produced by the manufacturing organization.
Integration With Project Management Processes
How can we ensure that all of the design controls, and device development activities are performed according to the design and development plan? The answer, Project Management. Incorporating all of the design controls, and device development activities and deliverables into the full project management life cycle will ensure successful achievement of project objectives. The project management life cycle is organized into five process groups/phases: Initiating, Planning, Executing, Controlling, and Closing (PMBOK® Guide 2000).Using the OPUS® deliverablesoriented approach, producing the deliverables for each phase prompts one to perform required project management, design controls, and other device development activities. The deliverables matrix in Exhibit 3 provides a high-level outline of the deliverables produced in each of the project management life-cycle phases for a medical device development project, and will be examined in detail in the following sections.
The initiating process identifies the project products and services, defines the project objectives, and produces the project charter. This information enables project owners and sponsors to make an informed commitment to proceed with the project, and begin the planning process (PMSI-PM 2000). During this process, the project team reviews and analyzes the inputs to the initiating process, which include the business case/plan, corporate policies and guidelines, and preproject documentation. Doing so assists the team in defining the strategic initiatives supported by the project, the impact the project will have on the performing organization, and the competitive significance of the project. Existing corporate policies, such as design controls SOPs, and other FDA regulatory guidelines impose potential constraints and quality specifications required by the organization and outside regulatory agencies. The primary output of the initiating process is the project charter, a document that formally authorizes the project (PMBOK®Guide 2000, p. 54). The project charter includes information, such as the strategic business alignment, stakeholders, project mission and objectives, scope and major deliverables, constraints, assumptions, project quality specifications, resource requirements, high-level time and cost estimates, project risks, information requirements, and any related products and deliverables. Information contained in the project charter will assist the project team with the production of the design and development plan, and the preliminary design input requirements. The project notebook is established and maintained throughout the entire project life cycle.
The project charter and associated documents are inputs to the planning process. This process produces a comprehensive project plan that identifies the tasks necessary to produce the required medical device. The plan also identifies activities required for managing all aspects of the project including scope, time, cost, quality, resources, communication, risk and procurement of additional materials and equipment. The planning process acknowledges that requirements and conditions may change as the project proceeds and includes development of project controls to manage the changes, which define procedures to:
• Manage changes to the project baseline time, cost, and deliverables
• Identify, assess, and resolve project issues
• Identify, assess, and mitigate project risks
• Ensure both a quality project experience and a quality product
• Ensure effective procurement procedures
• Perform effective project communications to ensure effective decision support information is disseminated to stakeholders. Lessons learned from previous projects identify beneficial activities to include in the project as well as problems to avoid and potential risks to mitigate. A work breakdown structure (WBS), which is a deliverables-oriented grouping of project components that organizes and defines the total scope of the project, is developed. Exhibit 4 presents a high-level WBS for the medical device development phase. The WBS is organized using the five phases of the project management life cycle. In creating the WBS, the following activities and associated deliverables are identified:
• Project management implementation and control activities
• FDA design controls implementation activities
• Device development implementation activities, not included in design controls.
The project management implementation and control activities include all of the tasks and deliverables required to ensure effective project management and quality checks for all nine project management knowledge areas: scope, time, cost, quality, human resources, communications, risk, procurement, and integration management.The organizational breakdown structure (OBS) and resource assignment matrix (RAM) define, in detail, the roles and responsibilities required for the project, the skill requirements for each role, and identify the responsibility each role has for the phases of the project. In addition to the project RAM, production of a design controls requirements and responsibilities matrix will ensure that the responsibilities for design controls activities and specific deliverables required to verify compliance are defined and assigned to the appropriate person.Design controls implementation activities include all of the required activities and deliverables to satisfy completion of all of the design controls phases. Other device development implementation activities are identified as those activities and deliverables that do not fall under design controls, and typically involve other functional departments such as sales/marketing, legal, regulatory, QA, and business development. Design inputs documents are produced prior to entering the executing and controlling processes. The design history file is established and maintained throughout the entire project life cycle.
Executing and Controlling Processes
Executing and controlling processes carry out the overall project plan, which is the action map to ensure the project is progressing as planned. The activities outlined in the plan for design controls, device development, as well as those activities to manage the project and provide required outputs, are performed and deliverables produced.Project quality assurance techniques in addition to defined design controls quality assurance requirements are applied to ensure project deliverables meet the specifications outlined in the quality management plan, and introduce corrective action to eliminate unsatisfactory performance. This process provides effective change management for all aspects of the project including overall change control, scope change control, schedule control, cost control, quality control, and risk response control. Project progress reports, and project performance reports are produced and distributed on a regular basis to all project stakeholders.At regular intervals, approvals at designated quality gates/checkpoints are required to continue executing the project plan. Design controls activities include finalizing the design input documents, and design review provides the quality gate for progression thorough the stages of design controls.As design outputs are produced, activities to complete design verification and design validation are performed. Design change requests are generated, and formal design review sessions are held according to the organization’s SOPs. Approved design change requests may initiate updated design and development plans, updated design output, design verification, and design validation requirements. These updates will be incorporated into the new baseline project plan. The executing and controlling phases end with the production of the final device and deliverables. Design input must match design output, and design transfer documentation is produced.
The closing process documents the final outcomes of the project both in terms of device delivery, and project management delivery. Project actual results are reported and documented, project contracts are closed, and lessons learned documents are produced. Final project reports include final documentation for accounting, scope, cost, quality, and risk.The project charter and the project plan are reviewed to assess project performance against the documented standards and guidelines. Final project archives are updated to include all project information.Design controls activities include device acceptance, production of final design review meeting documents, and the establishment of the final design history file. Upon approval of final design review, the device development project is now ready to enter the device-manufacturing phase.
Critical Success Factors
An organization has made the decision to begin implementation and deployment of integrated project management best practices. What are critical success factors that must be in place to ensure the organization embraces the integration?
Ensure Senior Management Support
Senior management involvement and support is essential if the process integration is to move ahead quickly and if full employee commitment and acceptance is to be achieved. Endorsement must be visible to employees and an executive champion must initiate and support the integration process and establish the vision early on.
Involve All Key Stakeholders
All organizational departments will be involved in performing or providing inputs into project activities at some point throughout the project management life cycle. It is crucial that these functional departments, such as, Project Management, Engineering, Quality Assurance, Regulatory, etc., support the integration, and participate in defining the final accepted process.
Provide Ongoing Training
Successful integration of project management with design controls, and device development processes can be achieved through providing training on project management concepts and techniques, as well as in the knowledge of design controls and the overall device development processes.Many project team members are well versed in product development activities/phases, e.g., define, design, development, deployment, but are less familiar with how these development activities fit into the full project management life cycle. Lack of understanding of formal project management processes can create resistance to integration and collaboration among project managers, engineers, and other project associates. Ongoing training will promote continued understanding of the relevance of project management activities and will encourage more effective team collaboration and cooperation.
Be an Effective Change Agent, Be Patient
Expect resistance and manage it. Resistance to change can create a roadblock to implementing and integrating project management with an organization’s design controls, and device development processes. It is usually the result of a belief that implementation of project management will cause the functional managers to surrender all or some of their authority to the project managers. As a result, numerous excuses will appear as to why project management is not needed or will not work.Defining roles, responsibilities and reporting relationships, and applying effective change management processes will contribute to acceptance, and buy in.
Perform Mentoring and Coaching—Inspect What You Expect
Once the integrated process is deployed, support is required to reinforce and encourage the transition. Project managers and project team members must be held accountable for producing project and product deliverables via project audits and performance reviews. On-the-job training and coaching for project managers, engineers, and other associates is essential to ensure the continued integration and deployment success of the new process.
Promote Team Communication and Collaboration
The best teams tend to have capable and committed members who successfully combine their skills and knowledge for the good of the team. The challenge for teams is to accept and appreciate the unique contributions that each member can make while effectively combining individual member contributions for the good of the team. The key to team success is the creation of synergy—the condition whereby team members together accomplish significantly more than they could if they acted on their own (Manz, et al. 1997). Incorporate team-building activities into your process integration, and develop reward and recognition systems to facilitate healthy team interactions.
Develop Effective Procedural Documentation
An important facet of deploying any process is to provide the people in the organization with procedural documentation on how to perform process activities and how to communicate in such a multidimensional environment. Project management policies, procedures, forms and guidelines, along with design controls SOPs, and device development guidelines can provide some of these tools for delineating the process, as well as a format for collecting, processing, and communicating project-related data in an orderly, standardized format.
Perform Continuous Process Improvement
Include a continuous process improvement plan as part of your process integration deployment procedures. Project management, design controls, and device development processes must undergo periodic review and assessment to ensure current best practices are being applied along with FDA requirements. Project lessons learned and feedback from process users will ensure capture of process improvement opportunities.
Traditionally, implementation of medical device development projects and adherence to FDA design controls has been the responsibility of the engineering and the quality assurance/regulatory departments. With more organizations implementing formal project management structures/processes and the development of centralized PMOs, project managers are required to work more closely with engineering and QA to ensure compliance with the organization’s design controls SOPs to increase the success of medical device development projects. It is important to understand that there is a learning curve that must be overcome when implementing and integrating project management best practices with design controls and device development requirements. The organization may already have well-defined design controls, and device development processes in place. Therefore, they may be resistant to project management and feel additional processes are not necessary. Only when the organization begins to realize the importance of project management and a singular methodology, the deployment of a project management process integrated with design controls, and other device development processes will occur. As organizations begin implementation, they sometimes become frustrated by the amount of time spent performing project management activities, or lack the time to perform such activities, and become discouraged. These experiences may lead to decisions to revert to previous practices, suggesting that the costs of implementing integrated project management processes do not justify the benefits. The benefits achieved from project management best practices are real, but a dedicated commitment to realizing these benefits is essential.
Center for Devices and Radiological Health. 1997. Design Control Guidance for Medical Device Manufacturers. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration (March).
Kerzner, Harold. 2000. Strategic Planning for Project Management Using a Project Management Maturity Model. New York: John Wiley & Sons, Inc.
Oliver, Daniel P. 1996. Implementation of Design Controls Offers Practical Benefits. Medical Device & Diagnostic Industry Magazine Archive. Devicelink.com, pp. 1–9.
PMSI – Project Mentors. 2000. OPUS® Operating Procedures for Universal Standards.
Project Management Institute. 2000. A Guide to the Project Management Body of Knowledge (PMBOK® Guide). Newtown Square, PA: Project Management Institute.
Proceedings of the Project Management Institute Annual Seminars & Symposium
November 1–10, 2001 • Nashville, Tenn., USA