How to Approach Design Control From Both FDA and ISO Viewpoints

It is important for a developer and manufacturer of medical devices and In-vitro diagnostics (IVDs) to grasp the crucial role that Design Controls play in the product’s overall quality and compliance. Not only is Design Control critical in the various phases of a successful device’s initial development, it’s also essential for effective premarket and post-market development and lifecycle management considerations. It is also common for developers and manufacturers to target multiple markets for their device, most commonly targeting markets regulated under the U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO). This article will provide a perspective of how to use a blended approach to both.

Getting Started with FDA and ISO

In comparing the two primary strategies —FDA and ISO — there are key points developers need to understand. Firstly, FDA provides requirements for Design Controls under 21CFR820.30 and the ISO Standard lists requirements under ISO 13485 Section 7 (Product Realization).

Looking at the introductory statements of FDA’s 21CFR820.30 Regulation for Design Controls:

Each manufacturer of any class III or class II device...shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

Meanwhile, the ISO Standard 13485 Section 7.1 states (paraphrased and used under the Fair Use Copyright provision):

Include planning and development processes needed for product realization. Planning of product realization needs to be aligned with the quality management system. Records of risk management activities should be documented.

There are commonalities between these requirements. For example, both require a formal planning process, but how this is done is left to the developer. They also require the plans be updated as development progresses.

For this early feasibility phase, it is beneficial to create the following:

• Design and Development Plan (covers overall goals/objectives, regulatory path intended use, team members, timelines, costs, deliverables, definition of the phases to be used, etc.)
• Risk Management Plan (documents the overall risk process and initial overall risk of the system)
• Initial version of the traceability matrix (start to document in tabular format the user requirements, inputs, outputs, verification and validation of the process)
• Initial feasibility information (documents early studies to help determine translate into User Requirements)
• Design Review requirements (which phases require design review, minimum requirements to move to the next phase, etc.)

The Total Design Effort

Once the development project is considered feasible and is formally approved, both The FDA and ISO defines this next phase as Design Input, which is stated as the results of the design effort at each design phase and at the end of the total design effort.

For a blended approach, the developer can utilize the more descriptive definition FDA provides of translating user requirements into unambiguous specifications. The developer also benefits from instructions in the ISO standard, which gives more detail on which inputs to use. The blended result provides for the following Inputs at this stage:

• Establish a Design Input requirements document
• Perform a Hazards Analysis
• Perform a Failure Mode Risk Analysis on the design
• Update the Traceability Matrix with the inputs developed in this phase
• Perform a design review for this phase

The Device and Its Intended Function

The next phase of development - Design Outputs -  are the results of the design effort at each design phase and at the end of the total design effort. The FDA requirements provide unambiguous instructions to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. The ISO standard provides good detail on what the outputs should include (info on purchasing, production and service provision, acceptance criteria and essential characteristics). The blended result provides for the following outputs at this stage:

• Finalize design
• Finalize specifications
• Finalize Production process
• Update traceability matrix
• Perform design review

Confirmation of the Device's Design

Design Verification is all about confirming by objective evidence that your device’s design output meets its design input, so that a manufacturer can say, “I made the product correctly.” In most cases, comparing outputs to inputs shows that the device performs according to specifications.

For this phase, the FDA requires the developer to establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The ISO standard once again provides the detail on how to execute the design verification. This phase should include:

• Design Verification protocol
• Produce final representative device
• Verify the device to ensure outputs met inputs
• Update traceability matrix
• Perform design review

Does the Design Meet the Users’ Needs?

The Design Validation phase helps the developer prove by objective evidence that the device’s specifications conform with user needs and its intended use(s). Or in other words, “I made the correct product.”

The FDA is specific about the representative nature where the product came from, and the ISO standard asks for it to be planned in the protocol. Therefore, the following should be considered for this phase:

• Develop Validation Protocol(s)
• Produce first pilot/clinical production run
• Validate product to ensure outputs met inputs and user needs are confirmed
• Complete traceability matrix
• Perform design review

The Final Stage

The purpose of the Design Transfer phase is to implement procedures that safeguard correct design transfer from device design on into commercial production.

There is good correlation between the FDA regulation and the ISO standard; you must perform transfer activities of your product to ensure consistent, high quality commercial production. The following actions should be completed at this phase:

• Transfer checklist of activities needed to be completed prior to commercial production
• Process Validation
• Production equipment/facility/utility validation
• Testing/methods validation
• Initiate device master record
• Final design review

Conclusion

Adhering to a blended approach of the FDA and ISO prescribed phases of Design Control for the development of a new device pays significant dividends in helping manufacturers get their products to market efficiently, with the flexibility to enter diverse global markets. In keeping an eye on overall compliance to both the FDA regulation and the ISO standard, it is possible to utilize the best of both approaches and build a design control system that serves your organization well and positions you for future growth and expansion into overseas markets.

References

U.S. Food and Drug Administration. “Design Controls,” by Joseph Tartal

U.S. Food and Drug Administration. “Design Control Guidance for Medical Device Manufacturers.” March 11, 1997