Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical when considering FDA validation and design compliance. But to accomplish this, first know what key elements should be incorporated in design controls before implementing formalized plans for their creation.

Fig. 1 - FDA QSR by subpart. Approximately 90 percent of 2018 FDA 483s cite Quality System Regulation issues (21 CFR 820). Of these, 14 percent are design control issues (CFR 820.30) as well as corrective and preventive actions (CAPA).

In addition to achieving better practices and designs, why should medical device companies focus on design controls? Establishing sound design controls can prevent FDA inspection observations and Form 483s — which can be very costly and even derail product launches. Both Form 483s and FDA warning letters are similar in nature and serve to inform all affected parties regarding issues that require corrective action. The Form 483, also called “Inspectional Observations,” convey conditions or practices that indicate a potential violation of FDA requirements. The warning letter is typically an escalation from insufficient follow-up on a 483.

Approximately 90 percent of 2018 FDA 483s cite Quality System Regulation issues (21 CFR 820), which are very concerning. The pie chart in Figure 1 shows that 14 percent are design control issues (CFR 820.30) as well as corrective and preventive actions (CAPA). The consequences are significant to affected companies. Medical device manufacturers avoid being listed on the FDA web site, as this kind of visibility can be detrimental to future sales and profitability. As a result of this, patients and physicians may lose confidence in the device. Medical device makers are also at risk from competitors that can exploit the information. Lastly, management and other resources can be pulled from priorities to address these issues, which can be quite disruptive to business operations.

A solid design control foundation simplifies FDA compliance, so that audits can be passed without a finding. These are the key elements of design controls (see Figure 2).

Fig. 2 - Key elements of design controls. Design Control Regulation 820.30/ISO 13485.

Design and development planning is the first element in the design control process. The plan includes activities, dates, and responsible people. The plan is documented and updated as it evolves. This leads to the next element, design input. Design input comes from users, patients, and physicians, along with other stakeholders. The design process results in design output, which is documentation describing the product. Design reviews are achieved throughout design development in order to check the design results and identify issues.

Verification ensures that the design outputs completely and unambiguously match the design input. During verification, personnel should be able to answer questions like:

  • “Do we have all the documentation we need?”

  • “Who has approved it and when?”

  • “What’s missing?”

Design transfer is the process of providing manufacturing with the design output they need, including bill of materials (BOMs), drawings, and assembly instructions. Design transfer is not frequently cited in 483s, yet companies frequently have issues with their design transfer processes. Often companies transfer information manually from engineering to operations, resulting in greater risk of delays and errors.

The next element is validation — testing to make sure the manufactured product meets the users’ needs. All these tests and results must be documented. Validation is the most commonly referenced subpart of the design controls 483s.

Design changes are the second-most cited issue under design controls. After releasing the first revision, updating ERP and other downstream systems can be tricky. Many aspects of the design may have changed, which makes it essential to understand what has changed as well as if components were added or removed. It’s also important to ensure that supporting documents have been updated. Change processes can have many variables, making documenting and following those processes more difficult.

Finally, the design history file (DHF) is the compilation of a company’s product design documentation and its evolution. This is an administration-heavy element that can be cumbersome to maintain and use. Traditional, document-centric QMS solutions can help simplify some of these processes. However, a product-centric QMS solution leverages a single system to manage the foundational product record in context with all related quality processes. This connected product record includes a relational BOM, approved manufacturers list (AML), and changes (ECOs). Managing the quality processes in the same system creates better visibility of issues and faster resolution with connected quality records like complaints and corrective and preventive actions (CAPAs) that can drive ECOs to correct any design issues. Ultimately, having a product-centric QMS helps companies with design transfer and design change processes as well as the FDA required file management. This also helps medical device companies establish solid design controls to avoid FDA warnings that can result in lost revenue, patient health issues, or, in some cases, death.

Medical device companies need full control, visibility, and traceability throughout the design, development, and manufacturing process.

This article was written by Ann McGuire, Product Marketing Manager at Arena Solutions, Foster City, CA. For more information, click here .