No medtech company wants to run afoul of the FDA. Implementing good design controls can keep regulatory issues at bay.

Ann McGuire, Arena Solutions

Medical device companies recognize that using 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. Companies need to know which elements to incorporate in design controls before creating formal plans to implement them.

Why use design controls?

In addition to achieving better practices and designs, sound design controls can prevent FDA inspection observations and notices (Form 483s) — which can be very costly and even derail product launches. A Form 483 and an FDA warning letter are similar in nature and serve to inform all affected parties about issues that require corrective action. The Form 483, also called “Inspectional Observations,” conveys 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.

Controls or consequences

Approximately 90% of 2018 FDA 483s cite quality system regulation issues (21 CFR 820), which are very concerning. The accompanying pie chart shows that 14% 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 website, as this kind of visibility can harm sales and profitability and may lead patients and physicians to lose confidence in the device. Medical device makers are also at risk from competitors who 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 controls foundation simplifies FDA compliance, so companies can pass audits without a finding.

What goes into design controls?

Design and development planning are the first elements in the design control process. The plan includes activities, dates and responsible people. It is documented and updated as it evolves. This leads to the next element, design input.

Design input comes from users, patients, physicians and other stakeholders. The design process results in design output, which is documentation describing the product. Design reviews occur throughout design development 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 bills of materials, drawings and assembly instructions. Although design transfer is not frequently cited in 483s, it can cause delays and errors when companies transfer information manually from engineering to operations.

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 sub-part of the design controls 483s.

Design changes

Design changes are the second-most cited issue under design controls. After releasing the first revision, updating enterprise system planning software 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.

Keeping track

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 quality management system (QMS) solutions can help simplify some of these processes. However, a product-centric QMS solution uses a single system to manage the foundational product record in context with all related quality processes. This connected product record includes a relational bill of materials (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 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.

Ann McGuire is product marketing manager for Arena Solutions.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.