CQ Guide: Design Controls 101 for Medical Device Quality & Safety

Need for Design Controls

Intel’s Andy Grove famously said, “Only the paranoid survive.” Of course, he said this in the context of how the world’s leading chip maker, Intel, had to reinvent itself in the face of competition from Japanese chip makers who were able to manufacture hi-tech chips at lower costs and with better quality. Yet the statement holds true in almost any scenario.

In sectors like medical device manufacturing, it is absolutely critical to design and manufacture products that are safe, effective and of high-quality. The Food & Drug Administration (FDA) in the US, the European Competent Authority in Europe, Health Canada in Canada and other similar agencies across the globe require medical device companies to comply with stringent rules and regulations. Not only do these regulations govern the end-product but also the product design & development process, called Design Controls.

The development of medical device products is complex, can take years of development and millions of dollars as investment. Teams are under pressure because a seemingly small problem with one mechanical component, or a mistake in one line of software coding, can lead to catastrophic product system failure.

In this guide, we highlight the challenges faced by engineering and quality leaders when it comes to compliant design controls. The paper throws light on how using a cloud-based, next-generation platform to automate design controls – right from capturing user needs to implementing a design change - can help with:

• Streamlining documentation and compliance requirements
• Improve collaboration across departments
• Track numerous changes and updates, and ensure actions are taken on time
• Proactively manage risks across the product development lifecycle

The Food and Drug Administration1 (21CFR 820.30) defines Design Controls as:

“a set/framework of quality practices and procedures incorporated into the design and development process of a medical device product to assure that device specifications meet user needs and intended use(s)”.

A Systemic Approach to Medical Device Product Development

Design controls enable integrating a systemic approach to design during the product development lifecycle to:

• Proactively identify gaps in design input requirements (as early in the lifecycle as possible)
• Recognize discrepancies between the proposed designs and requirements

With early correction of designs, rework can be minimized, costs kept under control, and resource allocation improved. This ensures the performance,quality and regulatory requirements of the product are met. It also helps increase design conformance to user needs while improving collaboration and coordination between the different stakeholders.

The other key feature of design controls is its integration with risk management, engineering, and quality assurance.

Why Automation of Design Controls is Critical: Robust documentation, data visibility and vigilance are key to protecting patients and users from flaws in design. With automation, it becomes easier to identify, track and monitor the checks and balances needed to instil quality and compliance into the design process.

Meeting Regulatory Requirements: The FDA (21CFR 820.30) requires that all Class 2 and 3 medical devices establish (Define, Document & Implement) and maintain (Review, Approve, Update) procedures to control the design of medical devices.

Medical Devices are on the rise: With technological advancements, more medical devices are emerging and playing a major role in the health of patients. (For instance: Apple Watch is now considered a Class II medical device)

Design Controls and Risk Management

In today’s uncertain world, risk management has become critical. I That’s why automating the process of identifying, analysing, controlling, and monitoring risks is key to designing high quality products.

Risk management should be an integral part of the product development cycle right from the time of documenting user needs. As the design evolves, so will the risks, which need to be identified and managed at every stage. As new risks manifest, putting appropriate controls can make the product more robust and improve its quality and safety.

Design Controls and Engineering Principles

Traditionally, in the waterfall model, the product development process was sequential. The engineering department would first design the product, which would then be transferred for production. Other departments or organizations would get involved based on the process flow. As a result, the gap between the design and the end product would be vast, requiring rework, redesign, recall, wastage, etc. This would lead to excessive costs as well as delivery time implications.

As businesses move towards an agile or concurrent development model, the process flow has changed and collaboration between all teams happens right from the design stage. The product is reviewed at every step of the product development process, thus reducing development time, controlling costs, and ensuring improved product quality.

In this approach, the line between development and production blurs. Design control becomes crucial as design enters the development stage before being completed. Therefore, it is essential to have a comprehensive matrix to track every component, process design, and the product.

In short, it is critical to understand the linkages and relationship between User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.

Design Controls and Quality Assurance

The third aspect of design controls is that it is closely integrated with the quality system underpinning the product development lifecycle, covering design, production, distribution, use, maintenance, and obsolescence.

A quality policy document is required to guide the processes associated with design controls.

Establishing a quality policy is an essential part of device development as it defines the processes and procedures that will guide compliance. Design controls are a part of this quality system and come into play from the time of developing and approving design inputs, to the design of the device and its production. The other three parts of the quality system are risk management, document control, records management, and supplier management.

But it does not end there. It still plays an essential part in any changes introduced to the device or the manufacturing process,, even after the product has been released. Changes could include new features, updated functionalities or correction of any causes of failure. It is an essential part of continuous improvement and being able to meet customer needs.

Therefore, design control is not a one-time task, but a lifelong process.

For more information on CQ Design Controls Solution, visit: https://www.compliancequest.com/design-controls/