Beyond compliance: The case for Quality System Regulations on Design Controls in Medical Devices (regardless of their regulatory relevance)

By: Ali HAMADEH

With all the rambling currently going on regarding the future of FDA once the new administration takes office next January, I wrote the following essay to make the case for Design Controls (21CFR part 820.30, subpart C ) beyond their regulatory relevance and importance.

@FDA @Design_Controls @Regulations @Medical_Devices

Executive Summary

Medical devices play a crucial role in public health with direct and significant consequences on medical diagnosis, treatment and delivery of care thus impacting healthcare outcomes and quality of life.

Even in the hypothetical absence  (or reduced authority) of the U.S. Food and Drug Administration (FDA), the implementation and adherence to Design Controls remain essential to design and develop reliable medical devices that ensure patient (and operator) safety while fulfilling their intended functionalities and performances throughout their expected service life.

This essay examines the inherent need for design controls within the medical device industry by examining each design controls element and establishing its significance and the role it plays in the product design and development cycle.

 1. Design Planning

Design planning sets the organizational foundation for the entire product (NPI) development process by defining objectives, timelines, and resource allocation. Regardless of industry, a clear and well-structured product design plan provides a roadmap that helps development teams collaborate, coordinate their efforts, and manage the deliverables for each project milestone.

Design planning also sets clear expectations for stakeholders thus helping to ensure that projects stay on schedule and within budget.

It is effective design planning that facilitates alignment, reduces uncertainties, and enhances teams’ accountability, making it a critical first step in any product’s development initiative.

As a result, whether mandated by the regulations or not, design planning activities are key to the success of the NPI cycle.

 2. Design Input

Design inputs are the physical and performance characteristics of the device and are used as basis for its subsequent design.

They formally capture user needs & requirements that a product must fulfill and the functional & performance requirements specifications stemming (flowing down) from user needs and requirements.

Formally documented and reviewed design input helps avoid confusion, misinterpretation and ensures stakeholders’ alignment to work towards the same goal which reduces the risk of re-work and that of developing a product that does not fulfill user requirements.

Traceability between user requirements and functional & performance system requirement ensures coverage of user requirements by system requirements (top-down) and justifies system requirements by identifying user requirements they are linked to (bottom-up).

Finally, design input is crucial to develop verification and validation test procedures to ensure the finished product meets its functional and performance requirements (verification) and fulfills its user requirements (validation).

The benefits of compiling a good set of clear, concise, non-conflicting and traceable design input extends way beyond regulatory requirements as they set solid foundations for the design and development cycle.  

 3. Design Output

Design output consists of the specifications, drawings, SW code and other documents that define the product’s final design.

It represents the outcome of the design process throughout the design cycle and serves as a reference for production, testing, and quality control.

Ensuring that outputs meet design inputs is essential for creating a product that fulfills customer and regulatory requirements.

In non-regulated industries, design output provides the same clarity and traceability, supporting consistent manufacturing and product quality.

 4. Design Review

Design review involves evaluating the design at various stages of the design cycle to ensure it meets objectives (as defined in the plan) and fulfills stated design input requirements.

Regular and cross-functional design reviews help early identification of design or organizational issues early thus allowing for taking proactive corrective action and avoid costly rework.

Design reviews encourage cross-functional collaboration, executive oversight & accountability and bring product stakeholders’ perspectives to the discussion table.

In any industry, design reviews are invaluable for fostering innovation, out-of-the-box thinking, reducing development time, and ensuring that products are designed with a comprehensive understanding of potential challenges (technical, organizational, external) thus yielding clear benefits regardless of their regulatory mandate.  

 5. Design Verification

Design verification confirms that the design output meets specified design input requirements.

This element includes testing and analysis of design outputs to ensure that the product performs as intended.

Verification activities are keys to identify defects that might otherwise escape or be overlooked, ensuring that the design conforms to specifications.

They also provide product management and leadership with an objective assessment how design output conforms to design input and bring awareness to potential deviations that need to be collectively addressed.    

Even in the absence of regulatory requirements design verification is critical to confirm functionality, safety, and performance at various levels of architecture (component, sub-system, system) thus indicating design readiness to proceed to the phases of validation & transfer.

 6. Design Validation

Design validation ensures that the finished product fulfills user needs and meets user requirements when operated by intended end users.

By simulating or testing real-life use conditions, validation checks that the product fulfills customer expectations prior to market release.

Like design verification, design validation activities are essential for early identification of potential defects and performing subsequent actions to resolve them before product launch which enhances trust in the product, improves brand reputation and reduces warranty cost.

Regardless of regulatory requirements, design validation is essential for any company seeking customer satisfaction and commercial success of the product upon its release since it won’t be wise to ship a product that has not objectively been tested to fulfill its user needs or user requirements.

 7. Design Transfer

Design transfer is the process of transitioning the product design from engineering to manufacturing, ensuring that production teams have all the information needed to build the product accurately and consistently.

This phase requires clear documentation and open communication between design and production teams to ensure alignment and avoid disconnects.  

Effective design transfer is vital to maintain product quality, reduce production errors, and streamline the manufacturing process.

Even in the hypothetical absence of design transfer requirements, companies have plenty to win from implementing solid and rigorous design transfer processes to ensure scalability of product manufacturing and help maintaining consistency over time.

 8. Design Changes

Design changes refer to modifications and adjustments made to the design after it has been initially approved.

A robust design change management process ensures that modifications are thoroughly evaluated, documented, their impact assessed and verified thus preventing undesired consequences that might affect the product’s safety, functionality, performance, or compliance.

With or without regulatory requirements, design change control is just as crucial as it helps predicting costs, avoiding defects, and maintaining product quality and compliance throughout the product lifecycle in response to new requirements or market demands.

 Conclusion

 While design controls are mandatory for FDA-regulated products, their core elements—planning, inputs, outputs, reviews, verification, validation, transfer, and changes—are universally applicable and their benefits extends well beyond compliance given the pivotal role they play across product design and development processes.

Design controls provide a solid framework and method that ensure products meet formally documented user needs, comply with safety standards, and maintain high quality.

The implementation of design controls enhances product reliability, shortens development cycles, reduces costs, and ultimately leads to products that satisfy market and customer expectations, making them indispensable to any industry that values quality and innovation.