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Design Controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries. Design controls are an interconnected set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process.
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Scope and Importance
Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.“Design controls” is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product's intended use. Design inputs, outputs, review, change controls, validation, verification, transfer, and the design history file all constitute aspects of design controls. Having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.
In addition to creating products liability risks for design flaws, failure to institute sufficient design controls is likely to result in regulatory actions. Design controls constitute about a quarter of what the FDA evaluates during a site inspection. This emphasis appears to be appropriate, as the FDA found that approximately 44 percent of the quality problems that led to voluntary recall actions during a six-year period in the 1990’s may have been prevented by adequate design controls As a significant part of the FDA’s focus in inspections, it is not surprising that 55 percent of Warning Letters issued in 2010 cited design controls as a deficiency’s. Design controls not only assure the most efficacious product design and that design inputs meet outputs, design controls also have important advantages for regulatory compliance and products-liability avoidance. Design controls are a component of a comprehensive quality system that covers the life of a device. The assurance process is a total systems approach that extends from the development of device requirements through design, production, distribution, use, maintenance, and eventually, obsolescence. Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes. Design control does not end with the transfer of a design to production. Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market. This includes evolutionary changes such as performance enhancements as well as revolutionary changes such as corrective actions resulting from the analysis of failed product. The changes are part of a continuous, ongoing effort to design and develop a device that meets the needs of the user and/or patient. Thus, the design control process is revisited many times during the life of a product.
The market was valued at US$1.56 billion in 2013 and is estimated to reach a value of US$4.49 billion by the end of 2020.With the help of regulatory affairs outsourcing, life science, pharmaceutical, and medical device manufacturing companies are able to get their drugs or devices approved or launched in the global market. Regulatory affairs outsourcing by biopharmaceutical companies has minimized losses due to recalls and product approval delays. Regulatory affairs service providers also provide effective services such as clinical trial services, medical writing, and pharmacovigilance to biotech, pharma, and medical device companies.
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