Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product that can be consistently and reproducibly produced for commercial use.
The process uses a systematic approach to define user needs (patients, care givers and clinicians) and translates that into an engineering set of requirements that can be verified and validated for the product’s intended use. The requirements to be met vary depending on the stage and depth of the product development process but are always ultimately connected with the needs of users and patients.
Given that medical devices intentionally impact patient health, authorities around the world have put in place a set of regulations for medical device developers and manufacturers to comply with, representing the safety and effectiveness requirements for the users and patients. Every market has distinct regulations, but they all require evidence of a safe and effective medical device design for the specified intended and indications for use (clinical claim).
What makes Design Control important?
Incorporating design controls into the design and development process is both a regulatory requirement and a proactive approach to systematically integrate assessments during all stages of product development, facilitating early identification and correction of any potential shortcomings. Consequently, design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use, and thus their importance for regulatory compliance and overall product quality.
Whether you are an established manufacturer or an early-stage spin-off working to introduce your innovation to the market, Design Control is an indispensable mechanism. It not only facilitates initial market access but, crucially, remains an ongoing process, continually providing evidence on the safety and efficacy of your medical device. This active approach ensures that your device remains in sync with advancements, ensuring sustained safety and effectiveness throughout its lifecycle by meeting the needs of users, patients, and regulatory bodies.
A closer look to the Regulation Landscape
From a regulations point of view, the requirement to establish a Quality Management System (QMS) is stated in Article 10(9) of Regulation EU 2017/45 (aka Medical Devices Regulation -MDR) for the European Union (EU) and by Part 820 of Title 21 of the Code of Federal Regulations (aka 21CFR820) and FDA’S QMSR for the United States of America (USA).
The European Commission recognizes the international standard EN ISO 13485:2016 – “Medical devices – Quality Management Systems – Requirements for regulatory purposes” as a harmonised standard, which means that its voluntary use confer presumption of conformity with the corresponding QMS requirements of the MDR.
This international standard is further recognized by other regulatory authorities for medical devices, and its requirements are similar to those stated in 21CFR820. So similar that FDA has recently published on 02.02.2024 an amendment to 21CFR820 to harmonize with ISO 13485:2016, effective February 2 of 2026.
21CFR820.30(a) states that manufacturers “shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met”. Similarly, section 7.3.1 of ISO 13485:2016 requires that “organizations shall document procedures for design and development”.
FDA further explains that “Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process” at its Design Control Guidance for Medical Device manufacturers.
Therefore, when we talk about design controls, we shall not limit ourselves only to what ISO 13485:2016 refers to as Design Review, but rather to the Design Control or Design and Development process, which is part of the organization’s QMS.
Keys to success: avoiding common pitfalls
Intended Use and Indications for Use
Since design controls ultimately provide an understanding of the degree of conformance of a design to user and patient needs, a clear and precise statement of the Intended Use and Indications for Use (FDA definitions here) is a crucial step for every medical device developer.
These definitions not only allow manufacturers and regulatory bodies to determine the regulatory pathway required to clear the device to market, but also provide the ultimate goal in terms of what the design and development output shall achieve for the intended users and patients.
Newcomers to the medical device environment regularly engage with regulatory strategy and options to attain the clinical claim that they are after. A proper regulatory strategy can offer multiple options in achieving that claim based on the company status and complexity of the claim.
Moreover, a well-defined Intended Use and Indications for Use statement can help the design team focus on the product, and establish a validation strategy to provide evidence of the clinical claim. We often see early-stage companies rushing to expand the use/s of their development rather than focusing on identifying the minimum viable product (MVP) that users and patients need, which results in requiring to handle multiple changes along the design and development phase with limited resources.
Design Inputs and Risk Management
Design control begins with the development and approval of User Needs, which will provide the goals to be achieved by the design, including its associated manufacturing process.
To further refine the Design Inputs, the search for applicable regulations, standards, or industry guidance documents becomes of vital importance to establish a comparison with the accepted state of the art for medical devices with a similar purpose. Regulatory bodies expect us to continuously monitor the introduction, updates or obsolescence of applicable regulations and standards.
A critical part of design revolves around risk management; understanding internal and external factors that impact the safety and performance of the medical device. ISO 14971 is an established standard adopted by regulatory authorities and an expected part of design control. The risk management process shall identify potential risk areas, their impact and all risk controls established as part of the design to allow for an acceptable benefit-risk assessment.
Similarly, a search for similar purpose medical devices in regulatory bodies databases, such as MAUDE from FDA, shall be made regularly to feed the risk management process, strengthening product’s safety.
Where manufacturers outsource design, development and testing activities, it is beneficial to establish a process to source, and verify the right partner to address the design needs. This is typically done through a supplier management process that defines the scope of activities needed by these outsourced entities and a guideline on how to ensure they have the right capability and capacity to address the design needs. This supplier management process will be extended to the parts and service providers for the actual medical device as the design is validated and prepared for production.
As part of the risk evaluation for the medical device, human factors and usability should be considered to prevent use errors that may impact the safe use of the device.
Usability Aspects
Since the user interface is part of the design, it is critical to incorporate usability requirements and design at an early stage. Failing to do so can limit the possibility to integrate information coming from studying users’ interactions with early prototypes, aiming to refine the user-related risk analysis (URRA), and opening the possibility to integrate a fresh external look into the development from the potential users of the device.
Costs to correct design errors are lower when those errors are identified early
We frequently encounter that human factor (HF) engineering (aka Usability) is kicked off only at the late stage of design and development, leading to a limited possibility to integrate information coming from studying users’ interactions with early prototypes, aiming to refine the user-related risk analysis (URRA), and opening the possibility to integrate a fresh external look into the development.
Similarly, the need for user training, or post-market activities such as installation, software updates, calibration, maintenance, repair and disposal, has to be taken into account early in the design process to establish the associated design inputs. Moreover, supplier agreements should be dealt with as early as possible to avoid unpleasant surprises, especially for critical services and components that will be difficult to replace later on in the development process.
Final Considerations
For a successful outcome, actions must be planned prior to conducting them and integrated within established QMS processes. Design Control being an evidence-based process, inputs and outputs of the design, development, test, transfer and release of the process must be managed to ensure they support all claims and can be reliably produced as a commercial product.
Manufacturers must establish a process to ensure that these activities are documented appropriately, and the generated records are maintained in the Design History File (DHF). The DHF tells the story (and, more importantly, provides evidence) on how the organization achieved the goal of fulfilling the identified user and patient needs stated in the Intended Use and Indications for Use definitions, with a medical device that provides users and patients clinical benefits that outweigh the risks associated with its use.
During commercialization, marketing activities shall represent claims in line with the validated design and the benefit-risks associated with the product to avoid false claims. False claims could result in user misuse or sanctions by regulatory authorities. As change is inevitable, procedures shall be in place to proactively seek for new or revised standards/guidelines and user feedback, review of product risk profiles, receiving user complaints to plan on corrective and/or preventive actions (CAPAs) that may trigger design change/s aiming to ensure sustained and up-to-date safety and effectiveness throughout the medical device lifecycle.
Wrapping up
Innovation continues to propel rapid advancements in the medical device field, leading to an increased demand for fast-paced design and development activities. Design Control is not isolated but rather central to and interconnected with the rest of the Quality Management System (QMS) of medical device manufacturers. Good design control practices can best support a good commercial product.
Moreover, when we also consider the necessity of staying updated with the evolution of the regulatory landscape, especially when dealing with modern technologies, we begin to understand the extensive bandwidth required throughout the medical device design and development lifecycle.
Effectively managing all design control requirements can be a smooth process, if planned and implemented in line with the product, business goals and regulations to avoid challenges for medical device manufacturers.
The Veranex Design Control Guide
To assist you with this endeavor, our team has meticulously mapped out key steps of the Design Control process in a comprehensive guide, accessible through the link below:
