The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control for medical devices

Due to its legal nature, an FDA guidance is a non-binding document intended to provide additional clarifications and recommendations to be considered by the medical device manufacturers and other parties involved. An alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.

The present article addresses the regulatory matters related to the design input defined as the physical and performance requirements of a device that are used as a basis for device design. It is stated that all design input requirements are subject to approval. Additionally, they should be duly documented. 

According to the applicable regulatory requirements, medical device manufacturers are obliged to introduce the processes and procedures necessary to ensure that design requirements are taken into consideration at early stages of the device development process and correspond to the intended purpose of the medical device in question, as well as the need of patients and those who will use the device. As part of such a procedure, there should be established ways to identify conflicting requirements. 

Regulatory Background 

First, the Agency states that the development of a medical device commences with the design input. The relevance and accuracy of the requirements considered at this stage will significantly impact the further development of a medical device and its safety and performance once manufactured. Consequently, according to the guidance, the development of a solid foundation of requirements is the single most important design control activity. Accurate and complete requirements will allow the manufacturer to streamline the development process and reduce potential errors and corrections associated thereto. Otherwise, the manufacturer could incur additional expenses (both in time and resources) due to redesign and rework required to ensure the safety and effectiveness of the product when used for its intended purpose. At the same time, complete and detailed requirements will reduce expenses associated with the development and significantly improve the overall quality of the product. Thus, medical device manufacturers shall pay special attention to the design requirements that constitute a basis for future development. 

In this regard, the authority mentions that currently, the quality system requirements for design input are often interpreted wrong: manufacturers are attempting to apply them as binding requirements to be precisely followed when they actually constitute general principles to be considered. Thus, the FDA has issued the present guidance in order to provide additional recommendations on applying these principles before the development commences. In particular, the document published by the authority highlights the most important points requiring additional attention to be paid. 

Concept Documents vs. Design Input 

In most cases, an idea for a new product or modifications to an existing one is reflected for the first time in a concept document based on suggestions provided by the marketing team or generated upon rigorous analysis of clinical activity reports. In some cases, this document, which is quite preliminary and general in nature, is used as the design input instead of more detailed requirements. The FDA emphasizes that due to the incompleteness of such a document, this approach could result in additional issues arising in the later development stages since some of the important aspects could still be missing. In order to avoid this, the FDA encourages medical device manufacturers to use such concept documents as a basis for more detailed requirements that will be used as design input. For this purpose, the concept document should be expanded and clarified with all important details covered. Hence, design input should be created on the basis of rigorous analysis of all important factors that will impact operations of the future medical device. 

Research and Development 

In certain cases, it becomes quite difficult to distinguish research and development as the first process slightly turns into the second one. For instance, the research could be performed in order to identify new opportunities or decide on the most important features of the medical device to be developed. Sometimes it makes sense to develop a first prototype of the device to be able to collect additional information to be considered in the course of further research. However, the Agency also mentions that quite often, such prototypes do not have all the necessary safety controls which the finished device should have. This aspect should be taken into consideration when assessing the design of products and the appropriate requirements. According to the document, it is acceptable for the initial requirements to be described using medical terminology, but the final version should be expressed using technical terms to avoid possible misunderstanding and ensure that product developed will meet the requirements.

Another important aspect the FDA guidance pays special attention to relates to cooperation between marketing and development teams. In particular, both teams can make assumptions regarding the needs of each other, and such assumptions sometimes could be incorrect. Thus, it is explicitly stated that all participants of the process should ensure the requirements are as clear and precise as possible. 

In terms of the way the requirements should be expressed, the Agency states that a basic principle is that design input requirements should specify what the design is intended to do while carefully avoiding specific design solutions at this stage. Thus, it should be stated what should be developed without indicating the particular way it should be done. At the same time, it is vitally important for the developers to understand the needs of customers to be able to decide on the optimal materials and solutions to be used due to the intended purpose of the product. However, in certain cases, it would be reasonable to indicate the particular solutions to be used – for instance, if the manufacturer intends to share components or production processes across medical devices of the same family. Additionally, if the requirements are related to a planned modification of a product, some of the functions and characteristics could be indicated as ones to be retained. In such cases, an additional assessment is required to identify potential conflicts and contradictions in requirements.  

In summary, the present FDA guidance highlights the most important aspects related to the design input and requirements to be used as a basis for the development process. The document provides additional clarifications regarding the way the regulations should be interpreted in order to ensure the final device meets both needs of patients and applicable safety and performance requirements. 


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