Medical devices play a crucial role in modern healthcare, helping diagnose, monitor, and treat patients. However, the successful development and deployment of medical devices are subject to stringent regulatory requirements to ensure their safety, efficacy, and reliability.

As a result, medical device designers and manufacturers need to carefully consider regulatory compliance throughout the design process to ensure that their products meet the necessary regulations. In this blog, Design Engineer, Luke discusses the key considerations for designing medical devices with regulatory compliance in mind:

Understand the Regulatory Landscape:

The first step in designing a medical device for regulatory compliance is to gain a comprehensive understanding of the regulatory landscape. Different countries and regions have different regulatory frameworks, such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and the Ministry of Health and Welfare (MOHW) in Japan, among others. Each regulatory agency has its own set of guidelines, standards, and requirements that medical devices must adhere to gain approval or clearance for market entry. It is important to thoroughly research and understand the regulatory requirements specific to the target market(s) before starting the design process.

Follow Applicable Standards:

Medical device manufacturers should adhere to relevant standards during the design process to ensure regulatory compliance. Standards such as ISO 13485 (Quality Management System for Medical Devices), ISO 14971 (Risk Management for Medical Devices), and IEC 60601 (Safety and Performance of Medical Electrical Equipment) are widely recognized and provide guidance on various aspects of medical device design, development, and manufacturing. These standards outline the minimum requirements for safety, performance, and quality management, and complying with them can streamline the regulatory approval process

Incorporate Risk Management:

Risk management is a critical aspect of medical device design to ensure the safety of the patient.  By identifying and evaluating potential risks early in the design process, appropriate risk control measures can be implemented to minimise the occurrence of adverse events and enhance patient safety.  ISO 14971: “Application of risk management to medical devices”, specifies a process for a manufacturer to identify the hazards associated with medical devices, to estimate, evaluate and control the associated risks, and to monitor the effectiveness of the controls. It is important to note that risk management should be used iteratively throughout the entirety of the development process.

New hazards can arise from changes to the design, increases in complexity, evolving regulatory requirements, or as a result of continuous improvement, and must be effectively managed. Risk management continues throughout the whole life cycle of a product. As with all sub-activities of medical device design, risk management should not be viewed as a tick box activity to comply with a regulation but should be employed primarily to ensure patient safety.

Document Design Controls:

The generation and maintenance of a thorough file of documentation relating to the design controls of medical device development (Design History File – DHF) may be a large undertaking, but it is a crucial element of not only compliance with regulatory requirements such as those of ISO 13485, but also demonstrating that the device has been designed to meet the user needs, is safe and effective, and the necessary risk mitigation strategies have been employed. They also provide a traceable record of the design process, which is often required by regulatory agencies during audits or inspections. This documentation may include (but is not limited to): design & development plan, design input requirements, design & development outputs, design review records, design verification & validation records, risk management documentation, and design transfer documentation.

Verify and Validate the Design:

Verification and validation encompass a range of activities that are performed to ensure the device meets its intended purpose and performance requirements.  Whilst they are related, they serve distinct purposes and usually occur at different points in the development process.

The goal of design verification is to confirm through objective evidence that design output meets design input. A design verification plan is usually developed in conjunction with the development of design inputs to ensure the inputs can be adequately satisfied. Verification activities are not limited to laboratory testing, and can also include various analyses such as FMEA, FTA, bio-compatibility testing of materials or even finite element analysis.

Validation on the other hand is carried out to prove the medical device meets the user needs and intended use and is usually performed in the late stages of development process. These activities also must be carried out using initial production units under simulated or actual use conditions.

Incorporate human factors – thoroughly!

Often overlooked and undervalued, human factors are of paramount importance to the development of a medical device. HF activities should not be viewed as another tick box for standards and regulations, but instead a crucial undertaking in order to ensure the device is safe, effective and meets the needs of all potential users, be that patients or healthcare professionals.  Human factors help identify and reduce potential usability issues and challenges that may be encountered when using the device, as well as any potential risks and hazards. They also offer valuable insight into the training needs of users, or better yet, insights into how the design can be improved in order to negate the need for training. A diverse range of users should be considered to ensure the inclusivity of those with any physical or cognitive impairments, different genders, and minorities.

Designing medical devices that comply with regulatory requirements is a complex and challenging process. Manufacturers must understand the regulatory landscape, involve regulatory experts early in the design process, deploy risk identification and management tools, use design controls, conduct user studies, and implement quality systems. By following these key considerations, manufacturers can design and manufacture safe and effective medical devices that meet regulatory requirements and user needs. At HD, we have our own highly successful ISO 13485 certified process for medical device development – please get in touch to discuss how we can help responsibly accelerate your medical device development projects.

Luke Brown - Design development Engineer at Haughton Design Luke Brown 2 August 2023

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Get in Touch with Luke Brown

Design Development Engineer

Luke graduated from Staffordshire University with a degree in Product Design and has since developed a broad range of skills from working in the HVAC & refrigeration industries to designing for sheet metal & fabrication. Luke has a keen interest in FEA and 3D CAD modelling as well as a strong knowledge of standards and patents – he is keen to contribute this experience to HD. Outside of work, Luke enjoys being creative be it through music or home improvements.

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