• The Medical Devices industry plays a crucial role in maintaining public health. Given its importance, the industry is well regulated and monitored in order to manage risk.

    • Production design to development in the current industry

      Even the smallest of errors within a medical device can mean the difference between life and death for the end-user. Considering it is such a high-risk industry, the entire supply chain must comply with their regulatory obligations. This includes all challenges and risks being managed with a strategic and thorough approach. Different challenges arise at every stage of a medical devices' life, with most of them proving surmountable with the correct Standards applied and regulatory obligations met.

      • Product Research

        Medical device manufacturing starts with product research. Manufacturers need to assess there is a need in the market for a specific device. Once it is ascertained, the form of the device itself needs to be researched. To address the market requirement, manufacturers may speak with a number of medical professionals and potential end-users about what features are needed in a device for it to be a viable solution. The research cumulates into a concept, which then proceeds to the design phase. 

        Product Design

        As the design phase begins, all products being designed must take into account all inherent and potential uses, configurations and risk associated with it. Current and future Standards are to be accounted for.

        Product engineers collaborate with the Product Development team to help turn concepts into reality. All medical device companies invest in developing regulatory strategies and implementation plans for the preparation and submission of new products. This process takes months or even years, and requires coordinated strategic effort and dedication to meet the relevant regulatory obligations. Failure to account for potential or inherent risks in the product could mean risking the health of consumers.

        A well designed product is less likely to cause health problems for consumers, or to be recalled. There is no room for error in this stage of a medical device's production. Dangerous design flaws can be avoided and minimized by implementing a comprehensive risk management system.  ISO 14971:2019 is an example of a Standard that can help manage risk at this stage. This Standard provides guidance on how risk should be assessed, analysed, monitored, documented and controlled to protect both the end user and the manufacturer. The framework it provides assists the medical device industry's process from start to finish. When a product's design is finalized, having met all regulatory obligations and criteria, production may begin.

        An example of a product design flaw

        In November 2019, hundreds of women that were left in debilitating pain caused by a faulty transvaginal mesh device won a landmark case against international medical device corporation, Johnson & Johnson. 1,350 women were treated with the mesh, but the device left them with severe pain, as it eroded internally in many cases. This caused many complications, including infections and was extremely difficult to remove. It came to light that the devices were not tested properly for safety before being sent to market. While the court case heard that the devices were allowed to be sent to market because they had been cleared for sale within the European Union, Johnson & Johnson have not addressed the claim that there was widespread and systematic noncompliance with the EU's requirements.

        Device Production

        Production of medical devices often requires multiple parts in order to function. All independent suppliers, contributors or manufacturers that lead to the production line must meet their regulatory obligations and safety requirements.

        In this stage, Product Safety Engineers, Product Engineers, and Biomedical Engineers work together to ensure the product is as safe as possible. All Standards used by the core manufacturer as well as the suppliers must be current and comply with any regulations within individual countries the device may be exported to. All regulatory information must be distributed amongst all departments involved with the production in a comprehensive system.

        Ensuring that all internal and external stakeholders meet the safety requirements of the product's development translates into lower risk levels, which means safer and more reliable solutions for consumers. Standards such as ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes can greatly assist in managing risk in this stage. 

        As regulations are enforcing stricter standards for safety and quality, the cost of failure of not meeting these standards can result in litigation and loss of life. Manage your risk effectively with SAI Global as your trusted compliance partner.

        • Medical Devices Standards Management

          Rigid regulatory obligations leave no room for error in the medical devices industry

        • Understanding ISO 14971:2019

          The updated Standard for the application of risk management to medical devices

        • 8 Benefits of Standards

          Discover the benefits to your business

        • Discover how to keep up with product Standards with SAI Global's management solution.

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