In the business of medical device manufacturing, there will always be risks. No device is 100% fail-safe, and manufacturers must take risk management very seriously. When medical devices fail, there can be serious and sometimes fatal consequences for both consumers and the companies making the devices. Thanks to the FDAs Class I Recalls list, it’s easy to find instances of failed medical devices and the companies affected by the recalls.

International Standards Organization

In 2019, MedTronic had to recall more than 1,000 MiniMed insulin pumps for cybersecurity concerns. It was found that the remote controls to the devices could be hijacked by bad actors to either over-deliver or suspend insulin delivery to diabetic patients using the insulin pump. When leveraging contract manufacturing of medical devices, you’re far more likely to have medical devices that are in compliance with ISO and FDA regulations. What ISO 1497 does for medical devices helps manufacturers identify and mitigate risks like that of the MiniMed insulin pumps. The standard is often reviewed and periodically updated to meet the changes in global medical device regulations. The ISO specifies review procedures and monitors device design, manufacturing, and post-production to help ensure compliance throughout the lifespan of the product.

Risk Assessments and Management Standards

Risk assessment began with the European standard EN 1441 and has evolved to include a standard that manages the whole risk process. All medical device manufacturers are required to have and demonstrate an effective risk management strategy. This includes identification, assessment, and control of processes to prevent failures, as well as performing risk analyses or assessments that can identify potential dilemmas that can occur when using a medical device. Without these management standards and risk assessments, there is little protection for those who are using defective or problematic medical devices, and litigation can lead to bankrupting a company.

Proactive Quality Management

As more and more technology becomes available, there’s a rush to create medical devices based on those technologies. But companies need to be sure that they’re placing more emphasis and value on device quality. Conducting a compliance audit can only ensure that a company is creating a product that is up to FDA and ISO standards, but it doesn’t help inform the manufacturer of any ways to anticipate and mitigate supply chain disruptions, optimize storage and distribution, and navigate the intricacies of compliance. That’s why it’s important to have proactive quality management strategies. Some ways to do this are to include predictive analytics that can leverage historical data to gain insights into possible outcomes, use quality management systems to identify potential problems, automate processes, create a corrective action plan, and reduce the margin for human error.

Patient lives and company reputations are at stake when medical devices fail to function as they should. So it is of the utmost importance that manufacturers have a firm grasp on how to mitigate the risks. The secret to mitigating the risks lies in the details and the systems that are in place to identify compliance issues and potential problems in the manufacturing process.