Basic Principles of Risk Management for Medical Device Design

Understanding how to treat a medical condition is a difficult process, and when it comes to needing to use technology in treatments, it’s important that any medical device created by humans is also safe for humans. While, in the past, safety wasn’t as important, these days, it’s the number one priority when creating medical devices. Medical devices designed by companies have to be used safely by patients. Sometimes they are just one time use, but very often, a medical device needs to be used everyday, and it must continue to function the same way every day for as long as possible. In order to ensure that medical device manufacturers are going to act in the way that they are designed, risk management must be a core part of medical device designs. Discovering what could go wrong and mitigating as many cases of failure as possible will ensure the device is safe to use for its designed product life cycle.

What is Risk Management, and Why Is It Important?

At its core, risk management is about identifying possible risks, understanding them, controlling them, and preventing product failures to ensure that the medical device that is manufactured is as safe as possible for the patient who is using it during both normal operation and failed states. Risk management is important because it ensures that a product can be used effectively for the treatment of a medical condition. Risk management is a requirement by law when creating medical devices, and more importantly, it is the right thing to do because it keeps patients safe from further harm that could befall them if they use an unsafe medical device. Medical device designs that are submitted to the FDA for approval must include a risk management analysis before they will even consider the device for public use. Risk management also helps identify issues before release so recalls do not have to be used by the company or the FDA. It’ll also protect the manufacturer from product liability damage awards in the event a catastrophic failure occurs while in use by a patient.

Identifying Hazards

A necessary step in risk management for medical device designs is to identify all potential hazards in a device’s design, and to mitigate them. Before even the final design has been developed or prototypes have been made, a list of components must be laid out, and all hazards with each component must be identified. Once you have an initial set of hazards, you have to decide what could go wrong and how that situation should be mitigated for each component. There are general hazards that all devices may have, such as: material toxicity; component sensitivity to temperature, humidity, and light; mechanical or electrical hazards; patient-device interface misconfiguration, etc. Before a prototype is made, it’ll be difficult to truly understand the likelihood of failure, but understanding the hazards and potential severity will help the design to be as safe as possible for first use. During prototyping, hazard and operability (HAZAP) studies, as well as a failure mode and effects analysis (FMEA) for class III devices, should be conducted.

Identifying Procedural Issues

Procedure analysis should also be part of your risk management analysis, allowing you to identify potential issues that could be caused by not only human error, but also delivery of the device and device software. Human error can be mitigated through fail-safes being designed into medical device designs, so that, when humans use it wrong, it goes into a safe failure state. When delivering devices long distance, environmental factors, such as temperature, need to be taken into account to ensure the device isn’t damaged en route. As well, software needs to be put through rigorous testing to ensure it functions properly, functions on time, and data is stored and used properly.

If you are looking into developing a new medical device, then consider IDSYS for your medical device designs creation. IDSYS follows all ISO 14971:2007 risk management standards for creating safe and effective medical devices. For more information contact IDSYS.