Four Tips for Designing Medical Devices with Safety in Mind

Designing and manufacturing medical devices is a complicated process and it can be challenging for medical device companies to adhere to the strict safety standards and federal regulations that the FDA has stipulated for every stage of the production process. To ensure that all medical device designs that the agency certifies are completely safe for potential users, the FDA is extremely vigilant about screening medical devices for compliance issues. A failure to abide by the rules and to meet its specifications will result in the FDA’s not giving its approval to the medical device.

To bring the product on the market, you will have to make the necessary design revisions to the medical device so that it meets the FDA standards. That is likely to cause delays in your production schedule, disrupt your delivery agreements with vendors, and end up increasing your design and manufacturing expenses. And that is why it is advisable to follow the FDA design guidelines and requirements from the start.

Tips for designing medical devices with safety in mind

Here are four tips for designing medical devices with safety in mind:

1. Get advice from a safety engineer

An experienced and competent safety engineer will know the requirements of the ISO 14971 standard. This is the international standard for designing medical devices that are safe for end-users. ISO 14971 provides designers with a framework to assess potential risks to the product’s core features and functions, and thus enables them to address and resolve these. The safety engineer will monitor the manufacturing process to make sure that all the ISO 14971 protocols are met at every stage, that the process is well-documented, and that the products undergo rigorous testing for safety.

That will help your medical device company to get past the FDA audits without a hitch. It will also save you the considerable cost of revamping the design and the production.

2. Work with a usability specialist

When designing a medical device, it is essential to consider how the end-users will use it in a home or clinical setting and also how they might potentially misuse it. A usability specialist will work with the safety engineer and others in the product design team to consider all possible risk factors. Along with attempting to eliminate critical errors, the usability specialist will try to prevent any secondary ones that might arise.

Additionally, the usability specialist will participate in the testing phase of the medical device in a clinical environment and provide validation that the device is working as intended. If there are any errors or issues, the specialist will note them and find ways to remove them.

The usability specialist will also be responsible for researching and creating the instruction documentation for the medical device. He or she will make sure that the device operating instructions are clearly stated with no room for ambiguity or misinterpretation. The specialist will also address concerns and questions that the average end-users might have about using the medical device.

3. Carry out a DFMEA

Conducting a Design Failure Mode and Effect Analysis (DFMEA) is essential during the entire creation cycle of the medical device. It can help the product designers to evaluate any potential failures in the product, process, or system at every stage. The designers will analyze how the device must operate to fulfill its main intended purpose and if there are any secondary purposes that it could be used for.

They will try to determine if any small design failures in the device could cause it to malfunction in its entirety and if such malfunctioning could cause harm to the end-user. The designers will then review the possible options to get rid of these failure points.

4. Identify the product’s essential performance

The product designer must identify the medical device’s essential features and core functions and find out if the device is working as it should. If any issues might compromise its basic safety, lead to its malfunctioning, and cause harm to the end-users, the systematic DFMEA process will have revealed these. After making note of the failure points, the product designers can then make the necessary design changes and improvements to enhance the safety aspects of the medical device.

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