Creating medical devices can be a complex challenge with all the regulations and safety standards from federal agencies that need to be followed, as well as with the additional requirement for the product to be truly safe to use for any potential users. The FDA has a very strict process for the certification of medical devices to ensure the safety of the products, and the entire design and making process must be to their strict specifications. If companies do not adhere to the FDA’s specifications, they could find that the entire design and making process of medical devices could be much more lengthy and costly than initially expected. So, what kind of tips do medical device designers need to follow to ensure that their product will be safe and approved by the FDA?
Designate a Safety Engineer on the Design Team
Early on in a medical device’s design cycle, a safety engineer should be designated to ensure that all the safety standards are followed throughout the entire process. The designated safety engineer for the medical device designer needs to be fully versed in the ISO 14971 standard: the international standard for designing devices with safety in mind for medical devices. ISO 14971 has, at its core, a framework for designers to follow in order to be able to properly assess risks throughout the entire design and prototyping process, both for core features and all functions of the devices. In order to avoid lengthy and costly delays from FDA audits, medical device designers should be following ISO 14971, and they should have a safety engineer with the authority to ensure it is followed, and that the product is well documented and tested.
Hire a Usability Specialist for the Project
Usability is an important aspect of any device, whether it is medical or not. Having a usability specialist on a project can help avoid costly mistakes, especially when it comes to the safe use of the medical device that is being designed. A medical device designer may have good intentions in mind when designing a product, but a usability specialist will be able to look at a design and determine how the average user would use or misuse it. They will also work with engineers to minimize the safety risks that occur when the item is misused and to improve the overall usability. Usability specialists will also oversee the creation of the instructions that go with a medical device to ensure it’s easy to understand for the average person that will be using the device. Finally, they will also validate the product during the testing phase to see how it is being used during clinical trials, and they will list any potential issues that need to be solved.
Conduct a DFMEA
A DFMEA is a Design Failure Mode and Effect Analysis, or a process by which a medical device designer can evaluate a potential system, product, or process’s failures during the entire creation cycle. Through DFMEA, the designer will determine a product’s core features and functions, and then they will determine its failure points so they can minimize any critical failure points that could cause harm.
Determine Essential Performance
At its core, the essential performance of a product is the function it is designed to perform. If a product can no longer perform its core function, then it is no longer suitable for its intended use, but it should also not harm the user of the product. A medical device designer creating a safe product must ensure that a product fails safely, and it must include well-made instructions that are clear and understandable so that the user knows how to use a product, and how to determine when a product is no longer functioning properly so they can stop using it in time.
Documentation is also very important for the entire design cycle. It needs a robust formal release system so that others can trace the exact process for design and manufacturing. With good documentation and safety in mind, a medical device designer can ensure the manufacturing process goes as smoothly as possible, with efficient approval and release processes for their devices.
IDSYS, Integrated Design Systems, is a premier medical device designer that always designs and manufactures products with safety in mind from concept to production-readiness. Contact us for more details.