Surgical tools and implantable, portable, and wearable medical devices aren’t produced from an idea overnight. They undergo rigorous design phases, prototype creation, testing, and more testing. By the time anyone has access to a prosthetic limb, a bone screw, or a hearing aid, they have already gone through countless hours of production processes to ensure they suit their intended purpose. You might be curious about what is actually involved in the creation of medical devices. Satisfy that curiosity with some of the following information.
Customer Needs Play a Huge Part
It goes without saying that medical equipment suppliers only stock products that are in demand by care facilities and hospitals worldwide. If it’s not something doctors, nurses, and support workers need, there is no point producing it.
That’s why whenever a new medical device enters the development stage, customer needs are assessed to conceptualize the best possible end result. Many factors play a part in this research and discovery phase, such as client needs vs. device functionality, the working environment of the device, and the best manufacturing materials and methods.
FDA Requirements Are Considered Early On
Even before the prototype creation phase, FDA regulations and ISO specifications are considered to avoid any potential hiccups at a later date. Medical device companies that factor electrical safety, sterility, and biocompatibility into those initial designs may speed up the quality control and approval processes toward the end of its completion.
Specifications Are Crucial
Whenever you see the long list of specifications on any product, you already have a fair idea of how much effort has gone into developing it. However, medical devices can be even more complex.
After time is put into research and discovery, engineers work on the mechanical, electrical, and software components of the device. They look at its functionality, any restrictions it might have, safety features, and materials. The more precise engineers are while factoring in FDA regulations, the less likely it is that they’ll need to make significant changes later on.
Engineers Rely On CAD Software
Though the engineering phase of medical device creation involves the use of raw materials, it can take some time to work out how the shape will form, how all parts will sit together, and how the overall design will affect its use.
As a result, engineers often rely on 3D CAD software, which is a form of computer-aided design. This software helps engineers and designers create, modify, analyze, and optimize the configuration of things like MRI and other medical imaging machines. Prototypes can eventually be produced from that CAD design, and tweaks can be made until manufacturers are happy with the final product.
Interestingly, the CAD software engineers use for medical device development doesn’t tend to be the same as what you would use for any other product. All medical devices must be created on medical-grade software that complies with the specific FDA software guidelines.
Several Prototypes Can Be Developed
Documentation is produced for each step, which then forms part of the FDA approval process before it finally makes its way to market.
Understanding just how much can be involved in the creation of medical devices may give you more appreciation for the exceptional products we now have at our disposal. Everything from thermometers to saline bags has gone through similar processes to provide you with complete confidence in their functionality and safety.