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Medical Device Concept Development: Important Factors to Understand

Author: Steven Hartman | Date: December 5, 2022

Healthcare professional developing a medical device concept

Medical Device Concept Development: Important Factors to Understand

Designing, developing, and bringing to market a new medical device is a complex enterprise. Each step is a learning process and trials must be done diligently with attention to detail to avoid extraneous costs that might hinder the product from reaching market mass production. The more you plan, test, and adjust along the way, the smoother your medical device development path will be to market. One way device manufacturers often do that is by starting their process with medical device concept development.

You don’t have to look much further than the phrase itself to define proof of concept. Medical device concept development, or the proof-of-concept phase as it is often referred to, means proving a concept can work by creating a preliminary model of a medical device. It gives project teams, investors, and potential users an idea of what the eventual product will look like – its look, size, feel, shape, and colors. It can help you outline things like where the operational features and power source will be located.

Having proof of a medical product concept can help test the feasibility of creating a device, get potential investors interested in funding the product, and help project teams visualize where they are going with a device.

Medical device concept development is a valuable endeavor for manufacturers, but there are some important things to consider as you embark on the process:

You must establish your needs and know your limitations. You have to decide where you are going before you can know how to get there. It sounds simple, but it is a crucial step too many developers skip. What are you trying to make? What problem are you trying to solve? Are you starting from scratch? Do you have an existing concept you want to fix? Are you trying to modernize a current product? Who will you be showing your model to – only project teams working on it, or will it be shown to outsiders like investors or clinicians? What is your budget? These are essential elements to lock down so you’re not spinning your wheels once you get to medical device concept development.

Medical device concept development is not prototyping. A proof of concept and prototype are not the same thing. While proof of concept is more about form, a prototype is about function. A proof of concept rarely has working features. A prototype takes the concept and makes it closer to reality. Medical device concept development usually includes one ideation of a product, while prototyping usually requires multiple iterations. Each is important, but each serves a different purpose.

Be sure to account for user experience. Medical device concept development is where you focus on the ability of the user to interact with the product. You can have a device that functions perfectly, but it’s not going to do much good if it is too heavy, cumbersome, or your users have a difficult time telling which end is up. Design methods like human factors engineering, industrial design, and UX/UI (user experience and user interface) design are critical to the proof-of-concept stage.

At Sterling Medical Devices, we have the skills you need to develop a product that not only does what it is supposed to do, but one that people can use. We have enhanced capabilities for product design, user based human factors research, intuitive UX/ UI design, and the ability to develop compelling medical products from the ground up. Whether you are looking for medical device concept development, medical device prototype development, or beyond, we have you covered. Contact us today to get started.

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