Designing, developing, and getting a medical device on the market involves risk. It requires a large investment of your company time, resources, and reputation. It also includes risk for the health and safety of your customers and patients. One way to reduce those risks is through using medical device prototyping. While device prototyping offers much value, it also holds some common knowledge gaps, especially when it comes to rapid prototyping for medical devices.
Medical device prototyping entails creating an initial model of a medical device to aid in the development of the final product. It is performed to diagnose problems and identify opportunities early in the process to avoid extraneous costs that might hinder the product from reaching market mass production. A prototyped medical device can also help you market your product and gain the attention of investors. Rapid prototyping of medical devices can be performed for a physical device with the use of 3D printing technology or software using digital mockups.
Some important things to remember in your medical device prototype development:
You will most likely need more than one iteration. Rapid prototyping of a medical device can take as little as one or two weeks for the first version of your device, but it will more than likely not be your only or final version, especially if you are building a device from scratch. You should plan for your first prototype to focus on the look, feel, and relative size of a device. A prototype that performs even some of the functions of your final product will come later. This approach allows you to make incremental changes and prevents you from going too far down the development road before you recognize design or manufacturing challenges.
Usability matters. Testing the user experience and human factors and usability engineering is an important step in the design of a product. It allows you to evaluate and change the design of a device to better fit the human body and its cognitive abilities. One way to start that process is to use a rapid prototype of a medical device in focus group testing, allowing you to observe how real people interact with your product on a basic level and presenting the opportunity to ask questions to inform subsequent design decisions. Too many medical device developers undervalue the importance of the usability of their device. It will only be as good as the human being’s willingness and ability to use it. Incorporating human factors and usability engineering to the design and development of your medical device will help minimize user error and, ultimately, human harm. Because of this, the U.S. Food and Drug Administration (FDA), the government entity that regulates medical devices in the United States, pays special attention to usability. Prototypes are part of the FDA’s design controls review. The regulatory body also reviews usability as a routine part of their pre-market approval process, making it essential for ultimate approval.
It will cost money and time to save you money and time. Investing time and money into medical device prototype manufacturing can be a tough sell to many companies, especially if functional or rapid prototypes of their medical device were not planned for in the initial timeline and budget. However, the farther into the development process you are, the harder it is to fix any problems you encounter, which translates into more time wasted and money spent. Prototyping is critical to successfully getting your product to market. It is a learning process and trials must be done diligently with attention to achieve your goals. Sterling Medical Devices walks clients through the design process—from sketches to 3D models to the prototyping stage. Sterling identifies medical prototypes not only as a necessary requirement to move from proof of concept to a physical product, but also to test with your customers in the clinical environment. If we can help you with your medical device prototype development, whether you need functional or rapid prototyping for your medical device, please contact us today.
February 18, 2021
September 8, 2020