Medical device prototypes are essential to the manufacturing and commercializing of medical devices and tools. Prototypes exist so that manufacturers can test their products’ functionality, appearance, and other key characteristics before launching full-scale production. The actual prototyping process begins after your idea has been validated, so you have some idea of what you’ll need to produce your prototype. Here’s an overview of the medical device prototyping process – the four steps you should take to bring your idea to market.
Benefits of Prototyping
A prototype is a version of your idea that can accurately represent what the end product will look and act like. Due to technological advances and decreasing costs, prototypes are less expensive and easier to produce than they were just 20 years ago. In addition, they can be modified to add or remove design features, and it’s easy to make adjustments on a CAD system, saving a lot of time and money down the road.
Step 1: Appearance Model
Begin by sketching your concept. Jot down your idea, as rough as it may be at this point, on a piece of paper or a computer program. Then redraw it to scale and illustrate how you plan to make this idea come to life. Sketch and redesign until you feel confident that you’ve developed the best possible design for your device; remember that it’s crucial to consider whether your device is scalable when doing this step.
This can be one of the easiest or most difficult parts of your prototyping process because it is the initial phase of bringing an idea to life. Once you have a sketch for your concept, you’ll need to develop it into an actual prototype to test it and get feedback from others on what works and what doesn’t.
A virtual model is created through 3D modeling. These models can be used as a guideline for creating a physical prototype. The virtual model is an engineering idea, whereas the physical model is what it will look like when manufactured. By creating a virtual model, designers can test multiple iterations of their product without wasting time, money, or materials.
Work with a team of designers and engineers, who all have their specialties. One person may focus on engineering the product, so it functions as intended; another may make sure it looks nice, and yet another might ensure that it’s cost-effective to manufacture. Once they come up with their final designs, they’ll send them off to have a physical model created.
Step 2: Proof of Concept
The model is made using a Computer-Aided Design (CAD) program, which we use to create an image of our design. Sometimes this will be just a virtual model, while we’ll need to print out a physical prototype.
Depending on the design’s complexity, this process can take weeks or months. Physical models give you something physical to show investors and customers, which is much better than describing your idea with words.
Prototyping helps us visualize the end product to make it more tangible for potential partners. Prototyping gives something concrete to share with engineers who might have questions about the specifications for manufacturing. And lastly, prototyping ensures we have gone through all the necessary iterations of a design before going into production – meaning errors can be fixed early on instead of after manufacturing has already begun.
Step 3: Alpha and Beta Prototype
In the Alpha Phase, the design is refined to refine any mistakes learned from the initial proof-of-concept evaluations and explore different aspects of the product.
An alpha prototype shows that a proven concept is possible to make into an actual product and may be both aesthetic and functional (but usually limited to a small number of functions). In Alpha prototypes, the software is usually demonstrated offline, using a simulation that is not functional. While electronic components are arranged across the lab bench, basic functionalities are demonstrated. There may be several design embodiments that survive and compete as the Alpha stage progresses, depending on the selection of mechanisms, sensors, and interconnects.
During the Beta Phase, features not necessary during earlier evaluations are incorporated, such as shielding, water ingress, and safety features. Prototypes are created that combine functions that might have been demonstrated separately during Alpha. With Beta Prototypes, details such as assembly breakdowns, fastening methods, and software division of labor are determined, and materials selection for patient contact components and packaging design are begun. Manufacturability issues are addressed prior to tooling start, and the design is reviewed to ensure that it can be manufactured.
Beta prototypes are made to support refinement testing and user evaluations post-Alpha. There is typically only one embodiment tested at this stage.
Step 4: Pilot Production
The fourth step in prototyping is to test and refine through pilot production. Here, you will try your prototype on people diagnosed with the same medical condition as you or similar medical conditions and consider their feedback. You may need to make changes based on their feedback and start with a new prototype until you get it right.
This phase takes the concept to life. It’ll ensure your product is working properly and user-friendly before investing time and money into manufacturing it. If anything needs changing, this is the best time to do so. Any adjustments can be made easily at this stage of the game.
Once this stage is complete, your device is off to be mass-produced! Depending on the type of device, it could take a few months to years for your idea to come to fruition. It’s important to be thorough during the testing phase to ensure no surprises when it’s being mass-produced.
