Medical device development takes a lot of work, and one of the most important steps in this process is prototyping. A prototype helps test the idea behind your new product or even makes it possible to create a working model of the product itself! These are just some of the many ways that prototypes are used in medical devices.
What Are Prototypes Used For?
Prototypes are essential for the development of new medical devices. They help engineers and designers test for functionality before being manufactured. Testing the device on a smaller scale can identify and fix potential problems early. They can show how a device will work to potential investors or partners.
Prototypes can also help to develop products more quickly. You can easily identify issues and make changes to improve performance or aesthetics by testing a product before it is manufactured. In some cases, part of a prototype may be manufactured as part of a pilot run, allowing you to test your design before manufacturing begins on a larger scale. You can then address any issues arising from mass production and save time by eliminating errors early on.
What Types of Prototypes Can Be Created?
Several types of prototypes can be created for medical devices. A physical prototype, for example, is an actual working model of the device that can be used to test the device’s functionality and get users’ feedback. Another example would be a virtual prototype, a computer simulation of the device that can be used to test its ergonomics and see how it will interact with other body parts.
A working prototype, however, is a version of the device that functions and is used to test whether a design will work and get feedback on design changes. The fourth type of prototype is a cosmetic prototype, which looks like an actual product but doesn’t function or contain all its components.
Stages of Medical Device Prototyping
Prototypes are early product versions that help test and refine the design. In the medical device industry, there are four main stages of prototyping: alpha, beta, pilot, and final product.
In the Alpha Phase, the design is refined to incorporate the learnings from proof-of-concept evaluations, to seek out the best alternatives among the many ways most devices can be built, and to explore the many tradeoffs inherent in any design.
In the Beta Phase, the design incorporates features that aren’t necessary during earlier evaluations, like shielding, water ingress, and safety features. Prototypes are built that combine functions that may have been demonstrated separately during Alpha. Details like assembly breakdowns, fastening methods, the system block diagram, and software division of labor are decided upon and evaluated with Beta Prototypes. Material selection, especially for patient contact components, and packaging design, are begun. The design is reviewed for manufacturability, and any issues are addressed prior to tooling start.
Pilot testing is when enough units are made for a small number of people to make changes before large-scale production begins. Final products undergo rigorous inspections and testing before being released for public use.
Benefits of Medical Device Prototyping
Prototypes play an essential role in the development of new medical devices. They help engineers and designers test the functionality of a device before it is manufactured. By testing a prototype, designers can identify potential problems and make changes to the design before mass production begins, saving time and money by avoiding costly changes after manufacturing the device. In addition, prototypes can test how a device will interact with other medical devices or the human body.
A prototype will typically have similar parts and components to a finished device. However, prototypes may be made with more affordable materials instead of expensive materials and parts. If new material is being used, designers can test its performance by creating a prototype out of it before committing to its use on an actual device. It is also common for some prototype components to be functional while others aren’t. Below are additional benefits to prototyping medical devices:
- Room for Modifications
- Optimization of Time and Costs
- Customization Facility
- Improve Efficiency
- Regulatory Compliance
- Patent Overlap
- If you’re ready to start prototyping, here’s a list of things to think about:
- What will the prototype look like?
- What is the purpose of the prototype?
- How can I get my hands on one to test it for myself?
- What is the budget for this project?
- How long do I have to work with it before showing it off or moving on to another one?
No matter how long you’ve been thinking about prototyping a device, you can work with companies specializing in prototyping to create something unique. They’ll have the tools and materials needed for all your prototyping needs.
If you are looking for assistance in creating a prototype for your medical device, contact DeviceLab to get started today!