In medical device manufacturing, the prototyping stage plays a major role in a wide range of product qualities: end design, function, material and time to market — which, in turn, makes a direct impact on the lives and health of the people for whom the device is intended to help. From that perspective, medical device prototype development is one of the most important steps of the
entire process, and should never be passed over or minimized.
Working with an experienced medical prototype manufacturer means that you can get more than just a sample representation of your medical product or component. A good manufacturing partner offers value at every step of the way, sharing its knowledge and expertise to allow for maximum flexibility and innovation in your medical prototype design, material selection, cost; and the design, use and function of the overall product.
Medical Prototyping and Manufacturing
Medical prototype manufacturers should be able to cover a broad cross-section of products, components and uses. Medical devices in general have a number of specialized requirements, including:
- Precision tolerances
- Unique, uncommon biocompatible materials
- The ability to withstand and properly interact with different chemicals, medicines and biological materials
- Innovative design
- Creative problem solving to meet medical needs
- And more
The Importance of Prototyping Your Medical Device
Medical prototyping also, however, covers the creation of more standard types of components that might be found in other products. The difference with medical devices is that every component must meet exacting health and safety standards, no matter how ordinary it may seem.
Medical device prototype development can (and often should) occur at several steps in the design and manufacturing process, and can cover a variety of needs and functions. A one-piece prototype can represent the form of a product, even one that, in production, will require a number of different components and assembly. The ability to create a sample at this early stage in the process can help you to calibrate dimensional requirements, tolerances, proper fit and function, and so on. What’s more, by creating a prototype rather than a full and likely more complicated production piece, you can save time and money as you fine-tune and adjust the design of your product.
Prototyping for medical devices can also cover only certain components or areas of a part. The complex and intricate operation of many medical devices means that they often require specialized functionality to carry out their purpose. Even for experienced medical engineers and product designers, enabling this functionality can prove challenging, requiring creative solutions and many different design iterations. Prototyping becomes critical here as an affordable way to view and test the form and function of these components and innovations — some of which may be new methods of design. The innovation that allows for medical breakthroughs and lower health care costs is only practically achievable through prototyping.
Manufacturability of Medical Device Prototypes
In addition to design and functional prototyping for medical devices and products, prototyping can also be carried out for manufacturability, as well as compliance with medical regulations. Manufacturability remains a chief concern in medical manufacturing and prototyping for several reasons:
- Can the product be effectively manufactured to fulfill its purpose without failing or malfunctioning?
- Does the product, as designed, meet required time-to-market needs?
- Will manufacturing be able to be scaled as needed?
- Will materials necessary for medical manufacturing be compatible with the manufacturing process?
This last point is especially important, as medical manufacturing can, at times, call for non-standard materials with unique properties that can spell a challenge to the typical manufacturing process. It also ties in to the last important use of medical device prototyping: ensuring compliance with medical regulations. Materials that are unable to be properly sterilized, or that may interact adversely with the human body, are unlikely to be suitable for medical devices. Materials must also be able to stand up to harsh materials and environments without weakening or interacting, and prototyping with the materials in question can help ensure that those needs will be met.
Why Is Medical Prototyping Necessary?
Prototyping is a key component of the product design and manufacturing process, and it remains a critical step for medical devices. Without prototyping, the designer or manufacturer may realize during production that the manufacturing process is producing too many failed or defective parts. At this point, prototyping must be halted and the product, or the manufacturing process, must be modified. Engineers and designers may also realize during prototyping that there is a better or more efficient way to design and manufacture the product, potentially resulting in higher quality and lower costs.
Though most importantly, in the medical field, prototyping can help ensure that a product will serve its intended purpose, potentially affecting and improving the health and lives of those who need it most. The more safely and efficiently a medical product can be designed, while pursuing the highest level of quality, the better it is for the end user. Medical device prototype development can help to achieve those goals.
What Types of Medical Prototypes Can RevPart Create?
We are experienced in prototyping for many types of products and materials, and medical prototypes are no exception. Whether using our plastic injection molding services to test living hinge design and functionality for applicators and containers, or facilitating your design for applicator syringe tips, we can work with you to determine the process, timeline and type of prototype that will best suit your needs.
Other examples of medical prototypes that we can create are ABS handles for surgical instruments, making use of a common yet sterilizable, strong and low-friction material to meet the unique needs of that type of product. Plastics for electronic medical equipment housings — whether in-room at recovery centers or found in hospitals or doctor’s offices — are also well suited to our prototyping services.
What Medical Prototyping Services Does RevPart Provide?
Depending on the needs of your prototype, as well as the specifics of your medical device or component design, we offer several services tailored to your needs. For fast turnaround prototypes where the production material is not required, our 3D printing services provide durable parts that can be tested for form, fit and, in some cases, functionality.
We also offer prototype and low-volume plastic injection molding services for situations where you’d like to test the manufacturability of a certain material, or would like to get an idea of how full production would work. We can work with you to create an affordable urethane (or other material) mold and carry out this important prototyping step.
Silicone molding is well suited to medical prototyping, and utilizes a material that is commonly found in medical devices. Plus, CNC machining remains an option for prototyping — even for plastic materials. We take pride in offering services along those lines that other shops will say they can’t do — and might even tell you are impossible. Contact RevPart with the details of your product and design, and let us assist you in prototyping to successfully complete your manufacturing process.