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Medical Device Prototype and Manufacturing

In medical device manufacturing and medical injection molding, 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 medical injection molding process, and should never be passed over or minimized.

Working with an experienced medical device prototype manufacturer means that you can get more than just a sample representation of your medical product or component. A good medical device prototype manufacturer 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. Injection molding medical devices is a highly intricate, specialized process, and your medical device prototype development partner must be up to the task.

Medical Prototyping and Manufacturing

Medical device 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 and medical device prototyping 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 medical injection molding design and manufacturing process, and can cover a variety of needs and functions. A one-piece medical device 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. An experienced medical device prototyping company 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 medical-grade plastics injection molding materials be compatible with the manufacturing process?
  • Is the partner experienced in working with biocompatible plastics that are able to operate as implants, tubing and other necessary medical functions?

These last points are 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, when injection molding medical devices, 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 a medical device prototyping company experienced in prototyping for many types of products and materials, and medical prototypes are no exception. Whether using our medical-grade plastics 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 device 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. 

Benefits of Working With RevPart

Working with RevPart for your medical device prototypes means you’ll benefit from our extensive expertise, quick response times and comprehensive array of capabilities. We have all the abilities necessary to handle your prototyping in-house according to your design guidelines and specifications, meaning you can rest assured you will have a single point of contact throughout the process. You’ll also have the assurance that the prototypes will be of the highest quality. Because we can work so quickly, you can reduce your cycle times and introduce your new products to a waiting market much faster than through other means.

Our experience in the highly complex and demanding field of medical prototype development means we also can work closely with you to test and validate your ideas. This ensures that your innovations can be turned into market-ready products with the confidence and dependability that comes with partnering with a known industry leader. We will stand with you every step of the way as we help you realize your ideas.

Contact RevPart with the details of your product and design, and let us assist you in prototyping to successfully complete your manufacturing process.