Prototyping is used throughout the development process and is critical to the design, styling, functionality, reliability, and safety of your medical device or diagnostic instrument. It is such an integral part of development that proficiency and prototyping capability can significantly affect your product performance.

Since 1984, Omnica has delivered top-quality medical device product development services. We are a design and engineering firm specializing in Class I, II, and III devices, IVD systems, and other laboratory instruments: Misonix Nexus, Therox AO System, and Thermo Fisher VeriSpray.

Medical Device Prototyping Steps

Here are the steps in medical device prototyping:

Step 1: Concept Development

Depending on when we get engaged in a project, Omnica is ready to assist in the early concept development. This stage involves a very high-level overview of the system’s architecture and the overall aesthetics of the design.

While we begin with 2D activities (sketches or renderings), the final design direction is usually arrived at by prototyping. These are crude prototypes that might only have the external shape so the users can decide among the final design contenders. Ergonomic mock-ups (prototypes) might also be constructed to help determine the final design direction.

Step 2: Proof of Concept (POC)

We engage in proof of concept development if we are very early in the design process. In this phase, we design a working system without concern for aesthetics, size, and other aspects. Often, this is done to prove that the technology and areas of high technical risk will function. Naturally, this requires prototyping to build a functional system using off-the-shelf (OTS) and simple custom parts.

Step 3: Alpha Design

Virtually all projects go through an alpha design phase, which is a fully functional system that performs all the required functions. Although the prototype may not resemble the final product, it is used to test all parts. It also determines the last approach that will be taken in the next phase of development.

Step 4: Beta Design

Once all the learning has been achieved from the alpha system, we will design the beta version. This fully functional version appears and operates similarly to the final design. It may incorporate advanced prototype parts, such as 3D printed plastic skins instead of injection molded components.

The beta prototype and its copies can also be utilized for pre-testing for usability, clinical studies, electrical safety, and marketing purposes. We will also use this design to develop the manufacturing instructions and in-process testing requirements.

Step 5: Transition to Manufacturing

Depending on the manufacturing strategy, documentation, fixtures, and assembly training may be developed. They are also typically provided to the eventual volume manufacturer (customer or contract manufacturer).

Importance of Prototyping

Prototyping is a crucial element of any development process but can also be a significant time commitment. This is why Omnica conducts 90% of its prototyping in-house. In addition, service bureaus can provide prototypes for sheet metal, machining, casting, or 3D printing. However, the turnaround time required for these outside services can add unallowable delay and risk to a project.

For instance, a 2D drawing with sufficient detail must be created and sent to the vendor if a machined component is needed. Then, there would be a period of back-and-forth communication to clarify critical dimensions, tolerances, and other design features. The vendor would then schedule the part and provide a turnaround time. This could take several days to weeks, depending on the working relationship with the vendor and their workload. Even after the part is received, design changes may still be required, starting another cycle.

When multiplied by various custom components in a system, it is easy to see how the prototype activity can significantly increase project time and risk. On the other hand, in-house prototyping also allows for faster design iterations, as two or three iterations can be built and tested in a single day.

Partner With Omnica Corporation for High-Quality Medical Device Prototypes!

Looking for a partner to help bring your medical device to market? Look no further than Omnica! We have a full suite of product development services, including industrial design, engineering, regulatory support, and pilot production. We can help take your idea from concept to commercialization!

We’re committed to delivering innovative solutions that meet your unique needs! Contact us today to learn how we can help make your vision a reality.