Prototyping allows for the evolution of medical device development because engineers can see and feel the physical device and make changes to get the device in a suitable space for users. However, making a prototype can be time-consuming and costly. Most medical devices are manufactured on assembly lines. It is not feasible for assembly lines to put together prototypes, especially since only a few units are needed at a time. Rapid prototyping is an innovative and cost-effective way to develop prototypes with limited resources and low cost.
Rapid prototyping refers to alternate manufacturing methods to develop a medical device. Whether a non-functional unit is needed or a functioning device prototype, there is a rapid prototyping method that does not utilize manufacturing resources. The most common types of rapid prototyping are computer-assisted design (CAD) and 3-D printing of models.
Computer Assisted Design (CAD)
As part of medical device development, engineers design specification documents and drawings to illustrate the device. However, these drawings can be challenging to read for a non-technical role and do not show the device in its totality. Computer Assisted Design (CAD) is a way to show a 3-D image of the device on the computer. The device is shown geometrically and graphically to illustrate its size of the device. CAD is a cost-effective way to bring a vision to life and show it across an organization. These models can be shared with stakeholders to illustrate the device and how it will look for users.
3-D Printing or Additive Manufacturing
3-D printing or additive manufacturing is a way of creating a cost-effective 3-D object that looks like the final medical device. 3-D printing is done by adding layers of a material to create an object. Traditional manufacturing methods will carve out materials in parts that are then assembled into the device. 3-D printing adds layers of a material or mixed materials to create one single device. Typically 3-D printing results in less material waste and is a cost-effective way to produce a fewer number of products.
3-D printing is typically time effective since models can be printed from within a few hours to days. Traditional manufacturing can take several days and may have business impacts. Since all materials cannot be used in 3-D printing, this method typically does not allow for working prototypes. These prototypes can be used to see how a medical device might work in a particular environment or to share with stakeholders or future users. Once a medical device is cleared through a 510(k), 3-d printed models may be shown in trade shows or in doctor train conferences.
DeviceLab and Rapid Prototyping
Prototypes are essential to bringing products to market and have a role in the device post-market. DeviceLab is uniquely positioned to help manufacturers develop prototypes. No matter your use case or stage of development, DeviceLab is here to help you develop prototypes of your vision. DeviceLab has a team of experts and manufacturer facilities here to help bring your device to life. Contact DeviceLab today to set up a consultation.
