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The Basic Mistakes Seen with In-House Implantable Medical Device Design

At NEO Tech, we provide a full range of services for all types of implantable medical devices as well as those used outside of the body. This includes working with your in-house design team in the early concept stages all the way to design validation, approval of the device, and even to production.

The earlier that our team is involved in the design of implantable medical devices, the less chance there is that work done by the in-house team has to be revised, reworked, or even rejected. This isn’t because the in-house teams aren’t experienced professionals, but they simply don’t have the expertise and the daily interaction with medical devices and design that our team offers.

To help point out areas where common issues occur, here are a few that our teams come across once they are involved in a new product development job.

Old Software

At NEO Tech, we use only the latest in state-of-the-art software for our design specialization areas. This is critical to ensure that the device is designed to the current guidelines, requirements, and standards and that all documentation of the design processes are captured and recorded.

Incorrect Materials

In many cases, the in-house team is not aware of different options in materials that could be used in the manufacturing of the device. This can result in designs that are heavier or more cumbersome than they need to be given the newer, more durable and lightweight alloys, plastics and exotic materials that are now available.

Lack of Understanding of the Process

The number of steps, tests, validations, and documentation required for approval of implantable medical devices, even those that are non-electronic and relatively simple in design, can be overwhelming. By working with our medical device design experts, all the documentation required for the application process will be provided as part of our service, taking the pressure off of the in-house design team. To learn more, call us at (818) 495-8617.

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