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Avoiding Common Medical Device Design Issues

One of the advantages we offer all our customers is the expertise and experience of our NEO Tech design teams. Each member of our staff specializes in one or more areas of medical device design, prototype development, and production.

With our team approach to medical device design, we can avoid many of the common issues that can occur. These problems are costly and can result in production delays that can be the difference in providing a groundbreaking technology or simply being one of a number of devices coming onto the market in the same general time frame.

Some of the most common issues that companies experience when they use internal medical device design teams without expertise are outlined below.

Not Understanding the Time Involved

Without working with an experienced design team, a company is often unaware of the actual time that is involved in the process. While our NEO Tech team can streamline the process, it typically takes over five years to move a new device from concept to approval.

Staying on time is possible when the process includes setting milestones for achieving specific steps in the process. Delays in any stage after concept development can extend this time significantly, often resulting in budget overruns that become impossible to support.

Not Planning for Validation

The most challenging aspect of most medical device design plans is the lack of understanding of the specifics required for validation and testing. Unfortunately, this results in rejection of the application for approval due to lack of quality control and validation measures.

With our experience, planning for validation and testing will start right at the point of our involvement with the project. This can alleviate this bottleneck during the process and ensure that your new device gets through the pre-clinical and clinical testing on time and in compliance with all standards required.

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President and CEO, Oraya