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The NEO Tech Difference in Medical Device Design

Many startup medical device companies, and even those with experience in working with contract manufacturing services, have a limited understanding of just how outsourcing medical device design can benefit their business.

Medical devices are complicated and challenging, particularly when it comes to the approval process. It takes years to go through the rigorous testing, and the verification and validation process to move from concept to market. According to a 2010 study, the average cost of obtaining 510(k) clearance for a medical device had an average cost of $24 million, and in a 2017 study, a high-risk type of device that was novel on the market may cost as much as $94 million.

With these types of costs, streamlining the process from medical device design to trials and approval is essential. Working with experienced engineering services from NEO Tech ensures the design process is streamlined, effective, and that it provides the base needed to move forward throughout the rest of the development process.

Understanding of Your Requirements

Our medical device design experts work closely with OEMs to understand how to optimize the design and development process for the specific medical device. We are able to manage the entire process, including low-to-medium production volume requirements, which allows for an efficient process.

Full Quality Control and Process Understanding

We offer facilities that are ISO 13485 certified, and we also have 5 locations that dually ISO 13485 and FDA registered. This allows us to create medical devices using the rigorous standards required by the FDA based on a given variety of medical device.

Our unique business model allows us to accommodate the production needs of our customers. With our experience in the medical device industry, and our reputation for quality control, validation, and verification, and our full understanding of the documentation needed, we are truly partner you can count on.

To talk with our medical device manufacturing team, call us today at 844-630-8324.

“Raytheon is very pleased with NEO Tech and we are
NOT easy to please”

 Chairman and former CEO, Raytheon

"Collaboration, communication and cooperation
trump lowest price"

COO, Oraya

"It was like having an internal manufacturing operation
without the overhead"

President and CEO, Oraya

"The middle ground is a little hard to identify, and we needed to find someone flexible enough to play both games"

President and CEO, Oraya