Having an idea for a new medical device that can treat a condition, restore mobility, help to alleviate pain or discomfort or to give someone a chance to get back to a healthy life is an amazing opportunity for a company. However, it is also just the very tip of the iceberg when it comes to actually getting the device designed, prototyped, tested, approved, produced and then marketed.
At Aztalan Engineering, Inc., we have worked with small medical device companies and some of the leaders in the industry. We understand the challenges and the steps in design to production of these devices. With our experience in the precision manufacturing of medical device components, we are also uniquely positioned to work with your team throughout the process.
In the design stage of any medical device components, our engineering team can work with your design and engineering team. This allows us to share our expertise to avoid extensive revisions of the design which will slow down the process and extend the time to approval and market.
Our engineers can also assist your design team in selecting the most appropriate materials. We understand the different requirements in materials for various classes of medical devices, which can make selecting the lowest cost and best-suited material much easier.
We can run a DFMA or Design for Manufacturability an Assembly report for you on the design once it is developed. This will allow your company to review the current cost of production. We can often suggest alternative materials or even different machining and manufacturing options that will achieve the same desired results in your medical device components while helping to lower overall production costs.
By taking advantage of these services, prior to the prototype development, project management and full production services we offer, your company can streamline this initial stage of the process. We can customize our services to meet your needs, making it a cost-effective option at any stage of development.
As we know, the manufacturing of all classes of medical devices takes a significant amount of stringent effort, quality control, expertise, and care. That’s why at Aztalan Engineering, we spend the majority of our time making sure that you receive the exact medical device components and accessories that you need for your medical device; quality and all.
Medical Device Components
The manufacturing of medical device components and accessories is heavily regulated by the FDA. This means there are set standards that all manufacturing companies must strictly follow in creating any medical device components and parts.
Through a classification system, the FDA determines the kind of manufacturing, labeling and packing that a medical device must have in order to be deemed acceptable or safe enough for use. These classifications also apply to medical device components and/or medical device accessories. There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III.
You may be asking the question: What do these classifications of medical devices have to do with choosing a medical device component manufacturing company? The answer is simple: everything. Choosing a manufacturing company that fully understands and stays up-to-date on these classifications and their impact on the quality of their medical devices is of the utmost importance.
At Aztalan Engineering, we know that Class I Medical Devices have the least regulatory control due to the fact that these devices generally have a history of safe use. Moreover, what this classification means for your potential medical device component is that its design and manufacturing need to be more simplistic, in accordance with good manufacturing practices.
With Class II (general control plus special control) and Class III (general and special control plus premarket notification) medical devices and their components, there are more detailed instructions or regulatory controls that must be abided by during the manufacturing process. Thanks to our extensive experience, we can guarantee to manufacture products that comply with regulations and have the highest quality in the market.