Taking Hold of the Rising Demand for Quality Medical Device Manufacturing
Posted On June 29 2021
The demand for quality medical device manufacturing is rising steadily and this trend is expected to continue. With the increasing demand for devices, developers are looking for electronic medical device manufacturers to partner with for production. A manufacturing partner will need experience and certain capabilities to meet this demand at the level of quality and regulation these products demand.
Why is There a High Demand for Medical Electronic Assembly?
Advancements in medical technologies, as well as how diseases are diagnosed, treated, and managed, has driven the demand for medical electronic assembly up drastically. Clinical wearables, blood glucose monitoring systems, in-vitro diagnostic platforms, and ambulatory systems are medical devices that require high-volume, complex consumables to make quality patient care more effective. These consumables are not only going away, but as medical technology continues to advance, the demand for medical electronic assembly may continue to grow. As the demand for assembly grows, the demand for electronic medical device manufacturers will also grow.
The Challenge for Electronic Medical Device Manufacturers
There are challenges for electronic medical device manufacturers regarding the assembly of electronic medical devices. The manufacturing process for electronic medical devices is unique, highly regulated, and exceedingly complex. Any partner providing medical electronic assembly needs to have rigorous internal quality control standards, parts forecasting and obsolescence management, and the ability to make these components at the needed volume while maintaining quality and reliability. Manufacturing high-reliability disposables at scale can be challenging, although seasoned design engineers know what to look for and how to handle the scalability while maintaining the integrity of the product.
Choosing the Right Partner for Electronic Medical Device Manufacturing
Experience in manufacturing for the medical device industry is of primary importance when looking for a partner for your electronic medical device manufacturing. The ideal partner will also have:
- A vetted supply network.
- An on-site engineering team.
- Design capabilities.
- Counterfeit mitigation processes in place.
- A testing process specific to the device in assembly.
- Re-design and reverse engineering capabilities.
- Compliance certifications such as ISO 13485.
Ultimately, although electronic medical device manufacturing has unique challenges with regards to the individual electronic medical devices, the processes and capabilities of the partner are no different than many other complex consumables. A turnkey manufacturing facility with the ability to manage the entire project is the most important piece. The right partner will have the ability to track every step in the complex process of taking the electronic medical device from concept and design through delivery. Once the process is designed, it will need to be made repeatable. As medical devices become more complex, the likelihood of human error grows. In the case of electronic medical device manufacturing, this must be avoided at all costs. Automation in electronic medical device manufacturing will help to meet the demand by assisting with quality control.
Finding the right partner can be a challenge. When looking for an ECM, find a turnkey shop with on-site engineers, experience in electronic medical device manufacturing, and high standards. With the right shop to partner with, meeting the demand for electronic medical devices can be met, even as the need increases. We are your one-stop-shop for medical device manufacturing. Here at Levison Enterprises we have experience working with many industries, and we meet high internal standards, certifications requirements, and employ knowledgeable staff- all of which are necessary to provide outstanding service and an end product you can be proud of. Contact us today for a quote.
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