Which is the better strategy: outsourcing medical device manufacturing or carrying out production in house? The answer depends on your circumstances. The outsourcing of assembly and production has fast become a critical part of the medical device manufacturing industry, but…
The expiry, or near expiry, of the shelf life of a medical device can be a problem for medical device manufacturers when your device is low volume with a large minimum order quantity (MOQ) or sales have not been as…
Shelf-life testing is a critical step in preparing a medical device for the market and is mandatory for all products. Fail to perform this testing correctly and you will likely have to recall products, and risk significant damage to your…
What a year it has been for everyone. As we look back on 2021, we’ve taken the opportunity to reflect on some of the highlights and events of the last 12 months that have made it a year to remember…
The ability to accurately measure and strictly control bioburden is integral to a high standard of medical device manufacturing and assembly. It is important therefore that your medical device contract manufacturer has systems in place that ensure the lowest possible…
Medical sterilization is most often the final part of the medical device contract manufacturing process and there are various sterilization methods that can be used. The main ones are gamma (irradiation) sterilization and ethylene oxide (EtO) sterilization. Gamma sterilization and…
In a marketplace characterised by increased globalisation, fast-paced innovation, fierce competition and stringent regulation, the protection of product intellectual property is a key priority for medical device companies. Therefore, when outsourcing medical product manufacturing, it is vital to choose a…
More and more medical device manufacturers are outsourcing the product development part of the manufacturing process to contract medical device manufacturers. A vital part of the manufacturing process, the standard of product development has a direct impact on the quality,…
A key area of medical device manufacturing is the development of new and improved medical products. Much of the development process can be outsourced to a contract medical device manufacturer but it is critical that you choose the right partner,…
The global medical device industry comprises a vast number of manufacturers. However, a small group of large companies hold a majority share of the market and it is these firms that will lead the sector in the post-Covid era. While…