Medical device contract manufacturing in the past
A few decades ago, medical device OEMs single-handedly developed and manufactured their medical innovations. The advantage of this kind of operation is the ability to have complete control over design and development, small pilot production, and large scale mass production. However, a large-scale ISO13485 compliant GMP manufacturing facility represents an enormous capital commitment.
Thus, medical device contract manufacturing organizations (CMO) were born to tackle this issue, allowing medical device OEMs to outsource the large-scale manufacturing of devices without the capital investment on expensive equipment. This also means that each CMO can focus on a few medical device manufacturing specialties such as device surface coating or high precision injection molding. It is a win-win for both the OEMs and the CMOs. Nevertheless, as more and more medical innovations are generated at a much faster rate, CMOs alone are insufficient to satisfy the product design and development needs of medical device companies. Here comes the medical device contract development and manufacturing organizations (CDMO).
What is a CDMO?
A contract development and manufacturing organization (CDMO) provides everything a CMO does and plus the ability to optimize device design and development. Medical devices nowadays are more complex than ever before. It requires an interdisciplinary team of experts across different fields, including materials, electronics, and IT. Due to the intricate nature of modern medical devices, many medtech innovators focus solely on the conceptual pilot product designs.
This poses technical challenges in the next development stage and downstream mass production. CDMOs are often veterans and experts in their respective device fields, so they have the knowledge and experience in optimizing existing product design and further product development. Moreover, CDMOs can translate their pilot designs to large-scale production more readily and efficiently.
A value-added CDMO, such as HKBio, provides end-to-end services to medical device OEMs. In addition to pilot and mass production, HKBio also provides local device registration services and product distribution services, facilitating the time-to-market and maximizing sales revenues with HKBio’s global distribution network.
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