Contract manufacturing
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changes, with many lower-risk devices in the EU now considered higher class. This has presented unique challenges and regulatory obligations for manufacturers, as complex Class III unsurprisingly devices require the greatest level of expertise and capabilities to build.
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Enter contract manufacturing organisations (CMOs). Because developing a new medical device is complex and costly – and actually building it is too – many original equipment manufacturers are instead leaning on CMOs. “Better and more established capabilities are being offered right now by CMOs compared to a few years ago,” explains Mohammed Behnam, a senior partner at McKinsey. There are many benefits to using a CMO, and over the past few years, there has been a noticeable shift in the industry towards OEMs leveraging CMO expertise in design, development and manufacturing to take their product development from concept to final product. Behnam, for his part, highlights two: better cost structure or flexibility, as well as greater access to specific technologies or manufacturing processes that an OEM might lack. Yet CMOs offer more than just high-quality and consistent manufacturing environments. Rather, they also have extensive experience and understanding of the complex regulatory requirements and quality standards demanded of Class III device manufacturing. By partnering with a CMO, OEMs can tap into this expertise and benefit from increased flexibility and scalability, cost savings and faster product development timelines. For Behnam, utilising CMOs “supports the patients” too, as their specific technologies and manufacturing capacity helps accelerate the product to market. With CMO capabilities focused on the manufacturing, moreover, this allows for OEMs to minimise their capital investment in manufacturing plants, equipment and personnel and reinvest in other areas of the business.
Effective devices
Beyond these headline strengths, however, what must companies actually do to ensure the effective production of Class III devices? Behnam highlights the importance of the relationship between OEMs and CMOs, suggesting that moving away from a vendor-customer relationship to a true partnership will inevitably lead to a more efficient process. OEMs, for their part, play a crucial role in supporting CMOs through various stages of the production process and work closely with CMOs to transfer technical knowledge and expertise, helping them understand the intricacies of the devices and the specific requirements for their production.
38 Medical Device Developments /
www.nsmedicaldevices.com
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