Contract manufacturing
CMOs have experience and understanding of Class III regulatory requirements and quality standards.
also essential for effective and accurate transfer to production. To explain what this means, Behnam points to design transfer excellence as something to get right. “This is one area in medtech that takes longer than other industries,” he says, “and being able to move from development into manufacturing… that’s another area that is extremely high-cost and getting that right would help a lot.” Cleanrooms are another factor to consider when building Class III devices. “This controlled environment, which reduces particulates, is crucial for maintaining the cleanliness and quality of medical devices, as any contamination can lead to serious health risks for patients,” explains Beddoe-Rosendo. With that in mind, adherence to strict cleanroom manufacturing processes and standards is critical to ensure that devices remain uncontaminated. “Sterilisation,” Beddoe-Rosendo adds, “is often a vital step in the production of Class III medical devices. Ensuring their sterility is critical to prevent infections and other complications post-surgery.”
Challenges ahead To maintain high standards of quality and safety in manufacturing, CMOs should have a QMS in place to control their processes and ensure a consistent output, Beddoe-Rosendo explains, something that’s particularly crucial for Class III medical devices. Not that the future is totally hurdle-free. Over recent years, after all, new difficulties such as global supply chain disruptions have increasingly come to the fore. “Challenges would come up if a CMO would not be able to meet the service level agreements they have with OEMs,” explains Behnam. This risks resulting in shortages, as CMOs fail to deliver on their promises. As Behnam says: “We’ve seen that through Covid years.” As Hannah Leadbetter, regulatory and clinical research specialist at KCL, says, however, the
Medical Device Developments /
www.nsmedicaldevices.com
MHRA recently stated that it intends to propose a requirement for legal manufacturers to inform it of potential supply chain issues or disruption that could cause a shortage of medical devices in the UK market. “We expect an increase in pressure to communicate more effectively along the supply chain,” Beddoe-Rosendo explains. “This heightened level of communication is essential to ensure that any potential disruptions are identified and addressed promptly, thereby maintaining the availability of critical medical devices.” Whatever these difficulties, at any rate, it’s also clear that the growth of Class III contract manufacturing presents significant opportunities for CMOs and OEMs alike. By focusing on compliance, advanced manufacturing capabilities, skilled workforce development, and robust quality management, CMOs can effectively produce these high-risk, high-reward devices. OEMs, in turn, must provide substantial support through knowledge transfer, investment, regulatory guidance, and strategic partnerships. No wonder the global medical device outsourced manufacturing sector is expected to hit $56bn by 2026. Looking ahead, indeed, Behnam is optimistic – and expects CMOs to continue contributing to better patient care through more accessible products. “We’ve seen this trend in pharma,” he adds. He’s right: over the past few years, CMOs innovated new processes and offered them to OEMs to create next-generation drug delivery technology. “This could happen in medtech, and I believe the opportunities are unlimited.” The future of Class III device manufacturing is bright, in short, with the promise of innovation and enhanced patient outcomes guiding the industry’s growth trajectory. As CMOs and OEMs navigate this complex landscape, their combined efforts will be instrumental in meeting the rising demand – and maintaining the highest standards of medical device production. ●
$623bn The expected
growth of the global medical device market in 2026, up from $471bn in 2020.
Nature.com 43
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Shutterstock.com
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