Medical life would be inconceivable without Class III technology. Representing high-risk medical devices – considered essential to support or sustain life – examples include pacemakers and defibrillators, which represent 10% of medical devices regulated by the FDA. Due to the level of complexity and the critical nature of these devices, meanwhile, it is no wonder that they undergo the strictest scrutiny for market approval. Compliance and regulatory adherence are paramount, as Class III devices are subject to stringent requirements from bodies such as the FDA, requiring rigorous quality control through documentation, and regular audits from outside experts.
Lawmakers, for their part, are transforming the Class III sector too. Since the adoption of the European Medical Device Regulation 2017/745 (EU MDR), the medical device field has seen significant 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.
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.
10%
The percentage of medical devices regulated by the FDA that are Class III.
Institute of Materials, Minerals & Mining
In practice, however, Behnam notes that “currently, some of the OEM leaders are careful in using CMOs”, highlighting the concern that they might be taken advantage of. All the same, Behnam is keen to stress that there are a number of successful partnerships where working together has been a “win-win”. One good example is Prolight Diagnostics, which recently partnered with G&H | ITL to develop its point-of-care Psyros system. Behnam, for his part, outlines the steps to breaking free from old mindset: openness, setting joint targets, and having goals across every single layer of the organisation. “Sometimes,” he adds, “the partnership agrees at the highest level of the organisation, but when you go lower that mindset is not there.” Of course, this could ultimately lead to miscommunication, and ultimately delays in getting products to market. One solution here is establishing fundamental good practices, tools and processes. “A must-have in this relationship,” warns Behnam, “is a quality process.”
Other experts, for their part, agree with him – especially when it comes to following the so-called Quality Management System (QMS) mandatory for any new medical device in the UK. “The degree of control implemented within the QMS should be proportionate to the risks associated with the specific device,” Jacqueline-Beddoe Rosendo, design quality and regulatory lead at King’s College London (KCL), explains. “By meticulously managing and monitoring suppliers, manufacturers can ensure that the materials and components provided consistently meet the required specifications. A minor deviation in the chemical composition of materials used can lead to catastrophic consequences, potentially compromising the device’s integrity and biocompatibility. Thus, maintaining stringent supplier controls is essential for the safety and performance of Class III medical devices.”
The UK is not alone in requiring QMS for medical devices: many countries require compliance with the voluntary standard ISO13485 to sell on the European market. ISO13485, an internationally recognised standard for quality management, is based on ISO9001. Serving as a framework for organisations to meet customer and regulatory requirements to improve processes, the standard consists of seven principles of quality management. That includes engagement of people, customer focus, and leadership, among several others. This serves as a basis for QMS compliance in many countries worldwide.
As Beddoe-Rosendo explains, meanwhile, another part of QMS is design controls, which are 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 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.
$623bn
The expected growth of the global medical device market in 2026, up from $471bn in 2020.
Nature.com
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.
