Contract manufacturing 10%


Institute of Materials, Minerals & Mining


The percentage of medical devices regulated by the FDA that are Class III.


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


40


Medical Device Developments / www.nsmedicaldevices.com


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