UK medtech firms are being urged to adapt their time-to-market strategies to seize new opportunities and navigate global challenges. Leading medical manufacturing specialist Europlaz believes companies who embrace modular documentation, strategic outsourcing and early regulatory alignment can unlock a competitive advantage against international rivals.
Technical Director Ian Goodacre made the rallying call off the back of progressive new NHS initiatives, such as NICE’s Early Value Assessment (EVA) programme and a renewed national focus on compliance by design.
“EVA is a really promising development aimed at addressing some of the traditional bottlenecks faced by the NHS,” added Ian, who works with more than 25 different manufacturers on product introductions.
“In theory, it should provide a structured pathway for technologies that meet national unmet needs to gain conditional NHS recommendations while further evidence is generated. This could be a real gamechanger.”
EVA offers rapid assessments for medical technologies, especially diagnostics, devices and digital tools. It also provides early value signals for promising innovations and conditional recommendations published as Health Technology Evaluations (HTEs).
Ian went on to add: “We are led to believe there will be support available for evidence generation so that full adoption, after the early positive signs, can be completed. It’s a welcome change of intent, we just need to see how it works in reality.
“The next five years offer both risk and opportunity. UK manufacturers who embrace strategic outsourcing, modular documentation and compliance-by-design will thrive regardless of external reforms.”
Europlaz’s blueprint for growth starts with streamlining documentation by using modular technical files that are adaptable across different jurisdictions.
OEMs should look to embed compliance (ISO 13485, MDR, CE, or UKCA) early in product design to avoid costly rework and delays, whilst aligning with NHS priorities by building real-world evidence.
Leveraging strategic outsourcing to mitigate staff shortages and accelerate throughput is the final point of the action plan and the area where the company has the most experience.
The Southminster-based firm has recently completed a £4m investment drive to create a world class production facility capable of injection moulding, assembly, product validation and access to modern cleanrooms – all certified to ISO Class 7 for the manufacture of Class I, Class II and Class III medical devices.
“Average approval timelines for UKCA/CE submissions currently range from 24 to 30 months,” explained Ian, who has headed up the technical team at Europlaz for almost a decade.
“Compare this to just 12 to 18 months under the FDA’s Breakthrough pathway in the US, or under a year in Singapore and South Korea and you quickly begin to understand why UK medtech needs to adopt this approach.”
He concluded: “Contract manufacturers like Europlaz aren’t just vendors – we are growth enablers. By embedding resilience, UK OEMs can secure lasting competitive advantage in a shifting global landscape.”
For further information, please visit www.europlaz.co.uk or follow the company across its social media channels.
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