约翰迅速, 欧文·芒福德的供应链主管, explains how to develop an effective operations plan to secure supply resilience alongside product development projects and programs.
注射给药装置的市场正在飞速发展, 预计到2030年，年增长率将超过10%. 这并不奇怪，因为60%的药物在R&D管线被设置为由注入物交付. Owen Mumford works on several products which will look to capture a share of the expanding market for injectable drug delivery devices in coming years.
Taking advantage of the growing market will rely on manufacturers being able to quickly react to the changing demand for a product throughout its lifecycle, 同时仍然保持产品质量. Responding to these changes requires a robust and meticulous operations strategy that: effectively scales demand and manages assets; works transparently with suppliers; and develops specialised centres of excellence.
在组合产品的整个生命周期中应对不断变化的需求, a clear operations plan for manufacturing the delivery device in both large and smaller quantities is essential. Low volume manufacturing requires single or low cavity moulding and semi-automated assembly, 而对于大批量生产, producers are likely to need high cavitation moulding with fully automated production. 优化生命周期规划, manufacturers must understand which of their facilities have the appropriate 设备 and resources to undertake different stages of the production process, 或者必须将这些功能整合到现有的设施中.
除了生命周期管理, companies must also have asset management strategies in place to support capacity growth and ensure 设备 and ancillary products are properly maintained. 资产包括注塑模具, 注塑机, 自动化装配机及所有相关软件, hardware and ancillary 设备 must be assessed on a regular basis to ensure they are fit for purpose.
Manufacturers need to proactively replace assets coming to the end of their lifecycle and monitor spare parts policies, 如果设备出现故障，防止生产延误. 当一个产品变老，慢慢地被新型号所取代, companies must prepare for the end of a product’s lifecycle – scaling down production to appropriate levels until their device reaches obsolescence. It’s important that asset management programs do not neglect mitigation strategies either, ensuring shocks to supply caused by external geopolitical events that could lead to difficulties in acquiring certain raw materials or machinery, 很容易被吸收.
与供应商密切合作来定义角色是很重要的, 责任, 以及升级程序. This ensures devices are consistently at the agreed level of quality and that suppliers can respond to changes in demand. 审核供应商是了解系统的重要工具, 设备, 方法, 以及合作伙伴的技能组合, allowing companies to recognise if anything will hinder their ability to provide devices. Working with suppliers to provide guidance on 设备 design and align 方法ology also reduces the risk of any small differences between products when compared directly.
在英国脱欧和COVID-19大流行之后, Owen Mumford Pharmaceutical Services carried out a review of supply chains to understand the potential risk areas in this challenging landscape and how they could be overcome. Using a ‘virtual factory management’ concept helped them set targets that can be reviewed regularly with suppliers to ensure viability and pre-emptively tackle issues with performance or capabilities.
Developing centres of excellence is critical both to ensure products are designed and built to the highest possible standards and to allow staff to develop exceptional knowledge of a particular field. 这些中心可以在操作流程的任何领域具有专长, 比如造型, 装配或自动化.
Creating these centres will make it easier to fulfil order requirements and allow rapid resolution to unforeseen technical issues during production. Ensuring the foremost experts in an area of production are placed together creates key skills and competency coverage in the event of unplanned leave or illness. 团队可以建立重点培训计划，让员工提高技能, 创造一个有助于提高员工保留率的环境, 同时也进一步降低了专家离职的风险.
Owen Mumford’s new production facility in Oxford was built according to BREEAM certification, 追求最高水平的环保, 社会, 经济的可持续性. 它专注于组装和自动化, 使其成为生产创新的Aidaptus自动注射器的理想地点.
Establishing effective operations programs helps to create strength within drug delivery device manufacturers, 鼓励他们的成长和发展. With lifecycle and asset management plans in place it’s easier to reduce the potential risks that large pharma companies may have when they enter clinical trials or require a rapid scale up in demand. 此外, 拥有强大的供应线可以专注于未来的发展, 而不是专注于当前的产品线. 反过来, this means more time to create innovative new devices that distinguish companies from competitors and more time to allow for further growth.