There are few industries as tightly interwoven with life and death issues as medical equipment. Getting everything right—from adherence to regulations to on-time product deliveries to perfectly performing products—is paramount. In the medical equipment supply chain, complete transparency is an absolute necessity. Transparency cannot be a part-time or a partial commitment. It must be an all-out endeavor to help achieve safer and more effective patient healthcare.
The regulatory pressure in the medical equipment industry is extraordinarily intense. Manufacturers of medical products—such as sonograms and X-ray machines—must comply with strict regulations and laws that govern safety and performance. Inaccurate product information in the medical equipment supply chain can threaten public health or induce penalties that either jeopardize companies’ abilities to operate or even put them out of business.
To help avoid these scenarios, it’s critical that medical equipment technology companies create end-to-end supply chain visibility that streamlines and accelerates product flows and increases awareness for all supply chain participants. Leveraging this framework, product delays, shortages and overstocks can be resolved before causing significant problems.
Medical supply chain objectives
The primary objective of medical supply chain visibility is to leverage increased transparency of product-related information to enable smoother and more efficient end-to-end processes; and effective regulatory compliance and improved decision-making—while avoiding redundancies, reconciliations and rework. Medical supply chain visibility consists of the complete management of product-related information along the supply chain from suppliers and original equipment manufacturers (OEMs) to customers in various countries. Information that needs to be managed includes master data; materials; products; bills of material (BOMs); vendors; customers; and transactional data such as purchase orders, manufacturing orders, delivery notes and invoices.
Medical supply chain visibility can deliver a range of potential benefits for medical equipment technology (MET) companies including cost savings, faster growth and reduced trade compliance risks. These companies face specific challenges in regulatory compliance.
The safety-critical nature of medical devices; the importance of regulatory compliance and tracing; and monitoring and controlling processes and data flows throughout the supply chain—combined, these elements create an even stronger need for supply chain visibility.
Supply chain visibility enhances patient safety and reduces regulatory compliance risks by maintaining historical tracking of device changes; delivering current and correct compliance data; and providing accurate and timely information of pre- and post-market approvals throughout the supply chain.
Improved regulatory compliance capabilities also help boost revenues and reduce costs. These potential benefits can be achieved by leveraging better re-use of submission information for different countries and products, which shortens ‘submission to approve’ cycle times; and enables the consistent use of globally harmonized processes, standards and templates.
Supply chain visibility can bolster revenues in other ways including greater process automation; more rapid data exchange; and faster cycle times throughout the supply chain. As organizations in other industries already learned, information transparency results in improved operational and sales effectiveness; better and faster decision-making; more effective performance management; and lower costs across end-to-end supply chain operations. This transparency reduces manual intervention and rework in the order flow through improved data quality, accuracy, availability and further process automation especially in importing and exporting transactions.
‘Vitals’ for medical technology companies