How to Digitize Your MedTech Manufacturing Operations

Even as digital transformation efforts accelerate in various areas of manufacturing, there remains an offline data gap created by device history records (DHRs) that rely on paper, spreadsheets, and other standalone systems. This gap slows production, quality review, and product release.

What is missing in medtech manufacturing operations is the electronic DHR (eDHR) solution. As explored in “The Ultimate Guide to Digitizing Medtech Manufacturing,” an eDHR solution can fully digitize medtech operations, extending digitization to the users who need it most, closing the digital gap, and delivering significant quality and productivity improvements.

Digitizing Quality Management at the Source

Using a paper-based system to manage DHRs usually means operators and quality teams must deal with inefficient processes, low visibility, and poor data quality. Manual data entry errors, remediation,and review, along with inadequate tracking capabilities, drive production costs up while reducing efficiency and throughput. These preventable errors result in shipping delays and wasted resources.

Modern manufacturing execution software (MES) enables manufacturers to build quality into the production process, rather than outside of it. MasterControl Manufacturing Excellence provides an entirely paperless, error-reducing system for tracking and managing production data that affects quality in medtech manufacturing operations. Error-proofing features reduce mismarks or missing information on DHRs, with automated real-time quality review at every step of production. MasterControl's modern medtech MES solution automatically tracks manufacturing changes, quickly identifies quality events, and enables real-time corrective action.

Extending Digitization in Manufacturing

Despite manufacturers investing heavily in enterprise automation and enterprise resource planning (ERP) systems, people responsible for DHRs have been left to deal with paper or disconnected systems to monitor, collect, and aggregate data surrounding production and quality processes. In these environments, complete information transfer is all but impossible, resulting in information gaps, blind spots, and preventable errors in medtech manufacturing operations.

A modern medtech MES solution like MasterControl's helps manufacturers create productive connections between data sources, processes, and people throughout the entire organization, for a holistic view of data. Rather than replace the organization's existing ERP or other enterprise systems, Manufacturing Excellence extends them to the shop floor, automating the GMP review and release. By integrating the disparate enterprise applications with a fully digital DHR solution, and capitalizing on platform dynamics, manufacturers can glean truly actionable, data-driven performance insights to drive quality and productivity improvements.

Augmenting Workers in Medtech Manufacturing Operations

Too often, smart manufacturing efforts focus on systems and machines and not enough on people. This opens the door for human error and data integrity issues that spread through the production process. For digitization in manufacturing to be successful, technologies must optimize processes for existing workers to increase efficiencies and reduce opportunities for human error.

Manufacturing Excellence takes a human-centric approach to digitization in manufacturing by focusing on such areas as eDHR templates, data input, information access, in-context information, and prescriptive actions. The modern medtech MES solution simplifies master template management, digitizes and error-proofs data input, automates review/traceability of changes on records, facilitates the multi-directional flow of data and actionable insights, and applies advanced analytics to equipment calibration and maintenance. The result: fewer data input errors, improved data access and visibility, greater insights, faster review processes, and proactive action.

Achieving Manufacturing Excellence

When a manufacturer's valuable data is trapped on paper or in siloed systems, much of the intelligence that data can provide is useless in accelerating product delivery and mitigating quality issues.

Organizations must use digitization in manufacturing to connect systems, people, and processes to gain a complete view of their data. Digitizing the collection and flow of data with a fully digitized eDHR closes the offline data gap, enabling manufacturers to better understand how their shop floor is working and make data-driven decisions.

Download “The Ultimate Guide to Digitizing Medtech Manufacturing” to learn more about how MasterControl Manufacturing Excellence helps organizations fully digitize medtech manufacturing operations.