Photo credit: Enot-poloskun

Published: 7 Jul 2020

Anca Thompson, Senior Vice President and Chief Quality Officer at Sanmina Corporation, San Jose, California, explores how medical device manufacturers can error-proof their production process using technology and automation.

The medical industry has made great strides over the past decade thanks to medical breakthroughs, technological advances and the rise of personalised medicine. This innovation has led to increased use of Class II and III medical devices that greatly improve or sustain the health and quality of life for patients.

At the same time, medical device manufacturers have been confronted with new challenges: costly product recalls, stricter regulatory requirements, increased manufacturing complexity and the need to maintain detailed historical records for every medical device produced.

In order to manage all these requirements, medical device manufacturers have turned to Electronic Manufacturing Service (EMS) providers to handle the intricacies of producing compliant products. While expectations are high, EMS providers with dedicated medical quality management systems have developed methods that ease the burden on medical companies, freeing them to focus more of their time on product innovation. 

Harnessing the digital factory to ensure compliance

At the core of the most successful quality programmes employed by medical device manufacturers and EMS providers is technology and automation. New developments in Industry 4.0 practices, machine-to-machine (M2M) communications and the cloud are being utilised to improve operational efficiency and ensure compliance.

These technological methods are helping to error-proof complex production processes, preventing common manufacturing errors and quickly isolating products that must be recalled if an issue is uncovered later.

In addition, some forward-thinking organisations have moved paper-based record-keeping required by the Food and Drug Administration straight to the cloud, as electronic device history records (eDHR) become the norm for ensuring regulatory compliance.

Because all equipment, materials and operator actions on the manufacturing floor are monitored through scannable barcode systems connected to a cloud platform, compliance is enforced at every step.

Machine data and quality records are automatically linked to the eDHR, ensuring a thorough compilation of records is stored pertaining to the production of every finished medical device.

Key error-proofing elements of a cloud-based digital factory include:

  • Controlled sequencing of operations. Pre-programming compliant processes in the cloud ensures that every step on the production line is performed accurately and in the proper order. Assembly units that arrive at the wrong workstation will be rejected as soon as they are scanned into the system.
  • Real-time operator validation. Operator training records are tracked in a database that is integrated with both the PLM (product lifecycle management) software and the cloud platform. If an operator scans his or her badge at a workstation and has not been trained on the latest work instructions, that person will be prevented from logging into the workstation until their training qualification has been met.
  • Machine vision systems with automated ‘pass’ or ‘fail’ capabilities. Camera-based system verification carefully monitors placement of materials at key test stations on the production line. These cameras compare visual information against known valid characteristics of a medical device more quickly and accurately than the human eye to ensure product quality. 
  • Proactive monitoring of throughput and yield. Because test and inspection equipment are connected to the cloud, throughput and yield can be monitored in real time. If yield falls below certain thresholds, connected factory machines send alerts to key personnel to investigate and resolve the issue. A record of all activity is continuously recorded and fed into the cloud, and reports are available to management.

Streamlining audits and product recalls

A digital factory can also speed responsiveness to regulatory audits and product recalls because production data and quality records are accessible in real time. Advantages include:

  • Faster isolation of affected components. Manufacturing personnel can quickly address medical device recalls by searching the eDHR database to identify affected components that are in the warehouse, on the factory floor and or in products that have already shipped – down to the individual medical device serial number.
  • Streamlined regulatory audits. With cloud-based eDHRs, regulatory personnel can access digital records in real time using a searchable database, instead of traveling to an offsite storage location and searching through paper-based records.
  • Increased confidence from regulatory organisations. FDA audits typically require that a manufacturing facility produce correct, clear and verifiable quality records in a timely manner. Being able to quickly deliver comprehensive data can improve a regulator’s overall confidence in a manufacturer’s quality management system.

The evolution of quality systems

Advanced quality programmes, combined with M2M communications, the cloud and eDHRs, provides a real-time framework that can prevent many of the most common errors in medical device production. With pre-programmed sequencing of machine operations, worker validation and machine vision systems, quality and confidence are greatly improved. Real-time access to quality data speeds problem-solving with automatic alerts that enable personnel to swiftly address any detected discrepancies, such as defective components or underperforming machines, to ensure that operations consistently meet customer expectations.

What’s more, eDHR can easily be searched online to isolate specific production data for swift mitigation of any issues. These features make the implementation of a cloud-connected digital factory worth considering for the manufacturing of medical devices.