Over the past decade, medical breakthroughs, technology advances, and the rise of personalized medicine have led to increased use of Class II and Class III medical devices—instruments that improve or sustain the health and quality of life for patients. While these innovations are producing positive outcomes for patients, the stakes are high when a product malfunctions. Recent high-profile device failures have led to major product recalls that are costly and impact patient care.
 
Adding to this situation, Class II and Class III medical devices have become highly sophisticated in both functionality and manufacturing complexity. They must also meet strict FDA regulations, requiring manufacturers to track, in some cases, the identity of every component, piece of manufacturing equipment used, and operator activity as a medical device moves through the manufacturing process. Another recent requirement is UDI (unique device identifier) labeling to facilitate the tracking of devices once they are out in the field.
 
For all of these reasons, medical device companies have extremely high expectations for quality performance during the manufacturing of medical devices. Many of them rely on electronic contract manufacturers who have developed advanced quality management systems and methods to ensure compliance and prevent medical device failures. More recently, new developments in Industry 4.0 practices, machine-to-machine (M2M) communications, and the cloud have emerged that are helping quality teams more seamlessly and efficiently “mistake proof” complex production processes, preventing some of the most common causes of manufacturing errors. Should a manufacturing issue be uncovered later, these new technologies can quickly and effectively isolate products that must be recalled.
 
Digital Factory Enables a Forced Quality Framework
Electronic device history records (eDHRs) have now been implemented by many medical device and instrument manufacturers. Some manufacturers have taken this approach a step further, connecting factory and test equipment for automatic upload and linking of these quality records to the eDHR. Several companies have taken the next step, connecting virtually all manufacturing equipment to a local or cloud network. This includes bar code scanners and label printers at individual workstations and operator badge scanning. With the right programming, this enables a “forced quality framework.” At Sanmina Corporation, for example, this manufacturing line connectivity has been implemented on many production lines using a cloud based MES (manufacturing execution system).
 
On the factory floor, all equipment, materials, and operator actions are scanned via bar code systems connected to the cloud MES platform, enforcing compliance at every step. This ensures the highest level of quality and predictability because processes are set up in the right way to avoid typical errors in the manufacturing process. Key error-proofing elements include:
 
Controlled sequencing of operations—If an assembly arrives at the wrong workstation, the system will reject the unit when it is scanned into the workstation. This ensures all previous required steps are successfully completed before a product can move forward.
 
Operator validation in real time—The database used to track operator training records is integrated with both the PLM (product lifecycle management) software and the cloud MES platform. If an operator scans his or her badge at a workstation and hasn’t been trained on the latest work instruction (stored in the PLM system), that person will be prevented from logging into the workstation until their training qualification with the new work instruction is met.
 
Machine vision systems for automated “pass” or “fail” capabilities—At key test stations on the production line, camera-based system verification is used to double-check placement of materials at levels the human eye cannot identify. These cameras compare visual information against known valid characteristics of a medical device so product quality can be verified.
 
Proactive monitoring of throughput and yield—Since test and inspection equipment is connected to the cloud MES, throughput and yield can be monitored in real time. If yield falls below certain thresholds, M2M communications ensure alerts are sent in real time 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.
 
Cloud-Based eDHR for Improved Compliance
Having all equipment and people effectively connected to the cloud in real time, combined with searchable eDHRs, enables quality personnel to instantly access production data and quality records anywhere and at any time. This benefits manufacturers and medical device OEMs in a variety of ways during regulatory audits or recalls, including:
 
Faster isolation of affected components—If a medical device recall occurs, manufacturing personnel can easily search the eDHR database to identify which affected components are still in the warehouse, what’s still on the factory floor in WIP (work in progress), and what products have been shipped—down to the individual medical device serial number.
 
Streamlined regulatory audits—Medical device manufacturers are subjected to rigorous regulatory audits. During an FDA audit, for example, manufacturing facilities must produce correct, clear, and verifiable quality records in a timely manner. With cloud-based eDHRs, regulatory personnel can access digital records in real time using a searchable database, instead of having to travel to an offsite storage location and search for paper DHRs.
 
Improved confidence from regulatory bodies and medical device customers—A manufacturer’s ability to deliver comprehensive, organized data in a seamless fashion can improve a regulator’s overall confidence in the manufacturer’s quality management system.
 
Bringing It All Together
Quality systems have now evolved and along with M2M communications, eDHRs and the cloud can provide a real time “forced quality framework” that prevents many of the most common errors in medical device and instrument production. With operator badge scanning and automatic linking to training records databases, scanning of an assembly at each workstation, and technology for component verification and traceability, quality and confidence are greatly improved. In addition, real-time access to manufacturing and quality data speed problem solving and yield improvement.
 
This same connectivity also enables eDHRs to be quickly searched in the event of a problem or a product recall. With operator badge scanning and component traceability, eDHRs can be searched online to isolate only those serial numbers produced by a specific production operator, or having a specific lot of components. These features make the implementation of a cloud connected, digital factory worth considering for the manufacturing of high-risk medical devices.
 

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As the senior vice president and chief quality officer at Sanmina, Anca Thompson leads all quality, regulatory, and operational excellence activities across the company. She has more than 20 years of operational and senior quality management experience in global electronics manufacturing for the telecommunications, industrial, aerospace, medical, and automotive industries. Leading up to her current role, Thompson held several positions in senior quality and operational excellence management at Sanmina from 2010 to 2012. At Foxconn, she held the position of VP of global quality for personal business computing operations from 2008 to 2010.