"COVID-19 Highlights Need for Flexible, Paperless Manufacturing Processes"

The COVID-19 outbreak has compelled many companies across the life sciences and health care industries to re-evaluate and adapt their production processes. To help address shortages of much-needed medical equipment, makers of all kinds – from hockey equipment and baseball jerseys to vacuum cleaners and spirits – stepped up, repurposed their facilities and modified their operations to produce face shields, facemasks, ventilators and hand sanitizer. Medical device manufacturers themselves ramped up production of medical equipment and personal protective equipment (PPE).

Companies everywhere were eager to respond in some meaningful way to the health crisis created by the novel coronavirus. For instance, to help enable others to contribute to the efforts, Medtronic shared its PB 560 portable ventilator design specifications and manufacturing procedures for free, letting companies access the design and manufacture the ventilator hardware.

Yet for any company pivoting from manufacturing core products to producing a ventilator, even with an existing design, how agile is the company’s production environment and how quickly can it scale?

The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes remain difficult to scale, can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality.

Even when manufacturers take steps toward paperless manufacturing by investing in factory automation such as a manufacturing execution system (MES), their efforts are too often stymied by production processes that remain paper-based, such as device history records (DHRs). Manufacturers often live with these rigid, paper-based processes because they believe it will take too long and be too costly to implement a new, electronic DHR (eDHR) system and adjust to new processes. In a recent MasterControl poll, 66.7% of life sciences professionals cited project length as the top reason they haven’t digitized their DHR process yet.

However, a configurable, purpose-built eDHR application can be fast to implement and deliver quantifiable benefits.

Paperless DHRs: An Experiment

Knowing it can take weeks to build from scratch a master DHR template for a new medical device, a small team at MasterControl recently set out to see how digitizing DHRs could affect operations in a time of COVID-19-driven change.

To build one new, paper-based DHR typically takes one full-time equivalent (FTE) employee anywhere from two days to two weeks, or even longer, depending on complexity of the DHR. Using the Manufacturing Excellence™ solution, MasterControl took Medtronic’s open-source design and built an eDHR in approximately two hours.

Broken down, the experiment required 60 minutes to review and add Medtronic’s design and documents, and then just 45 minutes to build and create two executable DHR templates.

The Manufacturing Excellence solution allows for full configuration such that the DHRs can resemble the paper records used by most manufacturers today. Additional advantages of the solution’s configurability include the following:

• When configuring and assembling the DHR output, predecessors and conditional paths can be set up at each level.
• Tables and repeatable operations can support a process where multiple iterations might be required, configuring the process as a set of steps that can be repeated as many times as necessary.
• Templates make building and managing subsequent master templates faster and easier, even for very similar product lines with minor differences.

Every desired configuration can be set, and many elements automated, with minimal training and without having to engage a third party. The digitized DHR’s familiar look and feel of a paper DHR makes training and transition to paperless easier, with little opportunity to make mistakes.

In addition to these capabilities, a configurable eDHR system can connect to other business systems and even extend existing information systems to the shop floor, making it possible to achieve a holistic view of data that helps accelerate production and ensure regulatory compliance.

The Medtronic experiment underscores the need for speed and agility to adapt to rapid shifts in demand, like that for medical equipment due to COVID-19. In manufacturing environments where critical processes on the shop floor continue to rely on slow, paper-based systems, a configurable and lightweight application that is fast to implement and fast to deliver productivity and quality improvements can effectively close the digital gap left by paper.

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References

“America is running short on masks, gowns and gloves. Again.” The Washington Post, July 8, 2020.

“Hockey equipment manufacturer Bauer makes coronavirus face shields for medical professionals,” USA Today, March 26, 2020.

“Fanatics shifts production from MLB jerseys to masks and gowns to fight coronavirus,” CNBC, March 26, 2020.

“James Dyson designed a new ventilator in 10 days. He's making 15,000 for the pandemic fight,” CNN Business, March 27, 2020.

“Distilleries Find a COVID Calling in Hand Sanitizer Production,” FSR Magazine, July 2020.

“Medtronic Shares Ventilation Design Specifications to Accelerate Efforts to Increase Global Ventilator Production,” Medtronic, March 30, 2020. 

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