Digitized Device History Records Streamlines Manufacturing Operations amidst COVID-19


The healthcare industries are forced to embrace the latest medical devices in the light of COVID-19. The outbreak has made manufacturers rapidly retool factories and repurpose their capacity to aid the citizens in safeguarding themselves from the novel coronavirus.

Medtronic, an Irish-domiciled medical device company, helps the firms fight the pandemic with its PB 560 portable ventilator design and manufacturing techniques. It lets them freely access the design specification and manufacture the ventilator hardware. However, the medical device and diagnostics manufacturers producing core products and scaling up the production of a ventilator, are often impeded by paper-based processes.

The rigid, paper-based processes are believed to be too long and too costly, especially while employing an innovative digital production structure or amending to the latest procedures. Nonetheless, the cloud-based digital production method alongside electronic DHR (eDHR) is demonstrated to deliver results quicker. It can be implemented in just an eight week, right from planning to building, testing, training, and going live.

An eDHR system assists the medical device manufacturers in hastening their production and upholding agility in shifting environs. It can actively streamline the manufacturing operations by eradicating data entry blunders, real-time authentication, and imposing quality controls without decelerating any production line.

While paper-based DHR systems are limited to track manufacturing variations, eDHRs assimilated with a quality management system can deliver deviation-tracking and real-time nonconformance devices to recognize quality events and proceed with the corrective action. The electronic framework guarantees the free progression of information, just as correspondence between various frameworks and individuals.

According to Brian Curran, MasterControl SVP of Strategic Growth, “Building one new, paper-based DHR typically takes one full-time equivalent between two days and two weeks, or even longer, depending on complexity. Medtronic’s DHRs fall on the less complicated side, so we estimated two to three days for each paper record.”

Curran adds, “Paper takes weeks. With digitization, we were able to take an existing design and create two DHRs in 45 minutes. Digitization lets medical device manufacturers easily create and manage their DHRs and quickly ship their lifesaving products.”

The digitized DHRs with a familiar look of paper records resembles the records used by almost every medical technology manufacturer. By digitally incorporating this framework and gaining on platform elements, one can rapidly integrate quality into their operations, augment shop floor profitability, and enhance right-first-time (RFT). Here, the manufacturer can ship the devices faster without lowering the product quality anytime.

With medical device manufacturers re-assessing and regulating the events to address the global health crisis, both the speed and suppleness endures describing the present manufacturing world. Simultaneously, the most recent pandemic has uncovered the centrality of digitization in the flexible clinical gadget producing fragment. In this environment, where fringe and basic methods depend on moderate, manual paper-based frameworks, one can digitize their current DHRs to seal the hole.