With more than a decade of experience as an engineer at medical device companies under her belt, Nicolle Cannon has a keen understanding of quality management. As we come out of a tumultuous 2020 and into 2021, she weighs in on the most critical MedTech quality management trends that are starting to emerge.
“In 2021, we will see an increased adoption of electronic quality management systems (eQMS) , as well as a bit of a paradigm shift. Previously, we had numerous clients sticking to paper-based systems with a ‘wait-and-see’ attitude toward adoption of an electronic system, but now more and more quality management professionals are interested in getting up and running earlier on,” Cannon said.
In part, this has to do with new market conditions created by COVID-19. We have learned that companies with digital tools are more adaptable to unforeseen events, and an eQMS is a critical part of being agile enough to respond to changes with minimal interruptions to business.
Increased adoption of eQMS can also be attributed to the U.S. Food and Drug Administration (FDA) signaling a move to the digital submission of safety data related to clinical trials for investigational drugs. As regulatory bodies become more efficient through the use of technology, regulated industries will have to follow suit. In the not-so-distant future, an eQMS will go from being a convenient tool to an essential part of compliance. Just as hospitals and health care systems had numerous vendors of Electronic Health Records (EHR) to choose from, there are numerous solutions providers offering eQMS platforms to Medtech companies. Cannon stated she sees many companies taking months to compare and decide, as features, strengths, and pricing vary.
Medtech companies need to plan sufficient time for a thorough selection process, as well as a realistic plan and budget for adoption, training, and platform support.
Prior to 2020, the default approach to auditing meant an onsite visit, whether it was a supplier audit, internal audit, or a notified body audit. With travel and visitor restrictions at most facilities, the Medtech industry has quickly embraced remote auditing as a way to continue fulfilling audit requirements. FDA initiated remote inspections as a response to the challenges of COVID-19 and in August released updated guidance about its onsite policies during the pandemic. Additionally, in April the EU Medical Device Coordination Group (MDCG) issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits.
“We’ve seen the industry make great strides in 2020 in remote auditing, both on the part of auditors as well as ‘auditees’,” Cannon said. “Now, most clients say that remote auditing is more efficient than onsite, and don’t see the industry going back to the level of onsite audits as in the past.” The industry has quickly picked up the best practices that make remote audits go smoothly and efficiently.
The trend to increased remote auditing will have positive effects on flexibility in scheduling, as the days previously required for travel to and from are eliminated in many cases. Auditors and auditees are able to break up an audit from an 8 to 10-hour one-day grind into more manageable sessions. As companies see the cost savings in reduced travel, those budgets are unlikely to rebound in the future.
The industry will likely see an expansion of remote auditing as technological advancements like high-end telepresence robots that could make walk-arounds and manufacturing inspections feasible.
Suppliers to the Medtech industry are also concerned about limiting staff exposure from frequent visits by auditors, and the best way to do that is to consolidate multiple audit requests from their customer base into one shared supplier audit, performed by an external third-party auditing firm. The supplier sends out a notice to all customers announcing a date for a shared audit serving multiple customers at the same time. The auditing firm’s team does all the coordination while maintaining strict confidentiality.
“We see the shared supplier audit program as a game-changer for suppliers,” Cannon mentioned. “This year especially, we audited a supplier in one day on behalf of almost 20 of their customers, saving them a lot of traffic into the facility as well as weeks of audit support time compared to 20 solo audits.”
This trend is expected to grow in the coming year, as exposure concerns from outside continue to linger, and as suppliers see it as low hanging fruit in their efforts towards streamlining operations. Unlike solo audits, shared audits are scalable, and more customers can be brought on to the shared audit without increased personnel burden.
Cannon anticipates this program will be popular throughout 2021 and beyond, as more suppliers see how easy it is to save themselves time and exposure risk at no cost to themselves.
The common thread in these trends is leveraging newer technology, sometimes only under duress, to challenge existing practices. It involves sometimes getting outside one’s comfort zone, yet new efficiencies are to be found on the other side.
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