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FDA Compliance

Eliminating the Digital Divide in Life Sciences, Part 2

Confronting the fear of being displaced by machines

Published: Tuesday, May 7, 2019 - 12:03

Despite the life science industry’s infatuation with modernity and trend chasing, even its most forward-thinking organizations have struggled to fully digitize and integrate their operations.

Yet, while the industry lags behind most other sectors in implementing business-streamlining digital technologies, many shrewd life science companies are working to close the digital gap so they can capitalize on the competitive advantages digitization affords.

As digital initiatives gain more traction, and as advanced technologies increasingly perform more of our mundane tasks, skilled life science professionals’ fears about job displacement are intensifying. Their digital apprehensions are undeniably intertwined with the global workforce’s general anxieties about automation, as highlighted in a 2017 PwC survey that reports 37 percent of the world’s workers are worried about eventually losing their jobs to automation. The unease is worsening, it seems, as only 33 percent of workers reported concerns about job-eradicating automation in the same survey in 2014.

The “rise of the machines” may not spell the end of humanity as predicted in science fiction tales, but the unrelenting wave of tech innovations in the life sciences is giving professionals legitimate reasons to worry that their jobs might become extinct.

The human side of the digital revolution

There are a number of interrelated factors underlying the obsolescence anxieties shared by professionals in the life sciences, such as:

Digital competency and user adoption uncertainties: As digital technology changes the way business is conducted, it’s natural for workers to worry that the new proficiencies required to survive in a digital world will also come with implausibly steep learning curves or dramatic shifts in job functions. Moreover, if an organization implements a new digital solution, will those proficiency doubts result in users rejecting it in favor of tried-and-true manual methodologies?

Disruption: The introduction of new technologies often alters an organization’s status quo and employees’ routines. These disruptions have the potential to make workers feel devalued. After all, what worker wants to spend years refining his skills if the possibility exists that he will be eclipsed by a machine?

Cascading technologies: Some employees worry that the slippery slope of their life science organizations’ digitization initiatives will beget further neomania. Might a new digital solution trigger an avalanche of additional—and possibly excessive—technologies? And will those solutions require massive redevelopment of personnel and progressively more intensive training?

These fears, while understandable, are the result of a reactionary, glass-half-empty mindset that dominates the change-averse life science industry. Analogous trends throughout history suggest that digitization has the potential to give life science professionals a glass that’s more than half full—in fact, it’s overflowing with upsides and opportunities. As chief economist Constance Hunter put it in KPMG’s Intelligent Augmentation report, “Digital labor from the ATM to Watson has so far enabled complementary assistance to human knowledge workers.”

Supplement, not supplant: The key to riding the digital wave in life sciences

When used effectively, robust digital tools should complement and assist life science occupations, not supplant them. Innovative technologies work best when we put the people who use them first, according to professor Klaus Schwab, executive chairman of the World Economic Forum. “All of these new technologies are first and foremost tools made by people for people,” Schwab stated in his book, The Fourth Industrial Revolution (Currency, 2017).

Several areas within life science organizations can benefit from people-centered digital tools. For quality-focused organizations, no digital initiative can have a greater impact than implementating an enterprise quality management system (EQMS) software solution. The following examples of EQMS digitization extending the expertise of life science personnel correspond to parallel benefits that can be gained through comparable digital initiatives.

Accelerating the classification and interpretation of data: An EQMS facilitates rapid visualization, analysis, and pattern-finding in data. Digital EQMS solutions accelerate data management processes far beyond the speed at which manual, paper-based systems can operate. Wellington Foods president and COO Tony Harnack says that integrating a digital EQMS with the company’s manufacturing processes has provided a level of transparency that broadens and expedites the actions his company can take with data. “It gives us real-time data and a better management feel for what’s happening on the shop floor,” says Harnack. “It allows us to create management dashboards so that we can understand what’s happening with our products.”

Enabling a proactive, preventive approach: Too many life science companies’ quality systems are stuck in a reactive posture that is habitually dedicated to fixing problems rather than focusing efforts on avoiding them. John Simonick, QA/QC vice president at Mission Pharmacal, said that his company’s EQMS has helped them become more proactive than ever. The digital system not only integrates quality functions but also permits corrective and preventive actions (CAPA), nonconformances, and out of specifications (OOS) to automatically launch other quality events. “Because these out-of-spec, nonconformance, and CAPA functions work so well together—they’re all interrelated and you can trigger one from another—it makes it easy to deal with the hiccups of the day when things don’t go the way they’re planned,” says Simonick.

Streamlining organizational decision making: Logic dictates that the longer decision makers have to wait for accurate information, the longer it takes them to make decisions. Quality manager Donna Kelley of OMNI Flow said the company’s digital solutions give executive and management teams direct access to actionable data, a benefit that the original equipment manufacturer’s manual systems never provided. “Now management can get answers without having to ask anybody to run a report,” she says. “I can make educated decisions much faster because I have the data readily available, and I know where I stand on a daily basis.”

Simplifying compliance: Quality compliance is challenging. Proving that you’re capable of maintaining it is equally difficult. OMNI’s vice president and general manager Michael Saiphoo said a digital EQMS solution has solidified the company’s culture of quality while also providing empirical methods of measurement and tracking, and trending capabilities that were lacking in the past. “This means that when global customers look to OMNI, they can see that we follow the ISO 9001 standards, and we’re able to demonstrate through performance what we’re about as a quality company,” says Saiphoo. “It’s not a statement on a wall or a tagline—it’s the way we live, the way we do business, and the way we will continue to do business 25 years from now.”

Reducing human errors: One oversight isn’t a big deal—until it forces everyone in the organization to drop their current tasks for rework. When 28 change order packets became lost in Megadyne’s paper-based quality management system, it became obvious that the medical product company needed a comprehensive digital solution. “Imagine the amount of time and resources that went into revising a quality system document only to have it lost and then go through that process again,” says Megadyne vice president of quality and regulatory affairs Haven McCall. “It’s incredible how it impacted our business.” Implementing a digital EQMS has had a dramatic effect on the company’s ability to minimize change-control lapses and inefficiencies. “You get back all the administrative time that a typical quality manager puts into chasing down change orders,” McCall says. “For me, that’s been a significant improvement.”

Eliminating repetitive processes: When knowledge workers are saddled with tedious tasks, it’s time they’re not spending performing their core functions. Before implementing an EQMS solution to bring its quality and document management processes together, Actelion Pharmaceuticals used separate systems, both of which involved numerous time-consuming and error-prone publishing, scanning, and approval protocols, according to the company’s vice president of quality, Rudi Frank. “We’re now able to streamline processes, have fewer errors, and publish documents much quicker,” says Frank.

Adapting to a digital future

While overall economic growth, fluid labor markets, and transition support will be crucial to stimulating future job growth in the life sciences, research from the McKinsey Global Institute indicates that automation will instigate a global incremental demand for 51–83 million additional workers in all industries by 2030. These estimates also indicate that jobs in healthcare device manufacturing and other subsectors tied to the life sciences will flourish, which signals that the industry will be both a primary and indirect beneficiary of this forecasted job growth.

The determining factor in life science workers’ professional futures will be their ability to administer and navigate digital technologies and work effectively alongside the machines that have been designed to streamline their tasks. Upgrading skills, reclassifying work, or even changing occupations will be inevitabilities for some professionals. Wage polarization could be another potential consequence. If most of the anticipated job growth in advanced economies occurs at the higher end of the wage distribution, the salaries of middle-income life science occupations will decline, according to McKinsey Global Institute reports.

Remember, though, that new technology breeds new technology jobs. If historical movements like the Industrial Revolution are indicative of where technology is taking us, it’s presumable that digital proliferation will allow many existing life science positions to flourish, cause other jobs to become obsolete, and create numerous occupations in spaces never before imagined. Our best bet is to equip ourselves with proven digital tools—reliable solutions that can be amplified only by a human touch—that deliver the results life science organizations need to thrive as we move into a future that is becoming exponentially more digital every day.

Only by being deliberate in the way we develop and implement digital innovations can we be assured of maintaining mastery over our technologies, rather than being superseded by them. We would do well to heed the advice of celebrated astrophysicist Neil deGrasse Tyson who said, “I will make it a life’s mission to remain more creative than any computer so that I cannot be replaced by it. They will in fact need me for new ideas.”


About The Author

Matthew M. Lowe’s picture

Matthew M. Lowe

Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now will continue his tenure as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.

Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year postmarket clinical study for orthopedic devices.

Lowe has a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.