Several months ago, MasterControl strategic partner KPMG released a report titled “Quality 2030: quality inside.” Then, at the 2019 Masters Summit, presenters Rajesh Misra and Anuj Kapadia used this information to explain what the future of quality in the life sciences industry will look like. That future involves quality being infused across the entire company, not just within the quality department. Technology and digital innovation will be a key enabler toward this transformation to a more proactive, and ultimately predictive approach to quality.
While Misra and Kapadia were talking about the future, they were very clear that some of these trends are already here, and companies need to start preparing now. They provided five ways companies could become more proactive with existing technology to be better placed for the future.
Artificial intelligence (AI) is slowly becoming more incorporated into how we do business, and the life sciences industry should be no exception. One branch of AI is machine learning, in which a program “learns” by identifying patterns from which it can then predict an outcome. An example of this could be a medical device company that analyzes complaint data to determine when a problem is going to occur. To do this effectively, all complaint data must be kept in a centralized, digital repository so that quality can see a problem coming and mitigate it.
The technology to do this exists now, and companies are investing in it. According to a 2019 survey from KPMG, 20% of companies are already taking advantage of on-demand platforms, the internet of things (IoT), robotic process automation, AI or machine learning. Even those that haven’t made these investments are headed in that direction. The same survey estimated that 52% of organizations would increase their spending on technology in the next year. Getting ready for the future of quality means making investments now in these innovative technologies.
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Compliance is important, but quality can and should affect the rest of the business. Sometimes quality takes a “Band-Aid approach,” fixing problems quickly while not looking at the root cause of a problem or attempting to prevent future problems. Some companies are forward-thinking enough to be proactive in their quality management. In today’s regulatory landscape, this is becoming a necessity. For one thing, many companies sell internationally, across the jurisdictions of multiple regulatory bodies. While there is some overlap in specific regulations, the effort that will pay off in every case is to improve overall quality. This big picture view has a transformative effect on an organization, as opposed to fixing a single issue.
Part of that big picture approach is taking quality beyond the quality department. Quality needs to become part of an organization’s culture that permeates everything the company does. However, KPMG wasn’t just talking about breaking down siloes within an organization; they were talking about the siloes that exist between organizations. Quality 2030 does remove departmental siloes, such as those between quality and manufacturing, but it also removes siloes between manufacturers and suppliers — and even regulatory agencies. Companies can take steps in this direction now by digitizing with software solutions that provide communication across multiple departments, thereby removing those siloes.
The quality departments of medical device or pharmaceutical companies don’t typically interact with the patients that will eventually benefit from their products. According to Misra and Kapadia, this is a mistake. Health care is increasingly becoming a consumer-focused business, and that should extend to life science companies that provide products for consumers. This is mentioned in the 21st Century Cures Act, which requires the collection of patient experience data in the drug development process.
The presenters suggested taking a more direct approach to getting consumer feedback by talking to patients and doctors. This is more proactive than waiting for complaints to arrive. By talking to consumers early on, companies will discover how to increase quality beyond what the regulations require. Moreover, since patients are taking a more active role in their health care, their perception of pharmaceutical and medical device companies is more important than it’s been in years past.
One surprising takeaway from KPMG’s presentation was the idea of improving quality by working with competitors. Misra and Kapadia aren’t suggesting that companies share proprietary data, but that they share information about quality processes that have the potential to benefit the entire industry. The Case for Quality already taps into this idea by compiling information from top quality medical device companies that can benefit other companies.
The presenters emphasized that this will ultimately cost less than having disconnected quality processes. This goes back to the Band-Aid approach that Quality 2030 advocates against. One of the advantages of proactive monitoring is that problems can be anticipated and mitigated before they occur. An example given by Misra and Kapadia is that when complaint data is centralized and analyzed, medical device companies can use predictive analytics to determine when a recurring problem is going to pop up again. They can then address the problem before it even happens. Companies can do this now by using software solutions that centralize data in a single location, which provides a complete picture and better analytics.
Perhaps the most effective way to approach quality proactively is through training and the digitized system that a company employs. The problem is that this may mean large overhauls of a company’s current processes and systems. For example, if a company has a different quality management system (QMS) for each site, data for those sites has to be manually compiled to be used. Manual data input increases the likelihood of human error and compromises data integrity. This is why Misra and Kapadia encourage a switch from paper-based or siloed systems to digitized, centralized ones.
They were both clear that digitization and automation won’t eliminate quality jobs — it’ll just return the job focus to value-added activities. It’s the boring, monotonous tasks that will be eliminated. And this is a step companies can take now. The technology already exists, and once it’s implemented quality professionals can dedicate their efforts to proactively improving quality.
Misra and Kapadia might’ve been focusing on Quality in 2030, but everything they suggested can be implemented now. The technology to enable quality professionals already exists, it’s just a matter of putting it in place and optimizing it. In this case, the biggest obstacle to proactive quality management isn’t technology — it’s convincing stakeholders that investing in that technology is worth it. Companies that don’t start this transformation now will eventually be left behind.
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