GxP Lifeline
3 Main Barriers to Connected Quality and How to Overcome Them
There always has been and always will be intense pressure on companies to accelerate new product introduction pipelines. One could say that there are only three certainties in life: the certainty of death, the inevitability taxes, and the fact that there is no such thing as getting a product to market too fast.
In the life sciences and other similarly compliance-focused industries, however, companies have the added obligation of getting to market without jeopardizing the highest quality standards for vital products that have direct impact on consumers’ lives. These quality challenges have been magnified dramatically in recent years as margins continue to shrink, products grow increasingly more personalized, and the number of hungry competitors clamoring for their share of the market surges.
Even as digitization and technology fuel quality’s evolution, too many companies doing business in regulatory environments still cling to their familiar yet inefficient processes and siloed systems for managing quality processes. Yet traditional quality management models are proving insufficient for companies that wish to stay ahead of competitors. Too many organizations are learning the hard way that they can’t link the requisite data points across the life cycle of a product if their systems and processes are disconnected.
The evolving life sciences industry is forcing more and more companies to change their approach to quality management as they strive to compete in rapidly accelerating markets. The broadening implications of the following three phenomena in particular highlight the glaring need for innovative tools and methodologies that will help organizations adapt to the shifts in the quality management paradigm.
Barrier #1: Diminishing Timelines
In most markets, the first one or two life sciences companies whose products enter the market first typically capture 80% or more of the available profits.(1) That means delivery timelines will continue to narrow in relative proportion with competitors’ aggressiveness. What’s more, in an age when consumers have come to expect gratification with the click of a button, customers are far less forgiving in their expectations for product availability. As a result, timely product launches and speed to market have never been higher on companies’ priority lists.
Being first to market can’t come at the expense of quality, however, if a company hopes to sustain a long-term business. This is especially true in the life sciences industry where products have a direct impact on consumer safety and health. Yet many product flaws aren’t detected until the downstream end of the development process, as confirmed in recent Gartner research showing that more than half of critical design flaws aren’t caught until the product launch, manufacture or development and testing phases.(2) The further down the line that flaws go undetected in the development cycle, the greater the impact will be of inevitable delays like rework and machine downtime. This issue is likely to be the main reason why Gartner also reports that fewer than a third of product developers report launching products on- or ahead of schedule.(3)
To be successful in an era of ever-constricting timelines, the quality function must be the primary driver behind the acceleration of a product’s time to market. But this is no small feat — just ask any quality manager. In fact, Gartner researchers did just that, and only 33% of quality leaders reported that they’re satisfied with their function’s ability to keep up with shrinking timelines.(3)
Implementing a forward-thinking quality strategy for adapting your quality practices to the demands of the evolving marketplace is a good start. But it may not be enough to compete with digitally savvy competitors. Life sciences companies need tools that are sufficiently powered to enable their quality experts to leverage real-time quality intelligence.
Barrier #2: Increasing Product Complexity
There’s no denying that products developed by life sciences companies have never been more complex. Medical devices designs are becoming more intricate, and the technologies driving them are becoming increasingly smarter. Biopharmaceuticals, according to McKinsey & Company experts, are “the most sophisticated and elegant achievements of modern science.”(4) Even some of the new release mechanisms of standard pharmaceutical products are staggeringly innovative.
Research from Deloitte indicates that products are also more diverse and have shorter product life cycles than ever before.(5) And running parallel to these trends is an increasing emphasis on outcomes and new delivery models.
As products become more complex and diverse, and as greater scrutiny is placed on outcomes, the reliability and accessibility of the quality data that supports those products must increase in equal measure.
Barrier #3: More Product Personalization and Customization
Personalized medicine and mass customization are significant disruptors in the life sciences. The trend toward more patient-specific therapies will result in an explosion of quality data, according to a recent Cell and Gene Therapies Insights journal article.(5) To avoid becoming bottlenecks and to improve their capacity to handle an increasing number of patients each year, quality control and quality assurance functions will need to be more automated and demonstrate continuous real-time capabilities.
Automation is only one part of the equation, however. Any technology that is implemented to streamline quality data management must also be capable of making that data accessible and relevant across the enterprise. Furthermore, it must be capable of ensuring the synchronization of data pulled from multiple sources so that a single source of truth can be maintained for all essential information across the enterprise and across the product life cycle.
Platform Connectivity: Taking Quality to the Next Level
New trends require new responses. The growing demand for acceleration and personalization, as well as the enhanced focus on data, is bringing software platforms to the forefront in the life sciences. The roles that advanced technology platforms play in quality management are expanding because they provide greater real-time visibility into data and allow companies to exert greater control over information and processes, even as complexity and velocity escalate.
Rather than piecing together disparate applications to coordinate multiple processes and data streams, a unified platform offers the reassurance of native connectivity and binds applications and processes together within a common database and architecture. A platform also enables a company to achieve greater governance over its quality management processes by running multiple applications within a natively integrated operating system. These expanded capabilities empower the organization to take an approach to quality and compliance that is inclusive of a product’s entire life cycle.
By their design, platforms allow multiple interrelated processes to operate and synchronize within the same digitized framework, which is the primary reason advanced platforms are proving to be the most effective mechanism for mapping data and process connections across product life cycles.
While platforms are establishing themselves as the best means of keeping up with the trends that are presently posing the greatest challenges to life sciences companies, that is hardly their only benefit. Platforms represent the future of data connectivity and true product quality intelligence. They are serving as innovation catalysts that enable organizations to take the concept of “quality culture” to the next level by providing an integrated set of specialized tools that tightly correlate data and processes across the enterprise.
To learn more about the power of platforms and how they can help your organization connect data across the product life cycle, download MasterControl’s complimentary “The Ultimate Guide to Pharmaceutical Quality Management.”
References:
- “The Ultimate Guide to Pharmaceutical Quality Management,” MasterControl, 2020.
- “Embedding Quality in Design,” Gartner, Inc., Sept. 27, 2018.
- “Three Emerging Trends Facing Quality and what You Can Do to Address Them,” Gartner, Inc., July 31, 2019.
- “Rapid growth in biopharma: Challenges and opportunities,” McKinsey & Company, Dec. 2014.
- “Unravelling complexity: The challenge of compliance in the life sciences supply chain,” Deloitte Centre for Health Solutions, April 2017.
- “Industry 4.0: a vision for personalized medicine supply chains?” Juergen Branke, Suzanne S. Farid and Nilay Shah, Cell and Gene Therapy Insights, July 6, 2016.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
