The considerable rise in regulatory complexity within the global medical device manufacturing community is a challenge that keeps many leaders rethinking the right approach. While the European Union’s Medical Device Regulation (EU MDR) is at the forefront today, the issue certainly isn’t limited to the EU.
Life sciences organizations have a choice with regulatory initiatives: spend the minimal amount to be compliant and live with a patchwork of “silo solutions” or look at challenges such as EU MDR as an opportunity to innovate and modernize information management practices. The increasing complexity of regulatory compliance requirements is consequential and requires a strategic, holistic versus tactical approach to deliver ROI over the long term.
Internal Factors May Intensify the Challenge
In addition to external pressures, many device companies have internal challenges that intensify the issue. A 2018 Gens and Associates study of 72 companies revealed these factors that complicate the regulatory compliance roadmap for device participants:
- 72% report inefficiency with key regulatory information management capabilities such as submission document management, registration management, health authority interactions, and label compliance tracking.
- 60% take longer than a week to report key regulatory information (e.g., regulatory status of products at a specific manufacturing site, status of label changes at the local affiliate office, and health authority commitment status) due to information fragmentation.
Furthermore, many organizations have undergone significant M&A activity and often delay integration of processes and systems. Operating structures are often regionally-focused. Investments at the global level are less frequent, limiting global visibility and knowledge sharing. Many use disparate systems, which create information silos that prevent regulatory teams from drawing insights about the ‘big picture.’
Taking a More Holistic Approach
Companies are exploring more efficient and effective regulatory organizations and capabilities. They are leveraging innovation and new organizational strategies to drive more cost-effective regulatory performance as well as reduced cycle times through:
- More Effective Collaboration throughout the Product Life Cycle
An organization’s regulatory team should play a pivotal role in product lifecycle decision-making. Ensuring that the regulatory team communicates early and frequently with R&D, clinical operations, manufacturing, labeling, and others will improve overall speed to market and compliance. For example, a regulatory team’s proactive input on the probability of regulatory success can influence product portfolio decisions and minimize costly spending on low potential products. This group can advise design teams on specific health authority requirements to maximize design efficiency by creating a “global” product. Strong collaboration between regulatory and manufacturing groups can result in better decisions about manufacturing changes that will support compliance and speed the change agenda.
- Global Centralization of Regulatory Services
Successful organizations consider the optimal location for each of the activities they perform. A local regulatory footprint is helpful to maintain strong health authority relationships and feet-on-the-ground understanding of local requirements and market nuances. However, centralization is paramount to enable efficiency, compliance, and profitability. While not all activities can or should be centralized, even partial centralization can produce benefits:
• Economies of scale.
• Knowledge sharing.
• Global adoption of leading practices.
• More consistent content and messaging.
• Improved availability and accuracy of data for reporting.
Many life sciences organizations find efficiencies centralizing global regulatory intelligence and knowledge management, regulatory analytics, RIM/registration management, submission publishing (especially electronic submissions), labeling, correspondence management, commitment management, and submission planning and tracking.
- Building a Culture of Quality
In an environment of increasing competition, regulations, and customer expectations, many life sciences leaders are being intentional about cultivating a culture of quality. They foster this culture not only to be compliant; they use it as a clear differentiator in the market and a way to improve bottom line results. For instance, as a collaborator with the Medical Device Innovation Consortium (MDIC) and FDA, Grant Thornton works to identify and share practices that elevate quality. Research suggests that a company with an embedded culture of quality spends, on average, $350 million less annually fixing issues than a company with a poorly developed one.1
Key quality culture characteristics include:
• Data about quality is proactively collected and shared in a transparent manner.
• Management sets clear quality objectives.
• Quality issues are remediated quickly.
• Management looks at leading indicators of quality, not just at lagging indicators.
• Employees stay up-to-date on current guidelines and regulations as well as trends. They consider not just the narrow wording of regulations, but the broader intent.
• Management prioritizes a continuous improvement focus and challenges the status quo.
• The company collaborates openly with stakeholders, such as providers and patients, to identify improvements.
This shift in mindset cannot happen overnight. Rather, it’s an evolution that requires strong executive leadership and buy-in throughout the entire organization.
- Using Technology as an Enabler
Many device companies are exploring ways to apply innovative software technologies to overcome environmental and internal hurdles. (See below for details on what technologies companies are leveraging.)
Source: Gens and Associates 2018 Benchmarking Study
For example, artificial intelligence (AI) provides a unique opportunity to mine sources, such as interactions with regulators, health authority correspondence, audit findings, and more, to create a more comprehensive regulatory intelligence landscape.
Some companies are using AI to identify unpublished requirements within correspondence, capture local country experience, and effectively synthesize intelligence. Previously, regulatory staff may have tried to capture details from these sources in an Excel file and then search the spreadsheet to find references. These searches were not just time-consuming—they were unlikely to uncover relevant facts. With AI, companies can automatically search multiple repositories for relevant details. AI solutions continuously learn so the searches return moretargeted results each time.
Although competitive and regulatory pressures continue to mount, medical device organizations that take advantage of transformative improvements can imagine a bright future. By enhancing collaboration, embracing a quality of culture, centralizing relevant regulatory activities, and using technology to drive innovation, there is reason to look forward with anticipation. Organizations that do will enjoy improved speed to market, greater customer loyalty, and stronger bottom-line results.
1. Harvard Business Review, April 2014