How MedTech QARA Strategies Are Evolving

Compliance with evolving global frameworks remains the key driver of regulatory strategy, with 68% ranking it as the most important factor. Organizations are grappling with the need to stay current with rapidly changing regulatory requirements, often without the resources or foresight for long-term planning. Regional policy shifts are gaining ground, especially in markets like China and Brazil, underscoring the need for region-specific strategies and stronger data governance. Meanwhile, regulatory authorities' own evolving processes and expectations around real-world data monitoring are adding new layers of complexity for QARA teams.

Other factors — such as real-time submissions, digital health, and post-market surveillance seem to remain as secondary concerns, in part due to limited digital infrastructure, siloed systems, and a reactive compliance mindset.

Which of the following external factors most influence your regulatory strategy today?

Please rank them by their order of importance with rank 1 being most important

While the external landscape continues to shift, the question remains: how well are QARA teams adapting internally? 64% leaders rate their organizations as “somewhat effective,” suggesting progress is being made, but there’s still a long way to go. Similarly, 64% say their regulatory strategies are “somewhat aligned” with broader corporate objectives, signalling movement in the right direction, though full alignment remains uneven across the industry.

The challenge isn’t lack of ambition, it’s execution.

While aligning regulatory strategies with corporate goals emerged as the top-ranked priority (21%), the distribution across second (17%) and third (11%) ranks suggests that it is a recognized need but not a dominant or runaway priority. Instead, many organizations are directing their focus toward tactical and operational challenges, such as streamlining fragmented processes and addressing regional inefficiencies, which collectively saw higher cumulative prioritization. This indicates that while strategic alignment is on the agenda, execution hurdles continue to take precedence, highlighting the need to balance long-term vision with near-term operational fixes.

On the technology front, digital tools are increasingly recognized as enablers, but not yet prioritized as central to transformation. Low Rank 1 scores (9%) and integration challenges indicate that while organizations see the potential of automation and AI, they’re still working through adoption barriers.

Which of the following external factors most influence your regulatory strategy today?

Please rank them by their order of importance with rank 1 being most important

Regulatory compliance emerges as the primary benchmark, with 25% ranking it as the most important KPI. Organizations remain focused on avoiding compliance risks over optimizing for speed or cost, reflecting a cautious approach to regulatory operations.

Meeting submission deadlines is also a critical measure of success, though challenges in consistently achieving them suggest trade-offs between speed and accuracy

Submission quality is just as crucial as speed, with respondents emphasizing the importance of “getting it right the first time”. The emphasis on first-pass approval rate (17% Rank 1) reflects a preference for efficiency through accuracy—minimizing back-and-forth with regulatory bodies.

Overall, success is defined more by high-quality, compliant submissions that minimize rework and regulatory friction, rather than by the speed of delivery.

Which KPIs do you use to assess the success of your regulatory submissions?

Please rank them by their order of importance with rank 1 being most important

Process standardization emerged as the top strategic priority (62%)—viewed as essential for enabling scalability, driving operational efficiency, and achieving consistent regulatory outcomes. Proactive regulatory engagement closely followed (57%), signalling a shift toward more collaborative, forward-looking relationships with regulatory authorities. Early and continuous dialogue is seen as critical to anticipating regulatory shifts, influencing policy development, and reducing approval timelines.

While AI/ML (42%) and workflow automation (36%) are gaining momentum, they remain emerging enablers rather than core strategic pillars at this stage. Organizations recognize the potential but are still in early phases of integration.

Structural considerations such as talent development (34%) and whether to centralize or regionalize QARA functions (34%) are important but not dominant, reflecting the ongoing debate about the optimal operating model in a global, complex regulatory landscape.

Which actions do you believe are critical to strategically advance your QARA function?

Collaboration tools and process automation are leading current QARA tech adoption (28% Rank 1 each), signalling a clear focus on breaking down silos and reducing manual workloads. Rather than jumping to advanced solutions, organizations are prioritizing seamless communication and core process efficiency as foundational enablers.

AI/ML is gaining traction (17% Rank 1) but remains in the early stages of impact. Manual oversight is needed particularly in critical areas like submission preparation, where accuracy and regulatory precision are non-negotiable.

Automated submission preparation and cloud-based platforms show moderate uptake. As regulators continue shifting toward digital-first models, cloud-based systems may become more essential, but for now, organizations are focused on solving immediate operational challenges before fully embracing more advanced technologies.

Which technological interventions are you currently using to enhance your QARA operations?

Please rank them by their order of importance with rank 1 being most important

Technology complexity is the most cited barrier to digital tool adoption in QARA functions (64%), with organizations struggling to integrate new solutions into legacy systems and workflows. Regulatory hesitation is another major roadblock (58%). Without clear guidance on AI-driven regulatory intelligence, automated submissions, or cloud-based compliance systems, organizations are proceeding cautiously, wary of compliance risks.

Data privacy also remains a significant concern (57%), further complicating efforts to digitize sensitive regulatory workflows. Finally, a talent gap (40%) is slowing the pace of digital transformation, underscoring the need for upskilling, reskilling, and better internal alignment to support QARA modernization efforts.

What are the primary barriers to fully adopting digital tools in QARA?

Compliance remains the non-negotiable baseline for QARA teams (36% Rank 1). Any future-facing investment, especially in digital tools, must first prove it can reinforce regulatory standards rather than compromise them.

Beyond compliance, regulatory adaptability is rising in importance, with strong showings across second and third ranks. Organizations are aiming to build an agile quality and regulatory organization that can keep pace with evolving regulations without sacrificing speed to market. Automation, predictive intelligence, and more proactive engagement with authorities are viewed as critical enablers.

Scalability may not top the priority list today (8% Rank 1), but it's clearly on the long-term horizon, reflected by its high third-rank importance (32%). As companies prepare for global expansion, centralized versus regionalized models will play a significant role in determining how efficiently and flexibly they can scale.

Which of the following outcomes are most important for future-proofing your QARA function?

Please rank them by their order of importance with rank 1 being most important

Most QARA teams feel reasonably equipped to support future growth, with 55% rating their operations as "somewhat scalable/flexible" and 19% calling them "extremely scalable/flexible." Only a small group (13%) view their systems as inflexible, indicating growing confidence—but also a clear awareness that more progress is needed.

Encouragingly, 91% of respondents say they align regulatory submissions with broader business objectives such as time-to-market and market share, signalling a more integrated and strategic QARA mindset.

Looking ahead, 75% feel somewhat or extremely prepared for the next five years, even as regulatory shifts and technological disruption accelerate.

MedTech Quality and Regulatory leaders have a clear view of the shifting landscape—what's changing, what's working, and where the gaps remain. This survey highlights an industry in transition, making steady progress while navigating the practical realities of transformation.

Organizations that are moving forward are doing so with a thoughtful balance, investing in what matters now while laying the groundwork for long-term scalability and agility. Based on the data, four themes stand out as critical

• Standardizing processes without losing flexibility
• Adopting digital tools without compromising compliance
• Building more collaborative relationships with regulators
• Ensuring QARA strategies align with broader business goals

The journey is ongoing, and there’s no one-size-fits-all path. But what’s clear is that QARA function is moving from a support function to a more strategic, connected part of the business and the leaders shaping that shift are already making meaningful progress.