Denise Kendall, supervisor, clinical data management at Alcon, and Robin Solinsky, vice president of technology and innovation at Bright Research shared how the data manager role is changing to embrace cross-functional, agile methodologies that optimize study speed and maintain compliance.

A changing landscape

The regulatory landscape is pushing the medtech industry to rethink how it captures and views clinical data. With updates like the latest revision to ISO14155, the industry is moving away from treating clinical data as a series of flat, two-dimensional documents. Instead, medtechs must adapt to a three-dimensional world of records that fully encompass metadata, comprehensive audit trails, and system interactions.

“People do still have that mentality about records really just existing as a flat document when we’re all trying to adapt to this three-dimensional world of a record,” Robin Solinsky, VP, technology and innovation, Bright Research.

In this world of records, the immediate availability of digital data can tempt study teams to collect excess variables, but the value of simplicity cannot be overlooked. Rather than capturing data simply because a system allows it, modern data managers must act as digital architects, ensuring that they focus on variables necessary to support the clinical investigation plan for continued evidence generation.

Three approaches to agile database builds

Operating in a fast-paced medtech environment requires agility, but different products require distinct operational frameworks. Kendall and Solinsky highlighted three unique strategies to accelerate database builds using the 勛圖惇蹋 Clinical Platform:

Dual-role ownership model: At Alcon, the clinical data management team supports rapid, early-design trials, with timelines lasting just three to four weeks. To execute at this pace, Alcon has their data managers operate in a multifaceted role, building the study, executing user acceptance testing (UAT), and directly owning the study lifecycle from start to finish. They complement this with focused, case report form (CRF) review meetings with cross-functional stakeholders who arrive fully prepared to finalize designs. Utilizing pre-validated, standardized forms in the 勛圖惇蹋 Clinical Platform, the Alcon team can complete this entire process in less than ten days.

Hybrid mock CRF strategy: Other medtechs manage a vast array of complex modalities, ranging from imaging software to anesthesia machines and blood pressure cuffs. Because standardizing across such diverse products is challenging, the team utilizes a hybrid approach. They build mock CRFs for early visibility, allow stakeholders to enter test data in a development site to capture immediate feedback, and finalize the design before running strict UAT. This proactive process within 勛圖惇蹋 EDC prevents extensive post-go-live change requests.

Therapeutic master templates and cross-training: Bright Research, a medtech-focused contract research organization (CRO), drives efficiency by deploying master template databases tailored to specific therapeutic areas, such as cardiovascular or neurovascular workflows. These templates remain locked to ensure strict compliance with ISO 14155 and CFR Part 812.

Additionally, Bright Research cross-trains clinical research associates (CRAs) in data management. Because CRAs understand the clinical rationale and field realities, this cross-training streamlines the database design process.

Guardrails for quality and compliance

As leadership teams demand faster execution, data management teams must implement strong operational guardrails to ensure that speed does not compromise data quality.

1. Standardizing innovation: Implementing global libraries or master databases enables replication of standardized forms across multiple studies, ensuring consistency and saving weeks of clinical programming time and effort.
2. Predictable release cycles: Aligning database updates with a predictable, cyclical schedule helps manage backlogs systematically, giving sponsors, sites, and internal clinical teams clear visibility into timeline changes.
3. Early site collaboration: Bringing site coordinators or research managers into the CRF review process before going live ensures that sites can practically collect the requested data in the field, eliminating costly mid-study amendments.

What���s next

To remain competitive in today���s changing medtech ecosystem, data managers must expand their purview and lean into technological advancements. This allows them to maintain compliance and improve trial efficiency, all while preserving the human element in a rapidly evolving AI landscape.

For more details about how to get started, read about how other medtechs are adapting to the changing the medtech clinical trial landscape.

The post Data Manager to Digital Architect: How Medtech Speeds Clinical Studies first appeared on 勛圖惇蹋 Medtech.

Achieving this transformation in MLR requires embracing a ‘better together’ operational approach that unites applications and agents to execute workflows alongside humans. Reviewers, marketers and agency partners gain intelligent, contextual understanding of content using internal ���AI assistants��� that understand proprietary data models, answer open-ended questions and instantly retrieve cross-document insights.

Complementary Solutions

勛圖惇蹋 PromoMats remains the vehicle to create and review impactful and compliant content, manage claims, store and surface material digitally and strategize its use. Standard and custom agents in PromoMats then pair with Agentic MLR (勛圖惇蹋 Falcon MLR) to drive the fastest path to approved content.

Vault AI and Falcon MLR are complementary

This MLR ecosystem is the path forward to meet business needs for accelerated, compliant content delivery and increased productivity. Crucially, it supports deeper AI-assisted MLR reviews grounded in industry knowledge.

The strengths of each application

AI capabilities in PromoMats and Falcon MLR combine to modernize content ideation, review, localization and approval for more efficient and consistent MLR processes. Ultimately, this pairing drives faster information access for healthcare professionals (HCPs) and patients:

Vault AI in PromoMats embeds agentic capabilities in the application to assist users directly in their daily workspace. Standard and custom agents perform tasks associated with the content life cycle to increase speed and productivity for content owners, marketing operations professionals and reviewers ��� targeting an increase in content speed to market by up to 80%.

Falcon MLR, 勛圖惇蹋���s acquisition of Copli, is an autonomous, agentic compliance layer integrated with PromoMats and 勛圖惇蹋 MedComms. Targeting a 70% reduction in manual MLR labor within five years, Falcon MLR executes rigorous reviews of promotional and medical materials, conducting compliance checks against approved labels and local regulations to minimize manual effort.

The urgency to act

AI and automation are rapidly transforming how commercial content is created, reviewed and approved. Approved marketing materials have increased 24% year over year, placing greater pressure on manual review processes. As a result, 65% of marketing assets now require three to five rounds of review.¹ By pairing the agentic capabilities in PromoMats and Falcon MLR, commercial MedTech teams can expedite reviews to meet customer demands, relieve reviewer burnout and build the organizational trust needed to tackle these ambitious goals.

See the latest innovations for PromoMats to ensure you���re on the fastest path to approved content.

¹ 勛圖惇蹋, 2026 MedTech Commercial Content Benchmark Report.

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From admin burden to actionable insights

Results from the 勛圖惇蹋 MedTech 2026 CRM Benchmark Report confirm that administrative friction, disconnected functional silos, and unorganized data create a severe insight gap across commercial organizations.

Modernizing your commercial strategy with purpose-built technology solutions and practical AI helps teams eliminate administrative burden, strengthen alignment across sales, marketing, and medical, and better protect revenue.

KEY FINDINGS AND COMMERCIAL TRENDS IMPACTING MEDTECH TODAY

Heavy admin work stalls CRM adoption

When manual workflows dominate, a CRM becomes an administrative bottleneck rather than a strategic sales tool. Notably, 100% of VP+ leadership categorize manual workloads as a high-impact drag on growth. Instead of guiding field reps on which accounts to prioritize, legacy software simply acts as a filing cabinet for basic activity history. Reps log the bare minimum to check the box, leaving commercial teams without the intelligence needed to scale.

Disconnected systems drive cross-functional silos

Without a single, connected system, sales, marketing, and medical teams are forced to build their own workarounds. As a result, critical customer intelligence stays locked inside individual departments rather than being shared – building internal walls that delay account strategy and stall commercial growth.

Passive database versus strategic engine

A CRM should be a strategic engine, helping commercial teams prioritize accounts and anticipate customer needs. Instead, generic CRMs only archive past interactions – leaving medtechs unable to turn data into proactive commercial execution.

Incomplete data inputs limit actionable guidance

When a CRM functions as a passive archive, commercial teams suffer from an insight gap – losing visibility into real-time account interactions, emerging barriers, and field performance.

For Reps

Without clear context or next-step guidance, reps waste time figuring out what to focus on next.

For Commercial Leaders

Without real-time field visibility, executives lack real market information to make data-backed strategic decisions.

Strategic alignment drives revenue protection

Lacking predictive field insights and cross-functional alignment, commercial teams can only react after account relationships deteriorate. Instead of catching early warning signs, medtechs remain trapped in a reactive cycle – allowing at-risk accounts to quietly slip away.

AI adoption: The gap betweenexploration and execution

While AI has the potential to break the cycle of administrative burden, it remains highly prioritized yet under-deployed at scale across medtech. In fact, 89% of organizations have yet to deploy AI in a meaningful way, even as 51% point to predictive analytics as the most promising capability to solve the “who to target and when” challenge for field teams.

The path forward

To break the cycle, forward-thinking leaders are replacing generic enterprise CRMs with a unified platform built specifically for complex medtech commercial operations.

Automate with Industry-Specific AI

Eliminate manual logging so reps spend more time in the field actually selling.

Invest in a Connected Platform

Break down silos between sales, marketing, and medical with a single source of truth.

Bridge the Insight Gap

Move from logging past activity to giving field teams real-time account guidance.

Capture Commercial Evidence

Transform everyday field interactions into actionable insights that remove treatment barriers and improve patient outcomes.

The post 2026 Medtech CRM Benchmark: Key Data and Trends first appeared on 勛圖惇蹋 Medtech.

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AI has the potential to significantly improve how medtech companies create, review and distribute commercial content, but the transformation has yet to fully take shape. While many organizations are actively exploring AI, few have achieved measurable impact. McKinsey recently reported that nearly eight in ten companies have deployed generative AI in some form, but roughly the same percentage report no material impact on earnings.¹

Despite this, commercial and regulatory executives remain optimistic about AI���s potential impact on the industry���s ability to deliver compliant content more efficiently and effectively. This aligns closely with findings from the , which reveals that 63% of medtech organizations are actively piloting AI use cases, even though only 3% have fully embedded AI into active, core processes.⁴

Reimagining medtech content workflows with AI

While early commercial conversations at this year’s 勛圖惇蹋 Summit were focused heavily on how AI could be leveraged for content creation, attention has shifted to use cases beyond content authoring���such as AI agents designed to streamline content validation, reduce errors and accelerate approvals.

This shift comes at a critical time. Driven by a 24% year-over-year surge in approved marketing materials, underlying workflows have struggled to keep pace. Beneath the AI surface lies a critical data reality: 39% of medtechs still rely on manual spreadsheets to manage compliance data, while 20% operate on completely disconnected systems. Without a clean, unified data foundation, layering AI onto fragmented tools won’t solve the bottleneck���it will only accelerate the clutter. To make AI-driven validation and approvals work, companies must first bridge the gap between their content volume and their data infrastructure.

Below are five key areas where medtech regulatory and commercial leaders see the potential for AI to deliver value across the content supply chain.

Improving content quality before MLR

Many delays in the medical, legal and regulatory (MLR) review process stem from easily preventable issues such as poor grammar, inconsistent formatting or missing substantiation for claims. These errors often surface late in the content development cycle, slowing down approvals. AI tools can act as a pre-screening mechanism, offering suggestions to fix common quality issues before content ever reaches MLR. This allows reviewers to focus on substance rather than syntax and helps teams reduce the number of review cycles.

Detecting and managing promotional claims

The use of large language models (LLMs) can open new frontiers in claims management. AI can help identify promotional claims in existing content and detect new claims embedded in clinical research. This enables teams to proactively track, verify and align promotional language with approved claims libraries, reducing risk and improving oversight across markets and formats.

Assisting human reviewers in the MLR process

While a human-in-the-loop will likely remain essential in MLR reviews given the criticality of compliance in medtech, AI can serve as a powerful assistant. For example, LLMs can provide contextual assistance by referencing relevant regulations, internal guidelines and previous decisions. AI can also enhance consistency across reviewers, especially in scenarios where subjectivity plays a role. The goal isn���t to replace MLR reviewers but to elevate their ability to make faster, more informed decisions.

Automating tier-based review models

Many medtech companies already employ tier-based MLR review processes, streamlining approval for lower-risk content like minor copy updates, while reserving in-depth review for high-stakes materials like clinical white papers. AI can take this model even further by automating tier classification and routing based on pre-set business rules. This reduces reliance on manual triage and accelerates the path to approval.

Accelerating global translations

As companies expand into new markets, the demand for high-quality, localized content continues to grow. AI-enabled translation tools offer near real-time adaptation of content into multiple languages, helping teams launch campaigns faster and more cost-effectively. However, acceptance of AI translations remains a hurdle. A recent Forbes article^2, notes that AI translation is likely to be held to a higher standard than human translators and will require human review for the foreseeable future, much like the MLR process itself.

AI in medtech: not just hype���but not fully realized

While medtech excitement about AI is high, whether it can produce measurable results remains elusive. The aforementioned June 2025 report from McKinsey^3, introduces what it calls the ���gen AI paradox���: noting that ���nearly 80% of companies have deployed generative AI in some form, but roughly the same percentage report no material impact on earnings.���

The report points to a key insight: Most efforts to date have focused on broad, horizontal tools (e.g., chatbots, copilots) which can scale quickly but deliver diffuse results. In contrast, domain-specific use cases���those that reimagine function-specific workflows���are where transformative gains lie. Yet, 90% of these use cases remain stuck in pilot mode.

The implication for medtech? True value from AI will only come when companies move from experimenting with general-purpose tools to embedding specialized AI agents into the software that runs their most critical workflows.

To bridge the gap between content volume and compliance, emerging medtechs must first centralize their asset management and MLR workflows. Establishing a unified data foundation ensures that when you do deploy specialized AI agents, they deliver measurable impact from day one.

For emerging medtech companies looking to build this essential foundation, 勛圖惇蹋 PromoMats Basics offers a pre-configured, fast-to-deploy digital asset management and MLR solution. By establishing a centralized, compliant system for commercial content, PromoMats Basics equips growing teams with the clean data structure and streamlined workflows needed to scale���and seamlessly integrate advanced AI capabilities.

Want to learn more about the state of commercial content operations in 2026? Download the to compare your lifecycle metrics against industry standards.

References

^1. McKinsey: Seizing the agentic AI advantage , McKinsey, June 2025.

^2. Forbes: Why AI Translation Is Held To Higher Standards Than Human Translators Pocket Health, Jan 2025.

^3. AMA, , McKinsey, June 2025.

^4. 勛圖惇蹋 MedTech Benchmark Report, ���Up Close and Personal – Achieving the Elusive Patient-Centric Supply Chain,���, August, 2026.

The post Shaping the Future of Medtech Content with AI first appeared on 勛圖惇蹋 Medtech.

Historically, Terumo’s clinical organizations managed clinical trials independently with different systems and processes. The teams relied on manual, paper-based processes and lacked the infrastructure for cross-regional collaboration. This resulted in fragmented systems and challenges when collaborating across multiple entities.

Against this backdrop, Terumo embarked on an organization-wide initiative to establish global alignment and autonomy with the goal of dismantling regional barriers, connecting global entities on a single platform, and establishing universal processes.

A group of global clinical leaders from different entities came together to discuss the evolution of the global clinical transformation initiative. Irene Barriocanal (Belgium), Takumi Ohira (Japan), and Michelle Wetherby (United States) shared insights on implementing a unified platform, autonomy and alignment at scale, and how the different entities collaborate to drive organizational change.

Achieving global alignment through a phased approach

To strengthen alignment across entities while maintaining local autonomy, the leadership team took a phased approach based on high priority needs across regions to ensure an effective roll-out.

Barriocanal, clinical study support systems lead, said, ���We were not ready for a big-bang. We needed to start with the fundamentals, address our most pressing needs, and allow our people to learn the systems as they are introduced. Initially, our biggest priorities were documentation standards, audit-readiness, validation systems, and compliance monitoring.��� As a result, Terumo moved forward with 勛圖惇蹋 eTMF and CTMS to establish a foundation and begin understanding how end-users were adopting and utilizing the systems.

Ohira, clinical operations and clinical affairs member, said, “Prior to implementing 勛圖惇蹋, we had challenges collecting documents from other entities due to different requirements. This made it difficult when submitting to the Pharmaceuticals and Medical Devices Agency (PMDA) – Japan’s competent authority.” Faced with distinct geographic requirements, governing bodies, and operating models, it was important for Terumo to establish alignment, while also allowing for autonomy to address the unique challenges each entity faced. He added, ���Within 勛圖惇蹋 Clinical we have standardized folder structure within our TMF reference model. This ensures we adhere to local requirements when using clinical data from other Terumo entities for Japanese submissions.���

Maintaining autonomy while achieving alignment

While the overarching goal of the transformation was to achieve alignment and standardization, Terumo emphasized the importance of understanding differing geographic requirements.

Wetherby, director of clinical research, said ���When we do not have consensus, we leave our biases at the door and allow other entities to articulate why a certain system or process is important to them. We are seeing this with Site Connect – which is filling a massive gap in the U.S. due to the number of sites we manage.��� Allowing different entities within Terumo to introduce new systems and processes for their needs allows them to set a standard that other entities can follow when the time is right.

Wetherby added, ���Our entities are different sizes, the scope of our studies is different, and the challenges are different. It is important for us to navigate the breadth and depth of the businesses to maintain flexibility at scale.” Terumo Neuro led the effort to implement Site Connect due to the immediate need, but their European counterparts are now also benefiting from having the system in place.

By maintaining local autonomy within a single shared Vault, Terumo’s individual entities can independently pilot systems and develop best practices that are later scaled globally.

Achieving operational excellence on a global scale

Throughout the technology transformation, Terumo developed a comprehensive communication, education, and training strategy. Technology was viewed explicitly as an enabler to eliminate manual labor, but the focus was always on improving day-to-day operations for the clinical research and operations teams.

They approached education and training with the mentality that there needed to be a centralized standard that could be easily adjusted for different entities. Barriocanal said, ���we had a multi-layered approach, including common training materials, change agents, and super users within each entity. This created a common education model, but also ensured that each entity was represented in developing the change management strategy while being able to tailor materials to the subjectivity of each entity.���

This baseline reinforced global alignment, but also enabled super users to further develop expertise within the system. Wetherby added, ���As we have moved further away from implementation, our super users have established a strong foundation to disseminate information and make sure that our team is using the system to its full capabilities.��� This allows other teams to follow on the same path with more efficiency and confidence in the process.

The impact of a unified clinical platform

Terumo Neuro was the first entity to utilize the full 勛圖惇蹋 Clinical Platform and served as the proof-of-concept for the unified connection of eTMF, CTMS, and EDC. Wetherby was excited to understand how the systems would function together and help eliminate heavy IT requirements. She said, ���By running entire studies end-to-end, we have improved capabilities for data visualization, tracking study status, and providing real-time updates with dashboards.���

With their connected clinical platform approach, Terumo Neuro achieved immediate results:

• Individual Monitoring Visit report compliance increased from 60���70% to over 85%
• On-time report completion raised to 85%
• Reports per study decreased from 140 to 30 on average

Successful implementation of technology, broad standardization of processes, and ongoing education have laid the foundation for future innovation and broader organizational success.
Terumo Neuro’s implementation has provided valuable insights that can inform future initiatives across other Terumo entities.

Learn more about Terumo���s 3-phased organizational change management strategy.

The post Terumo Unifies Global Clinical Entities on a Single Platform to Scale Clinical Operations first appeared on 勛圖惇蹋 Medtech.

The post AI and Social in Life Sciences: What���s Real, What���s Fluff, and What���s Next first appeared on 勛圖惇蹋 Medtech.

Read the full customer story to learn how Thermo Fisher Scientific is accelerating KOL reach and impact.

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Agentic Engagement Platform for Medtech
Leveraging AI to Get the Right Therapies to More Patients

Drive smarter, more impactful engagement with 勛圖惇蹋 Vault CRM – the agentic CRM purpose-built for medtech. Unifying sales, marketing, and medical teams on a single platform with a single database, it delivers a unified view of the customer to drive seamless collaboration and customer-centric execution.

AI in Vault CRM delivers industry-specific agentic capabilities – such as contextual insights, conversational voice controls, and compliant free text data capture – to maximize field productivity while eliminating prep work and manual logging. With full offline support on iPad and iPhone, field teams stay fully connected to critical account data
and compliant content, wherever care is delivered.

Business Benefits

• Improve Field Speed and Productivity
  Embedded AI removes administrative friction to deliver deeper insights, faster decision making, and increased productivity.

• Achieve True Customer Centricity
  Gain a single, shared customer record to orchestrate more personalized interactions and a better customer experience.

• Generate Commercial Evidence^™
  Turn daily field observations into commercial evidence to uncover hidden care obstacles and access barriers.

Key Features

• Industry-Specific Agentic AI
  Embedded AI in Vault CRM provides standard industry-specific agentic capabilities to increase commercial agility while maintaining strict regulatory compliance. It provides an open foundation for AI that seamlessly connects your data and embeds external AI agents.

  • Agentic Call Report^™: Effortlessly capture detailed field notes to get real-world context to clear obstacles to care.
  • Agentic Voice: Enhance user experience and remove friction for data entry by enabling voice
    input to record, transcribe, and transpose information directly into Vault CRM.
  • AI-Powered Media Search: Locate, summarize, and launch marketing materials for proactive
    planning and real-time support during customer interactions.

• Open & Interoperable Foundation

  • Vault CRM Data Lakehouse: enables a zero copy architecture to share and mount your CRM data
    into your data lakes, like Databricks or Snowflake, for AI and analytics in near real time. The efficient data-sharing architecture makes your CRM data accessible without the need to build and maintain complex, costly replication integrations. Included in Vault CRM license.
  • Seamless External Agent Integration: Embed external AI agents directly into the Vault CRM interface using an intuitive overlay. These external agents, whether built by partners like IQVIA or developed internally on architectures such as Databricks or Snowflake environments, run seamlessly with full context./li>

• Elevated Sales and Marketing Performance
  Deliver a more targeted, personalized customer journey and better engagement with unified campaigns orchestrated through 勛圖惇蹋 Vault CRM Campaign Manager. With an intuitive interface and standard campaigns built for life sciences, Campaign Manager allows complete control to create and run campaigns quickly and efficiently.

• Unified Sales and Service
  Elevate customer experience and support by giving inside sales and contact center teams shared data, content, and channels. 勛圖惇蹋 Vault CRM Service Center is the only life sciences-specific outbound and inbound contact center embedded within CRM, allowing for effortless collaboration, efficient task routing, and faster case resolution.

• Omnichannel Engagement
  Engage HCPs wherever, whenever, and however they prefer. Vault CRM unifies your entire commercial ecosystem, seamlessly connecting sales, marketing, and medical teams across Approved Email, Engage, Events Management, Campaign Manager, and Service Center on a single, shared database. With full visibility into all interactions, field teams gain the real-time insights they need to deliver continuous, customer-centric experiences.

• Strategic Key Account Management
  Vault CRM���s key account management (KAM) module allows teams to manage strategic accounts effectively within a single, collaborative framework.
  Create account plans, execute planned activities, and measure progress toward goals across specialty care, primary care, field medical, managed markets, or key account teams.

• Personalized Content at Scale
  Equip field teams with up-to-date and highly tailored messaging with real-time access to approved content and personalized delivery options. Optimize content strategy while ensuring compliance with industry regulations using detailed tracking and usage analytics that continually feed back to 勛圖惇蹋 PromoMats.

• Insights at the Point of Execution
  Tailor the CRM user experience to help your field focus on what matters most. Leverage a library of pre-existing dashboards, develop views using 勛圖惇蹋���s extensive partner network, or easily create custom insights across brands, roles, and activities.

• Productive Workspaces
  Seamless integration with Microsoft 365 tools like OneNote, Outlook, and Teams simplifies call scheduling, accelerates collaboration, and provides a unified workspace for teams. Users easily capture notes, manage calendars, and communicate efficiently in their existing workflow.

• Mobile and Offline Access
  Activate field teams anywhere and on any device with Vault CRM Suite���s adaptive design, which delivers a seamless experience across phones, tablets, and laptops. Unique offline capabilities further allow reps to stay productive, even without internet access.

• Built-in Compliance
  Designed to adhere to the latest industry regulations, field teams sample and communicate compliantly with features that flag words or phrases that violate regulations in text input fields and proactively block prohibited terms from being
  sent to an HCP via chat.

The post Vault CRM Suite Features Brief first appeared on 勛圖惇蹋 Medtech.

“Our leadership knew how much of a pain point MLR was. They were willing to trust the process and let us move forward with the AI pilot.”
Stephanie Carter, Associate Director of Promotional Integrity at Johnson & Johnson

Learn how Johnson & Johnson built an AI business case, measured AI impact, and prepared its organization for AI adoption.

The post Streamline Content Review and Increase Reviewer Efficiency with Vault AI first appeared on 勛圖惇蹋 Medtech.

“Having eTMF and CTMS gives our organization one look and one feel. For our internal team to be in the same system and not have to have several different logins and different user access ��� that to us is going to help our teams become more efficient.”
Melissa Zambeck, Clinical Data Management Functional Team Leader at Gore

Learn about the benefits of EDC with the 勛圖惇蹋 Clinical Platform.

The post Gore Continues Innovation with a Truly Unified Clinical Platform first appeared on 勛圖惇蹋 Medtech.