How to Build Literature Review Systems That Scale

Transforming compliance burden into operational advantage through standardized processes

During the recent Medical Literature Review webinar with AKRA TEAM, Romney Adams made this critical point:

"Once you've got processes standardised and perfected, there are so many opportunities to augment and expedite your literature reviews.”

- Romney Adams, Former Learning Specialist at DistillerSR

Expanding on this point captures a critical reality for medical device manufacturers: literature reviews under MDR aren't one-time events but recurring obligations that demand systematic approaches. Companies conducting ad hoc reviews for each CER, PMCF plan, or PSUR face mounting costs, inconsistent outputs, and regulatory risk.

[Download the Guide to Medical Literature Review]

The solution lies in building reusable frameworks that transform literature reviews from compliance burdens into streamlined operational capabilities. For manufacturers managing multiple product lines, this shift from reactive to systematic represents the difference between sustainable growth and escalating complexity. 

The Cost of Reinvention

Medical device companies repeatedly struggle with literature review demands across their regulatory obligations. Each new submission requires methodologically sound, current literature analysis—yet most organizations approach each review as a fresh start.

Without structured, repeatable systems in place, teams may find themselves recreating the process each time, leading to inconsistencies, wasted effort, and increased risk of non-compliance.

This reinvention cycle creates multiple problems: inconsistent methodology across products, wasted expertise on administrative tasks, and documentation that fails audit scrutiny. The webinar panel emphasized how standardized templates and workflows address these challenges while enabling scalability across product portfolios.

By defining a core methodology that can be applied to different devices and clinical areas, companies can maintain consistency while still allowing for necessary customization.

Framework Fundamentals: Templates That Work

Effective reusable systems begin with standardized Literature Search Plans (LSPs) and Literature Search Reports (LSRs). These templates provide scaffolding for consistent methodology while accommodating device-specific requirements.

Establishing templates for both documents enables manufacturers to reduce preparation time, improve documentation quality, and support audit readiness.

Successful templates include pre-filled generic content—database descriptions, appraisal scoring systems, standard risk language—allowing reviewers to focus on device-specific analysis requiring expert judgment. Checklists and structured fields prompt clear methodology documentation and decision rationale.

Critical to template effectiveness is regulatory mapping. Sections must explicitly align with MDR Annex XIV and MEDDEV 2.7/1 rev. 4 requirements.

To ensure traceability, it's important that templates clearly map to regulatory requirements.

This alignment enables direct inclusion in technical documentation without post-submission restructuring—a significant efficiency gain during regulatory preparation phases.

Technology as Force Multiplier

Software platforms extend efficiency gains beyond templates and search strategies. Advanced tools like DistillerSR offer end-to-end management capabilities that mirror LSP and LSR structures.

Customizable workflows within such platforms mirror the structure of LSPs and LSRs, enabling traceability from plan to execution.

Key capabilities include direct database imports, automated deduplication, multi-level screening management, reviewer task assignment, and real-time progress tracking. These platforms generate audit trails for inclusion/exclusion decisions and automatically populate reporting templates with extracted data.

Four Execution Strategies That Deliver Results

Beyond templates, efficient execution requires practical optimization strategies that reduce workload without compromising quality:

1. Strategic Search Refinement: Carefully designed search terms prevent thousands of irrelevant results. Using controlled vocabulary (MeSH terms), restricting to major topics, and filtering publication types eliminates noise while maintaining comprehensiveness.
2. Justified Timeframe Limits: Most regulatory bodies accept well-reasoned limitations to five or ten years unless older publications offer specific value. This dramatically reduces search volumes while focusing on current, relevant evidence.
3. Segmented Search Approach: Rather than exhaustive single searches, reviewers can conduct targeted sub-searches by concept—clinical condition, alternative treatments, benchmark devices, and similar devices. Each segment enables greater relevance control and manageable workflows.
4. Pre-validated Query Libraries: Organizations can develop reusable search strings for common conditions or device types. These pre-validated queries adapt quickly for new reviews while ensuring consistency across submissions.

AI-assisted features—keyword highlighting, PICO element identification, automated article type tagging—reduce reviewer burden while maintaining human oversight for interpretation and critical analysis.

For teams managing multiple devices or working with cross-functional stakeholders, cloud-based collaboration features offer further efficiency.

Geographic distribution becomes irrelevant when multiple reviewers contribute simultaneously while maintaining methodology alignment. Version control, reviewer logs, and permission settings ensure data integrity across collaborative workflows.

Portfolio-Level Strategic Advantage

Standardized processes create opportunities for portfolio-wide insights impossible with ad hoc approaches. Consistent review structures enable cross-product comparisons, systemic risk identification, and state-of-the-art monitoring at organizational scale.

Companies can develop libraries of accepted safety endpoints, performance benchmarks, or clinical comparators that apply across multiple submissions.

This approach particularly benefits manufacturers with product families sharing core technologies or clinical indications. Rather than duplicating efforts for each variant, teams reuse core search elements while adapting device-specific content—reducing time, cost, and improving documentation quality.

As regulatory scrutiny of literature-based evidence increases under MDR, organizations that build systematic, scalable processes are better positioned to respond to reviewer questions and avoid delays.

Maintaining System Effectiveness

Standardization requires balanced flexibility. Templates must accommodate device-specific characteristics while maintaining methodological consistency.

The literature review process should be viewed as a living system, updated as products evolve, guidance changes, or regulatory expectations shift.

 Successful organizations establish governance processes for literature review methodology: assigned ownership, periodic training, reviewer feedback collection, and continuous improvement based on audit results and submission lessons learned. 

Regular template updates ensure alignment with evolving requirements. These systems require maintenance like any quality system asset—static templates quickly become compliance liabilities rather than operational advantages.