Modular Digital Measurement Frameworks for Regulatory Standardization

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Solution Overview

Problem

Existing digital health technologies face limitations in standardization, choice of appropriate measures, data collection and analysis, integrity maintenance, and translation to clinical practice, hindering their adoption in regulatory decision-making.

Innovation Solution

A collaborative framework that leverages a central data structure to generate standardized digital solutions by combining components of previously approved solutions, incorporating user data, and receiving regulatory feedback, while defining roles and criteria for stakeholders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If digital health technologies are adopted for real-world evidence data generation, then productivity in clinical research is improved, but standardization and regulatory acceptance are compromised

Engineering Contradiction:

Improvereal-world evidence data generationVSAvoidstandardization

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent segments digital health technologies into modular components (digital phenotyping modules, measurement modules, data collection modules) that can be independently standardized and validated. This segmentation allows regulatory bodies to evaluate and approve specific standardized components while maintaining flexibility for productivity improvements.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent creates universal standardized frameworks and common data models that can be applied across multiple digital health technologies and clinical research contexts. This universality enables regulatory acceptance of standardized solutions while maintaining the adaptability needed for productive real-world evidence generation.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Productivity

If multiple digital health technologies are integrated into clinical trials, then productivity and data comprehensiveness are improved, but device complexity and difficulty in maintaining integrity increase

Engineering Contradiction:

Improvedata comprehensivenessVSAvoidintegrity maintenance

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent implements a nested architecture where standardized digital health technology components are embedded within a hierarchical framework of common data models, validation layers, and regulatory compliance structures. This nesting organizes complexity into manageable layers, maintaining integrity while enabling comprehensive data collection.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent introduces intermediary standardized interfaces and validation mechanisms that mediate between multiple digital health technologies and the regulatory framework. These intermediaries ensure data integrity and consistency across diverse technologies without limiting their functional comprehensiveness.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If digital health technologies are rapidly developed and deployed, then productivity is improved, but the lack of translation from ideation to actual practice increases

Engineering Contradiction:

Improvetechnology deployment speedVSAvoidtranslation to practice

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

The patent establishes preliminary standardized frameworks, validation protocols, and regulatory submission templates before digital health technologies are fully developed and deployed. This preliminary standardization accelerates the translation from ideation to practice by having ready-to-use frameworks in place that guide rapid development while ensuring regulatory compliance.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20250308711A1Collaborative frameworks for improving regulatory decision-making of measurement solutions

Publication Date: 2025.10.02 JANSSEN PHARMA NV

AI summary

In an aspect, a method of managing at least a component of a standardized digital solution for characterizing a disease is presented. The method includes obtaining, at a processor, a central data structure. The method includes receiving a request for a new standardized digital solution. The method includes generating the new standardized digital solution by leveraging one or more components of the previously approved standardized digital solutions in the central data structure. The method includes receiving feedback from a regulatory collaborator specific for a received input contributing towards at least a component of the new standardized digital solution. The method includes documenting the received feedback from the regulatory collaborator, wherein the received feedback comprises a regulatory acceptance of at least the component of the new standardized digital solution.