Item-based vs document-based approach to documentation in Medical Devices

Raise your hand if you’ve ever had a regulation change while designing your SaMD, SiMD, or more collectively referred to as SxMD (Software as/in a Medical Device). How much time did it take you to ensure that every related document was updated according to the latest guidelines? How much time did it take to ensure your team was trained and aware of the change? Managing a large volume of documents and spreadsheets can be incredibly challenging, offer limited visibility into traces, impede development, increase the risk of errors due to version control issues, and ultimately slow your time to market.  

As Medical Devices evolve and increase in complexity, managing their intricacies with methods intended for less complicated scenarios becomes significantly harder. It’s time to sunset the outdated document-based methods and embrace a more flexible and scalable item-based driven strategy for product development and quality control. 

Keep reading to see how an item-based approach to documentation increases efficiency, lowers costs, improves trace visibility, and enhances compliance. Learn more about the design history file (DHF) here.

Transform the way information is stored, accessed, and utilized

The item-based approach to documentation mimics many qualities of databases which were originally developed in response to the pressing needs of industries that needed to manage and organize large amounts of data efficiently. This approach allowed for rapid retrieval, insertion, and updating of data through structured queries so that users could access and manipulate data in a structured and scalable way, ensuring data integrity, reducing redundancy, and supporting data analytics. 

“From a software development point of view, another major advantage of MatrixALM is the speed with which we can deploy code documentation—including release notes, verification plans and reports, software requirements specifications, and more. Previously, we edited documents individually, spending perhaps 5 minutes on each one. With MatrixALM, document editing is effectively immediate across all items.” Marvin Sanchez, R&D Engineer, IDMED

Modularity accelerates productivity

Just as databases break down data into manageable tables and records, an item-based approach breaks down documentation into smaller, discrete pieces (items). This modular structure makes it easier to manage and update information. Take ISO 13485, the standard that outlines requirements for a quality management system (QMS) specific to the Medical Device industry, as an example. The document itself spans several sections, each addressing different components of a QMS, including documentation, management responsibility, resource management, product realization, and measurement analysis and improvement. Different people or teams are responsible for implementing or planning the various sections of ISO 13485 within the organization due to the wide range of processes, from design and development to production, and each area requires specific expertise. 

With an item-based approach, you can break this standard down into sub-sections all stored as individual items to make it easier to manage when authorities update parts of the standard. This means only the affected sub-sections of ISO 13485 will need to be reviewed and updated, and only the affected or responsible people or teams will need to be involved and only the linked procedures or work instructions related to the changes need to be reviewed and updated. By facilitating a more structured approach to compliance you accelerate productivity by not involving employees or teams in reviews or retraining when they aren’t directly affected, you have less content to review, and you have more time to focus on other duties. A document-based approach requires manual review and updates across potentially multiple documents making it more time-intensive and less intuitive for identifying the impact of change.  Review times will be longer and more people will need to be involved.

Enhanced traceability and compliance

Similar to how database tables relate to one another through keys and relationships, items can be interconnected and linked. This allows for creating a network of information that is easy to navigate and update to ensure that all actions, decisions, and changes are meticulously recorded and can be linked back to their origins to form a robust framework for managing the complexities of SxMD development and maintenance and ensuring product are safe, effective, and compliant with regulatory standards. 

An item-based approach enables tracking at the item level, e.g., a single requirement, test case, or bug report, providing detailed visibility and control. This granularity allows for precise tracing of how each element of the software is tested, changed, and related to regulatory requirements. A document-based approach manages this information in larger, less flexible blocks, making it harder to pinpoint specific interactions or dependencies between different elements of the software lifecycle. 

Scalability and flexibility

Just as databases allow for dynamic data queries to assemble information in various configurations, an item-based approach lets users compile and recompile documentation from individual items to meet specific needs or contexts. Meaning, that it can efficiently scale to accommodate an increasing volume of information without losing manageability or navigability. 

With an item-based approach, you pull dynamic items into a document. Dynamic content is always up-to-date and shows you the very latest version of each of your items so everybody is always working with the most up-to-date information. Items can be added to as many different reports as you want and you can create templates to control the format and layout of the different documents, forms, or reports you need to create. By leveraging an item-based approach, companies developing SxMD can more effectively and efficiently manage the complexities of catering to multiple markets with diverse regulatory landscapes. Regulatory changes in one market can be quickly addressed by updating relevant items, with changes automatically reflected wherever those items are used, supporting rapid compliance with minimal disruption. 

A document-based approach is limited by the static nature of documents making it harder to scale. Larger projects can result in unwieldy documentation that’s hard to maintain and navigate. Responding to regulatory changes is slower and more labor-intensive, often requiring significant revisions to multiple documents. 

Optimized product versioning

When it comes to product versioning, dynamic item-based eco-systems enhance precision, efficiency, and collaboration. An item-based approach allows for version control at the item level, meaning every individual requirement, specification, test, etc., can have it’s own version history. This granularity makes it possible to track changes and updates, understanding exactly what was modified, added, or removed in each version of the product. Changes to a specific item automatically update all instances where that item is referenced or used ensuring consistency across all related documentation making it easy to see how a particular requirement or design decision has evolved over time and how these changes have been verified in different product versions. 

Document-based approaches tend to be at the document level, making it more challenging to identify specific changes within a large document. This can obscure the details of what exactly changed from one version to the next, complicating the management of product evolution. They can hinder seamless collaboration, especially in teams that are distributed geographically. Sharing and co-editing documents can introduce complexities and with multiple versions of documents being circulated, it’s possible to act on outdated information. 

“Using MatrixALM, it’s easy for us to keep track of the complex relationships between our requirements and ensure that there are no gaps in our verification and validation activities. And with MatrixQMS, we can maintain a single source of truth for best practices, as well as audit-ready records for corrective and preventive actions [CAPAs], supplier management, and production traceability.” Rutger Flink, CEO and Founder, PulmoTech

Improved risk management

As the complexity of SxMD increases, the volume of documents related to risk management can become unmanageable, making it difficult to maintain a cohesive and responsive risk management strategy. By breaking down information into items, such as specific software functions, user stories or test results, it’s easier to identify risks at a more granular level. This precision allows for the early detection of potential issues that might be overlooked in a broader document-based analysis. 

With an item-based approach, you link risks directly to related items, such as requirements, design elements, and test cases making it easier to see how each risk is addressed and mitigated throughout the development process. As items are updated or changed, associated risks can be automatically reassessed in real-time, allowing for more proactive risk management

A document-based strategy means information about risks can be scattered across different documents, hindering effective communication and leading to inconsistent risk management practices. Achieving the same superior traceability of an item-based strategy requires manual cross-referencing across multiple documents and spreadsheets, which is time-consuming and error-prone. Documents become quickly outdated as the project evolves and can delay the recognition of new risks or changes in existing risks.

In conclusion, the traditional document-based approach to documentation is becoming increasingly inadequate. The challenges of managing regulatory changes, ensuring team awareness, and maintaining up-to-date documents highlight the need for a more flexible, scalable, and efficient strategy. Enter the item-based approach—a methodology that not only enhances productivity and compliance but also transforms the way we store, access, and utilize information.

Leveraging the principles of database technology, the item-based approach breaks down documentation into manageable, discrete pieces, allowing for rapid retrieval, updates, and efficient management of complex relationships. This modular structure, akin to the organization of data within databases, facilitates streamlined compliance, optimizes product versioning, and significantly improves risk management. By providing detailed visibility and control at the item level, it enables precise tracing of software elements throughout the development lifecycle. Moreover, its scalability and flexibility make it ideally suited for catering to multiple markets with diverse regulatory landscapes, ensuring that changes are addressed swiftly and with minimal disruption.

As SxMD continues to advance, embracing an item-based approach not only accelerates productivity but also ensures that products remain safe, effective, and compliant with regulatory standards. For those looking to navigate the complexities of SxMD development and maintenance with greater ease and efficiency, the item-based approach offers a compelling solution.

To truly understand the transformative potential of the item-based approach for your SxMD projects, schedule a demo for a comprehensive walk-through. Witness firsthand how it can streamline your processes, enhance collaboration, and significantly reduce time to market.

About the Author
Heather Laducer
Product Marketing Manager