Designing, developing, testing, validating, manufacturing, selling, servicing and sustaining medical devices requires special care, thorough scrutiny and a distinct risk-based approach. How can GenAI improve this process?

Overview of medical device development

In the medical device development process, the product design is transferred to manufacturing once activities are completed. The latest approved and released version of the design history file (DHF) sets the initial version of the device master record (DMR) and guides the regular sales manufacturing process.

A product device master record (DMR) includes comprehensive documentation of:

• The latest approved product design, including user requirement specifications (URS), design requirement specifications (DRS), labeling requirement specification (LRS) and technical specifications 
• Manufacturing processes, procedures and test record sheets 
• Approved supplier list (ASL) for new inventory items 
• Labelling and packaging drawings, instructions for use (IFUs) and instructions for servicing 
• Service protocols and operational workflows 
• Product SKUs for various regions and countries where the product is sold

Post-launch scenarios requiring changes

The DMR is considered final after launching a medical device. However, several scenarios may require changes to the product DMR and DHF, including:

• Manufacturing issues such as poor yield or tedious assembly processes 
• Supply chain challenges due to component obsolescence or supply chain constraints 
• Customer feedback indicating that product features or clinical workflows are not meeting expectations 
• Adverse events that require changes to the product design and manufacturing process ensure patient and operator safety 
• Service difficulties due to complex product assembly 
• Regulatory and standard changes impacting labeling, packaging or product design 
• Marketing requests for additional features beyond the original product design

Managing change control with GenAI

When a change is required to the product DMR and DHF, a thorough assessment of all elements derived from cross-functional inputs is essential. Within the organization, the Change Control Board (CCB) initiates a change plan, appointing a change owner and inviting various stakeholders to participate in the change control planning meeting.

During this meeting, stakeholders from different functions provide input on the proposed change's impact on their respective areas. The change owner assigns impact assessments to key stakeholders using a change control management (CCM) tool.

GenAI could play a potential role in facilitating the change owner to rightly identify key stakeholders from the different functions so that necessary functions are not missed from becoming part of the change control planning.

Another potential use of GenAI is to facilitate the impact assessors' parsing through the various documents that are part of their function and identifying the key impacting elements relevant to their function regarding the proposed change.

Facilitating impact assessment with GenAI

Once impact assessments are assigned, stakeholders review their part of the DMR and DHF documentation to identify affected elements and record these impacts. GenAI can assist this process by analyzing documents and highlighting relevant impacting elements.

When using GenAI for impact assessments, an organization can expect the following outcomes for stakeholders:

• Product design engineer: Identifying impacted URS/DRS, changes to product schematics, detailed design descriptions and system and sub-system architecture 
• Product risk engineer: Identifying relevant failure modes and risk mitigations 
• Product labeling engineer: Identifying content modifications in product labels, Instructions for Use (IFUs) and packaging drawings 
• Software engineer: Identifying software modules requiring changes 
• Manufacturing engineer: Identifying procedural modifications and impacted process Failure Modes and Effects Analysis (FMEA) items 
• Service engineer: Identifying impacted spares, SKUs, service manuals and protocols 
• Purchase engineer: Identifying impacted inventory parts for procurement or disposition 
• Regulatory and compliance engineer: Identifying affected regulatory clauses and ensuring product compliance

Facilitating quality review and approval using GenAI

The quality engineer reviews and approves all Change Control Management (CCM) workflows and deliverables. GenAI can assist them in validating data entered by impact assessors before final approval, ensuring thorough documentation and adherence to change control processes.

Conclusion

GenAI enhances the efficiency and accuracy of Change Control Management (CCM) by reducing the time and effort needed for support stakeholders to capture relevant content and ensure no critical elements are overlooked. This ensures successful change control activities, achieving predefined timelines and goals and helping MedTech organizations achieve their business objectives.