An Enhanced Agile V-Model: Conformance to regulatory bodies and experiences from model's adoption to medical device development.

Context: Medical devices fall under the broad topic encompass everything from basic hardware to integrated software systems. The integration of software into hardware devices is not simple due to requirements of regional regulatory bodies. Therefore, medical businesses need to oversee not only the creation of devices but also the observance of guidelines and standards established by regulatory bodies. While plan-driven methodologies prevented software from evolving or changing, agile methodologies have inherent characteristics of insufficient planning and documentation.

Objectives: The objective of our research is to propose a suitable process model for medical device development, keeping in mind the regulatory requirements.

Methods: First, based on the detailed analysis of literature and McHughs proposed model, we suggested the Enhanced Agile V-Model (EAV), which combines plan-driven and agile approaches. Second, we mapped the proposed model to the MDEVSPICE framework to confirm that it adhered to the rules outlined in the standard IEC62304. Finally, the proposed model is evaluated through implication to case study of wave therapeutic medical device.

Results: The support of both agile and waterfall approach in EAV model helps in accommodating new requirements in the medical devices and the proposed systems engineering approach helps in hardware and software integration. The mapping of the EAV model to the MDEVSPICE shows complete compliance. Moreover, the implication of the proposed model has been clearly shown statistically and successfully implemented in our case study. Further, device usability and efficiency metrics showed confidence of P < 0.05 and for device safety and efficiency, we conducted an experiment which shows significant improvement in selected parameters.

Conclusion: The proposed model shows conformance to regulatory standards, and successfully implemented in development of wave therapeutic device. However, its applicability to more compact and straightforward medical products is unknown and can be determined by using this model to analyze the performance of other medical products.