Intertech Engineering Associates, Inc.

Development of a Nerve Ablation Device for the Medical Industry

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Development of a Nerve Ablation Device for the Medical Industry
Development of a Nerve Ablation Device for the Medical Industry

A nerve ablation device used for pain management project was reassigned to Intertech Engineering Associates, Inc. This project was being driven by another service provider, was running significantly behind schedule and was lacking documentation. Intertech was tasked with the continuing development of this project with a new plan to successfully implement the original goals of improving performance.

The first step was to create a new Product Requirements Document (PRD) and Software Requirements Specification (SRS). Other existing documents were re-written to remove ambiguities and ensure testability, and a series of 62304 compliant plans were written for design and development. The existing software was reverse engineered, documenting the detailed design for both processors in the device as code was being improved for safety and stability. Detailed code reviews were performed, including a Fagan-style code inspection process, with the focus on independent review and critique. Configuration management and defect management plans were implemented with use of Seapine tools that allowed the client to remotely connect as the project progressed. The watchdog schemes and inter-processor communications for the multiprocessor system were completely re-factored and redesigned for better reliability. During this phase, Intertech acted as the cross-functional team leader working with previous code developers, managing and coordinating all defect fixes, new features, and code releases using the configuration management and defect management plans.

The final deliverables for this project included a re-written PRD and a SRS, multiple plan documents that were 62304 compliant, software FMEA, software architecture, source code and many other documents required by the customer and regulatory agencies for a final product delivery.

This project rescue took 14 months to complete. To learn more about this project or the processes used to complete, see the table below or contact Intertech directly.


Nerve Ablation Device Project Highlights

Project Description
When inherited by Intertech, the project was behind schedule and running without a clear process, due partially to a non-performing engineering service provider who was unfamiliar with the challenges of FDA regulated design. Intertech developed a plan, instituted design and development processes, and drove the project to completion thereby freeing client from the non-performing supplier. Work included both design and verification disciplines.
Project Outcome
Project was completed successfully with all features implemented in a robust and reliable implementation. Client was able to transition to internal maintenance of device.
Type of Project
Development and Validation Rescue
Tools Used
Multi-Processor Platform
  • PC104 – GUI board
  • Atmel 2560 – Embedded Controller board

Operating System

  • Windows Embedded CE 6.0
Development Environment
  • Visual Studio 2005 with Platform Builder
  • IAR tool chain
Languages
  • Assembly
  • C
  • C++
  • C#

Libraries

  • .NET Compact Framework
  • Mooseworks “Graph Control” Library
Technologies
  • USB
  • RS-232
  • Touch Screen
Other Tools
  • SourceMonitor – static analysis of source code
  • Seapine Surround SCM – version control
  • Seapine Test Track – defect management
Responsibilities
  • Completed the Product Requirements Document (PRD), Software Requirements Specification (SRS), and revised existing documents to remove ambiguities and ensure testability
  • Wrote a series of 62304 compliant plans for design and development
  • Created and implemented the configuration management and defect management plans with use of Seapine tools that allow client to remote connect
  • Reverse-engineered the software architecture of the existing design
  • Documented detailed design for both processors in the device as code was being improved
  • Inherited existing software that lacked robustness and had a number of known defects. Software was rapidly reviewed, refactored, updated, and improved. Safety and stability were paramount
  • Detailed code reviews were performed including a Fagan-style code inspection process with the focus on independent review and critique
  • Complete refactoring of the watchdog schemes to ensure maximum safety in the multi-processor system
  • Complete redesign and reimplementation of the inter-processor communications for increased robustness
  • Acted as team leader among cross-functional teams including other developers that wrote the early code
  • Developed and implemented test designs and procedures for Unit Test, Integration Test with full traceability upwards to requirements documents
  • Developed boot-loader to boot application and allow field upgrades
  • Developed custom Windows CE kernel image and release procedure using Platform Builder
  • Managed and coordinated all defect fixes, new features, and code releases using the configuration management and defect management plans
  • Coordinated applicable safety and EMC/EMI compliance.
  • Participated in all hardware reviews
Deliverables
  • Rewritten PRD, SRS
  • Software development plan (62304 compliant)
  • Software verification plan (62304 compliant)
  • Configuration management plan (62304 compliant)
  • Defect management plan (62304 compliant)
  • Unit, Integration and Functional Test plans (62304 compliant)
  • Software FMEA
  • Designs and procedures for Unit and System Level Tests with trace to requirements
  • Source code for both processors (GUI and Embedded)
  • Boot-loader for both GUI and Embedded that allows field upgrades via USB
  • Code review reports
  • Inter-processor communications protocol (design and implementation)
  • Software architecture document
  • Detailed design, using Doxygen embedded commenting
  • Design review minutes
  • Updated plans and schedules
  • Output of all design history file artifacts (defect management items, configuration management items, review minutes, test record artifacts, etc.).
Services Used
  • Requirements Rewriting
  • Software review and evaluation
  • Embedded software development
  • Graphics User Interface (GUI) Development
  • Electronics review
  • Defect tracking management
  • Configuration management
  • Verification and Validation
Processes Used
  • System engineering processes
  • Project management
  • Software development processes
  • Software Verification and Validation processes
Standards
  • Customer Specifications
  • IEC 60601-1-2
  • IEC 62304
  • Regulatory Compliance: US FDA
Delivery/Turnaround Time
14 months
Product Type
Surgical Ablation Device

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