Innovative Development and Adaptation of Advanced Heart Pump System

Company: Thoratec (and Subsequent Acquisitions)

Industry: Medical Devices

Use Case: Percutaneous Heart Pump (PHP) Development

Services Used: Electronics, Firmware, FPGA, Software, Systems Engineering

Results:

• Developed firmware and hardware updates for the project.
• Improved reliability and performance with innovative verification techniques.
• Streamlined documentation for a seamless FDA submission with no queries.
• Effectively adapted practices and documentation for new parent organizations.

Customer Introduction

Thoratec, a leader in percutaneous heart pumps, plays a crucial role in keeping ICU patients alive while they await heart transplants. The company initially faced issues with a previous engineering contractor for its percutaneous heart pump (PHP) project. It needed to partner with an expert to integrate and optimize its existing hardware, firmware, FPGA, and software. Voler Systems was selected for its strategic and tactical expertise in medical device development.

As the project progressed, Thoratec was acquired by a global medical device company and later by a leading multinational medical devices and healthcare company. With each acquisition, the project goals evolved to align with the priorities and standards of the new parent organizations. Voler Systems adeptly adapted to these changes, guiding each partner toward their desired outcomes. Voler's ability to analyze and respond to shifting objectives ensured success across all organizational transitions.

Problem/Goal

• Needed to integrate complex systems, including firmware, hardware, and software.
  The heart pump system will function seamlessly and reliably.
• Establish a robust system for verifying both software and hardware components.
  

  Meet the regulatory standards, including those outlined in IEC 62304.

• Develop clear and thorough documentation.
  

  Ensure smooth FDA submissions and minimize potential regulatory queries.

• Meet new requirements through various company acquisitions.
  Adapt project methodologies and documentation practices to align with each new parent organization's evolving standards and requirements.

Solution

Voler Systems utilized its deep expertise in product development to deliver a tailored solution for Thoratec, focusing on strategic and tactical improvements:

• Created hardware and FPGA for the standalone controller console, managing data acquisition and impeller speed control with a Linux-based GUI system.
• Developed a verification simulator to test software against real-world conditions to foresee and address potential issues effectively.
• Identified and organized software and hardware requirements into a comprehensive systems requirements document for clarity and compliance.
• Worked closely with new parent organizations, as a result of multiple acquisitions, to align project development and documentation practices with each one's specific regulatory and operational standards.

Results & Benefits

• New design and updates improved system functionality and performance, providing reliable life support for patients awaiting transplants.
• Robust documentation and verification approach facilitated a smooth FDA submission process with no questions regarding the software.
• Verification fixture significantly reduced testing costs and time by enabling rapid and accurate software verification.
• Successfully navigated organizational transitions to ensure continuity and compliance with new requirements.

Inspiration

At Voler Systems, we pride ourselves on providing strategic and tactical solutions that drive product success. Our work with Thoratec and successive companies exemplifies our ability to innovate and ensure precision in the most critical and complex applications.

"Voler's strategic insights and technical expertise were instrumental in advancing our PHP project, ensuring compliance and performance aligned with our high standards."

Voler Systems is dedicated to transforming complex challenges into innovative solutions. Let's collaborate to bring your vision to life. Contact us today to see how our expertise can benefit your next project.