CARDIOVASCULAR DEVICE DEVELOPMENT


 

 


 

An atherectomy device manufacturer had a controller board being manufactured in Europe with a modified firmware code base.  Internally they had no resources with knowledge of software verification and validation.  Lucid’s team came in and provided development expertise for a test methodology and protocol generation from initial requests through final design – including test reporting and other specific elements required through design and testing. The client needed guidance on creating a software development and verification process.

 


 

DISCOVERY

  • The system had a saline pump that directed fluid through the system when in use.  The existing system changed the delivery rate as the motor within the pump would heat up or cool down.
  • For proper allocation of atherectomy, the motion of the device head should be maintained under a specified velocity.

 

DEVELOPMENT

  • The Lucid team developed firmware to record the motor speed from hall sensors and would adjust the motor drive signal to produce a consistent speed, resulting in a consistent delivery of saline.
  • To enable physicians to better understand the application of the therapy, a device was created to use a proximity sensor and custom firmware to provide visual feedback for device head velocity as the physician was interacting with the training tool.

 

DEPLOYMENT

  • The main objective of this project was delivered – to develop a functional prototype for the company’s engineers to progress.
  • The device gained regulatory approval and is being used currently in the US and other markets.

 


 

EXPERTISE UTILIZED

Product Development

Other Case Studies - External