The Challenge

This client leveraged our AdvantagePFA Platform to develop a generator for atrial fibrillation.

The Challenge

Our client needed to rapidly enter the commodotized nerve ablation market with differentiated system that would set a new standard for precision, variety and procedural efficiency.

Having already leveraged our tried, tested and trusted AdvantagePlatforms® within their company, we were able to produce one of the most versatile and smart radiofrequency ablation medical devices with this client.

The Challenge

Redesign of a predicate device, that would allow the client to make a disruptive entrance into a single-competitor market.

Our team developed a new generator form factor that was compact and featured a touchscreen user interface, a peristaltic pump system for cooled RF and connector hub for seamless integration with several disposable options.

Leveraging AdvantagePlatforms® and Advantage Technologies, the first broadly commercialized Cooled RF system for bone tumors was developed.

The Challenge

This client was seeking a partner for a dual mode ventilator project, providing the software and algorithms for different breathing patterns and updating the electrical workings and mechanical structure of the predicate system.

In addition to the base ventilator, we were also tasked with adding a cost-effective internal and autoclavable handpiece that could withstand significant use.

The Complexity

• Dual mode design for invasive and non-invasive ventilation treatments
• Software algorithm for adaptive use, able to mask leaks
• Emergency features for quick response, including ventilation mode with alarms
• Revamped industrial design and graphical user interface (GUI)
• Real-time adaption to other patient conditions

The Challenge

A complete redesign of a life-sustaining breathing pacemaker, intended for use by patients who have lost neurological control of respiration. This Class III device with Major Level of Concern software needed a modern digital solution, improved user interface and software refinements to mitigate patient safety concerns.

The Complexity

• Complete redesign of the external controller from analog to digital, mirroring the predicate device’s inputs, outputs, and overall functionality to serve as a one-to-one replacement
• Refined user interface to include a keypad and a custom LCD screen
• A fully independent, redundant hardware solution in the external controller in case of software failure
• Multiple microprocessors, each dedicated to a unique task
• Rewrite of existing requirements to improve testability and support defining and testing for uncommon processes not considered in the existing DHF

The Challenge

A complete redesign of a life-sustaining breathing pacemaker, intended for use by patients who have lost neurological control of respiration. This Class III device with Major Level of Concern software needed a modern digital solution, improved user interface and software refinements to mitigate patient safety concerns.

The Complexity

• Complete redesign of the external controller from analog to digital, mirroring the predicate device’s inputs, outputs, and overall functionality to serve as a one-to-one replacement
• Refined user interface to include a keypad and a custom LCD screen
• A fully independent, redundant hardware solution in the external controller in case of software failure
• Multiple microprocessors, each dedicated to a unique task
• Rewrite of existing requirements to improve testability and support defining and testing for uncommon processes not considered in the existing DHF

The Challenge

CT Injectors are used to precisely administer contrast media into a patient’s bloodstream to enhance the image quality obtained in CT (CAT) scans. Vantage partnered with Bracco on their Empower Contrast Injection System to develop a quality user experience. Vantage designed a logical and intuitive workflow that still presented a visual feel that promoted the recognizable and respected Bracco brand.

The Complexity

• Users of the previous edition complained about difficult navigating the system. To combat this Vantage created an ordered landscape with zones allocated for related elements such as commands, status information, warnings and alerts.
• User error had been dangerously high in previous renditions. Vantage reduced user error by limiting user input options and restricting input to the minimum information required for the task at hand.
• To close the design development loop, Vantage conducted human factors testing with potential users in order to evaluate the safety, usability, and effectiveness of the UI (Heuristic evaluation).This allowed Vantage to elicit live feedback from key users and create a more effective UI.

The Challenge

Vantage was asked to design a intraoral imaging system in order to support surgeons with live intraoral imaging for use during oral surgery.

The Complexity

• Vantage designed and executed a human factors study, allowing for the selection of the most ergonomic grip design and camera angles for the surgical applications.
• Vantage developed Firmware to communicate with a companion PC App, providing for real time imaging.
• Vantage modified material composition and selection based on feedback given during human factors studies, providing for better traction and operability.

The Challenge

A complete redesign of a life-sustaining breathing pacemaker, intended for use by patients who have lost neurological control of respiration. This Class III device with Major Level of Concern software needed a modern digital solution, improved user interface and software refinements to mitigate patient safety concerns.

The Complexity

• Complete redesign of the external controller from analog to digital, mirroring the predicate device’s inputs, outputs, and overall functionality to serve as a one-to-one replacement
• Refined user interface to include a keypad and a custom LCD screen
• A fully independent, redundant hardware solution in the external controller in case of software failure
• Multiple microprocessors, each dedicated to a unique task
• Rewrite of existing requirements to improve testability and support defining and testing for uncommon processes not considered in the existing DHF

The Challenge

This client engaged us to develop a first of its kind cardiac pump controller to work with a balloon catheter for therapy delivery to patients who have acute decompensated heart failure.

This project began as a concept but has since become a multiple generation project, beginning with a First in Human system, pivotal study design and commercially viable product spanning multiple software enhancements as identified by the client during limited market release.

The Complexity

• Integrated pump and pressure transducer interface for balloon catheter-controlled inflation and deflation
• Monitoring occlusion through precise pressure changes
• Algorithm for inflation and deflation patterns
• Touch screen console with single board computer
• Battery backup for mobility of system without therapy disruption
• Specific criteria for system shutoffs to ensure patient safety

The Challenge

The client needed an image-guided surgery system that incorporated optical tracking devices and localization probes to assist surgeons in obtaining precise images of the operative field, particularly an organ. ​

The Complexity

• Complex, multi-component electromechanical system that includes an infrared diode-equipped wand connected to a PC, infrared tracking for the wand, signal processing.
• User interface capabilities on the PC,including live image display.
• Optical calibration systems and verification procedures of a laser rangefinder for organ surface mapping, and pre-operative software written in IDL to convert CT/MRI slices into 3D images. ​
• Support for 510K submission, including comprehensive documentation and validation to meet regulatory standards.​

The Challenge

A complete redesign of a life-sustaining breathing pacemaker, intended for use by patients who have lost neurological control of respiration. This Class III device with Major Level of Concern software needed a modern digital solution, improved user interface and software refinements to mitigate patient safety concerns.

The Complexity

• Complete redesign of the external controller from analog to digital, mirroring the predicate device’s inputs, outputs, and overall functionality to serve as a one-to-one replacement
• Refined user interface to include a keypad and a custom LCD screen
• A fully independent, redundant hardware solution in the external controller in case of software failure
• Multiple microprocessors, each dedicated to a unique task
• Rewrite of existing requirements to improve testability and support defining and testing for uncommon processes not considered in the existing DHF

The Challenge

This client was seeking a partner for a dual mode ventilator project, providing the software and algorithms for different breathing patterns and updating the electrical workings and mechanical structure of the predicate system.

In addition to the base ventilator, we were also tasked with adding a cost-effective internal and autoclavable handpiece that could withstand significant use.

The Complexity

• Dual mode design for invasive and non-invasive ventilation treatments
• Software algorithm for adaptive use, able to mask leaks
• Emergency features for quick response, including ventilation mode with alarms
• Revamped industrial design and graphical user interface (GUI)
• Real-time adaption to other patient conditions

The Challenge

The client approached Vantage MedTech with a critical need to address pain medication delivery for patients with spinal injuries. They faced a significant problem with their existing Class III pain medication delivery system, particularly the outdated Clinician Programmer’s limited user interface and cumbersome navigation. ​

The client required a complete redesign of the Clinician Programmer while maintaining compatibility with the existing communication method to interface with the implantable pump.