Keeping Broken Hearts Beating

The magAssist M01 device is the first extracorporeal ventricular assist device to be developed within China. The product is the culmination of an ambitious Chinese-Australian development program between Suzhou based medical technology start-up magAssist, Shanghai based Joymed Technology and Cobalt. The project and aims to address high incidence of heart failure and other related cardiovascular diseases within China, as it is estimated that over 10 million Chinese adults suffer from chronic heart failure.

The M01 system is typically used to treat patients with acute cardiac problems before, during and after heart surgery or to support life whilst a patient is waiting for treatments such as a heart transplant.

The device individually supports left and right ventricles, providing blood flow to supplement of replace heart function via surgically inserted inflow and outflow cannulas. An advanced centrifugal pump system has been developed to provide uninterrupted patient support for a period of up to 90 days. The patented system features mag-lev technology to create electrically driven mechanical pump without direct contact to minimise potential blood trauma.

Cobalt were engaged as lead development partner focused on overall system integration and industrial design, along with design and engineering of the system control unit (console) and an adjustable attachment device to locate and secure the motor/pump assembly to the console.

DESIGN OBJECTIVES

  • Class III medical device compliance under CFDA and IEC 60601
  • Designed for multiple in-hospital use cases
  • Develop compelling design language to emphasise product innovation
  • User centred design focus with emphasis on clinical usability
  • Intuitive device operation and user interface

COMMERCIAL IMPACT

  • First VAD developed specifically for the Chinese Market
  • Accelerated development time to minimise time to market
  • World class device design that will support magAssist’s global expansion
  • Novel motor arm design that has been patented
  • Provides credibility to magAssist as MedTec innovators

FOCUS AREAS

  • User Centred Design
  • Industrial Design
  • Medical Device Design
  • Graphical User Interface and Information Design
  • Product Engineering
  • Prototyping
  • Testing and Evaluation
  • Animation and Product Visualisation
  • Kynan Taylor
  • Rob Cuzner
  • Graeme Marshall
  • Andrew Fanning
  • Davis Tolley
  • Steve Martinuzzo

Critical Information

magAssist set out to develop a world class device not just for the Chinese market, but one which would rival competing products from leading global brands such as Medtronic and Maquet. The importance of user-centred design and seamless integration of design and engineering was a key driver for magAssist selecting Cobalt to ensure the design was world class. The development team drew upon input from leading clinicians, both within China but also from the USA and Germany. During the early stage user research, several design priorities were identified that would guide the overall device development.

These included:

  • Usability – an intuitive user interface that combines clear information display and simple device control, both of which are critically important in emergency situations.
  • Safety – integrated safety features to minimise patient risk such as continuous monitoring, user configurable alert limits and integrated back-up battery to provide up to 2 hours runtime
  • Adjustability – provide flexibility in mounting and positional adjustment of the motor/pump to ensure ideal operation for both the device and patient
  • Portability – portable system that is compact and lightweight to allow one handed carry whilst also providing secure protection for the motor/pump during transportation.
  • Compliance – Class III medical device designed to comply with CFDA standards and IEC 60601. FDA compliance also desired to allow global product release.

To compliment these magAssist were resolute in their drive for the design to be beautiful, precise and truly world class.

User Interface

Cobalt developed every touch point of the M01 with a focus on simple and intuitive user experiences. And as the device will be used in emergency situations, precise information transfer and rapid device operation could have life or death consequences.

The M01 user interface consists of an integrated capacitive touch screen with custom GUI, a rotating dial to control pump speed and a separate button panel. Direct control of the pump speed was identified as a critical element of the device operation and a digital, haptic dial was selected in preference of buttons or on-screen controls. The GUI was developed to emphasise critical information identified during early user consultation with magAssist and their clinical partners. Pump speed and flow rate are central to the GUI main screen, with a circular design that mimics the form of the motor and pump. An upper status bar provides operational status information including alarm and alert information, while a lower task bar is included with icons to access sub-menus. The GUI was developed for both Chinese and English – so icons were developed in place or text-based labels or buttons.

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