MoyoAssist® Extra-VAD

Beginning in June 2018 Cobalt implemented an accelerated NPD (new product development) process to develop the product to a first working prototype in just 7 months. To do this Cobalt established a highly collaborative involvement with magAssist's Suzhou-based team, with almost daily contact and numerous extended working visits (at least before COVID!). Following the initial stage and through 2019 magAssist continued development of their motor and patented impeller. Once Cobalt had set the console design direction, we began GUI development.

Extensive qualitative research of heart surgeons identified the need for clear and hierarchic information. From this, we developed a screen-based user interface that unambiguously displays critical information; and intuitive, precise control through the touchscreen and physical/haptic rotary controller. Meanwhile the console design and engineering CAD continued, culminating in the production of further prototypes and another in-person visit to magAssist. Remaining elements, including the adjustable motor arm, the motor enclosure design (with its distinctive cooling fins), right through to packaging design continued over the following months.

By early 2020, the first animal trials were successfully completed using live sheep. Since then magAssist has continued clinical trials and compliance proceedings for medical certification. Cobalt continued to support the project within a broader spectrum of work, with marketing support / animations, accessory design and production engineering refinement. Our work has also extended into other critical cardiac-care devices for magAssist, becoming a strategic development partner for the growing brand. To meet magAssist’s ambitious goals, almost every one of our staff had some involvement in this project in one way or another. So it was a special feeling in August 2021, when we learnt that the device had saved its first human life; a Chinese woman having a successful heart transplant after being kept alive for 12 days until a compatible donor heart was available.

FORM: Referencing surgeons’ preference for leading edge technology and design, the MoyoAssist® Extra-VAD's rational, minimalist form is designed to inspire confidence, and integrate into hospital environments. By contrast, the motor and other touchpoints are detailed as visual ‘jewels’; unexpected glimpses into the embedded innovation.

FUNCTION: The instrument’s ‘heart’ is magAssist’s patented magnetic impeller. CFD optimised and clinically validated, this technology reduces turbulence which damages red blood cells; reducing patient morbidity. This core technology is embodied within intuitive and functional design elements:

• Handle’s balanced CoG allows one-handed portability
• Patented, multi-positional and ambidextrous adjustable motor arm allows for short tube lengths regardless of patient position and hospital setups.
• Large touchscreen is complemented by a haptic/tactile multifunctional rotary controller allowing rapid control of speed/flowrates.

SAFETY: Beyond meeting IEC60601 and international medical device standards, integrated safety/failsafe features include *Clear GUI hierarchy designed to remove ambiguity during high-stress, time-critical procedures *Compact, rugged console body with an internal 2hr backup battery.

QUALITY: Quality is expressed throughout the instrument’s design (materials, finishes, absence of visible fasteners); its user onscreen interface and physical tactility of touchpoints; through to the unit’s consumables and packaging. Each of these integrates effectively within an overall user experience.

COMMERCIALITY: This product is on track to becoming a pivotal commercial success for magAssist. Already a lifesaver within clinical trials, MoyoAssist® Extra-VAD is on target for Chinese regulatory approval before 2023, and its endgoal of FDA and availability to millions of acute cardiac patients globally. This project marks an important high point for Australian design; a Chinese client choosing Victorian design talent for their ongoing new product development. We believe the outcome of this project and product speaks for itself across multiple measures.

As the first product of a young start-up, using a foreign design firm for the first time; the MoyoAssist® Extra-VAD is a remarkable ‘moonshoot’. Not only being the first device of its kind to be developed for the Chinese market; the product leapfrogs the leading devices from established US and EU incumbents. While magAssist’s VAD core function matches the market benchmark (Abbott’s CentriMag), magAssist’s unique design offers better human-factors performance and system integration allowing it to suit multiple scenarios beyond ICU environments, including emergency situations and patient transfers. More importantly, it is positioned to deliver this technology at a far more accessible price point (See Design Impact section). The objectives of superior performance and superior usability underpin the product’s industrial design and innovation. For example:

• Competitor instruments use traditional impeller drives or have separate in-ward (fixed) and transportable models. magAssist’s VAD Heart Pump uniquely combines all these attributes into one compact, lightweight and full-performance device; while leapfrogging the incumbents with a cutting-edge user interface.
• Through user insights, portability was broadened to mean easy onehanded lifting by even small stature female clinicians. Whilst this required careful weight reduction detailing, equally important was balanced weight distribution. Early configuration exploration and during ID we positioned components low and balanced around the unit’s handle. The result is a near-perfect CoG that increases control and reduces the perceived weight when moving the unit.
• The adjustable arm (with its own patent application) allows the motor to operate at any orientation, withstanding shocks and vibrations, all from an intuitive, single-locking lever. This arm and flexible motor positioning maximise patients’ health outcomes through shorter tube lengths and patient comfort.
• The patented maglev motor’s blade design was optimised through CFD (computational fluid-dynamics) simulation software to reduce shear forces and eliminate flow stagnation.

Design Impact Measured against health, social and commercial outcomes; this project is an exemplar of how Australian professional design, partnered with forward-thinking technology firms (no matter where they are located) being able to develop world’s-best products - which change lives for the better. Health Impact Globally 18 million people die from cardiovascular-related diseases (CVDs) per year. China’s death rate is higher than the world average - with many developing countries higher again.

These countries also have the lowest access to ventricular assistance devices. Even in developed countries, health authorities know the cost of ventricular assistance is the main barrier to treating CVDs. This situation underscores magAssist VAD’s focus of making their life-extending technology available to more people. The client and project are on-track for final Chinese NMPA (FDA equivalent) certification in 2022; with expectations of strong market demand leading to thousands of lives saved. Commercial Impact This project has established magAssist (a 2017 start-up) as a world-class innovator.

According to magAssist’s founder and CEO, Professor Po-Lin Hsu, “Cobalt has advanced our medical technology to a market leading level, domestically and globally”. Cobalt’s process and design outcome have allowed magAssist to give surgeons and clinicians more of what they need; differentiate their product offerings from competitors, and; develop their technology within an impressive timeframe. The company has successfully completed 3 funding rounds and been named in several top-innovation investment lists.

Relative to a high-volume consumer product, or single-use packaging, the orthodox view of 'sustainable design' is difficult to apply to highly complex, and long lifespan medical devices. For example, the regulatory requirements of a medical device are prioritised around patient safety and reliability. These strictly prescribe / limit materials selection amongst many criteria. Despite this sustainability is considered in all our work at Cobalt.

For example, we applied DFMA refinement (Design for Manufacture & Assembly) to minimise material use and production complexity, aiding in the overall sustainability of the physical device, i.e.through being easier to disassemble at its end of life. Within the broader principle of 'circular design' of adding to, and not diminishing lives; we believe the life-saving attributes of the MoyoAssist® Extra-VAD are clear. However, we are particularly proud of how we've helped democratise this technology; enabling millions of people in developing countries to access this currently unattainable medical intervention.