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«Monash Vision Group 2011 Annual Report Australian Research Council Research in Bionic Vision Science and Technology Initiative transcriber's note In ...»

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Monash Vision Group

2011 Annual Report

Australian Research Council

Research in Bionic Vision Science and Technology

Initiative

transcriber's note In the printed edition of this report, there are images appearing

at various places in the text. While there are some descriptions, these images do not

appear in this version and any enquiries regarding images can be directed to

03 9905 9526. /transcriber's note

Monash Vision Group is an ARC-funded Special Initiative with collaborative partners Monash University, Grey Innovation, MiniFAB and Alfred Health. This unique crosssector consortium has two key goals; to develop a cortical vision prosthesis for testing in patients in 2014 and to build upon existing knowledge to create outstanding research capabilities in bionic vision science and technology in Australia.

www.monash.edu/bioniceye Alfred Health is one of the four founding partners of the Alfred Medical Research and Education Precinct (AMREP), established five years ago on The Alfred campus.

Alfred Health is providing expertise in the clinical program, including the recruitment, testing and after-care of patients.

Grey Innovation is a cutting edge engineering technology commercialisation company with experience in complex software, hardware and mechanical architectures across a number of industries and markets. Grey Innovation is providing expertise for the development of external electronics and processing components of the vision system.

MiniFAB is a privately owned Melbourne-based company with a core business in the design, integration and manufacture of polymer micro-engineered systems for the Biotech, Health, Agriculture, Food and Environmental Sectors. MiniFAB is providing expertise in the design and fabrication of implantable devices and tooling.

Monash University is one of Australia's leading universities with an enviable record for research and development leading to commercialisation. MVG has Chief Investigators from departments within the Faculties of Engineering and Medicine, Nursing and Health Sciences, with key inputs into all aspects of the Monash Vision project.

Table of Contents At a Glance: The Monash Vision Group Note from the Chair Director's Report In Memory of Dr Mike Hirshorn Governance and Management Senior Investigators Product Development, Supporting Research and Testing Research Training and Skills Development Commercial Program Events and Communication Media and Marketing Infrastructure 2011 Highlights Issues Arising and Mitigation Strategies Financial Statement Key Performance Indicators Publications Acknowledgements At a Glance - The Monash Vision Group The Monash Vision Group (MVG) is a consortium of engineers, scientists and medical researchers from Monash University and Alfred Hospital in Melbourne, along with Victorian companies - Grey Innovation and MiniFAB. The MVG was established in April 2010 to develop a "direct to brain"bionic eye and is supported by an $8 million grant from the Australian Research Council. Its first human implant is scheduled for 2014.

How will this "Direct to Brain" bionic eye work?

The MVG's "direct to brain" bionic eye system will combine state-of-the-art digital and biomedical technology with consumer-friendly eye glasses. A digital camera embedded in the glasses will capture images from the user's environment. The camera will be linked to a cutting edge digital processor, which will modify the image captured by the camera. Using a wireless transmitter, the processor will send the modified image as a signal to an implanted chip at the back of the brain under the skull. The implant will then directly stimulate the visual cortex of the brain with electrical signals, which the brain will learn to interpret as sight. The implant will have many tiles, each with 45 electrodes designed to give over 650 pixels in all. The device also may be tuned to cope with different situations such as indoor tasks and outdoor navigation.

How will the device be inserted?

Using standard neurosurgery techniques, a small area of the skull will be temporarily cut away in surgery. A sterile, biologically inert chip will be implanted directly into the visual cortex of the brain. The small area of the skull will then be replaced and will heal to provide a natural barrier to protect against infection.

Who will it help?

This device is being developed for people of all ages with vision impairment caused by such conditions as glaucoma, macular degeneration and diabetic retinopathy.

These three conditions cause up to 85% of cases of untreatable clinical blindness.

The device can also help patients who have suffered physical trauma to the eye or do not have a functional optic nerve, which is often a limitation of other bionic eye technologies.

There are reportedly more than 160 million people experiencing some form of blindness worldwide. The figure for Australia is over 50,000. Importantly, when fully developed, the MVG "direct to brain" system may enable patients to continue using their regions of good sight with brain stimulation improving sight in deteriorated regions.

Note from the Chair

Calling the Monash Vision Group a special initiative seems to be quite an understatement. This group of dedicated researchers, surgeons, physiologists, engineers, manufacturers, and entrepreneurs have set themselves the audacious goal of implanting the first MVG bionic eye in a human subject by April 2014.





The growing list of MVG's accomplishments that are reported within this document are evidence that this incredible journey is well underway. Design and prototyping of key elements of the system have been finalised, and preclinical testing has been undertaken on sub-assemblies.

Key achievements over the past year include hitting technical milestones such as the development and delivery of the ASIC 1 design, production and preclinical testing of prototype surgical aids and development of signal processing algorithms, all of which have contributed towards the filing of two patent applications. It is also worth noting the Group's interactions with Bionic Vision Australia, which have resulted in discussions at both the Board and technical level around how to make the most efficient and effective use of resources on a combined basis.

This year the detailed plan includes integration of the full system and complete end to end bench and preclinical testing of the device itself. This phase is critical– communication across the Group will be the key in producing a functioning prototype device suitable for clinical use. This year is also the year for the Group to consider business strategies and make commercial decisions–this again will be the driver for the future development of the MVG prosthetic device beyond the current program of work and is where the benefits of our Industry Partners involvement will become further evident.

There are a number of significant challenges that the team will face this year, and whilst it is far from obvious how some of these will be overcome, the single mindedness of the team to achieve its ultimate goal will drive them to success.

Ms Vicki Tutungi Independent Steering Committee Chair, Monash Vision Group Director's Report I am proud to deliver the second annual report of Monash Vision Group. As you will read, we are progressing well with our development of a prototype visual prosthesis that will improve the lives of tens of thousands of people who are vision impaired, and build an Australian based capability for bionic brain implants.

In 2009, the Australian Research Council announced it would fund two projects under the "Research in Bionic Vision Science and Technology Initiative". Monash Vision Group received a grant of $8,000,000 for a 4-year project, "Direct Stimulation of the Visual Cortex: a Flexible Strategy for Restoring High-Acuity Pattern Vision".

Our system uses a conventional (mobile phone) camera to view the world. This image is processed to extract the most important information from the scene, which is sent through a wireless link to an implant. The implant sits beneath the skull and stimulates the brain using small and short pulses of current. Through direct stimulation of the brain, the system is designed to work for people whose eyeballs and optic nerve have been irreparably damaged. It will also work for people whose retinas have degraded or been damaged.

Our implant is actually a set of 10-12 tiles, which cover the V1 region of the visual cortex. Each tile has 45 electrodes, which penetrate into the surface of the brain, to stimulate the axons that communicate information between the neurons. Thus the electrodes can trick the neurons into thinking that they have been stimulated by visual input to the eye.

In Year 1 of the project, during 2010, we firmed up on the system design of the prototype, after investigating many alternate designs and implementations. Because many of the components, including the electrodes, implantable electronics (ASIC), hermetic packaging and external electronics are not available off the shelf, considerable effort has been expended on custom designs. In the case of the electrodes and the implant package, this has meant developing our own micromanufacturing and microfabrication techniques.

At the end of Year 2 (2011) we have a full end-to-end system design, including the pocket processor, ASIC and electrodes. Many of the parts have been prototyped, including the electrodes, implant casing, implant insertion tool, external electronics and wireless link, with the first ASIC design being provided to suppliers for manufacture in August 2011. We have made extensive use of computer simulation to verify our designs, and make design choices early on and have conducted preclinical trials on the subsystems to verify their operation.

In Year 3 we will produce a full bench-type prototype and a set of test jigs, so that we can test components, sub-assemblies and the whole system end-to-end.

A key challenge of this project is to develop a biocompatible implant. Unlike other medical devices for cochlear and heart stimulation, our device needs hundreds of electrodes to present a suitably-detailed image to the brain. In order to simplify the insertion procedure and improve reliability, we have avoided using a festoon of wires, as they are likely to put unpredictable mechanical forces on the electrodes during and after insertion process. This means that the electronics has to fit directly on top of the electrodes, limiting its area. This presents many design challenges for the electronics and mechanical design teams.

I am delighted that Dr Mehmet Yuce has joined us from Newcastle University, NSW, as a Senior Lecturer in the Department of Electrical and Computer Systems Engineering. Mehmet brings ten years of experience in electronics for biomedical implants, including high-speed wireless data and power links. Mehmet has also designed Application-Specific Integrated Circuits for implanted electronics, and is working with Dr Jean-Michel Redouté who has developed the first MVG prototype ASIC for the project with his team, Drs Damian Brown, David Fitrio and Anand Mohan.

Great advances have been made by our robotics vision specialists, Drs Wai Ho Li and Dennis Lui, who are applying powerful 3-D gaming sensors to the pre-processing of images. This technology allows the "important parts" of a scheme to be separated out from the camera's image. An example is removing far-away clutter from a visual scene, so the important foreground objects are presented to the brain. Thanks to the power of new microprocessors developed for the mobile computing market, our bionic eye can implement the latest advances in vision processing in a device that fits in the pocket.

The efficient management of the project is of critical importance given the short timescale and the unique combination of academic and industry partners in a research project with a development outcome. We have increased the interaction of the academic and industry teams by reorganising the project so the primary goal is to create a product, rather than to develop research ideas towards becoming useful for a prototype. There are still many academic questions to be answered, and innovations to be made; however, our efforts are concentrated on achieving the primary goal.

The management of the group is performed chiefly by the Steering Committee, which has representatives from all MVG partners who meet monthly. The Steering Committee sets the high-level goals of the project, including the requirements specifications and functional specifications, measures progress against their project plan, and allocates resources to fulfil the plan.

During 2011 Steering Committee has been chaired and driven by the late Dr Mike Hirshorn, AO, who contributed strongly to the efficient management of the project until he sadly passed away, using his vast experience at Cochlear and ResMed. I am delighted that Ms Vicki Tutungi, previously CEO of OptiScan Ltd, a high-resolution endoscope company, has taken over Mike's role on a pro-bono basis.

During 2010, the Technical Review Committee was formed to monitor technical progress and examine technical documents and designs in detail. This meets monthly, reports to the Steering Committee and includes members of the technical teams that are developing and testing the prototype. The technical specification and review process is critical to the design of the prototype, as each part of the project must function in conjunction with all other parts. Also critical is how the prototype can be manufactured, which often puts constraints on the materials that can be used.

Most critical is how the prototype will interact with the human body. This requires the experience of our materials, physiology and neurosurgery teams.

The Advisory Board has members from government, end-users and the senior members from project itself. Its job is to ensure that the project is meeting the expectations of the government and community by monitoring the projects progress and suggesting strategic initiatives such as industry and community engagement.

The Advisory Board met three times in 2011, chaired by Dr Mike Hirshorn twice, then by Professor Lyn Beazley.



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