Vanessa Med Tech Report2
Content
MONASH UNIVERSITY
Assignment 2
ECE4087
Vanessa Ashokkumar - 22638229 9/15/2013
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Contents
Introduction .................................................................................................................................................. 3 The conceptual model .............................................................................................................................. 3 Concept Development .................................................................................................................................. 4 Needs Analysis .......................................................................................................................................... 4 Concept Exploration.................................................................................................................................. 4 Nintendo Wii ......................................................................................................................................... 4 Google Glass.......................................................................................................................................... 5 Lumosity ................................................................................................................................................ 5 Concept Definition ........................................................................................................................................ 5 Research and Development .......................................................................................................................... 6 Funding ..................................................................................................................................................... 6 Legalities ................................................................................................................................................... 6 Regulation ..................................................................................................................................................... 7 Team, Design and Structure...................................................................................................................... 8 Social Context ........................................................................................................................................... 8 Testing ....................................................................................................................................................... 9 TGA Approval ............................................................................................................................................ 9 Manufacture ................................................................................................................................................. 9 Technology and Ecology.............................................................................................................................. 10 Marketing .................................................................................................................................................... 10 Bibliography ................................................................................................................................................ 11
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Hand-eye Coordination Technology
Improving the quality of life for children with Down’s Syndrome
Introduction
Down’s syndrome is a growing disability amongst young children, driven by the mutation of the 21st chromosome in human cells. Down’s syndrome is a common cause of intellectual disability and motorskills impairment. As a result of Down’s syndrome, children suffer from gait abnormalities, poor handeye coordination skills, speech impairment and also the ability to move quickly when needed. They experience a delay in displaying fine motor skills and tend to lag in gross motor skills. One of the main conditions of having Down’s syndrome is having poor visuo-spatial recognition and hand-eye coordination skills due to their lax muscles and reduced muscle tone [1]. This report aims to look at the process of developing a specific piece of medical technology which can be used to enhance visuo-spatial recognition and hand-eye coordination. It is based on a Systems Engineering approach along with the Medical Technology Model of Innovation process and will outline the conceptual model of developing this device from its base medical technology to commercial medical usage of it.
The conceptual model
This report outlines the procedure of developing this particular medical technology which will assist children with Down’s syndrome with their hand-eye coordination and visuo-spatial skills. It adopts the Systems Engineering Approach which consists of the Concept Development, Engineering Development and Post Development stages and the various phases that they encompass. The Medical Technology Model of Innovation will also be used closely to discuss the process of development. It comprises of the various aspects that need to be considered such as the Research and Development, Finance, Legalities, Technological, Regulatory, Ecological, Social, Educational and Medical Issues and the Competition that is present in the current market.
Figure 1: Systems Engineering Approach (adapted from ECE3092)
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Concept Development
This initial stage of the systems life cycle process looks at why we need to develop a new device or innovate existing technology. The concept development stage considers the current concepts that are available and what is required through the analysis of needs and by exploring and defining new concepts.
Needs Analysis
Down’s syndrome children struggle with their hand-eye coordination amongst other conditions [1]. This can be quite a strain to perform normal daily tasks that do not require much thought such as catching a ball or feeding themselves. This calls for an innovative approach to better their quality of life by improving their hand-eye coordination. At present, there is no specific technology that is developed for the sole purpose of improving hand-eye coordination skills. However, there are other means of assistive technology such as video games which benefit the user by improving their hand-eye coordination skills.
Concept Exploration
We have decided to invent a device which will specifically enable a user to have better hand-eye coordination and work together with their visual ability. It will also provide access for them to be monitored regularly by physicians and technical specialists. This device will comprise of infrared detectors and/or ultrasonic sensors which will be worn on the hand and give feedback to a receiver which will be worn on glasses or a similar optical head mounted display to help the user better localise their hand movements. Some of the concepts that are explored include the sensors and detectors used in video games such as the Nintendo Wii, brain-training application software such as Lumosity and devices such as the new Google Glass. Various aspects from each of these individual concepts are explored later to define our new concept and create a device and subsequent software that will help improve the hand-eye coordination of children with Down’s syndrome. Nintendo Wii The Nintendo Wii comprises of a remote controller with infrared detectors and built-in accelerometers to gauge its position in three dimensional space relative to a Sensor bar which has LEDs in it [1]. This design enables users to control the game with physical gestures and also by using the remote buttons. Bluetooth is required for the remote control to connect to the console base. The Nintendo Wii has given some inspiration to using accelerometers as well as infrared detectors to design a medical device that can be controlled by physical gestures for children who have Down’s syndrome. Figure 2: Nintendo Wii components [3]
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Google Glass The Google Glass is a device which is a smart, compact computer and has an optical head mounted display allowing a user to view through the glass as well as a projection onto it. It uses a camera and various light and motion detection sensors to deliver accurate data in real time. This device has given inspiration to use similar technology to create a receiver that can detect information from the infrared detectors worn on the finger and then use this information to help the subject better localise their movement and hand-eye coordination.
Figure 3: Google Glass [4]
Lumosity Lumosity is a software application which comprises of brain-training exercises and was developed from a neuroscience research company. This software has given inspiration to combine the medical device with a supplement software that the child can use to practice their hand-eye coordination and then gives feedback on the child’s performance to their parents and medical assistants. We can create a subsequent software with short games and activities that will require the child to use the medical device in order to complete the tasks to the best of their hand-eye coordination skills. The software will record and monitor the progress and improvement in visuo-spatial recognition and hand-eye Figure 4: Lumosity logo [2] coordination for children who have Down’s syndrome.
Concept Definition
This inspires us to derive a device that will be extremely easy to use and be accurate as well in terms of localising specific positions in a three dimensional space. At this stage, we are considering putting the components which will comprise of the accelerometers and infrared detectors in an easy-to-wear structure such as a simple ring which can be worn on the finger. The detectors will be placed on the ring so that when it is worn the detectors are facing the inside of the hand. Having the detectors face the inside of the hand will be most appropriate to detect an object and then grasp it if required. This type of structure and design which can be worn will provide easy mobility and not cause any harm or discomfort, whilst also being the most suitable location to detect and control hand movement accurately. The infrared detectors will relay information to the sensors that are in the optical head mounted unit and by doing so will enable the child to better coordinate their hand-eye movement. The software that will come with the device will be an easy way for the parents and physicians to regularly monitor the improvement in their child’s hand-eye coordination skills. The software will consist of short virtual games which will require the child to use the medical device to be able to complete the required tasks. It will collect information on the child’s performance and compare how they are improving. This information will then be collated and sent electronically to the corresponding care-taker and medical assistants. Based on the performance of the child, the physicians can then decide if the child’s hand-eye coordination, visuo-spatial recognition and ability to localise objects in 3D space has
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
improved and whether they will further require to continue using the assistive medical device. It is possible that with the help of using the device, the Down’s syndrome child has practiced and trained their hand-eye coordination and can now successfully carry out daily activities without the assistance of the medical device.
Research and Development
Extensive research will need to be carried out in order to develop this device from scratch. At present, we have an idea and we have used other modes of technology for inspiration. Now we need to thoroughly research the individual components and how they could work and then contemplate how we can integrate it all together to form a working medical device that will help Down’s syndrome children with improving their hand-eye coordination skills.
Funding
Adequate funding will be necessary to carry out the required research. The Australian Federal and State Governments issue various grants for university research and development projects. According to the ‘Grants and Assistance Finder’ on the Australian Government’s principal business resource website, some of the grants which may be applicable for this particular project include: the National Health and Medical Research Council Program Grant, the Research and Development Tax Incentive, the Rural Industries Research and Development Corporation Research Programs and the Games Investment Program [2]. There are various eligibility requirements that must be met in order for the grant proposal to be considered. Most require that the research team are all Australian-based, that the company is registered and eligible to undertake research and development activities, have ownership or copyright of the project under an approved joint venture arrangement. The governing body can demand reports on progress and other administrative duties. Other grants, scholarships and subsidised funding can be offered by the university at where the research is conducted or even by companies who are willing to be a part of such a project. The most applicable grant for this particular project would be the National Health and Medical Research Council Program Grant since this project requires medical research and aims to improve the quality of life for a child who has Down’s syndrome by developing an assistive medical device with subsequent medical technology.
Legalities
Some of the legal issues that will need to be considered when working on this project include the Intellectual Property Management of this particular concept and its development through to commercialisation. Although various aspects of developing this particular ‘hand-eye coordination medical device’ has been taken from the inspiration of other technologies, no such device has yet been developed for the sole purpose of monitoring and improving a Down’s syndrome child’s hand-eye coordination skills. Therefore, we can request a patent to protect this development idea as well as to protect ourselves legally with the authenticity of this development. ‘A patent is a right that is granted for any device, substance, method or process that is new, inventive, and useful. A patent is legally enforceable and gives you (the owner), exclusive rights to commercially exploit the invention for the life of the patent’ [3]. An idea or invention which has not been publicly disclosed previously can be patented. A patent for this particular medical device will ensure that we will be allowed to
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
commercialise this invention and it will protect us from having others steal any of the ideas. There are various patents that are available in Australia at present. The most applicable one would be the Standard Patent which lasts for 20 years and is used for a novel invention involving an inventive step. Searching for and obtaining the right patent is extremely important to also recognise that we are not breaching anyone else’s legal patent. Whilst being protected by a patent is crucial, the process of applying for one can be quite complicated expensive and time consuming. The IP Australia website has an ‘AusPat’ database which allows one to search for important information on obtaining a patent and ensuring that the idea hasn’t already been patented. Obtaining a patent from here will be in accordance with the Australian standards ensuring patent protection in Australia only. To be protected overseas, one must obtain a patent according to the specific country’s regulations. The IP Australia website has an ‘International Patent Classification’ tool which is used widely by patent offices around the world to classify patent documents [3]. The International Patent Classification is divided along extensive technological categories into eight sections which are then further subdivided. In total, the International Patent Classification has approximately 70,000 subdivisions. Searching through these databases, will ensure that the requirements to be granted a successful patent are met, information on whether another’s IP is being infringed as well as providing product information on competitors. Advice and help from a professional patent attorney is important to ensure that the patent application is accurate. Upon deciding the type of patent required, the application is filed and then checked and published in an office journal. In the case of a Standard Patent, it is published in the official journal before examination. The examination is mandatory prior to granting a standard patent and ensures that the patent can be enforceable. Once it has been examined and then published and if it is not opposed then the standard patent is granted. Annual fees must be paid in order to maintain the patent. A standard patent can be renewed for up to 20 years [3].
Regulation
For this device to be allowed in to the market and commercialised, it will have to be thoroughly tested and regulated. In Australia, TGA (Therapeutics Goods Administration) is the governing body who approves the regulation of any biomedical devices and medical technology including medical software.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Figure The structure of TGA [7] The above diagram shows the three main 5: divisions of the TGA: the Market Authorisation group, the Monitoring and Compliance group and the Regulatory Support group. In order to attain TGA approval, the following procedures must be carried out with the corresponding testing. The TGA system has five different classes for regulating medical devices. The medical device will be tested and classified based on the intended use of the device, the level of risk and the degree of invasiveness.
Team, Design and Structure
The team that will create and commercialise this device will need to consist of innovative biomedical and electrical engineers and programmers, medical physicians and therapists, a legal and financial advisor and children who have Down’s syndrome and their guardians. This ‘hand-eye coordination’ device comprises of the ring with the infrared detectors and the glasses style optical head mounted unit as well as the application software which can be used on any computer to enable remote patient monitoring. The ring design should be made so that it can be easily adjusted and worn by all patients. Each component and its subsystem will need to be thoroughly tested for TGA to regulate the device.
Social Context
This device is designed so that it can be worn externally: on the finger and on the head like a pair of glasses. Therefore it is widely visible. It is possible that the children or their parents do not feel socially comfortable with wearing such a device. However, much thought has been put in by the design team to make this device simple, efficient and easy to wear. The physical components being shaped like a ring and a pair of glasses has been the most innovative design yet to ensure that the device actually looks like an ‘everyday accessory’.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Testing
Various methods of testing will be required before the product can be fully commercialised. Initially, testing will be done of each individual component in a lab environment to ensure the proper functioning of each part of the device. The reliability and safety will be vital factors to be measured as well as any possible risks. Initial testing in a lab will allow us to tweak and remodel various components until they work accurately. After testing the system in a lab, it will need to be tested in a clinical setting by children who have Down’s syndrome. Their parents/ guardians will also be required for supervision, although the device is harmless, small components such as the ring should be carefully monitored and positioned on the child. Hence, this device should have a minimum age requirement of 3 years old to be sure that the child doesn’t accidentally swallow any component or carelessly damage it. Supervision to the child will be necessary until they have learned how to configure the device and use it properly. Medical staff and the child’s parents will be trained adequately so that they know how to operate the device and use the software to monitor progress in the child’s hand-eye coordination and visuo-spatial recognition. The device will need to be calibrated for each individual who tests it.
TGA Approval
For therapeutic goods in the market to be safe and of a high standard, the TGA regulates the goods through ‘pre-market assessment, post-market monitoring and enforcement of standards, as well as the licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts’ [4]. They also assess risks against benefits by identifying and evaluating any risks, taking the necessary measures to treat the risks and monitoring and reviewing these over time. TGA has a ‘Therapeutic product vigilance’ which continually evaluates and monitors the performance and safety of the products and manages any risks that may be associated with the product or medical device.
Manufacture
Once the device is approved by the TGA, specific companies can then be approached to enquire if they are able to manufacture the product and mass produce it. It could potentially be cost efficient to manufacture this particular device in an Asian country such as Japan where the electronic produce is large. If it is produced overseas, it is imperative that the production meets the Australian standards in order to be able to successfully commercialise it. The innovation process overseas would be similar to some extent as that of developing, fabricating and commercialising a product in Australia. There would still be legal and financial issues that would need to be addressed as well as thorough testing and regulatory approval that would need to be carried out. At present, it is best to manufacture the device in Australia, initially at least, so that the legalities will be much easier to process and the quality of manufacture will be of a high standard. It would not be valuable to innovate the design and manufacture the product in conjunction with another country since this would require legal rights, regulatory approval and testing in both countries according to the country’s own law. This could actually become more expensive on the whole and also take longer to process the development in two countries simultaneously.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Technology and Ecology
Whilst this medical device will be using new, state-of-the-art innovative technology and software, it is important to consider its impact on the environment especially once mass production begins. Fortunately, this particular device will not have any detrimental effect on the environment. Batteries on the optical head mount unit will need replacement, and eventually the infrared detectors will need to be replaced, but there will be no medical waste or biproduct residue produced.
Marketing
To successfully commercialise the product and target the right users, the ‘hand-eye coordination medical device’ and software should be marketed to paediatric wards in hospitals and clinics that monitor children with Down’s syndrome. It would also be beneficial to market such device at local schools and child-care centres that are specifically for children with Down’s syndrome. Marketing online on the ‘Down’s Syndrome Australia’ website and other non-government organisation websites would also be targeting the right audience for whom this device would be useful. If the product is highly successful in Australia, then it is worth considering marketing it in other countries too especially where Down’s syndrome is a common occurrence. If it is to then be marketed overseas, then fabricating the device overseas too would be cost efficient. Since this device is the first of its kind; specifically designed to aid Down’s syndrome children with handeye coordination and visuo-spatial recognition, there are no threatening competitors. Therefore, it is predicted that this device will do well commercially.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Bibliography
[1] D. M, G. S, A. A and T. F, “Improving motor functions in children with Down's Syndrome,” Medical Hypotheses, 2013. [2] S. S. D. A. Shruti Nadkarni, “Enhancing Eye-Hand Coordination with Therapy Intervention to Improve Visual-Spatial Abilities using ‘The Re-training Approach’ in Children with Down Syndrome: Three Case Studies,” Disability, CBR and Inclusive Development Journal, vol. 23, no. 2, 2012. [3] H. Wisniowski, “Analog Devices And Nintendo Collaboration Drives Video Game Innovation With iMEMS Motion Signal Processing Technology,” Analog Devices, Inc., 2009. [4] “The Australian Government's Grants and Assistance finder,” Australian Government, [Online]. Available: http://www.business.gov.au/grantfinder/grantfinder.aspx. [Accessed 13 Septemeber 2013]. [5] C. (. Officer), “IP Australia,” Australian Government Intellectual Property, [Online]. Available: http://www.ipaustralia.gov.au/get-the-right-ip/patents/index.html. [Accessed 14 September 2013]. [6] “Therapeutic Goods Administration,” [Online]. Available: http://www.tga.gov.au/about/tgastructure.htm. [Accessed 15 September 2013]. [7] “Lumosity,” 2013. [Online]. Available: http://www.lumosity.com. [Accessed 13 September 2013]. [8] “Zac Browser,” Zac Browser, [Online]. Available: http://zacbrowser.com/images/required.jpg. [Accessed 13 September 2013]. [9] “Tech Radar,” [Online]. Available: http://cdn1.mos.techradar.futurecdn.net//art/gadgets/Google%20Glass/google_glass_grey-58090.jpg. [Accessed 13 September 2013].
Assignment 2
ECE4087
Vanessa Ashokkumar - 22638229 9/15/2013
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Contents
Introduction .................................................................................................................................................. 3 The conceptual model .............................................................................................................................. 3 Concept Development .................................................................................................................................. 4 Needs Analysis .......................................................................................................................................... 4 Concept Exploration.................................................................................................................................. 4 Nintendo Wii ......................................................................................................................................... 4 Google Glass.......................................................................................................................................... 5 Lumosity ................................................................................................................................................ 5 Concept Definition ........................................................................................................................................ 5 Research and Development .......................................................................................................................... 6 Funding ..................................................................................................................................................... 6 Legalities ................................................................................................................................................... 6 Regulation ..................................................................................................................................................... 7 Team, Design and Structure...................................................................................................................... 8 Social Context ........................................................................................................................................... 8 Testing ....................................................................................................................................................... 9 TGA Approval ............................................................................................................................................ 9 Manufacture ................................................................................................................................................. 9 Technology and Ecology.............................................................................................................................. 10 Marketing .................................................................................................................................................... 10 Bibliography ................................................................................................................................................ 11
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Hand-eye Coordination Technology
Improving the quality of life for children with Down’s Syndrome
Introduction
Down’s syndrome is a growing disability amongst young children, driven by the mutation of the 21st chromosome in human cells. Down’s syndrome is a common cause of intellectual disability and motorskills impairment. As a result of Down’s syndrome, children suffer from gait abnormalities, poor handeye coordination skills, speech impairment and also the ability to move quickly when needed. They experience a delay in displaying fine motor skills and tend to lag in gross motor skills. One of the main conditions of having Down’s syndrome is having poor visuo-spatial recognition and hand-eye coordination skills due to their lax muscles and reduced muscle tone [1]. This report aims to look at the process of developing a specific piece of medical technology which can be used to enhance visuo-spatial recognition and hand-eye coordination. It is based on a Systems Engineering approach along with the Medical Technology Model of Innovation process and will outline the conceptual model of developing this device from its base medical technology to commercial medical usage of it.
The conceptual model
This report outlines the procedure of developing this particular medical technology which will assist children with Down’s syndrome with their hand-eye coordination and visuo-spatial skills. It adopts the Systems Engineering Approach which consists of the Concept Development, Engineering Development and Post Development stages and the various phases that they encompass. The Medical Technology Model of Innovation will also be used closely to discuss the process of development. It comprises of the various aspects that need to be considered such as the Research and Development, Finance, Legalities, Technological, Regulatory, Ecological, Social, Educational and Medical Issues and the Competition that is present in the current market.
Figure 1: Systems Engineering Approach (adapted from ECE3092)
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Concept Development
This initial stage of the systems life cycle process looks at why we need to develop a new device or innovate existing technology. The concept development stage considers the current concepts that are available and what is required through the analysis of needs and by exploring and defining new concepts.
Needs Analysis
Down’s syndrome children struggle with their hand-eye coordination amongst other conditions [1]. This can be quite a strain to perform normal daily tasks that do not require much thought such as catching a ball or feeding themselves. This calls for an innovative approach to better their quality of life by improving their hand-eye coordination. At present, there is no specific technology that is developed for the sole purpose of improving hand-eye coordination skills. However, there are other means of assistive technology such as video games which benefit the user by improving their hand-eye coordination skills.
Concept Exploration
We have decided to invent a device which will specifically enable a user to have better hand-eye coordination and work together with their visual ability. It will also provide access for them to be monitored regularly by physicians and technical specialists. This device will comprise of infrared detectors and/or ultrasonic sensors which will be worn on the hand and give feedback to a receiver which will be worn on glasses or a similar optical head mounted display to help the user better localise their hand movements. Some of the concepts that are explored include the sensors and detectors used in video games such as the Nintendo Wii, brain-training application software such as Lumosity and devices such as the new Google Glass. Various aspects from each of these individual concepts are explored later to define our new concept and create a device and subsequent software that will help improve the hand-eye coordination of children with Down’s syndrome. Nintendo Wii The Nintendo Wii comprises of a remote controller with infrared detectors and built-in accelerometers to gauge its position in three dimensional space relative to a Sensor bar which has LEDs in it [1]. This design enables users to control the game with physical gestures and also by using the remote buttons. Bluetooth is required for the remote control to connect to the console base. The Nintendo Wii has given some inspiration to using accelerometers as well as infrared detectors to design a medical device that can be controlled by physical gestures for children who have Down’s syndrome. Figure 2: Nintendo Wii components [3]
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Google Glass The Google Glass is a device which is a smart, compact computer and has an optical head mounted display allowing a user to view through the glass as well as a projection onto it. It uses a camera and various light and motion detection sensors to deliver accurate data in real time. This device has given inspiration to use similar technology to create a receiver that can detect information from the infrared detectors worn on the finger and then use this information to help the subject better localise their movement and hand-eye coordination.
Figure 3: Google Glass [4]
Lumosity Lumosity is a software application which comprises of brain-training exercises and was developed from a neuroscience research company. This software has given inspiration to combine the medical device with a supplement software that the child can use to practice their hand-eye coordination and then gives feedback on the child’s performance to their parents and medical assistants. We can create a subsequent software with short games and activities that will require the child to use the medical device in order to complete the tasks to the best of their hand-eye coordination skills. The software will record and monitor the progress and improvement in visuo-spatial recognition and hand-eye Figure 4: Lumosity logo [2] coordination for children who have Down’s syndrome.
Concept Definition
This inspires us to derive a device that will be extremely easy to use and be accurate as well in terms of localising specific positions in a three dimensional space. At this stage, we are considering putting the components which will comprise of the accelerometers and infrared detectors in an easy-to-wear structure such as a simple ring which can be worn on the finger. The detectors will be placed on the ring so that when it is worn the detectors are facing the inside of the hand. Having the detectors face the inside of the hand will be most appropriate to detect an object and then grasp it if required. This type of structure and design which can be worn will provide easy mobility and not cause any harm or discomfort, whilst also being the most suitable location to detect and control hand movement accurately. The infrared detectors will relay information to the sensors that are in the optical head mounted unit and by doing so will enable the child to better coordinate their hand-eye movement. The software that will come with the device will be an easy way for the parents and physicians to regularly monitor the improvement in their child’s hand-eye coordination skills. The software will consist of short virtual games which will require the child to use the medical device to be able to complete the required tasks. It will collect information on the child’s performance and compare how they are improving. This information will then be collated and sent electronically to the corresponding care-taker and medical assistants. Based on the performance of the child, the physicians can then decide if the child’s hand-eye coordination, visuo-spatial recognition and ability to localise objects in 3D space has
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
improved and whether they will further require to continue using the assistive medical device. It is possible that with the help of using the device, the Down’s syndrome child has practiced and trained their hand-eye coordination and can now successfully carry out daily activities without the assistance of the medical device.
Research and Development
Extensive research will need to be carried out in order to develop this device from scratch. At present, we have an idea and we have used other modes of technology for inspiration. Now we need to thoroughly research the individual components and how they could work and then contemplate how we can integrate it all together to form a working medical device that will help Down’s syndrome children with improving their hand-eye coordination skills.
Funding
Adequate funding will be necessary to carry out the required research. The Australian Federal and State Governments issue various grants for university research and development projects. According to the ‘Grants and Assistance Finder’ on the Australian Government’s principal business resource website, some of the grants which may be applicable for this particular project include: the National Health and Medical Research Council Program Grant, the Research and Development Tax Incentive, the Rural Industries Research and Development Corporation Research Programs and the Games Investment Program [2]. There are various eligibility requirements that must be met in order for the grant proposal to be considered. Most require that the research team are all Australian-based, that the company is registered and eligible to undertake research and development activities, have ownership or copyright of the project under an approved joint venture arrangement. The governing body can demand reports on progress and other administrative duties. Other grants, scholarships and subsidised funding can be offered by the university at where the research is conducted or even by companies who are willing to be a part of such a project. The most applicable grant for this particular project would be the National Health and Medical Research Council Program Grant since this project requires medical research and aims to improve the quality of life for a child who has Down’s syndrome by developing an assistive medical device with subsequent medical technology.
Legalities
Some of the legal issues that will need to be considered when working on this project include the Intellectual Property Management of this particular concept and its development through to commercialisation. Although various aspects of developing this particular ‘hand-eye coordination medical device’ has been taken from the inspiration of other technologies, no such device has yet been developed for the sole purpose of monitoring and improving a Down’s syndrome child’s hand-eye coordination skills. Therefore, we can request a patent to protect this development idea as well as to protect ourselves legally with the authenticity of this development. ‘A patent is a right that is granted for any device, substance, method or process that is new, inventive, and useful. A patent is legally enforceable and gives you (the owner), exclusive rights to commercially exploit the invention for the life of the patent’ [3]. An idea or invention which has not been publicly disclosed previously can be patented. A patent for this particular medical device will ensure that we will be allowed to
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
commercialise this invention and it will protect us from having others steal any of the ideas. There are various patents that are available in Australia at present. The most applicable one would be the Standard Patent which lasts for 20 years and is used for a novel invention involving an inventive step. Searching for and obtaining the right patent is extremely important to also recognise that we are not breaching anyone else’s legal patent. Whilst being protected by a patent is crucial, the process of applying for one can be quite complicated expensive and time consuming. The IP Australia website has an ‘AusPat’ database which allows one to search for important information on obtaining a patent and ensuring that the idea hasn’t already been patented. Obtaining a patent from here will be in accordance with the Australian standards ensuring patent protection in Australia only. To be protected overseas, one must obtain a patent according to the specific country’s regulations. The IP Australia website has an ‘International Patent Classification’ tool which is used widely by patent offices around the world to classify patent documents [3]. The International Patent Classification is divided along extensive technological categories into eight sections which are then further subdivided. In total, the International Patent Classification has approximately 70,000 subdivisions. Searching through these databases, will ensure that the requirements to be granted a successful patent are met, information on whether another’s IP is being infringed as well as providing product information on competitors. Advice and help from a professional patent attorney is important to ensure that the patent application is accurate. Upon deciding the type of patent required, the application is filed and then checked and published in an office journal. In the case of a Standard Patent, it is published in the official journal before examination. The examination is mandatory prior to granting a standard patent and ensures that the patent can be enforceable. Once it has been examined and then published and if it is not opposed then the standard patent is granted. Annual fees must be paid in order to maintain the patent. A standard patent can be renewed for up to 20 years [3].
Regulation
For this device to be allowed in to the market and commercialised, it will have to be thoroughly tested and regulated. In Australia, TGA (Therapeutics Goods Administration) is the governing body who approves the regulation of any biomedical devices and medical technology including medical software.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Figure The structure of TGA [7] The above diagram shows the three main 5: divisions of the TGA: the Market Authorisation group, the Monitoring and Compliance group and the Regulatory Support group. In order to attain TGA approval, the following procedures must be carried out with the corresponding testing. The TGA system has five different classes for regulating medical devices. The medical device will be tested and classified based on the intended use of the device, the level of risk and the degree of invasiveness.
Team, Design and Structure
The team that will create and commercialise this device will need to consist of innovative biomedical and electrical engineers and programmers, medical physicians and therapists, a legal and financial advisor and children who have Down’s syndrome and their guardians. This ‘hand-eye coordination’ device comprises of the ring with the infrared detectors and the glasses style optical head mounted unit as well as the application software which can be used on any computer to enable remote patient monitoring. The ring design should be made so that it can be easily adjusted and worn by all patients. Each component and its subsystem will need to be thoroughly tested for TGA to regulate the device.
Social Context
This device is designed so that it can be worn externally: on the finger and on the head like a pair of glasses. Therefore it is widely visible. It is possible that the children or their parents do not feel socially comfortable with wearing such a device. However, much thought has been put in by the design team to make this device simple, efficient and easy to wear. The physical components being shaped like a ring and a pair of glasses has been the most innovative design yet to ensure that the device actually looks like an ‘everyday accessory’.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Testing
Various methods of testing will be required before the product can be fully commercialised. Initially, testing will be done of each individual component in a lab environment to ensure the proper functioning of each part of the device. The reliability and safety will be vital factors to be measured as well as any possible risks. Initial testing in a lab will allow us to tweak and remodel various components until they work accurately. After testing the system in a lab, it will need to be tested in a clinical setting by children who have Down’s syndrome. Their parents/ guardians will also be required for supervision, although the device is harmless, small components such as the ring should be carefully monitored and positioned on the child. Hence, this device should have a minimum age requirement of 3 years old to be sure that the child doesn’t accidentally swallow any component or carelessly damage it. Supervision to the child will be necessary until they have learned how to configure the device and use it properly. Medical staff and the child’s parents will be trained adequately so that they know how to operate the device and use the software to monitor progress in the child’s hand-eye coordination and visuo-spatial recognition. The device will need to be calibrated for each individual who tests it.
TGA Approval
For therapeutic goods in the market to be safe and of a high standard, the TGA regulates the goods through ‘pre-market assessment, post-market monitoring and enforcement of standards, as well as the licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts’ [4]. They also assess risks against benefits by identifying and evaluating any risks, taking the necessary measures to treat the risks and monitoring and reviewing these over time. TGA has a ‘Therapeutic product vigilance’ which continually evaluates and monitors the performance and safety of the products and manages any risks that may be associated with the product or medical device.
Manufacture
Once the device is approved by the TGA, specific companies can then be approached to enquire if they are able to manufacture the product and mass produce it. It could potentially be cost efficient to manufacture this particular device in an Asian country such as Japan where the electronic produce is large. If it is produced overseas, it is imperative that the production meets the Australian standards in order to be able to successfully commercialise it. The innovation process overseas would be similar to some extent as that of developing, fabricating and commercialising a product in Australia. There would still be legal and financial issues that would need to be addressed as well as thorough testing and regulatory approval that would need to be carried out. At present, it is best to manufacture the device in Australia, initially at least, so that the legalities will be much easier to process and the quality of manufacture will be of a high standard. It would not be valuable to innovate the design and manufacture the product in conjunction with another country since this would require legal rights, regulatory approval and testing in both countries according to the country’s own law. This could actually become more expensive on the whole and also take longer to process the development in two countries simultaneously.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Technology and Ecology
Whilst this medical device will be using new, state-of-the-art innovative technology and software, it is important to consider its impact on the environment especially once mass production begins. Fortunately, this particular device will not have any detrimental effect on the environment. Batteries on the optical head mount unit will need replacement, and eventually the infrared detectors will need to be replaced, but there will be no medical waste or biproduct residue produced.
Marketing
To successfully commercialise the product and target the right users, the ‘hand-eye coordination medical device’ and software should be marketed to paediatric wards in hospitals and clinics that monitor children with Down’s syndrome. It would also be beneficial to market such device at local schools and child-care centres that are specifically for children with Down’s syndrome. Marketing online on the ‘Down’s Syndrome Australia’ website and other non-government organisation websites would also be targeting the right audience for whom this device would be useful. If the product is highly successful in Australia, then it is worth considering marketing it in other countries too especially where Down’s syndrome is a common occurrence. If it is to then be marketed overseas, then fabricating the device overseas too would be cost efficient. Since this device is the first of its kind; specifically designed to aid Down’s syndrome children with handeye coordination and visuo-spatial recognition, there are no threatening competitors. Therefore, it is predicted that this device will do well commercially.
Vanessa Ashokkumar - 22638229
ECE4087
Assignment 2
Bibliography
[1] D. M, G. S, A. A and T. F, “Improving motor functions in children with Down's Syndrome,” Medical Hypotheses, 2013. [2] S. S. D. A. Shruti Nadkarni, “Enhancing Eye-Hand Coordination with Therapy Intervention to Improve Visual-Spatial Abilities using ‘The Re-training Approach’ in Children with Down Syndrome: Three Case Studies,” Disability, CBR and Inclusive Development Journal, vol. 23, no. 2, 2012. [3] H. Wisniowski, “Analog Devices And Nintendo Collaboration Drives Video Game Innovation With iMEMS Motion Signal Processing Technology,” Analog Devices, Inc., 2009. [4] “The Australian Government's Grants and Assistance finder,” Australian Government, [Online]. Available: http://www.business.gov.au/grantfinder/grantfinder.aspx. [Accessed 13 Septemeber 2013]. [5] C. (. Officer), “IP Australia,” Australian Government Intellectual Property, [Online]. Available: http://www.ipaustralia.gov.au/get-the-right-ip/patents/index.html. [Accessed 14 September 2013]. [6] “Therapeutic Goods Administration,” [Online]. Available: http://www.tga.gov.au/about/tgastructure.htm. [Accessed 15 September 2013]. [7] “Lumosity,” 2013. [Online]. Available: http://www.lumosity.com. [Accessed 13 September 2013]. [8] “Zac Browser,” Zac Browser, [Online]. Available: http://zacbrowser.com/images/required.jpg. [Accessed 13 September 2013]. [9] “Tech Radar,” [Online]. Available: http://cdn1.mos.techradar.futurecdn.net//art/gadgets/Google%20Glass/google_glass_grey-58090.jpg. [Accessed 13 September 2013].
