## Project Aura: A Strategic Framework for the Collaborative Development of a World-Leading Dementia and Longevity Ecosystem

## Executive Summary

This document presents a strategic framework for the establishment of a globally recognised, open-collaboration ecosystem for the development and deployment of the "Aura of Intelligence." This medical-grade system is designed to mitigate the effects of dementia and disabilities, enhance longevity, and create a new paradigm for person-centred care. The ecosystem integrates three core components: the Aura Capsule , a technologically advanced therapeutic device; the AuraOS , a powerful Artificial Intelligence (AI) operating system; and the Aura Digital Twin Genesis Protocol , a scientifically rigorous user journey designed to create a dynamic, interactive digital representation of the individual. 1

The development will be driven by a novel hybrid governance model, leveraging the innovative power of open-source collaboration with leading academic partners-including The University of Queensland (UQ), Queensland University of Technology (QUT), Griffith University, University of Southern Queensland (USQ), and University of the Sunshine Coast (USC)-while maintaining the rigorous controls of a certified medical device manufacturer for the core regulated components. This structure is designed to foster rapid innovation in non-regulated areas such as AI research and user interface design, while ensuring absolute safety and compliance for the safety-important hardware and software.

The project is designed from its inception for "over-compliance" with the world's most stringent regulatory standards, including those set by Australia's Therapeutic Goods Administration (TGA) for Software as a Medical Device (SaMD), ISO 13485 for Quality Management Systems, and IEC 62304 for the software development lifecycle. 1 A phased clinical trial roadmap will be executed to generate Level 1 evidence of the system's efficacy and safety, providing the foundation for regulatory approval and clinical adoption.

This initiative directly addresses the immense societal and economic burden of dementia in Australia, which cost the nation almost $3.7 billion in direct health and aged care expenditure in 2020-21 alone. 4 The project aligns with national research priorities articulated under the Medical Research Future Fund's (MRFF) "Dementia, Ageing and Aged Care Mission" and provides a sustainable commercialisation pathway by positioning the system as a validated form of Assistive Technology (AT) for funding under the National Disability Insurance Scheme (NDIS) and My Aged Care frameworks. 1 By doing so, Project Aura presents a unique opportunity to improve millions of lives, generate significant cost savings for the national healthcare system, and establish Australia as a world leader in the next generation of medical technology.

## Part I: The Strategic Imperative & Vision

## 1.1 The Dementia and Disability Crisis: A National Call to Action

The imperative for a new approach to dementia and disability care is rooted in a profound human and economic reality. For millions of Australians, the diagnosis of dementia is not a distant statistic but a deeply personal and emotional journey that reshapes families and communities. 5 The condition progressively impacts not only memory but also core aspects of personality, social functioning, and the fundamental ability to connect with loved ones, leading to social withdrawal, stigma, and a diminished quality of life. 8 This human cost is the primary motivation for the Aura of Intelligence initiative.

This personal crisis is mirrored by a national challenge of staggering scale. In 2024, an estimated 425,000 Australians were living with dementia, a figure that is projected to more than double to over 1 million by 2065 as the population ages. 5 Dementia is already the second leading cause of disease burden in Australia and the leading cause for women, underscoring its pervasive impact on the nation's health. 9 The challenge extends beyond the elderly, with younger onset dementia (diagnosed before the age of 65) affecting an estimated 27,800 people, who face a unique set of challenges related to family, work, and social support. 10

The economic burden of dementia on the Australian health system and economy is immense and unsustainable. In the 2020-21 fiscal year, direct health and aged care expenditure attributable to dementia was nearly $3.7 billion. 4 This figure is dominated by the costs of institutional and community care, with $1.8 billion spent on residential aged care facilities and a further $741 million on community-based aged care services. 4 These official figures represent only a fraction of the true cost. They are known to be significant underestimates as they exclude the vast indirect costs of the condition, such as lost productivity from both patients and their carers, and the immense financial and emotional burden placed on informal support networks. 11 A 2018 estimate that included these broader impacts placed the total annual economic cost at over $15 billion, with projections showing a rise to more than $36.8 billion by 2056. 12

Central to this hidden cost is the impact on carers. In 2024, there were at least 102,000 primary informal carers of people with dementia in Australia. The role is disproportionately borne by women (76%), with over 42% providing 60 or more hours of care per week-a commitment far exceeding a full-time job. This relentless dedication leads to significant negative impacts, with 45% reporting adverse physical or emotional effects and 28% experiencing direct financial strain. 5 This data paints a clear picture: the current model of dementia care places an unsustainable strain on individuals, families, and the national economy.

## 1.2 The Aura of Intelligence: A Vision for a New Paradigm

The Aura of Intelligence is conceived as a holistic, systemic response to this escalating crisis. It is not a single product or a simple software application, but a comprehensive ecosystem designed to fundamentally shift the paradigm of dementia care. The vision moves beyond reactive management of symptoms towards a model of proactive, deeply personalised support, with the ultimate goal of staving off decline, enhancing quality of life, and potentially facilitating recovery of function. 1

The core of this vision is the creation of a "digital twin"-a dynamic, interactive, and high-fidelity virtual representation of the individual. 1 This is achieved by systematically fusing the person's life story, core values, and unique preferences with a continuous stream of objective, real-time biometric and environmental data. This twin becomes a "living memoir" and an intelligent partner in care, capable of understanding the individual's past, monitoring their present, and helping to navigate their future.

The ultimate purpose of this ecosystem is to empower individuals with dementia to maintain their self-reliance and independence for as long as possible. By providing personalised cognitive support, automating reminders, facilitating social connections, and predicting and mitigating behavioral triggers, the system aims to reduce the burden on carers and delay the need for high-cost institutional care. 1 This directly aligns with key government objectives to improve health outcomes while creating a more sustainable and cost-effective model for national programs like the NDIS and My Aged Care. 1

The project's architecture as a direct and actionable response to Australia's national strategy is a core strategic advantage. The Australian Government's National Dementia Action Plan 2024-2034 explicitly prioritises the improvement of dementia data and the enhancement of outcomes for both people living with dementia and their carers. 5 Furthermore, the Medical Research Future Fund (MRFF) has established the "Dementia, Ageing and Aged Care Mission," backed by $185 million in funding, to support research that enables older Australians to live independently for longer and access higher quality care. 6 The Aura of Intelligence project, with its foundational focus on deep persona mapping, longitudinal multi-modal data collection, and seamless integration with care networks, is purpose-built to address these national objectives. The system's capacity to generate a rich, clinically validated profile from a combination of narrative and biometric data directly answers the call for superior data infrastructure to guide care and research. 1 Therefore, this initiative is positioned not as an external proposal seeking support, but as a key partnership opportunity for the Australian government to execute its own national strategy, making an exceptionally compelling case for public funding and collaborative engagement.

## Part II: The Aura of Intelligence Ecosystem Architecture

This section provides a unified technical specification of the Aura of Intelligence ecosystem, synthesising details from foundational design documents to present a single, coherent source of truth for the system's architecture. The ecosystem is comprised of four interconnected layers: the physical hardware, the intelligence software, the user journey protocol, and the underlying data and sensor framework.

## 2.1 The Physical Nexus: The Aura Capsule

The Aura Capsule is the physical nexus of the ecosystem, a certified medical-grade hyperbaric device that provides the precisely controlled environment required for the digital twin creation process. 1

Its design is a synthesis of advanced material science and deep symbolic meaning, termed "Geopoetic Alchemy." The shell is a pressure-rated geopolymer composite, a durable and sustainable material. The foundational ingredient is 99% pure crystalline quartz sand sourced from Minjerribah (North Stradbroke Island), a location of significant cultural and natural heritage. This material forms the "structural and symbolic base" of every capsule. During a "Customisation Ritual," users select from a range of "Signature Blends"-such as "Clear Mind" (Rose quartz + selenite) or "Earthen Root" (Basalt, obsidian, ochre)-which are infused into the geopolymer matrix. This process embeds the user's intention into the capsule's very structure. Each capsule is assigned a unique, immutable Material Composition ID (MC-ID) that logs its exact "crystal-print," enabling future large-scale research into the potential effects of subtle material science on therapeutic outcomes. 1

An important innovation in safety and performance is the Personalised Atmosphere Delivery System (PADS). Rather than pressurising the entire chamber with a specific gas, the PADS delivers a precisely controlled atmosphere-including gas mixture, pressure, and flow rate-directly to the user via a comfortable, medical-grade sealed mask. The main capsule environment remains filled with normal, breathable air. This design dramatically reduces the fire risk associated with oxygen-enriched environments and allows for rapid, precise changes in atmospheric composition, enabling advanced protocols such as Intermittent Hypoxic-Hyperoxic Training (IHT). 1

## 2.2 The Intelligence Layer: AuraOS

The AuraOS is the central AI operating system that functions as the brain of the entire system. It is responsible for managing all session variables, orchestrating the user experience, capturing data, and generating AI-driven insights. 1

The core of the OS is the Chrono-Therapeutic Sequencing Engine. This engine treats each two-hour session not as a static event, but as a programmable timeline composed of distinct "Phases." Each Phase is defined by a specific "Modality Stack," which is the precise combination of all controllable environmental and therapeutic variables active during that period. The Modality Stack includes the atmosphere delivered via PADS, the full-spectrum LED light profile (colour, intensity, frequency), the scent delivered via RFID-chipped cartridges, and the audio/haptic program (e.g., binaural beats, guided meditation). 1

## 2.3 The AI Core & Digital Twin Cognitive Architecture

The cognitive architecture of the digital twin, termed AI VIBE CODING, is a modular system designed to mirror human perception, memory, and decision-making. It is organised into distinct layers for Sensing, Context Integration, Cognitive Processing, and Adaptive Interaction, ensuring the system is both scalable and adaptable. 1

The "brain" of the AuraOS is its AI Core, a Bayesian Optimisation Engine. This engine functions as an intelligent composer for the user's therapeutic journey. It employs a multi-armed bandit model, a sophisticated machine learning approach, to dynamically design and refine session protocols. This model allows the AI to intelligently balance the exploration of new therapeutic combinations with the exploitation of protocols that have already proven effective for the user, thereby maximising both personalisation and the discovery of novel synergies. 1

Underpinning the AI's understanding is a robust Ontological Framework. This knowledge graph formally represents the user's world, defining key entities (e.g., Person, Location,

FoodItem, Emotion) and the relationships between them. This semantic structure allows the AI to perform complex logical reasoning (e.g., "If user is at home in the evening and their biometric data indicates stress, then recommend a calming activity from their preference list"). It enables the system to maintain a "living narrative" of the user's life, understanding context and continuity through major life transitions. 1

The crucial link between the user's subjective experience and the system's objective data is the "Dialogue Loop." This is the core mechanism for building the twin's rich mental and emotional model. During sessions, the AuraOS initiates a conversation, prompting the user for subjective feedback via voice or a touchscreen interface. This qualitative input is then fused in real-time with the quantitative biometric data being captured at that exact moment. This process creates a single, deeply correlated data point that bridges the gap between the "quantified self" (the data) and the "qualified self" (the felt experience), forming the very essence of the digital twin. 1

## 2.4 The User Journey: The Aura Digital Twin Genesis Protocol

The Aura Digital Twin Genesis Protocol is the foundational 60-session user journey, with each session lasting two hours, meticulously designed to create, personalise, and validate the digital twin. 1 The protocol is structured in three distinct phases:

1. Phase 1: Discovery & Resilience Mapping (Sessions 1-20): This initial phase functions like a sophisticated "allergy test" for wellness stimuli. The AuraOS runs protocols consisting of short, sequenced "micro-exposures" to a wide range of different modalities (e.g., 10 minutes of red light, followed by a washout period, then 10 minutes of a specific scent). By measuring the user's biometric and subjective responses to each stimulus, the system maps their unique dose-response profile, identifying what they are most sensitive to, both positively and negatively. 1
2. Phase 2: AI-Driven Chrono-Therapeutic Design (Sessions 21-40): Using the detailed response map from Phase 1, the AI Core transitions from analyst to composer. It begins to design complete, synergistic two-hour sessions, described as therapeutic "symphonies." These sessions are designed to achieve specific, holistic outcomes (e.g., "Deep Systemic Relaxation" or "Maximal Neural Stimulation") by sequencing different Modality Stacks in a way that creates complementary or compounding effects. The AI refines these symphonies after each session based on feedback, creating increasingly effective and personalised protocols. 1
3. Phase 3: Validation & Mind-Over-Matter Quantification (Sessions 41-60): In this final phase, the AI refines and validates the user's optimal "Prime Protocol." The system then executes the "Placebo Gauntlet," where it runs placebo-controlled versions of this protocol. For example, it might deliver normal air through the PADS when the user

expects pure oxygen, while keeping all other sensory cues identical. By comparing the biometric and subjective responses between the true protocol and the placebo version, the system can rigorously quantify the user's individual placebo response, generating a personalised "Mind-Over-Matter" coefficient. This provides a powerful metric of the user's own ability to influence their biology through belief and expectation. 1

## 2.5 Sensor Integration & Data Architecture

The fidelity of the digital twin is contingent on the quality and breadth of data it receives. The Aura ecosystem is designed for multi-modal data integration from a diverse array of sources.

## The sensor suite includes:

- Biometric Sensors: A comprehensive suite of medical-grade sensors captures real-time physiological data. This includes wearable devices like smartwatches, Fitbits, and smart hearing aids for tracking heart rate, sleep patterns, and physical activity, as well as in-capsule systems like EEG headsets for brainwave activity and SpO2 clips for blood oxygen saturation. 1
- Environmental and IoT Sensors: The system interfaces with Internet of Things (IoT) devices in the user's environment, such as smart home thermostats, lighting systems, cameras, and microphones, to gain a rich, contextual understanding of their surroundings and daily routines. 1

To correlate the experiential data with deep biological changes, the Genesis Protocol incorporates an Integrated Bio-Kit . At key milestones, users provide biological samples (e.g., saliva, urine, breath, and micro-blood samples). These are analysed to track changes in hard biological outcomes, such as inflammatory markers, hormone levels, and even epigenetic clocks, providing a powerful link between the in-capsule experience and real-world physiological impact. 1

The entire data architecture is built upon a foundation of privacy and user sovereignty, aligning with the ethical guidance of "Data with Dignity." A federated data model is employed, which is an important design choice. All raw biometric and personal data remains on the user's local device (the capsule's onboard computer or a private server). The central cloud AI does not ingest this raw data; instead, it sends analysis models to the edge device. The local device runs the analysis and sends back only anonymous, aggregated results. This architecture allows the global AI to learn and improve from the experiences of all users without ever compromising the privacy of any single individual. 1

Finally, the system is designed for integration with Augmented Reality (AR) and Virtual Reality

(VR) technologies. These immersive platforms serve as powerful interfaces for the user to interact with their twin. Applications include memory reconstruction therapies, data visualisation (e.g., representing the "Aura" as a set of nested tori), and exploring a "Virtual Memory Palace" where memories are organised spatially to enhance recall and engagement. 1

| Layer        | Core Component        | Key Features                                                                                        | Primary Function                                                                                                              |
|--------------|-----------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Physical     | Aura Capsule          | Geopolymer Composite Shell, MC-ID, Personalised Atmosphere Delivery System (PADS)                   | Provide a safe, controlled, and personalised therapeutic environment for data capture and intervention.                       |
| Intelligence | AuraOS                | Chrono-Therapeuti c Sequencing Engine, Modality Stack, Bayesian Optimisation AI Core, Dialogue Loop | Personalise and orchestrate the user's in-session experience, fusing subjective and objective data to build the digital twin. |
| Protocol     | Aura Genesis Protocol | Phase 1: Discovery Mapping, Phase 2: AI-Driven Design, Phase 3: Placebo Validation                  | Systematically create, personalise, and scientifically validate the user's digital twin over a 60-session journey.            |
| Data         | Aura Twin Data Fabric | Multi-Modal Sensor Suite, Integrated Bio-Kit, Federated Learning Architecture, AR/VR Integration    | Ensure user privacy and data sovereignty while enabling global research and providing immersive user interaction.             |

## Part III: The Open Collaboration Framework: A New Model for MedTech Innovation

## 3.1 The Governance Paradox: Balancing Open Innovation with Medical-Grade Control

The core of the user's guidance is to pursue a multi-institutional, open-source development model. This approach presents a fundamental governance paradox. On one hand, open-source methodologies are powerful engines of innovation, transparency, and community engagement, allowing for rapid, collaborative development. 13 On the other hand, the development of a medical device is a highly regulated, liability-intensive process that demands rigorous, centralised control and meticulous documentation. 15

A "pure" open-source model, where code is freely contributed and modified by a distributed community, is fundamentally incompatible with the legal and quality assurance obligations of a medical device manufacturer. Key standards such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), and IEC 62304 (Software Development Lifecycle) require a designated legal entity to be responsible for the entire product lifecycle, from design verification and validation to post-market surveillance and liability. 1 A diffuse open-source community cannot legally assume this role. Case studies of successful open-source projects in healthcare, such as the Veterans Health Administration's VistA electronic health record system, demonstrate this principle; while the software benefits from open innovation, its deployment in clinical settings is managed by a central body that ensures quality, security, and accountability. 13 Therefore, a naive application of open-source principles would render the Aura of Intelligence system uncertifiable and clinically unusable.

## 3.2 Proposed Solution: A Hybrid "Open Core / Certified Shell" Governance Model

To resolve this paradox, a sophisticated hybrid governance model is proposed. This "Open

Core / Certified Shell" model is designed to harness the creative power of open collaboration for non-regulated components while enforcing strict, proprietary control over the safety-important, regulated elements of the system.

The Open Core is the collaborative heart of the ecosystem. This is the domain where the multi-institutional partnership will flourish, fostering innovation in areas that do not fall under direct medical device regulation. This layer includes:

- Fundamental Research: The development and refinement of the AI and machine learning models, research into the psychological and sociological impacts of digital twins, and the exploration of new therapeutic modalities. This is the primary purview of the university partners.
- Ontological Frameworks: The collaborative design and expansion of the knowledge graphs and semantic models that form the AI's understanding of the user's world. 1
- Non-Regulated Components: The development of user interface (UI) and user experience (UX) concepts, AR/VR visualisation modules (such as the Blender and Unity assets for the toroidal "Aura" visualisation), and data analysis tools for researchers. 1

Governance of the Open Core can be managed through a Foundation-Backed Model . 19 A non-profit "Aura Foundation" would be established, with a steering committee composed of representatives from all key partner institutions (universities, care providers, etc.). This foundation would manage the open-source community, facilitate research, and oversee the IP of the Open Core components, following best practices for multi-institutional research collaboration. 20

The Certified Shell is the proprietary, regulated layer that is legally owned and managed by a single, designated entity-the legal "manufacturer" responsible for TGA compliance. This entity could be a subsidiary of the Aura Foundation or a dedicated public-benefit corporation. The Certified Shell encompasses all components that fall under medical device regulations:

- Software as a Medical Device (SaMD): The final, compiled, and validated software that performs diagnostic, monitoring, or therapeutic functions and is submitted to the TGA for inclusion on the Australian Register of Therapeutic Goods. 1
- AuraOS Core & PADS Firmware: The safety-important software that controls the life-support functions of the Aura Capsule, including the atmosphere delivery system.
- Quality Management System (QMS): The complete set of controlled documents, procedures, and records required to demonstrate compliance with ISO 13485. 24
- Clinical Data Management: The secure, compliant architecture for managing sensitive patient health information according to privacy laws and clinical trial protocols.

The interface between these two layers is important. Contributions from the Open Core are not automatically integrated into the Certified Shell. Instead, they are treated as inputs to a formal, rigorous, and fully documented design control process managed by the legal manufacturer. Any new AI model, UI concept, or software library from the Open Core could be subjected to a complete verification, validation, and risk management process before it can be incorporated into a new version of the regulated SaMD product. This model provides the best of both worlds: the dynamic, creative engine of open collaboration and the uncompromising safety and accountability of a certified medical device.

## 3.3 The Stakeholder Ecosystem: Roles, Responsibilities, and Symbiosis

This hybrid model enables a "Mission-to-Market" pipeline where each partner has a clearly defined role and derives tangible benefits, creating a sustainable and symbiotic ecosystem.

## University Partners (UQ, QUT, Griffith, USQ, USC):

- Role: These institutions will be the primary drivers of the Open Core, leading fundamental research in their respective areas of world-class expertise.
- The University of Queensland (UQ): Will spearhead clinical research and validation through its leading centres like the UQ Centre for Clinical Research (UQCCR) and the Queensland Brain Institute (QBI). The Dementia & Neuro Mental Health Research Unit, led by Professor Nadeeka Dissanayaka, is an ideal anchor partner, given its specific focus on technology-assisted interventions, telehealth, and CBT for individuals with cognitive impairment. 25 UQ's expertise in digital health, sociology, and AI provides a broad research base. 30
- Queensland University of Technology (QUT): Will lead research in Human-Computer Interaction (HCI), user experience (UX), and gamification. The Games Research and Interaction Design (GRID) Lab is perfectly positioned to develop the non-regulated AR/VR interfaces, the "Aura" visualisation, and the motivational frameworks that enhance user engagement. 33
- Griffith University: Will contribute expertise in applied psychology, healthy ageing, and the integration of technology in care settings. Its research into social robotics for dementia care and its leadership in the Australian Aged Care Technologies Collaborative (AACTC) make it a vital partner for understanding real-world implementation challenges. 38
- University of Southern Queensland (USQ): Will provide research capabilities in digital health and the application of AI for assessing cognitive states, particularly through its Centre for Health Research. 42
- University of the Sunshine Coast (USC): Will contribute through its Thompson Institute's Healthy Brain Ageing Program, which focuses on dementia prevention and the use of neuroimaging technologies (MRI, EEG) to study the impact of lifestyle interventions. 45
- Contribution: University partners will contribute the expertise of their academic staff and PhD researchers, lead applications for national competitive research grants (e.g.,
- MRFF, ARC), produce high-impact peer-reviewed publications, and develop and maintain the components of the Open Core.
- Benefit: They gain access to a world-class, globally unique research platform (the Aura ecosystem), a rich source of real-world clinical data for their research, and a clear, structured pathway for translating their fundamental research into tangible clinical and societal impact.

## Community & Care Partners (Anglican Church Southern Queensland - ACSQ, and other religious/non-profit organisations):

- Role: These organisations will serve as the crucial bridge between the technology and the community, acting as clinical trial sites, providing invaluable domain expertise, and forming the primary pathway for real-world implementation and adoption.
- Contribution: ACSQ, through Anglicare, has an extensive network of residential aged care homes across Southern Queensland, including facilities with established Specialist Dementia Care Programs (SDCP) like St Martin's and Symes Thorpe, making them ideal partners for the phased clinical trials. 50 Their organisational mission is deeply aligned with the project's goal of providing holistic, person-centred care, and their strategic plan explicitly includes a commitment to innovation and technology adoption, as evidenced by their existing trials of client engagement apps and other assistive technologies. 50 Other faith-based providers such as The Salvation Army and Christadelphian Aged Care offer similar networks and mission alignment, representing a broad potential partner base. 54
- Benefit: These partners gain early access to a validated, evidence-based technology that has the potential to significantly improve their quality of care, reduce the burden on their staff, and enhance their reputation as leaders in innovative care. Critically, the system's alignment with the NDIS and My Aged Care funding models provides them with a pathway to a sustainable service model, creating a new revenue stream to support their core mission.

| Partner                 | Primary Role                           | Key Contributions                                                                                                                                      | Expected Benefits                                                                                                    |
|-------------------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| UQ (DNMH Research Unit) | Lead Academic & Clinical Trial Partner | Act as Principal Investigator site for clinical trials; recruit participants; conduct clinical assessments; lead research on technology-assiste d CBT. | Co-authorship on high-impact publications; secure major MRFF grant funding; translate research into a clinical tool. |

Part IV: The Pathway to Clinical Validation & Regulatory Supremacy

![Image]([IMAGE_DATA_REMOVED_FOR_AI_EFFICIENCY])

| QUT (GRID Lab)                | HCI & User Experience Research Lead                  | Co-design and develop the non-regulated user interfaces, including the AR/VR "Memory Palace" and gamified motivational elements.                               | Access to a real-world user base for HCI research; IP rights for non-regulated UI/UX components; publications in top HCI venues.            |
|-------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Griffith University (AACTC)   | Implementation Science & Technology Adoption Partner | Research on the real-world implementation of social robotics and other technologies in aged care; advise on carer training and workflow integration.           | Validate and publish best-practice models for technology adoption in aged care; inform national policy through AACTC.                       |
| Anglicare Southern Queensland | Lead Implementation & Clinical Trial Partner         | Provide access to residential aged care facilities for all phases of the clinical trial; offer domain expertise from carers and clinicians; champion adoption. | Access to an evidence-based tool to improve resident quality of life and reduce BPSD; new sustainable funding stream via NDIS/My Aged Care. |

## 4.1 The "Over-Compliance" Guidance: Building a Regulatory Moat

The project's stated ambition to be "over-compliant" is not a matter of preference but a core strategic guidance. In the high-stakes field of medical technology, particularly for a system interacting with vulnerable populations, regulatory compliance is the foundation of trust, safety, and market access. By designing the entire system for adherence to the most stringent global standards from its inception, the project builds a formidable "regulatory moat." This proactive stance de-risks the project for investors and clinical partners, builds crucial trust with regulators like the TGA, and creates a significant and durable barrier to entry for potential competitors who may attempt to follow with less rigorous approaches. The development process will not be a technical exercise with a later "compliance phase"; it will be a regulatory process enabled by technology from day one.

## 4.2 Clinical Validation Roadmap: The Phased Trial Protocol

The generation of unimpeachable, Level 1 clinical evidence is the engine of the entire regulatory and commercialisation strategy. The project will adopt the detailed, three-phase clinical trial protocol outlined in the Clinical Research and Implementation Plan , a design informed by successful large-scale Australian digital health trials. 1

- Phase 1: Feasibility and Usability Testing (Target N=10-15 dyads). The primary objective of this initial phase is to test and refine the A.o.I. prototype with a small cohort of end-users (a person with mild dementia and their primary carer). This phase will focus on gathering qualitative feedback and quantitative usability metrics (e.g., System Usability Scale) to ensure the technology is acceptable, intuitive, and fit for purpose. This crucial de-risking step will be conducted in partnership with a community-based organisation, such as Alzheimer's Queensland, to facilitate rapid recruitment and gather real-world insights. 1
- Phase 2: Single-Site Pilot Study (Target N=40-50 dyads). This phase aims to gather the first preliminary data on the efficacy of the A.o.I. system on key clinical outcomes. It will be a pre-post intervention study, or a small-scale randomised controlled trial (RCT) with a wait-list control group, conducted over 3-6 months. The primary outcome will be the change in a validated measure of Behavioural and Psychological Symptoms of Dementia (BPSD), such as the Neuropsychiatric Inventory (NPI). Secondary outcomes will cover cognition (RUDAS), function (DAD), quality of life (DEMQOL), and carer burden. This study will be conducted in partnership with a specialist dementia clinical trial unit, such as the UQ Centre for Clinical Research (UQCCR). 1 The data from this pilot is helpful for powering the sample size calculations for the full-scale trial and forms the

initial basis of the clinical evidence file for the TGA.

- Phase 3: Multi-Site Efficacy Trial (RCT) (Target N=150-200+ dyads). This is the pivotal trial designed to definitively determine the effectiveness and cost-effectiveness of the system. It will be a multi-site, pragmatic RCT, with participants randomly allocated to the A.o.I. intervention or a standard care/attention-control group for a period of 12 months. To enhance the generalizability of the findings, recruitment will occur across multiple sites in Queensland, including metropolitan, regional, and remote locations. This trial will also incorporate a formal health economic analysis to determine the system's cost-effectiveness, providing the high-quality evidence required for widespread adoption and government funding. 1

A central element of this roadmap is the "Clinical Wrapper" strategy. The A.o.I. system is designed to augment, not replace, existing and trusted clinical assessment tools. Clinicians are time-poor and trained to rely on validated instruments. The system's key advantage is its ability to perform continuous, longitudinal data collection in the background. At specified intervals, the AuraOS will synthesise this rich dataset and generate a report formatted to resemble a standard clinical assessment tool (e.g., a GPCOG or NPI report). The clinician receives the information they need in a familiar format, but it is backed by a far richer and more reliable dataset than a single, point-in-time test could ever provide. This strategy dramatically lowers the barrier to adoption for healthcare professionals. 1

## 4.3 TGA Regulatory Strategy: Navigating Software as a Medical Device (SaMD)

The AuraOS, with its intended purpose to monitor, predict, and alleviate symptoms of dementia, unequivocally falls under the TGA's definition of Software as a Medical Device (SaMD) and functions as Clinical Decision Support Software (CDSS). 1 A formal, proactive strategy for navigating the TGA's conformity assessment process is therefore an important path item.

- Classification: Based on the TGA's risk-based classification rules, the system will be conservatively planned as a Class IIb (medium-high risk) device. This classification is appropriate because the system provides direct recommendations for action to a carer or user regarding BPSD, where an incorrect recommendation could potentially lead to a negative health outcome. Planning for this higher classification ensures the most rigorous evidence and documentation standards are met from the outset. 1
- Conformity Assessment Process: The project will follow the TGA's structured process for achieving inclusion on the Australian Register of Therapeutic Goods (ARTG). 1 The key steps are:
1. Appoint an Australian Sponsor: A legal entity based in Australia will be appointed

to be responsible for the ARTG inclusion and post-market obligations.

2. Engage in a TGA Pre-submission Meeting: Early engagement with the TGA is crucial for a novel, AI-driven SaMD. This meeting will be used to confirm the proposed classification, clarify evidence requirements, and de-risk the formal application.
3. Prepare the Technical File: This comprehensive dossier will be prepared throughout the development process and will include the full clinical evidence from the three-phase trial, complete software design and validation documentation (per IEC 62304), a thorough cybersecurity and privacy risk assessment, and the usability engineering file from the Phase 1 trial.
4. Submit and Undergo Assessment: The application will be submitted via the TGA Business Services portal. The project will budget for the assessment process, which can take up to 255 working days, and be prepared for requests for further information. 1
5. Achieve ARTG Inclusion: Upon successful assessment, the device will be included on the ARTG, permitting its legal supply in Australia.

To facilitate this complex process, the project will engage with expert bodies such as ANDHealth, a joint initiative with the TGA that provides specialised workshops and one-on-one coaching for companies navigating Australia's SaMD regulatory environment. 59

## 4.4 ISO & International Standards Implementation Plan

Compliance with international standards is the practical mechanism for achieving the "over-compliance" guidance. The project's management framework will be built upon these standards from day one.

- ISO 13485:2016 (Quality Management System): A comprehensive QMS will be implemented at the project's inception. This is non-negotiable for any medical device manufacturer. The implementation plan will follow a structured, step-by-step process: defining the scope of the QMS, documenting all processes and procedures, establishing clear management responsibility and resource allocation, implementing rigorous design controls for product realisation, and embedding a culture of continuous improvement through measurement, analysis, and internal audits. 2
- IEC 62304 (Medical Device Software - Software Life Cycle Processes): The entire software development process for the "Certified Shell" will adhere to this standard. This provides a harmonised framework for ensuring the safety and effectiveness of the software. A formal, documented process will be established covering: software development planning, requirements analysis, architectural design, unit implementation and verification, software integration and testing, and a software maintenance plan. The
- level of rigor and documentation for each activity will be determined by the software's safety classification (Class C being the most stringent, which is appropriate for safety-important components). 3
- ISO 14971 (Application of Risk Management to Medical Devices): A formal risk management process will be integrated into every stage of the product lifecycle, from initial concept to post-market surveillance. This involves systematically identifying potential hazards, estimating and evaluating the associated risks, implementing and verifying risk control measures, and monitoring the effectiveness of these controls throughout the device's lifespan. 2

| Standard/Regulation   | Core Requirement                       | Project Aura Compliance Strategy                                                                                                                                                         |
|-----------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TGA SaMD (Class IIb)  | Conformity Assessment & ARTG Inclusion | Phased clinical trial to generate comprehensive clinical evidence file; Proactive pre-submission engagement with TGA; Full technical file preparation.                                   |
| ISO 13485:2016        | Quality Management System (QMS)        | Implement a documented QMS from project inception; Appoint a dedicated Quality Manager; Conduct regular internal audits and management reviews.                                          |
| IEC 62304             | Software Lifecycle Process             | Adopt a formal, documented software development lifecycle for the "Certified Shell"; Classify safety-important components as Class C; Rigorous verification and validation at each stage. |
| ISO 14971             | Risk Management                        | Integrate a formal risk management process into all design, development, and post-market activities;                                                                                     |

|                        |                         | Maintain a living Risk Management File.                                                                                                                         |
|------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Privacy Act 1988 (Cth) | Data Privacy & Security | Employ a federated "privacy by design" architecture; Ensure all personal health information is stored securely in Australia; Appoint a Data Protection Officer. |

## Part V: Economic Viability & National Impact

## 5.1 Funding Strategy: A Dual-Pronged Approach

The ambitious scale of Project Aura necessitates a sophisticated, multi-stage funding strategy that leverages both public and private capital, aligning the project's milestones with the distinct priorities of different funding bodies.

Public Funding - The Medical Research Future Fund (MRFF) Opportunity:

The project's clinical research and development activities are exceptionally well-aligned with the Australian Government's MRFF "Dementia, Ageing and Aged Care Mission".6 The Mission's Implementation Plan explicitly calls for investment in research that focuses on "using digital technologies to support care," developing "new or existing models of care" that are person-centred, and conducting "large-scale population and data linkage studies" to improve outcomes.63

The proposed Phase 2 and Phase 3 clinical trials represent a perfect fit for a Stream 2 grant application under a relevant MRFF funding round, which can offer up to $5 million. 64 The project's focus on implementation science, addressing inequalities in care, and developing new tools and technologies directly maps to the Mission's stated priority areas. The precedent for large-scale federal investment in this domain is strong, as demonstrated by initiatives like the $50 million 2023 BioMedTech Incubator grant for dementia and cognitive decline. 66 The initial funding strategy will therefore prioritise the submission of a high-quality, comprehensive MRFF application, leveraging the detailed clinical trial protocol as its foundation.

Private & Philanthropic Funding:

In parallel with public grant applications, the project will pursue private and philanthropic funding. The profound potential for social impact and the project's alignment with the core values of service and compassionate care make it highly attractive to philanthropic foundations and social impact investors. The mission-driven nature of the project resonates particularly well with the objectives of the key community and care partners, such as the Anglican Church, opening avenues for direct philanthropic support.

Once the initial clinical validation is achieved through the publicly funded trials, the project becomes a compelling case for private venture capital. The de-risked technology, validated clinical efficacy, clear regulatory pathway, and defined commercialisation model within the multi-billion dollar aged care and disability sectors represent a significant and attractive investment opportunity.

## 5.2 Commercialisation: The NDIS & My Aged Care "Prescription" Model

The primary commercialisation pathway for the Aura of Intelligence system in Australia is to position it as a form of Assistive Technology (AT) , eligible for funding under the two largest government schemes: the National Disability Insurance Scheme (NDIS) and My Aged Care. 1

- Positioning as Assistive Technology (AT):
- NDIS Pathway: For individuals with younger-onset dementia (diagnosed under the age of 65), the NDIS provides funding for equipment and devices that help a person perform tasks they cannot otherwise do, or do them more safely. 68 The Aura system, with its integrated reminders, safety features (e.g., wandering alerts), communication aids, and cognitive support functions, fits perfectly within this definition of AT. 1
- My Aged Care Pathway: For individuals over 65, Home Care Packages (HCPs) provide a flexible budget that can be used for goods and assistive technology linked to assessed care needs. 7 The Australian government is also moving towards a new 'Support at Home' program which is expected to include a dedicated AT scheme, further solidifying this funding channel. 1
- Evidence for Funding Justification: Access to these government funding streams is not automatic. It requires a formal assessment by a qualified professional (such as an Occupational Therapist, geriatrician, or NDIS planner) who could deem the technology "reasonable and necessary" to help the person achieve their goals. 1 The entire clinical trial protocol is strategically designed to generate the precise portfolio of evidence these assessors require. The trial's primary and secondary outcomes will provide objective proof of the system's benefits, including: improved safety, increased independence and function (measured by the DAD scale), reduction in BPSD (measured by the NPI scale),
- reduced carer burden, and improved quality of life (measured by the DEMQOL). 1
- Go-to-Market Strategy: The "Prescription" Model:
- The most effective go-to-market strategy is not a direct-to-consumer sales model, but a "prescription" model targeting the clinical gatekeepers. The commercial team's primary objective will be to educate and empower the OTs, nurses, geriatricians, and NDIS planners who make funding recommendations. The evidence portfolio generated from the clinical trials will be repurposed into a commercialisation toolkit, including training materials for allied health professionals and template justification reports, pre-populated with clinical evidence, to simplify the funding application process for them.1
- Value Proposition and Cost Context: The financial case for the Aura system is compelling. The average annual whole-of-system cost for a person with dementia in residential care in Australia is approximately $88,000. 70 Government subsidies for My Aged Care Home Care Packages range from approximately $10,000 per year for Level 1 to over $59,000 per year for Level 4. 7 The Aura system will be priced to demonstrate a clear and significant value-for-money proposition, showing that its adoption can delay or prevent entry into expensive residential care, reduce reliance on other high-cost services, and ultimately generate substantial net savings for the government.

## 5.3 National Impact: The Data Asset and Economic Savings

Beyond its direct impact on users, the project will generate two significant national-level benefits.

- The National Data Asset: The most significant long-term output of the Aura ecosystem is the creation of a national-scale, longitudinal, multi-modal dataset on dementia and ageing. This rich dataset, linking deep personal narratives with clinical, biometric, and environmental data, directly addresses an important data gap identified by the Australian Institute of Health and Welfare (AIHW). 11 Once de-identified and aggregated, this data becomes an invaluable national research infrastructure asset, enabling future research into the causes, progression, and treatment of dementia for decades to come.
- Economic Modelling and Savings: The project will include a formal health economic analysis to model the potential cost savings to the Australian government. This model will quantify the economic benefit of delaying entry into residential aged care by 6, 12, or 24 months for a percentage of the user base. Given the high costs of residential care, even modest delays in entry for a fraction of the dementia population can translate into billions of dollars in savings for the national budget, demonstrating a powerful return on investment for the government's initial support.

## Part VI: Strategic Implementation Roadmap & Recommendations

## 6.1 Phased 5-Year Roadmap

The successful execution of this complex, multi-faceted project requires a clear, phased implementation roadmap. The following 5-year plan integrates the parallel workstreams of partnership development, funding, research and development, clinical validation, regulatory compliance, and commercialisation.

- Year 1: Foundation & Feasibility
- Partnerships & Governance: Formalise anchor partnerships by executing Memoranda of Understanding (MOUs) with a lead academic institution (e.g., The University of Queensland) and a lead clinical care provider (e.g., Anglicare Southern Queensland). Legally establish the "Aura Foundation" or chosen entity to act as the TGA sponsor and legal manufacturer.
- Funding: Secure seed funding (approximately $1.5M AUD) from philanthropic and/or angel investors to cover Year 1 operations, key hires, and the costs of the feasibility trial.
- Team: Recruit the core leadership team, including the Principal Investigator (PI), a Clinical Trial Coordinator, and a Head of Quality & Regulatory Affairs.
- Clinical & Regulatory: Prepare and submit the Human Research Ethics Committee (HREC) application for the Phase 1 Feasibility and Usability Trial. Begin development of the Quality Management System (ISO 13485) and Software Lifecycle Process (IEC 62304) documentation.
- Milestone: Execute the Phase 1 trial with 10-15 dyads to refine the prototype and gather crucial usability data.
- Year 2: Pilot & Regulatory Engagement
- Funding: Prepare and submit a major grant application to the MRFF "Dementia, Ageing and Aged Care Mission" to fund the larger Phase 2 and 3 trials.
- Clinical & Regulatory: (Assuming HREC approval) Commence the Phase 2 Single-Site Pilot Study. Initiate a formal pre-submission meeting with the TGA to confirm the regulatory pathway and evidence requirements for the SaMD.
- R&D: Develop the "Certified Shell" prototype based on feedback from the Phase 1 trial. Expand the "Open Core" research activities with other university partners.
- Milestone: Complete the Phase 2 pilot study and generate the first preliminary efficacy data.
- Years 3-4: Full-Scale Trial & TGA Submission
- Clinical Validation: (Assuming MRFF funding and HREC approval) Execute the pivotal Phase 3 Multi-Site Randomised Controlled Trial (RCT) across multiple Queensland locations.
- Regulatory: Compile the complete TGA technical file, incorporating the final clinical evidence from the RCT, software validation reports, and all QMS documentation.
- Commercialisation: Develop the commercialisation toolkit, including training materials and template justification reports for NDIS and My Aged Care prescribers.
- Milestone: Submit the formal application to the TGA for inclusion of the Aura of Intelligence system on the Australian Register of Therapeutic Goods (ARTG).

## ● Year 5: Commercial Launch & Network Expansion

- Market Entry: (Assuming TGA approval) Launch the system in the Australian market, focusing on the "prescription" model targeting NDIS and My Aged Care funded clients.
- Dissemination: Publish the results of the Phase 3 RCT in high-impact, peer-reviewed medical journals to build credibility and drive clinical adoption.
- Scaling: Begin scaling the network of certified care provider partners across Australia.
- International: Develop a strategy for international regulatory submissions (e.g., FDA in the USA, CE Marking in Europe) based on the robust Australian evidence package.
- Milestone: Achieve first commercial revenues and establish a growing national network of implementation partners.

| Workstrea m     | Year 1                                         | Year 2                       | Year 3                          | Year 4                           | Year 5                     |
|-----------------|------------------------------------------------|------------------------------|---------------------------------|----------------------------------|----------------------------|
| Partnershi ps   | Formalise Anchor Partnership s (UQ, Anglicare) | Expand University Consortium | Engage Regional Trial Sites     | Onboard Commercial Partners      | Scale National Network     |
| Funding         | Secure Seed Funding ($1.5M)                    | Submit MRFF Grant            | (MRFF Funding Active)           | Seek Series A Venture Capital    | (Self-sustai ning Revenue) |
| R&D / Technical | Develop Feasibility Prototype                  | Develop Pilot Prototype      | Finalise "Certified Shell" v1.0 | Develop v1.1 based on trial data | Plan v2.0 Architectur e    |
| Clinical        | Phase 1:                                       | Phase 2:                     | Phase 3:                        | Complete                         | Publish RCT                |

| Validation         | Feasibility Trial                      | Pilot Study                             | Multi-Site RCT                        | RCT & Data Analysis        | Results                                   |
|--------------------|----------------------------------------|-----------------------------------------|---------------------------------------|----------------------------|-------------------------------------------|
| Regulatory         | HREC App (Phase 1), ISO/IEC Docs Start | TGA Pre-Submis sion, HREC App (Phase 2) | HREC App (Phase 3), Compile Tech File | TGA Applicatio n Submitted | (TGA Approval), Post-Marke t Surveillance |
| Commerci alisation | Develop Business Plan                  | Refine NDIS/My Aged Care Model          | Develop "Prescriber " Toolkit         | Pre-Launch Marketing       | Australian Market Launch                  |

## 6.2 Risk Assessment & Mitigation

A project of this complexity faces significant risks across multiple domains. A proactive risk management strategy is useful.

- Technical Risk: The accuracy of AI models and the reliability of sensor data are important.
- Mitigation: A rigorous verification and validation (V&V) process, mandated by IEC 62304, will be employed. The phased clinical trials provide a structured environment to test, refine, and validate all algorithms against real-world data before widespread deployment.
- Regulatory Risk: The TGA's requirements for novel, AI-driven SaMD are evolving, and there is a risk of classification changes, requests for additional data, or outright rejection.
- Mitigation: Proactive and early engagement with the TGA via a pre-submission meeting is the most effective mitigation. The strategy of planning for a Class IIb submission and generating a comprehensive clinical evidence file from a large-scale RCT is designed to meet the highest possible evidence threshold. The project will also retain experienced regulatory consultants specialising in SaMD.
- Clinical Trial Risk: Slow participant recruitment is a common cause of delays and budget overruns in clinical research.
- Mitigation: This risk is substantially mitigated by the strategic partnership model. Engaging directly with care providers like Anglicare and advocacy groups like Dementia Australia provides direct, trusted access to the target population and their carers, which is far more effective than traditional hospital-based recruitment methods. 1
- Collaboration Risk: In a multi-institutional project, there is a risk of misaligned goals, disputes over intellectual property, or lack of engagement from partners.
- Mitigation: The hybrid governance model clearly delineates roles and IP ownership between the Open Core and Certified Shell. Formal, legally-reviewed consortium agreements will be established in Year 1, defining the roles, responsibilities, and benefits for each partner as outlined in the Stakeholder Engagement Matrix.
- Adoption Risk: Clinicians, carers, and users may be resistant to adopting a complex new technology.
- Mitigation: The "Clinical Wrapper" strategy is designed to lower the adoption barrier for clinicians by presenting data in familiar formats. The co-design process with users and carers in the Phase 1 Feasibility Trial will be crucial for ensuring the final product is intuitive, valuable, and addresses their real-world needs.

## 6.3 Immediate Next Steps (First 12 Months)

To translate this strategic framework into action, the following steps should be prioritised and executed within the next 12 months:

1. Formalise Anchor Partnerships: Move from informal discussions to executed Memoranda of Understanding (MOUs) with The University of Queensland (specifically the Dementia & Neuro Mental Health Research Unit) and Anglicare Southern Queensland. These agreements will designate them as the lead academic and clinical partners, respectively, and form the basis of the consortium.
2. Appoint Key Personnel: The immediate priority is to recruit three important leadership roles: a senior, respected clinician to act as the Principal Investigator (PI) ; an experienced Clinical Trial Coordinator to manage the operational aspects of the research; and a Head of Quality & Regulatory Affairs to begin establishing the ISO 13485-compliant QMS.
3. Secure Seed Funding: Finalise a comprehensive pitch deck and business plan, using this strategic report as the foundational document, to secure approximately $1.5 million AUD in seed funding from a combination of philanthropic grants, social impact investors, and/or angel investors. This funding is important to cover Year 1 operational costs, salaries for the core team, and the direct costs of the Phase 1 trial.
4. Initiate MRFF Application: Immediately begin the process of drafting a major grant application for the Medical Research Future Fund. The application will be based on the detailed protocols for the Phase 2 Pilot Study and Phase 3 RCT, targeting the "Dementia, Ageing and Aged Care Mission" as the primary funding stream.
5. Establish Governance Structures: Legally establish the "Aura Foundation" (or the chosen corporate entity) that will act as the legal manufacturer and TGA sponsor for the regulated device. Concurrently, begin drafting the governance charter and terms of

reference for the "Open Core" research consortium in consultation with the anchor partners.

## Works cited

1. AURA GEODE to MACRO.pdf
2. 2.
3. Understanding ISO Standards for Medical Devices - Amtivo, accessed October 19, 2025,

https://amtivo.com/us/resources/insights/understanding-iso-standards-for-medic al-devices/

3. IEC 62304 Checklist: Key Points and Best Practices, accessed October 19, 2025, https://www.getsignify.com/blog/iec-62304-checklist-key-points-and-best-pract ices
4. Dementia in Australia, Costs of dementia - Australian Institute of ..., accessed October 19, 2025, https://www.aihw.gov.au/reports/dementia/dementia-in-aus/contents/costs-of-de mentia
5. Dementia in Australia, Summary - Australian Institute of Health and ..., accessed October 19, 2025,

https://www.aihw.gov.au/reports/dementia/dementia-in-aus/contents/summary

6. Dementia, Ageing and Aged Care Mission | Australian Government ..., accessed October 19, 2025, https://www.health.gov.au/our-work/mrff-dementia-ageing-and-aged-care-missi on
7. Home Care Package costs and fees | My Aged Care, accessed October 19, 2025, https://www.myagedcare.gov.au/home-care-package-costs-and-fees
8. Staying connected | Dementia Australia, accessed October 19, 2025, https://www.dementia.org.au/living-dementia/staying-connected
9. Dementia in Australia, Burden of disease due to dementia - Australian Institute of Health and Welfare, accessed October 19, 2025, https://www.aihw.gov.au/reports/dementia/dementia-in-aus/contents/deaths-and -disease-burden/burden-of-disease-due-to-dementia
10. National Dementia Action Plan 2024-2034 [Word - Department of Health, Disability and Ageing, accessed October 19, 2025, https://www.health.gov.au/sites/default/files/2025-07/national-dementia-action-pl an-2024-2034\_0.docx
11. National Dementia Data Improvement Plan 2023-2034, 14: Direct and indirect costs of dementia to the Australian economy, accessed October 19, 2025, https://www.aihw.gov.au/reports/dementia/national-dementia-data-improvement -plan-2023-2034/contents/dementia-data-gaps-and-improvement-activities/14direct-and-indirect-costs-of-dementia-to-the-au
12. Dementia Australia - Treasury.gov.au, accessed October 19, 2025, https://treasury.gov.au/sites/default/files/2019-03/360985-Dementia-Australia.do cx
13. Open-Source Health Care Software | Journal of Ethics | American ..., accessed

October 19, 2025, https://journalofethics.ama-assn.org/article/open-source-health-care-software/2 011-09

- 14.
- Open-Source Software in Healthcare: Promise and Precautions for ..., accessed October 19, 2025,

https://journal.ahima.org/page/open-source-software-in-healthcare-promise-and -precautions-for-hi-professionals

15. When Should You Use Open Source Software in Medical Devices?, accessed October 19, 2025,

https://starfishmedical.com/resource/open-source-software-medical-devices/

16. Building and Sustaining Open-Source Medical Device Projects - PubMed, accessed October 19, 2025, https://pubmed.ncbi.nlm.nih.gov/40257876/
17. Guide to ISO Standards for Medical Device Testing - Dot Compliance, accessed October 19, 2025,

https://www.dotcompliance.com/blog/medical-device-manufacturing/guide-to-is o-standards-for-medical-device-testing/

18. Making Open Innovation Ecosystems Work: Case Studies in ..., accessed October 19, 2025,

https://www.businessofgovernment.org/report/making-open-innovation-ecosyst ems-work-case-studies-healthcare

19. Understanding open source governance models - Red Hat, accessed October 19, 2025,

https://www.redhat.com/en/blog/understanding-open-source-governance-mode ls

20. Collaborative Research - Responsible Conduct of Research, accessed October 19, 2025, https://rcr.gatech.edu/collaborative-research
21. 1 Introduction - arXiv, accessed October 19, 2025, https://arxiv.org/html/2509.08553v1
22. Visualizing and Evaluating the Growth of Multi-Institutional Collaboration Based on Research Network Analysis - PMC, accessed October 19, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC4419767/
4. 23.
5. Understanding regulation of software-based medical devices ..., accessed October 19, 2025, https://www.tga.gov.au/resources/guidance/understanding-regulation-software-b ased-medical-devices
6. 24.
7. Applying ISO 13485 to Software for Medical Device Development, accessed October 19, 2025, https://www.bprhub.com/blogs/iso-13485-software-medical-device-developmen t
25. Sociology - School of Social Science - The University of Queensland, accessed October 19, 2025, https://social-science.uq.edu.au/research/sociology
26. The University of Queensland Centre for Clinical Research (UQCCR) - Dementia Australia, accessed October 19, 2025, https://www.dementia.org.au/get-involved/dementia-friendly-communities/deme ntia-friendly-community-groups/university-1
27. Neuro Mental Health - Dissanayaka Group - Centre for Clinical ..., accessed October 19, 2025, https://clinical-research.centre.uq.edu.au/dissanayaka-group
28. Dementia - Centre for Clinical Research - University of Queensland, accessed October 19, 2025,

https://clinical-research.centre.uq.edu.au/research/research-areas/dementia

29. Dementia research at QBI - Queensland Brain Institute, accessed October 19, 2025,

https://qbi.uq.edu.au/brain/brain-diseases-and-disorders/dementia/dementia-res earch-qbi

- 30.
- Digital Health - School of Health and Rehabilitation Sciences - University of Queensland, accessed October 19, 2025, https://shrs.uq.edu.au/research/research-engagement-themes/digital-health
31. Queensland Digital Health Centre QDHeC, accessed October 19, 2025, https://science.qld.gov.au/research/capability-directory/queensland-digital-health -centre
32. Queensland Digital Health Centre (QDHeC), accessed October 19, 2025, https://chsr.centre.uq.edu.au/research/queensland-digital-health-centre
33. Home - GRIDLab - Research - QUT, accessed October 19, 2025, https://research.qut.edu.au/gridlab/
34. Queensland University of Technology - Research Data Australia, accessed October 19, 2025,

https://researchdata.edu.au/contributors/queensland-university-of-technology?m =allsubjects

35. Dr Cody Phillips - Digital Wellbeing Lab - Research - QUT, accessed October 19, 2025, https://research.qut.edu.au/digitalwellbeing/people/cody-phillips/
36. Daniel Johnson - GRIDLab - Research, accessed October 19, 2025, https://research.qut.edu.au/gridlab/people/daniel-johnson/
37. Publications - GRIDLab - Research - QUT, accessed October 19, 2025, https://research.qut.edu.au/gridlab/publications/

38.

Research - Griffith University, accessed October 19, 2025, https://www.griffith.edu.au/griffith-health/school-applied-psychology/research

39. Our Research Groups - Griffith University, accessed October 19, 2025, https://www.griffith.edu.au/griffith-health/school-applied-psychology/research/ou r-researchers/our-research-groups
40. Neuroscience, Ageing and Dementia - Griffith University, accessed October 19, 2025,

https://www.griffith.edu.au/griffith-health/research/healthcare-practice-survivors hip/neuroscience-ageing-dementia

41. Co-designed technologies and people living with dementia: A qualitative systematic review - Griffith Research Online, accessed October 19, 2025, https://research-repository.griffith.edu.au/server/api/core/bitstreams/83327df9-75 16-46cc-92f2-ca3405004c91/content
2. 42.
3. Psychology degrees & courses - study psychology Australia ..., accessed October 19, 2025, https://www.unisq.edu.au/study/degrees-and-courses/health/psychology
43. UniSQ Centre for Health Research | UniSQ, accessed October 19, 2025, https://www.unisq.edu.au/research/institutes-centres/irr/centre-for-health-resear ch
44. University of Southern Queensland Centre for Health Research - Medicare Mental Health, accessed October 19, 2025, https://www.medicarementalhealth.gov.au/provider/university-of-southern-quee nsland-centre-for-health-research-17684
45. UniSC at epicentre of brain, lifestyle and nursing science | UniSC | University of the Sunshine Coast, Queensland, Australia, accessed October 19, 2025, https://www.usc.edu.au/about/unisc-news/news-archive/2025/september/unisc-a t-epicentre-of-brain-lifestyle-and-nursing-science
46. Thompson Institute | UniSC | University of the Sunshine Coast, Queensland, Australia, accessed October 19, 2025, https://www.usc.edu.au/thompson-institute
47. The LEISURE study | UniSC | University of the Sunshine Coast, Queensland, Australia, accessed October 19, 2025, https://www.usc.edu.au/thompson-institute/research-at-the-thompson-institute/ healthy-brain-ageing-program/the-leisure-study
48. Research at the Thompson Institute - Sunshine Coast - UniSC, accessed October 19, 2025, https://www.usc.edu.au/thompson-institute/research-at-the-thompson-institute
49. Research - Department of Psychology, accessed October 19, 2025, https://dornsife.usc.edu/psyc/research-labs-centers-and-faculty-2/
50. Specialised Dementia Care | Anglicare Southern Queensland, accessed October 19, 2025, https://anglicaresq.org.au/services/aged-care/residential-aged-care/dementia-ca re/
51. St Martin's Residential Aged Care Home, Anglicare Southern Queensland, accessed October 19, 2025, https://qfinder2.health.qld.gov.au/HealthServiceProvider/Index/f4d14acf-7637-e61 1-80d2-00505601056f
52. Anglicare SQ Symes Grove Home for the Aged Reviews, Photos & Availability | Caring Co, accessed October 19, 2025, https://www.caringco.com.au/providers/anglicare-sq-symes-grove-home-for-the -aged
53. Annual Reports | Anglicare Southern Queensland, accessed October 19, 2025, https://anglicaresq.org.au/about-us/annual-reports/
54. Aged Care Services | The Salvation Army Australia, accessed October 19, 2025, https://www.salvationarmy.org.au/about-us/our-services/aged-care-services/
55. Chomes - Why Choose Christadelphian Aged Care, accessed October 19, 2025, https://www.chomes.com.au/why-us/
56. Australia's SaMD Regulatory Transition - Asia Actual, accessed October 19, 2025, https://asiaactual.com/blog/australia-software-as-a-medical-device-samd-regula tory-transition/
57. Application instructions: Conformity assessment certification ..., accessed October 19, 2025,
19. https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-d evice/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidenceoptions-medical-device-application/tga-conformity-assessment-certification/ap plication-instructions-conformity-assessment
20. 58.
21. Applying for a Conformity assessment certificate for medical devices ..., accessed October 19, 2025, https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-cer tificate-medical-devices
59. TGA SaMD Regulation Navigation Support - ANDHealth, accessed October 19, 2025, https://www.andhealth.com.au/our-programs/tga-samd
23. 60.
24. ISO 13485 implementation - The complete guide, including a checklist, accessed October 19, 2025,

https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-impl ementation-and-certification-steps/

61. Ultimate guide to the IEC 62304 standard - Qualio, accessed October 19, 2025, https://www.qualio.com/blog/iec-62304
62. IEC 62304 Checklist.pdf - HubSpot, accessed October 19, 2025, https://cdn2.hubspot.net/hubfs/5229980/IEC%2062304%20Checklist.pdf
63. MRFF Dementia, Ageing and Aged Care Mission Implementation plan, accessed October 19, 2025, https://www.health.gov.au/sites/default/files/2023-12/medical-research-future-fu nd-mrff-dementia-ageing-and-aged-care-mission-implementation-plan-mrff-d ementia-ageing-and-aged-care-missi\_2.pdf
64. Archived Grant Opportunity View - GO7589 - GrantConnect, accessed October 19, 2025, https://www.grants.gov.au/Go/Show?GoUuid=af182dac-31e2-4e63-a45d-01bfac

9379b2

65. MRFF 2025 Dementia, Ageing and Aged Care - Research support - The University of Queensland, accessed October 19, 2025,

https://research-support.uq.edu.au/resources-and-support/research-office/resea rch-grants/funding-schemes/medical-research-future-fund/mrff-2025-dementia

-ageing-and-aged-care

66. MRFF 2023 BioMedTech Incubator - Dementia and Cognitive Decline Grant Opportunity | business.gov.au, accessed October 19, 2025, https://business.gov.au/grants-and-programs/mrff-2023-biomedtech-incubatordementia-and-cognitive-decline

67.

Aged care and support services available to people with younger onset dementia

- Australian Institute of Health and Welfare, accessed October 19, 2025, https://www.aihw.gov.au/reports/dementia/dementia-in-aus/contents/younger-on

set-and-childhood-dementia/aged-care-and-support-services-available

68. 5.7 Getting services - National Disability Insurance Scheme - Forward with Dementia website, accessed October 19, 2025, https://forwardwithdementia.au/article/getting-services-ndis/
69. National Disability Insurance Scheme (NDIS) support | Dementia ..., accessed October 19, 2025,
3. https://www.dementia.org.au/get-support/national-disability-insurance-schemendis-support
70. Direct health and residential care costs of people living with dementia in Australian residential aged care - PubMed, accessed October 19, 2025, https://pubmed.ncbi.nlm.nih.gov/29292541/
71. Direct health and residential care costs of people living with dementia in Australian residential aged care - PMC, accessed October 19, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC6032872/