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ANDHealth+ Applications CLOSED.

ANDHealth+ is the leading digital health commercialisation program in Australia, with a proven track record of scaling digital health businesses across a broad range of clinical and commercial metrics.
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ANDHealth+ is funded by the Australian Government under the Medical Research Future Fund Early Stage Translation and Commercialisation Support Program, with the intent of delivering a measurable impact on the selected SMEs’ ability to deliver new treatments or products to Australian patients, to undertake and provide access for more Australians to clinical trials, and to engage the clinician and patient community in embracing the potential of digital health and to the commercialisation and expansion of Australian digital health SMEs.

ANDHealth+ supports proof-of-concept stage, evidence-based digital health SMEs, which meet the MRFF definition of digital health as follows:
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‘technologies that use computing platforms, connectivity, software and sensors, either alone or in combination with physical products, to treat,

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diagnose, cure, mitigate and/or prevent disease or other conditions. Does not include digital health records, secure messaging, ePrescribing and other national digital health infrastructure.’

‍ANDHealth+ has a successful track record in taking businesses to scale, with the 10 companies selected in the pilot ANDHealth+ program raising over $70 million in funding, creating 296 jobs, undertaking 44 clinical studies and impacting over 200,000 patients in just four years.
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The program will open to applications annually with a new cohort selected each year on a competitive basis. SMEs who meet the eligibility criteria and complete the application requirements are assessed via a proven assessment and selection process, with five (up to a maximum of seven) SMEs selected each year.

Selected SMEs will share in up to $3.75M of project funding per intake from the ANDHealth Digital Health Accelerator Fund alongside substantial in-kind services from pre-vetted suppliers and a dedicated ANDHealth support team providing hands-on support to undertake project activities, procure specialist expertise and meet agreed milestones.

Program Overview

ANDHealth+ is not a grant program. ANDHealth+ is a commercialisation acceleration program, in which participants work with ANDHealth and an industry team of experts to drive growth in their business, with two stages of project funding made available through the ANDHealth Digital Health Accelerator Fund.

Successful applicants will be selected via a proven competitive process informed by a cross-section of multi-sectoral industry leaders with experience in evaluating and selecting high potential SMEs. Five SMEs will be selected each year (up to a maximum of seven in any one year), from FY2022 to FY2025.

Project engagements will run and be supported by dedicated and specialised ANDHealth staff, enabling SMEs to undertake pivotal activities such as clinical trials and real world commercial and clinical validation studies.

With support from ANDHealth and industry advisors, each SME will then prepare a project plan designed to deliver maximum impact utilising a combination of cash and in-kind services over two stages spanning 18 months. Key milestones and go/no-go points will be defined within each stage.

Funding and support will be provided to eligible activities that will significantly improve the applicant’s ability to commercialise, raise growth capital and/or execute on a market entry or growth strategy.

ANDHealth+ Projects

An Industry Advisory Panel (IAP) will be appointed for each cohort company, based on the specific requirements and optimal endpoints/outcomes for that SME with specific consideration given to ‘de-risking’ the company from the point of view of professional investors and enterprise customers.

In consultation with their dedicated ANDHealth support team and IAP, selected SMEs will design two interrelated projects designed to accelerate their progress on the commercialisation pathway:

Stage 1 (Duration 3-4 Months): Activities will focus on identifying key risks and addressing them using third-party expertise and the expertise of each company’s IAP.

Stage 2 (Duration 8-10 Months): Activities will focus on achieving key clinical and commercial milestones which will drive institutional investment and/or enterprise customer uptake.

Benefits to Applicants

✓ Direct access to the project funding, specialised expertise and ‘hands on’ resources needed to prove the clinical and commercial efficacy of your solution and accelerate your commercialisation, investment and growth outcomes.

✓ Multi-sectoral Industry Advisory Panel (IAP) of experts dedicated to your company.

✓ Access to an International Investment AdvisoryCommittee (IIAC), comprising internationally recognised investors, clinicians, founders and executives from a diverse range of digital health businesses.

✓ Facilitated deal flow days with selected investors and customers (national and international) to inform stage 2 project plans and company growth strategy.

✓ Facilitated introductions to national and international networks of investors, global healthcare and technology companies and specialised service providers alongside participation in events, conferences and facilitated programs specific to evidence-based digital health companies.

✓ Significant in-kind support from vetted suppliers, ANDHealth members and partners.

✓ Project management support from ANDHealth so that you can focus on your whole business while meeting the project milestones.

✓ No Equity Requirements: ANDHealth+ does not require any equity in consideration for participation.

✓ No Intellectual Property Transfer: ANDHealth does not assume any ownership of or require any royalties from intellectual property (IP) in the project.

✓ Cohort and Alumni only events, access to international experts, involvement in ANDHealth policy initiatives and promotion across the Australian healthcare landscape.

ANDHealth+ Alumni Case Studies

ANDHealth is extremely proud of the success experienced by our graduating cohort companies of FY2018 and FY2019. Their growth is indicative of the enormous untapped economic and healthcare impact potential of our nascent digital health sector.

Click on the links below to read about what our ANDHealth+ alumni has achieved.
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• Dose Me
• AllergyPal
• Atmo Biosciences
• Perx
• Seer Medical
• SkinView
• CancerAid
• Health Delivered
• Kesem Health
• Vitalic Medical

How to Apply

• Read the instructions and information on the website: https://www.andhealth.com.au/our-programs/andhealth
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‍•Register to attend an ANDHealth+ information session.

• After confirming your eligibility and attending the information session, book your 1-1 pre application consultation with the ANDHealth team here.

• Apply by submitting an application that addresses the eligibility and selection criteria and uploading all requisite attachments to the online application portal Gust : Apply here.
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• ANDHealth Lean Canvas template is available in Gust.
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• Letter of Board Support template is available in Gust.
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• Cohort Company Expectations document is available in Gust.

• Submit your completed application with all accompanying attachments via the online application portal by midday AEDT 11 October 2021.

Entities must:
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• Be an Australian SME i.e. a registered Australian corporate entity[1] employing no more than 199 employees[2] (SME) and be able to demonstrate that they are authorised to use any IP required to perform the project
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• Meet ASIC thresholds for small business including consolidated revenue of less than A$50M and/ or consolidated gross assets of less than $25M at the end of the previous financial year[3]
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• Have a minimum of one full-time employee engaged in the business. Preference will be given to applicants which can demonstrate sufficient management capacity and capability to effectively engage with the depth and breadth of the ANDHealth+ program
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• Have sufficient resources to service and complete the program and associated project plans (operational runway, time, resources, headcount). It is important to note that ANDHealth+ allocated funds are applied to direct project costs only and not the day-to-day operations of the participant’s business.

• Will report on requisite outcomes data and other reporting metrics requested by ANDHealth as required for three years beyond completion of the program.

Proposed technologies and projects must:
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• Meet the definition of “digital health” as outlined in the MRFF 2020 Early Stage Translation and Commercialisation Support Grant Opportunity Guidelines i.e. ‘technologies that use computing platforms, connectivity, software and sensors, either alone or in combination with physical products, to treat, diagnose, cure, mitigate and/or prevent disease or other conditions. Does not include digital health records, secure messaging, ePrescribing and other national digital health infrastructure.’

• Involve a product/service/technology which has reached or substantially demonstrated Proof of Concept/Proof of Principle

• Be evidence-based with a clear focus on improving patient outcomes.

‍Applicants must submit a fully completed application with all requisite attachments/uploads.

‍*Note: The ANDHealth+ Program has been designed primarily for ‘for profit’ enterprises. Whilst non-profit enterprises may be eligible to apply (assuming they meet other eligibility criteria), they will need to clearly articulate how their participation in ANDHealth+ will be ring-fenced from their ‘business as usual’ activities and how impact of the program and any funded activities will be captured and reported.

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[1] See https://asic.gov.au/for-business/small-business/#what for Corporate Entity structures
[2] MRFF 2020 Early Stage Translation and Commercialisation Support Grant Opportunity Guidelines. Page 27
[3] https://asic.gov.au/for-business/small-business/#what

Consideration will be given to:
• Extent to which the product delivers value through improved diagnosis, prevention, treatment, mitigation and/or management of chronic and acute conditions for the benefit of the patient.

Demonstrated understanding of the end user(s) and how they will interact with the product, including:
• Description of how the solution fits within clinical workflows and/or typical patient journeys.
• Differentiation between the user(s), payers and beneficiaries
• Evidence of Voice of User.

Uniqueness:
• Clear articulation of competitive position and product advantage.

Maturity of the technology, including:
• Technical: evidence of proof of principle/concept use in the clinical or market setting is detailed; where applicable, access rights to key data required for operation are outlined (e.g. AI/ML training data).
• Strategy for patient data privacy and security.
• Clinical: level of product evidence including clinical trials and technical certification.
• Regulatory: consideration of regulatory strategy including identification of TGA regulatory classification.
• Traction: use of the product in a clinical or market setting.
• Scalability: consideration of barriers to scalability, such as required integrations, and extent of stakeholder identification and engagement.

Market and business case, including:
• Feasible business model.
• Articulation of value proposition to identified payers.
• Evidence of market appetite, including Voice of Paying Customer evidence.
• Size of market and pathway to market.
• Intellectual property strategy and position.
• Barriers to market entry.

Team, including:
• Business skills.
• Technical skills.
• Track record and ability to achieve market uptake.
• Diversity and inclusion: evident diversity in the advisory board, board, management team and a feasible strategy for maintaining/ achieving diversity.

Proposed Projects:
•Extent to which the proposed projects will positively affect clinical and commercial readiness of the project.

Preference will be given to companies who can demonstrate significant understanding of the complexity of the challenges of commercialisation of digital health.

All applications must be lodged through the online platform Gust, accessible here.

Before lodging your application, follow the steps below:
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1. Interested applicants should register for an information session here.
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2. Once eligibility is confirmed and you have read the information on the website and attended the information session, applicants are encouraged to book a pre-application consultation appointment here with an ANDHealth team member to discuss your proposed application and specific questions via the ANDHealth website, this will be released after the information session.
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3. The application consists of application questions, a proposed project outline, and upload of four attachments:
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   • Investor Pitch deck
   • ANDHealth Lean Canvas
   • 3-5 Year Financial Model
   • Letter of Board support (in the event that the applicant does not have a board, an option will       be made available for a letter from the CEO)
   • All applicants must articulate two projects (see ANDHealth+ Types of Projects tab) for which participation in the program will improve the likelihood of securing investment and/or substantially progress market entry.

4. To submit the application, applicants must also read and agree to the cohort company expectations document which is found on Gust.

5. Applications are assessed by the highly experienced ANDHealth team and ANDHealth Industry Selection Panel.

6. Top 10 applicants will undertake a 60 minute presentation and interview with the Industry Selection Panel.
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7. The International Investment Advisory Committee (IIAC) will review and ratify the Industry Selection Panel’s recommendations for successful applicants.

8. Successful applicants will be notified. All unsuccessful applicants are provided with written feedback specific to their application.
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Proposed Projects should focus on the development of clinical and/or commercial evidence to significantly improve the project’s ability to commercialise, raise growth capital and/or execute on a market entry or growth strategy.

‍Two sequential projects will be supported with relevant milestones and go-no points defined within each.

Stage 1 (duration 3-4 months):
‍Activities will focus on identifying key risks through a ‘working backwards’ model and, where possible, addressing them using third party expertise and the expertise of each company’s IAP. Outcomes of Stage 1 activities and the Stage 1 Investor & Customer Deal Flow Days will be used to inform Stage 2 project activities.
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Stage 2 (duration 8-10 months):
Activities will focus on achieving key clinical and commercial milestones which will drive institutional investment and/or enterprise customer uptake. Project activities will be focused on significant pieces of work which will have a clear and demonstrable impact on the growth trajectory of each cohort company.
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‍Note: Stage 2 projects will be subject to review by the IIAC and it is expected that some companies may not progress to stage 2.
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‍Eligible activities include but are not limited to:

Product Development
• Product Verification and Validation
•End-User Studies
•UX/UI development to drive improved clinical outcomes
• Intellectual property strategy
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Clinical Developments and Outcomes
• Clinical Trial Planning and Protocol Design
• Clinical Trial/Study Design and Execution
• Clinical Trial Data Analytics
• Efficacy in a clinical or industry setting
• Voice of End-user(s) in clinical settings

Manufacturing
• Manufacturing assessments
• Designfor Manufacture
• Scaleup Manufacturing plans
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Commercial Strategy, Evidence and Outcomes
• Go-to-Market Planning
• Voice of Paying Customer Studies
• Commercial Pilot Programs
• Health Economics Assessments
• Business Validation in End User Settings
• International Market Strategy
• Health Data and Independent Market Intelligence
• Business and Financial Modelling

Regulatory and Reimbursement
• Independent Regulatory Strategy and Audits
• Regulatory Certification or roadmap to certification (eg,TGA, FDA)
• Reimbursement and Pricing Strategy, Verification and Audits
• Cybersecurity
• Data collection, storage, security and privacy
• Quality Management Systems planning
• Multi-jurisdictional compliance planning

‍Ineligible activities include expenses not directly related to the projects approved within the ANDHealth+program. ‘Business as usual’ operations will not be supported.

Ineligible activities include (but are not limited to):
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• General and administration costs for day-to-day business expenditure
• Non-related staffing or contracting costs including the time commitment of applicant’s staff to supporting project activities
• Ongoing software and hardware development
• Marketing and branding costs
• Fees paid to incentivise customers to use/ purchase your product or services
• Costs of non-project specific travel and associated quarantine/ medical costs
• Fees to government agencies such as ASIC.

‍This is not a grant program. Project funds approved by the ADHAF are managed and paid directly to third-party suppliers by ANDHealth on behalf of successful applicants where possible. In certain situations, project funds may be paid to participating companies directly for expenditure on agreed outcomes. Participating companies will be required to provide verification of expenditure upon request by ANDHealth.

‍Please note: Third-party activities supported by ANDHealth+ and financed by the ADHAF are carried out via a competitive tender. The tender process and contracting are supported by the applicant’s ANDHealth project support team. Within the application, applicants should focus on outlining the proposed activities and targeted outcomes, rather than including specific proposals from third-party providers.

ANDHealth may determine that expenditure is ineligible and not directly related to the specific project at its discretion.

Can I talk to someone about the program and my application

Yes. Once you have confirmed eligibility and attended an ANDHealth+ information session, you can book a 30 minute meeting with the ANDHealth+ team to discuss your application.

Who is on the selection panel?

ANDHealth primarily utilises the expertise of its multi-sectoral members, alongside its extensive international digital health network, to ensure that all selection panels are comprised of C-Suite executives with proven expertise and demonstrable track records in commercialising digital health products and services.

When do I find out if I am shortlisted or successful?

We anticipate applicants will be advised if they have been successfully shortlisted by November 2021, with final outcomes advised prior to the end of December 2021.

What happens to the information I submit?

All information collected by ANDHealth programs is subject to the ANDHealth Data Collection Policy. Application specific information is treated as commercial in confidence. All members of selection and advisory panels and committees operate under direct confidentiality agreements with ANDHealth.

What is the right stage for ANDHealth+? What is too early or too late?

Companies should have a working prototype, or ideally a product which is well progressed that have achieved proof of concept/proof of principle. Some customer traction or pilot activity should have been undertaken or in progress. Your company should have at least 1 FTE (with preference given to those with a full-time core team) and have the resources to complete the two stage project plan (operational runway, time, resources, headcount).

Who are the Industry Advisory Panel?

The Industry Advisory Panel for each cohort company will be different and tailored for each cohort company according to their specific needs. ANDHealth is rigorous in their selection of panel members to ensure they consist only of individuals with a proven track record in their specialised area contributing to the commercialisation of digital health. All can demonstrate real-world experience in their area of expertise.

Who is the International Investment Advisory Committee (IIAC)?

The IIAC comprises internationally recognised investors, clinicians, founders and executives from a diverse range of digital health businesses. The IIAC receive combined recommendations from selection panel and ANDHealth team and provide expert advice and input into project plans and investment amounts at both stages of the program. You can learn more about the IIAC, including its members, here.

Do you fund clinical trials?

The program will fund clinical and commercial studies where the endpoints articulated are considered to be highly relevant to the company’s successful commercialisation of its technology. “Types of Projects” link outlines the types of eligible projects activities that are expected be undertaken through ANDHealth+ based on prior experience.

What is the ANDHealth Digital Health Accelerator Fund (ADHAF)?

The ADHAF deploys the funding for the approved ANDHealth+ projects through a rigorous investment approval and governance process. All funding disseminated to applicants is subject to approval by the International Investment Advisory Committee and the ANDHealth Board.

When does my company receive the money?

This is not a grant program. Most, if not all funds, will be issued to third party providers to deliver services on your behalf. The allocation of funds and the selection of providers will be done in consultation with your company, ANDHealth, and the Industry Advisory panel. Any allocation of funds by the ADHAF will be subject to the approval of the ANDHealth Board. ANDHealth+ does not fund ‘business as usual’ expenditure and applicants must ensure they have sufficient runway and resources to fully participate in the program.

Will there be more intakes of ANDHealth+?

There will be four intakes to the ANDHealth+ program in FY2022, FY2023, FY2024 and FY 2025 with 5 companies accepted into each intake (up to a maximum of seven per intake).

What is the IP policy for ANDHealth+?

ANDHealth was founded on a core principle of ensuring SME intellectual property remains solely under the ownership and control of each participating company. ANDHealth and its members retain no legal rights, liens or rights of first refusal over any participating SME’s technology. Instead, we work closely with companies to both protect existing IP and create and protect new IP as a consequence of their participation in our programs. Companies accepted into ANDHealth+ execute an ANDHealth+ Participant Agreement. This agreement acknowledges that all SME background IP and Project IP flows to the participant company.

Do you accept university and industry spin outs?

SMEs/spinouts from universities, research institutions and industry that meet the eligibility criteria are welcome to apply. Where such spin-outs still lean heavily upon the resources of the parent entity or major shareholder, similar to non-profit enterprises, such entities will need to clearly articulate how their participation in ANDHealth+ will be "ring-fenced" from parent company/ shareholder ‘business as usual’ activities and how impact of the program and any funded activities will be captured and reported.

If at least 1 person is to be full-time, can funding be used towards a basic salary?

ANDHealth+ is a time-intensive program and is designed to fund high impact activities which accelerate the path to commercialisation, over funding ‘business as usual’ operational expenditure. The selection panel will be looking for companies that can support their day-to-day operations whilst the program is investing in high impact growth and commercialisation activities to accelerate growth.

Can funding be used to cover the costs associated with IP protection, patent lodgment etc.?

If the IP strategy is part of your approved project activities, then some IP related costs can be covered. For example, in many cases, the program can get you access to IP advice from firms and IP professionals with experience in supporting digital health technologies and companies. However, the program is not able to fund the direct cost of patent/registration fees and licences, which are deemed ineligible expenditures within the MRFF funding guidelines.

We already have MRFF funding, can we still apply?

Yes, however you cannot ‘double dip’ on activities already funded under an MRFF grant agreement. All ANDHealth+ program activities will need to be clearly separated from activities funded under other MRFF funding streams.

If we specify project activities in the application, can these change if we are successful in being selected (once we have advice)?

Yes. In our pilot program, this happened more often than it did not. After intensive reviews of application material and several meetings between you and your Industry Advisory Panel, you will likely receive feedback on project activities that the IAP believe will result in the highest impact for your business from the funds available to you. All project activities are jointly agreed upon and supported by you, your Industry Advisory Panel and the ANDHealth+ team – with a view to achieving the best outcomes for your company.

Is the program suitable for SME’s located outside of Melbourne?

ANDHealth is a national organisation with staff currently based in Queensland, New South Wales, Victoria and Western Australia. ANDHealth+ is a program that is designed to be delivered virtually, Australia-wide. All Australian SMEs which meet the eligibility criteria are encouraged to apply.

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