9 September, 2022

Clinical Translation & Commercialisation Medtech (CTCM) Program – Round 2

Newsletter | September 9, 2022

MTPConnect’s Clinical Translation and Commercialisation Medtech (CTCM) program is a funding opportunity offered under the 2020 Early Stage Translation and Commercialisation Support Grant of the Medical Research Future Fund’s Medical Research Commercialisation Initiative.

The $19.75 million CTCM program is a four-year initiative which will identify and nurture high-quality medical device projects that have commercial potential and support their translation through early clinical trials.

By supporting the development of innovative medical devices, the CTCM program aims to improve the health and wellbeing of Australians, while also helping projects to generate commercial returns and create high-paying jobs in the medical products sector.

For the purposes of this grant opportunity, medical devices are defined by section 41BD of the Therapeutic Goods Act 1989 and further informed by the Therapeutic Goods (Articles that are Medical Devices) Specification 2014. You should refer to this definition for any regulatory purpose, including preparing your application. In summary, medical devices are defined as:

are used for humans
are hardware innovations intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body
generally achieve their purpose by a physical, mechanical or chemical action. Round 2 applications will be assessed in a multi-step process:
- Phase I: non-confidential Expressions of Interest (EOI)
- Phase II: consultation interview via videoconference
- Phase III: Full proposal Activities supported will include, but are not limited to, product development and testing, clinical trial activity and regulatory support.

Ideas and concepts, with no technical validation at the time of application, and preclinical studies, are out of scope for this funding. Projects to develop research tools (e.g., databases or animal models) in isolation are not eligible. Non-human health programs are not eligible.

There must be evidence of experimental research that has been undertaken that validates the problem or the potential of the product/solution.

The applicant must demonstrate understanding of the market/end-user.

TIMELINE

EOI Open: Friday 9th September 2022
EOI Close: Friday 7th October 2022
EOI Outcome: Late Nov 2022
Consultation: Late Nov 2022 to Mid Jan 2023
Consultation Outcome: Early Feb 2023
Full proposal application: Early Feb 2023 to Early Mar 2023
Full proposal outcomes: Late Apr 2023
Contracting: Early May 2023 to Late Jun 2023
Funding term: On contract execution (24months)

WHO CAN APPLY?

For a proposal to be deemed eligible for CTCM Project Funding it must meet the following criteria:

The lead applicant must:

be a registered Australian based business
be incorporated in Australia
have an Australian Business Number (ABN).
have less than 200 employees.
Demonstrated capacity to match the co-contribution requirement.
The applicant’s project must involve the development of a medical device.
The applicant must provide evidence of technical and/or commercial feasibility of their product.
The applicant must control or have the legal right to access and use the relevant know-how and/or existing and/or potential intellectual property (IP), that will be necessary to undertake the proposed activities of the Research Project and to translate, implement or commercialise their product(s)/solution(s).
Applicants must meet any applicable timing, formatting, system or other similar administrative requirements from MTPConnect during the application process.

It is understood that the lead applicant may not be the group manufacturing the device prototypes or final product design. To accommodate this scenario, partnerships and collaborations with Australian medical device manufacturers are allowed. A partner is not a mandatory requirement and is not considered an advantage or a disadvantage.

If a manufacturing partner is named, that partner must satisfy the following eligibility criteria. The partner must:

be an Australian registered business
be incorporated in Australia
have an ABN
establish and operate the manufacturing facility in Australia
be ISO13485 accredited, achieve accreditation within the project activity period, or operate a quality management system aligned to ISO13485.

Other partner organisations can include, but are not limited to:

universities
medical research institutes
clinical organisations or health care providers
health systems
consumer groups
private research entities
commercial entities
not-for-profit organisations
other end-users.

A partner or collaborator is not required to provide an additional matched cash co-contribution; however, any cash or in-kind co-contribution will be considered favorably.

FUNDING AVAILABLE

Funding of between $250,000 and $1.5 million is available per project across two funding rounds (FY2022 and FY2023).

FUND OBJECTIVES

The Clinical Translation and Commercialisation – Medtech Program aims to support early clinical development of medical devices with commercial potential.

While product development, manufacture and testing will be considered eligible activities, all projects must include clinical testing of devices.

The Clinical Translation and Commercialisation – Medtech Program will:

Deliver consultation and commercialisation advice to guide project development and assessment
Facilitate access to broader NCRIS and other critical engineering, fabrication and prototyping facilities to accelerate translation of early-stage discoveries
Emphasise collaboration, partnering and consultation to nurture the next generation of health and medical research innovators and provide ongoing SME education
Employ a process of continuous evaluation, based on established commercial principles, to optimise the potential for project success and maximise return on investment.

WHAT WILL BE FUNDED?

Examples of eligible expenditure include, but are not limited to:

project consumables directly attributable to the delivery of project outcomes
salaries (whole FTEs or fractional) directly attributable to the delivery of project outcomes. The maximum salary claimable per person, including packaged components (superannuation) is limited to $175,000 per financial year. On a case-by-case basis, where it can be adequately justified, CTCM funding may support salaries greater than $175,000 per financial year
Commonwealth funded positions can be considered eligible to count towards an in-kind contribution. However, the Commonwealth funded position cannot also draw a salary from funds awarded through this grant opportunity for the same activity
labour expenditure for leadership staff (e.g., founder, CEO, CSO, CMO) is considered eligible, provided there are direct, demonstrated and monitored links to project objectives and outcomes. Salaries for leadership staff will be limited to 10 per cent of the total amount of eligible labour expenditure claimable per person (i.e., maximum $17,500). On a case-by-case basis, where it can be adequately justified, CTCM funding may support leadership salaries greater than $17,500 per financial year
labour on-costs are eligible. Examples of labour on-costs are employer paid superannuation, payroll tax, workers compensation insurance and leave entitlements (including paid maternity leave, sick leave, long service leave and recreation leave). These costs must be reasonable, appropriate and separately identified in the project budget
accessing specialist professional services including regulatory consultants, manufacturing and product development firms, clinical research organisations, technology evaluation, process evaluation, key opinion leaders or strategic stakeholders
accessing IP expertise as a service, freedom to operate search costs and provisional and PCT
drafting and filing costs (or costs associated with comparable stages of IP protection e.g., trade marks, designs, copyright circuits etc.)
access to specialist equipment, hardware and software essential to the research
purchase of equipment that is essential to research capped at $80,000 in total. Justification for purchase and why the applicant(s) cannot support the expense must be provided
prototyping and development of a Minimum Viable Product
market research/testing and engaging with major customers and end-users including clinical trials
data procurement and efforts to obtain regulatory approval
international activity expenditure where it can be justified that this work cannot otherwise be performed in Australia and is critical to the success of the project. If proposed international activities and expenditure exceeds 10 per cent of the total CTCM project funding (grant funding plus co-contribution), the Department of Health must provide its approval (which will be managed by MTPConnect)
essential travel within Australia directly related to project activities
essential travel overseas on a case-by-case basis directly related to project activities

More Information

For further tips for lodging your Clinical Translation & Commercialisation claim,
Give us a call or schedule an assessment

Services
Ryan can assist with services such as:

Scope your potential to claim various grant programs
Assist with the preparation and lodgement of grant applications
Review or provide a health check on your internally prepared grant applications
Establish record-keeping practices as required under various grant programs
Provide prepayment loans against future cash refunds under the R&D Tax Incentive
Keeping industry informed on all new Government policy and grant initiatives

Don’t hesitate to give us a call or schedule a free assessment.

Clinical Translation & Commercialisation Medtech (CTCM) Program – Round 2