NSW Medical Devices Fund

Commercial in Confidence

NSW Medical Devices Fund

Round 5, 2017-18

Full Application

(Invitation Only)

General instructions

Application Form and attachments

·  Please answer the questions using the text boxes provided and limit your responses to the stipulated word/page limit.

·  The questions within the application form are to be used as a guide for answering each section, except for the tables in the Risk Management & Corporate Governance and Financials sections. These tables must be completed and incorporated as part of the page limit for those sections.

·  Please provide the relevant attachments highlighted in the application form only.

·  Ensure that the declaration is signed by an authorised representative of your organisation. This declaration makes reference to the NSW Medical Devices Fund Standard Terms and Conditions that need to be reviewed by an appropriate person within your organisation. A copy of these Terms and Conditions will be sent to you by OHMR prior to submitting your full application.

How to submit your application

Please submit one copy of the application electronically and ten physical copies, along with the USD drive containing your video submission.The Office for Health and Medical Research requires all hard copies to be formally lodged (i.e. in person, signed courier or registered post).

Hard copies should be sent:

By mail to: OR In person or by courier to:

Ms Anne O’Neill Ms Anne O’Neill

Director Director

Office for Health and Medical Research Office for Health and Medical Research

NSW Ministry of Health NSW Ministry of Health

LMB 961 73 Miller St

North Sydney NSW 2059 NORTH SYDNEY NSW 2060

The electronic copy should be emailed to:

Please ensure physical copies are double-sided, hole punched, clipped, but NOT stapled or bound.

Application Checklist

☐ Application Form filled in

☐ Market Research attached

☐ Features and Benefits of device versus competitors table attached

☐ Financial statements for FY2014/15, FY2015/16 and FY2016/17 attached (for Companies only)

☐ Management team resumes attached

☐ Relevant Peer reviewed journals attached

☐ Independent testing reports attached

☐ Risk Assessment attached

☐ International Search Reports for patents attached

☐ Project team resumes attached

Indicative Program Timeline

Please note, dates are subject to change

Application Form

Briefly describe your medical device in lay terms. This will potentially be used for media releases, brochures and OHMR website. (200 words)

1.  Commercial Case

a.  Market (1 page)

Describe the relevant political, economic, social, technological, environmental and legal factors that have recently influenced the market for your device.

What is the Total Accessible Market for your device?

Please provide your main assumptions and attach any evidence for your claims.

Which parts of the market are experiencing the biggest growth?

Describe the competitive environment for your device.

What are the key elements of your competitive advantage?

Please attach to this application a table that summarises the key features and benefits of your device versus your competitors.

Who is your biggest threat and how will you differentiate yourself from them?

Are there any other innovative aspects of your product/service offering (apart from your device) that will help differentiate your product in the market?

b.  Business Model (1 page)

What is your business model for offering the device to the market?

Are you planning to sell your device with a direct sales force or through a distributor? Please explain the reason for this choice.

What will be your main challenges in accessing customers?

What is your pricing strategy?

What Gross Margin do you expect for your device and how will you manage this through the product lifecycle?

What measures have you taken to strengthen your business model/market offering to ensure it is more sustainable?

Describe the steps that you have taken to ensure that the device, the way it is manufactured and the associated commercial structure can easily scale to service a global market?

c.  Management Team, Commercialisation, Funding and Exit Strategy (1 page)

Provide an overview of the management team, their roles, relevant experience and any previous experience they have had working together.

Please attach a one page CV for each of these team members.

Identify and describe the three biggest challenges for the commercialisation of this device.

What other key non-project commercialisation activities will be performed over the next three years and how they will be funded?

Are you considering accessing other Government funding over the next three years? Please specify.

What is your fundraising strategy over the next five years?

What is your exit strategy for the business?

d.  Risk Management and Governance (1 page)

Provide an overview of your key business risks using the following table:

What is your ownership structure?

Do you have a Board of Directors or Advisory Board? How often do they meet?

Describe who is on the Board, what are their roles and their experience?

Are there any legal proceedings that you are aware of involving an employee, director or investor that may have an adverse effect on the reputation of your company?

How often do you have shareholder meetings?

Is there a clear separation between the Board and the operations of the Company?

NB: For research organisations (e.g. hospitals, universities) – what structures are in place to manage the project separate to the day to day operations of the organisation?

e.  Financials (for companies only) (1 page)

Provide a summary of your historical and forecast financial performance using the following table:

Please use amounts in units of $1000’s

What have been the key drivers of the Company’s Profit and Loss over the last 30 months?

What are the main assumptions that underpin this Profit and Loss forecast?

What have been the key drivers of the Company’s cash flow over the last 30 months?

What are the main assumptions that underpin the cash flow forecast?

Please attach to this application your Balance Sheet and Profit and Loss statements for FY2014-15 and FY2015-16 and FY2016-17 (as at 31/12/16).

2.  Medical Device (4 pages)

What are the key innovative aspects of your device?

Please attach any relevant peer reviewed papers with this application

Does the device leverage any technological drivers (e.g. Moore’s Law) and how will these help with creating subsequent generations of this device?

What do you expect the product lifecycle for this device to be and what plans have you made to prolong the lifecycle?

What is your product development plan for this device?

What level of independent testing has been conducted on your device in terms of verification and validation?

Please attach results of this testing to this application.

Is the device using any components/technology platforms that are well tested in the end user environment?

Has a Device Risk Assessment been performed? Please summarise the main findings.

Please attach the results to this application

What is the regulatory approval strategy for your key geographical markets? This should include a hazards analysis and the proposed clinical pathway and route to market.

Have you identified and recruited key opinion leaders and luminary sites from around the world for clinical validation and subsequent trials?

What do you expect the regulatory approval status for your device to be by the end of this project?

Describe how robust the key elements of your IP portfolio are in your target geographical markets and provide evidence based on feedback from global patent and trademark offices

Please attach International Search Reports and other relevant documentation to substantiate your claims with this application

Describe any key patents or trademarks owned by competitors that will affect your freedom to operate in your chosen markets and how you will respond to this challenge?

Describe the ownership status of your IP? Have you licenced any IP or have patents been acquired from another organisation?

Are there plans in place to sell/on-licence any IP following potential success of your device?

How will the key inventors be incentivised to continue with the development of the device?

Who are the key inventors and what % contribution have they made to the IP Portfolio?

3.  Project (3 pages)

What are your key project activities?

How will this project address your three big challenges for commercialisation?

Provide a description of each member of the Project team (internal and external), their roles and any relevant experience they have. Please attach a 1 page CV for each team member.

What approaches will be used to manage this Project successfully? e.g. Gantt chart, project meetings, collaboration software etc.

What are the biggest project risks, and how will these risks be managed?

What are your project milestones?

Please provide a detailed project plan.

Project Budget: Please provide a project budget that identifies the line items with a description, the nature of the expense (e.g. labour, equipment, consultant, testing by an external lab etc) and the cost of the item.

Will the project involve any Interaction with Health Organisations? Please specify.

4.  Health and other benefits (4 Pages)

What is the clinical relevance of your device for NSW/Australia/Globally? Please include evidence of claims

Provide a detailed description of the target patient population, the size of the population and the impact the device will have on them.

What are the requirements of potential patients and health professional for your device?

How does your device integrate with established health system infrastructure, systems and resources currently in use in NSW and elsewhere?

Describe what impact the device will have on:

a.  clinical practice and

b.  the health system

Have you conducted any health economics analysis on the device (cost-minimisation, cost-effectiveness, cost-utility and cost-benefit analyses)? If so, please provide detail.

What is your reimbursement strategy?

Is there a possibility that your device will be supported and/or mandated through medical guidelines? What is your strategy to achieve this outcome?

Provide a detailed description of the economic, social and environmental benefits of the device.

CEO/Vice Chancellor/Director’s Declaration

I ______(Name of Director/CEO/Vice Chancellor or delegate) from ______(name of applicant organisation) declare that the information provided in this application form is true and correct. I understand that this application may be circulated to third parties as required by the secretariat or the MDF Expert Panel. I provide consent for the primary contact details and lay description of the device (non-commercial in confidence), along with a brief summary of the project to be forwarded to third parties so they may make contact if they can assist.

Position: ______

Signature: ______

Date: ______

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