Services for Participants - Flinders University to Participants... · We provide design related services from concept generation ... resource or working with their in-house design

Services for Participants MDPP participants can access the following offers by contacting any of the service providers below.

Note: the following list is provided in good faith. However, MDPP does not endorse the services of these providers or accept liability for any

third party’s use or reliance on these service providers.

BUSINESS DEVELOPMENT

LeMessurier Solutions - refer to Government Grants section below

The Black Tree The Black Tree is a privately owned management consulting business specialized in MedTech, Life Sciences and Medical Devices. It is a sole tradership by Dirk Beelen.

Consulting services:

We focus on business management, commercial management, strategic business development, and market development, in both the services as well as the goods industries.

Interim Management:

We provide short and medium term managerial solutions for situations where a permanent hire of an experienced executive would not be a viable or realistic solution. Typical assignments could be: peak workload support, managing the organization towards a structure ready for growth, ad hoc replacements or support to ensure business management continuity, etc.

Dirk Beelen has 20+ years of MedTech, Life Sciences and Medical Devices experience as a senior business management executive in small start-ups as well as in blue chip listed companies (Johnson and Johnson Inc, CR Bard Inc).

His added value:

- overseas business management

- successful introduction of new medical technologies and medical devices

- organizing market feedback on R&D projects and prototype products

- experience in market assessments, feasibility studies, business cases

- managing start-ups from pioneering level to a state of the art company

- value and profit generation by optimal product positioning

MDPP participants will receive: Consulting: 1st hour of services free of charge Interim management: 2 hours of support free of charge.

Email: [email protected]

Venture Catalysts Venture Catalysts is a growth consultancy company who have worked with a number of start-ups in the medical technology space, 3D printing and online marketplace, as well as larger companies and Government departments. Their impact is mostly in strategy and marketing but are able to assist in areas such as;

- Product Development (in the product-market-fit, user requirements, user interaction/experience, design etc). - Hiring, management, evaluation, planning - Sales (plans, scripts, teams, management etc) - Advertising, promotion, user acquisition - Market research - Fundraising/investment

MDPP clients will receive no charge until we figure out if and how we can help you. (However many “hours” that takes)

Email: [email protected]

DESIGN + MANUFACTURE

Arkidelo Pty Ltd Arkidelo is an organisation providing totally integrated Product Realisation services in Plastics, from concept generation through to manufacture and packaging.

We offer a seamless process, ensuring that the transition from idea generation (ideation) to manufacture is fast and effective.

We provide all forms of plastics manufacture via our shareholders and extensive collaborative supply base.

Arkidelo will provide MDPP participants with free consultation on any project that may require the use of plastic to discuss the possible benefits and challenges that may arise.

Website: www.arkidelo.com

Atamo Proof of concept... what's next? The management team at Atamo has created electronics-based products and delivered them to global markets for 20 years. Our core competencies are electronics design and production engineering, but we have a network of specialists we use from industrial design and branding through project management to volume manufacturers. We also have people on tap who have developed medical devices and understand the rigours of TGA regulations. Design for manufacture, design for test, and regulatory compliance are standard in our work. Atamo maintains its links with academia; our engineering manager sits on the UWA Faculty of Engineering, Computing and Mathematics Industry Advisory Board. We were a member and sponsor of the inaugural year for Knowledge Commercialisation Australasia, and we have completed a number of projects in the area of university technology transfer (see http://www.atamo.com.au/index.php/clients/universities). If you have a great idea, we'd like to hear about it. As an introductory offer, we are happy to host a one-hour Skype video conference to discuss your plans with you. We will then provide you a short feasibility assessment and advice on next steps to help you realise your place in the market.

Website: www.atamo.com.au

Blown Plastics Blown Plastics are a privately owned company based in South Australia specialising in both injection and Blow Molding.

With 5 sister companies producing services ranging from machining for defence to German engineered workshop fit outs Blown Plastics is able to provide flexibility at very competitive prices. Current customers include CCA – Coke, RESMED, Munroe, Bickfords, GM Holden and Ford.

Services available to our customers include Consultation, Design, Project Management, Prototype tooling, New tools and production of existing tools. At Blown Plastics we aim to be a Quality, low cost base, innovative and preferred plastic molding supplier to the Australian and global manufacturing industry.

MDPP Participants will receive a free CAD design consultation and 5% discount on any new tool production.

Email: [email protected]

Blue Curve Pty Ltd Blue Curve is a product development consulting company that works exclusively in the medical device and diagnostics market space. We focus primarily on systems engineering and project lifecycle management for new devices.

Our business is assisting our customers to get their medical and IVD products designed, validated and transferred to manufacture.

Blue Curve’s services focus is primarily on design planning, systems engineering and verification. Our services typically cover the entire product development lifecycle and include:

Product development planning

System planning and engineering

Technical project management

Product Risk Planning and Assessment

Verification and Validation planning

Design review

Design Vendor management

Manufacturing vendor search

Transfer to Manufacture

Product safety test planning

Blue Curve extends the offer to MDPP participants of a free initial consultation and evaluation of their product.

Website: www.bluecurve.com.au

Clarke & Severn Electronics

Clarke & Severn Electronics are suppliers of a range of micro and nano elctrical connectors and cables used in a variety of medical devices. In particular, Omnetcis Neuro Connectors used by Neuroscientists worldwide, as well as Harwin and Odu products.

Clarke & Severn can offer our experience to help you through the design phase with a Free Consultation on incorporating our connectors and cables. We can build samples and prototypes for initial test, biocompatibiilty and approval, if required.

Website: http://www.clarke.com.au/medical.html

Design & Industry Pty Ltd

Design & Industry are Australia’s most awarded product design company. We have completed over 4000 projects for our clients in 28 years in business. More than 95% of our product designs are commercialised. Our team consists of some of the most experienced product design and development individuals in Australia. 40% of projects are completed for international clientele. Complex projects involving new technology innovations are our specialty – we have an extensive portfolio of new, early-stage medical device technology projects. Design for manufacture within tight commercial parameters underpins all of our practices. Our methods rely on open, collaborative and enduring client relationships – we have clients that have worked with us for n excess of 20 years. Our initial contribution is consultative as we set out to understand the project and the client’s needs. Working with both start-ups and MNC’s over many years has enabled them to capture key insights early and then ascertain how they might assist effectively. They provide detailed project proposals scoping the stages, timing and anticipated costs for the design journey. Client’s often use this information for business planning and key stakeholder negotiations. Beyond this, they are commissioned by clients on a fee for service arrangement working against the tasks and timelines detailed in the proposal. Design & Industry are offering an initial consult to MDPP participants as they set out to understand the project and the client’s needs. Website: www.design-industry.com.au

Designmakers Pty Ltd

Established in 1987, Designmakers Pty Ltd brings together innovation and experience in product design that has seen it receive a number of national and international design awards, including an American Medical Design Excellence Award.

Having developed a wide range of medical products from disposable plastics right through to surgical ophthalmic lasers, Designmakers’ approach has been to combine a sound knowledge of materials, processes and technologies with creative, analytical skills to generate innovative, market-focused solutions.

Designmakers are happy to offer MDPP participants up to three hours of their time at no charge. This could be used for an initial briefing meeting and the preparation of a detailed project proposal, or, if preferred, up to two hours of straight design consulting time.

Website: www.designmakers.com.au

Design momentum Design Momentum can develop a custom design package for your medical device, working with your team to assist you on your path to commercialisation. Design Momentum are offering MDPP clients a no cost and confidential project feasiblility assessment

Website: http://www.designmomentum.com.au

Fingo Fingo is a product development and research consultancy offering design solutions for industry. We provide design related services from concept generation through to product commercialisation.

Whether you are an individual with little more than a great idea or a large multi-national manufacturer, Fingo can help you with your product development requirements. For the inventor, we can develop your product idea through to commercialisation, drawing on the experience of successfully bringing our own retail product to market. We have extensive experience in developing products for manufacturers with no internal design resource or working with their in-house design teams as a complimentary resource.

As a special offer to MDPP participants, we will offer a 1 hour consultation free of charge for new projects.

Website: www.fingo.com.au

Formero Formero accelerates your products to market by offering services that streamline each stage of the product development process from prototyping through to tooling and manufacture. Our cutting edge rapid prototyping facilities allow us to supply high quality prototypes, simulating the production intent of the final components. We further fast track the product path-to-market by providing a manufacturing risk assessment and utilise Design for Manufacture principles to achieve the most efficient production costs. With a project management team operating in our Melbourne headquarters and in Shenzhen, Formero offers tooling and manufacturing services tailored to your product development requirements. Over many years, we have built strong relationships with manufacturing partners’ worldwide, matching customer requirements with our supplier capabilities to deliver on-time and within budget. Our in-house engineering team provides constant quality management of all our suppliers and stays at the forefront of emerging technologies. Our services are all aimed at improving your company’s bottom line. MDPP participants will receive on request a free product development sample kit of Additive and Subtractive Manufacturing technologies offered by Formero. This includes samples from SLA, SLS, Objet 3DP, Vacuum Casting and

CNC Machining, allowing MDPP members to analyse the various technologies and determine which process is best suited to their product development application. Formero will also offer MDPP participants free advice on product development in various Prototyping, Tooling and Manufacturing technologies.

Website: www.formero.com.au

Garon Plastics Pty Ltd Garon Plastics Pty Ltd offers computerised custom plastics injection moulding manufacture with complete product development and tooling services through a highly experienced network of engineers, industrial designers and toolmakers. We utilise both in house and sub-contracted designers, subject to project needs.

From small batch jobs to high volume production, our production scheduling and warehousing can be tailored to match your manufacturing needs.

Our experience in developing and marketing proprietary product in the international market enables us to understand the client perspective and develop partnerships.

QUALITY

Garon is a quality-endorsed company that provides component production under the ISO 9001:2008

Production standards and quality assurance programs can be tailored to your quality requirements. Consistency of production and stable moulding quality is supported by the well laid out, modern, clean, air conditioned facility that is maintained and operated by well trained and experienced staff. We have a clean room suitable for the manufacture of some medical products.

VALUE

Garon has four decades of experience in a manufacturing environment that is highly competitive. We understand the need for competitive pricing and have maximised the efficiency of our plant to provide value for money. Conveyors and robotics enables cost reductions to be provided to our customers.

Experience / Manufactured Product

Our clients include representation from the medical, automotive, whitegoods, electronics, agriculture/aquaculture, and leisure goods industries. We have a South Australian and Interstate customer base, and also export proprietary products.

Garon will provide a free two-hour consultation for early stage product development. This will include advice on design, material selection, tooling requirements and production options.

Website: http://www.garonplastics.com.au/

Hydrix Pty Ltd Hydrix designs & develops the finest medical devices, instruments & systems for Clients across Australia and around the world.

Fully ISO 9001 & 13485 certified, Hydrix has an enviable track record of design of successful and innovative, market ready medical devices from Class 1 low-risk to Class 3 high-risk devices, including:

• Implantable;

• Insertable;

• Wearable;

• IVD;

• PoC;

• Laboratory and Test equipment.

Hydrix employs a team of top-flight engineers with wide industry backgrounds and using leading processes and tools to provide a range of services that include:

• Project & risk management;

• Systems Engineering;

• Electronics, hardware & software development;

• Prototyping;

• Design for manufacture;

• Production transfer & validation;

• Regulatory compliance.

Hydrix can also assist with IP landscape reviews, strategic product roadmap planning, IP productisation and commercialisation.

A selection of current and recent Clients include Resmed, LBT Innovations, Universal Biosensors, CSIRO, Sunshine Heart and many others with ultimate end customers including companies such as J&J and Siemens Healthcare.

Hydrix engineers possess an average 18+ years of R&D and product development experience working to commercial timeframes and budgets, which means that we are adept at translating proof of concepts and prototypes to market ready products on time and on budget.

Hydrix are pleased to offer an across the board 10% reduction in our normal hourly rate for South Australian MDPP participants. If you are a South Australian registered company, contact the MDPP to take advantage of this offer.

Website: www.hydrix.com

Motion Technologies Pty Ltd For 25 years Motion Technologies have specialised in supplying bespoke engineered motion solutions to Universities, Defence, R&D, Medical manufacturing, and general industry, including for some very specialised and difficult applications. We can supply standard or custom components from our extensive range of suppliers, or if required, complete turnkey solutions including design, fabrication, machining, electricals and programming. All this can be done in-house but our wholly Australian owned company.

Our collaborative approach to design ensures customer satisfaction within budgetary limits.

MDPP clients will receive free design assistance through to final concept sketch/quotation stage for suitable projects.

[Note: offer will remain valid unless specified otherwise by company]

Website: www.motiontech.com.au

Neo Self Service Solutions We will evaluate any medical device development with a view to partnering with you to complete design, prototyping and manufacture of your product. Until we have developed a formal concept and scoping document with you to begin prototype and manufacturing design for a product selected by us for further evaluation, our consultation services are at no cost to you. As a guideline, this can be up to one week of pre-scoping consultation.

Website:www.neoproductsgroup.com

Outerspace Design Group If you need a partner to help make your product the best it can be in a short timeframe,

Outerspace Design offers:

- A diverse team of 20 professional designers and engineers

- Over 20 years of experience

- Broad portfolio across a range of industries

- Strong track record of commercially successful and award-winning product launches.

The Outerspace Design team is driven to help Australian companies compete with large multinationals through:

- Leveraging technological advancements

- User-centred design approach

- Best practice product development and engineering processes

- Innovation analysis and workshops

- Working with you as a team to leverage your knowledge and resources

We don’t claim to be experts at everything. We specialise in turning basic market research and consumer insights into product development ideas and opportunities, and realising those opportunities as successful products through clever design and rigorous engineering while identifying and minimising costly risks.

Over the years we’ve built a reliable network of partners that can help you navigate other important aspects of:

- Legal: intellectual property protection

- Electronics engineering

- Regulatory approvals (FDA/TGA)

- FEA, rapid prototyping and testing

- Tooling and manufacturing

- Government grants and funding

Let us help you develop a winning product development project plan. Please visit our website to see inspiring examples and contact us for a meeting.

For MDPP participants, at our first meeting we are more than happy to discuss your design concept and offer advise over the phone or face to face, with no charge and obligation free.

Website: www.outerspacedesign.com

Phantom Precision Engineering

Phantom Precision Engineering is a precision CNC machine workshop located in Adelaide, South Australia. We are dedicated to providing an on time service for rapid prototyping or small batch run machining projects. Expertise in machining all material types (including plastics) on our HAAS machining centres and lathe, give us an advantage over general large batch run workshops.

We specialize in providing advice to design engineers when wanting to machine complex, unusual material type parts. Jobs in the past included aluminium, stainless steel, brass, berrilium copper, titanium, acetal, nylon etc.

Prototyping and short runs

We would be more than happy to work with you on short runs or prototyping projects. This will enable us, to establish the most cost effective way of volume producing the parts you need.

Our experienced team can make fast work of set ups and preparations with our equipment so that costs are minimized even if you just want a few components run off

Coatings and specialist finishes

Through a variety of specialist partners we can arrange a diverse range of finishes and coatings for your components. From high grade polishes or gold plating to simple powder coatings and practical finishes such as chrome plating, zinc plating or anodising to ensure a robust finished article that can withstand the worst possible weather and toughest environment.

For MDPP participants, we will provide 2 hours consultation free of charge for each new project.

Website: www.ppen.com.au

Precise Precise Machining and Manufacturing has been supporting leading organisations with quality engineering services for over 35 years.

Precise will provide up to 1 hour free of confidential consultation to assist you with deciding on the best path to take for the designing and manufacturing of the moulds and tooling as well as how to best mould or manufacture the assemblies and / or machine the components to suit your specific project requirements.

For MDPP participants, we will provide 1 hour free of confidential consultation.

Procept Pty Ltd

Procept is a privately owned Australian company which provides independence, electronic expertise and world class processes to transform your ideas into commercial reality, on time and on budget. We understand the complexity and uncertainty of new product development and work closely with you, guiding and assisting at every stage from concept to first run.

We have specific expertise in Embedded systems, Wireless, Low power and Inertial technologies which are used and recommended by customers in Research, Healthcare, Mining, Communications, transport and logistics across Australia.

For MDPP innovators and entrepreneurs, Procept offers peace of mind, reduced risks, greater certainty and a partner in the process from concept to commercialisation. We would like to offer MDPP participants an initial technical appraisal and feasibility evaluation at no cost. Please call our office to arrange a confidential consultation.

Website: www.procept.com.au

Proen Proen is a leading South Australian provider of product design, engineering and CAD drafting resources. We assist our customers to undertake product design and engineering projects by providing consulting, contracting and recruitment services. We offer a full range of services from feasibility assessment, financial modelling, research and brainstorming through concept development, detail design, prototyping and manufacturing preparation. Our experience spans several hundred product development projects over more than 10 years and our medical clients range from small start-ups to multinational companies such as Resmed.

Proen offers a range of free introductory services to MDPP participants:

Free on-site ‘scouting’ visit (in Adelaide metro area) to identify opportunities for innovation within your business

Free initial consultation to discuss your product or project and develop a design brief

Free quotation including work breakdown and cost estimates

Website: www.proen.com.au

RADLogic Pty Ltd RADLogic is an Integrated Circuit Design Services company with more than 20 years of Mixed-Signal (Analog & Digital) chip-design experience. Members of our staff were involved in the development of the Speech Processor Chip for the first commercial version of Cochlear’s Bionic Ear.

We also have a solid understanding of the requirements and techniques for neural stimulation and sensing, and have a wealth of experience in Radio Frequency Identification, which shares a lot in common with the subcutaneous communication and power transmission methods used with medical implant devices.

We can provide full services in microelectronics design ranging from system and device architecture through to process selection, implementation, and delivery of mask databases and interfacing to a wafer foundry for manufacture.

RADLogic offers to provide two hours of free consultation to help MDPP participants assess initial feasibility and practicality of their proposals from the microelectronics perspective.

Website: http://www.radlogic.com.au

SMC Corporation SMC Corporation acknowledged globally as the leader in fluid control and automation solutions has a wide range of specialty products designed specifically for medical device manufacturers, including chemical processing, and specialty gas control Temperature Control. A comprehensive range of air cooled, water cooled process temperature solutions (Thermochillers) are available with a wide range temperature control and stability to ±0.01°C.

Fluid Process Control. With valves, tubing, fittings, flow control and pressure control devices suitable to inert gases and a wide range of chemicals SMC can support the critical process and analysis requirements of the medical device industry.

Specialty Gas Control. With an extensive range of pressure regulators and process valves developed for specialty gases,

including oxygen and many of the highly toxic and corrosive gases SMC can support many of the critical gas control processes required in medical device applications.

Integrated Fluid and Gas Solutions. Medical analysers and devices often require integrated control solutions. Using

composite valve manifold technology SMC can design and manufacture a specialized manifold solution to suit your specific process requirements. Incorporating many of the specialized valves and control components SMC can provide the complete solution.

SMC Corporation will provide free consultation, product literature and access to many demonstration products (subject to availability) for MDPP members. Website: www.smcaus.com.au

Tiller Scientifc + Medical Tiller Scientific + Medical Pty Ltd specialises in the design and development of medical devices and highly complex products. Our team develops products to stringent standards, and delivers them into the toughest market environments. Tiller Scientific + Medical Pty Ltd is one of the Tiller group of companies and has a highly experienced and skilled team of designers, engineers, software and electronics experts and systems engineers.

The company leverages all the skills of Tiller Design Pty Ltd and Tiller Manufacturing Pty Ltd, with the addition of:

ISO 9001 accreditation in process.

Dedicated medical device team fully trained in ISO 13485.

QMS records + history files for medical design (document control).

Risk reduction through detailed project procedures.

Software and electronics development.

Systems engineering.

The combined services of the Tiller group of companies include design and user research, planning, concept and design development, prototyping, production, certification and ongoing supply of product if required. Our approach is unique, with all facets of the development process under one roof. This means projects are well-managed, low risk and highly successful.

Tiller Scientific + Medical Pty Ltd will provide a free, 1 hour initial consultation to participants of the Medical Device Partnering Program. Website: www.tiller-scientific-medical.com

FINANCIAL SERVICES

Westpac Banking Corporation Westpac understands the healthcare industry. This allows us to offer the right support for your banking and financial services needs at every stage of the business lifecycle. We are proactive, responsive and innovative, working to help you achieve your financial, business and personal goals.

We believe that with the right support, we can do just about anything. Westpac provides Healthcare Banking Specialists who not only have in-depth knowledge, they can also assist you in boosting productivity and maintaining profitability, helping you to look to the long term, supporting a successful business result for you.

Because the Healthcare Industry is influenced by new developments in technology, new pharmaceuticals and advanced medical, surgical and diagnostic procedures, we understand the importance of working with you. To keep up to date with advances in technology and funding, we also work closely with various associations in the Healthcare Industry. This helps us understand what we need to do to help you compete for business.

We’ve always maintained a simple philosophy: if something is worth backing, we back it.

Westpac will provide you access to their team of Westpac Healthcare Banking Specialists, who can help you by providing tailored banking solutions and practical insights that they have gained by working with a number of healthcare customers.

Our team of specialists understands how you need to manage your cash flow to meet everyday costs, regular payments and large outlays for capital equipment.

We understand that having an experienced team of specialist bankers who genuinely take the time to partner with your business is important. It helps you build a healthy business and helps ensure that all your required banking solutions are appropriate and implemented successfully. This includes:

Equipment Finance

Cash Flow Management, including accounts payable and receivable

Trade and Export Solutions and Advice

Transactional Accounts, including online banking

Insurance Premium Funding

Term Loans

Wealth Management

Access to Financial Education Tools, through Westpac’s Davidson Institute

Whether you need business support or financial advice, your Westpac Healthcare Banking Specialist is on hand.

Website: http://www.westpac.com.au/business-banking/industries/healthcare/

GOVERNMENT GRANTS

LeMessurier Solutions LeMessurier Solutions is a boutique consultancy delivering strategic business, management and corporate advisory services to assist clients in developing and achieving strategies for sustainable business growth.

The principle of LeMessurier Solutions, Hugo LeMessurier, is an experienced entrepreneurial business leader with a proven track record of successfully implementing complex business solutions within an international environment. For over a decade Hugo has held directorships and senior management positions in start up, listed and multinational organisations in the USA, EU and Australia. He has founded and directed private and listed Australian companies in the Biotechnology, Health Care, Food and service industries with specialist experience in diagnostics, medical devices, tissue engineering and food safety.

LeMessurier Solutions specialty industries include Strategic business planning and implementation, Business development and contract negotiation, technology evaluation, feasibility, licensing and commercialisation, sales and marketing, international business development, investor readiness, grant funding, management and mentoring and non executive directorships. Hugo LeMessurier is currently the South Australian Business Advisor for the AusIndustry "Commercialising Emerging Technology" (COMET) grant program. COMET is a merit based grant assistance program designed for early stage and high-growth companies providing funding to subsidise a successful applicant's access to third-party service providers for activities that have been agreed with COMET business adviser.

LeMessurier Solutions will provide two hours of initial consulting free of charge for Medical Device Partnering Program participants.

E-mail: [email protected]

INTELLECTUAL PROPERTY

Madderns Madderns is a leading Australian patent and trade mark attorney firm based in Adelaide.

Founded in 1968, the firm provides specialist advice and assistance to many clients, within Australia and internationally, on all aspects of intellectual property law. Madderns specialises particularly in the registration and prosecution of patents, trademarks and designs, both in Australia and overseas.

Madderns has a strong patent practice in the fields of Medical Devices and Life Sciences. Our team is the largest in Adelaide and includes highly qualified Engineers and Scientists (four with PhDs). The team has a great deal of enthusiasm and a desire to assist South Australians in their commercialisation of Medical Device and Life Sciences products and services.

In addition to being able to offer advisory services in relation to patents and designs across a wide range of technologies, we have a trade marks group that can assist with branding and trade mark advice.

The attorneys in Madderns’ Medical Devices Group have expertise in areas that include: cochlear implants; electronic medical sensing devices; internal mechanical fixation systems of various kinds including arterial stents and bone fixation devices; medical instrument location using radio frequency sensors, x-ray and CAT/PET scan image manipulation and display.

Madderns offer extended free initial consultations (of up to one hour) to members of the Medical Device Partnering Program.

Website: www.madderns.com.au

Phillips Ormonde Fitzpatrick Since its inception in 1888, the Phillips Ormonde Fitzpatrick group has grown to incorporate a patent and trade mark attorney firm, a litigation firm and a research and investigation company which work together to provide a seamless and comprehensive intellectual property service.

Our Medical Technology Industry Focus Team comprises experienced attorneys who are expert in dealing with a range of medical technologies, from devices and implants through to diagnostics, informatics, therapies and delivery systems. We understand the challenges involved with protecting new Medical Technologies, and we tailor our services accordingly, from drafting patent applications and pursuing patent rights in Australia and overseas, to patentability and freedom to operate searching and IP auditing. In addition we advise on and prepare all kinds of intellectual property agreements including licensing, collaborative research and technology transfer agreements and patent litigation.

Phillips Ormonde Fitzpatrick will provide free initial consultation at the premises of participants of the Medical Device Partnering Program.

Website: www.pof.com.au

Roach Corporate Law Roach Corporate Law is an innovative, new, South Australian law firm which acts for businesses at all stages of their lifecycle.

Its Director, Daniel Roach, has worked in both private practice and in-house and is able to prepare agreements, provide advice and resolve disputes. He can assist technology driven companies in most facets of their operations and his experience includes IP and technology commercialization, project financing and venture capital, commercial agreements, employment, shareholder and governance matters.

Roach Corporate Law takes a client centred approach- which is surprisingly unusual for a law firm. Its services are designed considering each client’s particular needs and business as a whole. Whether the client needs flexibility in: where the lawyers do their work; the way their lawyers are retained; how the firm charges; or the timing of invoices- Roach Corporate Law will always try to accommodate. And by working collaboratively with clients and learning their businesses well, their clients get better results- tailored advice, earlier intervention and guidance, greater efficiency, lower fees, a better relationship and fewer surprises.

Roach Corporate Law will provide MDPP participants with an initial consultation of 1 hour, together with a Non-Disclosure Agreement template drafted for the participant’s use, free of charge.

Website: www.roachcorporatelaw.com

Rosey Batt & Associates Rosey Batt & Associates is a boutique legal practice that provides legal and business advice to both individual and corporate clients in a range of commercial and personal matters, including business, intellectual property, family, succession planning and conveyancing.

Rosey Batt founded Rosey Batt & Associates in 2001 after a number of years as a partner with a large international law firm and having completed a Master in Science and Technology Commercialisation.

The firm, located on Glen Osmond Road consists of six solicitors and five law clerks. Each member of staff understands the importance of confidentiality and integrity and offers excellent client services in a friendly atmosphere at affordable and competitive prices.

Rosey Batt & Associates will provide 10% discount to MDPP participants

Website: www.roseybatt.com

REGULATORY

Acrapack Acrapack is an Australian Medical Device Regulatory Consultant company based in Brisbane advising companies of all shapes and sizes on their regulatory and quality challenges, from implementation to post-market sustainability.

As dedicated regulatory consultants and compliance guidance advisers we provide regulatory and quality assistance on registration and compliance issues faced by medical device medical device companies in the life sciences, biotechnology and healthcare industries.

We offer full comprehensive management of product compliance, resolution of regulatory concerns, offering companies focused inclusive solutions to achieve their market visions.

Our key consultant Anne Jones is proficient at resolving any regulatory and compliance hurdles faced by our clients. When required by our clients, Anne takes ownership of any projects through to the end to our client’s satisfaction.

Anne’s regulatory knowledge and process oriented approach helps medical device companies seeking regulatory assistance to achieve registration of their medical devices ensuring compliance to TGA regulations.

If you are a start-up company, Anne will work with you to navigate the regulatory processes and to accomplish hassle free regulatory approvals and enable you to launch your medical device in Australia. A manageable schedule is set and attention to detail keeps any project on track.

Acrapack is offering a one hour initial consultation free to participants of the Medical Device Partnering Program.

Website: http://www.registermedicaldevice.com.au/register-medical-device.php

Kea Dent & Associates KD&A specialises in providing an extensive range of business and regulatory services to manufacturers of medical devices and in vitro diagnostics, sponsors and other organisations. Some of these services include:

Regulatory Advice

Technical Documentation

Assistance with Quality System Certification

Exporting Assistance

'KD&A provides its services by looking at the big picture – not just the regulatory issues. We understand that gaining regulatory approval is just one aspect of your business, thus KD&A offers complete business and regulatory solutions.' - quote by Managing Director, Kea Dent

KD&A will provide a free 30 minute consultation to participants of the Medical Device Partnering Program.

Website: www.kdas.com.au

Voisin Consulting Voisin Consulting has a particular focus on emerging medical technology companies. Because of this, we understand the unique needs (and limitations) of startup enterprises. With six international offices, our multidisciplinary and cross-geographical integrated structure allows us to bring enhanced communication, reactivity and flexibility to our client’s projects. Services we often provide to early stage companies include:

Develop GLOBAL REGULATORY STRATEGIES and/or review business plans to ensure the regulatory position stated is sound and reasonable

Develop QUALITY SYSTEMS that are compliant and operationally efficient

Determine the most appropriate tests/studies required to support NONCLINICAL STRATEGIES and assisting with NONCLINICAL PROTOCOL DEVELOPMENT to avoid timely and costly errors

Ensure that all necessary DESIGN CONTROL activities are well defined, documented and meet regulatory requirements

Develop SUPPLIER EVALUATION PROCESS and conduct SUPPLIER ASSESSMENTS to avoid costly mistakes, including poor quality materials and delayed deliveries

Prepare, submit and follow-up of REGULATORY FILINGS to regulatory agencies in USA, Europe, Australia and Asia

Provide CUSTOMIZED ON-SITE TRAININGS on a number of quality and regulatory topics to assist companies become more self-sufficient

Voisin Consulting is offering one hour of initial consulting free of charge for Medical Device Partnering Program participants.

Website: www.voisinconsulting.com

The information contained in this document is correct as at August 2017