What we're about

A community of Medical device innovators - people who are interested in medical devices, health assistive technologies and health tech; registered and non-registered, hardware based and software-only.

The group is intended for Clinicians who have problems to be solved or solutions they want help with, Designers, Engineers, Software Developers, and Technicians who have skills to build the solutions and those who are interested in entrepreneurship, innovation and startups in the health technology area.

By coming together as a community we can share what works and assist in each others success.

Upcoming events (4)

IT in healthcare - getting your product to market [Regulatory Compliance & IP]

IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897 - be sure to select the Brisbane Event.

Understanding [the FDAs] 510K for [Medical] Devices [Brisbane]

The Entrepreneurs' Programme brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227 Please note: currently the Eventbrite description says 2018, but it is wrong - use the "Register" button to see the correct dates.

IT in healthcare - getting your product to market [Regulatory Compliance & IP]

IT in healthcare applications, devices and systems has seen rapid growth and expansion in recent times. The activities in this sector will only expand over time and companies (SMEs) and researchers should be aware, knowledgeable and prepared for these changes. Join this free workshop to hear from three experts in the field from an operational, intellectual property and regulatory perspective to assist you in getting your product to market. Expert Panel Lusia Guthrie With over 35 years in the pharmaceutical and bioscience industries, Lusia Guthri is an experienced CEO and medtech entrepreneur. She has a passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch. She has particular experience and ongoing interest in the development and commercialisation of new healthcare products that embrace automation, robotics, machine learning and artificial intelligence. Rob McInnes Rob McInnes is a lawyer with a technical background in the life sciences, who has practices for more than 25 years in the commercialisation of IP and technology. He is ranked in the top tier of Australian IP commercialisation lawyers, and holds the US-based Certified Licensing Professional accreditation. Rob assists research organisations, start-ups, established businesses and investors with the capture, protection, management and licensing of IP rights. Terry Walsh Terry Walsh has over 15 years' experience with the regulated space spanning biotech, pharma, blood products and mecial devices. Walsh has started, run and led three businesses over the last decade in Australia to support the regulated industry in aspects of engineering, IT, quality and regulatory compliance. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/it-in-healthcare-getting-your-product-to-market-registration-45366992897 - be sure to select the Sydney Event.

Understanding [the FDA's] 510K for [Medical] Devices [Sydney]

The Entrepreneurs' Programme brings together two experts in the field that will be able to assist SMEs to understand from a regulatory and operational perspective what is required to ensure FDA - 510(K) compliance. This workshop will be valuable to both companies that have this accreditation but also those making the transition and aspire to operate in the medical devices sector. Presenters Andrew Batty - Lincoln Consulting Group Andrew is an experienced MedTech CEO that has developed, executed and managed business strategies to commercialise innovative and emerging technologies. Andrew has experience managing regulatory teams and external consultants to facilitate local and international device distribution. Arthur Brandwood - Brandwood Biomedical Brandwood Biomedical is an international medical device and IVD regulatory consultancy, with deep knowledge and experience of US FDA processes including successful traditional and de novo 510(k) submissions and preconsultation interactions with FDA – both remote and face to face. Founder and Principal Consultant Arthur Brandwood has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments in both start up companies and university applied research, has held senior roles including Director of Device Registrations at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific. Entrepreneurs' Programme Event registration page: https://www.eventbrite.com.au/e/understanding-510k-for-devices-registration-44819465227 Please note: currently the Eventbrite description says 2018, but it is wrong - use the "Register" button to see the correct dates.

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