Open source designs and rapidly conceived new devices are appearing daily. But there are regulatory and IP risks and opportunities you should consider prior to launching your device.
In the present global pandemic, there is a rush to find solutions to diagnose and treat COVID-19, resulting in a great deal of medical device innovation. This dynamic environment may offer the possibility of rapid market access, but at the same time raises questions in how to navigate the regulatory system, and what IP issues you need to be aware of.
How can you manage your IP strategy to both protect your commercial interests and contribute to the public good?
Can you fast-track regulatory approval?
What are the risks of encountering regulatory log jams or IP affecting your freedom-to-operate?
Please join us for this webinar to hear from industry experts from Hydrix and FB Rice as they reveal and discuss strategies to help you navigate a more certain regulatory and IP landscape.
Michelle is the Clinical and Regulatory Manager at Hydrix Limited and is a qualified Audiologist and Certified Professional with the Association of Clinical Research Professionals. She is an experienced clinical program manager in identifying the scope and requirements of clinical evidence to support global regulatory, marketing and reimbursement needs at Cochlear Limited.
Michelle started working in 1995 as a research audiologist at the Bionic Ear Institute under Professor Graeme Clark AC, the inventor of the first multi-channel cochlear implant. In addition, Michelle’s previous research is published in peer-reviewed journals with over 400 citations and 2,600 reads.
In her current role, Michelle draws on her significant professional experience in the area of patient related safety and effectiveness of active implantable medical devices (cochlear implants) in adults and paediatrics to provide evidence-based outcomes for medical device manufacturers.
Madeleine Kelly – FB Rice
Madeleine is a partner with the FB Rice engineering team, specialising in computing, telecommunications, electronics and medical device related inventions. In addition to being a Registered Australian and New Zealand Patent Attorney, she has also qualified as a European Patent Attorney and an Irish Patent Agent.
Madeleine draws on her international experience to provide clients with strategic global IP advice that caters to their legal and commercial needs, both within Australia and overseas. She represents a wide range of clients, from individual inventors, start-ups and SMEs, to local and international universities and multi-national corporations. She is recognised for her aptitude in assimilating and critically analysing information across a broad range of technologies and conveying information to audiences at all levels and disciplines.
Toby Thompson – FB Rice
Toby is a Senior Associate with FB Rice and is qualified as a European, Australian, New Zealand and UK patent attorney with 12 years’ experience.
Before moving into intellectual property Toby spent five years working for a multinational pharmaceutical company in medicinal chemistry, identifying new drugs for respiratory and inflammatory conditions. Toby also led a group which provided large scale quantities of candidate drugs for preclinical studies and he is named as an inventor on seven patent families. Toby has a PhD in Synthetic Organic Chemistry from Nottingham University, UK.
Toby presents regularly on IP, and since 2018 has delivered the IP module in an RMIT Entrepreneurship course for PhD students, together with colleagues. He was also a lecturer in Advanced Medicinal Chemistry at Nottingham Trent University, UK, during his time working in research.
Hydrix Limited (ASX: HYD)is a product design and engineering company, specialising in complex, regulated and safety-critical projects. We partner with clients to help design, develop and commercialise transformative technologies in the medical sector.
FB Rice is Australia’s leading privately owned independent intellectual property firm. Founded 70 years ago, we respond to all your IP needs with a full suite of services and the right technical expert every time.