Building Regulatory and Trial Readiness for Medical Devices & SaMD - HealthTech Hub Masterclass
Description
Precision and clarity in your regulatory plan is the key to a successful production and scale-up journey for medical devices.
Navigating the regulatory pathway is notoriously difficult. From understanding complex compliance requirements to managing different guidelines across various jurisdictions, many founders and researchers struggle to determine the right steps for their specific projects.
This full-day, hands-on masterclass is designed to help you stop "palming off" regulatory concerns to external experts and instead build a robust internal toolkit. By mastering design control, risk minimisation, and study optimisation, you can protect your reputation and significantly increase your chances of successfully accessing the market.
Eligibility applies*.
What to Expect
Delivered in partnership with The Adjutor Group, this workshop covers the full product cycle - from initial design and development to regulatory compliance and Quality Management Systems (QMS).
Participants will walk away with the ability to:
Identify Product Classification: Determine your likely category under the TGA framework (Class I, IIa, IIb, III, etc.).
Understand Impact: See how your classification dictates evidence requirements, clinical trial needs, and design control.
Build a Roadmap: Begin outlining a tailored regulatory strategy based on your product’s current development stage.
Global Navigation: Distinguish between Australian and international frameworks (e.g., FDA 510(k), CE mark) and understand how they affect your planning.
Practical Execution: Explore essential first steps including conformity assessments, documentation, and engaging with regulatory consultants or NATA labs.
Strategic Integration: Learn to weave regulatory planning into grant writing, business development conversations, and QMS development.
PANEL DISCUSSIONS:
Panel 1. Getting Regulatory Right Early
Panel 2. From Strategy to Execution
Who Should Attend?
This masterclass is specifically designed for:
Researchers, developers, and engineers working on Medical Devices or Software as a Medical Device (SaMD).
Clinical entrepreneurs and founders who have are working through their proof-of-concept stage (laboratory prototype or clear blueprint) looking to understand how to move towards product development and establishing clinical trial.
Applications are Subject to Eligibility
*Eligibility
This hands-on workshop provides the opportunity for researchers, developers and founders to work directly with experts from reputable Contract Research Organisations, to gain insight and professional advice from industry professionals specific for their research project in moving from proof of concept to regulator ready.
All successful applicants will receive confirmation of placement prior the workshop based on eligibility and project readiness.
Lineup
Rob Parbery
Consultant, The Adjutor Group. Rob is a highly experienced regulatory affairs professional with a long experience of guiding products from development through approval and post-market lifecycle management across medicines, medical devices, IVD, cosmetics and consumer health products. Rob has a strong combination of scientific expertise, regulatory strategy and operational execution, with a proven ability to navigate complex regulatory frameworks while maintaining focus on speed to market and commercial outcomes. Throughout his career Rob has managed large product portfolios across both Australia and New Zealand with diverse regulatory requirements. Rob has also played a key role in modernising regulatory systems, including implementing digital artwork and promotional materials approval processes and leading the transition to eCTD submissions.
Deb Cooper
Chief Operating Officer, Adjutor Healthcare. Deb is Adjutor’s Chief Operating Officer and a project management expert with a passion for finding pragmatic solutions to complex problems. She has extensive experience in therapeutic product development, regulatory affairs, and commercialisation with significant proportion of her career spent in senior roles in pharmaceutical innovator companies and Australian and international consultancies. Throughout her career, Deb has established a reputation for coordinating large numbers of projects simultaneously, maintaining a very broad local and international industry network, and gaining extensive experience working in close collaboration with regulators. At Adjutor, she seamlessly switches between managing operations and delivering a wide range of projects, consistently exceeding clients' expectations and foreseeing issues in projects while finding creative solutions and workarounds. She is respected for understanding complicated concepts quickly and translating them into terms others can understand.
Dr Joseph Badolato
Chief Business Development officer, Adjutor Healthcare Joseph (Joe) Badolato, PhD, has over 25 years’ experience in senior management roles in the medical technology, biotechnology and pharmaceutical sectors and has a solid background in running local and international clinical trials. As the Chief Business Development Officer with Adjutor Healthcare, he engages with biotech, MedTech and pharmaceutical companies to help them deliver their product development, regulatory, clinical and commercialisation plans. Joe is an effective communicator, focused on building relationships with stakeholders and decision-makers. Most importantly, he is passionate about contributing to the advancement of healthcare services for the benefits of the patients. He has a vast local and international network and broad experience working with stakeholders from government, research institutions, small and large sponsors and manufacturers. Joe also has a proven track record in strategy implementation, clinical operations, training, and quality. During his tenure at ARCS Australia (an Australian peak professional body), he was responsible for the development and implementation of strategic and operational plans (which included projects in the Asia Pacific region) and delivered of the first TransCelerate accredited GCP program in Australia.
Oona Reardon
Oona Reardon is the founder and Director of Pulse Economics and a senior health economics and market access specialist with over 20 years' experience spanning public sector, health technology assessment (HTA), academia and industry. She leads all MSAC submissions at Pulse Economics, with particular expertise in feasibility assessments and high-risk submissions for novel medical technologies.
FAQs
- What is the Cicada HealthTech Hub?
Cicada Innovations is proud to be collaborating with the Westmead Health & Innovation District, Australia’s fastest-growing health and innovation precinct, for this commercialisation masterclass series. These masterclasses are to help bridge the gap between research and commercialisation.
Find out more about the Cicada HealthTech Hub
The Cicada HealthTech Hub is proudly supported by NSW Government and is part of the Westmead’s Health & Innovation District. The district includes 4 major hospitals, 4 world-leading medical research institutes, 2 university campuses and the largest research-intensive pathology service in NSW. By 2036, the number of full-time staff will increase to more than 50,000 and the number of students will expand to more than 10,000. Among the first projects for development is a viral vector advanced manufacturing facility to provide ground-breaking trial therapies for infections, cancer and genetic diseases.
Tickets for good, not greed Humanitix dedicates 100% of profits from booking fees to charity
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