On 10 and 11 June, the HealthTech Activator (HTA) delivered its much-anticipated Clinical Investigation Process for Medical Devices workshop at Callaghan Innovation’s Auckland hub. Spanning two half-days, this in-person event attracted medical device developers, startup founders, clinical leads, and regulatory professionals from across Aotearoa.
The workshop provided a comprehensive roadmap for those navigating the complex world of medical device clinical investigations. Whether participants were preparing for their first in-human trial or planning post-market studies to support ongoing commercial success, the workshop offered insights and strategies to help them move forward with confidence, while taking into consideration market access and global competitiveness.
Julie Jones, CEO of BioValeo, with over 20 years of clinical research expertise led the sessions with an approachable, engaging style. Rather than lecture, Julie fostered dialogue — encouraging questions, sharing real-world examples, and offering practical advice drawn from managing clinical trials. Attendees described the workshop as “an interactive conversation rather than a presentation,” appreciating how Julie made complex topics relatable and actionable.
On Day One, participants explored medical device definitions and classifications across major markets (NZ, Australia, USA, EU) and how these shape regulatory strategies. Julie explained the purpose of clinical investigations, differences between pilot, pivotal, and post-market studies, and the importance of early regulatory planning. Key standards like ISO 14155, ICH GCP, and the Declaration of Helsinki were brought to life through discussion on protecting participants and ensuring data integrity.
Day Two focused on operations — from building a strong Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB) to selecting and validating essential systems such as a Clinical Trial Management System (CTMS) and Electronic Case Report Forms (eCRF). Julie shared insights on budgeting, vendor selection, and the importance of contingency planning. Beyond cost, she encouraged teams to consider vendor experience, communication, and fit — emphasising that well-aligned partnerships can make or break study success.
Julie maintained high engagement with thought-provoking questions, open discussions, and scenario-based exercises. Rather than focus on one case, participants explored varied examples to understand how design, regulation, and operations impact cost, timelines, recruitment, and participant burden. The collaborative, discussion-driven format was a clear highlight, with attendees valuing the chance to learn not only from Julie but from each other.
By the end of the workshop, participants had developed a clearer understanding of:
Attendees also received a comprehensive booklet of reference materials, checklists, and templates to apply in their own work.
Participants shared overwhelmingly positive feedback about the Clinical Investigation Process for Medical Devices workshop, praising its comprehensive coverage, practical insights, and engaging delivery.
"The workshop was excellent. It covered a broad range of topics in detail, enough to give a good overview. It was engaging and I learned a lot.”
“Very comprehensive coverage!”
“The complexity and expertise needed to navigate this process was well presented and an important message.”
“Conducting a good clinical trial is essential for the success of a medical device startup.”
This workshop provided a much-needed space for healthtech innovators to gain clarity on the clinical investigation process, from high-level strategy to the operational details that make or break a study. Julie’s facilitation created an inclusive, engaging environment where participants could test ideas, seek advice, and build connections.
For many, the workshop delivered not only knowledge but renewed confidence and direction. As part of HTA’s wider mission to strengthen Aotearoa’s healthtech sector, sessions like this equip innovators with the tools they need to navigate regulatory pathways, reduce risk, and accelerate access to international markets.
If you missed this workshop, more opportunities are coming. Keep an eye-out on the HTA events page to learn about upcoming sessions designed to support your commercial journey.
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