OUR TEAM

Nicolette brings more than 20 years’ experience across global medical device development, regulatory registrations, quality management and post‑market surveillance. Her experience spans the Australian, European and US regulatory landscapes, with deep expertise across TGA, EU MDR/IVDR and FDA pathways.

 

She is known for translating complex regulatory, quality and clinical requirements into clear, proportionate strategies that support commercial objectives — ensuring compliance frameworks are robust, scalable and aligned with long‑term market presence.

 

At Lumina Medtech, Nicolette leads regulatory, quality and clinical strategy, supporting partners across regulatory pathway planning, Australian Sponsor responsibilities, post‑market obligations and quality system design. She is also a Committee Member of the Medical Technology Association of Australia (MTAA).

Kirsty brings more than 20 years’ commercial leadership experience across medical technology marketing, sales and operations, working both within global multinational organisations and early commercial‑stage companies and as a consultant. She is a medtech commercialisation and market entry specialist with a strong track record of translating new technologies into Australian clinical and healthcare settings.

 

Her experience spans market opportunity assessment, go‑to‑market strategy, pricing and reimbursement considerations, channel design and extensive new product launch execution. She is recognised for bridging clinical value, customer adoption and commercial scalability.

 

At Lumina Medtech, Kirsty leads commercial strategy, market assessment, launch planning and market development, working closely with founders to build practical, staged pathways to sustainable growth within the Australian healthcare system.