Building Australia’s factory for medical devices
Taking an idea and turning it into a commercial reality takes more than passion and belief in what you’re creating.
Vision and intent can quickly evaporate without the support, expertise, and clear pathways needed to move from concept to market.
And, when it comes to complex, highly regulated sectors such as medical devices, translation of innovation into impact requires access to the right infrastructure, regulatory know‑how, and industry partnerships as non-negotiables.
Market growth
The medical devices market is poised for substantial growth, driven by growing chronic and acute diseases and a growing awareness of treatment options, resulting in rising numbers of diagnostic and surgical procedures.
In 2025, the global medical devices market was valued at approximately $801 billion and is projected to grow to $846 billion in 2026, expanding to over $1.4 trillion by 2034.
Medical device partnering program
For nearly two decades, Flinders University’s Medical Device Partnering Program (MDPP) at Tonsley Innovation District has been a national leader in developing medical technologies with global market potential.
Led by its founder and director, Professor Karen Reynolds, the MDPP is an ideas incubator that accelerates market research, product validation, and prototyping by bringing together a network of stakeholders to move concepts closer to commercial reality.
Since 2018, the MDPP, with funding through the South Australian Government, has assessed more than 1,000 product ideas with more than 130 projects completed.
Clients receive up to 250 hours of professional expertise, with the resulting IP retained by the participant. Clients are also provided with guidance on future R&D pathways and potential funding opportunities, supporting confidence to progress to clinical trials or further research.
Medical devices
Some innovations developed through MDPP include:
NeoMorph
A pioneering over-the-counter mouthguard designed by a dental hygienist, Amanda Trennery, bridging the gap between a costly dental device and an ill-fitting pharmacy brand.
Pulse Tile
A compact pulse-detection device developed to help responders quickly confirm the presence or absence of a pulse during cardiac arrest emergencies.
DeflectaCath
A specially designed catheter created to improve navigation through the male urinary tract and enhance urological care.
Taking the next step
Professor Reynolds says Flinders University is poised to take the MDPP a step further by addressing a critical gap in the medtech sector between product validation and clinical trials.
“As many as 80 per cent of the companies that come through the MDPP go on and get more funding to advance their innovations,” she says.
“But many of them come back asking for our help to manufacture devices required for clinical trials, and we’ve had to say no because we’ve not been able to.
“That’s why we’ve surveyed the industry, spoken with experts, and identified the missing capability and what we can realistically do to address it.”
Flinders Factory of the Future
Flinders University is working to establish FORGE, a flagship program within the Flinders Factory of the Future (FFOF). FORGE: MedTech will provide ‘short run’ manufacturing capability specifically for medical devices.
FFOF, which welcomed a new facility in 2025, is a collaborative space for innovative organisations and Flinders’ researchers supporting Australia’s sovereign advanced manufacturing sector across areas such as medical tech and defence.
It is where new technologies, manufacturing techniques and processes can be tested, trialled and adapted for small and medium enterprises and large facilities.
“The FORGE program will have manufacturing capability within Flinders Factory of the Future, where small quantities of products can be trialled, all underpinned by quality controls and validations needed to take them to clinical trials,” Professor Reynolds says.
“Products within the medtech sector tend to be niche, and because it’s a highly regulated sector, it can cause quite a lot of headaches for people seeking to move their ideas forward.
“We want to work with our supply chain, local companies, as part of this initiative, and we see it having an important role in skills development across the industry, but also connecting with students here at Flinders University.
“For example, we will have engineering interns be part of the process, supporting the product development and quality assurance processes required for the product.”
Keeping expertise in SA
Professor Reynolds says that bringing more manufacturing in-house, it aims to prevent companies from looking offshore.
“We’ve got quite a few partners who have already indicated that they’re looking for this kind of facility, and we have a shortlist of companies that we think might be interested to come through in the initial phase,” she says.
“MDPP is now the longest-running medtech-specific innovation program in the country, and the benefit is we can draw upon our experience and see where innovations have either fallen over or taken a very long time and be able to apply those insights.”
The model we’re developing is intended to be scalable and replicable across other industries that face similar challenges.
Professor Reynolds
Professor Reynolds holds a Master’s in Biomedical Engineering from the University of Oxford and a PhD from the University of Leicester. She has received multiple engineering and scientific accolades over her career, including South Australian Scientist of the Year, and has appeared four times on Australia’s Top 100 Most Influential Engineers list.
