UTS research is supporting the commercialisation pathway for precision medical device technology in Australia.
The UTS Business School has worked with global medical technology company Stryker since 2017, applying a new research methodology that supports commercialisation of technology in Australia by building a value proposition and business case based on end-user experience.
Business researcher Dr Katrina Skellern says making a robust business case for commercialisation is an integral but often overlooked step in the medical technology commercialisation pathway.
While companies routinely conduct market research after a new technology is developed, researchers at the UTS Business School explored stakeholder needs and how Stryker could address them from the beginning of this project.
“Product development is usually very tech-focused – it looks at the value of the technology and whether it meets a clinical need,” says Dr Skellern, an Adjunct Research Fellow at the Business School.
“But by partnering with UTS Business School, Stryker brought a different lens to their product development mindset through the application of a new methodology that highlighted the perspective of the value proposition for the customer.”
The "Just-in-time implants" project will have a wider impact on Australian business and the economy. Photo: James Giggacher, RMIT
The new research methodology was developed by UTS in its role as part of the Innovative Manufacturing Cooperative Research Centre (IMCRC) project based in Melbourne, a research partnership between Stryker, four Australian universities and St Vincent’s Hospital, Melbourne, to develop just-in-time (JIT) patient-specific implants for sarcoma patients.
JIT implants are customised bone implants made in the hospital through a combination of 3D printing, robotic surgery and advanced manufacturing. The aim is to significantly improve outcomes for sarcoma patients by reducing the time it takes to manufacture implants off-site and removing the risk the implant will not be appropriate for the patient.
JIT technology holds promise internationally but has yet to be implemented in any clinical service in Australia because there is generally no business readiness in hospitals to develop JIT manufacturing capability.
The Business School and Stryker worked together to improve the development and implementation of the JIT solution. The researchers started by mapping the entire journey of each stakeholder, including industry, government, non-government, health, community advocacy and universities, to identify gaps and what value Stryker could add.
Over five years, UTS researchers investigated the market opportunity, identified the value proposition, and found process efficiencies, using theoretical business methodologies that commercial companies do not traditionally use.
“We looked at the project through a commercial lens for Stryker, but also from the point of view of the hospital, the health system, the potential economic impact and the regulatory framework – all of the potential challenges the company might need to consider,” Dr Skellern says.
The UTS researchers identified that there was no need to manufacture each implant within five hours in the operating theatre, as the developers had suggested, and that a seven-day turnaround was what the Australian health system required. The developers then pivoted the project to make the implants deliverable within seven days.
The researchers went on to work with Stryker as the company developed a new R&D Lab in Australia.
Stryker's R&D Lab will focus on digital health, robotics, enabling technologies and advanced manufacturing research, and will bring its new patient-centric focus to all that it does.
“Stryker’s project with the IMCRC demonstrated the importance of collaborative, open R&D and helped shape our current approach to innovation,” Stryker Senior Director, Research and Development and IMCRC Partner Investigator Rob Wood said.
Dr Skellern says the innovative use of a business methodology to support medical device commercialisation has other potential implications for the sector in Australia.
The UTS research team is partnering closely with regulatory authorities such as the Therapeutic Goods Administration (TGA) and the Department of Health and Aged Care to address limitations in the regulatory and reimbursement frameworks for patient-specific devices.
In future, this could lead to better incentives for companies to commercialise their products in Australia, says Dr Skellern.