An innovative Australian micro screw created to help significantly reduce complications in the management of orthopaedic injuries and the fixing of fractures in the hand and wrist will be used in a world-first operation in Brisbane by internationally-renowned hand surgeon Dr Greg Couzens on Wednesday 30 January.
The Field Micro Screw by Brisbane med-tech start-up Field Orthopaedics has already been hailed by orthopaedic surgeons throughout the world as of huge benefit for better patient recovery and outcomes and is predicted to change the treatment and recovery of fragment fractures forever.
Dr Couzens, assisted by Field Orthopaedics CEO Dr Chris Jeffery, will use the micro screw for the first time since its US FDA approval last year and subsequent manufacture. They have received special permission to use the device here in Australia to treat a young patient whose complex finger fracture resulting from sport is expected to have far better recovery and long-term results using the Field Micro Screw than other medical devices on the market.
The Field Micro Screw is the smallest orthopaedic screw on the market. Made of smaller, stronger screws that can be inserted over wires for faster and more accurate repairs, it uses stronger and smaller wires suitable for use in smaller bones such as those found in the hands, delivering real value to the management of these common injuries.
The product will officially launch at the American Academy of Orthopaedic Surgeons Annual Meeting on March 12 in Las Vegas, where it is expected to be extremely popular. The micro screw is currently undergoing CE certification for approval in Europe and TGA certification for use in Australia.
In addition to its innovative solution to an ongoing problem faced by orthopaedic surgeons during surgery, the micro screw is remarkable for being developed two and a half times faster and 65 times cheaper than the US average timeframe and cost to develop a medical device.
Developed for less than AUD$600,000, the Field Micro Screw development journey resulted in a 98.46% reduction in the AUD$39 million average cost to bring a low-to-moderate-risk 510(k) product from concept to clearance (according to the Nov 2010 ‘FDA Impact on U.S. Medical Technology Innovation’ report). ** The product was developed in just 12 months rather than the industry standard average of 31 months (also quoted in the report). ***
Field Orthopaedics CEO Dr Chris Jeffery, 31, said the initial response to the product in the USA was overwhelming and proved that Australian products were not just competitive but world-leading on the international stage.
“The United States is the largest target market for medical devices, with an estimated global market share of around 45 percent,” he said.
“Given the size of this market, the timeframes associated with the US FDA process, and considering the longer time parameters around the Australian TGA timeframes, we sought approval for our device in the US marketplace first.
“The Field Micro Screw has had overwhelming support from the Australian orthopaedic surgical community and endorsement by world-leading orthopaedic surgeons internationally, not just for its outcomes, but also for the usability and ergonomics of its design.”
The Field Micro Screw and the Kit it is packaged in won Product Design Gold at the 2018 Australian Good Design Awards® and is an industry breakthrough for the advanced storage, safety and sterilisation it offers to the surgeons and hospitals using it.
To minimise error during the surgical process, each Micro Screw element can only go in a specific niche and the case itself is also designed to be sterilised with the implements to ensure the highest form of safety for patients and ease for medical staff.
Dr Jeffery gained his medical degree after serving in Afghanistan for the Australian Army as an engineer. His combination of ingenuity, persistence and ability to apply army-model thinking to medical device development to result in industry-changing savings of time and money to bring new products to the market is starting to change Australia’s place in the medical device development industry.
“The reality is that millions of people undergo operations every day,” he said. “To create products that have the potential to radically improve the outcomes of those operations based on our research, development and creation with world-renowned surgical experts for a lot less cost and timeframe than traditional methods are both a medical and a business model game-changer.”
* https://www.orthoworld.com/index.php/publications/orthoknow_content/orthopaedic-industry-reaches-49-billion-in-2017
**&***:https://www.advamed.org/sites/default/files/resource/30_10_11_10_2010_Study_CAgenda_makowerreportfinal.pdf
MEDIA CONTACT: Nicole Fisher 0419 661 085
About Field Orthopaedics
Field Orthopaedics (FO) is a rapidly growing Australian Orthopaedic devices company that focuses on the design and manufacturing of orthopaedic devices to address the shortcomings in the trauma, extremities and biological markets. With their team of surgeons, engineers and researchers, FO has created a range of orthopaedic devices that provide evidence-based solutions for longstanding concerns in extremity surgery.
Currently, the company has several projects in their portfolio, one of which has US FDA approval and three of which are in active development expected to gain regulatory approval within the next three years. Formed to bring back innovation to medicine, FO creates products that address under-serviced markets and that realise solutions to problems impacting patient care and outcomes. FO was created from within the medical community, with the founders forming a significant collaboration with surgeons and physicians to identify their greatest industry problems and work alongside them to create innovative solutions.
FO is passionate about innovation and utilises profits to support ongoing orthopaedic research. The team believes that collaboration is the key to innovative design and is proud to develop and manufacture products that not only make sales, but also make a positive difference by empowering users and greatly improve outcomes.
