The Brisbane entrepreneurs who cut through US red tape to develop medical devices

The Brisbane entrepreneurs who cut through US red tape to develop medical devices

A Brisbane medical innovation start-up is revolutionising medical product development in Australia and the US by creating their latest product from concept to US FDA approval at two and a half times faster and 65 times cheaper than the US average timeframe and cost to develop a medical device.

Orthopaedic innovation and devices company Field Orthopaedics has been operating for two years and their unique, collaborative business model is based on immersion of the medical and engineering disciplines with world-renowned surgeons rather than the traditional silo method of product development.

This has resulted in total costs of just less than $600,000 for the development of their latest product, the Field Micro Screw, which is a 98.46 per cent reduction on the $39 million average cost to bring a low-to-moderate-risk 510(k) product from concept to clearance (according to the November 2010 'FDA Impact on US Medical Technology Innovation' report).

Field Orthopaedics CEO Dr Chris Jeffery (pictured left), who along with co-founder Dr James Fielding (right) was named as a finalist in Business News Australia's Brisbane Young Entrepreneur Awards 2017, says their business model has overhauled the traditionally expensive, time-consuming and complicated task of medical device development and creation.

"We focus on the creation of a culture and platform to give surgeons access to experienced design and engineering teams that can turn the problems they face every day into solutions, rather than just creating products to sell to doctors," Dr Jeffery says.

The benefits of being a 'nimble' startup

"This collaborative, problem-focused model of development combined with our new-age, start-up spirit of execution has seen these efficient and economically advantageous results for the Field Micro Screw and for our other products in development.

"Our 'profit-for-purpose collaborative pipeline' system and style of development is creating life-changing ideas that don't break the bank. As a result, our profits from sales can readily go into the development of the next solution or product rather than be tied up in recouping millions in costs over many years.

"As a start-up we are streamlined, efficient and nimble. We have combined our purpose and insight with new ways to engage with the end-user, proving that it doesn't have to cost a fortune to make a difference in the orthopaedic medical device arena."

The most recent Field Orthopaedics product completed and submitted to the US Food and Drug Administration is a complete redesign and optimisation of the orthopaedic screw. In injuries to the arms and legs, 40 per cent of the time surgery can be complicated due to issues related to the device.

"Factors making operations to these areas more difficult are the lack of specialised instruments to help handle and hold the injured bones in place whilst surgeons operate, the inability to accurately place implants and the size and strength of the permanent fixation," Dr Jeffery says.

For development of the Field Micro Screw, the Field Orthopaedics engineers worked with world-renowned hand surgeon Dr Greg Couzens to understand the issues that affect surgeons and impact patients in the management of these fractures. They then completely re-imagined and redesigned all components of the product to help surgeons deliver better outcomes.

"This new range of products is made of smaller, stronger screws that can be inserted over wires for faster and more accurate repairs. In addition, stronger and smaller wires are suitable for use in smaller bones such as those found in the hands, delivering real value to the management of these common injuries," Dr Jeffery says.

Applying business principles to medical devices development

Expected to be approved by the US FDA in April this year, the Field Micro Screw has had overwhelming support from the Australian orthopaedic surgical community and endorsement by world-leading orthopaedic surgeons internationally.

It has been enthusiastically welcomed by US medical device companies and will be showcased at the American Academy of Orthopaedic Surgeons for the US market, which is aware of and waiting for this innovative product that will change the treatment and recovery of fragment fractures forever.

"We have streamlined and measured our process to the point that each Field Micro Screw we sell pays for one engineer to work on a new product for a day. This equation is applied to all of our products in development," Dr Jeffery says.

"Another forward-thinking aspect to our Field Orthopaedics business model is that we sell to existing medical device companies rather than to individual surgeons, so we avoid conflict of interest issues and can work with any surgeons or medical staff who have ideas and solutions on which they would like to collaborate with us.

"The reality is that millions of people undergo operations every day. 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 is both a medical and a business model game-changer."

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