Biofabrication is becoming a reality, as innovative Australian companies collaborate with universities and scientific organisations to develop custom-designed 3D-printed products for medical applications. By Carole Goldsmith.
Dr Mia Woodruff’s exciting vision of ‘hospitals of the future’ is for every Australian hospital to have 3D printers sitting beside its imaging equipment. She also sees a future where patient’s cells will be stored at hospitals, early in the patient’s life, until the cells are needed to custom-make sterile on-the-spot implants. These implants can take the form of bones, organs, cartilage, blood vessels, breast implants and multiple tissues.
As Associate Professor and Group Leader of Queensland University of Technology’s (QUT) Biofabrication and Tissue Morphology Group in Brisbane, Woodruff and her team are working together to achieve this vision by researching the high-tech sciences of tissue engineering and biofabrication. She explains that biofabrication is the production of organs and tissues using 3D printing to address health challenges in medicine.
In a 2014 TEDxQUT video, “Absolutely Biofabulous”, Woodruff explained how fabrication of patient-specific replacement tissue and organs is safe, cost-effective and routine: “3D printing is used to build complete houses in China and create clothing for Paris catwalks. So we are now researching how to use 3D printing for the inside of our body.”
Speaking from her QUT office, Woodruff explains: “Every year thousands of people suffer a large amount of tissue loss through cancer, congenital birth defects, or road accidents. If we can custom-build tissue replacement for these people, as opposed to grafting tissue from another part of their body, this will greatly increase their recovery times after surgery and reduce their suffering.”
Woodruff works with a team of chemists, biologists, physicists, mathematicians, engineers and medical doctors. She says proudly: “My team is already building our own 3D printers specifically to address research challenges in tissue and cell regeneration. We are using these machines to build a 3D structure from dissolvable polymers. In the future, this will provide a platform to grow the patient’s tissues on. We are getting very close to having enough research data to apply for a grant to do clinical trials.”
Woodruff mentions two current projects: “We are working closely with the charity, Hear and Say, on building customised polymer ear prosthetics for children, who suffer from Microtia and may have no ear or no ear canal or underdeveloped ears.
“We have also had discussions with Anatomics (a Melbourne-based 3D printing medical implant company) about jointly developing customised 3D scanning and printing technologies to create patient specific implants.”
Woodruff and her team recognise the importance of multidisciplinary collaboration and already conduct biofabrication research with surgeons and hospitals across Brisbane. She speaks of one initiative in the pipeline – the development of the world’s first biofabrication institution in Brisbane.
“We all need to work together at a hospital campus to achieve success in biofabrication,” says Woodruff. “Now is an exciting time for researchers, educators, clinicians and industry to bring all our skills together to create the hospital of the future. This will deliver innovative and cost-effective solutions to a range of health issues and the first step towards this is to create a biofabrication hub on a hospital campus.”
Oventus – 3D-printed oral medical devices
Dr Chris Hart first developed an oral medical device to treat his own sleep apnoea around five years ago. Then he made customised devices for around 50 of his dental patients. Little did he know then that his invention would lead to the O2Vent oral device, which his company Oventus developed in collaboration with CSIRO. These devices are now custom-made by Oventus at leased facilities at CSIRO in Melbourne, for patients Australia wide.
Speaking from Oventus’ Brisbane head office, Hart explains that the O2Vent provides relief to people with sleep-disordered breathing, from snorers to those with more severe problems including nasal obstruction. As well as being the company’s founder, Hart is its Clinical Director. He says that the O2Vent’s design is the world’s first and only sleep therapy that directs the user’s air flow through the back of the throat. It bypasses nasal and soft palate obstructions and prevents tongue blockage.
“The device incorporates a ‘duckbill’ which extends from the mouth like a whistle and creates a separate airway that allows the air to flow directly to the back of the mouth,” says Hart.
Using proprietary CAD software to create a 3D drawing of the patient’s mouth and bite, Oventus then uses 3D printing technology to manufacture medical-grade mouthguards from titanium.
“When we were developing the device, our patent attorney introduced me to Neil Anderson, a biomaterial scientist and a specialist in medical devices,” says Hart. “Neil, who is now our CEO, suggested that we speak to CSIRO about further developing and commercialising our device. We then worked alongside CSIRO scientists at Lab 22, developing the proprietary 3D printing software and technology, then building a prototype device.”
Lab 22, at CSIRO in Clayton Victoria, provides Australian companies with access to metal additive manufacturing machines and technologies. Since the device prototype was developed two years ago, Oventus has been renting space at Lab 18 (an adjoining work space of Lab 22) to print the titanium mouthguards, using an Arcam Q10 printer
“The patient’s mouth data is captured by the dentist or sleep specialist, digitalised and then uploaded to the proprietary software,” says Hart. “Then the patient’s design file is exported to the 3D printer, printed in titanium and polished in the lab. Each custom-made device is printed with its patient’s identifier number.”
The devices are then shipped to Oventus’ Brisbane dental labs where polymer insets are made, which go between the titanium and the mouth. Once completed, they are sent to the customer’s clinicians Australia-wide. Later this year, Oventus aims to be printing the polymer mouth parts also.
Oventus has 26 employees, with 21 based in Brisbane, three at the CSIRO site in Melbourne, and two in Sydney. The company is launching in the USA later this year.
“After the success of our clinical trials, the Oventus O2Vent device was registered with the Therapeutic Goods Administration (TGA),” says Hart. We have recently received FDA clearance for the device, as required for our USA marketing and sales commencing later this year.
“We attended and exhibited at the American Academy of Dental Sleep Medicine conference this year. Our clinical trial results’ abstract was also displayed on our poster. Overall it was a great success as we had 350 USA dentists and sleep physicians register their interest in being involved in our USA expansion.
“Following the USA launch, we will be expanding to the EU and Asia progressively. We are also developing some new oral devices and they will be brought to the market over the next two-to-three years.”
Lab 22 – Printing patient’s bones
Stefan Gulizia, Research Team Leader at CSIRO, provided AMT with a tour of the Lab 22 additive manufacturing facility and the adjoining Lab 18, where the titanium part of the Oventus O2Vent device is printed. At the Lab 22 entrance, Gulizia shows a model of a replacement heel bone, 3D-printed in titanium alloy. This was created by CSIRO in association with St Vincent’s Hospital and Anatomics. He also shows a sternum plate that CSIRO 3D-printed for an Anatomics patient in Spain who had chest cancer.
“We’re creating customised parts for patients here at Lab 22 and as we are at an advanced stage in 3D printing, we can now replace any bone,” Gulizia explains.
He adds that for manufacturers wanting to find out more about additive manufacturing and see the 3D printers in action, Lab 22 provides regular tours and networking for industry. Manufacturers can also contact CSIRO Manufacturing Research Group Leader Leon Prentice (leon.prentice@csiro.au) to discuss their company’s 3D printing needs.
Speaking on the Oventus project, Gulizia says: “Chris and Neil from Oventus approached me two-and-a-half years ago to see if we could develop a 3D printed design for their oral device. We worked on the device’s unique features, then Oventus and CSIRO jointly patented the design and technology. CSIRO’s proprietary software is licenced out to Oventus who is the device’s owner.
“As part of the development, we created an STL file format for the powder bed 3D printer. This file can be sent globally.”
In Lab 18, Oventus’ Production Supervisor Dr Afshin Hosseini opens the Arcam Q10 printer to reveal the nest of 3D-printed O2Vent titanium parts. Prior to taking on the Oventus position, Hosseini completed a PhD in additive manufacturing at CSIRO, and was trained on the Arcam Q10 printer in Sweden, where the machine is made.
He transports the nest of devices to an Arcam powder recovery system (PRS) machine, and uses a spray gun to remove the titanium dust. The powder disperses and all 15 devices appear, each with their own patient number. Anna Walsh, who worked with 3D printers in the Netherlands, assists Hosseini in production. She shows the four-step process of polishing the devices on special grinding machines.
Austofix – Orthopaedic innovation
An innovative medical device that removes the need for X-rays during orthopaedic surgery is helping South Australian manufacturer Austofix expand into the Middle East and China. The company utilises 3D printing for both rapid prototyping and in selected products, including the soon-to-be released VRP 2.0 wrist system.
Austofix launched its Ezy-Aim electronic digital targeting system last year and it is driving sales of its stainless steel and titanium surgical nails. The device, developed at the company’s facility in Adelaide, allows the surgeon to accurately locate the implant inside the bone without the use of X-rays. The Ezy Aim System and associated nails are used to repair fractures of the femur, tibia and humerus bones.
Austofix General Manager Chris Henry says the device was key to the company’s recent success in the Middle East. “The Ezy-Aim has been a catalyst for our growth in the Middle East. We have experienced double digit growth in a number of countries and we expect this to continue.”
Austofix has been designing and manufacturing medical devices for over 25 years. Its world-class R&D team work with surgeons to design effective, innovative products for patients requiring orthopaedic surgical treatment. These products are then distributed world-wide by international partners.
“Dr Anthony Ingman was the founder of Austofix,” says Henry. “As an orthopaedic surgeon, and with his interest in engineering, he was perfectly placed to design and produce our initial range. Following on from this success we understand the need to ensure clinical input with our designs and ensure clinical leads are involved.”
The company has an efficient team based at its Adelaide head office responsible for Austofix’s core work. This is supplemented with a range of strategic international and domestic partners to grow its business. Like other medical device manufacturers, Austofix is required to hold current quality certification to ISO 13485 and CE approval. This system is regularly audited by a notified body such as the TGA.
“The Ezy-Aim Distal Targeting System is a unique innovation used by the orthopaedic surgeon to locate the holes of the nail that is implanted in the bone,” says Henry. “Screws are then inserted in these holes, fixing the nail in place.
“Without the Ezy-Aim, multiple X-rays would need to be taken – exposing the patient and surgical team to radiation. The Ezy- Aim System reduces the need for these X-rays and provides the surgeon with accurate targeting to insert the screws.”
Austofix manufactures a range other products all of which are used to treat bone fractures. Henry explains that orthopaedic surgeons determine whether nails, plates or screws should be used to treat a fracture. These fixation devices are used to stabilise fractures and support bones to heal, and Austofix designs and manufactures instruments that support the surgeon in safe, efficient surgical procedures.
“We are fortunate to have strong partnerships with leading providers of 3D printing in Australia,” says Henry. “The University of Adelaide’s Institute for Photonics and Advanced Sensing (IPAS) is at the forefront of this sector and we have established a successful collaboration with this team during the development of the VRP 2.0 system.”
The VRP 2.0 (Volar Radius Plate) relies on 3D metal printing for part of its manufacture and can also be fitted more easily by surgeons. The design includes an improved locking mechanism for the plate and an increased variable angle for the screws, which means surgeons can get a better hold on the wrist bone, leading to quicker healing.
When asked what the company’s plans are for the future and its challenges, Henry emphasises a focus on investing in R&D to create a platform of innovative devices targeting the upper limb.
“Advanced manufacturing plays a key component of our R&D programme and we are keen to see future research and investment in improving this growing sector,” he says. “The company’s current markets are Australia, Asia and the Middle East. We are now targeting both North and South America as well as strengthening South-East Asia and India.
“We face many challenges through competing in a highly competitive and regulated global market. We are also faced with challenges at a macro-level through our international expansion. As a specialised company we believe we are well placed to respond to these challenges to grow our business.”