Spinal fusion surgery has a historically high failure rate. This leaves many with the unenviable choice between follow-up surgeries with an elevated risk of further complications, or accepting a lifetime of continued discomfort.
There has been much controversy around the efficacy of existing fusion procedures, which fuse two or more vertebrae to stabilise the patient’s spine and reduce pain.
Sydney-based Dr William Parr, whose work focuses on spines and spinal fusions, wondered if the high complication rate could be due to ill-fitting fusion devices that directed forces to points of spinal weakness, rather than strength.
Through his PhD at University College London and the Natural History Museum (London) and subsequent post-doctoral research, he examined bone structures to understand better how the forces and stresses travelling through them influences their shape and how this influences surrounding anatomy or devices.
Working subsequently at the Surgical and Orthopaedic Research Laboratories (SORL) in Sydney’s Prince of Wales Hospital, Dr Parr noted a common factor of failed fusions was that many implants didn’t fit well. “With spinal fusion, you’re actually putting something into an anatomical space, so making it fit is important,” “this is different to say a hip or knee replacement where you are replacing the anatomy” he says.
That led him to co-found 3DMorphic in 2015, a company that manufactures custom-made devices to improve the success rate of spinal fusion surgeries.
The importance of a perfect fit
“Our business is making patient-specific devices for patients that have particularly degenerative spines,” explains Dr Parr, who is now the Managing Director of 3DMorphic.
“Imagine that you had to wear a pair of shoes for the rest of your life, you would want those shoes to fit, you wouldn’t want them to give you blisters.
“Our differentiating point is that we make devices that fit the patient’s anatomy and also restore normal bone configuration to the patient and we do this fast, so there is no need to delay the patient’s treatment.”
Dr Parr says that just as every person has a unique fingerprint and facial appearance, the same is true of body proportions and composition. “There’s a lot going on inside in terms of geometry. Being able to actually have a patient-specific device means that you can really account for all those different parameters being unique.”
Taking a leap forward with i4 Connect
Fast-forward to 2022 and 3DMorphic is now on the fast-track to success. It has received significant financial and operational assistance from the Entrepreneurs’ Programme Accelerating Commercialisation service and i4 Connect, which administers the program and appoints an experienced facilitator to guide outstanding start-ups through the often-fraught path of establishing a business and successfully commercialising their product.
With the assistance of i4 Connect facilitator Jenny Aiken and an Entrepreneurs’ Programme Accelerating Commercialisation grant of $337,600, 3DMorphic is undertaking the regulatory and quality management activities required to achieve listing on the Australian Register of Therapeutic Goods (ARTG).
Fostering a revolutionary approach
i4 Connect Facilitator Jenny Aiken is an experienced founder, entrepreneur and non-executive director who is also a health and medical sector specialist and qualified physiotherapist. She believes 3DMorphic has achieved a strong value proposition in the medical implants market by developing a process to custom-design and 3D-print a spinal implant in under five days.
Previous processes to create a customised device could take six weeks to three months. This is typically an unviable timeframe in medical cases such as trauma or cancer, leading to use of generic devices that have been beset by high failure rates.
Jenny says the “exceptional expertise” of Dr Parr was pivotal in creating the unique new process. “I believe he is at the forefront of revolutionising the approach to spinal surgery,” she says.
Building a backbone for business success
Dr Parr was initially not as skilled in business management as he was at creating medical implants. “When I started, I was spending a lot of time buried in computers, but now it’s not so much about getting technology and 3D printers to work, it’s very much about getting the business to work,” Dr Parr says.
“So the focus has shifted towards ‘what are the commercial goals and how do we achieve them? What are the regulatory hurdles we need to overcome? What are the pathways?’. It’s a totally different focus now to what I started with.”
When 3DMorphic applied for the Entrepreneurs’ Programme Accelerating Commercialisation grant, the business was connected with Jenny, who assisted on a number of levels from completing the extensive application process to guiding the company through a complicated regulatory environment.
“Jenny is also helping us with connecting to relevant people within the industry, and other opportunities to take commercialisation further. Connecting people at a higher level, interfacing with government bodies,” Dr Parr says.
Use the i4 process to perfect your pitch
He urges other emerging businesses to apply for the Entrepreneurs’ Programme Accelerating Commercialisation grant. “Even the application process will help define and refine your commercial business case for your technology, or whatever it is that you’re trying to build your business on,” he says.
“Even if you don’t succeed, that’s potentially useful for other grants or raising private funding, because it will help you crystallize your market size, your average selling price, how much money do you need to achieve your milestones and timeframes.”
Parr credits the Entrepreneurs’ Programme Accelerating Commercialisation grant as the positive influence that has made his vision both commercially viable and practically achievable.