Daniel Spencer is a business manager at Charlton Morris, an executive search firm specialising in the medical space. Here, he argues that 3D printing is transforming the spinal implant marketplace, and will play an ever-increasing role in shaping the future of spinal implant manufacture as the printing technique becomes more efficient.
There are 33 separate vertebrae in the spine. That’s 33 opportunities for something to go wrong, move, slip or break. As such a complex structure, the spinal space will often be where you find the most cutting edge developments in orthopaedic surgical technology.
In my position, as a spinal specialist, I work across the entirety of the spinal market, which means that I have a uniquely objective view of the whole market. Over the past couple of years, one of the most interesting technological advances I have seen emerge has been within 3D printing or, more specifically, 3D printed spinal implants.
3D printed technology is nothing new, but the innovation I’m coming across in the spinal implant space at the moment has led me to ask: is this technology the future of the whole market?
Why are people interested?
If you will excuse the pun, any surgical procedure is carried out on a knife-edge. Whatever operation is taking place, surgeons are operating within the most miniscule error margins. For surgeons working in spine, with so many different parts, this is amplified even further.
So any technology that can increase the chances of success, or decrease those margins for error, understandably cause a big stir, which is where 3D printed implants come in. The way in which they are manufactured means that, whether completely bespoke or part of a range of ‘off the shelf’ implants, they are more likely to reduce the chances of the implant not fitting correctly and subsequently having to repeat a surgery.
Aside from the obvious physical pain that comes with repeated surgical procedures, a surgeon showing a patient a model of their spine, and using a physical model to explain how a surgery will go as opposed to a complex MRI scan, will also help with a patient’s emotional well-being.
It has been well documented that mental trauma and anxiety can hinder recovery within patients, or have them more on edge when entering theatre – being better informed and therefore better prepared, means that patients are much less likely to feel as though they have no control or clue what is happening to them when under anaesthetic.
The benefits are clear then. Improved chances of success for surgeons, and more confidence for patients. Unsurprisingly, there are a whole host of companies getting into the 3D printed space.
Emerging Implant Technologies are one such company, and their mantra of ‘get it right first time’ is something surgeons can clearly get on board with. They manufacture a full line of ‘off the shelf’ implants, so these are not individualised, but the cellular titanium used means that the chances of a successful surgery are greatly increased.
Fifty-seven percent year on year growth is impressive for any business, and it’s a statistic that 4WEB Medical, a US based competitor of EIT, can boast for 2017. They have also reported an 84% increase in surgeon usage for their range of ‘off the shelf’ products – representative of an exciting marketplace. We are also seeing even more companies entering the market, with K2M and Si Bone two more exciting businesses creating some really innovative products.
When it comes to truly individual and personalised implants, then Medicrea are the pioneers. Each one of their individually personalised implants is unique and bespoke to the patient. Implants and technologies like theirs represents the ushering in of a new era of truly individualised precision medicine.
Medacta also have their own 3D printed MySpine range—an example of a major international business adopting 3D printed spinal implants as an additional product line, as opposed to being their central focus.
What are the problems?
Implants like those produced by Medicrea or Medacta are at their most useful when a patient is experiencing a particularly rare or individual problem. A congenital deformity, severe spinal degeneration or destruction of the spine from a tumour are all applications when their implants have the most benefits.
They are a fantastic solution for these sorts of problems, which are usually long-term and therefore patients will not deteriorate rapidly in the time it takes to produce the implants. For other, more urgent, procedures, even where a personalised implant would be preferable, the time scales involved in designing, modelling and creating an implant just don’t work.
The current process can take days—timings that just do not work in hospital Accident and Emergency departments or emergency rooms, when time is so critical to success.
In addition to the speed with which they can be produced, another objection some raise is cost. A 3D printed implant can cost anywhere between US$300–US$1000 more than a traditional commoditised product. With the number of spinal operations happening every day in hospitals around the world, this cost can very quickly run into the millions of dollars.
There is a counter argument to this though: increased success rates mean that the amount of repeat procedures would decrease—potentially offsetting the cost by avoiding the far more expensive second procedure.
What does the future hold?
In my opinion, the future of spinal implants inevitably lies with 3D printing technology, but the reservations I have mentioned will need to be addressed before we see widespread adoption and a 3D printer in every hospital.
Competition will help. As demand grows, we are already seeing more and more businesses emerge every year, and as competition increases, I am sure that we will see the innovation needed in both the software and computer aided design technology needed to bring production times down from days to hours or even minutes.
I am also confident that we will see a reduction in some of the regulatory hurdles that come with creating individual implants—something that organisations like the FDA will be working towards in order to allow a more competitive market.
I am personally really excited about the future of the market, and am fascinated in hearing about the latest products coming to market.
Daniel Spencer is a business manager at Charlton Morris, Leeds, UK.