osteobionix: the 3D Printing Company Personalising Orthopaedic Surgery

Bobby Hall, an executive search consultant specialising in Orthopaedics and Spine at RW Search, has been exploring how 3D printing has the potential to revolutionise the manufacture of spinal implants, and how one company is gaining a foothold in this market.

Last week, RW Search spoke with Francesco La Palombara, Co-Founder of osteobionix, a medical device company founded in 2018 as a spin-off of the Canary Islands Institute of Technology (ITC – Instituto Tecnológico de Canarias), and the team have worked on innovative 3D printing solutions for bone and cartilage reconstruction and regeneration within the ITC Department of Biomedical Engineering since 2006.

osteobionix is a company dedicated to advancing the standards of care for people suffering from cartilage or bone loss. Cartilage and bone loss may result from a variety of causes including osteoarthritis, trauma, and tumours, and can severely affect a person’s everyday life. As a company, their goal is to provide people suffering from cartilage or bone loss with innovative, high-quality, proven, customized solutions, which can help them regain the lifestyle they deserve. osteobionix collaborates with surgeons in designing and manufacturing reliable, cost-effective solutions, which consider the uniqueness and complexity of each single surgical case. They are striving to become an industry leader in the progressive paradigm shift from replacement to regeneration in cartilage and bone surgery.

Surgeons are constantly on the hunt for high-tech, and less invasive medical advancements that can restore patients’ health – and 3D printing technology is a tool that offers the scalability and precision to make life-saving spinal implants more readily available to all.

Orthopaedic and Spinal surgery are therapy areas that can benefit the most from the advantages of these tools, and specialists are beginning to look at 3D printing as one of the latest medical advancements to restore health to patients’ spines. 3D printing allows surgeons to design a personalised prosthetic that perfectly align in a patient’s body. Using special tools, surgeons can correct joint or disc problems through using implants made of high-tech materials that mimic bone, instead of steel screws and rod, which are traditionally used, that could potentially cause infections. Given the sensitivities of the spinal system, the potential that 3D spinal implants have to offer are particularly exciting.

The market for 3D printed medical devices is projected to increase at a CAGR of 17.5% and is forecast to reach nearly $2 billion globally by 2022. With about 1.6 million instrumented spinal procedures performed each year, this is a field with substantial prospects, set to reach somewhere around $6 billion by 2028. With the first 3D-printed spinal implant surgery being conducted in 2016 in Sydney, Australia, this is evidently still an emerging technology in orthopaedics, and specifically spinal surgeries. But certainly, we’re already seeing a wider adoption of 3D printing technology among some of the major medical device manufacturers. Some that immediately comes to mind is Stryker and its 2018 acquisition of K2M who plan to invest $200 million in research and development in this area, as well as J&J’s acquisition of Emerging Implant Technologies (EIT), a private German company.

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Initially, I thought it was apt to ask Francesco, who is based in Switzerland, to tell us about his history in the industry, where his personal career started and what trajectory it has taken?

I’m a biomedical engineer by training, and whilst studying, I worked in hospitals and research institutions in Italy focusing on orthopaedics, and I stayed there to work on computer assisted surgery and orthopaedics robotics.

I then decided to jump into the industry to combine my passion for healthcare with business. Firstly, I joined a couple of orthopaedic companies starting as a product manager and ultimately progressing to business unit director. Following this, I joined a US-based company which was launching a new device, and I was responsible for developing the business in Southern and Eastern Europe and the Middle East. As we were launching a new device from an unknown brand, it was all about building. I had nothing in my hands except samples of the implant, and I was told to ‘build the market’. I had very knowledgeable people behind me in the USA and Europe, and an enthusiastic team, and it felt like we had a start-up in our hands. But I was an employee and not a shareholder, and eventually the company decided to stop operations in Europe, to focus on FDA studies.

That was when I decided to create something. I studied consulting, partnering with start-ups and medical device companies, which I still do on the side. I was consulting for go-to-market strategies, product launches, and business development. I then spoke with a friend of mine, a department director at ITC, and we thought it was the right moment to create a spin-off of the institute, ITC top management also saw an opportunity in our initiative, they supported us from the very beginning and we still have an extremely fruitful collaboration.

From a commercial standpoint we started from scratch in 2018, with a lot of existing technology and knowledge, but nothing in terms of corporate structure and mentality. The team had been working under the umbrella of a public institution conducting applied research, so we had to build everything; a corporate image and network. Being self-funded we have been growing steadily, but it could not be exponential as funding and resources are limited.

Furthering on from this, I was intrigued to find out the aim of the company, and what problems Francesco was trying to solve at the time its conception?

We are already witnessing the future of medicine, which is personalised medicine and treatment, and this implies that the patient is an individual with unique problems, and the solution is personalised. We thought there were a lot of niches from a market perspective, a lot of issues with suboptimal solutions, so the idea was to work closely with the surgeons to help find the optimal solution in the field of bone and joint reconstruction and regeneration. Not only do we provide orthopaedic solutions, but also in spine, thoracic and CMF surgery. Wherever there is bone and joint, we are there. We actively seek highly challenging cases.

I then asked Francesco what osteobionix’ unique selling points are, and why surgeons trust them to provide the most optimal solutions?

We are knowledgeable on design, manufacturing, biomechanics and comprehend all surgical aspects. We have extensive experience working intimately with surgeons, so we directly understand what their surgical problem is, whereas other companies can be limited in that they start from a purely engineering angle. Being capable of designing a nice implant does not guarantee that, when it comes to the application, issues can arise in terms of surgical technique, and interaction with the surrounding anatomical structures or long-term mechanical resistance or long-term mechanical resistance and performance. Designing an excellent patient-specific implant does not only mean replicating the anatomy of the area you want to reconstruct.

We have not just worked on specific bones and joints; we have developed a lot of very different solutions. This enables us to blend all the knowledge acquired from our experience, and ultimately create new and unique solutions. We are very creative, and our solutions are original, we don’t merely modify a default implant.

This is a very specific competitive advantage of ours. When surgeons start working with us, they want to continue. There is a lot of confidence there, which was developed over many years and required very long hours in the OR. We are not a company which hides in the lab, very often we are out in hospitals and OR with surgeons and this creates the difference.

Who are your main customers, and do you see this changing as the technology develops?

We have worked with larger hospitals who are recognised as reference centres for specific surgeries. We are generally focusing on difficult cases, which tend to concentrate in specialised centres.

However, I think that in future that will change, personalisation will be more standard for treatment and therapy. In the future every hospital and OR will provide custom implants. The concept of custom implants will change also. The customisation process will be streamlined, implying the designing and manufacturing of a custom implant will be less cumbersome in terms of time and resources, and ultimately cost.

So, do you see price as the largest barrier to widescale adoption of custom implants?

It’s the time and resources (human and capital) involved in the process, that result in high price. So, it’s more a question of technology and processes. It requires rethinking. The whole chain, from diagnosis to surgical theatre to rehabilitation needs to be rethought and streamlined. If that process becomes simpler and more standardised, then creating a custom solution will be quicker and require less resources.

COVID-19 has had a significant impact on the entire healthcare sector – I asked Francesco to share whether the pandemic affected osteobionix’ operations?

It did have an impact in terms of the kind of surgeries we worked on. Many hospitals became solely COVID hospitals, so a lot of the elective surgeries we work on were delayed or halted altogether. We mainly worked on surgeries that cannot be delayed, oncology for example.

We also have a sister company that sell personalised solutions for veterinary surgery. Dogs and cats can’t get COVID and vet surgeons never stopped working so we compensated the delay we experienced at osteobionix with an acceleration in biosurgex.

There was a lag and impact on business, but we managed to grow anyways, although we might have grown more without COVID.

Can you share your plans for expansion?

The first target is expanding customer base and entering new markets within our specialty, as there is huge growth space for a company with our background. We started in Spain and Italy, and this is where we conduct most of our business. We don’t have a direct sales force, so we collaborate with distributors. we still need to develop a business structure for the European market, and eventually the USA market.

Every day we are networking within the industry, and we have already received offers of collaborating on projects that aren’t in our specialty, but they are adjacent in terms of our business segment and operations. If we go for an expansion in our product range, we will be considering opportunities that are close to our current work.

Furthering on from this, as osteobionix plan to capture the USA market, I asked how they plan to gain FDA approval, and how does this work with custom devices?

We just do custom implants; from an FDA point of view, we cannot go for a full P&A and we cannot apply for a 510k as we would need to find a predicate device for each single implant we design. Custom implants don’t follow the regulatory pathways designed for standard implants. In the EU you must be approved as a custom implant manufacturer, which we are, so you must comply with some very specific EU regulations, but you don’t get a CE-mark for each product as it changes every time you manufacture.

And finally, what does the future hold for osteobionix?

At some point we will need funding, and we are already looking for investors. We are growing nicely and the finances are very good currently; however, we cannot have a steep ramp-up in order for us to accelerate towards exponential growth, we need an injection of capital, which will allow us to work in different ways.

Our main objectives are to expand from a commercial point of view, improve our R&D process, and ultimately become more independent in terms of operations.

osteobionix is offering life-changing solutions in the implant market, through their high quality and innovative devices and it was a pleasure speaking with Francesco, whose experience in the medical industry is undoubtedly an engine of growth for their expansion as a company, and the precedent that they set on the customer having the best experience possible emphasises osteobionix’s position as one of the key players in this market.