What existing technologies does your business have licences for and can you explain a bit more about how this technology works?
The scaphoid is one of the bones in the wrist that sits right next to one of the bones in the forearm. In the case of a fracture to the scaphoid bone, if there is a large displacement of the fracture, a cast is not sufficient and there is usually a need for surgical restructuring with a compression screw. However, this treatment is not rotationally stable and can result in scaphoid pseudo-arthritis if the fracture fails to heal. Generally, most scaphoid fractures do not heal as well as other fractures and the healing period is also longer.
The Medical University of Vienna has developed a technology for this, to fix these two fractions of scaphoid bone with an additional screw, which significantly improves the chances of healing. In addition, the patient does not develop any pseudo-arthritis and the bone is able to fuse without causing any pain. The Medical University has also built its own initial prototypes. Hofer Medical has picked up on the patented idea, which was formulated very generally in 2014, and implemented these end-certified implants with the first appropriate directional drilling tool. Because the additional screw is inserted in parallel, or at a particular angle, to the normal compression screw, an appropriate directional drilling tool is also required.
Since 2014, we have continued to develop the technology and are now reaching the point where any doctor can use it confidently to achieve success with their patient.
The size of a directional drilling tool and additional screw compared with a 1-cent coin, Source: Hofer Medical Solutions
Why did you decide to in-license a technology and not develop it yourself?
In 2008, I came across Dr. Jochen Erhart, who has been head of Trauma and Orthopaedics at the Brothers of Brothers of Saint John of God Eisenstadt since 2018 and who referred to the subject of the scaphoid bone, at a symposium. I found this very exciting and wanted to do more in this field at Hofer Medical. In 2014, we came full circle and our paths crossed again. He told me about the patent and shortly thereafter, we concluded the agreement with the Medical University of Vienna.
We don’t steal ideas. If somebody has a good idea, we need to approach them to see if we can cooperate with them. This also helps us to gain a better understanding of the material and to generate new approaches. In addition this potentially results in faster development and enables development costs to be kept to a minimum. Otherwise, Hofer Medical would have had to get around the patent. In the first place, that is not legitimate and in the second place, the Medical University of Vienna had already put in a lot of previous work which was great for us to be able to build on. The Medical University had previously considered various screws with engineers and developed the technology on the basis of these results.
What are / were the greatest challenges in developing the technology further?
One challenge for us at the start was building on the preliminary work done by the Medical University of Vienna, as this required strong cooperation with the medical profession that supported us in the development. We only have developments here where doctors have been involved, as we are engineers at Hofer Medical and medical requirements profiles can therefore only be developed by working together with doctors.
Medical requirements, such as the operational method for screwing the scaphoid bone, need to be clearly defined as well as technically possible to implement and everything must comply with the legal framework and directives for medical devices. We have managed to achieve this with the directional drilling tool we have developed. The additional implant - this directional drilling screw - can now be implanted and removed according to the doctor’s requirements. It enables both screws, with a tip diameter of just 2.8 mm, a length of 20 - 24 mm and a head diameter of 3.8 mm, to be properly fastened together, without any collision.
When completing a clinical assessment and performance evaluation, and thus an analysis and evaluation of the clinical data for a medical device, the benefits and risk factors of the implant have to be verified. The benefits to the patient must be the overriding factor, otherwise approval would not be granted. From construction to patient recovery, all these areas need to be covered in the clinical assessment; and that can take time. In most cases, you need to allow between 2 and 5 years for approval to be granted.
What do you see as being the key aspects that need to be considered for fair in-licensing and a fair licence partnership?
It is important to have professional support from a reliable authority, who can support you with questions on the licensing project, provide the necessary information and advise on preparing for negotiations. In our case, we received particularly good advice from Austrian Promotinal Bank (aws).
There also needs to be trust on the side of the licensor and potential licensee. The protection of confidential expertise and confidential business information is particularly important here. Negotiating partners should sign a non-disclosure agreement. If someone has invented something and has invested a lot of money in it along the way, prospective customers should acknowledge all the work done previously and not copy it or issue documentation based on it and subsequently abort contractual negotiations and do it themselves.
Mutual support and fair conduct are likewise crucial aspects. Cooperation partners should be well disposed towards each other and have a positive attitude with each other. Great care should be taken with in-licensing but no one should be put under pressure. We were lucky that there were not too many competitors and we now have an exclusive agreement. Hence, there was also no stress or pressure put on us by the Medical University. If the process is being set in motion for the first time, you need to show that it will lead to implementation. Because both parties will benefit from this. The licensor receives licence fees and the opportunity to potentially open up other markets and the in-licensing party can have quick and relatively inexpensive access to innovative technologies and expertise and develop the technology. In our case, the licence fee was a lump sum of a few percent of turnover. This enables both parties to continue to grow and also enjoy their work. When people work fairly, you can still look each other in the eye after 20 years of cooperation.
(Interview with Dr. Christian Maier conducted on 3.4.19 by Diana Wieden-Bischof)