Progress Report Hofer GmbH & Co KG 

Which existing technologies have you in-licensed in your enterprise and can you explain the operating principle of the technology in more detail?

The scaphoid bone is the bone in the wrist, which is directly adjacent to a bone in the forearm. If with a fracture in the scaphoid bone, a greater displacement should occur, then plaster cast would be inadequate and it would normally lead to a surgical restructure with a compression screw. However, this treatment is not rotationally stable and it can happen that a scaphoid pseudoarthrosis arises in the absence of the fracture healing. Generally, scaphoid fractures do not normally heal as well as other bone fractures and the healing process also takes longer.

In this case, MedUni Vienna has developed a technology to fix these two bone parts of the scaphoid together with an additional screw to ensure rotational stability, whereby the healing opportunity is significantly greater, the patient does not suffer with pseudoarthrosis and the bone can fuse together free from pain. MedUni has also built a few of the first prototypes. Hofer Medical picked up the patent idea, which was very generally formed in 2014, they then implemented these end-certified implants with the first appropriate directional drilling devices. A corresponding target drill device is also necessitated for the additional screw that is inserted parallel or at a particular angle to the normal compression screw.

Since 2014, we have constantly developed the technology and we have almost reached the end so that every physician can work securely with it and success with the patient can be achieved.

Size comparison for directional drilling device and additional screw and 1 cent coin, source: Hofer Medical Solutions

Why did you decide to in-licence a technology and not to develop it yourself?

I got to know Dr. Jochen Erhart in 2008, he has been the Head of the Department for Orthopaedics and Traumatology at the hospital of Barmherzigen Brüder Eisenstadt since 2018, and he referred to the matter of the scaphoid bone at a symposium. I found this really interesting and wanted to do something at Hofer Medical in this area. In 2014, the circle completed and we bumped into each other again. He spoke of the patent and after just a short time, we were able to conclude the contract with the MedUni Vienna.

We do not steal. I somebody has a good idea, then you should ask whether you can collaborate. This also helps to gain a better understanding of the subject matter and in the generation of new approaches. As a result of this, it is also possible to develop quickly and to minimise the development costs. Otherwise, Hofer Medical would have had to bypass the patent. Firstly, this is not reputable and secondly, MedUni Vienna had already put in a lot of preparatory work on which is was possible to build. In advance, MedUni looked a many different screws with engineers and on the basis of these result, the technology was developed.

What are/were the greatest challenges in the further development of the technology?

A challenge for us was to build upon the advance work of MedUni Vienna in the beginning, because it needed a good collaboration with the medical profession, who supported us in the further development. Here we only have developments with physicians behind them, because we, at Hofer Medical, are technicians and therefore the medical profile of requirements can only be revised together.

Medical requirements for e.g. the operational method of the scaphoid screw fitting must be clearly defined, as well as being technically viable and compliant with the legal framework and guidelines of a medical product. We have achieved this with out develop directional drilling device. The additional implant, therefore this directional drilling screw, is only implantable and explantable according to the physician’s requirements. This enables both screws, with a tip diameter of just 2.8mm, a length of 20 - 24mm and a head diameter of 3.8mm, to be correctly fixed to one another, otherwise it would end in a collision.

If a clinical assessment and a performance assessment are carried out, therefore an analysis and assessment of the clinical data for a medical product, the use and risk factor of the implant must be proven. Its use must absolutely prevail for the patients, otherwise you would not obtain approval. From the construction, through to the recovery of a patient, all of these areas should be covered in the clinical assessment and this can take time. In most cases, you can factor in between 2 and 5 years until approval.

In your opinion, what are the important aspects that should be considered in a fair development of in-licensing and licence partnership?

It is important to maintain professional support from a trustworthy authority that will provide support where there are questions regarding licensing intentions, provide necessary information and advice in the preparation for negotiations. In our case, we in particular received very good advice from aws Austria Wirtschaftsservice.

Trust must also be provided on the part of the licence provider and potential taker. Here, it is the protection of the trustworthy expertise and confidential business information that are of particular significance. Business partners should sign a confidentiality agreement. If somebody has invented something and has already accepted a lot of money for it, then the interested party should recognise the advance payments and not recreate or receive documents, then terminate the contractual negotiations and build themselves.

Mutual support and fair conduct are likewise important aspects. The cooperation partners should be sympathetic to one another and face each other positively. When in-licensing, nothing should be skimmed over and you should not allow anyone to put pressure on you. Our luck is that there were not too many competitors and now we have an exclusivity agreement. As a result, there was no pressure and stress from MedUni. Once the ball gets rolling on the process, then you should ensure that it leads to implementation. Because it is then that both sides benefit. The party who is licensing receives licensing fees as well as the possibility to potentially develop other markets and the party who in-licences can retrieve innovative technologies and expertise relatively affordably and quickly, and further develop the technology. In our case, the licence fee is a lump sum, which is a few percent of the turnover. With this, both sides can continue to grow and also have fun in their work. If you have worked fairly, then after 20 years’ cooperation you can still look each other in the eye.

(Interview Christian Maier, led on 03/04/2019 by Diana Wieden-Bischof)