This article originally appeared at Medtech Innovation News.
Researchers at the Rensselaer Polytechnic Institute in New York have developed an innovative method of 3D printing vascularized artificial skin for grafting onto patients. The result is artificial skin containing vasculature (blood vessels) that greatly assists in the integration of the skin with the host. This allows transfer of blood and nutrients between the host and the graft to keep the graft alive.
By making use of recent developments in additive manufacturing, the researchers were able to deposit bio-inks to form a skin-like structure in the lab. The skin was printed in two layers – a vascularized dermis layer containing cells for the vasculature such as endothelial cells and pericyte cells, and an impermeable epidermis layer for protection. The tissue was then cultured in vitro to allow it to mature before being grafted onto a host (in this case, a mouse).
The researchers found that over the course of two weeks in vitro, the skin graft started to develop a biologically relevant vascular structure. This has previously been difficult to produce due to the complexity of biological systems.
Pankaj Karande, the lead researcher on this work, explains: "As engineers working to recreate biology, we've always appreciated and been aware of the fact that biology is far more complex than the simple systems we make in the lab. We were pleasantly surprised to find that, once we start approaching that complexity, biology takes over and starts getting closer and closer to what exists in nature”.
This indicates that, whilst the ability to 3D print complex biological structures might be beyond current additive manufacturing techniques, such complexity can be developed in vitro after the appropriate biological material has been printed.
Once the skin was grafted onto the host, the vasculature of the host integrated with that of the graft. This is an important step in ensuring that the graft remains healthy.
The developments by Professor Karande and his team are indicative of the wider spread of additive manufacturing beyond its original use in the rapid prototyping of mechanical products. As the technology develops, it becomes a feasible manufacturing method in a wide variety of fields, including biotechnology, medical devices, pharmaceuticals and food technology.
This increased crossover in technologies helps to foster innovation but also poses disruptive risks for established businesses. Furthermore, as with all technology development, it is important that new innovations are protected in order ensure that their value to businesses in maximised.
The traditional avenues of protecting innovations (such as patent and design right protection) will need to adapt in order to cope with this changing landscape of technology. Biotechnology companies that are used to protecting methods of manufacture and products manufactured by specific processes may not be aware that protection could equally be obtained for software processes, such as the control or design of an additive manufacturing process.
This can be particularly important where processes may be distributed geographically. In this digital age, there is no need for a 3D printer to be controlled locally. The designer and controller can be located remotely to the 3D printer. Whilst this be a great benefit in improving access to technology to more remote areas, this can also pose issues when it comes to protecting innovations as legal rights tend to be issued in individual jurisdictions.
These risks can be resolved through the careful crafting of intellectual property protection, but forward thinking is necessary. Given the 20 year lifespan of a patent, products that may be unprintable today may be easily produced via additive manufacture before the expiry of the patent. Innovators should therefore look to future-proof their intellectual property against further developments in additive manufacturing.
With the growth of 3D printing, and as traditional areas of technology become increasingly intermingled, it is important for businesses to adapt to ensure that they are not left behind. Businesses involved in product research and development need to start planning now for a brave new world and, in particular, ensure that the intellectual property protection that they are applying for today will stand up to the test of time, and still be fit-for-purpose 20 years down the line.
