Additive manufacturing promises a revolution in the way we manufacture and distribute goods in a range of industries. The opportunities for the medtech sector are immense, for business, healthcare professionals and patients alike.
Ultimately, the benefit of this technology lies in the deskilling and decentralising of the manufacturing process – giving users the ability to manufacture (possibly hitherto impossible to manufacture) designs at the touch of a button. The advantages conferred on legitimate manufacturers by 3D printing however, are also conferred on the counterfeiters and several existing barriers to market are significantly diminished.
Currently counterfeiters must acquire the ability to manufacture counterfeit goods that are close enough to the individual product to evade detection. 3D printing however enables the production of devices that are, at least in appearance, identical to those of the original manufacturers.
A second challenge for counterfeiters currently is the transporting of fake goods to markets of choice. Given that digital designs for 3D printing can be shared electronically however, this too becomes easier for counterfeiters, and renders traditional border controls ineffective.
Digital first IP
Intellectual property (IP) protection has traditionally focused on products – tangible objects with components and dimensions readily describable in a patent. While physical products remain important, in the brave new world of 3D printing, products will also have digital versions, and businesses will need to place a much greater emphasis on protecting computer-aided design (CAD) files.
If effective protection against 3D enabled counterfeit goods is to be obtained, manufacturers will need to refocus their IP strategies. This will require new approaches to defining the breadth of IP protection, as well as approaches to geographic coverage.
Given the ability to easily share data – and CAD files – globally, broad geographical protection will be increasingly necessary for medtech manufacturers.
Currently, IP protection focuses on geographies well-known for manufacturing. Whilst this principle is set to endure, the decentralisation of manufacturing enabled by 3D printing, will mean territorial protection in key markets may also become more important.
IP rights that have cross-border scope are particularly attractive in this regards. Such rights include the European registered design right as well as the (European) Unitary Patent (which will hopefully come into force in 2019 subject to wrangling at the German Constitutional Court and the eventual shape of Brexit).
Traditionally, manufacturers IP strategies have focused heavily on patenting. While the importance of patents is unlikely to diminish, a greater focus on protecting digital expressions of a product will lead to further emphasis on other IP rights. Design rights in particular will be key in preventing the illicit dissemination of CAD files. Design rights are especially important in light of ongoing efforts by the European Parliament to improve legislation in this area. As the trend towards ever more bespoke products in the medtech space continues, the manner in which design protection is pursued is also likely to change, with increased focus on maximising the scope of protection provided.
Traps for the unwary
New ways of manufacturing require new ways of thinking about manufacturing. Companies currently employing 3D printing techniques may be well placed to anticipate the actions of 3D printing counterfeiters. For others however, who’ve had less exposure to this technology, imaginative and competent IP advice will be vital. Choosing the right advisors will ensure IP protection is future proofed against a changing business environment. Lessons should be learned here from similar processes in other sectors. What can be learned from the computer industry for example which had to adapt quickly from a business model based on stand-alone machines, to one based on networks of machines interacting with each other?
Tech solutions to tech problems
Technical problems often come with technical solutions, and alongside revisiting approaches to IP, medtech innovators should also consider the opportunities afforded by other new technologies. Blockchain encryption for example has huge potential in tracking products and enabling end users to verify the genesis of a product in question. 3D printing is poised to change the medtech industry. Focusing IP strategy on the challenge now, will ensure the innovators stay one step ahead of the imitators.