During the last Regulatory conference organized by QED in Brussels, 3D printing companies, European Commission representatives and stakeholders discussed the legislative landscape of the industry.
Regulations and standards: two key challenges for 3D printing industries
by Giorgio Magistrelli
The next industrial revolution is arriving and is already impacting all the sectors of our life: from aerospace to automotive, from medical to consumer goods, from fashion to constructions, 3D Printing is the real revolution which will influence directly how we produce and how we live.
The possibilities are almost unlimited. However, these possibilities also raise several issues and potential threats. From a business perspective, standards, safety regulations and intellectual property rights issues are among the most important challenges. On June 10 numerous stakeholders discussed in Brussels the status of the industry, the opportunities and the regulatory issues.
The first panel focused on 3D Printing perspectives and opportunities and was opened by the conference moderator, Benjamin Denayer, Additive Manufacturing Expert at Sirris. 3D printing is considered by Sirris as one of the key high technologies which could support the transformation of Belgian companies becoming factories of the future. The AM centre has 22 engineers and technicians, 15 high-tech additive technologies in house and is the most complete installed base in the EU. One key support to companies has been related to the evaluation of the value chain of 3D printing and to the dissemination to beneficiary companies of specific added value interventions, particularly in terms of machineries and their modifications, materials and design, manufacturing processes and the related AM applications, the post process and the leading edge application components. For Sirris, which is focused on the technological and R&D development of 3D Printing, the regulatory aspect plays a fundamental role.
Adam Watson Brown, Head of Sector Media Task Force at European Commission DG CONNECT, is working on foresight in the Knowledge Management unit. KM is a multi-disciplined approach aiming at achieving organisational objectives by making the best use of knowledge and to get officials and institutions to consider the future as something other than the linear extension of what they are working on. New Economic models include the concepts that industry should be less wasteful, based much more on local involvement and individual customization, three key characteristics of 3D printing. Mass customization is also another key features of 3D printing with a wide range of applications (unanimated products, medicines, body parts, etc.) while also security threats should be considered. Moreover, further than single 3D printers for private use, we can forecast a growth of network-enabled 3D printers also linked to the development of cloud computing. AM could also be instrumental in bringing manufacturing back to Europe from the Far East, while at the same time impacting the logistic industry. Intellectual property right issues, however, need to be tackled and require further intervention, specifically with concern to patented designs: however, while there could be threats related to piracy as in the media industry, there could be also opportunities linked to the large distribution of files and the assistance of specific professionals in creating new designs.
Carla Van Steenbergen, Legal Counsel of Materialise informed that Materialise applies very strict policies to refuse any applications of 3D printing technology for the development or the production of any weapon and introduced 3D printing starting from the specific example of the University of Michigan which created with AM techniques a bioresorbable device that could rescue the life of a baby who could not breath correctly, having his collapsed bronchus blocking the crucial flow of air to his lungs.
Materialise developed 3D printing in the past 24 years with constant and growing investments in R&D (around € 20 M just in the past 3 years of which more than € 5 M funded by the European commission and from the Government of Belgium).
3D Printing is different from the classic ways of manufacturing, because “additive manufacturing” is based on creating products layer by layer. There are four main reasons to choose AM. Firstly, it makes it possible to create new and amazing products that do not yet exist (as a medical device to save the life of a baby or a fashionable dress). Secondly, products can be produced at a very low cost and perfectly customized (as in the hearing aids industry which might entirely switch to 3D printing). Moreover, products can be manufactured with functional elements included in the manufacturing process (as not to need assembly whatsoever) and can be completely customized as in the case of the metal reconstruction of a part of the skull of a cancer patient.
However, 3D printing is much more than “pushing a button”: to manufacture a product which could answer to specific manufactory, quality safety and health requirements it is needed to develop engineering, to have people capable to design a product that can be realized by additive manufacturing technology, further than to use suitable materials and the required post production process and finishing. Ms Van Steenbergen therefore presented to the audience the case of a hip bone reconstruction, which required 5 hours of production time and 95 hours for the designing process, supported by high and good quality images, perfect engineering and materials together with a direct collaboration with medical professionals.
At the same time 3D Printing has also the possibility to stimulate local entrepreneurship: product developers can just create a design and – thanks to the platform i.materialise.com – producing it.
In regulatory terms 3D printing is facing three main challenges:
1) Quality is at the centre of Additive Manufacturing and represents a constant challenge.
2) Presenting a dedicate Position Paper (described in a parallel article) distributed to the audience, Ms Van Steenbergen indicated that the present legislation on medical devices is not guaranteeing the safe usage of additive manufacturing technology in the years to come.
3) Another issue to be specifically covered is Copyright and the related protection, as in the case of the Super 8 Cube recreated by Todd Blatt who risked being sued by Paramount.
Alain Strowel , Of Counsel, Covington & Burling LLP commented that legal issues related to 3D printing are not only related to protecting intellectual property rights, and that it is important to distinguish between objects and designs.
3D Printable objects can be protected by three different rights: copyrights, design and trademarks. However, 3 dimensional trademarks have some constraints because if the shape has a technical effect, it cannot be registered as a valid trademark, while other shapes (as a chocolate bunny) could not be protected because they are not distinctive. In case of design rights (as for shoes) protection is possible and earrings can for example be reproduced if they are for private use.
In general, a 3D-printed object can generally be protected under copyright laws if it is an original form of expression and is eligible for design protection if there is the new appearance of a product with an individual characteristic. The exceptions to IPR protection are related to private copying, personal use of articles protected by design, the eventual applicability of levies on 3D-printers sold to individuals, reprography and repair.
Other challenges to copyright protection are related to digital designs files and 3D software and therefore very much linked to B2B business. Digital blueprints and designs can be original and protected by copyright (with the exclusion of the shapes having a purely technical function and open sources developed software) as well as 3D-software. However, there are exceptions related to software reverse engineering, exhaustion for downloaded software and private copying, and repair of blueprints.
In terms of protection from online piracy, also for 3D printing there could be Digital Rights Management (DRM) technical solutions protected by laws and also the possibility to act (as for example for music files) against software distributing platforms. However, it is still necessary to wait in which directions the business could evolve before being in condition to forecast legal countermeasures.
There are also other European Laws which may impact 3D Printing, as Medical Devices Regulations, Toy Safety and General Product Safety Directives, REACH Regulations, Non-food Product Labelling and Consumer Protection rules.
In terms of standards, various standardization bodies already set up specific committees on 3D printing as SASAM (European Standardization in Additive Manufacturing), CEN (European Committee for Standardization), ISO (International Standard Organization), BSI (British Standards Institution) and ASTM (American Society for Testing and Materials) which could favour or jeopardize the market for specific 3D printing corporate actors. There is therefore the need to intervene on incremental changes to current IP laws in order to effectively deal with particular challenges (as 3D printing piracy), to support for a legitimate licensing or transactional framework and also to coordinate with regulatory developments outside the EU.
The second panel analysed in details 3D Printing Challenges and Threats and was opened by Bonifacio Garcia Porras Head of Unit B3 – Innovation Policy for Growth at the DG Enterprise of the EU Commission who intervened on how 3d Printing can complement the present industrial policies of the EC on Advance manufacturing, identifying the potential opportunities for a European industrial renaissance. According to EU Commission strategies, manufacturing should represent the 20% of EU GDP (at the moment it is just 15.1%). Job loss is also great concern as are lower demand of products and investments and the dropping of orders for machines tools. Furthermore, in the future there will be an increasing scarcity of resources, higher energy prices, increasingly complex and large sets of data will enable manufacturing firms to optimize the value chains. There is also a trend towards mass customisation and the European industry needs innovation to quickly respond to those trends. In 2013, the EC set up a task force in advanced manufacturing as to have all stakeholders involved and which includes the improvement of products processes, waste management reduction and new business models. The report produced by the task force indicated three pillars for advanced manufacturing: commercialization of specific technologies, how manufacturing can update technologies and the related barriers to be overcome, and new technical skills required by the industry.
3D printing can contribute to European Advanced manufacturing as to become much more modern quicker and adaptable to customer needs, creating new products while being a tool in finding new business (as design thinking, design management and co-creation) and process models. Use of design and innovation can improve process efficiency, not only in aesthetic terms but also in terms of processes.
In terms of future steps, for the EU is important a holistic approach, strengthening the links between digitalisation and manufacturing and between European regions, using structural funds for the modernization of the industry, and monitoring the gaps and barriers for the uptake of advanced manufacturing by the industry.
Frits Feenstra , Senior project manager TNO, member and coordinator of the European Additive Manufacturing platform presented how Additive Manufacturing is impacting the future of the European industry and how the future of 3D printing looks like, specifically presenting Hybrid manufacturing systems, the AM Standardisation Roadmap and the AM Strategic Research Agenda.
3D printing is at the moment at the peak at our expectations and industrial applications together with personal 3D printers are those aspects attracting most attention. One of the most interesting applications of AM is related to low weight production which can also benefit of no waste as for example in case of Titanium brackets production for the aerospace industry.
However, while current systems are still batch wise, slow and mono (or maximum two) materials related with no inserts, future AM systems will be hybrid, characterized by high speed, multimaterials, combining different technologies. Dr Feenstra therefore sees the history of AM characterized by an initial period based on monomaterial AM (1999 – 2005), followed by multimaterial AM (2005–2018) and then by a phase focused on the Integration of sensors (2015 – 2025).
Future products should be modular, smart, multilateral, with high added value, environmentally friendly and integrated while future manufacturing should integrate material extrusion and jetting, powder bed fusion coating, laser ablation, grinding, milling, sheet lamination etc., The practical consequence will be to pass from batch to continuous production which integrates optics and sensors in hybrid high speed manufacturing, as realized during the “PrintValley” project in the Netherlands.
With concern to AM Standardisation Roadmap, the SASAM project had the goal to create a road map for AM standardization, involving for 18 months more than 100 AM related stakeholders. The aims of standardisation are to improve the quality of products, processes and services, a more economic use of materials, energy and human resources, to improve communications, to support international trade and to enhance industrial efficiency. The main conclusion of the project have been the urgent need of globally and internationally accepted standards, quality systems, material & part qualification, reliability of machines and processes, while considering customer needs & requirement main drivers while standards could also represent market opportunities.
The roadmap for standardization indicated by the SASAM project for the period 2014-2022 considers specific processes stability and product quality requirements (as numerous tolerances) , materials (as for example titanium standards, according to specific requirements by the aerospace and the medical industry), Productivity (as process monitoring and databases with material properties) and Goals (as certification for quality of life enhancing, energy savings and on mechanical applications)
With concern to the AM Strategic Research Agenda, the SASAM report indicates the needs to promote AM on the European Stage, to highlight the advantages of AM, while setting out recommendations and a timescale for future development to enable mass exploitation as to ensure that AM is high on the agenda in the EC at a technical, political and personal level.
At present, the industry focus for AM is on specific sectors (Aerospace, Automotive, Consumer, Electronics and Medical/Dental) while the key recommendations are related to quality assurance, higher speed for lower cost Hybrid machines, design optimization, standardisation (SASAM,CEN,ASTM-F42, ISO261) and Supply chain & procurement adaptation & optimization.
Specifically focusing on biomedical challenges and the opportunities (as the replacement of human organs, tissue engineering etc.), Prof Dr Denis Dufrane , Head of the Endocrine Cell Therapy Unit, Université Catholique de Louvain commented that 3D printing is moving in diverse directions and it is expected that in the coming future it will further expand its horizons. Considering that there is still a much larger scope for 3D printing in the medical field, cells are the smallest functional units of life and tissues, comprising of different cells and arranged in specific 3D orientation depending on the functions they perform. Tissue engineering technology has used different fabrication methods for bringing cells together to generate appropriate tissues and the basic technology protocol for tissue engineering is to have a biomaterial scaffold, to provide structural support and shape to the structure (which is then combined with cells), and to generate 3D structures for use as implants for in vitro and in vivo applications. With concern to regenerative medicine, the market includes tissue engineering, cells and genes therapies, small molecules and biologics; specifically for tissue engineering, the present break down of commercially available products are in the majority for non –healing wounds and skin (46%), Muscolo-skeleton (35%), followed by cancer (10%), ocular (7%) and cardio vascular (2%).
However, for Prof Dufrane it is not often considered the balance between bio implants characteristics (as tissue remodelling, functionality, biocompatibility, cellular viability, proof of concept and pre-clinical conditions) to be matched with the host and tissue organ anatomy, physiology, cellular engraftment and angiogenesis. As an example, bone tissue engineering is quite complex and requires to consider all the biology principles that condition the future success of Bone Tissue Engineering (BTE), as the use of pluri- or multipotent stem cells, the identification of critical genes, growth factors, and signal transduction cascades that mediate bone formation, the physical process of bone formation, complex interactions between epithelium and mesenchyme within the underlying connective tissue, the understanding of mesenchyme encoding tissue-specific patterns and that normal tissue healing involves progressive remodelling and restructuring of pre-existing tissue structures, further than the importance of the tissue microenvironment’s physical properties (as “mechanotherapy”) and the angiogenesis and neo-vascularization of the newly formed bone tissue.
Notwithstanding the constant development of texts published on BTE, at the moment there are still no BTE clinical solutions to replace a bone infected if not with a human donor bone tissue.It will therefore be critical to demonstrate that the BTE algorithm for 3D bio printing can show its effectiveness to the clinics, and also that there will not be only convenience for the patient but also for the medical system in general in terms of quality control, time and costs.
Dr Peter Troxler, Research Professor at Rotterdam University of Applied Sciences, founder and member of the Board of the International Fab Lab Association introduced the concept of FabLabs, a “fabrication laboratory” which is a small manufacturing place. Fablabs started around 10 years ago from the inspiration of Prof Neil Gershenfeld at MIT aiming at giving to students the possibility to create everything. Such scope then developed to offer to ordinary people access to additive manufacturing technology and from one fablab, there are now more than 300 worldwide.
However, fablabs are much different from companies like Materialise or from bioprinting laboratories: in fablabs there are basic machines (i.e. home 3D printers) which generally use ABS (Acrylonitrile Butadiene Styrene) plastic or PLA (polylactic acid). Also in terms of operations and production, micro factories as fablabs run in a complete opposite way in comparison with traditional manufacturing. A clear example on the role of fablabs is a comparison with film-making techniques 50 years ago and present smart phones technology. Fablabs do not operate as a unique factory: they form a part of global networks but there is not a central control, neither a franchise specific model.
In terms of legislations, being a global network fablabs often face different regulations according to local national jurisdictions, and the majority of their owners, managers and users are even not aware of EU directives; however, talking about international standards could help educating fablabs people about manufacturing because it is important to educate engineers and students on what 3D printing technology can and cannot do.
Furthermore, in terms of IPR protections, Fablabs share an open source, which for Dr Troxler represents a business strategy to deal with inventions and creations; furthermore, in numerous cases new technology does not require new legislation, but some specific use of technology should be legally addressed.