Speakers’ sound-bites, key notes and take-away

Dario Tamburrano, Member of the European Parliament (EFDD) 3D printing is not only the future but the present and what seems now impossible, could soon become reality. Technological innovation needs to be closely monitored and politically addressed to avoid and prevent dangerous applications as it happened with nuclear energy. Skills development and education play a key role and young

students need to be heard, specifically when it comes to innovation. Advanced technologies need to be considered as to avoid the mistakes of the industrial revolution, in order to achieve better income and wealth redistribution and a reduction in working hours. It is fundamental in supporting the synergy between dentists and professional of dental laboratories.

Patrizia Toia, Member of the European Parliament (S&D) 3D printing is playing a key role in the development of the European and worldwide industry, also in terms of mass-customization. H2020 is fundamental in supporting the development of innovative SMEs.

Jerzy Buzek, Member of the European Parliament, ITRE committee chair

Innovation and economic development should grow together following a holistic approach. All policies concerning health, SMEs development, technologies and innovation, should be coordinated and allow an integration of the existing and future legal landscape together with political and institutional frameworks. 3D printing helps the development of specific sectors as the dental sector and it is important to be opened to innovation, even if it leads to different professional habits and strategies.

Marco Landi, President of the Council of European Dentist CED`s key mission is to allow high oral health standards to European Citizens. We need to focus on having new technologies specifically tailored for and used by professional dentists, considering that shrinking health expenses puts at risk the levels of cures in Europe and the safety of the patient. We also need to focus on necessary technologies and cures, not on interventions that won`t improve patients’ health, and to be careful that new technologies do not increase costs. Excessive deregulation could lead to a lower quality in terms of health service.

Pierluigi Delogu, President of the Italian Dental Association (AIO) 3D printing is a new frontier for dentistry and it is fundamental to avoid the mistakes of the past, when technologies have sometimes not been accurately tested. There are three development ways to be explored on 3D printing in dentistry, to be summarized in the acronym TRL, as follows: Training, Research and Laws. The development of the inter-disciplinary areas of nanotechnology, advanced materials and material properties will soon require a number of new reference measurement standards and methods in the physical as well the chemical fields. Processes and CE

certifications or materials and procedures should be taken in consideration as the coordination among all related procedures and the reduction of bureaucracy.

Alessandro Gamberini, President of the Federation of the European Dental Industry As an active member of the EC working group NET (New and Emerging Technologies), FIDE is involved in several subgroups (the so-called SIG, Special Interest Groups). Considering the importance and the constant development of 3D printing application, one of these is the SIG 3D, i.e. the Special Interest Group on 3D Printing which is focusing on the setting up of a white paper on 3D technologies, detailing the fields of application of 3D printing

technologies and their potential regulatory framework in the light of the upcoming changes in the Medical Device Regulations.

Colette Maloney, Head of Unit, Photonics - DG CONNECT All industries in Europe require a strong digital sector and the broad digital transformation of the entire industry offers a unique opportunity to strengthen Europe's digital sector. The digital value chain is critical for the competitiveness of all sectors and there are three dimensions of Value Creation from Digitisation: the so called “Digital inside", i.e. innovations inside all types of products, as well as the processes and the business models. Additive Manufacturing is one of the key technologies driving the Digitisation of European Industry and has a huge potential because it is also one of the

technologies to respond to the needs of individualised mass production, which is a major trend in the industry. Challenges that need to be solved include software ease of use, compatibility and process control, the utilization of more suitable materials and the related standards, speed, cost, precision, surface quality, repeatability of hardware; in terms of workflow challenges are related to design reliability, pre and post processing, consistency; while in the legal field safety, piracy, copyright are still key issues. Another key role is played by regional Digital Innovation Hubs, instrumental in allowing European SMEs to access digital technologies and expertise within "working distance.

Tapani Piha, Head of Unit, Cross Border healthcare, E-Health - DG SANTE Digital innovation is becoming crucial in the e-health sector. The role of digital is central in EU health policies. Under the Digital Single Market (DSM) Strategy there are five actions: exchange of health data, promotion of telemedicine, access to own health data, “mhealth” and the standardisation in medicinal products. Existing key challenges are related to data protection and trust, present lack of legal framework knowledge,

of interoperability between health systems in the EU and in some cases safety of health apps.

Salvatore Scalzo, Legal Assistant, Unit Health technology and cosmetics - DG GROW The existing reference regulations on medical devices which at present do not include 3D printed medical devices are Dir. 90/385/EEC on active implantable medical devices and Dir. 93/42/EEC on medical devices while the Regulation on in vitro diagnostic medical devices is the Directive 98/79/EC on in vitro diagnostic medical devices (IVDs). The forecast is related to the full application of MDR in 3 years and of IVDR in 5 years. While existing regulations are not specific on 3D printed devices, medical software

and 3d printed custom-made devices are regulated by the directives in terms of definition of "custom-made" medical devices. It should be therefore considered the possibility to extend the application of the "custom-made" regime to 3d printed devices, how to capture a fragmented

manufacturing process and specifically the legal status of the "data-set" and the legal obligations for the relevant economic actors.

Jose-Lorenzo Valles, Head of Unit, Advanced manufacturing system and biotechnologies - DG RTD Additive Manufacturing has numerous effects as the disruption of the manufacturing value chain, allowing a shift from mass production to full customisation, the manufacturing of light weight structures which retain structural strength, using less material, less waste, less energy, less CO2 emissions, reduced time to market and freedom in design, which can create new business models and market opportunities and the enabling of production on a local basis, closer to the point of consumption,

strengthening the regional economies. The EC provided AM related funds since the First Framework Programme (FP1, 1984-1987), and under FP7 (2007-2013), over 60 AM projects were funded with more than €160 million in EU funding and an overall budget of around 225 million and Horizon 2020 supported at least 27 AM projects in 2014-16, with over €113 million in EU funding. Non-technological challenges for AM are related to Patent protection, Training and skills at all level and legal and financial issues for the AM industry.

Giorgio Magistrelli, EFDD Group adviser for Additive Manufacturing 3D Printing is a revolution and all the stakeholders have to deal with its impacts as well as taking advantages of the related professional opportunities: it is therefore fundamental to invest in skills and education, as well as in research and innovation.

Peter Mercelis, Co-Founder and Director of applied technologies, 3D Systems Innovative materials will enable clinical use of 3D printed prosthetics, while bone-replacement structures in metal and inert and biodegradable polymers could provide an improved solution for bone augmentation and automated high-speed SLA technology will enable both chairside 3D printing and automated centralized dental manufacturing. Practice lab manufacturing will play an important role in the future driven by higher

penetration of intra oral scanning, easy to use and fast printing technologies and fully integrated workflows of scanning, prosthetics design and printing. Manufacturing costs of dental prosthetics will come down further, potentially bringing back additional outsourced work from low labor cost regions and in lab manufacturing, centralized dental manufacturing and practice lab manufacturing will continue to co-exist, depending on business models and prosthetics types. With concern to regulatory and legal considerations, closed solutions of

software, hardware and materials are losing market shares to ‘open systems’, while Chairside 3D printing solutions are around the corner.

Daniela Lavezzi, Sales Manager, DWS The exclusive DWS DPRS® process is a combination of the DFAB® dental printer and the innovative nano-composite called TEMPORIS® offering specific solutions, from intraoral scanning data to class IIA, long term provisional 3D printed dental restorations”.

Martin Bullemer, Business Development Manager Medical, EOS EOS`s philosophy is based on a well-balanced AM Triangle where Process, System and Material are fully integrated and constantly ensure high quality parts, this being Quality Management`s key for EOS. Hybrid Manufacturing is fundamental when considered for Dental Superstructures because they are patient matched in many cases and - while AM delivers the foundation - parts must be finished with

conventional methods (milling). Hybrid Manufacturing as well as milling is very beneficial, but it represents a regulatory challenge for dental milling centres and needs to be addressed. Key role will be played by Improved Osseointegration, allowing the manufacturing an AM implant to minimize stability risks.

Philip Oris, Director Business Development Medical & Dental, SLM Solutions GmbH The “Selective Laser Melting” – SLM – Process and the related Powder Bed Fusion Technology, which allows thermal energy selectively fusing the regions of a powder bed is a key enabler for 3D Digital Dentistry both on the surgical side and the restorative side allowing complex geometries, integration of functions, customization, productivity and cost advantages. Specific applications are the manufacturing of Dental Bridges offering

Patient-Specific high precision Prosthesis, crowns and bridges, implant bars and frames, implants and abutments. In terms of materials powder SLM solutions provides Titanium, Cobalt-Chrome, Tool Steel and Stainless Steel, Nickel Based Alloys and Aluminium.

Eric Erickson, Business Manager, Dental Solutions, EMEA, Stratasys Stratasys, has been at the forefront of 3D printing and additive manufacturing innovation for 25 years. Headquartered in US and Israel and publicly traded on NASDAQ (SSYS), Stratasys has sold over 150,000 systems, over 1,200 granted or pending additive manufacturing patents globally, over 30 technology and leadership awards, and $696 M revenue (2015). Polyjet is a unique, versatile jetting Technology

which offers specific benefits to Key Stakeholders (patients, dentists and dental technicians and laboratories). It is important “not to only look at the Labs as of today , even if they are key target group because it is not only about make production more efficient for them, but also for the dentist while offering the best product for the consumer: patients will be a key driver for that technology. Key applications of 3D printing are “stone models, cast partial frame, surgical guides, maxfac models implant models”.

Vittorio Gaudino, Sisma SpA General Manager Sisma, established in Italy in 1961 represents a worldwide reference for the design and production of extremely high precision machinery. Conferences as this one are fundamental, specifically for the complete alignment of all stakeholders in terms of how to cooperate for the development and the applications of 3D technologies. When we talk about 3D manufacturing machines we have to

consider integrated systems and – as according to Sisma’s philosophies – open systems integrating overall spectrum of the value chain in its entirety. One issue is surely related to the need to develop efficient regulations, a classification of 3D devices in conjunction with the new Medical Device Regulation, the clarification of what is the definition of "industrial manufacturing" and the eventual importance of the number of pieces essential, as well as the Classification of 3D printers.

Frank Schwalba-Hoth, founding member of the German Greens and former MEP It is important to consider the impact of 3D printing on occupation and the potential risks and opportunities.

Gerhard K. Seeberger, past national President of AIO and speaker of the Federation Dentaire Internationale (FDI) The beneficiaries of the 3D printing development in the dental sector are to be considered all the citizens of all our countries, while focusing on the opportunities also in the education sector by innovative technologies. All stakeholders must work together, just like during our conference, for the ultimate goal of providing benefits to all citizens.