Industry Panel | Sep. 11, 14:40 CEST

Regulatory Affairs for 3D Printed Medical Devices

Session Chair
Folker Spitzenberger | Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Germany

Building a qualified serial production program with AM

Philip Oris, Director of Business Development Medical & Dental, SLM Solutions Group AG

Philip Oris is Director of Business Development Medical & Dental, SLM Solutions Group AG, He holds Master Degrees in Biomedical Engineering Postgraduate, KU Leuven (Belgium)and Mechanical Engineering, KU Leuven Campus Group T (Belgium). Since 2016 Philip Oris is responsible for business development for the healthcare markets at SLM Solutions. The company headquartered in Lübeck (Germany) is a leading provider of metal additive manufacturing equipment and services. Prior to joining SLM Solutions Philip worked as sales manager for minimally invasive surgery equipment for two market leading companies, and as expatriate general manager for additive manufacturing software and services for a market leading company. Philip has been active in additive manufacturing for the healthcare market for 14 years.

ACTIVA3D COPPER

Stefan Ritt, SPEE3D GmbH

Scientific paper

SPEE3D is a manufacturer of metal 3D printers based in Dandenong, Melbourne. The world leading metal 3D printing technology developed by SPEE3D has been exported globally and has recently been adopted and deployed by the Australian Defence Forces. In a successful pivoting effort, the company developed ACTIVAT3D for touch surfaces in order to help stop the spread of COVID-19.

ACTIVAT3D copper is antimicrobial copper that can be rapidly deployed using SPEE3D technology. New algorithms allow SPEE3D printers to coat existing metal parts with copper which is more efficient than printing solid copper parts from scratch.
Australian NATA accredited clinical trial speciality laboratory, 360Biolabs, tested the effect of ACTIVAT3D copper on live SARS-CoV-2 in their Physical Containment 3 (PC3) laboratory. The results showed that 96% of the virus is killed in two hours and 99.2% of the virus killed in 5 hours, while stainless steel showed no reduction in the same time frame. 
While the exact mechanism by which copper kills bacteria is still being studied, the laboratory data is compelling - on copper surfaces, bacteria and viruses die. When a microbe lands on a copper surface, the copper releases ions, which are electrically charged particles which react with moisture and oxygen to produce reactive oxygen. Copper ions and reactive oxygen rupture the outer membranes and destroy the whole cell, including the DNA or RNA inside. Because their DNA and RNA are destroyed, it also means a bacteria or virus can’t mutate and become resistant to the copper, or pass on genes (like for antibiotic resistance) to other microbes.
The lab results show ACTIVAT3D copper surfaces behave much better than traditional stainless, which may offer a promising solution to a global problem as Stainless steel is currently the material typically used in hygiene environments. The technology can be used in any high traffic public area such as hospitals, schools, on ships or shopping centres.

The Northern Territory Department of Trade, Business and Innovation was the first organisation to deploy antimicrobial ACTIVAT3D copper throughout their building to help fight the spread of COVID-19. SPEE3D was contracted to replace existing door handles within the building with ACTIVAT3D copper products. With these handles now installed, staff, and the community they interact with, are already experiencing the benefits of antimicrobial copper. The lab results have sparked global interest in this technology and SPEE3D receive daily enquiries from organisations looking for proactive ways to protect their communities. 

After earning his engineering degree in technical physics from the University of Applied Science in Lübeck, Germany, Stefan Ritt started his career in RP/AM in 1985 when running a prototype lab in the R&D arm of a coffee and vending machine company. After that, he held positions in QA and product management for mid-sized Dutch and Danish companies. In 1998, Stefan took on international sales and marketing of RP tooling products for a UK/German joint venture that transformed into the SLM solutions group. In this capacity, he was successful in international markets with the development and support of the transition of RPT and metal AM equipment into production equipment.  He could manage to bring the first powder-bed Laser metal printer on display at an AMUG-conference into the US among other significant steps for the AM-industry. He now works for SPEE3D from Melbourne-Australia, which brings another new metal AM technology for production into the market, as their European managing director in a newly founded European office in Lübeck. He is a part-time lecturer for supply chain management at the technical university of Lübeck and guest lecturer for international business communication in marketing at the Technical University in Hamburg. In 2011, he was appointed as the European liaison officer and global ambassador for AMUG, the world's biggest user group for additive manufacturing applications. In 2015 he was awarded the AMUG-DINO for his continuous support and involvement for the user group and industry. Every year he brings the latest news, trends and future outlooks of the AM industry from around the world to multiple audiences and conferences and now engages himself  strongly into the vision to integrate Additive manufacturing into everyday life and production processes. 

Regulatory challenges for 3D printed personalized medical devices

Ward Callens, Materialise GmbH

Abstract: 3D printing can be used to manufacture both standard devices, as well as personalized devices. For the latter, a number of jurisdictions around the world allow those products to enter the market not following a normal conformity assessment. As an example, the EU has the system of custom-made devices. As regulators realize that 3D printing leads to a strong growth in personalized devices, these regimes have become more restrictive. This presentation aims to provide a brief overview for some jurisdictions, including the EU, USA and Australia.

Ward Callens obtained a master’s degree in law from KU Leuven (1998) and an MBA from Vlerick Business School (2008). After having started his career in regulatory affairs roles in the telecommunications sector, he joined Materialise in 2008 and served in a number of management functions. Since 2015, he heads the Materialise corporate quality management and regulatory affairs department. He has been involved in various industry consultations about the topic of personalized and 3D printed medical devices.

Materialise incorporates 30 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world. Materialise Medical, which has pioneered many of the leading medical applications of 3D printing, enables researchers, engineers and clinicians to revolutionize innovative patient-specific treatment. Materialise Medical’s open and flexible platform of software and services, forms the foundation of certified Medical 3D Printing, in clinical as well as research environments, offering virtual planning software tools, 3D-printed anatomical models, and patient-specific surgical guides and implants.