Exhibition Gold

Materialise GmbH


Materialise GmbH 

About Materialise’s Medical Division 
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 that helps improve and save lives. Materialise Medical’s open and flexible platform of software and services, Materialise Mimics, 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. For additional information, please visit:  medical.materialise.com 
 

Enabling mass personalisation

Pieter Slagmolen, Materialise GmbH

Abstract: Personalisation is quickly becoming a customer expectation in many industries. Driven by digitization, companies are increasingly offering personalised solutions, tailored to the user in form, fit or function. In healthcare, personalisation is driven by the desire to address unmet clinical needs and the will to tackle the massive challenges that the healthcare system is facing. Medical device treatments can leverage technological innovations in 3D printing, artificial intelligence or mixed reality to further advance their level of personalisation and clinical implementations of these technologies in personalised planning, surgical guidance or implants are becoming widely available. With targeted investments in infrastructure, software, knowledge and partnerships, personalisation can be made accessible to all patients, driven by the creation of cost-effective solutions that provide a better answer to current or future clinical challenges.


Pieter Slagmolen is a passionate healthcare innovator, driven to create clinical value for patients and caregivers by addressing meaningful applications with 3D technology. After obtaining his engineering degree and PhD on medical image processing at KU Leuven, he became committed to the mission of Materialise to create a better and healthier world. There, he introduced solutions to help hospitals around the world with running a certified point-of-care 3D printing activity. Today, Pieter is one of the drivers for innovation in the medical team at Materialise, aiming to make mass personalisation in healthcare a reality by following customer-centric design strategies in collaboration with clinical and technology experts and partners.

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.