New trends in surface technology for medical implants

9 November 2021

Technical University of Denmark
Anker Engelunds Vej 1
Bygning 101A, Mødelokale 1
2800 Kgs. Lyngby

An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure.

Some implants contain electronics (e.g. artificial pacemaker or cochlear implants) while others are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.

This seminar focuses on interactions of implants with biological systems, coating technologies, durability, test possibilities, as well as the new MDR requirements for medical devices. You will learn about both recent advances from research institutions as well as from private companies.

Target audience:
The seminar is aimed at employees in the medical and materials science industry who could benefit from learning more about materials and surfaces in medical implants.

08:30 - 09:00
Registration
09:00 - 09:10
Welcome by ATV-SEMAPP
09:10 - 09:45
Chemical characterisation of medical devices incl. implants

Helle Stendahl Andersen, Business Manager, Danish Technological Institute

The presentation will focus on the requirements of chemical characterization according to MDR and FDA and will include the various phases of a test program. All considerations and information required to perform chemical characterization of a medical device will be discussed.
Chemical characterization must be performed on the final product but can with advantage already be used in the product development phase. The presentation will explain why it is important to consider the final test strategy early in the process.

Helle Stendahl Andersen (Eng. MSc) is Business Manager at the Danish Technological Institute. She has 5 years of experience in advising manufacturers of medical devices in relation to chemical characterization. She is a member of the Danish delegation for CEN/TC 194: “Biological and clinical evaluation of medical devices”.
09:45 - 10:20
Orthopaedic implants: adverse events and the importance of multidisciplinary collaboration

Jan Duedal Rölfing, Orthopaedic Surgeon and Associate Professor, Aarhus University Hospital and Aarhus University

Orthopaedic implants, i.e. plates, intramedullary nails and screws are most often manufactured of either stainless steel or titanium. From a clinical point of view, titanium implants tend to be difficult to remove due to excellent biocompatibility and bone and soft tissue adherence, while stainless steel implants are easy to remove and have a higher loading capacity.
Motorized implants can be used to lengthen bone and elongate the soft tissues. These implants have to be removed. Recently, a collaboration between all four Danish University Hospitals, The Technical University of Denmark, and Force Technology has uncovered an implant failure of a stainless steel (Biodur 108) limb lengthening nail. We showed that the implant was susceptible to mechanically assisted crevice corrosion with a significant impact on the patients. The talk will highlight that properties of the implant’s surface are highly important for a safe clinical application.
Furthermore, a glimpse of the forefront of personalized medicine with 3D-printed titanium implants will be given. This collaboration includes Aalborg and Aarhus University Hospitals, the Danish Technological Institute and the Centre for Clinical 3D Print, Aarhus University Hospital.

Jan Duedal Rölfing is an orthopaedic surgeon and associate professor at Aarhus University Hospital and Aarhus University. He is editor and board member of the Danish Orthopaedic Society and supervises several projects in basic science, paediatric orthopaedics, limb lengthening and reconstruction.
10:20 - 10:50
Coffee break
10:50 - 11:25
Preclinical assessment of antibiotic surface coating of bone implants and prosthesis

Louise Kruse Jensen, Associate Professor, Københavns Universitet

Getting a bone implant like a new hip or knee prosthesis can turn into a long and painful nightmare if the implant and the peri-implant bone tissue get infected with bacteria. This talk describes how the bacteria form biofilm on the implant surface and within the surrounding tissue and, thereby, become extremely difficult to eradicate. Furthermore, the talk also describes how to perform preclinical studies in animal models in order to investigate preventive antimicrobial surface coatings of bone implants. Studies and projects based on porcine models will be included as examples.

Louise Kruse Jensen is an Associate Professor in Veterinary Pathology DVM, PhD, dr.med. (DMsc) and a veterinarian with a specialization in experimental pathology. She is specialized in development and application of porcine models of bone infection in humans and is currently investigating new applications form for local antibiotics.
11:25 - 12:00
Metal 3D print of implants and surface functionalization

Lasse Haahr-Lillevang, Consultant, Danish Technological Institute

Metal implants are often 3D printed due to the high strength combined with the high degree of design freedom and the possibility of patient customized solutions. The technical demands to 3D printed implants are presented as well as the possibilities which the technology offers. Furthermore, a review of the typically used surface treatments of 3D printed implants are presented together with its limitations and future possibilities.

Lasse Haahr-Lillevang holds a PhD in physics from Aarhus University. He has been a Consultant in the Center for Industrial 3D print at the Danish Technological Institute since 2017.
12:00 - 13:00
Lunch
13:45 - 14:20
Light triggered biomimicking implants

Peter Thomsen, CEO, Biomodics

The incidence of chronic kidney disease (CKD) and related kidney failures are increasing dramatically, and the cost of treatment places an enormous burden on global healthcare systems. As an example, according to the European Kidney Health Alliance, dialysis reimbursement costs generally 40,000 to 80,000 €/year per individual, depending on the country. The annual mortality rate for CKD patients in hemodialysis (HD) treatment is above 20% [1]. The most common causes of kidney disease are obesity, high blood pressure (hypertension) and diabetes. In 2016, 1.18 M people died from kidney failure, a 32% increase since 2005 [2]. State-of-the-art (SoA) devices used for vascular access (VA) during dialysis treatment fail because of tissue ingrowth, infections, and blood clots, as. There is, thus, a clear medical and economic need, confirmed by physicians, for a device that provides rapid vascular access for hemodialysis, and that prevents or significantly delays complications and failure.
Biomodics has developed a novel arteriovenous graft (AVG) for chronic dialysis patients, that greatly improves the patients’ quality-of-life by reducing the physical and emotional burden associated with regular dialysis. The graft significantly reduces the risk of infection, thrombosis and restenosis due to a unique recipe comprising our proprietary biomimicking polymers. Our fully integrated graft allows greatly improved treatment, entails much fewer complications and allows for non-invasive monitoring of dialysis and graft performance. The graft will also open the possibility of remote monitoring in a home-dialysis setting.

Peter Thomsen manages several companies and a wide range of international collaborations. He advises a range of large and small health care companies in connection with development of new flexible polymer scaffolds and coatings. He is highly endorsed and winner of international tech and innovation contests such as Techtour.
14:20 - 14:55
Neuro-electronic interfaces: biocompatibility and functional aspects

Jens Schouenborg, Professor, Lund University

A key requirement for valid and high quality recordings/stimulations of neural tissue is that the microelectrodes themselves do not impair the functions of the neurons nor cause major alteration of the organization of the targeted neuronal networks. Hence, the surgical procedures and the implanted microelectrodes need to be highly biocompatible. Another requirement is that the microelectrodes can stably record or interact with the same neurons over time. Consequently, it is crucial to understand how to minimize the tissue reactions to implanted foreign objects and how to maintain a stable position of the microelectrodes in targeted neuronal networks after implantation. This lecture will discuss how to comply with these requirements and remaining challenges.

Jens Schouenborg has a background in integrative neurophysiology focusing on pain mechanisms and sensorimotor integration and got a full professorship in Physiology in 1998 at Lund University, Sweden. Since 2006 Jens Schouenborg has headed the interdisciplinary Neuronano Research and Innovation Center at Lund University, Sweden, which focus on developing a new generation of truly biocompatible neural interfaces for understanding fundamental brain functions (www.lu.se/nrc) and for therapeutic applications (www.neuronano.se) in e.g. chronic pain, neurodegenerative diseases and epilepsy.
14:55 - 15:15
Coffee break
15:15 - 15:50
Brain-machine interfaces for science and emerging technologies

Anpan Han, Senior researcher, DTU Mechanical Engineering

The Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative (the Obama BRAIN Initiative) is aimed at revolutionizing our understanding of the human brain. Brain-machine interfaces (BMI) technology is core to this initiative. Anpan Han will present two BRAIN projects: (i) develop MEMS BMI devices for scientific studies of movement, (ii) research MEMS BMI devices for artificial vision technology.

Anpan Han did his master's studies at KU in theoretical biophysics and PhD in Switzerland in Bio-MEMS technology. In addition, I have research experience from the USA and Aarhus University. Today, he works at DTU MEK, MPP section. Together with colleagues, he teaches “Production technology” , “Introduction to 3D printing”, and other MPP courses. His research interests are MEMS technologies, BMI applications, instrument development, and fighting climate change.
15:50 - 16:00
Closing remarks

New trends in surface technology for medical implants, 9 November 2021

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Registration fee

 DKK 2,400  Members of ATV-SEMAPP and promoting partners listed in the registration form
 DKK 2,975  Non-members
 DKK 975  PhD Students
 DKK 200  BSc and MSc students (Membership is free of charge – register here.)

All prices are excluded of Danish VAT 25 %.

The fee includes talks, breakfast, lunch and coffee breaks and access to speakers’ presentations.

Early bird discount of DKK 300 when registering before 15 October 2021 (not applicable to students).

Binding registration
Registration is binding, however substitutions are accepted at any time.

Questions
Please do not hesitate to contact ATV-SEMAPP by e-mailing atv-semapp@mek.dtu.dk.