Ethics & Compliance at BIOTRONIK

In a life-or-death situation, South African farmer Faan Botha received a donated BIOTRONIK pacemaker in 2013, profoundly transforming his life. Inspired by this experience, he founded the Revived Pulse Foundation, which, with the support of BIOTRONIK South Africa, now provides approximately 10 to 20 life-saving devices annually to patients lacking health insurance coverage. We also plan to gradually raise this level of support. 

Each year, BIOTRONIK's Portland, Oregon team wholeheartedly joins the American Heart Association's annual Heart and Stroke Walk. Their participation is a dynamic team effort, aimed at both increasing awareness and generating funds to combat heart disease and stroke, ultimately contributing to the mission of saving lives. 

Cardiovascular disease is the most common cause of death in adults from industrialized nations, with coronary heart disease (CHD) making up a high share of these deaths. CHD affects around 126 million people worldwide and its incidence only increases with age. Strokes, heart attacks, heart failure, and bleeding are but a few of the most common CHD complications. To help prevent these, experts with the EU-funded TIMELY project are currently working with artificial intelligence (AI), to see how physicians can improve patient outcomes.  

“After a heart attack, it’s particularly essential not to repeat old behavior patterns. This involves changing your lifestyle to include more exercise and a healthier diet. But many patients find that difficult without the right support. After they’re rehabilitated, it can be hard for them to find motivation and structure. This is where TIMELY comes in. It’ll support patients with intelligent digital solutions to improve their health,” says Roberto Belke, Managing Director of BIOTRONIK Germany. 

The TIMELY project works to support CHD patients after rehabilitation individually at home. BIOTRONIK is contributing to this process by developing an IT-supported platform together with SEMDATEX and 11 other partners. Patients, therapists, and physicians will all have access to the platform with all relevant health data.

Implantable cardiovascular medical devices are some of the most advanced, life-sustaining technologies used at a large scale. Their development, however, remains a major challenge. Computer-based (in silico) methods for development and validation of these devices can help to improve their quality, efficacy and safety, while also reducing time-to-market. In silico methods could improve access to treatment and minimize the need for in vivo studies such as animal studies and clinical studies.  

In the EU-funded project SIMCor, BIOTRONIK and 11 partners from eight EU countries will establish a joint and open digital research and development platform to support device design and validation along the entire research and development pathway – from in silico modeling and simulation to virtual animal and clinical studies. For this purpose, computer models of the heart and blood vessels as well as of the implants will be developed to investigate device fitting, vessel-device interaction and impact on blood flow. 

The project will also develop a method for creating virtual patient groups, known as virtual cohorts. These will enable new implantable devices to be tested using a large range of vessel anatomies, pathological changes in geometry and structure, and physiological and pathophysiological conditions such as different disease states and exercise conditions. These virtual clinical trials will help reduce the risk of adverse clinical events prior to starting real clinical studies, thus hopefully providing patients with safer and more effective medical solutions. 

How can we make innovations more readily available to patients? The research project Enabling Heart is investigating these and other questions. Together with regional partners such as LB Engineering, Charité, and the German Heart Center, BIOTRONIK is working to create two development tools that will enable research and development work to a large extent without the need for preclinical in vivo tests for active implants. 

As a first step, the project team will create a virtual model for in silico development, which models and combines the mechanical and electrical properties of the heart in a computational model. This will make it possible, for the first time, not only to virtually test the mechanical interaction between implants and organs, but also to evaluate the functionality of new implants in terms of sensing and pacing, and thus predict eventual therapeutic success. 

Next, a physical development tool will be created, allowing the development of new implantation techniques through practical experiments without relying on preclinical in vivo tests. 

One major advantage of the new tool will be its ability to represent various anatomies of human hearts, reflecting the wide variation seen in patients' hearts. These new development tools will enable BIOTRONIK to serve a diverse patient cohort more effectively in the development of new products, conduct design iterations quickly and cost-effectively, and significantly reduce the time from concept to market launch while achieving better design output. Additionally, there are plans to use these tools for training medical staff, which will enhance patient safety. 

The project is co-financed by the European Regional Development Fund (ERDF) and lasts three years from 2023 to 2026.