Archives: Speakers

Maike Hiller is a Clinical Development Scientist at Philips with a focus on PMCF studies in the business unit Hospital Patient Monitoring. In her career in the MedTech industry over the past 20 years, she gained extensive experience from various positions in Product Management and Marketing, User Training, Business Development and Clinical Research. Her in-depth product knowledge reaches from class I to class III products in the clinical domain of Acute Care and spans product applications in very developed but also developing markets. In her Clinical Development role, she focusses on real world evidence generation in mixed method Post-Market-Clinical-Follow-up (PMCF) activities. Besides meeting regulatory EUMDR requirements and focusing on patient safety and closed loop product improvement, efficiency, scalability and cost-effectiveness are key aspects in her study designs. In this rather new domain of PMCF, she values knowledge and best practice sharing through different MedTech associations work groups and maintaining also an active dialogue with the different stakeholders on opportunities and limitations in this regulatory field.

I have spent over 25 years in the medical device industry focusing on two core challenges: identifying the essential clinical evidence needed for an innovative device and strategizing the most efficient way to acquire it. My work is driven by the conviction that innovation thrives when we eliminate excess overhead and are willing to cross geographic borders to get the evidence we need.

Dr. Ulrich Nitsche, M.D./Ph.D., is Global Director and Head of the Clinical Centre of Excellence at the notified bodies TÜV SÜD NB0123 and TÜV SÜD NB2443. In addition to his work as an internal clinician, Ulrich Nitsche is member of the German Institute for Standardisation (DIN-Normenausschuss) in the Clinical Trials / Clinical Evaluation Working Group. In addition, he is member of the Ethics Committee of the Technical University of Munich and of the Specialised Ethics Committee for Special Procedures of the BfArM. Ulrich Nitsche is a specialist in visceral surgery and a senior emergency physician.

Dr. Tonia Jeiter is a board-certified gastrointestinal surgeon with ten years of clinical experience at a German university hospital. She joined TÜV SÜD Product Service GmbH in 2018, progressing from clinical reviewer to team lead and global clinical data trainer, where she managed a multidisciplinary team of clinical evaluations specialists and provided expert training on EU MDR compliance on a global capacity. Dr. Jeiter also served as a senior clinical panelist and trainer for Team NB. In 2024, she became Senior Clinical Consultant at Akra Team GmbH, advising manufacturers on clinical evaluation and conformity under EU MDR. Currently, she is Senior Manager, Clinical Evaluation and Clinical Lifecycle Management at Alcon, driving clinical regulatory strategies for new product development portfolio and providing comprehensive, cross-functional oversight and guidance on all aspects of clinical evaluation and clinical lifecycle management.

I am focused on MAKING IT EASY FOR MY CUSTOMER TO SUCCEED. I am passionate about creating success all around me. My career path has led my on an amazing journey through R&D, Operations, Business Intelligence, Product Management, Marketing, Sales, Business Development and now in Senior Leadership of a multi-billion dollar packaging company. This path has given me an understanding of the many challenges faced by all aspects of the businesses and allowed me to understand that everyone has their unique challenges. Born and raised in the St. Louis, Missouri (USA) area I have three sons and a daughter (two sets of twins) and an amazing wife, Megan. Not much free time but I do enjoy playing and coaching soccer (thats football for all the non-Americans) and DIY.