LSA – Lübeck Summer Academy on Medical Technology

26. Juni 2019 ganztägig
MediaDocks, Lübeck
Dr. Dirk Hermsmeyer
0451 6006-191

Lübeck Summer Academy is organised by
IHK Lübeck



Welcome to LSA2019!

Our topics are regulatory affairs for medical devices, and artificial intelligence / deep learning.

Regulatory Affairs

Transition to the Medical Device Regulation (MDR) until May 2020 (end of transition period) continues to be the dominating topic in the medical device industry. The designation process of notified bodies (NB) in accordance with the MDR remains ongoing. In our session on Regulatory Affairs we will try to give you an overview on the state of play, and will examine a number of particular aspects, including the role of the new qualified person and the impact of the MDR on Over-the-Counter (OTC, or borderline) products. Also included is a report on experiences of a medical device start-up with European and US regulations. The session is organised by Life Science Nord’s Working Group on Regulatory Affairs.
Download PDF data: Complete Information for LSA 2019 (Flyer)
logo-biomedtec-wissenschaftscampus   logo-life-science-nord

Artificial Intelligence and Deep Learning

In 2017 we first included Artificial Intelligence (AI) as a session into the Lübeck Summer Academy. Since then, IHK zu Lübeck’s Working Group on AI has discussed both emerging and already implemented applications of AI and Deep Learning (DL) in the regional industry, research organisations and universities. Besides technological aspects, ethical issues remain an important matter of the discussion, particularly when health applications come into play. This year’s AI session at LSA describes a number of novel AI-based medical applications, and highlights how ethical concerns in system design gradually advance into legal guidelines and industry standards. The session is co-organised by Fraunhofer MEVIS and the Institute for Electrical Engineering in Medicine of the University of Lübeck.
A common introductory session with key notes, panel discussions in both sessions, and a table-top industry exhibition will complete LSA2019.
You are most cordially invited!
Heike Wachenhausen, Conference Chair
(Head of Life Science Nord Working Group on RA)


8.30 hrs Registration and coffee
Plenum Session: Welcome and Introductory Key Notes, Room MF 500
9 hrs Welcome
Heike Wachenhausen, Life Science Nord Working Group on Regulatory Affairs and Wachenhausen Law, Lübeck
9.10 hrs Key note 1: AI and Medical Devices – The Point of View of the Federal Institute for Drugs and Medical Devices
Wolfgang Lauer, Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM, Bonn
9.40 hrs Key note 2: The Future of AI in Radiology
Mathias Goyen, Universitätsklinikum Hamburg-Eppendorf, Hamburg and GE Healthcare, Solingen
10.20 hrs Discussion
10.50 hrs Refreshments and exhibition
Parallel Sessions
Parallel Session 1: Regulatory Affairs
Room MF 500
11.30 hrs Transition to the MDR – State of Play
Almut Fröhlich, German Federal Ministry of Health, BMG, Berlin
12.15 hrs EU-MDR: Challenges for “Other” Economic Operators – Authorised Representatives, Importers and Distributors
Frank Wilmerstädt PENTAX Medical, Hamburg
13 hrs Lunch and exhibition
14.15 hrs Legal Responsibility and Liability of
the New Qualified Person
Susanna Dienemann, Wachenhausen Rechtsanwälte, Lübeck
14.45 hrs Experiences in Complying with New Regulatory
Requirements in the EU and US
Oliver Marseille, Hemovent GmbH, Aachen
15 hrs Refreshments and exhibition
15.45 hrs Impact of the MDR on Over-the-Counter (OTC)
Medical Devices
Guido Middeler, Diapharm GmbH & Co. KG, Lübeck
16 hrs Panel Discussion: Regulatory Affairs for Medical Devices
16.30 hrs Get-together: Refreshments and exhibition
Parallel Session 2: Artificial Intelligence and Deep Learning
Technological and Ethical Aspects of AI- and DL-Based Products

Room MF 100-1
11.30 hrs Deep Learning – A Game Changer for Radiotherapy Planning?
Jonas Honegger, Varian Medical Systems, Baden, Switzerland
12.15 hrs Experiences of ThinkSono – The Implications of using
Deep Learning in Diagnostic Care
Sven Mischkewitz, ThinkSono, Potsdam
12.45 hrs The Planned Multi-MicroFlow Facility at PTB
Corinna Kroner, PTB National Metrology Institute of Germany,
13 hrs Lunch and exhibition
14 hrs IEEE Standards Association – P7000 – Model Process
for Addressing Ethical Concerns During System Design
Clara Neppel, IEEE Technology Centre GmbH, Vienna, Austria
14.30 hrs Legal Challenges Regarding the Use of AI in Medical Technology
Peter Schüller, Christian Dierks & Co., Berlin
15 hrs Refreshments and exhibition
15.30 hrs Human-Centred Pattern Recognition for Assistive Technologies
Marcin Grzegorek, Lübeck University, Lübeck
16 hrs Panel Discussion: Technological and Ethical Aspects of Health-AI
16.30 hrs Get-together: Refreshments and exhibition