LISAvienna Business Seminar

Strategic planning in the development of medicinal products: from clinical trial and evaluation to HTA and reimbursement

On September 20, LISAvienna invited to its Business Seminar and 54 participants from 46 enterprises and organizations followed the call. Valuable information was provided in four lectures on the topic of the individual stages in the development of a medical device. Wolfgang Ecker, Manager of Department III /3 for drugs and medical devices at the Federal Ministry for Health highlighted in his lecture “Clinical trial and evaluation“ the fundamental requirements for the approval of a medical device. In addition, the audience gained a first insight into the imminent revision of the Medical Device Directives. Claudia Wild, Institute Director at the Ludwig Boltzmann Institute for Health Technology Assessment in Vienna illustrated by means of examples how the HTA is used as an aid in scientific decision-making for effective and efficient use of resources in the provision of medical care. Jon H. Hoem, CEO of the Vienna based company Miracor Medical Systems GmbH, demonstrated by means of practical examples in his lecture, the different stages in the development of PICSO® technology and at the same time examined particular hurdles that had to be overcome by the start-up company in the process. Martin Schmid, founder and CEO of the company Schmid KG explained how to go about strategically planning the development process of a medical device at an early stage against a background of regulatory requirements. After intense discussions with the presenter, the Business Seminar ended with casual networking over sandwiches and Viennese wine.

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