Product development of medical devices is progressing through a relatively fast sequence of technical development steps. If successfull, this process translates into a serial product suitable for commercialisation. Subject to the new product’s risk classification and the need for clinical evidence it’s specific clinical environment, it may pass a regulatory approval process and can be launched without providing additional clinical data. However, in many cases a validation of each of the above technical development steps in clinical routine and healthcare practice occurs too late, is suboptimal or completely missing. One reason for that: MedTech Start-ups and SMEs are facing difficulties to get access to a set of physicians, who represent key opinion leaders and who perform procedures of the respective indication in high volumes.

Consequently, medical device entrepreneurs a prone to risk developing a new product that is not well differentiated in its competitive environment, that is not well customized to the specific needs in the target market segment, and that is missing powerful reference centers and product champions. As a result, MedTech entrepreneurs fail to accomplish market share-, profitability- and sales goals. Such a situation presents an actual thread to the viability of the entire medical device company.

The Unit for Clinical Advisory is dedicated to prevent such a situation through facilitating real-time validation of technical product development steps in clinical routine and healthcare practice early on.

Expert:

Prof. Dr. Norbert Gretz
Managing Director, Institute of Medical Technology, Mannheim

Professor Gretz assumes leadership and expert roles as Managing Director of the Institute of Medical Technology, Director of the Medical Resaerch Centre, Professor for internal medicine and experimental medicine, Head of the Steinbeis–Transfer Centre Organic Electronics Consulting  and as co-founder of Mannheim Pharma und Diagnostics GmbH. Professor Gretz can help Start-ups access clinicians  with particular expertise in a required indication, broad experience in treatment of such real-life patients, and with an extensive network in the respective physician community in order to become a partner for the MedTech Start-up’s product development and validation.