DS Attends the Drug/Device Combination Products Summit 2018

From December 3rd to 4th, our German employee, David Grosse-Wentrup, joined the Drug/Device Combination Products Summit in Berlin, Germany.

Drug and device combination products present new opportunities in drug delivery. Yet, the domain is heavily regulated. Unique challenges stand in the way of effective design control, risk management, and human factors.

To better navigate this complex terrain, David and numerous experts from the field of combination products connected in Berlin. Their discussions addressed the latest trends and developments. David shared his expertise about how usability engineering contributes to successful products and efficient approval processes. He also had a chance to broaden his understanding of drugs and devices beyond human factors.

The topics discussed at the convention ranged from regulations—including the implications of MDR Article 117 and the varying regulatory pathways for different types of drug/device combination products—to risk management and the integration of design control and human factors.

The most valuable aspect of the summit was the relatively small setting, which allowed for an extensive exchange among the expert participants. David’s already looking forward to next year’s summit in Vienna.

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