Decision-Making in Risk Treatment in MedTech

The assessment of the factors that are influencing the decision-maker to start, stop or continue a risk treatment.

Modern products’ lifecycles increase in complexity and networking at a fast pace and the resulting degree of interaction makes the decision whether to treat a risk or not in order to optimize overall risk a complicated task. In the area of medical devices, detailed knowledge about the possible risks during the product lifecycle and the respective risk treatments is essential to increase patient safety but might not be attainable at the required cost rate. In order to establish effective risk treatment, the factors influencing decision-making to start, halt or omit treatment need to be understood, especially in cases where an outsider’s point of view on the evidence would suggest otherwise.

In order to get a veridical overview of the most common and important factors of influence, an empirical study will be conducted. It will provide insights into how manufacturers of medical devices enforce risk management in the product lifecycle.

This study shall identify and classify these factors of influence through a qualitative approach by conducting semi-structured interviews with decision-makers to german companies. Based on the results, their impact on the diverse implementation of risk management in MedTech companies shall be measured quantitatively by applying a mass online survey to german companies.  Following, all qualitative information shall be prepared in a way that consecutive research can highlight the most common inhibitors and accelerators and give a best-practice compendium.

In detail, the following tasks shall be solved:

·         Selection and compilation of suitable methods and material for the empirical study

·         Literature research on the classification of factors of influence in decision-making

·         Investigation, compilation and analysis of the most common factors of influence regarding their probability and significance