Regulatory navigation: A digital tool to understand medical device classification pathways
Bergmann J., Hendricusdottir R., Lee R.
© 2019 Elsevier B.V. All rights reserved. There is a need to create new digital and data-driven tools that can be used to inform users and provide insights into the regulatory process that is required to bring medical devices to market. These kind of tools could also support regulators by identifying specific bottlenecks within the regulatory pathway. A more data-driven approach will provide a more effective and objective assessment methodology. It gives the medtech developer the opportunity to potentially streamline the course that is taken by optimizing it from a regulatory perspective. This chapter describes the development of such a notion and showcases how this concept could be implemented. Simulated data are initially used to explain the underlying framework. Subsequently, the digital tool is applied on a small set of sample data to further describe how it could be implemented. The work particularly focuses on the link between medical device classification and the classification rules. It is shown that individual rules might not provide much information gain in the decision making process. The information gain can help to determine which attributes are the most important within a set of rules and potentially allows the comparison between different regulatory frameworks across the world. This work shows how a digital tool can be used to collect data and how this information could inform relevant stakeholders within the field of regulatory navigation.