ABSTRACT
The advent of digital technologies is creating significant advances in the combination product space. Technologies such as connected devices, advanced data analytics, and machine learning hold promise not only to improve the way patients interact with their medical products, but also to enable a more precise and personal approach to treatment. This chapter discusses the emerging phenomenon of incorporation and combined use of drugs with digital products. The chapter presents a number of examples, provides advice on when digital products may be regulated as devices and might be considered to comprise “combination products” with medicines, and offers regulatory strategies for successful marketing approval. This chapter aims to provide the reader with a basic knowledge of strategies needed to advise their company on creating approvable digital tools intended for use with combination products and medicines.
