A new era has dawned in space travel, characterized by a rapid shift from government agencies to commercial companies. Global (private) investment in new space technologies is reaching record levels. Great potential is seen in the manufacture of medical devices, biomaterials, or tissues in zero gravity. Technical feasibility is currently the main driving force behind this development. However, little attention is paid to regulatory aspects (MDR, GMP, ISO 13485, etc.), even though compliance with these is essential for market approval. In addition, the authorities are not yet prepared for such products on the market.
Project goal
The aim of this work is, on the one hand, to conduct a market analysis of medical devices that are manufactured wholly or partly in space. In addition, the regulatory requirements and hurdles are to be identified and solutions to be developed.
This work is in a very dynamic field of development. The project combines space science with commercial and regulatory issues in a novel way. In this thesis:
• you will gain insight into space travel
• you will learn to assess regulatory issues in new fields of application
• you will learn to assess technical, regulatory, and economic risks
• you will be able to plan and structure projects
