Leadership and Management
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Dr Andrew Mkwashi

Devices Lead

Andrew is a Senior Research Associate with the Innovation Observatory: Aligned to the Devices, Diagnostics and Digital Programme, he leads on Medical Devices.

His research is at the intersection of health innovation, horizon scanning and evidence synthesis methods in relation to innovations in medical devices and healthcare delivery. A key focus of his research is in the areas of Software as a Medical Device (SaMD), Artificial Intelligence as a Medical Device (AIaMD), remote controlled devices, and surgical robots, all of which are crucial to accelerating the adoption of technological innovations that will improve the health care of patients and the NHS.

Andrew is an interdisciplinary researcher with an academic background in regulatory science, business administration, and computer science. He has extensive experience in medical device regulatory affairs; industry and policy engagement; teaching and consultancy. He holds a BSC hons in Computer Science from London School of Management, a MBA from the University of Bedfordshire and a PhD in Regulatory Science from The Open University.

Before joining the Innovation Observatory, Andrew worked for University College London as a Research Fellow in Regulation and Standardization of Connected, Intelligent Medical Devices (REG-MEDTECH). His research focus was seeking to understand the extent to which current regulatory frameworks and standards address the critical challenges and unique risks posed by Connected, Intelligent Medical devices (CIMDs) and provide possible solutions to these challenges.

Andrew’s research interests are on the regulation, standardization and development of health technologies, the governance of emerging regulatory frameworks, emerging health technology assessment, medical device innovations horizon scanning, IOMT cybersecurity and exploration of Artificial Intelligence (AI), Data governance and policy issues in regulatory science.

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