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Staff Profile

Dr Andrew Mkwashi

Senior Research Associate, Health Innovations (Medical Devices), NIHR Innovation Observatory

Background

Dr Andrew Mkwashi is a Senior Research Associate, Health Innovations (Medical Devices). He provides oversight and technical expertise to research projects in accordance with the priorities set, with a particular focus on regulatory science. 

His research is at the intersection of health innovation horizon scanning, foresight analysis, and evidence synthesis methods in relation to innovations in MedTech (medical devices, diagnostics, digital & AI health technologies) and healthcare delivery. Andrew is an interdisciplinary researcher with an academic background in regulatory science, business administration, and computer science. He has over ten years of experience in medical device regulatory affairs, industry and policy engagement, as well as teaching and consulting experience. He holds a Bachelor of Science Honours degree in Computer Science from London School of Management. He also holds a Master of Business Administration (MBA) from the University of Bedfordshire, United Kingdom, and a PhD in Regulatory Science from The Open University, United Kingdom.


About the NIHR Innovation Observatory

Home - NIHR Innovation Observatory

The NIHR Innovation Observatory is a world leading health and care innovation scanning centre providing data-driven insights to foster innovation and equitable access to high quality care. We aim to transform health systems and improve population health by providing advanced data-driven insights that foster innovation and equitable access to high quality care. At the core of our work is the development of data-driven methods to identify, capture and synthesise intelligence on new health innovations. We develop and share cutting edge methods in horizon scanning, building capacity in the systems across the public, voluntary and industry sectors.

We deliver essential intelligence and insights about medicines and MedTech innovation to the National Institute of Health and Care Excellence (NICE), NHS England, the Medicines and Healthcare Products Regulatory Agency (MHRA), the NIHR, the UK Health Security Agency, the Department for Health and Social Care and industry - allowing these organisations to prepare for policies, regulation and frontline delivery for new, emerging and disruptive technologies.

 

Research

Research Summary

 

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

Before joining NIHR IO at Newcastle University, Andrew was a Research Fellow at UCL working on a research project on “Regulation and Standardization of Connected, Intelligent Medical Devices (REG-MEDTECH)” which seeks 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. The REG-MEDTECH is an EPSRC-funded project, part of the prestigious PETRAS National Centre of Excellence on IoT Systems Cybersecurity. 

His PhD examined the influence of healthcare systems regulation on industrial capabilities and affordable healthcare technologies using case studies from the UK and South Africa. His research focused on the EU regulatory policy and law, development and commercialization of healthcare technologies in general and medical devices in particular. He explored issues such as regulatory planning and policy, global product strategy, product lifecycle strategy, regulations and standards management (such as ISO 13485 – Quality Management System, ISO 14791 – Application of Risk Management and IEC 62304 – Software Life Cycle Processes), impact of the medical device regulations on innovation, legal requirements placed on medical devices and In Vitro Diagnostics (IVDs) approval and CE marking process. 


Publications