Regulation and ethics for MedTech Innovators and Start-ups
Clinical Research Women
Tuesday, 21 January 2020, 8.45am to 5pm
St Catherine's College, The Arumugam Building, Manor Road, Oxford, OX1 3UJ
The NIL lab at the University of Oxford in collaboration with Bucks HSC Ventures, are hosting a workshop to discuss regulatory requirements and ethical consideration for medical device and digital health innovators and start-ups. At this workshop you will learn about the key requirements, concepts, ethical considerations and the overall process for CE Marketing under the Medical Devices Regulation (MDR) which is required when bringing a medical device/ digital health solution to the market.
Who should attend?
People who are working in the area of medical devices / digital health solutions, including: academic researchers, clinicians, science students, innovators, start up’s, SME’s, research council, research services and tech transfer support.
What will you learn?
By the end of the workshop, you will be able to:
- Identify if a device/ digital health solution is a medical device
- Classify a medical device according to the Medical Device Regulation (EU) risk levels
- Plan the next steps in the regulatory pathway
- Describe the key requirements and concepts within the Regulations
- Recognize the ethical considerations when bringing a medical device/ digital health solution to the market.
- Light breakfast
Jess is the policy lead at University of Oxford's evidence-based medicine DataLab directed by Dr. Ben Goldacre, AI Subject Matter Expert at NHSX and student researcher at the Oxford Internet Institute where she is a member of the Digital Ethics Lab directed by Professor Luciano Floridi. In all capacities Jess focuses on 'governing the digital health ecosystem' working to understand the technical, cultural and regulatory barriers to the use of health data for better care. You can follow Jess on Twitter @jessRmorley.
Jess will cover the concept of governance of digital health as a whole - ethics, standards & guidance, regulation - looking at how these different levers interact and why we need pro-ethical design to ensure the best possible outcomes from digital health innovation. In particular Jess will cover why regulation is the 'minimum viable ethical product' that will only tell you the rules of the game - not how to win it - and provide an overview of the tools and methods available to innovators to help them consider the ethical implications of their product and how these change over time.
Rita holds a PhD from the Medical Research Centre (MRC) at King’s College London. Throughout her career, Rita has been part of international multidisciplinary networks and has led large international initiatives in bridging the gaps between different scientific disciplines. Rita played a significant role in setting up and leading the training workstream within ELIXIR, European infrastructure for big data within biological research. She also has experience in working with big pharmaceutical companies. Rita previously worked for the University of Edinburgh and is currently overseeing the development of a data-driven tool to help navigate the medical device regulation at the Natural Interactions Lab based at the University of Oxford. She was involved in the REFORM research on ‘Data-driven healthcare: regulation & regulators’ and closely works with key stakeholders in the regulatory area, such as the MHRA and NHSx. She has given workshops on MDR classification for IEEE and EIT Health and has published on the topic of digital solutions for regulatory navigation.
Rita will be providing an interactive workshop on when innovators / startups have to adhere to the medical device regulation and reveal an easy method to classify the device / digital solution according to the Medical Device Regulation (EU).
Dr Azad Hussain
Dr Azad Hussain is an experienced engineering professional with over nine years of industrial and academic research experience. He completed his PhD studies in 2004 at Queen Mary College, University of London, in the field of biomechanics, biomaterials and tribology. Upon his PhD completion, Azad worked as a research scientist on an interdisciplinary and collaborative project with industry, focused on the research, testing and analysis of implants using new materials and designs.
In 2006, Azad held a R&D engineering role at Smith and Nephew Orthopaedics. He gained valuable experience in the areas of laboratory set-up, NPI (New Product Introduction) and managing a UKAS (UK’s National Accreditation Body) accredited QMS, the first of its kind in the field of orthopaedic bioengineering. Following a career break, Azad returned to work with the Functional Materials Group at Coventry University, where he worked on various projects in electronics and automotive industry.
Azad’s expertise includes Medical Device Regulations, manufacturing methods and process improvement, with previous applied experience in setting up QMS (ISO 17025, working in ISO 13485 compliant manufacturing site and class III medical devices). Currently working at the Medical Device –Testing & Evaluation Centre, the Institute of Translational Medicine, University of Birmingham.
Please register here