RegMetrics – How to Navigate the Complex Regulatory Landscape of Medical Devices

This workshop is designed for UoB and BHP staff working on medical devices at any career stage. No prior regulatory knowledge is required to take part.

Are you working on medical devices? What is the classification of your device? Do you know which part of the regulations do you need to adhere to? How can you progress the development of your medical device without getting 'stuck' in the complex network of device regulations?

RegMetrics is an online digital platform developed to support health technology innovators to navigate the complex world of medical device regulation. The technology was initially developed at the University of Oxford as a solution for a need observed within the community of innovators.

Join us on the 26th June 2024 10:30am –14:00pm, at Chemical Engineering Building room 112 to learn more about Medical Device Regulation Pathways and how this can help you to secure funding. No prior regulatory knowledge is required.

*Please note to take part in the hands on experience of the RegMetrics tool you will need to bring your own laptop.

Program

10:30am - 11:00am: The pitfalls of translational research in medical technologies: Understanding the regulatory pathway early on - Richard Williams (Chemical Engineering/HTI)

11:00am - 13:00pm: RegMetrics - Helping you navigate medical device regulation - Rita Hendricusdottir (CEO and co-founder for RegMetrics)

13:00pm - 14:00pm: Lunch and Q&A

The workshop will cover the following topics:

• Understand the importance of the regulatory pathway early on and its impact on translational research funding.
• How to identify if a device / digital health solution is a medical device.
• How to classify a medical device according to the Medical Device Regulation risk levels.
• What are the requirements that medical devices need to conform too.
• Hands on experience in using the regulatory tool: RegMetrics.

Rita Hendricusdottir

Rita Hendricusdottir is the CEO of RegMetrics and holds a PhD in Neuroscience at King’s College London. She is passionate about making sure that patients have access to the latest technologies that can improve their life. In order for MedTech companies to bring new medical devices to the market, they have to adhere to the medical device regulations. The challenge is to bridge the knowledge gap between engineering and law. Rita has always been fascinated in how to best connect disciplines in order to generate the strongest outcomes. Her previous work experience has been on bridging the gap between biology and bioinformatics to ensure better collaboration (ELIXIR) or to ensure that Pharma departments had the same understanding of a subject area (Oxford PharmaGenesis). Rita is a mentor for regulatory queries for EIT Health and provides multiple workshop for academics and early stage start-ups through universities, accelerators and incubators.

Richard Williams

Richard Williams is the CEO of University of Birmingham spin-out, Healome Therapeutics. He built a career blending academic science with healthcare translation over 11 years at the School of Chemical Engineering and the Healthcare Technologies Institute, University of Birmingham.

His core experience is in the process of developing scientific breakthroughs from the lab into products to fulfil unmet needs in healthcare. This includes planning and securing funding to advance from proof of concept to product, establish product safety and manufacturing approach, gaining regulatory approval to enter clinical studies, and the challenges that can arise along the way. Richard brings experience of securing funding along this journey from £50k concept grants to £1.3m product development awards and private funding.

This talk will explain why confirming the regulatory classification of your proposed product is critical to planning, properly resourcing, and executing on the development journey ahead.

This event is supported by the Translational Research Team (TRT) and the Institute of Translational Medicine (ITM).

If you would be interested in attending you can register using the following link: 
https://buytickets.at/universityofbirmingham4/1273290