INVITATION ONLY
This event is invitation only. If you have any questions about this event, please contact Rachel Sosin, Ecosystem Manager Health and Resilience, at [email protected].
The Medicines and Healthcare products Regulatory Agency (MHRA) has postponed the date for new UK medical device regulations by a year. Meanwhile, changes to the EU’s European Medicines Agency (EMA) medical and in vitro device regulations are also changing. What does this mean for Enterprise Hub members pursuing regulatory certification? What can we expect in 2024, when new MHRA regulations are slated to take effect?
Moderated by Hub Member and medical device regulations expert Alan Finnerty (Javelo Health), our panel will include experts from ABHI and BSI as well as Hub Members James Roberts (mOm Incubators) and Lucy Jung (Charco Neurotech). The panellists will discuss past experiences, near-term expectations, and future predictions.
Having successfully navigated the CE mark certification process, James and Lucy will share practical tips and best practices that will be valuable in developing effective approaches for gaining market access in the UK and EU, ensuring successful product launches. The panellists will share insights into the intricacies of compliance, market access, and strategic considerations that are crucial for success.
Whether you're a seasoned entrepreneur or navigating your first venture, this panel discussion promises to be an invaluable resource, providing a better understanding of how to integrate regulatory considerations into your overall business strategy for sustainable growth and provide an opportunity to explore what the future might hold.
An opportunity for networking with other Hub Members and Academy partners will take place after the panel discussion and light refreshments will be served.
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Alan Finnerty
COO, Javelo Health. Alan completed his formal training as an Engineer with a master’s degree from the University of Cambridge and has 25 years of experience in the Medical Device industry ranging from start-ups to large multinationals such as Medtronic and Olympus. Working his way up to leading the R&D function he has more recently led related functions such as regulatory affairs, quality, and operations; personally overseeing the development and regulatory approval of over 30 Medical Devices launched in international markets. Alan completed the Royal Academy of Engineering SME Leaders Programme in 2018 and has been engaged with the Enterprise Hub since. Following the successful sale of Medovate, Alan has recently joined Javelo Health as Chief Operating Officer where he is leading the development of a novel medical device family set to launch in 2024.
James Roberts
CEO and Co-Founder, mOm Incubators Ltd. James Roberts is a product designer by training. In 2014 he was awarded the global Sir James Dyson award for innovation for his project, mOm the inflatable incubator. Since then, he has gone on to complete the Royal Academy of Engineers’ Enterprise Fellowship, named as a MD-DI MedTech rising star as well winning the Princess Royal Silver Medal. James created a company based off his university degree project and has gone on to raise the funds to develop and commercialise the device, having received an MDR CE mark with the help of an A-list team. The incubator is now impacting children's lives in the NHS and overseas.
Lucy Jung
Co-Founder and CEO at Charco Neurotech. Lucy Jung, a founder and CEO of Charco Neurotech, is a design engineer focused on projects related to patient care. She studied Innovation Design Engineering MSc/MA (Distinction) at Imperial College London and Royal College of Art, Industrial and Informatic Design BA from Korea University and holds a Certificate of Management Excellence (CME) diploma from Harvard Business School funded by the Royal Academy of Engineering (RAEng). She gained experience as a Product Designer at Samsung Design Membership and PDD London and as a Marketing Intern at Cheil Worldwide. She is a speaker at the Cambridge Judge Business School (CJBS) accelerator programme and Cambridge Network Event for EMBA students and alumni. As a trained Unified Parkinson’s Disease Rating Scale (UPDRS) assessor, she focuses on a patient-centric approach to develop innovative solutions to improve the quality of life of people with long-term conditions.
Phil Brown
Director, Regulatory & Compliance, ABHI. Phil started his career at Smith and Nephew qualifying as a Graduate of the Royal Society of Chemistry in 1984, before joining the Company’s Woundcare Regulatory Affairs team at the time when the Medical Device Directive was being enacted. Company moves to Genzyme Biosurgery, Quintiles, Wright Medical Technology and more latterly Kinetic Concepts Inc., (an Acelity company), included work with novel technologies, liaising with National Authorities, the European Commission, Trade Associations and standards bodies on issues related to regulation and ethics. Phil is the Director of Regulatory and Compliance at ABHI having joined in June 2016. In addition to his Trade Association duties, Phil chairs the BSI standards working group TC/210, which covers Quality and Risk standardisation and is a Fellow of TOPRA.
Purvi Patel
Regulatory Lead, BSI, Dr Purvi Patel, PhD CEng, is a Regulatory Lead at BSI who speaks about how the Medical Device Regulation (MDR) is changing the regulatory landscape for medical devices. Currently, she is working on CE schemes and the implementation of UKCA legislation at BSI. Purvi has an extensive background in conducting BSI technical reviews under the MDR/Medical Device Directive (MDD) for orthopaedic and dental devices. Prior to joining BSI over 6 years ago, Purvi has held various positions in the medical devices industry working at Zimmer Biomet, Renishaw plc, Surgicraft Ltd. and Finsbury Orthopaedics Ltd. Purvi holds a master’s degree (Biomedical Engineering) and PhD (Screw Fixation of Implants to the Spine) from the University of Birmingham (UK) and has over 16 years of experience working with medical devices in academia, industry and the Notified/Approved Body.