Thank you for your interest in our Bench to Bedside event, we hope you enjoyed the day. The event formed part of a range of planned educational and digital navigational tools to be delivered through Element’s Global MedTech Academy to support effective and efficient access to the market of innovative and safer medical technologies.
We have included the recordings and presentation slides of the event below for you to watch at your own leisure.
If you haven’t had chance yet, please click here to complete our event survey to let us know your feedback from the event, this is important to us and will help to improve our events and workshops going forwards.
MedTech Industry Landscape
Listen to a thought leadership piece on what may lie ahead in the MedTech industry with leading experts Michael Kipping (Chair), Ashleigh Batchen (Head of Regulatory Affairs BIVDA), Phil Brown (Director, Regulatory & Compliance, ABHI) Eammon Hoxey (Director, E V Hoxey) and John Wilkinson (MedTech Vision consultant and GMDN Chair). This lively interactive session will cover the effect of evolving regulations in the global marketplace, reimaging healthcare in the 21st century – how digital health is transforming healthcare, and global harmonization of standards - can we achieve 'one test - one certificate'?
NIHR Funding Opportunities
Professor Michael Lewis from the University of Birmingham and Joint Director of the NIHR discuss how NIHR funds health, public health and social care research that leads to improved outcomes for patients and the public. Learn about the Midlands economic hub for life sciences giving greater access to leading research and facilities. Click here to download a copy of the slides.
Innovation Landscape & Funding for Regulatory Support
Lewis Oakley, the Innovation Lead for Health Technologies at Innovate UK presents the UK innovation ecosystem and provides insight into Innovate UK's role including; funding opportunities for regulatory support to assist the development and commercialisation of innovative products and services. Click here to download a copy of the slides.
Role of Regulation in Accelerating Innovation
Considering regulatory pathways at an early stage can optimize your chances of success. How a regulatory strategy can help support investment into your business and the likelihood of bringing products to market. With Michael Kipping, the Director for Medical Technologies at Element. Click here to download a copy of the slides.
Establishing a Regulatory Strategy
Expert James Pink, Director, Medical at Element, discusses the importance of formulating a regulatory strategy and what it entails. Click here to download a copy of the slides.
Holistic Approach to Clinical Evaluations
Learn about sufficient clinical evidence within the context of a clinical development plan and when a clinical investigation is necessary with Burhan Mehmedi, Medical Writer Director for Eclevar Medtech. Click here to download a copy of the presentation.
Human Testing of Physiological MonitorsÂ
Paul Batchelder, Chief Clinical Officer at Element (formally part of Clinimark) helps you understand how to meet FDA requirements for human testing for 510k and de Novo submissions, when to test, FDA recognized standards, and the difference between FDA and CE requirements. Click here to download a copy of the presentation.
How to Avoid Common Testing & Certification Pitfalls
Learn how to avoid unnecessary delays or regulatory hold ups, and what are the key considerations during the R&D phase to ensure a smooth journey to certification. With James Daniels, General Manager, Connected Technologies. Click here to download a copy of the presentation.
Digital Engineering
Understand how simulation and modelling and other digital methods can be used to accelerate R&D, with insights into real-world applications within the life-cycle of a MedTech product. With Maria Artiles, Senior Consultant and Harvey Stubbs, Senior Engineer from Element Digital Engineering. Click here to download a copy of the slides.
Beyond Compliance
Nicole Small, Senior Manager for Medical Technologies at Element, will discuss why developing relationships with regulators (pathways for consultation and advice) through early and effective communication is a tool to support market access, particularly in the post-market phase. Click here to download a copy of the slides.
Dynamic Q&A Session and Closing Remarks
A range of leading industry experts address questions and comments from the floor, Slido and pre-submitted questions.