Product development strategies: medical device diagnostics

The University of Oxford is host of a very vibrant research and innovation ecosystem. In the recent year, the Oxford Institute of Biomedical Engineering, through its spin-out Organox, has seen its first therapeutic device, a novel organ preservation device, approved by the FDA in 2021. The device is the results of more than 15 years of cross-disciplinary works between several department at the University and its spin-out. OxVent, a social enterprise from the University of Oxford and King’s College London rapidly developed a deployable and low-cost ventilator due to the accrued needs through the Covid-19 pandemic in a record time. Developing a medical device is however no walk-in the park and require a broad set of knowledge, collaborative work, between scientific, commercial, legal and regulatory teams.

In this webinar series, we intend to bring knowledge, tools and a network to academic researchers developing their own device and ideas at the university. This series aims to support the academic community transitioning from basic and fundamental research into the translational research space, where the bases for a commercial, or non-for profit and impact driven projects, needs to be lay down. Following the 2021 webinar series ‘Developing a Medical Device: turning your idea into a successful commercial product that’s improving detection, diagnosis or treatment’, we will continue the series in 2022 to address topics.

In this session we explore product development strategies with an emphasis on medical device diagnostics led by Expert in Resident Rouzet Agaiby and David Warwick from eg technology.

Starting with an overview of the product development process for medical devices, this webinar will then focus on key aspects of the development process specific to diagnostics solutions. Topics to be covered include: – Understanding the key things to consider from the outset of any development programme – What standards you need to comply with – Discussing common issues in diagnostic development programmes – Adopting a risk-based approach – The importance of putting the user first – Discussing example case studies of diagnostic products and lessons learned