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Dr Toni DayDr Toni Day is a member of our Experts in Residence network, a scheme managed by the Translational Research Office, the Business Partnerships Office and Oxford University Innovation to give Oxford's research community access to world-leading expertise and advice across multiple industry sectors. Toni works closely with our Royal Society Entrepreneur in Residence, Dr Nessa Carey to develop a programme of support for our medical devices community who will be navigating the rather complex regulatory pathways within their translational strategies. Toni is Director of Quality and Regulatory Affairs at OrganOx Ltd.

We talk to Toni about her career to date, how her role as an Expert in Residence can help Oxford researchers, and why it is more important than ever to understand MedTech regulatory pathways.

Firstly, tell us a bit about your career to date

On completion of my DPhil, I worked for a number of Oxford MedTech start-up companies. Usually this involves working with the founders and CEO to develop strategies for the company progression. I love the energy of these companies, the steep learning curves and the variation of work involved, often leading the regulatory routes to market for novel products. The challenges are new every day and you are usually working at the cutting edge of medical technology. I have worked with both medical devices and in vitro diagnostics and I am currently the Global Director for Quality and Regulatory Affairs at OrganOx Ltd. This is a very exciting company with an extremely novel medical device to allow the normothermic perfusion of a donated liver for up to 24 hours prior to transplantation.

What attracted you work with Oxford and our Experts in Residence Scheme?

It has become very clear that there is a large void in the regulatory education of academics, entrepreneurs and scientists who believe they have a marketable medical product. I have previously set up a series of informal Monday morning networking events (The CE Marking Forum), take up was well received. The Experts in Residence Scheme is a great opportunity to educate to educate a wider audience and to help budding entrepreneurs get their product to market in the least burdensome way.

How do you see your role as an expert in residence in shaping and supporting the translational research culture at Oxford?

With the ever changing regulatory landscape it is more important than ever to educate the younger scientists and to support academics, entrepreneurs and scientists to progress their MedTech products in the least burdensome way. I would love to see Oxford as the first centre of excellence for MedTech regulatory affairs.

How can Oxford researchers learn more about the expertise you offer?

I would recommend that anyone interested in learning more should contact the Translational Research Office. They can help you identify the right expert and book you a one hour meeting.

Additionally, I am working with the Translational Research Office to set up a series of online training events for Oxford researchers. The first webinar in the series 'Developing a Medical Device: turning your idea into a successful commercial product that’s improving detection, diagnosis or treatment' is in early June, and hopefully the full series details will be available very soon. In the future, I am hoping to be able to expand this into face-to-face sessions and eventually larger events, such as a potential degree module and summer schools.

Could the Experts in Residence scheme help projects that are in the early stage of development?

Absolutely, the early stage of development is the perfect time to get in contact with an Expert in Residence. It’s so easy to start off down the wrong path, end up repeating work or having to perform certain parts of the development cycle at the wrong stage in development. This can be costly, risky and time consuming. There can also be delays and long leads times for test houses and Notified Body reviews. The earlier you get advice the better, it's never too early. It can also help define budgets and project timelines.

Find out more about the Royal Society Entrepreneur in Residence scheme

Visit the Translational Research Office webpages