EIR Brochure Final 2 Paperturn - Flipbook - Page 4
WEBINAR SERIES: DEVELOPING A MEDICAL DEVICE
BACKGROUND:
In spring/summer 2021, the Translational Research Office (TRO)
coordinated a six-week webinar series to support Oxford
researchers developing new Medical Devices. Twelve Experts in
Residence delivered this engaging training programme, sharing
their knowledge towards the successful development of medical
devices to change clinical practice and improve patient lives. Core
translational development questions were addressed: how to build
a market and commercial strategy for your device; how and when
to address medical device regulatory requirements; how to design
and develop a robust intellectual property and investment
strategy; and how to facilitate the clinical adoption of your device.
Comprehensive assessment of market and commercial opportunities
was highlighted - is the cost of a medical device justifiable against
the service or health benefit it provides? Considering your market is
key to making your project a long term viable investment, and
creating a sustainable business model can support a successful spinout venture. Robust intellectual property strategies are critical to
leverage the technology benefits and assets and to ensure further
development and deployment within a clinical setting. A key
message from the webinar series was to learn early on how to
incorporate regulatory, market, intellectual property and
investment strategies into translational research programmes.
OUTPUTS:
Resources from the webinar series are available to the Oxford
research community; the relevant Experts in Residence are on hand
to discuss specific projects with researchers.
The webinar series brought a radical perspective to designing and
implementing our translational research project. It provided the
understanding and tools to allow the harmonious integration of
hardware, software, and regulatory requirements from the very
earliest stage of the project; this has resulted in a much sounder
project and multiplied our perspective of securing further funding
and delivering high-impact publications.
Dr Jean Debarros and Professor Huiling Tan
Researchers, University of Oxford
KEY MESSAGES:
Medical device class types follow different development pathways
towards clinical deployment. The webinar series brought
awareness to the importance of incorporating regulatory
requirements at an early stage of development, ensuring an
appropriate level of clinical data is generated. Incorporating endusers into programmes early was encouraged, product design
greatly affects usability which directly impacts success or early
market failure.
It is exciting the be part of this venture that aims to fill the gap in
current education surrounding technology transfer for medical devices.
In the second series we will be joined again by successful entrepreneurs
and experts to discuss in detail the aspects of design and development
that require specific actions and testing. This will be followed by the
opportunity to attend some face to face clinics and hackathons.
Dr Toni Day
Director of Quality & Regulatory Affairs, OrganOx