Developing a medical device
So you want to develop a medical device? Creating a medical device which meets a healthcare need is fantastically satisfying but might be much more challenging than you expect. The University of Oxford discussed the experience of innovators who have successfully navigated their way through the mazes of regulation, commercialisation and clinical adoption. Key learnings and experiences from leading scientists, experts and entrepreneurs are presented and summarized here.
Exploring the commercial opportunity
You may have an idea for a medical device which is original, technically feasible and serves an unmet medical need. Unfortunately, that does not guarantee that it will be a commercially viable product. In this section, Dr Nessa Carey, Royal Society Entrepreneur in Residence at the University of Oxford, will utilise a real case study to explore the key commercial questions you need to address very early in the translation of your device idea.
Here we present a case study-based exploration of key questions, led by Dr Nessa Carey, Royal Society Entrepreneur in Residence at the University of Oxford
Navigating the regulatory process
Your idea for a medical device has been shown to potentially be commercially viable product, the next step is to prove your device is safe for the patient and user. In this section, Dr Toni Day, Experts in Residence at the University of Oxford, and Global Director of Quality and Regulatory Affairs at Organox, will take you on a journey through the CE Marking process to ensure you are prepared for the next step, design and development.
Here we present a framework to help you navigating the regulatory process - led by Dr Toni Day, Experts in Residence at the University of Oxford, Global Director of Quality and Regulatory Affairs at Organox
Product design and development
In this section, you will be guided by our experts in residence, Patrick Hall (Designing Science), Kerry Briggs (Head of Medical, Kinneir Du Fort) and James Holmes (Head of Electronics, Kinneir Du Fort). You will learn how to plan ahead, improve usability and managing technical risks.
Navigating Intellectual Property Strategy and Investment
In this section, we will explore how you can develop your medical device so that your intellectual property strategy becomes a true asset, not a just cost, driving your project to its next step. We will discuss how investors, or companies, will look at your data, where the value of your project lies, may that be in patent, design rights or trademarks, and what components will attract investments and collaborative opportunities. Intellectual Property is a core part of any business and despite being an intangible assets has utility in many forms including; as a commercial asset, a tool from which to build and can be utilised to protect commercial value and competitive position.
Clinical adoption and market access
You have now identified what your intellectual property strategy would look like, how to integrate it with your regulatory strategy and the technical development of your device. Your project development phase is progressing well and you have started the prototyping phase of your device. How can you now facilitate the transition from R&D phase to its clinical adoption and make sure your device will ultimately be used in the clinics?
Our experts in residence from Odelle Technology, Deborah Rizzi, Dr Steven Haken and Claire Edwards have provided key principles that you can implement in the development phase to eliminate roadblocks to facilitate the clinical adoption of your device.