CHI-Zone Fellowship Session 5: Building with Integrity
Week 5 of the CHI-Zone Fellowship focussed on building with integrity, bringing important discussions around regulations, ethics and IP. A crucial, but often complex and daunting subject. The Fellows were given practical advice on how to protect their work, navigate rules, and avoid costly missteps later.
Understanding the rules early
Our online masterclass was delivered by Ele Harwich (Newmarket Strategy), who offered an introductory look at the regulatory landscape for digital health.
A key focus was one deceptively simple question: is the product a medical device? With a focus on software, Ele lead the Fellows through some myth-busting around how digital tools can fall under the definition of Software as a Medical Device when they perform a medical function rather than just supporting general wellbeing. Ele also unpacked the risk around marketing claims, and how the line between lifestyle and healthcare is thinner than many founders expect.
We loved how Ele’s masterclass focussed on providing practical advice, highlighting how to cut out the noise and find the regulatory advice that applies to you. She also highlighted importance of early regulatory thinking, and how evidence requirements, data considerations and risk classification all shape development pathways. Leaving this too late can lead to redesigns, delays and extra cost, while non-compliance can block routes to market altogether.
From ideas to protected innovation
For the in-person workshop, Claire Lightfoot, European and UK Patent Attorney at Venner Shipley, provided a grounded introduction to intellectual property rights. Fellows explored the different forms of IP, including patents, trademarks, designs and copyright, and what each actually protects.
Claire also covered the realities of patenting, and particularly how for early innovators, she highlighted the need to align publication, funding and commercial plans with IP strategy.
We were delighted to also have representation from the University’s Enterprise Team - Zining Wang outlined how researchers and innovators can identify, protect and develop digital IP. Through real case studies, Zining showed how innovators can partner with the university, from sharing digital assets to enable external development, to venture building around AI technologies and managing IP within funded projects.
Outside the Classroom - Visit to the Digital Innovation Facility
This week, our Fellows also visited the University’s Digital Innovation Facility, seeing first-hand the environments and capabilities that support digital health development. CHI-Zone Fellows, Ebin and Finn, along with colleagues the Virtual Engineering Centre team, gave us a tour showcasing forward-thinking innovations, and sparking discussion around the art of the possible.
Building the right foundations
Week 5 made one thing obvious: Innovation in health is not just about what you build, but how you build it. Regulatory awareness, ethical thinking and a solid IP strategy are not barriers to creativity. They are the foundations that allow good ideas to reach patients safely and sustainably.
For the CHI-Zone Fellows, this session was about gaining the confidence to ask the right questions early, bring in the right expertise, and build technologies that are not only innovative, but robust, compliant and ready for the real world.
If you’d like to know more about the Fellowship, or are interested in getting involved with future cohorts, drop us an email.