- Understanding Value Proposition – Stakeholder Considerations – Early Value Modelling – Introduction to Intellectual Property (IP) – Importance of IP in Early Stages – Freedom to Operate – Identifying and Valuing IP Assets
- Speakers: Marc Barlow, Annemijn Eschauzier, Lucy Gregory, Stephen Carter
HDR UK x Hardian Health: Bringing Software as a Medical Device to Market
This two-day workshop aims to equip early-stage innovators with the confidence and knowledge needed for proper healthtech market entry.
A limited number of tickets, generously discounted at 50%, are available for NHS staff, HDR UK Alliance members, students, and other organisations. Additionally, if you are interested in a group booking, we do have discounts in place for this. Please get in contact with Learn@HDRUK.ac.uk and confirm your name, position and institution to check your eligibility or gain more information on this.
A two-day in-person course with Hardian Health‘s multidisciplinary team, brought to you by HDR UK. The course consists of four half-day workshops, focusing on interactivity and engagement through round table discussions, exercises, and practical examples.
The aim is to equip early-stage innovators with the confidence and knowledge needed for proper healthtech market entry, including strategic decision-making, streamlined regulatory processes, robust clinical and economic evidence, and intellectual property protection. This course is aimed at those with a solid foundational idea, potentially with a prototype product and clear intended use.
Cost: £240
Agenda
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- Technology Readiness Levels – Strategic Regulatory Planning – Risk Classification – Engaging with Regulators – Comparing MDR, UKCA, and FDA Regulations – EU AI Act – Quality Management Systems (QMS) – Focus on Mental Health and AI (Based on Feedback)
- Speakers: Mike Pogose, Karandeep Badwal, Hugh Harvey
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- Practical Intended Use Exercises – Safety Reporting – Roles and Responsibilities – Stages of Clinical Validation (Feasibility Studies, Clinical Evaluation Reports, Clinical Investigation Plans)
- Speakers: Hugh Harvey, Ankeet Tanna, Felicity Lock
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- Budget Impact Modelling – Cost-Effectiveness Analysis – Go-to-Market Strategy Insights
- Speakers: Lucy Gregory, Marc Barlow, Annemijn Eschauzier
Interested in accessing more training from HDR UK? Sign up to HDR UK Futures to access our growing online curriculum.