Workshop series: Bringing Software as a Medical Device to Market

This series of four live, virtual workshops will provide a more comprehensive introduction to bringing software as a medical device to market. Each session will contain a presentation, interactive Q&A and walk-through of a pre-selected use case. Recordings of each session will be made available on HDR UK Futures.

These workshops are designed for engineering and physical sciences innovators with little or narrow prior knowledge of commercial technology development in the health sector. However, the workshops’ tiered approach facilitates engagement across a potentially broader multi-sectoral audience.

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  • Thursday 9th March 2023 09:00-12:00

    Intellectual Property in Healthcare – Stephen Carter 

    The right approach to protecting innovation is to put in place an IP strategy at the earliest opportunity and to revisit it regularly as a business grows or pivots. This workshop will cover early stage patent and trademarking for healthtech, do’s and don’ts to avoid infringing others’ work and strategic thinking about IP.

    Register here for 9 March

    Thursday 16th March 2023 09:00 – 12:00

    Medical device regulations and quality management – Mike Pogose & Karandeep Badwal

    Most software intended for a clinical benefit is a medical device, which comes with a regulatory burden. This workshop will explain the regulatory framework in the EU and UK, with a focus on software development lifecycles, quality management and risk management, as well as an overview of the applicable ISO and IEC standards.

    Register here for 16 March

    Thursday 23rd March 2023 09:00 – 12:00

    Health economics for software devices – Trishal Boodhna & Lucy Gregory

    Reimbursement pathways can be confusing for new entrants to healthcare. This workshop will cover health economic evidence requirements including budget impact modelling and cost-effectiveness analysis for digital interventions, as recommended by the NICE Evidence Standards framework for Digital Health Technologies.

    Register here for 23 March

    Thursday 30th March 2023 09:00 – 12:00

    Clinical evidence for software devices – Hugh Harvey & Ankeet Tanna

    Regulators, payers and end users demand clinical evidence that your product works, and your claims are backed up by the science. This workshop will look at clinical evidence standards for a variety of digital products, including diagnostic software, digital interventions and therapeutics. Standards covered include legislative ones such as ISO 14155, as well as academic best practice and reporting standards.

    Register here for 30 March

Interested in accessing more training from HDR UK? Sign up to HDR UK Futures to access our growing online curriculum.

HDR UK Futures