Webinar series: Bringing Software as a Medical Device to MarketThursday 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.
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.
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.
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.
