Digital Hub Development Agency and HRB Clinical Research Coordination Ireland recently joined forces to deliver a workshop on Connected Health, highlighting the critical factors involved in bringing medical device software to the healthcare arena.
Held at The Digital Hub on Wednesday 30 November, the workshop attracted researchers, early-stage and established software companies involved in the development of software medical devices.
Topics were delivered through interactive sessions, case studies, presentations and discussions led by industry experts (see agenda for details of speakers), resulting in a better understanding of the factors involved in the translation of software technology to the healthcare arena.
• Integration of human factor engineering in the development and life-cycle management of a product is critical and will reduce the risk of safety issues and user errors.
• Devices that help to prevent, diagnose or treat illnesses or improve bodily functions may be classified as a medical device and therefore are subject to further regulation. Modern medical devices that incorporate software as well as standalone software are gaining complexity, and as the connectivity to the internet, cloud, and outside world increases, so do the regulatory and security challenges. Regulatory bodies require researchers or companies specialised in medical device software to provide objective evidence, delivered in a quality management system that is safe and reliable. Therefore, developers need to improve development approaches, knowledge, tools, and techniques to overcome challenges.
• In 2016, the EU General Data Protection Regulation (GDPR) “On the protection of natural persons with regard to the processing of personal data and on the free movement of such data” entered into force. This has significant implications for data controllers and data processors in the product life cycle and non-compliance can result in fines up to 4% of annual global turnover as well as reputational damage and the risk of losing key clients.
• In a climate of ongoing change and economic uncertainty, having a strategic business plan that presents a clear direction, highlights the need for a collaborative approach and defines key steps that need to be taken in order for e-health to be adopted into healthcare systems across the world is critical.
The workshop featured presentations by two software companies, Healthbridge Technologies and patientMPower, who provided insights into their respective journeys and lessons learnt in establishing their businesses in the digital health area.
The final presentation was delivered by the Health Service Executive on the new ‘Quality Innovation Corridor’ (QIC). This programme represents collaboration between clinicians, industry, academia and eHealth Ireland to develop innovative healthcare digital solutions.
For further details see www.thedigitalhub.com/news/insights-on-translating-software-for-healthcare/