The MedTech industry is going through a time of revolutionary change. Fuelled by the COVID-19 pandemic, the development of a wide variety of digital health technologies and wellness applications has been dramatically accelerated to meet clinical need. However, it isn’t enough to simply have a ‘great idea’. To successfully launch Medical Device Software into the market, you need to have the right software development and engineering practices in place.

This workshop will provide a comprehensive guide to industrialising your software development, so that you can take your innovation to market more efficiently and maximise continued market access.

Topics to be discussed will include:

• Understanding the intricacies of developing Medical Device Software vs. other types of software development
• Focusing on the importance of understanding clinical input and ensuring that this is integrated into your algorithm development from the outset
• Discussing specific modelling techniques that can make your software development more efficient
• Outlining methods for scaling up your Medical Device Software development and engineering 

Bringing together a panel of knowledgeable voices, with an overview of the digital health and medical technology sector, this opening session will consider how the COVID-19 pandemic has accelerated interest in the opportunities that digital health technologies and Medical Device Software offers and how this is being reflected in the industry:

• How has the COVID-19 pandemic accelerated the development and adoption of Medical Device Software to diagnose, treat and manage patients?
• Understanding the developing start-up landscape and the emergence of new health technologies
• What is the impact on existing Medical Device manufacturers?
• How should the industry respond to meet the demand and maximise the opportunity of this moment in time?
• What are some of the potential challenges and how might these be overcome?

Ezthera offers a range of specialised CTO-led services focused on state-of-the-art digital health technologies, with a focus on Digital Theraputics and Software as a Medical Device and bringing together R&D, software engineering, clinical teams, regulatory and quality management.

• Understanding the need to industrialise software development and engineering to effectively bring your medical software to the market
• Discussing the methodologies to speed up achieving compliance with standards including ISO13485 and IC62304
• Building development models that successfully integrate clinical input at an early stage to better define algorithms from the beginning of the process