The events of the COVID-19 pandemic have rapidly accelerated the rate of medical device software development to meet unmet clinical needs and bridge the gap in healthcare delivery that the global public health emergency has created. As complex algorithms and Artificial Intelligence (AI) are now being incorporated into an ever-increasingly...

Medical devices are becoming increasingly complex with rapid advancements of their software and Artificial Intelligence (AI) acting as a smarter ‘brain’ behind their hardware. The advancements of medical device software and a new clause from the Medical Device Regulation (MDR) has seen the industry face increased regulatory scrutiny and caused...

According to the World Health Organisation, there are approximately 1.5 million medical devices available in the market today, ranging from low-cost devices like the stethoscope to more expensive devices like MRI and chemotherapy machines. With the role of medical devices continuing to advance and its technology becoming more complex, understanding...

Previously at the Software Design for Medical Devices Forum, we were joined by Pat Baird, Global Regulations and Standards for Philips. Within this presentation, they discussed the importance of Regulatory Awareness within Digital Health, the bigger picture of Machine Learning and AI, and the beyond Agile Guidance.Download the presentation here...

In February 2020, we’re taking our innovative focus to the next level to ensure your teams can best achieve regulatory compliance, are protected from cyber threats and are implementing agile methodology into your software, all while embracing cutting edge designs to get your product to market faster and staying ahead...

At SDMD 2019 we heard from Moni Wolf, Principal Design Director at Microsoft Healthcare where she delivered a brilliant presentation on 'Transforming healthcare with User Experience (UX) design'Within this presentation Moni explores key topics including:How bad UX can cause real harmTaking it from three to four goals in healthcareTrends in...

As the healthcare environment evolves and patient care moves outside the hospital environment, both patients and carers must be able to use increasingly complex medical devices safely. Medical device manufacturers spend millions developing the latest medical technologies, but often neglect to incorporate user experience, human factors and overall usability early...

Ensuring the technical security of a connected device now necessitates incorporating cybersecurity in the development process, recategorising device vulnerabilities as patient safety issues and forming a coherent foreseeable risk management strategy. To discuss this topic in more detail, Pharma IQ spoke exclusively to Georg Heidenreich, Director Healthcare IT Standards, Siemens...

New digital elements in medical devices are shaping a modern approach to patient care. These novel elements provide benefits in the form of new market participants, who have in turn brought innovation and new manufacturing processes. Ahead of his participation in the Software Design for Medical Devices Global Forum, we...

Medical devices, like other computer systems, are vulnerable to security breaches that potentially impact the safety and effectiveness of the device. Recent security scandals have shown that hackers are increasingly developing new and effective methods of executing cyber attacks on the historically lax security embedded within medical devices. As a...