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 in the design process, leading to costly delays later.
In light of this, we spoke exclusively to Moni Wolf, Principal Design Director, Microsoft Healthcare to discuss the importance of incorporating user experience and human factors in the software design process for medical devices ahead of her session at SDMD Berlin 2019.
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 Healthcare ahead of his presentation at the Software Design for Medical Devices Global Forum 2019.
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 spoke to Pat Baird, Regulatory Head of Global Software Standards, Philips about the impact that the latest software developments are having on regulating a new generation of medical devices.
In this exclusive interview Patrick Reichmann, Quality Assurance & Regulatory Affairs Manager at Agfa HealthCare, speaks about the main challenges being faced by companies in regulatory affairs and what he thinks will be the major trends in the regulatory side of medical device software in the next couple of years. Reichmann also runs through the key steps in applying the ISO 27k framework in order to advance information security and privacy and discusses the importance of safeguarding your existing legacy products.
Medical Device companies operating in today’s stringently regulated environment require comprehensive software systems and solutions that deliver robust functionality and support full compliance with regulatory requirements. In the area of software design for medical devices, adherence to the applicable regulations and standards is a complex and expensive process.
Ahead of the 8th annual SDMD conference Pharma IQ surveyed 100+ relevant individuals about the challenges, investments and predicted future trends in this area.
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 result, device security has taken on a new urgency for manufacturers and healthcare providers.
This piece discusses the changing nature of cybersecurity threats in the medical device space, and the role of political, regulatory and organisational influences on the prevention of cyber breaches.