In the medical device industry, the issue of software design is an important one. It can not only improve homogeneity and streamline processes, allowing for increases in safety and production, but also has to comply with a strict range of ever-changing and evolving regulations.
In the medical device industry, the issue of software design is an important one, but one which is often affected by the need to comply with industry regulations. Across Europe, complying with the EU Medical Device Directive has been a tough challenge for many companies, but in the US, organisations have had to struggle with a lack of legislative action due to a change of congress and uncertainty about what the new congress has planned
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.
Many in the area of software design for medical devices area have already moved to Agile and last year’s survey suggests that many more are thinking of implementing Agile methodology. However, the first step is the hardest and when starting out the choice can feel so vast as to be paralyzing. To counter this, Nancy Van Schooenderwoert, President and Managing Director of Agile Development Practice has written a hypothetical case study to simplify the process. In this article, she also gives her 6 don’t and 5 do’s for those who want to implement Agile.
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 are undergoing a technical transformation in terms of software, interconnectivity and interoperability. This increase of function comes with an increase in risk from cybersecurity threats which puts not only the patients with medical devices potentially at risk, but has wider implications for connected digital infrastructure too.
The safety, security and privacy of patients must be protected and the providers of software for medical devices must work with regulators and the wider industry to ensure this.
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.