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 large number of medical devices and health technologies, companies are under enormous pressure to ensure not only the clinical effectiveness of their medical device software, but also to take advantage of the accelerated adoption of these technologies to help them to stay one step ahead of the competition. In the face of such pressure, building resilience and agility to maximise the speed of your software development, whilst maintaining compliance are more important now than ever before to survive and thrive in this digital age.

Ahead of the 10th Annual Software Design for Medical Devices Global Forum, we spoke exclusively to Patrick Alff, Founder of Ezthera, and John Mulcahy, Vice President Product at S3ConnectedHealth, on all things digital healthcare, and go into detail about the impact of the pandemic, the risks and opportunities, and the future of digital healthcare for software-enabled medical devices or Software as a Medical Device (SaMD).

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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 unique challenges such as, different regulatory demands across countries, ever-changing guidelines and a lack of consensus between manufacturers. In the face of such challenges, compliance and quality assurance of medical device software is more important now than ever before.

Ahead of this year's Software Design for Medical Devices event, this infographic explores the current compliance and regulatory issues facing medical device software and provides solutions to help industry professionals maintain regulatory compliance.

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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 medical software development has never been so crucial.

Alongside John Mulcahy, CEO, HealthGenuity, Pharma IQ explores the top three challenges facing the medical device industry and provides solution summaries to help industry professionals uncover greater global market opportunities in software development while maintaining regulatory compliance. 

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Other key benefits to downloading the full report:

• Gain an in-depth insight on the challenges around software development and understand how to take a more agile approach in the life-cycle development of a medical device
• Understanding how regulatory compliance can affect hardware and software of a device with some best practice suggestions for overcoming these challenges
• A deep-dive analysis on increasing market demand and competition
• Explore how the medical device industry achieve end-to-end traceability while overcoming compliance, quality and cost issues in software development

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.

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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 of your competition.

In light of this rapidly evolving landscape of software development for medical devices, Pharma IQ has created a post-show report highlighting the most exciting takeaways from last year’s event.

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Other key benefits to downloading the full report:

• An overview of bullet-proofing the security of your device against increasing levels of cyber threat during the digital transformation of healthcare
• An understanding to ensure regulatory compliance across the globe with effective documentation and a deep understanding of EU and US regulations

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 harm
• Taking it from three to four goals in healthcare
• Trends in this market
• How inclusive design supports consumers
• The three key design practices they follow

Download this presentation here for insights >>

Explore more insights such as these at the 10th annual SDMD Global 2020 this February. More information available here.

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.

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.