Solutions to Overcome Compliance, Quality and Cost in Software Development for Medical Devices

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. 

Download the full report on the right >>

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

Transforming Healthcare with User Experience Design

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 Security of Systems of Devices

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.

Shaping the regulatory landscape for a new generation of devices

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.

Addressing Cybersecurity Threats in 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.