Addressing Software Safety Challenges in Medical-Device Development

What you’ll learn:

The medical-device industry is rapidly advancing, from surgical robots to AI-enabled software diagnostics, yet balancing innovation with stringent safety and security requirements continues to be a challenge.
How many engineers report delays in project timelines due to certification requirements.
The biggest challenges for achieving safety certifications.
How many engineers admit to compromising on safety requirements due to deadlines.

A transformative era of innovation in the medical-device industry offers the potential for extraordinary benefits for both patients and practitioners alike, including improved care, greater accessibility to cutting-edge healthcare solutions, and enhanced device performance.

Achieving this promised future using smart health devices isn’t without its challenges, though. Medical-device developers are on the front lines of having to strike a balance between the rapid pace of innovation with the need for uncompromising safety, security, and compliance.

A recent survey of 1,000 software developers, including those in the medical-device sector, sheds light on the tradeoffs of this dichotomy. Developers face growing pressure to deliver timely software-powered applications that are not only innovative, but also compliant with the stringent safety standards in the healthcare space—no small task. These challenges underscore the need for a unified approach that prioritizes safety without stifling innovation.

Why Safety Certifications are Critical

There’s no room for error in healthcare. Medical devices play a vital role in safeguarding and improving patient outcomes, making safety certifications like IEC 62304 and ISO 14971 indispensable. These certifications establish rigorous standards for functional safety, risk management, and reliability—ensuring devices meet the highest performance and security requirements.

However, achieving these certifications is often a significant challenge. BlackBerry QNX’s recent survey revealed that 66% of medical-device software developers experience project delays due to certification requirements, with cost and complexity cited as major barriers by 34% and 29% of respondents, respectively. The certification process involves exhaustive testing, detailed documentation, and extensive validation to meet safety standards. While essential, these steps can extend project timelines, increase costs, and delay patient access to life-saving technologies.

In the high-stakes healthcare sector, device performance must be flawless under all conditions, as even minor disruptions can have severe consequences. Alarmingly, 57% of respondents reported performance issues stemming from compromises made to meet certification requirements. Such issues in a healthcare setting can result in device downtime, directly impacting patient care and, in extreme cases, endangering lives.

Rather than viewing certifications as obstacles, the industry looks to pre-certified components, such as safety-certified operating systems, which can significantly streamline the process, saving both time and costs. Certifications provide clear guidelines for design, testing, and validation, helping developers address potential risks before they reach patients.

Still, the challenges can’t be ignored. Meeting certification requirements often strains resources and pressures development teams to balance rigorous standards with tight deadlines.

To address these issues, the industry must explore ways to simplify certification processes without compromising safety. Leveraging advanced technologies and fostering collaboration among developers, manufacturers, and regulators can help navigate compliance complexities, ultimately accelerating the delivery of safe, reliable medical devices to the market.

Embracing Innovation Without Compromising Safety

As complex software becomes increasingly central to medical devices, the industry must adopt new technologies and strategies to navigate these challenges. Artificial intelligence (AI), for instance, has emerged as a transformative tool in medical-device development. AI-driven solutions can enhance device performance, predict software failures before they occur, and optimize functionality in real-time.

By integrating AI into the development process, manufacturers can significantly reduce the likelihood of performance disruptions. Predictive analytics and machine-learning algorithms are able to identify potential issues during the early stages of development, enabling teams to address them proactively. This not only improves device reliability, but also supports developers in meeting regulatory requirements.

Building a Culture of Collaboration

Addressing the challenges of medical-device software development requires a collective effort. By fostering a culture of collaboration, the industry can share best practices, streamline certification processes, and develop innovative solutions that meet both safety and performance standards.

Developers and manufacturers must work closely with regulators to ensure that certification processes are both rigorous and efficient. This includes adopting new tools and technologies that simplify compliance while maintaining high safety standards. Furthermore, engaging in proactive research can provide valuable insights into the challenges faced by developers, allowing the industry to develop targeted solutions that address their needs.

Certifications, while challenging, should not be viewed as mere hurdles to clear. They represent a commitment to patient safety and device reliability, serving as the foundation for the future of healthcare innovation.

Medical-Device Dev at a Critical Juncture

The medical-device industry is at a pivotal moment, where the need for rapid innovation must be balanced with the uncompromising demand for safety. Achieving this balance requires a multifaceted approach that includes investing in proven and trusted platforms, embracing emerging technologies, and fostering collaboration among all stakeholders. By integrating AI and predictive tools into the development process, developers can optimize device performance and reliability while reducing time-to-market.

Ultimately, by committing to rigorous standards and embracing new technologies, the industry will be able to deliver life-saving solutions that redefine what’s possible in healthcare. Together, we can create a future where safety and innovation go hand in hand, improving patient outcomes and transforming the healthcare landscape.