Digitise or die: balancing safety and innovation in mission-critical software development

Many older medical devices simply need new software to smooth the rough edges and improve connectivity

While developers have always been under pressure to create and deploy increasingly rapidly, the accelerated digital transformation brought about by the pandemic has made speed of delivery even more important, and opened the industry's eyes to the need for efficiency going forward.

For developers working on life-saving medical devices, in particular, fast delivery and a quick time to market is essential.

However, in the medical space, developers don't just have time pressures. They also have to navigate a labyrinth of complex regulatory requirements, with no margin for error.

Life-saving tech

The medical device sector is integral to modern healthcare. In the last decade, it has undergone significant growth in innovative technologies that have dramatically improved services, reduced patient recovery time, and lowered cost of treatments.

Spurred by the rapid evolution of the Internet of Things (IoT), hospitals and doctors' surgeries have been quietly upgrading and connecting devices. The Internet of Medical Things (IoMT), a sub-sector of the IoT, was growing organically, and healthcare looked set to gradually join the ranks of industries undergoing digital transformation. Then, the pandemic struck.

The outbreak of Covid-19 further exposed a lot of medical devices as archaic, poorly designed and in desperate need of an upgrade.

During the pandemic, hospital machinery such as ventilators simply were not fit for purpose when deployed to makeshift treatment facilities. Hospitals stopped admitting non-Covid patients, appointments were conducted virtually, and doctors started monitoring symptoms remotely. Suddenly, connected devices went from being a convenient luxury to an essential cog in the healthcare machine.

The shortcomings of medical devices exposed by the pandemic have accelerated the growth of the IoMT, opening the industry's eyes to the need to create new technologies with more intuitive user experiences (UX) and user interfaces (UI), and better connectivity.

Unfortunately, the process of introducing a new medical device to market can be long-winded as any new products are subject to the rigours of in-country certification and market clearance processes.

These devices, such as the latest iterations of pacemakers, insulin pumps and blood pressure monitors, will eventually come into contact with patients, sensitive information and, in severe cases, life-and-death situations.

As a result, there are regulations and processes to ensure these technologies reach consumers only after passing a demanding battery of clinical trials.

The pandemic and the continued need for new, more intuitive technologies have created more challenges than ever for medical device developers, bringing issues such as cybersecurity and data integrity to the forefront. So, what is the role of developers in helping to revolutionise the medical devices industry?

Putting the dev in devices

When it comes to industry regulation, developers need educating. However, responsibility for and familiarity with various guidelines and specifications in the world's second-most regulated industry is, in the mind of most developers, outside of their remit.

For truly seamless design and manufacturing of new medical devices, an understanding of the regulations would be hugely beneficial. Unfortunately, the likelihood of time-tight developers attaining such comprehension is unlikely given their complexity, and its unreasonable to expect them to do so.

Instead, developers should focus their efforts on producing software for existing devices, that provides users with a UX and UI akin to those that they have come to expect from modern consumer products such as smartphones and tablets.

Just as consumers now expect new devices to run with Apple-like efficiency, the healthcare industry and its patients should expect modern medical devices to be equally intuitive.

Many existing devices have been in circulation for years and some are verging on obsolete. If the benchmark for device UX and UI is the latest software used in Apple or Android smartphones, a number of critical medical devices are operating on something closer to Windows 95.

This is where developers can play a major part in modernising the industry. These old devices are still saving lives every day, and many of the ventilators that kept Covid patients alive during the pandemic are outdated; but they simply require new software that can smooth some of the rougher edges. Connectivity, for example, is something that developers can write into code for existing models so that when new devices are manufactured with touch screens and all the trimmings, they can be linked to hospital infrastructure, connect life-saving data, monitor symptoms and make diagnoses from remote locations.

A new era for medical devices and pandemic proof healthcare

The pandemic has shone a light on what has been understood in the medical devices industry for decades. What has been reconfirmed is that a significant challenge to navigate is the high degree of regulation, guidelines and specifications that govern the manufacturing of new, life-saving products.

The approval and certification of new devices can be a huge bottleneck in a device company's go-to-market planning It is evident that more can be done through the product development and design process to streamline and increase the efficiency of the regulatory approval and certification process to help shorten a medical devices' time to market

Such is the urgency to digitally transform, developers are often subjected to unreasonable and highly pressurised demands to expedite product time to market. In an industry as regulated as healthcare, these expectations can be overwhelming.

The focus for developers should be on creating software with the capacity to deliver smartphone-like UX and UI for users and patients. In doing so, developers can play a critical role in helping to revolutionise the medical devices industry.

Roger Mazzella is senior product manager at The Qt Company