Next-gen medical devices demand new breed of architect

As the technical lead in medical device development, software architects have a challenging role to fulfil. This is compounded in the digital age. Connectivity unlocks opportunities to enhance treatment and improve clinical outcomes. And off-the-shelf software components can be used to accelerate device development. But these factors also introduce new risks, which can complicate regulatory approval and increase the likelihood of project overrun.

With discrete, unconnected devices, software code is contained within a single functional unit. End-to-end code development is owned and controlled by the manufacturer. However, the rise of connectivity and commodity software changes this. Today’s software architects need to be mindful of cybersecurity as well as conventional aspects of patient and user safety.

The evolution of the software architect

Managing the convoluted – sometimes conflicting – requirements associated with connected devices is not easy. Experience in technical leadership for the medical domain will only take you so far: it’s important to acknowledge the unprecedented complexity of today’s challenges.

Medical device companies need to assess the aptitude and attitude of their software architects, and identify any gaps that need to be addressed. 

It takes more than technical skills and sector knowledge to drive success in the connected world. Softer factors like personality traits also have a bearing. In our experience, working both as software architects and with software architects, there are three common ‘types’. Some of them probably sound familiar:

• The cautious one

While prudence is a desirable characteristic in a software architect, some are a little circumspect in their approach. Seeking to minimise exposure to external threats, they opt to develop everything themselves. This increases the likelihood of costs and/or time overrunning. It’s also counterintuitive, because relying on a high percentage of bespoke code presents a risk in itself.

• The buccaneer

Naturally, software architects have an interest in ‘shiny new things’. A passion for technology goes with the territory. And it’s essential to keep up-to-date with developments that can unlock better efficiency or effectiveness in medical devices. But too much dependency on emergent technologies can cause serious issues surrounding safety, future-proofing and usability.

• The generalist

Some architects tend to work generically, even when developing a framework for a very specific purpose. They want to devise architectures that work in any situation – even if they only need to work in one. This approach can introduce unnecessary overheads which impact testing, performance and future development pathways.

Best-of-breed

Each of the above tendencies can hinder progress, while inadvertently exposing devices to unacceptable or unnecessary risk.

So, what distinguishes a good software architect?

In the connected world, this role calls for someone knowledgeable, experienced and pragmatic. They’re keen to maximise opportunities, but highly aware of the associated risks and mindful of their own limitations. They look at requirements clearly and from multiple perspectives. And they are not wedded – either psychologically or commercially – to any individual technology.

Importantly, software architects shouldn’t work in an ivory tower, handing off implementation to a project development team. Outcomes are far better when they’re involved for the duration. It’s not just about having ‘skin in the game’. It’s about ensuring the rationale behind architectural decisions is properly understood and reiterated once coding begins in earnest.

A fine balance

Medical device companies have a duty of care to maximise the safety and security of patients and users. At the same time, their raison d’être is to continually raise the bar with new features and technical improvements.

Finding the right balance between these dual objectives starts with good decisions about software architecture.

Our whitepaper ‘Medical devices: the shift from embedded to connected’ outlines five factors that underpin informed and prudent upfront technology choices. They bring awareness, clarity and objectivity to decision-making, which adds a layer of assurance. And that’s the cornerstone of pioneering, industry-compliant devices for improved clinical outcomes in the digital age.