Bridging Hardware and Intelligence

As Sr. Director of Electrical and Software at Ensera Design, I’ve been at the heart of this evolution for decades. What began as hands-on product development has now evolved into a leadership role guiding the creation and integration of software in life-saving devices.

Whether I’m consulting with clients or developing with a soldering iron in hand, I’ve seen firsthand how essential software is to modern medical devices. But to understand this landscape, it’s important to clarify terminology often misused or misunderstood in the industry.

Clarifying the Software Spectrum

Terms like “Software as a Medical Device” (SaMD) and “Software in a Medical Device” are not interchangeable. SaMD refers to software that functions independently as a medical device and is not tied to specific hardware—think of an app running on a mobile device or a web-based health analysis platform. In contrast, Software in a Medical Device is embedded within the physical device itself—such as a heart monitor or imaging system.

While these definitions are nuanced, understanding the regulatory distinctions is crucial. Mislabeling or misunderstanding these classifications can lead to compliance issues and costly project delays. In short, the seemingly subtle distinction between SaMD and “Software in a Medical Device” is a crucial fork in the road for product development. It dictates the entire regulatory roadmap, and deviations can be detrimental to a company’s success and, most importantly, patient safety.

Early Integration is Essential

A recurring theme in successful medical device development is the early inclusion of software in the design process. Software is not an afterthought—it should be part of the planning from day one. That means addressing all applicable regulatory strategies, understanding user needs, and mapping out the intended use of the device and software together.

This early integration helps define the risk classification, determine which international standards apply, and create a roadmap for submission and approval.

Designing for Scalability and Longevity

Software development in the medical device space is fundamentally different from consumer tech. While the latter thrives on rapid iterations and fast updates, medical device software must be thoroughly vetted and validated before any updates are deployed.

That’s why scalability must be part of the conversation from the beginning. Will the device need to support cloud infrastructure? Will it be localized for use in different countries and cultures? Is it designed with modularity and post-market cybersecurity in mind—especially as quantum computing begins to challenge today’s encryption methods?

Thinking through how a device will scale, be localized, and securely handle sensitive patient data isn’t just technical—it’s a strategic and legal requirement that is essential for long-term success.

Avoiding Common Pitfalls

For startups and seasoned players alike, medical device development presents its own set of challenges. Among the most common missteps is underestimating the full scope of the regulatory process. Entrepreneurs often don’t realize how extensive (and expensive) compliance can be until they’re deep into development. “If I’d known what it was going to take, I wouldn’t have started,” is a phrase I ears more often than I’d like.

To avoid these challenges, companies must understand the entire development lifecycle: from concept and feasibility to development, verification, and validation—all the way through to clinical trials and market approval. Partnering with a knowledgeable, experienced development team can dramatically reduce risk, cost, and time to market.

The Bottom Line

As software becomes more integrated and influential in medical devices, companies must adapt their development strategies accordingly. With a meticulous approach, early planning, and the right partners, software can elevate innovation, improve patient outcomes, and ensure compliance in a complex regulatory landscape.

At the intersection of engineering and healthcare, the future of medical devices is digital—and the code written today will define the life-saving tools of tomorrow.