Pragmatic systems engineering in medical technology: 4 transformative developments

Medical technology is one of the most exciting and dynamic industries for systems engineers. Although (or perhaps because) this industry started using systems engineering relatively late compared to others, it has been able to benefit from the experiences and mistakes of others. As a result, pragmatic and effective systems engineering is often practiced there.

Late starter with clear advantages

Industries such as automotive, aerospace and defense started with systems engineering decades earlier. This also gave them a competitive advantage in the early days. However, some approaches turned out to be dead ends, some of which still weigh on these pioneers:

• Automotive: Tens of thousands of requirements are not unusual in a vehicle specification book. While this provided clarity and structure at the turn of the century, today it slows down innovation and burdens suppliers.
• Space travel: In the 1960s, systems engineering made the moon landing possible. But classic systems engineering fails to realize the potential of agile product development to unfold.

Many medical technology products are far less complex than spaceships or cars. While in aviation, for example, highly networked systems with thousands of components have to function flawlessly for decades, medical devices often focus on specific, clearly defined tasks.

Although medical devices are also subject to regulatory requirements, their functional requirements are often less comprehensive than in more complex industries. However, complexity is increasing and proof of compliance is becoming more demanding. Manufacturers are therefore increasingly introducing systems engineering.

Best practices from other industries

The late adaptation of systems engineering enabled medical technology to adopt best practices from other industries, avoid dead ends and implement a pragmatic approach. For example:

• Risk management: ISO 14971 offers an established framework for risk management that has been adapted from the aviation and automotive industries.
• Usability EngineeringStandards such as ISO 62366The development of user-friendly products is supported by a team of experts from the consumer electronics industry.
• Model-based developmentMBSE and selective modeling help to shorten development cycles and accelerate verification.

4 Transformative developments

However, the use of systems engineering in medical technology is currently accelerating. In addition to increasing compliance requirements, the following technologies are driving this trend:

1. Software - As in other industries, more and more software is being built into medical devices. And that's not all: more and more often, the product consists solely of software, for example in the form of smartphone apps or virtual reality applications.
2. Integration of data - Combining large amounts of data makes it possible to recognize patterns and make predictions about disease progression. This supports personalized treatment approaches and improves patient care.
3. Artificial intelligence - Of course, AI should not be missing from such a list. AI is a driver of complexity that can only be mastered with systems engineering, especially in regulated industries.
4. Digital twins - The creation of digital images of patients makes it possible to test treatments virtually and develop individual therapy approaches.

Medical technology: Ready for pragmatic systems engineering

Medical technology is a domain in which we will see an enormous number of new products in the coming years. The less complex requirements make it possible to concentrate on the essentials: the development of safe, effective and user-friendly systems. At the same time, engineers benefit from the late adaptation of systems engineering, as mistakes made in other industries can be avoided from the outset.

Medical technology shows how pragmatic systems engineering can make a real difference - not only for the industry, but above all for the patients whose lives are improved as a result.

Photo by Marcel Scholte on Unsplash