What Is Systems Engineering in Medical Devices (And Why Your Project Needs It)
Technical innovation is often the easy part when it comes to developing a medical device. The hard part is navigating everything else—FDA pathways, safety standards, usability requirements, cybersecurity protocols, and quality systems.
Most companies discover these requirements too late, when addressing them means expensive redesigns instead of simple adjustments.
Fixing a problem during the requirements phase might cost $1,000. That same problem discovered during testing could cost $100,000. And after market launch, it could cost millions.
The companies that avoid this trap understand what is systems engineering in medical devices and engage that expertise early. Those that don’t end up wasting time and money trying to get their device to market.
Here’s why medical devices need systems engineering.
The “Unknown Unknowns” Problem
In the medical device industry, there’s a fundamental challenge: most companies don’t know what they don’t know.
This knowledge gap affects companies of all sizes. Startups and businesses developing their first medical device have deep expertise in their core technology—whether it’s robotics, software algorithms, or mechanical innovation—but they’ve never navigated the requirements that medical device development demands. Meanwhile, established companies tackling larger or more complex product development efforts often need specialized expertise to supplement their existing teams. Even experienced organizations benefit from bringing in experts to ensure major projects start off properly, especially when facing unfamiliar regulatory pathways or scaling beyond their current capabilities.
This knowledge gap affects all companies, but especially startups and businesses developing their first medical device. They have deep expertise in their core technology—whether it’s robotics, software algorithms, or mechanical innovation—but they’ve never navigated the requirements that medical device development demands.
Unlike consumer electronics or industrial equipment, medical devices can’t just satisfy functional requirements. They also need:
- FDA regulatory pathways and documentation
- Safety standards and risk management protocols
- Usability engineering and human factors validation
- Cybersecurity requirements for connected devices
- Manufacturing quality systems and supply chain considerations
- Integration challenges across multiple engineering disciplines
Each of these areas influences the others in ways that aren’t always apparent to teams focused on their individual specialties.
Common Medical Device Development Challenges (That Systems Engineering Can Help With)
Without systems engineering coordination, teams inadvertently create medical device development challenges that lead to expensive late-stage redesigns:
- Software developers create user interfaces without understanding the FDA’s human factors requirements
- Mechanical engineers design enclosures without considering EMC testing implications
- Hardware teams specify power requirements without coordinating with software processing demands
- Regulatory teams develop submission strategies in isolation, missing the critical connection between regulatory approach and technical implementation
- A team can implement an AI-based algorithm that doesn’t meet current FDA expectations challenges
How Medical Devices Got Too Complex for Traditional Engineering
Medical devices weren’t always this complicated. In the 1970s, most medical devices were primarily mechanical with simple electrical components. An infusion system, blood pressure cuff, or basic monitoring device could be developed by a small team of engineers working closely together.
But the evolution of medical technology has created complex issues that need to be addressed early on in the development process:
- Software Integration: Modern devices are essentially computers with medical applications, requiring software development, cybersecurity protocols, and user interface design.
- Connectivity Requirements: Internet-connected devices must meet cybersecurity standards while maintaining reliable clinical performance.
- Advanced Algorithms: AI and machine learning capabilities add layers of regulatory complexity and validation requirements.
- Multi-Modal Devices: Devices that combine imaging, therapy, and monitoring require coordination across multiple engineering disciplines.
- Stricter Regulatory Environment: FDA oversight has expanded to address patient safety concerns, requiring more documentation and validation.
What Goes Wrong Without Systems Engineering
Without proper systems engineering, medical device projects typically suffer from predictable failure modes that represent the most common medical device integration problems:
Problem #1: Integration Issues
Teams develop components that work individually but fail when combined. A software team might develop algorithms that exceed the hardware’s processing capabilities, or mechanical designs that interfere with electrical components.
Problem #2: Critical Requirements Get Lost in Development
Without systematic requirements management, teams lose sight of critical system requirements during development—especially key safety, usability, and security needs. As engineers solve immediate technical problems, fundamental requirements that protect patients get deprioritized. The Systems Engineer holds these critical requirements, reminding the team throughout development why they’re essential and ensuring they’re actually implemented.
Without systematic requirements management, projects expand in scope without corresponding timeline or budget adjustments. What starts as a simple monitoring device becomes a comprehensive diagnostic platform.
Problem #3: Late-Stage Design Changes
Critical issues discovered during testing require fundamental redesigns when simple modifications won’t suffice. These changes cascade through multiple systems, creating delays and budget issues.
Problem #4: Regulatory Roadblocks
Teams may develop technically sound solutions that don’t align with FDA expectations, requiring extensive rework or alternative approaches during the submission process.
Problem #5: Resource Misallocation
Without understanding technical dependencies, teams over-engineer some components while under-resourcing critical path items, creating bottlenecks and inefficiencies.
The Systems Engineer as Technical Quarterback
The best analogy for understanding what is systems engineering in medical devices comes from sports. If the program manager is like a coach calling plays from the sideline, the systems engineer is the quarterback on the field—actively participating in the game while coordinating how all the players work together.
This quarterback needs to understand how each position works and how their actions affect the overall strategy. They need the experience and perspective to see the bigger picture and make real-time decisions that keep the team moving toward their goal.
In medical device development, this means:
- Understanding how software decisions impact hardware requirements
- Recognizing when mechanical design changes affect regulatory pathways
- Coordinating testing strategies across multiple engineering disciplines
- Creating an AI algorithm that meets FDA expectations or that can be implemented on hardware and still meet power and battery requirements
- Managing technical budgets for power, weight, performance, and error allocation
- Translating between engineering teams and business stakeholders
System Engineering Benefits for Medical Devices
Companies that have experienced good systems engineering often describe an “aha” moment when they realize what they’ve been missing. One executive described it as finally having someone who could see around corners—anticipating problems before they became crises and understanding how all the pieces of their complex device needed to fit together.
This realization usually comes after companies have struggled through projects without proper systems engineering support. They’ve experienced the late-night crisis calls, the expensive design changes, and the frustrating delays that come from working without a technical quarterback.
But increasingly, companies are learning this lesson from others’ experiences rather than their own mistakes. They’re recognizing that medical device complexity has reached the point where systems engineering isn’t a luxury—it’s a necessity for predictable, efficient development.
So why do medical devices need systems engineering? Because system engineering results in:
- Earlier problem detection when changes are still inexpensive to implement
- Better coordination across software, hardware, mechanical, and regulatory teams
- Reduced integration risks through systematic requirements management
- Faster FDA approvals with documentation that aligns with regulatory expectations
- More predictable timelines by identifying and managing technical dependencies
- Lower overall costs despite the investment in systems engineering expertise
Discover the Power of Systems Engineering and Technical Leadership With CMD MedTech
As medical devices continue evolving, the need for systems engineering will only grow. Companies that embrace this discipline early will have a significant competitive advantage over those that continue trying to manage complexity through traditional engineering approaches alone.
The question isn’t whether your medical device project needs systems engineering expertise–the question is whether you’ll engage that expertise early enough to realize its full value, or whether you’ll discover its importance the expensive way.
Ready to learn how systems engineering can benefit your medical device development project? Contact CMD MedTech to discuss your specific challenges and discover how our technical leadership expertise can help you avoid costly pitfalls while accelerating your path to market.