Teaching Safety Through Design
The Revolution Transforming Biomedical Engineering
When Design Determines Safety
Imagine a scenario where a medical device fails catastrophically during a critical procedure—not due to manufacturing defects or user error, but because of an inherent design flaw that went unrecognized until it was too late.
The High Stakes of Biomedical Engineering
Biomedical engineers design technologies that sustain and improve human health. When these technologies fail, the consequences can be dire.
Proactive Safety Integration
A new generation of engineers is learning to embed safety considerations into every stage of the design process.
This article explores how a revolutionary approach called "Safety-by-Design" is transforming biomedical engineering education and practice, creating a future where medical technologies are inherently safer, more inclusive, and more effective from the moment they reach patients 1 .
The Safety-by-Design Paradigm: More Than Just a Checklist
Reactive to Proactive
Safety-by-Design represents a fundamental shift from finding problems after they occur to anticipating potential risks and designing solutions that prevent harm before it happens 2 .
Lifecycle Approach
This approach considers the entire lifecycle of a medical device or system, from initial conception through development, clinical use, and eventual decommissioning 3 .
From Industrial Roots to Biomedical Applications
The philosophy of embedding safety into design isn't entirely new. Other engineering disciplines have long recognized that inherently safe designs outperform those that rely on add-on protections or user compliance 4 .
Chemical Engineering
Fail-safe valves and containment systems designed to prevent catastrophic releases.
Aerospace Engineering
Redundant systems and fault-tolerant designs that ensure safety even when components fail.
Biomedical Engineering
Adapting these principles to account for the complexity of human biology and vast differences across individual patients.
Transforming Biomedical Engineering Education
Clinical Immersion
Engineering students participate in clinical immersion experiences where they observe medical procedures and device use in actual healthcare settings 5 .
Interdisciplinary Learning
True safety in biomedical design requires collaborative competence—the ability to work effectively across professional boundaries 6 .
DEI Integration
A crucial evolution in safety-through-design education is the recognition that equitable design is safe design 7 .
Clinical Immersion in Action
In one documented program, engineering students partnered with nursing students in simulation laboratories and real clinical environments, including:
- Cataract surgery
- Hand surgery
- Robotic prostate surgery
- Emergency department
- Physical therapy clinic
Through these experiences, engineering students directly observe how medical devices interact with patients and healthcare workflows 5 .
Evidence from the Classroom: Does Safety-by-Design Education Work?
Risk Factors
Factors that significantly increase accident occurrences in educational settings:
- Class enrollment exceeding 24 students (48% increase in odds of accident)
- Higher percentage of time spent on hands-on activities
- More students with disabilities in a course
- Increased number of course preparations
Protective Factors
Factors that significantly decrease accident occurrences:
- Comprehensive safety training (49% less likely to have an accident)
- Appropriate PPE for all students
- Dust collection systems connected to equipment
- Safety tests required before lab activities
- Undergraduate safety teaching methods course completed by instructor
Impact of Comprehensive Safety Training
When controlling for significant safety risk factors, safety protective factors, and completion of undergraduate coursework covering safety topics, "the odds of an accident occurrence decreased by 83%" .
The BME Educator's Toolkit: Essential Resources for Safety-by-Design
| Resource/Solution | Function in Safety Education |
|---|---|
| Clinical immersion experiences | Exposes students to real-world device use contexts and potential failure scenarios 5 |
| Simulation laboratories with high-fidelity mannequins | Allows safe practice and failure analysis without patient risk 5 |
| Interdisciplinary team projects | Develops collaborative safety competencies across engineering, clinical, and regulatory domains 5 |
| Case studies of device failures | Teaches root cause analysis and preventive design strategies |
| Regulatory pathway exercises | Introduces FDA and global regulatory frameworks that ensure device safety |
| Diversity and inclusion frameworks | Ensures consideration of varied patient populations and usage scenarios 7 |
| Prototyping and testing resources | Enables iterative safety refinement throughout design process |
| Safety standards documentation | Familiarizes students with industry safety standards and compliance requirements |
Technical Factors
These resources address the engineering principles that ensure device reliability, performance, and failure prevention.
- Material selection and compatibility
- Structural integrity analysis
- Electrical safety standards
- Software validation and verification
Human Factors
These approaches account for the realities of human use in diverse clinical environments.
- Ergonomics and usability testing
- Cognitive workload assessment
- Use error anticipation and prevention
- Accessibility and inclusive design
Designing a Safer Future
The integration of Safety-by-Design principles into biomedical engineering education represents more than just a curriculum update—it signals a fundamental transformation in how we prepare engineers to create technologies that heal rather than harm.
Safety as Innovation Enabler
This approach recognizes that safety isn't a constraint on innovation but rather an essential component of truly successful biomedical technologies.
Holistically Prepared Engineers
These engineers will be equipped not only with technical expertise but with the systems thinking, collaborative skills, and ethical frameworks needed to navigate the complex landscape of modern healthcare technology.
The ultimate beneficiaries of this educational evolution will be patients worldwide who can trust that the devices and technologies they depend on have been designed from the ground up with their safety as the primary consideration. In the high-stakes world of biomedical engineering, building safety into the educational foundation may be the most important design feature of all.
For further reading on Safety-by-Design frameworks and biomedical engineering education innovations, see the extensive references provided in the research articles cited throughout this article.