4 How Medical Device Systems Engineering differ to other industries
Table 4.1 presents a comparative analysis of systems engineering practices across four diverse industries: Medical Device, Aerospace, Automotive, and Consumer Electronics. Each industry operates within distinct regulatory frameworks, market demands, and stakeholder expectations, leading to unique approaches in managing safety, performance, cost, complexity, and customization in product development.
| Feature | Medical Device Industry | Aerospace Industry | Automotive Industry | Consumer Electronics Industry |
|---|---|---|---|---|
| Focus | Safety and regulatory compliance (FDA requirements) | Performance, reliability, and safety for critical applications | Safety, cost-effectiveness, and manufacturability | Cost, functionality, and user experience |
| Life Cycle | Highly regulated with strict change control processes | Long development cycles with significant upfront investment | Cyclical development with model year changes | Fast-paced development with shorter product lifecycles |
| Stakeholders | Broader range including patients, doctors, and regulatory bodies | Primarily engineers, government agencies, and airline customers | Consumers, dealerships, and regulatory bodies | Consumers, retailers, and internal marketing/design teams |
| Risk Management | Extremely high focus on mitigating risks to patient safety | High focus on mitigating risks of catastrophic failure | Focus on safety while balancing cost and manufacturability | Focus on user safety and product liability |
| Cost Considerations | Balancing cost-effectiveness with safety and regulatory requirements | Cost is a major driver, but safety remains paramount | Balancing cost with performance and consumer expectations | Cost is a major driver, with emphasis on economies of scale |
| Complexity | Devices can be complex with software, hardware, and user interaction | Highly complex systems with long development timelines and extreme performance demands | Complex systems with a focus on integration and manufacturability | Range from simple to complex, with emphasis on user experience and ease of use |
| Customization | Typically low customization allowed for medical devices | Limited customization, with focus on platform development for different variants | Some customization for different markets and customer segments | High degree of customization for specific features and functionalities |
Table 4.2 presents a comparative analysis of systems engineering approaches across four diverse industries: Medical Device, Aerospace, Automotive, and Technology.
MedTech |
Aerospace & Defense | Automotive | Tech | |
| Environments of Use | Complex (Physiological) |
Complicated | Complicated to Complex (Level 2 Self-Driving and Above) |
Complicated |
| Reliability Expectation | High | High | Medium | Low |
| Cadence | 2 weeks - 6 years | 10 years | 1 year - 5 years | 2 weeks - 1 year |
| Complexity | Medium | High | Medium | Medium |
| Users | Medium variation in training and capabilities (Multiple Specialties) | Consistent training and capabilities | High variation in training and capabilities | High variation in training and capabilities |
| Variation | Medium | Medium | High | Medium |
| Funding | Market Demand | Contract, Limited Buyers | Market Demand | Market Demand |
| Procurement | Individual, Healthcare System | Contract, Limited Buyers | Individual, Fleet | Individual, Fleet |
Table 4.3 provides examples of differences between systems engineering in medical device industry and other industries.
| Feature | Medical Device Industry (Example) | Other Industries (Example) |
|---|---|---|
| Focus | Safety and Regulatory Compliance | Performance and Technical Specifications |
| Example | A cardiac pacemaker is being developed. Systems engineers focus on volume, power efficiency, and therapy performance to achieve optimal therapy performance and longevity. | An airplane wing is being designed. Systems engineers focus on weight, strength, and aerodynamic efficiency to achieve optimal fuel consumption and flight performance. |
| Life Cycle | Highly Variable Regulation and Change Control Processes | More Flexible and Iterative Development Cycles |
| Example | A significant software bug is discovered in a blood glucose monitor after initial release. A software patch is prioritized, developed, verified, validated, and released relatively quickly through a field update. A minor software bug is discovered in a remote monitoring system for blood glucose monitors after initial release. A software patch can be released quickly through a nightly deployment. |
During the development of a new car model, engineers discover a significant issue with the Advanced Driver Assistance Systems (ADAS). A software patch is prioritized, developed, certified, and released relatively quickly through an over-the-air update. During the development of a new car model, engineers discover a minor issue with the infotainment system. A software patch can be released relatively quickly through an over-the-air update. |
| Stakeholders | Broader Range Including Patients, Doctors, and Regulatory Bodies | Primarily Engineers and Internal Stakeholders |
| Example | Systems engineers for a new insulin pump consider not only technical specifications but also user needs (e.g., easy for elderly patients to operate) and feedback from doctors regarding functionality and integration with existing hospital systems. | While developing a new type of engine, the primary focus for systems engineers might be on meeting internal performance targets set by the company and collaborating with mechanical and electrical engineers on achieving those goals. |
| Risk Management | Focus on Mitigating Risks to Patient Safety | Risk Management is Important, But Tolerances May Be Higher |
| Example | A potential risk identified during the development of a surgical robot is the possibility of unintended arm movement during delicate procedures. Systems engineers use design for reliability to identify the required tolerance for minimizing the risk, and evaluate the design concepts against the required tolerance using cost-benefit analysis and engineering calculations. | When designing a new bridge, there’s a risk of structural failure during an earthquake. While safety is crucial, there might be a tolerance for a certain level of risk based on cost-benefit analysis and engineering calculations. |
According to Joseph Green Chief Systems Engineer from Medtronic from an email conversation on May 6, 2024, the main differences between how systems engineering is performed in the medical device industry versus other industries are as follows:
Funding and procurement require MedTech to self-fund or seek financing leading to a market-driven expectation. This leads to several differences in the systems engineering role: the need to understand the stakeholder business, negotiate trade-offs between a large number of (conflicting) external stakeholders, and make trade-offs throughout the program duration based on market fluctuations.
The strong, and growing, overlap between Tech and MedTech industries drive stakeholder expectations that MedTech provides similar user experience and cadence as Tech while maintaining reliability expectations of traditional MedTech. This leads to several differences in the systems engineering role: the need to understand and maintain knowledge of current Tech industry trends, adopt or at least accommodate agile methodologies, plan and execute the delivery of incremental value on short(er) timelines, and accommodate/compensate for the lower reliability of Tech products while integrating more of them into the healthcare environment.
The environments of use (i.e., use conditions) are very harsh and difficult to reduce to first principles. This leads to several differences in the systems engineering role: the need to continually reassess applicability of known use conditions, and identify and develop unique models for each application.
The cadence of release is highly variable and highly sensitive to market conditions. This leads to several differences in the systems engineering role: the need to dynamically negotiate and alter project scope based on competitive analysis and announcements, and continually and simultaneously focus on both increasing capability and reducing cost.