In healthcare, reliability is not optional — it’s essential. A medical device that fails even once can put patients at risk, disrupt clinical workflows, and damage brand reputation. For executives, ensuring reliability is more than an engineering requirement; it’s a business imperative.
But building reliability into devices requires foresight. It’s not something that can be “tested in” at the end. Instead, it must be designed into the product from the very beginning, with careful attention to controls, materials, usability, and manufacturability.
At Boston Engineering, our Design for Reliability (DfR) discipline, combined with our Control Systems, Embedded Systems, and Digital Solutions COEs, ensures devices are engineered to perform consistently — in every environment, every time.
At Boston Engineering, DFX is a core part of creating values during our product development process. We focus on several key DFX areas that align with our expertise:
Learn more about Design for X (DFX) at Boston engineering: Boston Engineering Design for X
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A diagnostic company developing a complex imaging platform needed to improve system reliability under demanding clinical conditions. Early prototypes were inconsistent, raising concerns about accuracy and regulatory approval.
Boston Engineering strengthened the design by:
Outcome: The imaging system achieved greater reliability and accuracy, giving clinicians confidence in results and positioning the platform for smoother regulatory approval.
An innovator sought to design an infusion pump that delivered precise micro-volumes of medication over extended periods. Early designs lacked safeguards for accuracy and reliability in variable conditions.
Boston Engineering ensured reliability by:
Outcome: The infusion pump achieved highly reliable dosing accuracy with built-in redundancies, earning stronger clinician trust and preparing for regulatory readiness.
While some view AI as a potential job replacement threat, the reality is that these advanced capabilities are better positioned as “workforce multipliers” that will amplify the abilities of doctors, nurses, technicians and other medical professionals.
During the development of a next-generation ventilator, reliability was paramount. The device had to perform consistently under intensive use, with no margin for error.
Boston Engineering contributed by:
Outcome: The ventilator platform was proven reliable across diverse use cases, delivering the confidence needed for both clinicians and regulators.
Across imaging platforms, infusion pumps, and ventilators, the key to success wasn’t last-minute testing — it was reliability engineered from the start.
Boston Engineering ensures reliability by:
This approach ensures devices perform not just once, but every time they’re needed.
For executives, reliability is more than an engineering metric — it’s what drives clinician trust, regulatory approval, and long-term commercial success. A device that performs consistently becomes the standard of care; a device that fails risks irrelevance.
Boston Engineering has demonstrated its ability to deliver reliability by design across complex systems like imaging platforms, infusion pumps, and ventilators. By combining technical expertise with systems thinking and project management discipline, we help innovators deliver devices that perform consistently and safely in the real world.
When you partner with Boston Engineering, you gain a team committed to ensuring that your product not only works — but works every time, without fail.
In this eBook, we’ll dive into the real-world experiences of DFX subject matter expert John DePiano, exploring the common areas where existing product owners excel, as well as the key opportunities where targeted DFX support can drive major improvements.
Understanding the Importance of a DFX approach in medical device design & development
Applying Design for X (DFX) methodologies upfront in medical device development optimizes the entire lifecycle by improving manufacturability, testability, reliability, usability, and other critical characteristics. This avoids costly redesigns later on, facilitates high-quality products that satisfy customers, reduces manufacturing and service costs, and supports flexibility through modularity and platforms. The holistic perspective of DFX drives efficient, cost-effective delivery of successful products that provide competitive advantage. Investing in DFX early pays dividends across the entire product lifespan.
Do you offer training on DFX for your medical engineering teams?
Education is critical to effectively implement DFX principles. We provide training tailored to your engineers’ roles and product lines. This includes overall DFX methodology, deep dives into specific disciplines like design for reliability or manufacturability, and practical application workshops. Our hands-on approach combines real-world examples and case studies with tutorials on leading DFX software tools. The goal is building organizational DFX expertise and establishing repeatable processes that endure beyond individual projects. Investing in DFX knowledge pays dividends across your entire product portfolio.
Ready to Begin your next medical device DFX Project?
No matter the challenge, our team possesses the expertise in the engineering disciplines and technologies you need to bring your vision to life. Impossible Challenge? Try Us.
Impossible Challenge? Try Us.
Selecting a partner to help you complete your design project is a valuable option to reduce project duration and save money.
The Boston Engineering product development system encompasses DFX to ensure a smooth product launch and success in the marketplace. Boston Engineering has DFX knowledge and experience to address aspects and values of a product such as manufacturability, test, reliability, safety, serviceability, cost, and compliance with industry standards and government regulations.
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