Diagnostics are at the center of healthcare decisions. From identifying disease at its earliest stage to guiding treatment strategies, diagnostic devices provide the information clinicians rely on to act quickly and confidently.
For executives at medical device companies, the challenge is clear: diagnostics must be accurate, fast, cost-effective, and easy to use. In practice, this means integrating precision engineering with user-centered design and manufacturing foresight. Without this combination, even promising diagnostic innovations can face adoption hurdles or scale-up failures.
At Boston Engineering, we specialize in transforming diagnostic technologies into reliable, scalable, and user-friendly products. By integrating our Centers of Excellence (DfX, Embedded Systems, Robotics, Digital Solutions, and Control Systems) with systems engineering discipline, we help innovators deliver diagnostics that succeed both in the lab and in the marketplace.
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 client had a single-use diagnostic consumable that worked in principle but was too costly and complex to manufacture at scale. Without redesign, commercialization was out of reach.
Boston Engineering applied its DfX expertise to:
Outcome: The consumable became reliable, cost-effective, and manufacturable at high volumes, enabling successful scale-up without sacrificing performance.
Another innovator was developing a portable point-of-care diagnostic tool for use outside of traditional labs. While technically promising, the prototype was fragile, difficult to use, and not optimized for reliability in diverse environments.
Boston Engineering helped by:
Outcome: The point-of-care device achieved greater durability, usability, and reliability, making it practical for widespread adoption and clinical confidence.
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.
A diagnostic company needed to automate a traditionally manual laboratory test to improve speed, consistency, and throughput. The challenge was creating a system that delivered high repeatability while reducing the risk of human error.
Boston Engineering delivered by:
Outcome: The automated instrument achieved significant improvements in speed and repeatability, reducing variability and freeing up clinical staff for higher-value tasks.
Across consumables, point-of-care tools, and automated instruments, the key to success wasn’t just technical feasibility. It was designing for the realities of manufacturing, usability, and adoption.
Boston Engineering ensures that:
This holistic approach enables diagnostics to move from promising prototypes to trusted clinical products.
In today’s healthcare environment, diagnostic innovation must balance accuracy, speed, cost, and usability to succeed. For executives, that means choosing a partner who understands not only how to engineer precision systems, but how to deliver them as complete, market-ready products.
Boston Engineering has done this across consumables, point-of-care devices, and automated instruments. By combining deep engineering expertise with program management, regulatory awareness, and systems discipline, we help innovators deliver diagnostics that clinicians trust and patients rely on.
When you partner with Boston Engineering, you gain more than a product development firm — you gain a team committed to making sure your diagnostic innovation delivers real-world clinical impact at scale.
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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