Accelerating Time-to-Market Through Digital Solutions

Why Digital Matters in MedTech Today 

In medical device development, time is everything. Every month a product is delayed, patients wait longer for life-changing innovations, and competitors have more time to get ahead. Traditional development processes that rely heavily on physical prototyping, iterative rework, and late-stage usability testing are simply too slow and too expensive. 

That’s why digital engineering has become a competitive advantage. Simulation, digital twins, data visualization, and immersive testing allow engineers to evaluate designs earlier, refine them faster, and reduce costly rework. For medical device executives, the result is clear: lower risk, faster time-to-market, and stronger adoption by clinicians and patients. 

At Boston Engineering, our Digital Solutions Center of Excellence (COE) integrates these tools into the full product development lifecycle. By combining digital engineering with our systems approach, we help companies bring safe, effective, and user-friendly devices to market more efficiently. 

Read more below.

The focus and discipline of DFX is a powerful tool if used as part of a broader strategic approach to developing product/process differentiation, and a sustainable advantage against competition. Involve Design for X in Strategy. Once your team has determined the focus of your strategy, place the focus of design on developing competitive advantage. 

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:

• Design for Manufacturability (DFM)
• Design for Assembly (DFA)
• Design for Cost (DFC)
• Design for Testability (DFT)
• Design for Reliability (DFR)
• Design for Serviceability/Maintainability (DFS)
• Design for Usability (DFU)
• Design for Modularity (DFMo)

Learn more about Design for X (DFX) at Boston engineering: Boston Engineering Design for X

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Case Example 1: Surgical Navigation System Usability in VR

A client was developing a surgical navigation platform with advanced capabilities, but clinician feedback showed the interface was unintuitive. Physical redesigns were costly and time-consuming, threatening to delay approval. 

Boston Engineering stepped in with digital tools: 

• Built a virtual reality simulation of the interface so surgeons could interact with it before physical prototypes were built. 

• Captured feedback on ergonomics, workflow, and ease of use in a realistic clinical environment. 

• Applied data visualization to analyze surgeon behavior patterns. 

• Iterated the design digitally before finalizing physical builds. 

Outcome: Clinician adoption improved significantly, usability concerns were resolved early, and the platform advanced toward regulatory submission with confidence. 

Case Example 2:  Diagnostic Imaging Platform Simulation

Another innovator needed to validate the performance of a diagnostic imaging system that involved complex thermal, optical, and structural interactions. Physical prototypes were expensive and limited in the range of conditions they could simulate. 

Boston Engineering leveraged digital solutions by: 

• Using multiphysics simulation to model fluid dynamics, heat transfer, and vibration impacts. 

• Identifying potential failure points early, reducing the need for costly prototype iterations. 

• Validating that performance met clinical and regulatory requirements under a wide range of conditions. 

• Creating digital data packages to support regulatory documentation. 

Outcome: The imaging platform achieved higher reliability and faster verification, saving time and reducing program costs. 

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Case Example 3: Infusion Pump Virtual Verification

An infusion pump developer needed to demonstrate precise dosing accuracy and safety, but physical verification required extensive hardware builds and time-consuming testing. 

Boston Engineering provided digital acceleration by: 

• Creating a digital twin of the infusion system to test dosing accuracy under varied operating conditions. 

• Running thousands of digital test cycles to identify edge cases before hardware was finalized. 

• Mapping requirements directly to virtual verification scenarios to strengthen regulatory submission. 

• Refining the control algorithms digitally to improve real-world performance. 

Outcome: Verification timelines were significantly streamlined, reducing late-stage surprises and accelerating progress toward market readiness. 

The Common Thread: Digital + Complete Product Development 

In each of these examples — surgical navigation, diagnostic imaging, and infusion systems — digital engineering made the difference. But the real value came from Boston Engineering’s ability to integrate digital tools into the entire product development process. 

Our approach ensures that: 

• Simulation complements physical testing, not replaces it, reducing iterations. 

• Digital twins predict long-term performance, improving confidence in reliability. 

• VR and AR testing identify usability issues early, improving clinician adoption. 

• Visualization tools provide actionable insights to guide design and business decisions. 

• Digital documentation strengthens regulatory submissions, making approvals smoother. 

By weaving digital solutions into systems engineering and project management, we ensure they deliver real-world business impact, not just technical data. 

Faster, Smarter, Lower Risk Development 

For executives, the mandate is clear: bring products to market faster, without compromising safety or quality. Digital solutions provide the tools to do exactly that — but only when they are integrated into a disciplined product development process. 

Boston Engineering combines digital expertise with robotics, embedded systems, control systems, and DfX to create smarter, faster, and more reliable product development pathways. We don’t just use simulation or VR in isolation — we use them strategically to reduce risk, accelerate timelines, and ensure devices succeed in clinical and commercial settings. 

If your organization is developing a next-generation device, Boston Engineering can help you leverage digital solutions to shorten time-to-market and deliver innovation with confidence. 

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Developing successful new products from scratch is challenging enough, but what about improving on existing designs? 

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 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? 

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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