By applying these DFX methodologies with a focus on faster time to market, medical device companies can quickly update and extend the life of existing products.
By focusing on speed-to-market in the redesign process, companies can maintain market relevance, quickly address evolving customer needs, and potentially gain first-mover advantages in competitive healthcare markets. This approach allows for rapid product improvements and updates while minimizing the time typically required for completely new designs.
Key benefits of this approach include:
- Reduced regulatory burden: By building on existing approved designs, companies may be able to use abbreviated regulatory pathways.
- Faster production ramp-up: Utilizing existing manufacturing infrastructure minimizes delays in scaling production.
- Quicker market acceptance: Building on familiar products can speed up adoption by healthcare providers and patients.
- Reduced development risks: Incremental changes are typically less prone to unforeseen issues compared to completely new designs.
The resulting updated products can offer enhanced features, improved performance, or better usability while leveraging existing regulatory approvals, manufacturing processes, and market presence. This strategy can help companies respond quickly to market demands, stay ahead of competitors, and capitalize on emerging opportunities.
Let's dive deeper to understand how each design area can be applied to faster time to market when extending the life of an existing medical product design.
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
The following are illustrative examples of a potential product design decisions a company might make to take strategic advantage of the noted benefits of introducing a new product to market vs. updating an existing product. The cases are presented to evoke thoughts and questions around the potential business case for such decisions, and the reasoning behind each.
(continued from above)
Design for Manufacturability (DFM)
Example: For the orthopedic implant with improved materials
A DFM expert could focus on:
- Designing the new implant to use existing manufacturing processes and equipment
- Minimizing changes to part geometries to reduce the need for new tooling
- Optimizing the design for rapid prototyping techniques for faster iterative testing
Faster time to market: Reduced need for new manufacturing setup, allowing for quicker production ramp-up.
Design for Assembly (DFA)
Example: For the ventilator with new software features
Working with a DFA expert might involve:
- Ensuring new components can be integrated into the existing assembly line with minimal changes
- Standardizing connectors and interfaces to speed up assembly and reduce errors
- Designing sub-assemblies that can be prepared in parallel to the main assembly process
Faster time to market: Streamlined assembly process reducing production time and minimizing retooling.
Design for Cost (DFC)
Example: For the pacemaker with extended battery life
A DFC expert could suggest:
- Utilizing readily available, off-the-shelf components where possible to avoid supply chain delays
- Minimizing the number of new custom parts to reduce procurement and qualification time
- Optimizing the design to reduce the number of steps in the manufacturing process
Faster time to market: Reduced sourcing and production complexities, allowing for quicker product launch.
Design for Testability (DFT)
Example: For the surgical robot with advanced instruments
Example: For the surgical robot with advanced instruments
DFT considerations might include:
- Designing built-in diagnostics for new features to speed up testing and quality assurance
- Creating modular test protocols that can be quickly adapted for the updated product
- Developing automated testing procedures to reduce manual testing time
Faster time to market: Accelerated testing and validation processes, reducing time in the quality assurance phase.
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Design for Reliability (DFR)
Example: For the infusion pump with updated user interface
A DFR expert might focus on:
- Utilizing proven, reliable components to minimize the need for extensive reliability testing
- Conducting accelerated life testing on only the new or modified components
- Designing redundancies that can be easily integrated without major structural changes
Faster time to market: Reduced time in reliability testing and validation, especially for unchanged components.
Design for Serviceability/Maintainability (DFS)
Example: For the surgical robot with advanced instruments
DFS considerations could include:
- Designing new components to be easily swappable in the field, reducing the need for extensive service training
- Creating plug-and-play modules for new features to simplify installation and updates
- Developing remote diagnostics capabilities to speed up troubleshooting and reduce on-site service time
Faster time to market: Simplified service procedures and reduced need for extensive service network updates.
Design for Usability (DFU)
Example: For the infusion pump with updated user interface
A DFU expert might suggest:
- Maintaining core user interaction patterns to minimize the learning curve and reduce user testing time
- Employing rapid prototyping and user testing techniques for quick iteration on new interface elements
- Designing intuitive, self-explanatory features to reduce the need for extensive user manual updates
Faster time to market: Reduced time in user testing and training material development.
Example: For the surgical robot with advanced instruments
DFMo considerations could include:
- Designing a standardized interface for new instruments to simplify integration and testing
- Creating a modular software architecture that allows for independent development and testing of new features
- Developing a scalable power and data system that can accommodate new instruments without major redesigns
Faster time to market: Parallel development of new modules and features, reducing overall development time.
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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?
Whether you’ve created a new technology, or have an innovative way to use an existing solution, Boston Engineering will turn your ideas into reality. Our experts and Industry Partners will enhance your current team or manage the entire Product Development Process from Market Analysis to Production. Don't leave complex projects or high visibility product launches to chance. Know you're going to get the results you want by working with industry leaders in design, development, and deployment of innovative products driven by Novel Engineering. Contact Boston Engineering Today to get started.
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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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