By Sean Fenske, Editor-in-Chief
Every medical device company wants to save costs and get to market faster as they also enhance quality and reliability. While there is no magic formula to ensure this happens, there are tools and techniques that can be employed to help get a product development project moving toward that end. Design for Manufacturability (DFM) is one such protocol.
Unfortunately, some engineers view DFM as a corporate mandate in their development process without truly recognizing the value it brings. Or, they may look to employ it too early or too late in the design phase to truly gain the full benefits it can provide. As such, it’s important to work with supply chain partners who maintain experience in this capability to enjoy DFM’s complete advantages.
Since understanding exactly when and why to enlist this capability is not always clearly understood, Jeff Randall, PE, vice president and chief technical officer at MRPC, provided some insights in the following Q&A. He addresses questions on the ideal phase in which to leverage DFM, its impact on quality, and tools that can aid with its use.
Sean Fenske: Many use the phrase Design for Manufacturability, but would you please explain what it actually is?
Jeff Randall: The phrase Design for Manufacturability (DFM) can mean different things to different people. At the core of DFM is the drive to refine the part design to make it easier and less expensive to manufacture without sacrificing part performance, quality, or speed to market. While pursuing perfection is a fool’s errand, a well-executed DFM methodology can often yield significant improvements toward all these goals.
Fenske: At what point should DFM take place?
Randall: DFM should NOT occur at the very beginning of the design phase, because creativity may be stifled if practicality is too heavily weighed early in the process. Likewise, the value of performing DFM is diminished if the design is all but frozen. The sweet spot for DFM is after brainstorming and concepts have started to be developed, and the DFM process should continue until the design is released to production.
Fenske: How does DFM improve quality?
Randall: DFM improves quality by considering and challenging the manufacturing method and optimizing part features for compatibility with the manufacturing process. Understanding the capabilities and limitations of the manufacturing process allows the DFM team to avoid features that will be problematic in production.
While injection molding, for example, the best part quality is achieved by processing the material the way it wants to be processed. It may be possible to “process around” minor deviations from good design practices, but every process deviation (or compromise) results in a smaller process window—the range of critical process parameters that result in good part quality. The smaller the process window, the less robust the manufacturing process will be, and the more likely you will produce a defective product.
Fenske: Are there tools used as part of the DFM process, such as software, or is this accomplished based around engineering experience?
Randall: Certainly, engineering experience plays a significant role in the effective execution of a DFM event. Knowing the written and unwritten rules helps the team sift out and prioritize the best options. Creativity is also extremely important. Being able to apply lessons learned from previous projects and designs is a valuable skill for the DFM team.
Flow analysis and finite element analysis help the team evaluate the options and determine which approaches are most likely to succeed. Rapid prototyping provides an opportunity to test the design options—in some cases, allowing the team to produce samples using the desired material and the manufacturing process of choice.
Fenske: If a company approaches you with a design already developed, are you able to aid with DFM at that point or is it too late?
Randall: It is only too late to perform DFM if the design is not open to change. If a DFM event is held only so the designer and/or organization can “check a box,” then the event is a waste of time.
Recently, a customer asked me to “perform a DFM” on a proposed component. “But the design, dimensions, tolerances, and material cannot be changed.” They had to meet the geometry of an existing part. The objective, it turns out, was to check DFM off the required activities defined in their new product development procedure. It is unfortunate because we have some good ideas that would improve performance and extend production tooling life if they were open to minor design changes.
Fenske: How do other “Design for…” processes tie into DFM, such as Design for Inspection or Testing?
Randall: All design review activities are interrelated. MRPC approaches every DFM situation as an opportunity to improve the design, regardless of from where those improvements come.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
Randall: Your suppliers have a wealth of knowledge that very few device manufacturers tap into. Oftentimes, concerns about “locking into a supplier too early” minimize their leverage to get the lowest price. Change your mindset! The advantages of designing a better device in less time with a quality-minded partner significantly improve your ability to get to market sooner with a superior, more efficiently produced product. That is the value of a truly engaged manufacturing partner.
To be truly effective, it is important to “leave all egos at the door.” Don’t be married to your design. Even incremental improvements can make a big difference.
It takes courage to invite others to review your work. Don’t think of DFM as critiquing your design. Rather, be proud of your ability to leverage the varying experiences of the team.
Click here to find out more about MRPC >>>>>
Every medical device company wants to save costs and get to market faster as they also enhance quality and reliability. While there is no magic formula to ensure this happens, there are tools and techniques that can be employed to help get a product development project moving toward that end. Design for Manufacturability (DFM) is one such protocol.
Unfortunately, some engineers view DFM as a corporate mandate in their development process without truly recognizing the value it brings. Or, they may look to employ it too early or too late in the design phase to truly gain the full benefits it can provide. As such, it’s important to work with supply chain partners who maintain experience in this capability to enjoy DFM’s complete advantages.
Since understanding exactly when and why to enlist this capability is not always clearly understood, Jeff Randall, PE, vice president and chief technical officer at MRPC, provided some insights in the following Q&A. He addresses questions on the ideal phase in which to leverage DFM, its impact on quality, and tools that can aid with its use.
Sean Fenske: Many use the phrase Design for Manufacturability, but would you please explain what it actually is?
Jeff Randall: The phrase Design for Manufacturability (DFM) can mean different things to different people. At the core of DFM is the drive to refine the part design to make it easier and less expensive to manufacture without sacrificing part performance, quality, or speed to market. While pursuing perfection is a fool’s errand, a well-executed DFM methodology can often yield significant improvements toward all these goals.
Fenske: At what point should DFM take place?
Randall: DFM should NOT occur at the very beginning of the design phase, because creativity may be stifled if practicality is too heavily weighed early in the process. Likewise, the value of performing DFM is diminished if the design is all but frozen. The sweet spot for DFM is after brainstorming and concepts have started to be developed, and the DFM process should continue until the design is released to production.
Fenske: How does DFM improve quality?
Randall: DFM improves quality by considering and challenging the manufacturing method and optimizing part features for compatibility with the manufacturing process. Understanding the capabilities and limitations of the manufacturing process allows the DFM team to avoid features that will be problematic in production.
While injection molding, for example, the best part quality is achieved by processing the material the way it wants to be processed. It may be possible to “process around” minor deviations from good design practices, but every process deviation (or compromise) results in a smaller process window—the range of critical process parameters that result in good part quality. The smaller the process window, the less robust the manufacturing process will be, and the more likely you will produce a defective product.
Fenske: Are there tools used as part of the DFM process, such as software, or is this accomplished based around engineering experience?
Randall: Certainly, engineering experience plays a significant role in the effective execution of a DFM event. Knowing the written and unwritten rules helps the team sift out and prioritize the best options. Creativity is also extremely important. Being able to apply lessons learned from previous projects and designs is a valuable skill for the DFM team.
Flow analysis and finite element analysis help the team evaluate the options and determine which approaches are most likely to succeed. Rapid prototyping provides an opportunity to test the design options—in some cases, allowing the team to produce samples using the desired material and the manufacturing process of choice.
Fenske: If a company approaches you with a design already developed, are you able to aid with DFM at that point or is it too late?
Randall: It is only too late to perform DFM if the design is not open to change. If a DFM event is held only so the designer and/or organization can “check a box,” then the event is a waste of time.
Recently, a customer asked me to “perform a DFM” on a proposed component. “But the design, dimensions, tolerances, and material cannot be changed.” They had to meet the geometry of an existing part. The objective, it turns out, was to check DFM off the required activities defined in their new product development procedure. It is unfortunate because we have some good ideas that would improve performance and extend production tooling life if they were open to minor design changes.
Fenske: How do other “Design for…” processes tie into DFM, such as Design for Inspection or Testing?
Randall: All design review activities are interrelated. MRPC approaches every DFM situation as an opportunity to improve the design, regardless of from where those improvements come.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
Randall: Your suppliers have a wealth of knowledge that very few device manufacturers tap into. Oftentimes, concerns about “locking into a supplier too early” minimize their leverage to get the lowest price. Change your mindset! The advantages of designing a better device in less time with a quality-minded partner significantly improve your ability to get to market sooner with a superior, more efficiently produced product. That is the value of a truly engaged manufacturing partner.
To be truly effective, it is important to “leave all egos at the door.” Don’t be married to your design. Even incremental improvements can make a big difference.
It takes courage to invite others to review your work. Don’t think of DFM as critiquing your design. Rather, be proud of your ability to leverage the varying experiences of the team.
Click here to find out more about MRPC >>>>>