What Could Go Wrong If Designers Don’t Understand Manufacturing?

Designers should understand the commercial, technical, and compliance aspects of manufacturing to produce devices effectively while minimizing costs, says an expert speaking at MD&M Minneapolis’s MedTech Central.

DFM in action:  MICRO’s customer originally envisioned this component as stamped or machined with a costly secondary sharpening operation.  A DFM review resulted in a metal injection molded part that achieved the 0.005-in. radius tip with no secondary operation – reducing cost without sacrificing performance.

Design for Manufacturability (DFM) entails designing products so that they are optimized for production, Steve Santoro of MICRO told MD+DI. “DFM is extremely important and allows potential problems to be identified and addressed during the design phase. This process can save time, money, and wasted resources in the long run,” he said. However, “many times, product design engineers find themselves in a dilemma, due to the pressures associated with cost, time, or other factors, and dismiss manufacturing considerations—which could prove detrimental to ultimately producing the parts successfully.”

Santoro will convey the value of DFM at the upcoming MD&M Minneapolis talk, “The Value of Design for Manufacturability to Achieve Product and Cost Efficiencies.” He will be speaking Thursday, November 1, at 10:30 AM at MedTech Central (Booth 1347).

Designers who don’t keep DFM in mind could end up in one of two situations. “On one hand, a product can be over-designed where it’s functional, but may be too complicated to manufacture in high volume,” he said. “On the other hand, a product can be under-designed, which could lead to failure to create a functional result.

“DFM is designed to achieve the lowest technical risk while providing deep understanding of individual processes,” he continued. “For example, when it comes to laser cutting a component for an articulating medical device, it is important to consider the removal of slugs. If each individual cut is not designed properly, you may not be able to effectively remove slugs generated by the process, which will render the component—and therefore the device—unusable.”

Discounting DFM could also add cost. “There can be a considerable cost involved if errors in design are missed and not addressed early on,” Santoro said. “No one wants to create a product that is going to cost too much to manufacture and result in low profit margins. As it relates to metal components and assemblies of surgical instruments, we have found that coming up with an effective “Design For Manufacturability” requires about 80 percent experience and 20 percent cleverness, ingenuity, and problem solving.”

Developing an efficient design is also crucial to keeping costs manageable and return on investment high, he added. “This is especially true for components and devices that require more sophisticated features. This is where the essence of value is key,” he said. “DFM helps to achieve the best possible cost to repeatably produce a functional product that will pass all necessary approvals to reach the market. Value is not always about lowest price, but rather it is about making the most cost-effective and efficient device that will be profitable. The lowest price doesn’t always result in the best outcome. All-in-all, you want to make sure that a product can be manufactured effectively to keep costs down because going back to make changes can result in significant overruns in terms of time, effort, and money.”

Santoro said that MICRO seeks to help on the “front-end” by manufacturing components and subassemblies effectively, avoiding costly reiterations down the road. “We take into account the need to design processes that will minimize scrap and possibly eliminate costly secondary operations. All of this consideration in the design phase also can result in improved development and product launch timing.”

Santoro advised balancing the following elements for optimizing design for product realization:

  • Commercial. Cost is driven by cycle, floor space, and automation.
  • Technical. Determine whether the approach is feasible and how much work needs to be applied to develop the process
  • Compliance and risk. Take into account materials, construction, and approvals needed such as FDA for medical devices.

When asked for a couple DFM tips and tricks typically not considered, Santoro offered the following:

  • DFM can help customers to see value in alternate approaches that could be more cost effective and efficient than the ones they had originally considered. For example, if a customer comes in saying that a product needs to be made through machining, engaging on DFM early can help them to convey the possibility of other approaches such as metal injection molding or stamping that might help to keep costs down while still achieving the desired result. At MICRO, we offer a knowledge of a broad basket of metal fabrication technologies.
  • DFM can also help customers to build realistic cost models to achieve effective results. Through the DFM process, customers become more educated and aware of pricing for processes that they may or may not be familiar with, providing them with an array of options to produce a product which achieves their cost targets without giving up efficiency or functionality and products that are more realistic. MICRO is strives to be transparent in this regard. We discuss the process and explain our recommended processes in relation to the cost model that we run our business on.

Santoro said that DFM is a “must-have approach” in any development process. “Taking this extra, extremely important step can help to keep product development on track while balancing the need for manufacturing efficiencies, cost considerations, and ultimately, FDA approval.”

He encourages companies “to partner with an experienced CMO (contract manufacturing organization)—one that has the manufacturing expertise and historical product knowledge that can help draw out the most value from a DFM approach.” He offers MICRO’s Frank J. Semcer Development Center, which allows customers to work “side-by-side” with MICRO’s development team. “This interaction allows for greater communication during the development process, resulting in improved timeliness, efficiency, and quality,” he said.

Don’t miss Santoro’s MD&M Minneapolis talk, “The Value of Design for Manufacturability to Achieve Product and Cost Efficiencies,” Thursday, November 1, at 10:30 AM at MedTech Central (Booth 1347). MICRO will be exhibiting at booth #1119.

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device packaging, labeling, manufacturing, and regulatory issues as well as pharmaceutical packaging for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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