Consider More Than Just End-User Needs When Designing New Products

Suppliers, assemblers, and contract manufacturers each have their own unique requirements to efficiently produce a medical device. OEMs can use Design for Manufacturability and Assembly (DFMA) principles to address these special concerns early in the product development process.

“Design for Manufacturability and Assembly is all about making decisions that will have the greatest impact sooner, rather than waiting and dealing with more complicated issues downstream,” said Marnie Smith, senior director of quality at Network Partners, in a recent interview with Design News. Smith will be presenting “Design for Manufacturability and Assembly (DFMA) in Medical Device Development” at MD&M West, during which she’ll cover how using DFMA can help companies, as well as their suppliers, avoid delays in product launches, or potentially even future recalls. 

After a long career in the medical device industry, Smith is currently responsible for the medical device portion of the quality market at Network Partners, where she finds new projects and also consults with other companies. In her experience, she has learned that to prevent issues from occurring downstream, companies have to plan for them upfront. “One of the things that’s important for medical devices is that there is a heavy weight on design controls,” she said. “What it’s all about is putting structure around your product development process where you have to plan,” she said, noting that such structures can include methodologies like DFMA.

DFMA should occur early in the product development process, Smith said. “When you’re sitting down and putting together all of your user requirements, which should turn into design inputs, you should be asking what are the things this product needs? It doesn't necessarily mean just for the patient, though,” she explained. “Engineers can have a very confined view of that when it comes to product development. If you consider users beyond just those areas, you can build in those expectations early and design for it up front.”

Smith cited an example of what can happen when manufacturers don’t consider these factors. Early in her career, as a product was launching, it was discovered that the engineers had not planned for how a crucial small plastic part was to be made. “Many times, when products are launching, you kind of have to make those pinch decisions of ‘we're just going to run with this and we're going have to fix it later,’” she said. 

The team decided to machine the plastic component from a big piece of plastic, but this is expensive. Smith’s solution was to convert the machined plastic into an injection molded part. “We had to wait a little, and put some money into a tool, but it went from being something like a $30 part, of which there were two per unit, to a $0.75 part,” she explained. “Those kinds of things seem like you can deal with them later. But when you’re making these design decisions, you should be thinking about setting a goal upfront of making sure that certain technologies or certain cost items are taken into account.”

It is those kinds of situations that Smith hopes her attendees can learn how to prepare for and possibly avoid. She said she wants those who come to her session at MD&M West to realize that they can reframe their product development processes by planning for some of the common issues they can expect to experience with their customers. 

OEMs should be asking, “What is the feedback I should be using from my manufacturing team or my supplier team—anyone who’s handling or touching the product when it’s being manufactured. How can I take that into consideration in the product design process that will help eliminate those issues downstream," she said. “It's really around reframing those issues into how to make it not an issue.” 

Smith also encourages suppliers who are working or partnering with OEMs to attend her presentation. “And I would also include any of those OEMs who are trying to figure out the challenges that they deal with, some supplier quality-related issues,” she said. She welcomes any questions that attendees might be wondering about as well. “I really want people to come ready to ask questions and talk about things,” she concluded.

“Design for Manufacturability and Assembly (DFMA) in Medical Device Development” will be presented on Tuesday, February 6, from 1:15 to 2 p.m., in Room 206AB.

MD&M West will be co-located along with Design & Manufacturing West, ATX West, WestPack, and Plastec West as part of the Informa Markets Engineering (IME) West show held February 6-8, 2024, at the Anaheim Convention Center.