The new product development process is often complex, not solely based on the design and manufacturing themselves, but because of myriad voices that need to be considered. DF(x), the more modern philosophy of design for manufacturability, allows companies to ensure that products are developed in alignment only customer needs, as well as business needs, which can get lost or overlooked early in the design process.
In a recent BONEZONE webinar, orthopedic veteran Dale Tempco advised how to use a DF(x) approach, explaining why and how to account for user and business needs and demonstrating DF(x)’s impact on the design process, departmental relationships and the business.
“The intent of DF(x) is to develop products that make the business successful,” he said. “DF(x) is a map that leads to successful products, allowing you to look back at any point in time and determine if you’re on the wrong road heading the wrong direction.”
Here are three important considerations that Tempco mentioned during his presentation.
1. Understand Your Customer and Business Needs
It’s important to start DF(x) activities early on, beginning with the first step of the design process: understanding the voice of the customer and the business needs. Both sets of needs must be identified so that you’re able to appropriately track them in each step of the design controls process. Tempco said that this can be a little tricky. But considering this cross-functional input early in the process can avoid problems stemming from engineers focusing too narrowly on the design.
Tempco gave an example of a design that called for a low-reflective coating on an instrument. A surgeon had told an engineer that he didn’t want instruments to be shiny, because they reflect the operating room lights and make it hard to work. The engineer was impressed by a small startup that had developed an anti-reflective coating, and so included it as a requirement in the drawing. Marketing also liked the coating because of its sleek look. However, the coating made the instrument more expensive. The launch was also delayed because the startup wasn’t on the company’s approved supplier list. Also, the startup had limited capacity and couldn’t handle the needed volume. In the end, the launch fell short of revenue projections.
“Did this special coating meet the user need? Yes.” Tempco said. “However, it conflicted with a business need. Maybe you could have met the user need with a simpler solution that still provided a non-reflective coating. A review of design outputs and user and business needs during design verification and design validation would have brought this to light and resulted in a much better product. The best design is one that meets user needs and business needs.”
2. Prioritize Your Needs
A lot of people and departments are involved in new product development. The larger the company, the greater the chance that the process can become bureaucratic and hectic.
Tempco said that a DF(x) approach requires prioritizing the business and user drivers that affect your design inputs.
“Remember, DF(x) doesn’t necessarily tell you which way is right, but it can tell you if you’re on the wrong path and what’s important,” he said.
Many times, decisions are a give-and-take situation between the most critical, costly or time-consuming.
Just as important as prioritizing these decisions is prioritizing who is going to guide the decision-making process. Tempco advised that the leader should be someone who understands the entire process and can understand prioritization issues, and then take them to the project team.
“It’s been my experience that they [executive management] don’t know the details,” Tempco said. “They don’t have the answers because they don’t really know the intimacy of what’s going on. The project team needs to step up and say, ‘Look, I have three options. I can do A, B, or C.’ And then bring that to your steering committees or whatever checkpoints you have along your design and ask, ‘Which way do you want me to go? I can launch this a little earlier. I need to spend some more money. I can take these features out and I can save time.’ ”
3. Consider Risk in Your Design
Tempco noted that, of course, you’re going to consider risk in your design. But taking it a step further, he recommended documenting off-label or misuse activities.
“Considering off-label use for design inputs may sound crazy, but we know that people are using products off-label in our industry,” Tempco said. “And some of that off-label use is high-risk.”
Tempco said that he understands the topic can be controversial and unnerving.
“One test for when you’re having these discussions, is … what would happen if you were in a court and you had to defend your company?” he said. “We should do what’s right.”
Tempco suggested putting this and other business needs information in the design failure mode and effect analysis (DFMEA). While mixing business needs with what will eventually be a design history file makes some people uncomfortable, Tempco said, it’s not an issue for FDA.
“FDA doesn't really care about your business, so I don’t think it would really be an issue if the business needs were clearly identified, but if mixing them is a problem, just do it in another document.”
Kathie Zipp is an ORTHOWORLD Contributor.