When is the best time to bring a Supplier Quality Engineer (SQE) into product development? According to Marnie Smith, senior director of quality at Network Partners Group, the window of opportunity for design decisions to reinforce design for quality can be missed by bringing in SQE after the design transfer step in the production process, causing increased costs from inspection rejections, rework, and more complex downstream design changes.

In her session at IME West in Anaheim, CA, called “Supplier Quality and the Link to Product Realization,” Smith explained that the role of an SQE from a medical product overview standpoint is an intersection of the design of a product, the manufacturing of a product, and, especially important in medtech, compliance. Within that intersection are the rules of engagement. This is the role of an SQE as they become the gatekeeper of purchasing controls, the voice of OEMs, and also the voice of the supplier.

“They own the requirements related to purchasing controls and making sure that our suppliers and vendors are providing [a] good product,” Smith said. “But not only that, [they’re] also the voice of the supplier internally at the medical device manufacturing site. Whether it's new product development team, [or] it's the manufacturing quality space, they're the voice of the supplier there to help the site understand the decisions that were made in the quality of the product. At the same time, when they're interfacing with the supplier, they're the voice of the OEM, and the voices of the medical device manufacturer to the supplier, ‘Hey, supplier, we need this; I need you to be accountable for this.’”

Understanding the Design Controls Waterfall

As seen in the design controls waterfall known from FDA, the steps of product development begin with understanding user need. “We have a product, we want to make [it] for the market to save patient lives,” she said. “Before we can make anything, we have to understand what the user needs, what is the patient requirement.”

The next step is design inputs, which entails understanding what information the engineering team and product development team needs in order to translate user requirements into a product. In the design process step, the members of the development team go through and make the device better, tweak it. Once that stage is finished, it needs to be documented through design outputs. “We're going through the cycle, translating all of that [information] into established outputs so we can communicate those requirements,” smith said. After all of that is finished, everything comes together for the last step, medical device.

Design reviews take place at every step along the waterfall. Additionally, a verification process happens to make sure design outputs meet the design inputs. A validation process is also done for the actual end product, making sure the team can demonstrate it fulfills all user needs.

Usually, the supplier gets pulled into the process between the design output and medical device stages, according to Smith, which in her opinion is too late. Instead, she explained that the supplier should be brought into the conversation at the design process step. As for the SQE, they usually come into the picture around the design process and design outputs stage of development. However, she noted that they should be part of the process starting at the design inputs stage.

“I think the supplier should be pulled in right in the midst of the design process” Smith explained. “What I mean is that in the midst of the medical device process or in the design process, we're creating checkpoints where we're pulling in the supplier as kind of a sanity check. ‘Hey, supplier, we're expecting you're going to be able to make this; is this something that's actually manufacturable?’ But, in order to have this happen, we should be pulling the SQE in as early as possible because it is an important element to keep into account for design inputs. Sometimes we have a very classic linear approach of [design inputs] where we think about it being tied solely to patient need. But really a design input can be more than that. It can be the role of the clinician who's handling the product, it can be the role of manufacturing person who is putting the product together.”

Integrating SQE Development Tools

In her presentation, Smith explained that this kind of early engagement is critical to the success of the process. Additionally, she emphasized that there are tools available to help support SQE’s. One such tool is Deming’s 14 Point’s for Total Quality Management. Within the 14 points, she highlighted 4 that have ties to supplier relationships.

3. Cease dependence on inspection to achieve quality.

4. End the practice of awarding business on price alone; instead, minimize total cost by working with a single supplier.

5. Improve constantly and forever every process for planning, production, and service.

9. Break down barriers between staff areas.

Communication Equals Success in Product Development

She highlighted that communication is key for the success of the process and simplified how to best capitalize on the practice in three steps. First, she wrote in her presentation, establish a line of open and transparent communication between channels early in the process to help promote a foundation of trust in order to develop the best possible product. Next, ensure empathy and understanding of problems are central to your message. Lead all conversations back to how you can better support their business and end users by addressing the necessary change. Lastly, stay success and results focused by sharing how making a difficult change to a project can bring greater success back to the team by mitigating risk and ensuring quality.  

“Please remember the communication aspect of it,” Smith said. “What I want you to remember is the role of the SQE, how important it is and how it impacts the product. I want you to remember early engagement is critical to success. We should be talking upfront, trying to make design changes upfront before it gets real and costly downstream.”