Quality in Component Fabrication—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Medical device manufacturers are constantly seeking quality in their supply chain, but how they identify that can be tricky. They must successfully find a component supplier with the experience and expertise they need for their next project—and feel confident in their selection. That process can be challenging, so it is important to speak with suppliers to determine how they address these concerns.

Quality may not have the same meaning to all suppliers. For some, it’s a defect rate; for others, it’s a word in the firm’s mission statement. Still, for others, it’s something they seek to achieve on a daily basis and ensure it exists in every project in which they are involved.

Considering how crucial quality is to medical device OEMs, Bruce Dworak, president of Hobson & Motzer—a supplier of precision metal components and assemblies to the medical device manufacturing space—offered a candid look at his views on quality. He speaks about how important the belief in quality is to his company, how they live the philosophy, and why he thinks quality is not the same for all medical device suppliers.
 
Sean Fenske: As president of Hobson & Motzer, what does the word “quality” mean to you?
 
Bruce Dworak: Quality means meeting or exceeding customer expectations; that’s the first line. At Hobson & Motzer, that’s exactly what we want to do. Then, the second line is understanding of requirements—knowing what constitutes quality. So, in order to achieve expectations, we have to know what quality means. As such, that’s something we try to work in throughout our culture. This involves a cultural mindset at Hobson & Motzer within every phase of production—from design and development through to delivery. All staff are given a voice and encouraged to participate in ongoing improvement initiatives. Everyone is trained and supported to uphold the highest quality standards for the critical components we manufacture. People truly have a sense of personal pride in knowing their work is instrumental in what comes together in the form of a medical device, instrument, or robotic surgery platform, all aimed improving the lives of others. 
 
Fenske: From a performance standpoint, is Hobson & Motzer performing at a high level in terms of quality; and as president, are you satisfied?
 
Dworak: We have a very good track record. To expand on that, our five-year average of customer returns is only 0.0003 percent of product that actually comes back to us. We also track our customer complaints and look at complaints in terms of product quality, paperwork, and other factors. Those have had favorable trends over the last few years as well. But we’re still always striving to improve. That’s an additional aspect of our quality policy—continually improving performance—which will lead to increased customer satisfaction.
 
Fenske: In the medical device manufacturing sector, many say quality is a given. Is that true? And what separates Hobson & Motzer from the competition?
 
Dworak: I would argue it’s not a given; many people say it, and some are adamant about it, but my experience has been that it’s not always the case. For example, in the situations where we were dual-sourced, over time, we ended up earning a favorable status and won more market share. The customer would run our parts on an automated system that requires more consistency, or they’d run our parts over the weekend when there’s less support staff on hand to deal with any quality problems. Sometimes, there are disruptions in our customers’ lines because there’s a quality problem with components from elsewhere in their supply base. Fortunately, that very rarely happens with components from us. This is why I’d argue that quality is not a given in this industry.
 
As far as what separates us from the competition, there is a lot. What comes to mind is consistency and reliability, something we often hear from our customers. As a company, I think we offer a wealth of experience, too. Hobson & Motzer is over a century old, and we have been fortunate to maintain a strong, high-performing team at every level of the company. Quality requires a lot of different expertise; maintaining the integrity of that expertise, systemically, from generation to generation has been key from a quality perspective. We practice what I call “authentic” lean manufacturing, something that is ingrained in our culture. In recent years, we adopted the principles of the Shingo Model with the goal of overall enterprise excellence. Further, we embrace a holistic kind of strategic thinking throughout the company, involving the scientific approach, as well as a focus on process.
 
Fenske: As medical device OEMs have continued to innovate, how has this impacted your approach to quality?
 
Dworak: It hasn’t really changed our approach. Certainly, the technology has evolved, and we are at the forefront of adding those new solutions—such as in metrology—and improving our capabilities with data acquisition and data analysis. We also maintain the capabilities to offer 100 percent automated inspection. Those are some examples of how we’ve evolved. They help to maintain our expectations in terms of the quality level we want to achieve.
 
Fenske: Can you discuss some other specific examples of equipment you have recently brought online and how it has impacted quality?
 
Dworak: Well, we’ve had multi-sensor systems for many years—the vision laser and touch probe type systems. We’ve recently augmented to the latest and greatest capability, however. Some of these advancements include five-axis scanning probes and TTL (through the lens) lasers, which allow better laser contouring. And this is within a multi-sensor system. In addition, we just recently added a state-of-the-art CMM system, which enables a three-dimensional scan.

 
Fenske: When you bring new equipment like these online, is there a “ramp up” phase before getting the quality to where you require it or is it ready to go at the start?
 
Dworak: We’re able to get them implemented and enjoy the benefits from these technologies rather quickly. Getting them fully optimized, however, may take a little bit longer. For example, with the new CMM I mentioned, we just added it a few weeks ago, and we’re already using it for a prototype job we’re doing for a customer. So it’s already in use, but it’ll be streamlined and made more efficient and effective going forward.
 
In addition, we have our First Step program, which is geared toward development work. Much of this work tends to be for next-generation medical device and surgical instrument components and components used for robotic surgery platforms. In most cases, these projects put us at the very front end of the design process with customers. As such, they involve significant DFM (design for manufacturability) work. We have our engineering and applications teams working very closely with customers on their design. We bring that precision into the prototype development. It’s a systematic NPD (new product development) process that delivers a better outcome, reduces time to market, and improves the end results.
 
The more we learn in the development phase of projects like these helps to reduce the friction of getting a new system on line. It’s a challenge for any new technology to be used to its full capabilities right out of the box. Our process helps to eliminate that friction as quickly as possible.
 
In addition, we have over 80 CNC machines between our two plants. One of the newest additions to the lineup is a five-axis, ultra-high-precision, multitasking machine. It allows for full five-axis milling. We’re currently working to get into very precise parts that we can make very quickly and in a semi-automated manner without significant fixturing.
 
Fenske: Considering the OEMs with whom you already work, what would you say makes for a quality relationship with customers?
 
Dworak: It may sound a little cliché, but integrity is a major factor for Hobson & Motzer. The customer has always looked to us for that characteristic and, as such, we have integrity tied into our quality, alongside our business practices. OEMs must be able to trust their supplier and the OEMs we work with trust us. This helps to drive a high level of customer satisfaction, which is reflected in the customer surveys we’ve received over the years.
 
Fenske: Given all it takes to produce medical device components from raw material to final form, how do you ensure quality throughout your supply chain?
 
Dworak: We obviously need to have strong processes to ensure incoming raw material is top quality, but beyond that, we really aspire to be a vertically integrated organization. We started as a tool shop and developed into a stamping house. From there, we continued to add several secondary operations. Now we’re able to provide full assemblies. In many cases, these were subcontracted in the past, but over time, we ultimately brought capabilities in-house so we could control the quality and run a leaner process flow without shipping components and assembled devices back and forth. We own the quality from beginning to end—and don’t rely as much on supply chain as other companies may.
 
For example, we have three new products we’re working on in new product development, and they have adjacent processes we don’t have in-house currently. These are metal forming/metal transformation processes, but they are adjacencies. So that’s a technology we are now looking to bring in-house to master and offer as an additional capability to our customers.
 
If you look at the history of our company, we have deep expertise as tool and die makers, and that’s still the heart of the company. It’s what allows us to be experts at stamping. But we also design and build our own fixtures, which positions us as a great machining company. We’ve been able to collect experts from different areas who lend their experience to the collective knowledge of the company, which only goes to better serve our customers.

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