How Cirtec Medical Capitalizes on Precision Component Consultancy

Sitting down with Sean Harz, senior director of business development and strategy at Cirtec Medical, and Asheesh Divetia, General Manager at Cirtec Medical, at MD&M West, both detailed how the company is leveraging components for class II and III medical devices throughout a product's entire design evolution, what sets them apart from traditional machining, and how consultancy can be the difference between a $30 part and a $10 part ending up in a finished device.

You've graciously agreed to discuss how Cirtec leverages precision components for class II and class III medical devices. Could you give the readers an intro to the company and how it specializes in those areas?

Harz: I'm the senior director of business development and strategy here at Cirtec, but I've been in contract medical device design, process development, and manufacturing for the better part of 25 years. This segment of the industry is not new to me, but the company Cirtec, that I've been with now for nine years, is quite unique. We're a full service outsource provider, which means that we provide componentry, sub-assembly and full-assembly manufacturing for primarily class II and class III medical devices. The types of medical products that we typically work on fall into what I would say are higher complexity, and higher regulatory oversight. By nature, the manufacturing requirements and the quality requirements for those products are significantly higher, which requires a lot of investment in our infrastructure to be able to support that.

Within Cirtec we have three main segments: interventional, which is basically catheter-based systems, delivery systems; precision components which includes metals, electronics, and silicone; and then we have active implantables, which includes, as the name implies, smart orthopedics, neuromodulation, and implantable drug delivery to name a few.

The componentry business is interesting because within every component business, there are subspecialties that cater to a very unique industry and product category. The value from Cirtec is that we can help the customer design and manufacture these parts in-house, they go immediately into our supply chain, and into their finished products. We also replicate that on the silicone side. We sell silicone components directly to customers, OEMs. But we also now can make silicone components internally for our own supply chain to support customer device manufacturing.

What sets Cirtec apart from traditional machining and metals manufacturing?

Asheesh Divetia: One of the core philosophies of Cirtec is engineering technology in whatever shape or form. What we try to project to the industry is that you only know what you know and if you only have a hammer, you're only going to look at it as a nail. Cirtec has broad capabilities. We know what our machines are capable of and if we don't, we go straight to the machinists. Having this great precision component capability really allows our engineers to have that leg up. We have access to machinists, to the silicone mold builders, to the chip makers, to the lead makers, to the extrusion people, we can work with them while most engineers can't because they don't have access to that supply chain.

Harz: A lot of what I would call traditional metals manufacturing or large machining companies will sacrifice innovation for volume because at the end of the day they want to keep all the machines they've invested in running 24/7. Our customer base tends to require very specific customized features, complex tight tolerance features into medical devices. If you think about it, that slows the process down. A lot of the traditional metals manufacturers don’t want to deal with that. That gives us a niche in the industry where we can focus our talented engineering resources towards trying out different types of design iterations with the default componentry to find that right solution. Having that in-house vs. having to rely on a third party or fourth party is such an advantage.

When it comes to partnerships with OEMs, what conversations are needed to make sure the best decisions are being made for the product to enter the market? Do those conversations include considerations for the supply chain and material choice?

Divetia: We typically run a five-phase process. For us, phase one includes the feasibility of [design for manufacturing] DFM, material selection, future biocompatibility, and looking at supply chain. DFM for Cirtec means you work with the people who are going to be manufacturing it early enough to get all those risks into the design process. Here are the must-have requirements and the nice to have requirements, let's focus on the must have.

We don't call ourselves a machine shop, we are a vertically integrated finished device design and manufacturing business with precision metals capabilities. The difference is that most machine shops don't have an engineering arm, we do. In our philosophy of design for manufacturing (DFM), early prototypes should not have to be compromised because you don't have access to precision.

Harz: Again, you don't know what you don't know, right? Starting in phase one and phase two, at some point, you're going to be in phase five, and selling this product on the market. Have you considered that things like platinum, nitinol, and gold are expensive? Even though you're making 100 parts today, what if you're making a million parts a year from now? Is that a cost that you're willing to accept? Because if it's not, then let's look at alternatives because we might be able to solve the same problem using a different material like stainless steel or titanium. My team will oftentimes ask, what's the cost target? Because the answer is sure, we can make it exactly how you put it on your print but it's going to be $30 a part. However, if you add a radius, or open up the tolerances, or if we have the design freedoms to shorten this length, reimagine the angles on this part, or some of these complex features, we can take a potentially $30 part and make it a $10 part. If you don't have a group that can actually collaborate and challenge you or ask these questions, they're just going to give you a $30 part because that's what you asked for.

Divetia: Also, I think it’s ingrained into engineers that we've got to reduce the number of parts. Sometimes in doing that, they end up making this complicated 3D part. If I break this into two parts, laser weld them, you won't know the difference but now it is half the cost. I tell them don't just reduce part count for the sake of reducing part count, it should be to reduce complexity and costs.

When you're doing partnerships with OEMs, do you prefer that they come to you at the beginning of the design process or later down the line?

Harz: I always encourage customers to come to us as early in the process as they possibly can. The point of what we're doing here is that at the end of the day, we're a manufacturer that also happens to do product design and development. But ultimately, we want to be manufacturing your device. Because we have that in mind, we're always thinking that while we're designing this today in phase one, someday we hope this is in a cleanroom and that we're going to be manufacturing it. If we're going to manufacture it, we want it to be cost effective, efficient, we want the process to be the best that it possibly can because we're the ones that are going to inherit that manufacturing process. The earlier that we can get engaged in the process to start looking at some of these design challenges and material selections, the better. We add more value to the conversation and the innovation of product if we're allowed to engage in that earlier.