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Help wanted: Designers, OEMs, toolmakers and contract manufacturers willing to collaborate

We know we always should, but we don’t always. I’m talking early-design efforts involving all of us – from designers and OEMs to tool makers and contract manufacturers. After all, we’re in this together, right?

Device designers often develop concepts without consulting the contract manufacturer who will actually make the product. It happens even with the most tenured medical designers. When it does, the supplier sometimes gets final specs that lack practicality on the shop floor resulting in designs that get scrapped, tools that must be rebuilt, and a lot of added time, costs, and headaches.

Throughout my career as an engineer and now as president and CEO of a value-added manufacturer, I’ve witnessed firsthand the troubles wrought by a lack of upfront collaboration among designers, OEMs, and contract manufacturers.

I’ve also seen that it doesn’t have to be this way. Designers who work closely with contract manufacturers from the get-go can cut time to market, reduce costs, and optimize product quality. In short, project management is smoother and more effective. I’d like to share a few examples.

Complete supply chain partnerships

We recently had the chance to help a medical-device OEM develop a new generation of automatic external defibrillators (AEDs). Our engineering team sat down with their product developers early in the design phase and identified several ways to design out cosmetic and quality issues they’d been having with the previous overseas supplier in earlier product launches.

Applying mold flow analysis, part design and two-shot processing capabilities, we worked together to make a variety of adjustments to parts design, tooling, and materials that improved manufacturability, repeatability, durability, cosmetics, and total costs. We also helped eliminate steps from the value stream by performing value-added secondary operations and vendor-managed inventory at our facility.

Material selection support

Materials analysis is another prime example of a valuable capability your contract molder may provide.

Expertise in materials can be especially beneficial for medical devices, many of which have strict requirements for antimicrobial properties as well as impact and temperature resistance and more. Increasing regulatory threats regarding the use of phthalates—plastic additives that can enhance a material’s property—add to the material selection challenge.

Early in the design process, a molder with materials analysis capability may be able to identify a better-performing or more cost-effective material than specified. This capability came in handy recently when a medical-device OEM turned to us in developing a part for a neonatal hearing tester. We helped identify an alternative material for the main part that reduced scrap by 5% over the previous material, improved time to market, and cost 10% less. As part of the project, we also supported the FDA review process and invested in a Class 10,000 cleanroom.

We’ve also worked on several projects involving handheld devices that control medical instruments. In such cases, by getting involved early on in the design process, we’ve been able to use our materials expertise and point out that natural skin oils, along with lotions and other skin products, will typically transfer from human hands and degrade common polycarbonate materials. In many cases, we’ve been able to identify an appropriate alternative that won’t degrade, thus improving the long-term quality of the handheld device.

Smarter designs and processes

While you’re focused on the ergonomics, functionality, and appearance of your product, your contract molder can help make sure it can be manufactured in a timely and cost-effective manner.

Moldflow, PFMEA (process failure mode and effects analysis) and other DFM (design for manufacturing) techniques lead to a better process, part and mold design. Your company may not have these capabilities in house, but chances are your molder has at least some of them.

The biggest opportunities involve changing the geometry of the tool. Many times, for example, we’ve been able to eliminate unnecessary undercuts, thereby reducing the costs of a tool. Other times, we’ve been able to incorporate a part feature into a tool that had been planned as a secondary operation. And sometimes there are ways to decrease part thickness to reduce material costs and cycle time.

In addition, we enhance the manufacturing process by taking the scientific molding approach. This approach focuses on tool and process parameters as they relate to the characteristics of the material we’re working with. The manufacturing process is then closely monitored in the mold via state-of-the-art sensors and software. So our customers get a more predictable, controlled process, along with more consistent parts.

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© 2012 Penton Media Inc.


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