or unwilling to make the machine tools used to manufacture them. Tis type of outsourcing from other suppliers not only extends the supply chain, but also can create the opportunity for inaccurate communication or even slight mismatches between tool and component specifications. In an industry where microns can make all the difference
and risk mitigation is a must, the threat of even the slight- est manufacturing inaccuracy must be eliminated. OEMs should look for suppliers that have chosen to keep toolmaking in-house—designing both simple and complex tools that effi- ciently take OEM projects from design to production in order to significantly minimize the risk of error. With in-house toolmaking as an integral part of the
supplier-OEM partnership, skilled suppliers will oſten strive for continual improvement, such as creating new, advanced tools and implementing new concepts that can help OEMs make their devices more efficiently.
example, can lead to severe patient injury if the functional components are not embedded in a fail-safe process. Such proper mechanics need to be established in the product-devel- opment stage. Suppliers who understand and comply with medical device
regulatory guidelines can help OEMs ease the due-diligence process. And those who go the extra mile by offering engi- neering design assistance will continue to build successful relationships with their OEM customers.
Engineering Savvy Aſter a supplier has passed the capabilities and industry-ex-
pertise tests, the next thing to evaluate is its engineering abilities. Most suppliers offer engineering services to some extent,
but relatively few have the resources necessary to allow OEMs to place most of their supply-chain needs—from design to as- sembly—in their supplier’s hands.
Suppliers need to know what the OEM is doing, why they are doing it, and how they can work together to do it better.
Other supplier capabilities, such as CNC, vertical- and
long-bed precision machining, robotic pick-and-place tech- nology, metal finishing and multifunction manufacturing processes improve manufacturing and product details. Sup- plier operations with complementary component manufactur- ing services under one roof can help improve accuracy and provide complete product manufacturing solutions.
Medical Industry Manufacturing Expertise Manufacturing expertise is fundamental but because of the
complexities of the industry, suppliers should have medical industry manufacturing expertise and a proven track record. Without it, they are just taking orders and skimping on adding value to the overall process. Proof can be found in a supplier’s robust internal auditing
system, along with documented quality and delivery perfor- mance. Te FDA has not only stepped up the frequency and intensity of surveillance with large medical device manufac- turers, it also is starting to directly interface with the supply chain, as well. Compliance with ISO 13485 standards and European
medical device directives’ RoHS, WEEE and REACH (require- ments for hazardous materials used in medical devices and disposing of electrical components and waste created during manufacturing), also adds evidence of industry expertise. Suppliers also need to understand and collaborate with
OEMs to help ensure their manufacturing processes ad- here to proper tolerances, while meeting the functional and “critical-to-safety” requirements of the product. Machines that deliver X-rays and isotopes using mechanical movements, for
One of these resources is 3D modeling. By creating a 3D,
digital model of a component, engineers can make adjust- ments in real time. Tis capability enables suppliers to trouble- shoot designs, create fabrication tooling fixtures, order custom dies, and program machining and inspection equipment without ever seeing the finished part. Tis 3D modeling allows for tremendous flexibility, as
engineers are able to use an active, working model to test the prototype components to help ensure they meet the required tolerance and dimension specifications. If they do not, sup- plier engineers can make real-time changes during the design cycle instead of waiting to see how the component turns out before going back to the drawing board. Tis can be a huge savings of time and resources. A consolidated supply chain further heightens these ben-
efits. As the partnership develops, the supplier becomes more familiar with the parts and the context in which they are used. It can better understand each part’s essential functions, how it in- teracts with and impacts other parts of the system, and why its aesthetic, durability and weight requirements are what they are. Tis familiarity puts the supplier on the same page with the
OEM design engineer and enables them to work together to design for manufacturability—to create components that are easy to use and manufacture. For example, one medical device manufacturer that was
having design problems with a component worked with a supplier to seek an entirely new component solution instead of ordering the same set of replacement components and perpetuating the problem. Te new solution jointly created by OEM and supplier engineers involved evaluating the
Medical Manufacturing 2014 27
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