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A new year is upon us, bringing great optimism and opportunity for the manufacturing industry. The ticking clock, however, reminds us we are closer to the end of the decade when a perfect storm of a limited employee pipeline, a retiring workforce, reshoring and the changing pace of technology is expected to place even greater labor demands on manufacturers, challenged by an already slim supply of skilled workers.

In previous editions of the SME Medical Manufacturing Yearbook, P&M Corporate Finance has provided commentary on a variety of market forces impacting medical device manufacturers, such as regulatory considerations, reimbursement, M&A and venture capital activity. This year’s article will touch on several of those same dynamics, with a focus on the 510(k) approval process and the 2.3% medical device tax, which went into effect on January 1, 2013.

Laser technology for drilling precision holes has taken a leap forward with faster, cheaper, high-accuracy fiber lasers, which are used in the aerospace industry for turbine engine hole-drilling and other industries. Short-pulse picosecond fiber lasers are likewise making inroads, drilling small, precise holes for the medical and microelectronics industries.

Electrical Discharge Machining (EDM) has been removing metal by spark erosion for more than half a century—with sinker (ram/Elox-) style EDMing for molds and wire EDM for precision parts cutting, especially dies.

The growing need for nano and micro components in the medical industries is challenging manufacturers to continually improve upon their manufacturing processes and take a scientific approach to injection molding and tooling.

“Five years ago, our fit and finish was below average,” said Dr. Raj Kawlra, director of dimensional strategy and management of Chrysler Group (Auburn Hills, MI). “To be the future world-leaders, we knew that we had to focus on all aspects of quality … vehicles that look good, feel good, sound good, and are reliable.”

Until the middle of 2010, first-tier subcontract machinist, JJ Churchill, could produce turbine blades only if they had their fir-tree root-forms preground elsewhere, or if they were subsequently added by another subcontractor. No longer is this the case.

Process improvement encompasses a wide range of tools, techniques and strategies. When properly deployed, shop-floor data collection and monitoring systems can help factory-floor managers leverage key data metrics including overall equipment effectiveness (OEE) and total effective equipment performance (TEEP) that measure machine uptime and pinpoint bottlenecks or other problems in order to improve machining performance.

Nesting is the process of arranging parts to be cut from sheets of metal or wood in the most efficient manner possible in order to maximize yield and speed the cutting process. By reducing scrap and accelerating the cutting process, fabricators are saving on material cost while running more jobs.

With thousands of fastener locations that need to be drilled and filled to complete a plane, drilling and fastening remain the largest areas of opportunity for automated robotics applications in aerospace. New developments are also making robots more attractive than ever in the aerospace and defense space—especially improved rigidity and accuracy in the robots themselves.