Healthcare spending will grow to $6 trillion annually, an average of 5.5% compound annual growth rate (CAGR) to 2027, according to The Centers for Medicare and Medicaid Services. That growth continues boosting demand for medical devices. Valued at $425.5 billion in 2018, the global medical device market is forecast to reach $612.7 billion by 2025, registering a 5.4% CAGR. A growing global medical device market leads to expanded medical device outsourcing, with Reports and Data indicating that the global medical device outsourcing market, valued at $96.6 billion in 2018 will reach $208.4 billion by 2026, a CAGR of 10.1%.
Beyond these strong forecasted numbers, 2020 also began with the permanent repeal of the medical device tax (see Regulatory, pg. 16) and the growing, aging population where globally, there are more centenarians than at any point in history and average life expectancy has increased from 67 to 72 in the past 20 years. And, while connected technology has been quickly adapted by younger generations, 76% of those 65 and older report that connected care technology is important to enable them to age at home; the market is projected to grow at a CAGR of 30.27% through 2025, reaching $232.9 billion.
Medical device manufacturers must establish and follow quality systems in accordance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (CGMP) to ensure that devices are safe and function as intended. The quality system regulation (QSR) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.”
It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeting these requirements, which involves creating or selecting a quality management system (QMS).
NSI is a leader in the field of Continuous Process Improvement by using Automated Microscopy Software. The company specializes in medical device, pharmaceuticals, electronics, wafer technology, and other sectors involving challenging inspection requirements. The company’s breakthrough platform, the NSI Toolbox, can detect any deviation and categorize it as a defect whether it be a dimension or an attribute surface defect, and then presents it to an operator in a result-driven interface. The NSI technology digitizes a production document, taking any process, converting it into a digital algorithm, and reducing the inspection to a simple one button press action.
The partnership allows Nikon Metrology to target the medical device community in which NSI specializes, but this type of automation can be used in conjunction with any type of microscopy, or even images from the Nikon Metrology’s NEXIV video-measuring system. The software is fully configurable, taking images from an optical device and analyzing them while presenting them on a result driven interface in micro-seconds. Even process specific and customized algorithms can be added to the standard NSI Platform to further improve that process.
“We work with Nikon because they have a premium optical product which complements our NSI Software Toolbox” says John Moore, sales and marketing director for NSI.
“We recognize that the marketplace is changing and that customers are looking for more automation,” says Darrell Sanderson, vice president of Industrial Products and Services at Nikon Metrology Americas. “NSI brings to us this automation and a degree of artificial intelligence that allows microscopy to move into the next decade.”
The partnership between these two technologically savvy organizations is an example of how advanced manufacturing processes are permeating all levels of industry.
“What we’re striving for is to bring microscopy to the fourth industrial revolution,” Moore says. “At first, you might have an operator at a system pressing a button, but in the due course of time this will be an automatic decision-making system in itself that keeps all data centralized for audit management, reusing that data for further process and product optimization. This is what NSI ultimately strive for.”
“We are automating microscopy and applications primarily to move process and technology forward, and that’s a great thing for the customers that Nikon Metrology and NSI will be serving together,” Sanderson concludes.
Micromachining, cutting where the volume of chips produced with each tool path is very small, is not a high-speed operation in relation to chip load per tooth. Rather, it involves a high spindle speed relative to cutter diameter. The part may be physically larger, but details of the part require ultra-small profiles achieved only by micromachining. In other words, micromachining is not limited in scope to only miniature parts.
In medical work, where tight tolerances are standard, dynamic runout (the measurement of the spindle at high speeds, performed using laser or capacitance resistance technology) and balance must be controlled to deliver and maintain viable tool life. Much of this burden falls on the holder. Balance doesn’t change as spindle speed increases, however the forces it creates increase exponentially alongside speed. The impacting results appear quickly in micromachining.
When runout occurs, the edge most affected takes over the bulk of the cutting. Uneven wear causes the tool to fail more quickly than if the tool rotates about the centerline as intended. In one customer application, we found that drilling into a steel workpiece 0.590" deep with a 0.118" diameter carbide drill in a holder with 0.00008" runout accuracy produced 2,300 holes. A holder with 0.00060" runout accuracy produced nearly two-thirds fewer holes, only 800. In this scenario, the shop could save hundreds of dollars a month in carbide costs – as well as labor costs due to less tool changing – by making one smart tool holder choice.
Holder attributes that can boost production include symmetrical design, a perfectly concentric collapse of the collet around the cutter, and a ball-bearing raceway nut with precision-ground threads.