Apr 7, 2016

Regulations, competition are causing part makers to tighten profit margins, part tolerances and cycle times By Michael C. Anderson, Manufacturing Engineering The medical device market finds ways to stay in the headlines in one way or another, whether it’s because of big mergers (such as Medtronic’s acquisition of Covidien) or tax-inversion moves (such as Medtronic’s subsequent relocation of its headquarters to Ireland). Medical device companies and their lobbyists continue to push back against the US medical device tax used to cover some of the costs of the Affordable Care Act. And recalls of medical products certainly get into the media. But away from the front page of the business section, manufacturers in the medical device field are feeling the effects of a shift in health care practices. “The regulatory environment in North America and Europe has driven a shift to value-based healthcare solutions, which in turn has resulted in increased competition, changing business models, and innovative strategies to achieve sustainable growth,” medical market analyst Bryan Hughes of P&M Corporate Finance LLC (Chicago) said. The ripple effects from all of these developments are reaching the medical device side of the machining business, resulting in a tightening of a number of parameters, from profit margins to part tolerances and more. Tighter Margins Scott Walker, president of Mitsui Seiki USA Inc. (Franklin Lakes, NJ), gives an example of the way hospitals do business has changed—and how that change affects medical manufacturers and their suppliers. “Ten years ago, a hospital used to go in and buy the entire range of components,” Walker said. “For knee replacements, for example, a hospital would buy a box and in it would be, say, 15 sets of knees. They didn’t know until they cut your leg open what size would fit in there, so they were ready with a range of sizes that they had purchased.” No longer, he said. “Today the way it works is, a knee-replacement salesman goes into the room with the surgical team, he brings in a box of knees, and the hospital only buys and uses what goes into the patient.” That kind of practice means a lot fewer knees get sold, and so the manufacturers are...

Apr 20, 2015

By Design-2-Part Magazine Feinstein Institute Uses MakerBot 3D Printer to Repair Tracheal Damage The Feinstein Institute’s research combined two emerging fields: 3D printing and tissue engineering. Tissue engineering is like other kinds of engineering, except instead of using steel or computer code to make things, living cells from skin, muscle or cartilage are the raw material. Researchers at the Feinstein Institute know how to make cartilage from a mixture of cells called chondrocytes, nutrients to feed them, and collagen, which holds it all together. Shaping that cartilage into a nose or a windpipe is another matter. That’s where 3D printing comes in. A 3D printer can construct scaffolding, which can be covered in a mixture of chondrocytes and collagen, which then grows into cartilage. “Making a windpipe or trachea is uncharted territory,” noted Mr. Goldstein. “It has to be rigid enough to withstand coughs, sneezes, and other shifts in pressure, yet flexible enough to allow the neck to move freely. With 3D printing, we were able to construct 3D-printed scaffolding that the surgeons could immediately examine, and then we could work together in real time to modify the designs. MakerBot was extremely helpful and consulted on optimizing our design files so they would print better, and provided advice on how to modify the MakerBot Replicator 2X Experimental 3D Printer to print with PLA and the biomaterial. We actually found designs to modify the printer on MakerBot’s Thingiverse website to print PLA with one extruder, and the biomaterial with the other extruder. We 3D printed the needed parts with our other MakerBot Replicator Desktop 3D Printer, and used them to modify the MakerBot Replicator 2X Experimental 3D Printer so that we could better iterate and test our ideas.” “The ability to prototype, examine, touch, feel, and then redesign within minutes, within hours, allows for the creation of this type of technology,” says Dr. Smith. “If we had to send out these designs to a commercial printer far away and get the designs back several weeks later, we’d never be where we are today.” The Feinstein Institute had looked previously at other 3D printers that can extrude living cells, but the options are few and expensive....

Mar 13, 2015

“Personalized Care Drives Innovation in Medical Product Design and Manufacturing” By Mark Shortt, Design-2-Part Magazine But the more things change, the more they stay the same, as medical device OEMs hold fast to requirements for quality, reliability, and shorter lead times. It’s hard to talk about medical devices without getting into what makes them tick. As with so many other products that are entering the commercial marketplace today, it all starts with electronics, which play a key role in control management, monitoring of medical device function, and — most recently — connectivity. “What’s really neat about electronics today is that so much of it is computer controlled,” said David Estes, senior systems engineer at Digicom Electronics, an electronics manufacturing services provider based in Oakland, California. “And, of course, with computer control, you have the concept of software. The really nifty part about software is that it allows the instant customization of devices to incorporate very finely honed ideas and concepts and their operation. It also allows for the incorporation of refinements through software updates, just as your phone is updated. So I think that’s one of the nicest aspects of electronics today.” Welcome to the new age of smart, connected products, where the smooth interaction of electronics, software, and hardware is fast becoming a central design requirement that knows no boundaries. Wireless technologies that fueled the rise of consumer electronics have quickly spread to the medical device industry, where they’re reshaping product designs and spurring new business models. Lux Research, a market research firm focused on emerging technologies, sees big things ahead for mobile health (mHealth) devices, projecting eight-fold growth in the market from $5.1 billion in 2013 to $41.8 billion in 2023. Rising adoption of clinical vital signs monitoring devices and in vitro diagnostic (IVD) devices are expected to drive growth in the mHealth market, according to Lux, which anticipates vital signs monitoring devices to grow from a $372 million market in 2013 to $16 billion in 2023. “Consumer devices have seen a lot of hype, but clinical devices will surpass their consumer counterparts in revenues by 2020, helped by value-added software services and generally larger revenue streams,” said Lux Research Associate Nick...

Feb 9, 2015

By Rebecca Carnes, Design-2-Part Magazine Featuring quick-turn manufacturing and advanced in-house capabilities, NPI Medical offers prototype to production capabilities at top speeds One of the biggest frustrations for medical device companies is that when they have a new product in mind, the time it takes to go from concept to production could take two years. But the professionals at NPI Medical use a unique DynaClass™ tooling and molding system that provides plastic injection molded parts at the highest speed to market. “That’s our competitive advantage,” said NPI Medical General Manager David Kelly. “We have the capability to design the mold in-house, build the mold in-house, and turn it around in a rapid manner.”   With a cutting-edge Quick-Turn Manufacturing department offering parts from one to 500,000, the DynaClass system has four options to meet a customer’s production, cost, and lead-time needs (see below chart). The system was developed to fill the void between prototype tooling and full-blown production tooling. NPI Medical’s goal is to keep the customer with them from initial concept and prototype development, all the way through to production. The company makes prototype tools that are production quality and provides in-house capabilities, including DFM, clean room molding and assemblies, secondary assemblies, and specialty packaging/kitting. Full-process validation protocols — FAI (First Article Inspection), and APQP (Advanced Process Quality Planning), and IQ / OQ / PQ are also offered. NPI Medical provides tremendous diversity based on customer needs and is not just a prototype molder. “We will not only help the customer with the total concept and development side from a prototype standpoint, but our end goal is to have the customer stay here and let us develop the product all the way through to production,” Kelly said. With two Grade 7, Class 10,000 clean rooms for low-volume, short-run assemblies, NPI also has a Grade 8, Class 100,000 certified clean room equipped with injection molding machines from 28- to 110-ton capacities to meet a customer’s tight tolerance medical device requirements. “Our strategy is to not just be a prototype molder. We do prototyping for our customers, but we want the partnership through the whole project,” Kelly said. Rapid and prototype molding are great alternatives...