The watchdog in the United States for medical devices is the esteemed government agency known as the Food and Drug Administration (FDA). The FDA, however, is flummoxed about how to handle 3-D printing of medical devices.It’s not that the FDA has lost its smarts, it’s just that the 3-D printing technology has spread so quickly, they are behind the curve.
In summer of 2014, the FDA approved the first 3-D-printed medical device for use in the United States. However, the agency never mentions the manufacturing technology in its approval letter. Instead, the device was reviewed as a 501(k) approval.
All Oxford Performance Materials, the maker of the OsteoFab Patient-Specific Cranial Device did was to prove it was “substantially equivalent” to similar devices on the market. Before this device was approved, 3-D-printed medical devices were approved on a patient-by-patient basis.
For now, the FDA plans to continue approval of 3-D-printed medical devices as if they were devices manufactured using more traditional methods. Susan Laine, an FDA spokesperson, told LiveScience at the end of the summer of 2013 the following:
“We evaluate all devices, including any that utilize 3-D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used. In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device.”
In late 2013, the FDA announced that it planned to publish approved guidance for this new technology by 2015. It appears that the regulators have an initial favorable reaction to the 3-D printing, which they prefer to call additive manufacturing.
At this point, it seems unlikely that the agency will make its self-imposed 2015 deadline for approval guidance. They are still in the stage of collecting data from all stakeholders.
During an interview with Plastics Today, Steven K. Pollack, Ph.D., director of the FDA’s Office of Science and Engineering Laboratories, talked about the FDA’s challenges in regulating 3-D printing in the medical device field.
“3-D-printing techniques have different technical considerations than standard manufacturing, with each type of 3-D printing technology having its own specific set of considerations,” Pollack said. “However, devices constructed using 3-D-printing technology are subject to the same regulatory review standards as devices constructed using traditional manufacturing practices.”
For now, manufacturers can continue to apply under the existing 501(k) approval system. Changes in processes move through the FDA at a snail’s pace, but once approved, new processes come into being fast. Makers of 3-D medical devices must stay informed to stay in business.
About the Author
Alan Kelsky is a freelance writer with a master’s degree in business administration from Xavier University with a specialty in healthcare management. Alan was formerly a hospital CEO with an active emergency room and was the CEO of an urgent care center in Pompano, Florida. He is also formerly the owner of Electric Control Services. His company worked with manufacturers and commercial building owners by offering energy audits, energy efficiency technology sales, installation and follow-up monitoring.
STEVEN FELDMAN JOINS HILCO INDUSTRIAL (MDNA member firm)AS SENIOR VICE PRESIDENT OF ASSET SALES
(January 15, 2015) – Hilco Global announced today that Steve Feldman is returning to its Hilco Industrial operating unit as Senior Vice President of Asset Sales. Feldman, who has been running his own firm SJF Auctions LLC since 2013, returns to Hilco, where he spent 11 years as a Senior Vice President, Manager of Machinery & Equipment Appraisals from 2001 through 2012.
In his new role, Mr. Feldman will be responsible for sourcing and managing asset acquisition and disposition transactions and developing and executing initiatives designed to enhance Hilco’s visibility to companies looking to maximize their return on underutilized machinery and equipment.
“We’re thrilled to have Steve re- join the team at Hilco Industrial. His background in business operations and his deep expertise in asset sales and auctions as well as his collaborative personal style will help us continue to grow our organization”, said Steve Wolf – CEO of Hilco Industrial.
Steve’s experience spans several industries, including metals, construction, and many more. He has worked extensively with large corporations and institutions designing and executing on capital asset disposition projects in dozens of industry verticals. Feldman has 30 years of experience in asset valuation, auctions and liquidations throughout the world. He has also served as a consultant to financial institutions on asset-based loans and recovery and is regularly called upon to testify as an expert witness in litigation. Prior to joining Hilco, Steve worked at Norman Levy Associates / DoveBid Appraisal Services, from 1993 to 2001 as Vice President, Manager of Machinery & Equipment Appraisals, and, from 1979 to 1993 at Industrial Plants Corporation / IPC Levy as Vice President, Manager of Auction Services and an Auctioneer.
Steve earned a Bachelor’s degree at Syracuse University. He is a member of the National Auctioneers Association since 1980, as well as the Machinery and Dealers National Association (MDNA) since 1975 and a member of the Association of Machinery and Equipment Appraisers (AMEA).
About Hilco Industrial: Hilco Industrial (hilcoind.com) provides industrial asset disposition services, specializing in machinery, equipment and inventory auctions and negotiated sales. It sells the broad range of industrial assets found in manufacturing, wholesale and distribution companies. Hilco Industrial performs dispositions through on-site, online and combination webcast auction sale events as well as negotiated (private treaty) sales. In addition to providing services on a fee or commission basis, Hilco Industrial has capital to put at risk and often acquires assets or provides guarantees.
Hilco Industrial is part of Northbrook, Illinois based Hilco Global (hilcoglobal.com), the world’s leading authority on maximizing the value of business assets by delivering valuation, monetization and advisory solutions to an international marketplace. Hilco Global operates twenty specialized business units offering services that include asset appraisal, retail and industrial inventory acquisition and disposition, real estate repositioning and renegotiation, strategic advisory, operational consulting and strategic capital equity investments.
Burt White Chief Investment Officer, LPL Financial
Jeff Buchbinder, CFA Market Strategist, LPL Financial Member FINRA/SIPC
Unlike the footballs that the New England Patriots used in the AFC Championship game against the Indianapolis Colts, the U.S. dollar has remained well inflated. The dollar, which has been trending higher for nearly four years now, rose 13% in 2014 and is up another 5% so far in 2015. The latest leg up has been driven by anticipation and arrival of quantitative easing (QE) by the European Central Bank (ECB). Bold stimulus from the ECB, and other central banks around the world including the Bank of Japan, has put substantial downward pressure on the euro, the yen, and other currencies, while boosting the dollar. In general, more supply of a currency drives down its value. In this week’s commentary, we discuss some of the causes of the strong U.S. dollar and some of the most important implications for investors.
The dollar, which has been trending higher for nearly four years now, rose 13% in 2014 and is up another 5% so far in 2015.
WHY SO STRONG?
The U.S. dollar is strong for a number of reasons, all of them good things. Relatively strong U.S. economy. Our economy has been outperforming most international economies in recent years — especially the developed economies that are our biggest trading partners in Europe and Japan. A relatively good (even if not great) economy has helped boost U.S. financial markets and made the U.S. a more attractive destination for foreign capital. Improving trade balance. The U.S. trade balance has improved dramatically, thanks in large part to the boom in U.S. energy production and resulting drop in oil prices that has reduced U.S. imports and increased exports. By keeping more dollars here at home, a smaller trade gap is bullish for the dollar.
Improving budget deficit. The measures that the United States has taken — in some cases painfully — to reduce the deficit by cutting….
John Canally Chief Economic Strategist, LPL Financial
The outlook for global growth is important to investors, since it defines the ultimate pace of activity that creates value for countries, companies, and consumers. As investors digest the S&P 500 earnings reports for the fourth quarter of 2014, we provide an update on how consensus estimates for economic growth for 2015 and 2016 — in the United States and worldwide — have evolved over the past few years, and in particular, since oil prices peaked in mid-2014.
The International Monetary Fund (IMF) cut its global growth forecasts for both 2015 and 2016 last week (January 19 – 23, 2015). While the IMF raised its estimate for growth in 2015 for developed economies, all of the increase to that estimate came in the United States; the IMF lowered its estimates for all other developed economies, except the United Kingdom where 2015 growth estimates were unchanged. The IMF sharply lowered its 2015 growth estimate for emerging markets (EM), with oil-producing, EM nations like Russia, Saudi Arabia, Mexico, Brazil, Venezuela, and Nigeria seeing the largest markdowns in growth.
Typically, when the IMF releases a forecast, the majority of financial market participants
take little notice of the report, and that was generally the case last week, as markets
focused more on the price of oil and the European Central Bank (ECB), than on the IMF.
Why? Because consensus forecasts for global gross domestic product (GDP) growth are available monthly from sources like Bloomberg News, and because markets constantly react to changes in projected paths of economic growth amid the daily, weekly, and monthly drumbeat of economic data and global events.
WHY GLOBAL GDP GROWTH MATTERS
In the past, prospects for U.S. economic growth garnered the most attention from market participants, but in recent years markets have focused more on the prospects for global GDP growth. Why does global GDP growth matter? As we have noted in prior Weekly Economic Commentaries, financial markets — especially equity markets — focus intently on earnings. Broadly speaking, earnings growth is driven by “top-line” growth, or revenue growth, less the costs incurred earning that revenue, with labor accounting for….
The thermoforming process typically consists of heating thermoplastic sheet, film or profile to its softening point and then forcing the hot, flexible material against the contours of a mold in three ways:
pneumatic means — differentials in air pressure are created by pulling a vacuum between the plastic and the mold, or the pressure of compressed air is used to force the material against the mold
mechanical means — plug, matched mold, etc.
a combination of pneumatic and mechanical means
Recent advances in thermoforming have come in both software and machinery. For example, injection molders are not the only plastic processors that can benefit from process simulation software. Accuform SRO has developed T-SIM, a thermoforming simulation software package. A consortium of 11 European thermoforming companies supported the development of the software.
T-SIM simulates positive or negative forming with or without plug assist. The software predicts the final wall thickness distribution based on the specified processing parameters (the pressure level, the speed of tools, the sheet temperature distribution, etc.). Time-dependent sheet sagging is included.
T-SIM is also able to predistort images for printing them on the flat sheet, so that once thermoformed, the images appear true. An image projection manager enables projection of multiple images using various projection methods (planar, cylindrical and spherical projection).
Let’s delve further starting with custom thermoformers like the Profile Plastics Corporation, who are specialists in heavy-gauge, custom-molded, highly engineered plastic parts manufactured via vacuum, pressure and twin-sheet thermoforming processes. The company has prospered for 50-plus years by steadily investing in and innovatively applying the latest technology.
Profile’s use and development of an unconventional vacuum-forming machine from Geiss Thermoforming USA is an example. The unit was one of the first halogen-heated, in-line closed-chamber-style machines in the U.S.
Profile specializes in large, technical parts for medical, analytical and electronic equipment, as well as appliances and materials-handling components. The acquisition of the Geiss machine with its halogen heating has helped Profile to maintain its momentum by extending its use of heat-sensitive materials.
Of the successive operations (clamping, heating, forming, cooling and trimming) carried out to produce a thermoformed part, heating appears to be the critical step. The sheet has to be evenly heated at the proper temperature.
Heating is conventionally performed by means of medium-wave (quartz) or long-wave (ceramic) radiators, but the Philips infrared halogen lamp is providing a great improvement in the heating process. For a given installed power, infrared halogen lamps are more efficient as they create a higher irradiance at a given distance from the plastic sheet, compared to both quartz and ceramic.
Although it takes minutes for quartz and ceramic radiators to reach their operating output, infrared halogen lamps (short wave emitter) only require a few seconds to get the same level of energy. Infrared halogen lamps also generally give a better temperature gradient over the plastic thickness. This is due to short wave radiation, a unique feature of infrared halogen lamps that has been shown to be more penetrating than long wave or even medium wave radiation.
Infrared halogen lamps can be instantly adjusted to the optimized heat level by simple dimming. Adaptation to various kinds of shapes and colors is not a problem. Infrared halogen lamps are 100 percent dimmable, which allows fine tuning of the process.
Profile’s goal is to thermoform parts equal to injection molding in look, quality and precision, while outdoing them in design ingenuity and economy. Such an objective was not feasible 20 years ago, as it was not possible to trim parts with precision equal to injection molding, and it was difficult to measure part dimensions to guarantee quality on a repeatable basis.
Multiaxis CNC routers provided a way to address trim-speed and precision, and Profile pioneered their use in thermoforming. All of Profile’s parts are now CNC-trimmed. Profile also addressed the need for precision measurement by investing in coordinate-measuring machines, computer-aided devices for measuring critical part parameters on a repeatable basis. The move allowed Profile to pursue more demanding applications.
Next, Berry Plastics Corporation’s original purchase of Landis Plastics Inc. has turned out over time to bring Berry a larger injection molding/packaging base. It also gave Berry Landis’ polypropylene (PP) thermoforming technology. Putting the companies together brought together Berry’s state-of-the-art technology for deep-draw, post-trim thermoforming and Landis’ PP trim-in-place thermoforming technology that is also state-of-the-art.
Within the plastics industry, it was believed that PP could not be drawn deeper than 4 inches, but Berry developed a new PP thermoform drink cup line that draws just over 8 inches deep, yielding drink cup sizes of 22-44 ounces.
A polypropylene drink cup that unlike other materials won’t crack, leak or break is attractive to consumers, while retailers are also interested in a value-added product that provides premium image potential yet is cost competitive with traditional plastic, paper and foam cups. Barry’s new technology provides the fountain industry with a drink cup that can be crushed and straightened out and will still hold liquid.
The new drink can also spell profits for retailers who have discovered that reusable polypropylene drink cups — viewed as premium products by consumers — are a cost-effective alternative to traditional paper, plastic or foam cup materials.
Other companies are thermoforming PP, too. PP is expected to grow 9.1 percent in thermoforming applications. Less than 100 million pounds of PP was used in thermoforming 10 years ago, and about 750 million pounds is expected to be used this year. By combining its deep-draw PP thermoformed product with PP trim-in-place thermoforming technology, Berry is advancing in all sorts of single-service products including ready-to-eat packages, salad packages and snack containers.
Finally, custom thermoformer, Kintz Plastics — a recognized leader in heavy-gauge thermoforming — offers three thermoforming processes:
vacuum forming (with design flexibility at reduced tooling costs)
pressforming (a cost-effective alternative to injection molding)
twin-sheet forming (which compares favorably to blow molding, in both function and cost).
The company, which produces plastic parts for the medical, computer and transportation industries, has installed the largest thermoforming machine in North America. Partly customized in-house, the four-station rotary machine dubbed “jumbo” makes parts of up to 9-by-13-by-5 feet from a single sheet of plastic.
Kintz forms a full range of large parts with the machine, including products such as exterior vehicle panels, spas, pool stairs, office tabletops, kiosk and vending machine panels. Some captive thermoformers make parts of equal or larger size, such as truck bed and refrigerator liners.
The machine can be operated in vacuum, pressure or twin sheet modes. Kintz foresees considerable potential in large twin-sheet hollow parts, such as underground storm water drainage vessels.
Another market of significant interest to Kintz is unpainted decorative parts. This market segment is experiencing high growth utilizing Bayer MaterialScience’s and Sabic Innovative Plastics’ weatherable, high-gloss sheet products. These applications also benefit from a push to replace thermoset fiberglass composites in various recreational and agricultural vehicles, riding mowers, spas and showers, and also window and siding profiles.
About the Author
The Plastics Institute of America (PIA) at the University of Massachusetts Lowell is a not-for-profit educational and research organization dedicated to providing service to the plastics industries since 1961. The PIA is led by Prof.-Dr. Aldo Crugnola, executive director; Prof.-Dr. Nick Schott, secretary and director of educational programs; and Dr. Donald Rosato, publications chairman (pictured).
John Canally Chief Economic Strategist, LPL Financial
Last Friday, January 9, 2015, the United States Bureau of Labor Statistics (BLS) released its monthly Employment Situation report, providing financial markets and the public at large with the state of the labor market as 2014 ended. The U.S. economy created another 252,000 net new jobs in December 2014 and 3 million over the course of 2014. More net new jobs were added in 2014 than in any year since 1999 [Figure 1]. The unemployment rate fell to 5.6% in December 2014, the lowest reading since mid-2008.
Although the labor market has improved markedly over the past year or so, it still has a long way to go to get back to “normal,” and the Federal Reserve (Fed) is unlikely to begin raising rates until a broad range of labor market indicators are back to normal or on track to get back to normal. In our Outlook 2015: In Transit, we noted that Fed Chair Janet Yellen and the other members of the Federal Open Market Committee (FOMC) are tracking a “broad range” of labor market indicators. (See pages 10 – 11 of the Outlook for details.) Eleven of these indicators were updated with last Friday’s release, with six of them improving versus November 2014, four deteriorating, and one remaining the same.
In an otherwise solid report, one of the big disappointments was the deceleration in wage growth as measured by the year-over-year change in average hourly earnings. Hourly earnings decelerated from 1.9% year over year in…
Burt White Chief Investment Officer, LPL Financial Jeff Buchbinder, CFA Market Strategist, LPL Financial
Earnings season is here and, as we wrote in our earnings preview last week (“A Tale of Two Earnings Seasons”), low oil prices and the energy sector will be the market’s main focus. Energy companies begin to report earnings this week, as energy services provider Schlumberger releases results on Thursday, January 15, 2015, although most of the sector’s results will come the last week of January and first week of February. While we try to gauge the energy sector outlook, we will also pay close attention to sectors and industries that potentially benefit the most from cheap oil, particularly in the consumer discretionary sector and the transportation industry, or the transports. (This week’s Weekly Economic Commentary, “Drilling into the Labor Market,” discusses energy’s impact on U.S. and state economies and labor markets.)
Depending on your assumptions, savings for the average American
from lower energy prices could reasonably be estimated at
over $1,000 per year.
IT STARTS WITH THE CONSUMER
The obvious place to start when analyzing beneficiaries of cheap oil is the consumer discretionary sector. The “tax cut” from lower prices at the pump is significant. U.S. consumers purchase about 140 billion gallons of gas annually, so a $1.00 drop in gasoline is a net savings of $140 billion (or about 1% of gross domestic product [GDP]). Each household that has been spending about $2,500 per year on gasoline (roughly the national average) will see a drop of perhaps $600 annually, based on U.S. Energy Information Administration (EIA) forecasts. For someone making the median income in the United States (about $52,000), that’s almost an extra week’s paycheck. And the total does not include home heating costs, where additional savings are captured, as the decline came just ahead of the coldest winter months (the sharp drop in natural gas prices is also helping). Depending on your assumptions, savings for the average American from lower energy prices could reasonably be estimated at over $1,000 per year, which for many, is like getting a raise. Keep in mind the consumer represents two-thirds of the U.S. economy.
Read the 2018 SPRING/SUMMER edition of the MDNA News Magazine online here! Published by the Machinery Dealers National Association . Highlights In this edition: Convention Coverage, New Board of Directors, Chicago Chapter Dinner and more…
Read the Fall edition of the MDNA News Magazine online here! Highlights inside the latest issue include: Austin D. Lucas Scholarship Winners/ Recipients, MDNA Convention, NEW Members and More…
Read the 2017 Summer edition of the MDNA News Magazine online here! Published by the Machinery Dealers National Association . Highlights In this edition: Weekend With The Pros, Chapter News, New Board of Directors, MDNA Board Report Highlights, New Members…
Read the 2017 Winter edition of the MDNA News Magazine online here! Highlights inside the latest issue include: MDNA Convention, MDNA Board Report, NEW Members, AMEA Staff Change and AMEA appraisers Forum!
Read the 2016 Fall Edition of the MDNA News Magazine online here! Highlights inside the latest issue include: Austin D. Lucas Scholarship Winners/ Recipients, MDNA Convention, NEW Members and More…
Read the 2016 Summer Edition of the MDNA News Magazine online here! Highlights inside the latest issue include: Chapter News, MDNA Convention Coverage, MDNA Board Report, NEW Members and More…
Read the 2016 Winter edition of the MDNA News Magazine online here! Highlights inside the latest issue include: Section 179, Chapter News, Cover Story, MDNA Convention, New Educational Program, MDNA Board Report, NEW Members
The 2015 FALL edition of the MDNA News has been published! IN THIS ISSUE: Austin D. Lucas Scholarship Trust Recipients Awarded, MDNA 2016 Convention, Weekend With The Pros Re-Cap, The Golden Years and more…
The 2015 SUMMER edition of the MDNA News has been published! IN THIS ISSUE: THE NEW BOARD, COVER STORY- THE YEAR OF WOMEN IN MACHINERY, SPONSORS, NEW MEMBERS AND MORE….
Machinery Dealers National Association (MDNA) Member Firm, ReSell CNC was recognized in The 2014 Inc. 5000 Magazine as the #155th fastest growing privately held company in the United States and the #8th fastest growing Business Services Company.
ReSell CNC was established in 2008 and is headed by MDNA member, John Butz. ReSell started as a small one man shop and has grown into a full stocking dealer with twenty employees and representatives across the United States.
ReSell CNC stocks all types of used CNC machine tools while focusing on metal cutting machinery such as Mazak, Haas, Mori Seiki, Okuma, Makino, Fadal, Daewoo, Kitamura, Citizen, Star and many more CNC machine brands. ReSell resells manufacturing equipment through auctions and liquidation sales.
John Butz, the founder and president of ReSell CNC and Mike Mills who joined the company this year and runs ReSell CNC West, the office in Scottsdale, AZ, have worked in the CNC business for over twenty years and bring the knowledge and experience that was needed to grow the company so fast.
Matt Horn, Vice President of Operations, ReSell CNC remarks on how they were able to get here-
“Our rapid growth has been propelled by the addition of auction capabilities to the already extensive retail services we can provide to customers and by the addition of our Western US office in Scottsdale, AZ. These two additions have allowed us to bring more comprehensive solutions to our customers and to expand our customer base into the Western US.”