Moon’s Rise: Extreme Molding’s Joanne Moon Reflects on 38 Years in Medical

By: Tony Deligio 13. May 2015

Joanne Moon, who in 2002 cofounded custom molder Extreme Molding with Lynn Momrow-Zielinski, will bring the breadth and depth of that experience to Molding 2015 (June 16-18, Chicago) where she’ll deliver a presentation as part of the Medical and LSR session.


Recently, Moon reflected with Plastics Technology on her ever-changing path in the industry:


  • Plant Manager at C.R. Bard in 1978 in charge of manufacturing extruded and molded catheters
  • Employee No. 2 at startup UroMed Corp.
  • Worldwide General Manager for Healthcare Products for Saint-Gobain
  • Co-founder Extreme Molding (Read Plastics Technology’s July 2013 Onsite for more on Extreme)


She also gave her insights on the future of the sector, including where technology is taking it. Extreme Molding specializes in molding plastics and silicone life sciences products and high end consumer products, with overmolding as a core competency. As a contract manufacturer, Extreme also provides packaging and fulfillment for its customers “shipping around the block or around the world.”


PT: What are some of the processing challenges associated with molding silicones and thermoplastics in the same facility? How do you overcome these?


Moon: The two materials are totally different processes, one running the final product in a  hot mold, the other a cold mold. We therefore have to stagger the equipment for chilling and heating requirements. We also have to have technicians with different skill sets in the installation and process set-ups of each type. We have done a great deal of training and planning to overcome the differences.


PT: What are some of the reasons Extreme Molding has been able to reshore jobs? Is this trend continuing?


Moon: We have been competitive in our pricing, and emphasized quality and delivery as well as volume flexibility. We receive probably 3-5 calls a week from companies producing overseas eager to transition to the states. The most vulnerable group is in infant and female healthcare products, where material integrity is such a concern. The trend is increasing.


PT: What is the biggest challenge associated with over molding, particularly mixing materials?


Moon: The biggest challenge with over-molding is the temperature and processing parameters of the two materials. The second biggest challenge is bonding of the two materials.


PT: Given when Extreme was founded (September 2002), and the market challenges that plastics in particular and manufacturing in general have seen since that time, what have been the keys to the company surviving and succeeding?


Moon: Extreme has always focused on markets that were less “commodity pricing” focused, and we have been very fiscally conservative. The economic black cloud was seen by us, and we started doing contingency planning and really reigning in our expenses. We turned down several opportunities if they were not a good fit with our material and molding expertise and could not yield the level of gross margin we needed to be profitable.


PT: In the ‘old boys club’ of plastics, has it been difficult to succeed as a woman-owned business?


Moon: Just the opposite—many of the customers for the markets we serve prefer dealing with women. At the end of the day, all that matters is that we can deliver to our customers a quality product, at an affordable price, on time.


PT: From a process and technology standpoint, what are the keys to serving the medical/healthcare market? 


Moon: The process and technology must support a repeatable process with very little variation in specification and quality. We perform statistical quality control as well as 100% inspection on all the products we ship. In addition, impeccable material and lot traceability is critical to our customers.


PT: What new technologies is Extreme most excited about and/or interested in?


Moon: We are most excited about new techniques for imbedding electronics into substrates, new over-molding techniques and new materials, such as the evolution of TPE/TPU grades. We are also intrigued with a new class of fast cure silicones as well as fiber reinforced silicone.


To learn more about Molding 2015, visit the event’s website where you can view the full agenda and register.

20 Questions for Medical Molders

By: Tony Deligio 6. May 2015

“I call it the 20 questions, and I want to know the answers before I’m even going to give you one iota of advice,” Mark Bonifacio, principal of Bonifacio Consulting Services says with a laugh, although he’s not entirely kidding.


Equipped with a degree in plastics engineering from the University of Massachusetts Lowell, Bonifacio began what has been two-decades-plus in medical plastics manufacturing in 1993 at device OEM, Baxter Healthcare.


In the intervening years, he cofounded medical injection molder and contract manufacturer, APEC, which was sold and became Helix Medical in 2004. In January 2007, he founded Bonifacio Consulting Services, where he he’s currently using his 22 years of experience and those 20 questions to help companies launch new devices, offering expert advice on the technical and business aspects of medical manufacturing.


On June 16, Bonifacio will deliver the keynote address at Molding 2015, celebrating its 25th year and organized by Plastics Technology magazine (for the full agenda, click here).


So what are some of the questions you should be ready to answer for Bonifacio?


  • Where are you going to sell the product?
  • Is it a really big product or a small product?
  • Does it have a lot of assembly?
  • Does it have a lot of materials?
  • Does it have a lot of IP?
  • Is it complicated?
  • What are the tolerances?
  • Has it been done before?
  • Does it involve complex processes?

“Every one of those questions you ask, you get a different answer in your matrix,” Bonifacio says, “and you’re going to see that there are a lot of factors in play here.”


The Big Mistake
Bonifacio’s time in the industry has been spent tackling technical and business questions from both sides of the supply chain (OEMs and contract molders) and for all manner of devices, including artificial heart components, IV systems, syringes, implantables and safety products, in disciplines as diverse as respiratory, anesthesia, ophthalmological, neurology, cardiac, and more.


Using that broad and deep reservoir of experience, Bonifacio has consistently seen one mistake made in the launch of devices. “The biggest thing that I see is everyone wants to use one example or something that they’ve done as the blueprint for everything that follows, and I tell people we’re way beyond that,” Bonifacio says. “The supply chain—especially when you talk globally—has become so sophisticated and so complicated that there is no one kind of cookie-cutter solution.”


Past success most definitely does not guarantee future returns, according to Bonifacio. “We have people say, ‘Hey, when we built that IV catheter, we did this,’ and then they move on to either another company or a totally different device, and they want to treat it the same way. I really caution people about doing that because the supply chains are very different; the capabilities of your suppliers are different; the ordering patterns are different; so you really have to look at everything holistically.”


Keep An Eye on 3D Printing and Robotics
In a wide-ranging presentation at Molding 2015, Bonifacio will also highlight how technology advances are impacting the device industry. Asked about which technologies he’s most interested in, Bonifacio answered quickly: 3D printing and robotics.


“Certainly the proliferation in the advancements in 3D printing,” Bonifacio said, pointing out that  developments seemingly come out every day. “That is changing how we think about things; how we’re developing products; and how we’re launching things. No doubt about that.”


Robotics impact on the healthcare industry is multipronged, according to Bonifacio, ranging from automation in manufacturing at suppliers to home health to the operating room. “The other area is robotics,” Bonifacio says, “and I think that automation and robotics are continuing to advance at such a rapid pace.”


Learn more about Molding 2015 here, including the full agenda. (Photo courtesy Bayer MaterialScience).

Tiebarless Training in Tennessee

By: Tony Deligio 24. April 2015

The 85-ton tiebarless Engel victory spex and 110-ton all-electric machines were installed at the Tennessee College of Applied Technology (TCAT) Pulaski as part of its revamped Advanced Manufacturing Program that’s busy readying workers for the region’s booming automotive sector.


GM, Nissan, and Volkswagen all build cars in the state, supported by parts suppliers like Denso, Calsonic Kansei, Yorozu Automotive, and M-Tek, with more companies on the way.


In the first quarter alone, Denso, Unipres USA Inc., Nissan, Magneti Marelli, and Hicks Plastics announced  investments in the state, which according to the Tennessee Automotive Manufacturers Association (TAMA), employs 115,939 in auto manufacturing jobs with more than 1000 auto manufacturers and suppliers statewide.


To help those companies fill out their shifts, Tennessee has spent more than $80 million in automotive industry training since 2006, according to TAMA. Receiving a portion of that money is the TCAT Pulaski. Located in South Central Tennessee, Pulaski sits 75 miles south of Nashville and only 20 miles from the Alabama border.


TCAT Pulaski is one of 26 applied technology centers in Tennessee, part of a statewide system created in 1963. The centers’ Advanced Manufacturing Education offers students three career paths: robotics automation, PLC automation, and plastics injection molding, and students that complete the program are awarded an engineering technician diploma. The plastics engineering technician certificate is comprised of three labs and an internship/shop project totaling 1296 hours.


Dino Owen, Advanced Manufacturing Education (AME) Instructor at TCAT Pulaski, told Plastics Technology that the two new Engel’s will replace a hydraulic Nissei that had been used in training for 12 years. Owen said at this time there are 17 students in the AME program, with 10 of those on the injection molding track.


A recent lesson for those 10: molding machine installation. Owen said the students assisted in rigging, leveling, and wiring the machines for their initial start up. The 85-ton press, which was purchased, and the 110-ton machine, which is on loan, will now ready those students for the molding world around them.


“Thanks to the governor’s grant we received, our equipment was updated and technology advanced to meet employment needs of local business,” Owen said. “Students feel they are working with state-of-the-art equipment, which closely matches equipment used by growing companies within 100-mile radius.”


Owen said that all students must complete hands-on projects focusing on areas like injection speed, transfer, pressure, temperature, and cycle optimization. In addition, students working towards the Injection Molding Masters Diploma, also study tool and die technology, including practice building insert molds, with draft angles, vents, waterlines, part design, and more taught as they cut their molds.


Owen said in the program students build their molds in aluminum, with a recent project calling for 3D printing of a simple cavity. “Our record thus far is 20 parts from a plastic 3D-printed cavity,” Owen said.


Partnering on behalf of plastics training isn’t new for Engel, which over the last three years has also set up machines at Bradley University (2013: 30-ton hybrid e-victory), Clemson University (2014: 30-ton victory); and Nypro University (2015: 105-ton e-mac). Its efforts, and those of programs like TCAT, come at a time of need for the U.S. plastics industry.


“Our goal is to help bridge the skills gap that manufacturing is experiencing,” Owen said. “I feel the 27 TCATs’ statewide are the best match for student and business to achieve this goal.”

New Design Standards Present Challenge, Opportunities for Connector Molders

By: Tony Deligio 20. April 2015

The tubes and catheters that carry oxygen, medication, nutrients, and fluids to hospital patients had been connected to delivery systems via universally designed small-bore Luer connectors, with that standardization occasionally leading to misconnections and subsequently, patient injury or death.


In response, an international collection of clinicians, manufacturers, and regulators, including the FDA, worked with the International Organization of Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI) to develop ISO 80369 standards that govern the redesign of small-bore (inner diameter of less than 8.5 mm) connectors, with one goal, according to the Global Enteral Device Supplier Association (GEDSA): “make it difficult, if not impossible, for unrelated delivery systems to be connected.”


GEDSA launched its Stay Connected initiative to support the changeover, calling the new connectors ENFit to differentiate them from the traditional luer connectors. Feeding tubes with the ENFit connector are projected to be available in the second quarter of 2015.  


The new connector design standards will initially apply to liquids and gases in healthcare applications. Eventually they will dictate connector size and shape for breathing systems and driving gases, enteral, limb cuff inflation, neuraxial, and intravascular-hypodermic applications. Once the standards are completed, luer connector will only be used for intravascular and hypodermic applications. All other small-bore connector delivery systems will be changed to ensure they can’t be misconnected to luers.


Proactively Switching Resins
German injection molder and mold maker A. Hopf Gmbh, Zirndorf, recently announced the development of newly designed enteral connectors utilizing Tritan copolyester from Eastman, Kingsport, Tenn., to proactively satisfy the ISO/DIS 2 80369-3 requirements. The company noted that the application of copolyester, versus PC, also satisfies French legislation banning BPA in food-contact materials for children, passed in 2013. That ban expanded to cover all such applications in January 2015.


At the MD&M West show in Anaheim, Calif. this February, Eastman discussed the new regulations in the small-bore connector market and how they’re impacting connecter molders and their material suppliers.


In the past, the use of flexible materials—like PVC, TPE, and TPU—in connectors, could allow a healthcare worker to “force” the connectors together, creating the potential for error. As part of the new design standard, materials must be stiff, with a flexural modulus above 700 MPa. In this space, Tritan will compete with materials including PC, ABS and PMMA. Eastman said that in addition to moldability and toughness, Tritan also maintains clarity, color and functional integrity after ethylene oxide and gamma sterilization.


In a July 2014 letter to its customers, medical device supplier Covidien, which is a charter member of GEDSA, noted that new enteral feeding tubes with ENFit connector would be available in April 2015, with the transition to the new ISO standard connectors completed in January 2016. 

Without Data All You Have Is An Opinion

By: Tony Deligio 15. April 2015

If you’re a plastics processor on the fence about taking the free, anonymous benchmarking survey we’re launching in 2015, I’d encourage you check out the executive summary of the Top Shops survey from our sister publication, Modern Machine Shop, to get a sense of the type of information you can expect to receive.


Survey participants, of course, will get the complete report, not just the executive summary, which will be chock full of data that can not only give you a better perspective on your own plant’s performance, but also help you assess where the industry’s headed (and if you’ll be joining it).


Most plastics processors have seen the light when it comes to tracking their operations, gathering data on all sorts of manufacturing metrics. This has given them much more than an opinion about their own facility, but by completing the survey you can move past ‘opinion’ when it comes to your competitors and get into the facts of how well you stack up.


Take the survey today

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