MedPlast Appoints First COO

Tempe, AZ —MedPlast, Inc. announces the appointment of Chris Morton as its first Chief Operating Officer. He will be responsible for all the company’s manufacturing operations and its drive to increase its total value stream. Mr. Morton has 25-plus years experience in contract manufacturing with extensive involvement in the medical products sector. He has spent the prior ten years with Flextronics, a world-wide, integrated contract manufacturer.

A major priority for Mr. Morton is increasing MedPlast’s value engineering. “Our goal is to develop a strong scientific-based engineering competency in which to support our customer’s development function,” states Morton. “We want to work with customers up front and open up the design opportunities for their products. MedPlast has unique plastic and rubber molding capabilities and we want our customers to take full advantage of that,” concludes Morton.

MedPlast, with its acquisition of ATP Engineered Rubber and Plastics Group and K&W Medical Specialties, offers its healthcare and select industrial customers engineered thermoplastic, silicone and rubber molding and assembly capability. The company will augment this capability with product design, tooling, engineering, quality and precision manufacturing expertise.

MedPlast Announces Director of Sales

Tempe, AZ —MedPlast, Inc. announces the appointment of Paul Rudzinski as Director of Sales – Western Region. Based in Southern California, Mr. Rudzinski will focus primarily on the healthcare products sector in Western United States and
Northern Mexico.

Mr. Rudzinski has over 25 years experience in the capital equipment sector of the plastics industry. His long sales managerial tenure at Milacron Inc. provides customers with a deep understanding of plastics technology, process and design.

“My experience at Milacron gives me a strong overview of the plastics industry and the dynamic nature of the healthcare products sector,” says Rudzinski. “MedPlast is in a unique position to service this market and I’m excited to be a part of it. I’m ready to leverage my experience for the benefit of MedPlast and its customers,” concludes Rudzinski.

MedPlast offers its healthcare and select industrial customers engineered thermoplastic, silicone and rubber molding and assembly capability. The company augments this capability with product design, tooling, engineering, quality and precision manufacturing expertise.

MedPlast Formed to Serve the HealthCare and Select Industrial Markets

Tempe, AZ - MedPlast, Inc. proudly announces that it has simultaneously acquired ATP's Engineered Rubber and Plastics Group (ERPG), Wayne, Pennsylvania, and K&W Medical Specialties (K&W), Westfield, Pennsylvania. MedPlast will be headquartered in Tempe, Arizona, and will serve the healthcare and select industrial markets.

MedPlast selected ERPG and K&W because both companies stress strong customer service, technical excellence, and world-class manufacturing. K&W has built a significant position in the healthcare products field with its thermoplastic molding and contract manufacturing capabilities. ERPG focused on growing its healthcare base and serving selected industrial markets with its thermoplastic, silicone, and rubber molding expertise. Both companies are well know in the industry and are respected by both peers and customers alike.

The New Organization
By combining ERPG's and K&W's resources and talent, MedPlast will uniquely provide its customers with engineered thermoplastic, silicone and rubber molding and assembly expertise. Key to the markets that the company will be serving is its product design, tooling, engineering, quality and precision manufacturing capabilities. MedPlast will operate five plants across the United States with approximately 800 employees.

Customer Benefits
A strong customer asset is MedPlast's strict quality focus and its driving principles of ISO, cGMP and Six Sigma. A high level goal of the new company is the assurance of customer program continuity and the continued customer confidence in quality and delivery. To insure this, with the exception of the new company's senior management team, current company management and operating personnel will remain in place. MedPlast places a high value on its talented workforce and will continue to foster employee involvement.

The Outlook
MedPlast's strategic goal is to build a strong position in the healthcare and select industrial markets. The company plans to leverage its capabilities in product design, engineering, manufacturing and automation to become the preferred supplier in its niche markets. Target annual revenue by end of 2008 is expected to reach $100 million.

Management
As stated, no management changes are planned for MedPlast's operating plants. Harold Faig, CEO, will lead a highly experience management team at the company's headquarters in Tempe. Mr. Faig has spent over 35 years in plastics and medical contract manufacturing. Most recently, he was CEO of The Tech Group. Prior to this tenure he was President and COO of Milacron, Inc.

"This is a tremendous opportunity for everyone involved with MedPlast," explains Mr. Faig. "The healthcare products industry is very fragmented. What separates MedPlast from the competition is our thermoplastic, silicone and rubber molding capabilities, combined with our human resource talent and engineering / manufacturing expertise. This is exciting for MedPlast employees and customers alike." concludes Mr. Faig.

ATP Engineered Rubber & Plastics Group Steps Up - Its Six Sigma Fortification
Maybe it's driven by customer satisfaction, maybe it's the desire for improved performance, or maybe it's just the drive to be the best, but ATP Engineered Rubber & Plastics Group is driven to excel as a Six Sigma Enterprise. Although this is a company-wide initiative, the battle has its beachhead at ATP's Tempe, AZ, facility. The Tempe facility currently has one Six Sigma Black Belt and three Six Sigma Green Belts, with seven more Green Belts slated for certification in December, 2007.

Six Sigma enthusiasts, of whom ATP's Armando Ramos, Director of Six Sigma and Statistics is one, preach that Six Sigma principles formalize quality and performance improvements by continuously identifying root causes of process variation. It is based on improving the process by understanding and controlling variation.

"In a narrow view, Six Sigma has evolved to the widely accepted definition of a process that limits defects to 3.4 parts per million," explains Mr. Ramos. "ATP has taken this concept and established a paradigm for continuous improvement embracing the latest Six Sigma techniques and methods. Control variation and the business process are automatically improved," states Ramos. "However, ATP doesn't look at Six Sigma as a quality control process. To us it is a business initiative to reduce not only our costs but our customers' costs as well," concludes Ramos.

ATP's Six Sigma program is structured along proven practices. The Tempe facility's Senior Champion is Tom Cummings, General Manager. The Champion's role is to sponsor projects, select project leaders, and support, align and integrate the Six Sigma program into the organization. The program is mentored by Mr. Ramos, who received his black belt from Motorola University, and his Master Black Belt Certification from the Six Sigma Academy where he was personally trained by Dr. Mikel Harry, the leading proponent of Six Sigma and President of the Six Sigma Academy.

Prior to Mr. Ramos' arrival at ATP Tempe, the facility had one Six Sigma Green Belt. Today that Green Belt is now a Black Belt; there are three new Green Belts, with seven more Green Belt candidates in training. All the ATP Tempe Belt candidates are coached and supported by Ramos, the Master Black Belt. All Belt students are required to complete two projects as well as pass an oral defense to obtain their certification. Student projects are averaging $100,000 in cost savings and process improvements. This is a significant contribution to ATP Tempe's performance level.

Example Projects
One completed student project studied measurement variation during in-process dimensional inspection. The project goal was to reduce or eliminate variation caused by quality personnel when performing in-process dimensional inspection. This project was initiated when significant variation was noted between shifts. The question posed was whether the variation was caused by the process or by humans.

A careful study was conducted using Six Sigma procedures. It was determined that the variation was caused by personnel and not by machinery. After determining the cause, a remedy was initiated. The variation was reduced through a combined program of establishing more detailed instructions and improved training.

A second example of the impact student projects have on performance, cost and quality, is one that studied regrind utilization. This particular project was set up to determine if the blending of 25% regrind into a particular critical part application would significantly change key dimensional and visual characteristics. After measuring samples run with 25% regrind/75% virgin and samples run with 100% virgin, it was concluded that there were no significant differences or changes in the key dimensions or surface appearance. Tensile strength testing will be conducted by the customer to verify overall strength and component integrity.

What's Next
When asked what's next, Armando Ramos responded enthusiastically. "After we get our Green Belts certified I'm looking at 40% of them going on to Black Belt training. And remember," continues Ramos, "we have the same student project requirements for Black Belts as we do for Green Belts. We also have three additional manufacturing plants in the U.S. And they have aggressive Six Sigma programs to mentor." And after that…"Well maybe we'll offer Six Sigma training to our customers," projects Ramos.

ATP Adds Experience to Science and Technology
Manufacturing is not an art; it is a science and a technology enhanced by experience. The manufacturing evolution of a recently introduced medical device illustrates this concept and presents the benefits of experience coupled with science and technology.

A world leader in restorative and esthetic dental devices and systems recently developed a combination presentation tray and tool holding system. This new product and its introduction presented numerous production challenges including program timing, material selection, color matches, assembly and silk screening. Additionally, the company required various tray/cover sizes and assemblies. Capping off the challenges was the need for the tray/holding system to withstand repeated point-of-use sterilizations.

The Experience
The polymer vendor supplied the science and ATP Engineered Rubber and Plastics Group provided the technology and experience. ATP Engineered Rubber and Plastics Group is a global contract manufacturer with plastic, rubber and silicon injection molding expertise. Additionally, the company specializes in two-shot molding, over-molding and insert-molding. ATP also offers clean room and white room capability, assembly, and packaged product programs for the medical device and health care custom commercial markets.

The ATP Elkhorn facility, Elkhorn, WI, was selected as the lead manufacturing source for this project because of its silicone and rubber over-molding and insert-molding capabilities, as well as its engineered plastics molding experience. ATP routinely molds a variety of polymers including polyphenylsulfone (RADEL), polyisoprene, polyisobutylene (Butyl), nitrile rubber (NBR, Buna), ethylene propylene diene monomer rubber (EPDM), fluoroelastomer and silicone.

The Science
Polyphenylsulfone was chosen as the engineering plastic for the tray and cover because of its clarity (for the cover), its coloring characteristics (for the tray), minimum sink rates, ability to withstand repeated steam sterilizations, and its exceptional toughness and impact resistance. Another advantage of this polymer is its ability to tolerate the heat produced during the silicone over-molding process.  

The tray was designed to have a soft outer surface for esthetics and impact resistance. To achieve this soft texture silicone is overmolded onto the plastic tray. Silicone was specified as the over-molding material because it readily accepts coloring agents, and more importantly, to its ability to maintain material integrity during sterilization on a commercial or point-of-use basis. Silicone also has excellent color stability, an important aesthetic property.

Silicone polymers are playing an increasing role in today's health care market because of its manufacturing versatility, its unique chemical structure, and its improved mechanical properties. Silicone maintains its functional characteristics in both low and high temperature ranges, is resistant to chemical and ozone attack, and is resistant to sterilization systems. Silicone is one of the most extensively tested materials for biocompatibility. Its inert properties make it suitable for human body implantation for periods greater-than-29-days. Silicone has become a material-of-choice for health care and medical devices.

The Technology
ATP designs and builds its own tooling systems minimizing lead-times and shorting time-to-market periods.  Mold design of both the silicone and plastic tooling is also important since silicone tends to flash even with excellent shut-off systems and clamping forces. ATP offered the medical device customer the tri-capabilities of tool design, plastic molding and silicone/rubber molding from a single source. This minimized lead-time and enhanced quality because the control remained with a single source. 

An early decision made by ATP Elkhorn was the type of delivery system employed to transfer the liquid silicone to the molding press. How this is accomplished has significant implications on machine utilization and efficiency. The annual demand forecast for this product was considered less than optimal for a press employing a two-shot molding system, which is geared for very high production rates. ATP engineers determined that a more efficient approach was to mold the plastic trays and then transfer them to the liquid silicone injection machine in a batch operation.

The next manufacturing step involved part transfer between presses. Although ATP Elkhorn has automated pick-and-place robotic arms available, the decision was made by the manufacturing engineer to manually transfer the trays from the plastic injection press into the liquid injection molding unit. This better suited the production process because different size trays were being molded. With an eye for efficiency, ATP met the customer‘s budget and unit cost drivers by working within volume constraints.

Achieving a good chemical bond between rubber and plastic, or rubber and metal inserts, requires a thorough knowledge of material compatibility and bonding technology. A self-bonding liquid silicone was selected for this application because it does not require the use of an adhesive.

ATP molds the clear plastic cover at its sister plant in Monticello, Iowa, due to the cover size and the facility's in-house silk screening capabilities. Final assembly and packaging are also carried at this location. Adding to the synergy, ATP Monticello also designed and produced the tooling.

Summary

Silicone over-molded onto engineered plastics is a growing material choice for the medical device market. New processing technology and shortened time-to-market periods are taking advantage of a material that is very consumer friendly.

Elkhorn Wisconsin Plant Next ATP Facility To Expand  Medical Device Production Capabilities. ATP's Engineered Rubber and Plastic Group announces that its Elkhorn, WI, facility is developing advanced technology to further penetrate the medical device manufacturing market. ATP Elkhorn specializes in rubber molding, including a full range of silicone and organic polymers. Capabilities also include rubber over-molding of plastic and metal components.

ATP Elkhorn has long served the medical device market through its engineering expertise, including design capabilities, R&D and rapid prototyping; in addition to its controlled molding environments. The company maintains ISO standards for "clean room" production; operating an FDA compliant Class 10,000 clean room for long- and short-term implantable devices together with medical "white" rooms. ATP Elkhorn also employs two six sigma Black Belts, one Master Black Belt, and is currently training ten employees for "Green Belt" certification.

One recent innovation has been the implementation of an automated visual inspection (AVI) system. This system is used for high volume parts requiring 100% inspection. AVI looks for, and isolates, such nonconformities as flash, inclusions and under-fills. Typical applications include critical seal components such as trocar seals and duckbill valves. ATP Elkhorn plans to employ AVI as it expands into new high volume markets such as syringe plunger tips, injection sites and luer tip caps.

Another technology innovation utilized by ATP Elkhorn is gateless molding. This technology, through an innovative valve design, eliminates flash, gates and runners.  Gateless molding is a zero-waste process developed in the thermoplastic industry, but difficult to implement in rubber injection molding due to the complexities of the thermosetting process. This technology permits the company to run equipment fully automated, without human intervention, creating a process that is repeatable and consistent. 

Bernie Stritzke, Vice President and General Manager, is focused on applying new and innovative technology to become Best in Class. "For us, automation is key. ATP Elkhorn incorporates zero-waste, automated molding and AVI to remain competitive and to be an asset for our customers," explains Stritzke.

"It is our company goal to stay ahead of the technology curve. We are a supplier to the medical device market today, and we will be a supplier to the medical device market tomorrow," continues Stritzke. "We have put into practice numerous innovations that allow us to compete on a world stage."

All ATP facilities are ISO 9001:2000 certified and boasts a robust Six Sigma Enterprise. In addition, facilities focusing on medical device manufacturing, such as Elkhorn, are committed to achieving ISO 13485 and FDA requisition where required.

ATP Expands Manufacturing Expertise for Medical Device Production. ATP's Engineered Rubber and Plastics Group announces that its West Berlin, NJ, facility is now poised for an increased role in the medical device manufacturing market. ATP's specialty in medical device manufacturing is overmolded/insert molded components for surgical apparatus. Typical overmolding consists of a polycarbonate substrate with a thermoplastic elastomer (TPE) overmolding.

The 60,000 sq. ft. facility operates a Class 100,000 Clean Room with two conventional molding machines. The company's longer range goal is to expand the current clean manufacturing room to encompass ten molding machines ranging in size from 50 tons to 300 tons. In addition to the clean room, the West Berlin plant dedicates a white room facility containing three 200-ton, two-shot auto-rotating molding machines to medical-related products, with plans to add two more machines by 2008.

A feature of all ATP manufacturing facilities is its tool design/building capability. West Berlin has the capacity to build the majority of its tooling requirements in-house. The company maintains relationships with qualified outside tool makers who can be called upon when needed. The company also offers full product design and assembly capability.

All ATP facilities are ISO 9001:2000 certified and boasts a robust Six Sigma Enterprise. In addition, facilities focusing on medical device manufacturing, such as West Berlin, are committed to achieving ISO 13485 and FDA requisition where required.

Robert Piccoli, Vice President and General Manager of ATP West Berlin explains the company's growth philosophy as customer centric. "We feel that ATP is a synergistic partner with medical device manufacturers/suppliers," states Piccoli. "With our product design, tool engineering and molding/assembly expertise we offer the confidence that a new project can be initiated, launched, and maintained. You might say we offer a turn-key operation. And should we need to augment or expand our capabilities we have the resources and corporate commitment to do it," concludes Piccoli.

ATP Engineered Rubber & Plastics Group provides global turnkey manufacturing solutions with a core competency of producing world-class engineered rubber and plastic components and assemblies. The company concentrates on "total solutions" in the following markets: medical devices and equipment, pharmaceutical packaging, industrial hand-held electronics, and consumer products

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