Skaneateles Falls, N.Y. – Welch Allyn, a leading medical diagnostic device company that delivers pragmatic innovation at the point of care, today introduced its next generation OAE Hearing Screener, a fast, objective pediatric hearing-testing device that can be administered at the push of a button. The portable, handheld device delivers sounds into a child’s ear canal and measures the otoacoustic emission (OAE) response produced by outer hair cells in the cochlea. Designed to detect hearing loss in newborns, infants, toddlers, pre-school and school age children, the device does not require patient response or practitioner interpretation of exam results. The rechargeable, portable device features wireless Bluetooth® connectivity that enables automated patient data transfer to Data Manager software that lets users sort data and generate reports.

“The new Welch Allyn OAE Hearing Screener gives providers a fast, accurate, objective response so their patient doesn’t have to,” said Rick Farchione, senior global category manager at Welch Allyn. “But this new hearing screener is more than a state-of-the-art diagnostic device – it’s a connected solution for healthcare professionals who will now be able to enroll even their youngest patients in early intervention programs to help prevent language disabilities before they occur. In a matter of seconds, it provides data that the clinician can use to help improve patient outcomes.”

The compact Welch Allyn OAE Hearing Screener presents a soft pair of tones through a probe placed in the patient’s ear canal. A small microphone in the probe measures the OAE and compares the response to normal data – assigning a pass or refer result to the screening on an intuitive full-color display. The presence of passing OAEs is highly correlated with normal hearing and middle ear function.

The Joint Committee on Infant Hearing (JCIH) 2000 recommends universal screening of hearing loss before hospital discharge. The JCIH 2000 statement promotes a system as essential for the diagnosis and intervention of early hearing loss. That system is composed of screening before hospital discharge, follow-up and diagnosis for infants needing additional care and the intervention and habilitation for infants identified with hearing loss.

“Significant hearing loss can develop after the newborn period, so screening at birth is important, but it is not enough,” Farchione added. “Regular hearing screening is important throughout childhood. The availability of a fast, accurate and objective screening device can help pediatricians perform tests on younger patients, potentially increasing the number of at risk patients that are referred to a hearing specialist for further evaluation and treatment.”

The OAE Hearing Screener can be fitted with a variety of disposable ear tip sizes including newborn, infant, toddler, and adolescent. It features on-screen prompts and in-the-ear calibration and comes equipped with patented noise canceling technology to help eliminate poor test results due to ambient sound. Features include data storage for up to 250 tests, a charging cradle, and a Bluetooth thermal printer that can provide graphic and tabular reports in seconds.

Source: Welch Allyn Inc.

Needham, Massachusetts – PTC officials announce the successful submission of UDI data to the preproduction version of the U.S. Food and Drug Administration's Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA's UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices. 

The FDA's first UDI compliance deadline for high-risk Class III devices is Sept. 24, 2014. High-risk devices are identified as the most complex life-sustaining medical devices like pacemakers, defibrillators, vascular stents, and ventilators. Medical device manufacturers need to implement compliant processes and technology to meet the UDI requirements and avoid any potential negative consequences. 

According to Jay Crowley, vice president of UDI practice at USDM Life Sciences, "It's important that device companies have a solution that's fully capable of meeting current FDA GUDID requirements, while also being scalable and flexible for future global UDI requirements. The PTC UDI Solution enables medical device manufacturers to submit the appropriate records to the FDA's GUDID." 

PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill platform, the PTC UDI solution is a preconfigured, enterprise software solution designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. The solution is fully validated in accordance with 21 CFR Part 11 requirements and enables manufacturers to gather, submit and track GUDID data. 

The PTC UDI Solution enables manufacturers to:

• Communicate and track GUDID submission data, managing the electronic relationship with - including responses from - the FDA's GUDID and tracking submissions across product lines to ensure enterprise-wide compliance.
• Govern GUDID submissions in accordance with FDA regulations, enabling customers to oversee and control the status and progress of all submissions across product lines within a 21 CFR Part 11 compliant solution including software validation, training and electronic data management.
• Manage and synchronize changes to GUDID submissions through robust software architecture to easily manage large sets of similar data as well as ensure that product changes in upstream data stores kick off new or revised GUDID submissions to meet ongoing compliance needs. 

"The only real certainty with GUDID compliance is that global requirements will likely change. Continuing compliance will require a practical solution that's fully capable of meeting all current UDI regulations for submission data, and fully scalable to support the many more global UDI requirements anticipated for the future," said Mark Hodges, division general manager, PLM segment, PTC. "The PTC UDI Solution delivers accuracy, scalability, and quick response times for GUDID compliance initiatives."

Source: PTC 

Center Valley, Pa. – Olympus officials announce the commercial availability of its 510(k) cleared, next-generation ENDOCAPSULE 10 System for small bowel capsule endoscopy procedures.

Today, thousands of Americans are plagued with disorders of the small bowel, including chronic constipation or diarrhea, bleeding, infections, cancers, ulcers, obstructions, celiac and Crohn's disease, and irritable bowel syndrome among others. Advances in endoscopic technology – including capsule endoscopy – have helped physicians better detect and treat small bowel disorders at earlier stages. According to Truven Health, 137,850 outpatient capsule endoscopies were performed in the United States in 2012.i

"The new ENDOCAPSULE 10 System offers advanced, minimally invasive technology designed to improve diagnostic capabilities, procedural efficiency and patient comfort," said Luke Calcraft, president of the Medical Systems Group at Olympus Corporation of the Americas. "The system can help facilities fulfill the requirements of healthcare reform aimed at improving quality of care, decreasing costs and enhancing patient satisfaction."

Outstanding visualization
The ENDOCAPSULE 10 System features advanced Olympus lens technology and sensitive, high-resolution image sensor technology to provide clear and vivid imaging results for fine observation of a variety of abnormalities in the small bowel. The capsule's 160° field of view sees 10% more mucosa than the other capsule endoscopy products featuring a 145° field of view. In addition, the new system offers a long 12-hour battery life to maximize the amount of images taken and improve exam completion rates.

Improved efficiency
Intelligent software built into the system simplifies the reading and analysis of the captured imagery, automatically detects images that require closer inspection and indicates where each thumbnail image was captured to determine location of any detected abnormalities. A 3D tracking function allows the system to display the capsule position inside the body to check its progress as it moves through the intestine. 

Enhanced user features
In addition to improvements in the imaging and software technologies, the system also features improvements that increase ease of use for clinicians and patients. The recorder unit is now lighter, more compact, and more comfortable to wear with an improved harness and an antenna that can be worn over clothes rather than applied directly to the skin. The recorder allows quick initialization by the clinician and allows image to be viewed in real time or via download later to the system's workstation.

Source: Olympus Medical Systems Group 

^{i Data for use in this study were supplied by Truven Health Analytics Inc., Ann Arbor, Michigan ("Truven Health"). Any analysis, interpretation or conclusion based on these data is solely that of the authors and Truven Health disclaims responsibility for any such analysis, interpretation or conclusion.}

Boston, Massachusetts – Commemorating the 45th anniversary, ResTech Plastic Molding LLC (RPM) is looking back at what helped it sustain American manufacturing growth during the last 45 years.

“For decades, ResTech Plastic Molding has been driven by a desire to continuously improve quality and service, rather than the offshoring model, outsourcing services and personnel overseas,” said George E. Danis, CEO of ResTech Plastic Molding. “We never reconsidered our ‘Made in America’ manufacturing strategy and macroeconomics with the draw to move some of operations overseas. Unlike other companies, we continued to adapt to what our new and current customers were demanding: a long-term perspective to provide low-cost manufacturing.”

First American manufacturing company
In 1968, Danis successfully launched his first American manufacturing company to serve the state of Massachusetts emerging high-tech industries with electronic manufacturing services. Every company that they dealt with had its own service, quality, and supplier requirements. They quickly learned that managing the customer’s drawings, quality paperwork, and logistics was just as demanding as managing production of the product itself. To meet growing customer demand, they relocated to Hudson, MA, into an 80,000ft² manufacturing campus with expansion plans for Cleanroom facilities. The facility was upgraded and includes a climate controlled tool room and tool storage space. ResTech started designing and making its own tools on-site with a preventative maintenance program, guaranteeing the life of all its tooling projects.

Integrated vertical manufacturing
Danis launched Plastic Molding Mfg. Inc., (PMM) a custom injection molder and single source manufacturing company for molded plastic components, plastic design, and assemblies in 1982. At that time, he wanted to solve problems no one was addressing: an all-inclusive local partner, shortening the time-to market and lowering costs.

“Our integrated manufacturing and product development model solved this problem with a focus on small and medium size OEMs, brought together Box-Build capabilities, PCB assembly and mechanical services and engineering, all under ‘one roof’,” said Danis.

During the SARS epidemic, there was urgency for inexpensive, non-hospital testing for the virus. They stepped-up to the challenge when this medical equipment leader called upon PMM to meet the worldwide demand, ‘revved up’ production and shipped units directly to Asian logistic centers on-time for field testing and distribution. This durable, easy-to-use diagnostic product is designed for critical patient care by healthcare professionals who require hospital-grade quality in non-hospital settings.

Enterprise Resource Planning system
PMM was doing business nationally, with several Fortune 500 companies who conducted site audits. That year, the company decided to make a critical decision replacing the dated computer program designed for accounting and billing, but not managing supply chain or administering quality procedures. They knew they needed a better quality system and a better management system. In 1999, ResTech migrated all of its data into a single ERP application that would manage all aspects of its business: the solution integrates supply chain management, accounting, inventory, and production.

“We continued to adapt our Made in America manufacturing strategy,” said Danis. “Whether or not we won their job, we knew we needed a new system and, to implement additional best practices to provide low-cost manufacturing.”

First acquisition
The company acquired a Clinton-based plastic injection molder company and merged with PMM. The new combined entity in 2010, re-branded and became

ResTech Plastic Molding, operating a total of 28 injection molding machines with contracts in medical, industrial, defense, automotive and food service industries. A majority of new customers, domestic OEMs who offshored work and well-paying jobs, were spending more time managing multiple suppliers and long-distance relationships. Their sense of urgency shifted from quality intensive due to constantly re-evaluating sourcing and costs of overseas production. They found ResTech’s engineering and manufacturing systems yielded some promising results: reducing total cost of production, return to localized sourcing with the ability to reshore manufacturing back to the USA: they could make their products here, in New England.

Participation in statewide manufacturing program
Danis joined Building Bridges to Growth: A Roadmap for Advanced Manufacturing in Massachusetts in 2011. Launched by Governor Deval Patrick, the initiative is an ambitious plan designed to revitalize and enhance the competitiveness of the manufacturing industry. That same year, Massachusetts State Senator Jamie Eldridge (in picture, center) toured the Hudson manufacturing campus and said, “Skilled manufacturing is a thriving industry in Massachusetts thanks to companies like ResTech Plastic Molding. To keep it that way, we need to increase our investments in workforce development and building our infrastructure are the best things we can do to grow our economy over the long run. I’m committed to making sure these are the economic priorities of our Commonwealth.”

Enhanced quality system
The company completed a new ISO Class 8 100,000 Cleanroom with 6 JSW Electric Molding Machines with clamping forces of 40 to 120 tons.

“We focus on growth and excellence, but the only people who can do it are the employees. And to get the results you need to give them the tools, and the training program is one of them,” said Danis.

Usually a book or paper is prepared to help with a job, but ResTech wanted to go further and installed a video system on machines that details what to watch for and how to handle a job. The Mobile Automated Trainer (in picture, right) is installed company-wide. The process is tightly controlled: various departments and the customer have to sign-off before it is implemented and, shows what finished products look like and even how to pack them.

Adding two-shot molding technology
Perceptive companies closely follow the total cost of ownership to reevaluate offshoring vs. reshoring. ResTech has been focused on a new turnkey approach, providing a customer-driven single-source solution accelerating low-cost manufacturing for its customers and to keep them from offshoring. In January 2014, ResTech acquired Northeast Mold & Plastics, adding Two-Shot molding technology to its portfolio.

Danis said, “The real payoff of two-shot plastic injection molding of thermoplastic materials is an economic one: parts of two different materials can be fabricated with the speed, efficiency, and economy of thermoplastic processing. This eliminates the labor-intensive secondary operations used for so many years and replaces them with high-speed automated operations, to yield a more consistent, higher quality fabricated part at a significantly lower cost.”

Leading the future in plastic molding technologies
Today’s ResTech Plastic Molding, is a leading Northeastern United States injection molder and a single source manufacturing company, and employs more than 200 people in Massachusetts and Connecticut. Danis said sales have been steadily rising 15% over the last three years and expects the same this year. The company is also getting a boost from work coming back from China, gaining 2 projects that been manufactured overseas. Although focused on the future, ResTech Plastics Molding tries not to forget how far it has come in 45 years.

“For a company like ours to grow in an increasingly competitive global economy, the need for exceptional people is a given,” said Danis. “However, having first rate quality systems and technology will be more critical.”

Source: ResTech Plastic Molding LLC