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Posts Tagged ‘medical device’


Monday, November 10th, 2008

Free Seminar for Medical Device Makers on Importance of Sterile Package Validation Set for Nov. 12th

AGAWAM, MASS. – Nov. 10, 2008 – A free morning-long seminar to help New England-based medical device manufacturers negotiate the increasingly important – and complex – challenges of sterile package validation is scheduled for November 12th in Agawam, Mass.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs,” says Steven Richter, Ph. D., president and CEO of Microtest, a leader in medical device testing services, including medical device package stability and validation testing.

The seminar will detail the necessary sterilization processes and test methods that should be part of any reliable validation program to avoid such failures, Richter said.

Titled “Package Validation Requirements for Medical Devices and Combinatory Products,” the seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies. Specific topics will include:

  • ISO 11607 Overview
  • Physical Package tests vs Microbial
  • Stability & Accelerated Aging
  • Combinatory Products
  • Flexible Packaging
  • ISTA Shipping Testing

The seminar will be held Nov. 12, 2008, from 10 a.m. through Lunch at Microtest Laboratories, Inc., 104 Gold St., Agawam, Mass. The seminar is free and lunch will be provided.

The seminar is free, but prior registration is required. To register, call toll-free 1-800-631-1680.

For directions to Microtest, visit http://www.microtestlabs.com/contact-us/index.html.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Tuesday, October 28th, 2008

“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference

AGAWAM, MASS. – October 28, 2008 — Merribeth Morin, PhD, of Microtest Laboratories will present “Biosafety Testing of Cell Lines used in Vaccine and Virus Vector Production” at the WilBio Viral Vectors and Vaccines conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy, at 11:15 am-Noon, on Tuesday, Nov. 4, 2008 in Santa Barbara, Calif.

Dr. Morin’s presentation will discuss the safety concerns for the use of cell lines, in reference to their use in vaccine and vector production.

“The use of cell lines for the production of virus vectors and vaccines is widely applied. The ability to manipulate cells in culture and grow them to large scale is advantageous, and in the case of vaccines, presents a more attractive and consistent process than some more traditional methods for vaccine products. As for any type of biological product, using cell lines presents various safety considerations. There are a number of regulatory guidance documents that address the characterization of cells used for the production of biological products. The safety program for cell lines needs to be reasonable, but thorough, to address the safety concerns outlined in these documents,” said Dr. Morin.

Dr. Morin is Director of Virology for Microtest Laboratories, (http://www.microtestlabs.com/), a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. She received her PhD in Virology from Harvard University and has spent a number of years in both in vaccine research and in contract testing. Her research included developing DNA vaccines for the treatment of influenza virus infection and other infectious diseases, and the development of an attenuated vaccine for Herpes simplex virus infection.

Based in Agawam, Mass., Microtest’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

The Viral Vectors and Vaccines Conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy runs Nov. 3-5, 2008. For more information, visit http://www.wilbio.com/.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Monday, October 27th, 2008

Texcel Introduces Innovative Programmable, Implantable Stimulation System for R&D of Specialty Stimulation Therapies

East Longmeadow, Mass. – October 27, 2008 — Texcel, a leading provider of custom medical device development and manufacturing solutions, has introduced its innovative new StimX programmable, implantable stimulation system.

Designed for use in the research and development of specialty stimulation therapies, the StimX system is the industry’s first-truly programmable, implantable customizable platform.

The StimX system’s programmable stimulation parameters “will directly benefit medical researchers and medical device developers by dramatically reducing the time, cost, and risk involved in creating devices for use in testing stimulation therapies in variety of applications,” said Keith Checca, Texcel Director of Business Development.

“With the StimX implantable system, we are freeing researchers from the hours and dollars that they’d otherwise invest in designing and developing their own devices– and to literally re-allocate their resources back into their research,” said Checca.

Neural stimulation therapies, including direct nerve and brain stimulation, are used to treat people who suffer from epilepsy, Parkinson’s disease, clinical depression and other diseases. Targeted stimulation areas range widely from direct brain surface, deep brain stimulation, to the spinal cord and peripheral nerves.

Texcel’s new StimX platform includes an implantable stimulator, laptop and output customization program, proven wireless communication and charging modules.

The need for the system was realized as a result of Texcel’s years of innovation in the field of custom medical device manufacturing and it was made possible by Texcel’s partnerships with medical electronics development resources.

For more information, visit the Texcel website at: http://www.texcelmedical.com; or call the company at (413) 525-5700.

About Texcel
For more than 21 years, Texcel has partnered successfully with companies around the globe to accelerate the commercialization of their implantable, surgical, and interventional medical device technologies. Texcel is staffed with over fifty (50) talented, experienced, and passionate medical device industry employees within an ISO 13485 and ISO 9001 environment. Texcel provides specialized services and/or full medical device solutions including device design, development history file maintenance, quality (QA & QC), regulatory assistance, process validation, and general manufacturing, electronic testing, laser welding, and clean-room packaging for a wide range of product applications. Texcel is based in East Longmeadow, Mass. Visit Texcel on the Net at: www.texcelmedical.com.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Wednesday, October 22nd, 2008

Texcel to Introduce a Programmable, Implantable Stimulation System at MD&M Minneapolis 2008

East Longmeadow, Mass. – October 22, 2008 — Texcel, a leading provider of custom medical device development and manufacturing solutions, will introduce its innovative new StimX programmable, implantable stimulation system at MD&M Minneapolis, October 22-23, 2008, in exposition booth # 236.

Designed for use in the research and development of specialty stimulation therapies, the StimX system is the industry’s first-truly programmable, implantable customizable platform.

The StimX system’s programmable stimulation parameters “will directly benefit medical researchers and medical device developers by dramatically reducing the time, cost, and risk involved in creating devices for use in testing stimulation therapies in variety of applications,” said Keith Checca, Texcel Director of Business Development.

“With the StimX implantable system, we are freeing researchers from the hours and dollars that they’d otherwise invest in designing and developing their own devices– and to literally re-allocate their resources back into their research,” said Checca.

Neural stimulation therapies, including direct nerve and brain stimulation, are used to treat people who suffer from epilepsy, Parkinson’s disease, clinical depression and other diseases. Targeted stimulation areas range widely from direct brain surface, deep brain stimulation, to the spinal cord and peripheral nerves.

Texcel’s new StimX platform includes an implantable stimulator, laptop and output customization program, proven wireless communication and charging modules.

The need for the system was realized as a result of Texcel’s years of innovation in the field of custom medical device manufacturing and it was made possible by Texcel’s partnerships with medical electronics development resources.

For more information, visit Texcel at MD&M Minneapolis 2008 in booth # 236; visit the Texcel website at http://www.texcelmedical.com/; or call the company at (413) 525-5700.

About Texcel
For more than 21 years, Texcel has partnered successfully with companies around the globe to accelerate the commercialization of their implantable, surgical, and interventional medical device technologies. Texcel is staffed with over fifty (50) talented, experienced, and passionate medical device industry employees within an ISO 13485 and ISO 9001 environment. Texcel provides specialized services and/or full medical device solutions including device design, development history file maintenance, quality (QA & QC), regulatory assistance, process validation, and general manufacturing, electronic testing, laser welding, and clean-room packaging for a wide range of product applications. Texcel is based in East Longmeadow, Mass. Visit Texcel on the Net at: http://www.texcelmedical.com/.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Friday, October 3rd, 2008

Microtest Honored as Regional Example of Success; Receives Hampden Achievement Award, Induction into STCC Western Mass. Entrepreneurship Hall of Fame

Agawam, Mass., October 3, 2008 – In recognition of the company’s growth, success, and importance to the region, Microtest Laboratories of Agawam has received the Hampden County Achievement Award and has been inducted to Springfield Technical Community College’s Western Massachusetts Entrepreneurship Hall of Fame.

“The achievements of Microtest Laboratories’ growth and success serve as a powerful model for the future of Massachusetts, and Microtest will serve as an inspiration to thousands of people who visit every year,” said Dr. Andrew M. Scibelli, President of Springfield Technical Community College (STCC).

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries and has made numerous multi-million capital investments and expansions of its facilities the past several years – along with growing its professional workforce to more than 100. The company works closely with Western Mass. economic and business organizations as well as the region’s educational institutions.

Microtest President and Scientific Founder Steven Richter, Ph. D., is an ardent supporter of regional technical training programs as a means to ready both current and future workers to contribute to – and reap the benefits of – the area’s burgeoning life science industry.

“It is an honor for all of us at Microtest to be recognized for our achievements,” said Richter. “If we can serve a role for others, then let it be as a example of the potential that’s available throughout Western Mass. when working partnerships among our entrepreneurs, education, residents, and government are permitted – and encouraged – for the benefit of all.”

The Andrew Scibelli Enterprise Center is committed to furthering regional economic development, entrepreneurship education and workforce development. It is home to the Western Massachusetts Entrepreneurship Hall of Fame. Established in 2000, it honors innovative entrepreneurial individuals and businesses in Western Massachusetts, in hope to inspire the next generation of business leaders.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/


Wednesday, September 12th, 2007

Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

AGAWAM, MASS. – September 12, 2007 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (http://www.microtestlabs.com/).
The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

Microtest Sterility White Paper Pharma For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue, visit Microtest on the Web: www.microtestlabs.com or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/)


Monday, July 9th, 2007

New, Free White Paper Details Compliance Requirements for Pharmaceutical, Medical Device Manufacturers

AGAWAM, MASS. – July 9, 2007 – A new, free white paper, detailing critical industrial sterilization and contamination control programs and compliance challenges in the pharmaceutical and medical device manufacturing industries is now available for download at www.microtestlabs.com/environmentpaper.

One of the biggest challenges faced by medical device manufacturers is determining exactly what is required for compliance. For parenteral manufacturers, the environmental control parameters are highly stringent and pose significant compliance challenges.

In the white paper, titled “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” Microtest Project Manager Scott Mackin, reviews key elements of a best practice environmental testing program, including sterilization standards, FDA compliance requirements and vital factors in maintaining controlled environments.

At Microtest (http://www.microtestlabs.com/), Mackin has assisted a number of medical device manufacturers in designing, implementing, and maintaining both sterilization and environmental monitoring programs.

Microtest, a full service testing services and contract manufacturer, offers a complete range of onsite and remote monitoring programs for specialized environmental testing services. Microtest experts utilize cutting edge technology and processes to determine viable microbial and nonviable particulate levels of any area used for medical device and pharmaceutical cleanroom or manufacturing purposes.

Download the free white paper, “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” at: www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Press release contact: Tiziani Whitmyre, http://www.tizinc.com


Monday, June 4th, 2007

Med-Conduit Turns to Microtest for Medical Device Testing Services

AGAWAM, MASS., June 4, 2007 – Med-Conduit, an innovative developer and marketer of central venus catheters (CVCs) has teamed with Microtest Laboratories of Agawam, Mass., a leading provider of testing services to the medical device industry.

CVCs are found in use at intensive care and long term units in hospitals. When inserted into a patient, it enables that patient’s skin to grow into the device and form a biological seal that has a significant impact on preventing infection at the site of insertion, explained Dr. Gerald Bousquet, M.D., President, Med-Conduit.

Microtest is conducting bacteria testing on a new cap that Med-Conduit is implementing for its CVCs, said Dr. Bousquet.

Dr. Bousquet turned to Microtest for its current testing needs after working with the company and its founder, Steve Richter, Ph.D., on a previous project.

Dr. Richter had assisted Dr. Bousquet to navigate the stringent US Food and Drug Administration (FDA) application process and successfully obtain the critical FDA approvals he required to manufacture and sell a product at his previous company, Microwave Medical Systems. The product, the Microwave Sanitizer, is a microwave designed to sanitize the catheter connection area to decrease the risk of infection for patients in peritoneal dialysis.

“Dr. Richter’s prior experience working at the FDA, combined with his deep expertise and background in medical device development, and his personal passion to succeed, made all the difference in securing the approvals we required,” Dr. Bousquet said. “Dr. Richter even traveled with our company principles to meet with the FDA in Washington, DC.”

Microtest offers a host of single-source solutions that assist medical device manufacturers facing a rising volume and complexity of challenges in product development and validation, including:

  • Medical device sterilization validations
  • Package validations
  • Microbiology and clean room services, and
  • Analytical services.

A new free white paper written for medical device manufacturers discusses sterility testing as well as reviews different testing methodologies Titled “Sterility Testing: Essential Things You Must Know,” it’s authored by Dr. Richter, and is available for download at: http://www.microtestlabs.com/sterilitypaper.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Wednesday, May 30th, 2007

Microtest to Highlight Medical Device, Analytical Capabilities at MD&M East

AGAWAM, MASS. – May 30, 2007 – Microtest Laboratories will highlight its expanded medical device, contract manufacturing and analytical testing capabilities at the Medical Device & Manufacturing (MD&M) East Conference, June 11-14 at the Jacob Javits Convention Center in New York City.

With the completion of a $7.5 million capital improvement program, the addition of new resources and skilled professionals, and the purchase of a MicroSeq® Microbial Identification System, Microtest has bolstered its services and emerged as a leader in the medical device manufacturing market.

Microtest’s enhanced medical device sterility validation and release testing services (www.microtestlabs.com/medical-device-testing) includes:

  • Gamma/EO Sterilization Validation: Bioburden; Bioburden Recovery; Bacteriostasis/Fungistasis; Sterility; Dose Calculation; Spore Strip Population; Ethylene Oxide Residuals
  • Reusables: High/Low Level Disinfection; Cleaning Studies; Steam / EO / Chemical SterilizationEndotoxin: FDA / USP Gel Clot; Chromogenic; Turbidimetric
  • Sterility: USP; ANSI/AAMI/ISO; Product Immersion; Product Flush; Biological Indicator; Membrane Filtration; Steritest(TM) / Sterisolutest(TM)

Microtest’s upgraded analytical services (www.microtestlabs.com/analytical-chemistry-testing), performed as needed in accordance with USP/ISO/BP/AOAC/AAMI/JP requirements, include:

  • Services: ETO, ECH, EGLY Residuals Analysis; ETO, Pilot Vessel Studies; Formaldehyde Residuals Analysis
  • Water Testing: TOC (Total Organic Carbon); pH and Conductivity; Total Chlorine; Total Nitrates and Heavy Metals
  • Wet Chemistry: Heavy Metals; Non-volatile Residues; Residues on Ignition; Direct Titration; Nitrates

For more information on Microtest capabilities and services, visit Steve Richter, PH.D., Microtest President, in the Microtest booth, number 1544, at MD&M East, June 11-14 in the Jacob Javits Convention Center in New York City. Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption.

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Wednesday, March 28th, 2007

Symmetry Medical Enhances Total Solutions® Offering Through Partnerships With Independent Test Laboratories

WARSAW, Ind. – March 26 , 2007 – Symmetry Medical Inc. (NYSE: SMA), an independent provider of products to the global orthopedic device industry, announced today it has partnered with two independent testing laboratories to further enhance Symmetry Medical’s Total Solutions® offering. Symmetry has partnered with Sherry Laboratories, which is located at Symmetry’s Design & Development Center (DDC) in Warsaw, Indiana, and with MicroTest Laboratories, Inc., which is located at Symmetry’s DDC facility in Manchester, New Hampshire.

Sherry Laboratories’ specialization in instrument durability, impact load cell testing and torque testing will enable Symmetry’s Warsaw DDC to identify necessary product modifications and quickly address the changes during the development cycle. Implementing the testing process into the overall manufacturing timeline is expected to reduce the time it takes to move product to market.

“Sherry Laboratories has been serving the medical device industry for nearly twenty years and is delighted to establish this unique partnership with Symmetry Medical,” said Christopher LaMothe, Chairman and CEO of Sherry Laboratories. “This industry leading concept allows Symmetry Medical’s customers to enjoy the confidence of independent third party testing as an integrated part of product design, development and quality assurance.”

“As the world’s leading independent provider of implants, related instruments and cases to orthopedic device manufacturers, as well as an established product design and development provider to several other segments of the medical device market, Symmetry recognizes the value that independent, on-site testing will bring to our design and development cycle. Partnering with Sherry Laboratories provides a natural extension of our value added services, which enable our customers to achieve greater speed to market,” said Barry Parker, Senior Vice President, Symmetry Medical Design & Development Center.

In partnering with MicroTest Laboratories, Inc., a leader in third-party independent testing services and contract manufacturing for the medical device, pharmaceutical and biotechnology industries, Symmetry Medical’s DDC in Manchester, New Hampshire becomes the first surgical instruments case manufacturer in the U.S. to offer services ranging from sterilization validation to cleanability testing.

“Symmetry Medical’s ability to consolidate third-party validation into the case design and manufacturing process provides a significant time-to-market advantage to medical device manufacturers. By instituting these measures, Symmetry ensures its customers the highest levels of quality and efficiency and positions itself ahead of what may soon to be a requirement throughout the industry,” said Dr. Steven Richter, President and Founder of MicroTest Laboratories, Inc.

“Our ongoing partnership with MicroTest Laboratories, a world class test organization, provides Symmetry Medical with the ability to enhance its Total Solutions offerings to its multitude of medical product customers,” said Michael Curtis, Senior Vice President and General Manager, Medical Products, Symmetry Medical. “The opportunity to provide total design, manufacturing sterilization and cleanability testing for all our medical products maintains our position as a supplier of choice in the medical device market.”

About Symmetry Medical Inc.
Symmetry Medical Inc. is a leading independent provider of implants and related instruments and cases to the orthopedic device industry. The Company also designs, develops and produces these products for companies in other segments of the medical device market, including dental, osteobiologic and endoscopy sectors and provides limited specialized products and services to non-healthcare markets, such as the aerospace market.

Forward-Looking Statements
Statements in the press release regarding Symmetry Medical Inc.’s business, which are not historical facts, may be “forward-looking statements” that involve risks and uncertainties, within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are predictive in nature and are frequently identified by the use of terms such as “may,” “will,” “should,” “expect,” “believe,” “estimate,” “intend,” and similar words indicating possible future expectations, events or actions. Such predictive statements are not guarantees of future performance, and actual results could differ materially from our current expectations. Certain factors that could cause actual results to differ include: the loss of one or more customers; the development of new products or product innovations by our competitors; product liability; changes in management; changes in conditions effecting the economy, orthopedic device manufacturers or the medical device industry generally; and changes in government regulation of medical devices and third-party reimbursement practices. We refer you to the “Risk Factors” and “Forward Looking Statements” sections in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as the Company’s other filings with the SEC, which are available on the SEC’s Web site at www.sec.gov.

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Posted by Tiziani Whitmyre, www.tizinc.com


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