New Clean Room at Jabil Centralizes Design, Prototyping Services

New Clean Room at Jabil Centralizes Design, Prototyping Services

Jabil Circuit Inc. has opened a class 100,000 clean room for rapid prototyping of medical devices. Located at the company’s St. Petersburg, Fla., headquarters, the expanded clean room facility will bring design and prototyping under one roof, which, according to company officials, will help customers accelerate time to market with new concepts.

In addition, the clean room provides technology capabilities and standard operating procedures that mirror a full-production environment, which can help to simplify the transition to higher-volume manufacturing.

“Customers are asking for more development work, so this became a necessity,” Gaet Tyranski, business unit director for Jabil Healthcare & Life Sciences, toldMedical Product Outsourcing. He said the company’s U.S.-based, single-use device design, engineering and prototyping services now are centralized for efficiency and customer convenience. The facility also means that designs no longer have to be shipped to another Jabil facility to create product samples.

“We carefully designed our clean room to be a mini factory with the same assembly capabilities and processes used in manufacturing plants,” he added. “That way, device companies can reduce costs, save time and achieve optimized, production-ready, repeatable design.”

The new clean room offers ultrasonic welding, ultraviolet curing, solvent bonding, over-molding, laminate airflow, bag and blister packaging and testing.

“Our customers must see us as an extension of their business,” said Alan Myers, Jabil’s newly named vice president, Global Business Units, Healthcare & Life Sciences. “We think like a medtech company—we have to act and operate as if we were on the OEM side of the business. Part of that is the constant improvement of quality and investment in our infrastructure and people.”

At present, most of Jabil’s medical device manufacturing of single-use devices is in Asia. The company, however, plans to expand geographically in the United States and Europe to be closer to its base of OEM customers, Tyranski said.

Aastrom, ATEK Medical Form Strategic Partnership

Aastrom Biosciences Inc. has formed a strategic deal with ATEK Medical. Under the manufacturing and development partnership, ATEK will supply key components and technology for use in Aastrom’s cell manufacturing process, according to a joint news release provided by the companies. The new collaboration expands upon a previous supply deal between the two firms.

“Aastrom develops new, proprietary cell technologies to treat severe cardiovascular diseases,” Dave Mabie, ATEK

Medical’s vice president of business development, said. “Their development programs and automated cell manufacturing system require components that meet the highest standards of cGMP and FDA [U.S. Food and Drug Administration] compliance. Our technology expertise andmanufacturing experience for regulated products make us an ideal partner to support the technology needs of theiradvanced development programs.”

Based in Ann Arbor, Mich., Aastrom develops expanded autologous cellular therapies that are based on bone marrow samples. Cell therapies developed through its automated, proprietary cell-manufacturing system are given back to patients to regrow damaged tissues.

Aastrom President and CEO Tim Mayleben said ATEK’s manufacturing expertise will help his firm advance its cardiovascular programs and treatment therapies.

“ATEK has an outstanding track record in leveraging its technology expertise to produce high-quality components and medical devices and to improve and upgrade procedures used in the manufacture and processing of novel therapies,” Mayleben noted. “We expect that this collaboration will be a critical advantage for Aastrom as we move our cardiovascular programs into the final stages of clinical development. We are also very pleased to be joining with another Michigan-based company in this collaboration. We believe that this partnership will result in the creation of high-paying jobs in Michigan.”

Founded in 1979, Grand Rapids, Mich.-based ATEK Medical offers full-service manufacturing services for the medical, disposable, electro-mechanical and implantable device markets.

New Space Gives Millstone More than 100K Square Feet

Millstone Medical Outsourcing has added space close to its headquarters in Fall River, Mass. The company signed an agreement to lease a 26,000-square-foot buildingwithin steps of its existing facility. According to the company, the new building will provide significant expansion space for materials management, post sterile release processes, kitting and assembly work, and warehousing and distribution activities.

The addition of this facility increases Millstone’s active square footage in Fall River to 80,000 square feet and to 125,000 square feet overall, including its location in Memphis, Tenn.

“The new Fall River building is a clean, open environment we can tailor to support our service offerings as we expand to meet the growing needs of our customers,” said Chris Ramsden, Millstone’s CEO. “Benefits of the expansion space are the ability to easily load in materials that enable us to offer tier-one material purchasing and management services, extra space for post sterile release services, and an ample, streamlined area for kitting and assembly.”

Millstone, which is ISO 13485-certified, provides inspection, clean room packaging, loaner kit processing, and distribution services to medical device—primarilyorthopedic—and dental device manufacturers worldwide.

ThermalTherapeutic Systems Forges Strategic Alliance

ThermalTherapeutic Systems Inc. is teaming up with a Boston, Mass.-based device distribution company to broaden its customer base.

The agreement ThermalTherapeutic drafted with Applied Medical Products and Solutions Inc. will give the Pittsburgh, Pa.-based firm immediate access to the greater New England area medical market, ThermalTherapeutics executives said. Applied Medical’s regional distribution area covers Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island and Vermont, according to the company’s website. The firm sells, distributes and supports products used in cardiovascular surgery and perfusion-related therapies.

“We are very selective about the products that we represent and the companies with whom we work,” said Applied Medical President Giovanni Cecere. “The perfusion system developed by ThermalTherapeutic Systems clearly fits our criteria of innovation, precision and safety.”

Founded in 2006, ThermalTherapeutics has developed a device that is designed to standardize the use and improve the medical control of hyperthermic and non-thermal perfusion (the process of delivering arterial blood to a capillary bed in biological tissue). Executives said the alliance with Applied Medical will give the firm immediate access to New England customers.

“With expertise and reach in the perfusion, diagnostic and therapeutic markets, Applied Medical Products not only provides our company with immediate access to the medical community in the greater New England area, but it has a deep understanding of the emerging opportunities in the broader market with respect to critical perfusion services and applications,” said Raymond F. Vennare, ThermalTherapeutic’s president and CEO.

Nexcore Acquires Endoscopy Product Line

Waldwick, N.J.-based Nexcore Technologies Inc. has a new product line. The company purchased the Meditron line of gastroenterology endoscopy products from CooperSurgical Inc. of Trumbull, Conn. Terms of the deal were not disclosed.

The acquisition turns the Meditron product line into a wholly owned subsidiary of Nexcore Technologies. Company executives are hoping the acquisition will further fuel Nexcore’s growth in gastroenterology endoscopy products.

Robert Auerbach, senior vice president and chief medical officer at CooperSurgical, said the deal will enable the firm to consolidate its position in women’s health while allowing Nexcore to expand available technology in the gastroenterology field.

Sprechen Sie Deutsch? Emergo Heads to Hamburg

Add Germany to the growing list of overseas offices operated by medical device consultancy firm Emergo Group Inc.

The office in Hamburg (the seventh-largest city in the European Union, with an estimated population of more than 1.8 million residents) is the fourth Emergo has opened in Europe. Its other offices are located in France, the Netherlands and the United Kingdom.

Jens Grothues, a businessman with 17 years of experience in the medical device industry, will serve as general manager for the new German office (dubbed Emergo Deutschland GmbH). Grothues has held various regulatory and quality assurance roles with German device manufacturers and certification bodies including TÜV NORD and MedCert.

Emergo’s newest office provides a wide range of medical device regulatory, quality assurance and distribution consulting services that can help them access markets in Europe, the United States and Japan.

“German manufacturers are well established as strong medical device exporters and many of those companies are now looking to expand into emerging markets such as Brazil, Mexico, India and China,” said Colin Rylett, Emergo’s managing director of European operations. “We can help companies reach those markets.”

Emergo maintains offices in Australia, Brazil, Canada, China, Japan, Mexico, Russia and the United States.