What are you searching for?

Sign in

Reglera LLC Opens New Office to Accommodate Increased Demand

Reglera LLC Opens New Office to Accommodate Increased Demand

Industry News



Reglera LLC Opens New Office to Accommodate Increased Demand

Reglera LLC has entered the Israeli medical device market.The quality assurance consulting firm has opened a new office in Ra’anana, Israel, a northern suburb of Tel Aviv with a population of 73,100 people. Founded in 1921 by the Ahuza Alef Society of New York, the city has a large English-speaking population and the highest quality of life in Israel. It also has been ranked as the safest city in the Middle East.

Reglera opened the Israeli office to meet a growing demand for its services there. The Lakewood, Colo.-based company provides regulatory compliance and quality assurance consulting and outsourcing services to medical device and tissue bank firms. The new office will enable local companies to access to Reglera’s services, including quality system assessment and development, design control, regulatory submissions, validations, compliance remediation and outsourcing services.
“This is perfect timing to expand our offerings to the Israeli market,” said Clay Anselmo, Reglera CEO and president. “We’ve been growing at a 10-year compound annual growth rate of more than 35 percent, and we see Israel as a great opportunity to further leverage our growth. The Israeli medical device market is the largest medical device market in the Middle East, with an overall estimated market size of $885 million last year.”

Its medical device market is also the largest sector in the growing Israeli life sciences industry, Reglera noted. As of 2007, about 55 percent of the total life sciences companies in Israel were medical device firms, while only 12 percent of Israeli life sciences companies were pharmaceutical firms, a trend opposite of that found in the U.S. life sciences industry.
The new office will be led by Oded Zur, an Israeli resident with more than 25 years of experience in multi-disciplinary technology development. He served as vice president of R&D for superDimension, a company in Herzliya, Israel, that develops and markets minimally invasive pulmonary devices.

During his tenure with the company, Zur had various responsibilities, including: leading a multinational team of engineers, developing the company’s products, implementing and improving the firm’s quality system to better meet requirements from the U.S. Food and Drug Administration and the International Organization for Standardization, and managing the company’s intellectual property portfolio.


Oliver Medical and TOLAS Healthcare: Perfect Together



Oliver Medical, a supplier of die-cut, roll stock, and pouch products to the medical device and pharmaceutical markets, has acquired TOLAS Healthcare Packaging. The two companies now operate under a new moniker, Oliver-Tolas Healthcare Packaging.
Integration of the two companies began in the first quarter of the year, according to a news release announcing the acquisition.

“Combining our individual company names reflects the consolidation of our extensive resources, technology and experience while also acknowledging the individual histories and strengths each company brings to the organization,” said Jerry Bennish, Oliver-Tolas Healthcare’s CEO and president.

The merger did not affect manufacturing and administrative activities at any of Oliver-Tolas Healthcare Packaging’s facilities, officials said.

“Together, as Oliver-Tolas Healthcare Packaging, our increased presence in the market, broadened product line, and expanded coating and manufacturing operations place us in an even better position to provide our customers with the industry’s best medical device and pharmaceutical packaging solutions,” Bennish added.

Oliver Medical is based in Grand Rapids, Mich. It has manufacturing facilities in Grand Rapids (which is ISO 13485 certified) and Venray, the Netherlands, and a sales office in Suzhou, China. Tolas Healthcare Packaging manufactures sterile-grade packaging, including peelable or tear-open pouches and heat-seal coated lidding. Tolas operates manufacturing facilities in Philadelphia, Penn., and Cincinnati, Ohio.

Oliver Medical was acquired in June 2007 by Mason Wells, a private equity firm based in Milwaukee, Wis.

BSI Launches Program for Class III Medical Device Reviews



BSI has developed a new program designed to expedite the medical device review process for products that require European CE Marking Design Dossier Reviews.

The program, called CE-Onsite FastTrack Review, expedites the review process through live, onsite interaction that facilitates more efficient communication. The program is designed to complete the review process in 45 working days, according to a news release from the company.

“The interactive aspect of the CE-Onsite FastTrack Review compresses the review time, improves the predictability of the review’s outcome, and promotes a faster time-to-market,” said Ibim Tariah, technical director of BSI, Healthcare. “BSI provides thorough and fair reviews that focus on what really matters, but we never guarantee a CE Marking. The integrity of each review is critical to ensuring a medical device is deemed safe for its intended use.”

The CE-Onsite Review is similar to the CE-45 FastTrack Program but has one major difference: BSI product experts visit the manufacturer in person to perform the review.

BSI officials said performing the review in person expedites the process by eliminating communication through mail, email, fax or phone. The face-to-face opportunity also gives product experts accessibility to all relevant parties in the review process.

The new CE-Onsite program gives product experts instant access to documents and allows them to see productsfor themselves. Despite the advantages of the program, BSI officials warned that the CE-Onsite system may not be suitable for medicinal, blood and animal tissue products. And, while the program is designed to complete the review process within 45 days, the length of the review could vary depending upon the preparedness ofthe manufacturer.

•••

Millstone Medical Celebrates Opening of New Facility



Millstone Medical Outsourcing has expanded its operations in Fall River, Mass. The company last month opened a new 30,000-square-foot facility that includes an advanced mechanical inspection area, a 5,000-square-foot state-of-the-art clean room, and significant floor space for packaging operations.

“We are excited to add to our Fall River operations to meet customer demand for advanced inspection and clean room services,” said Christopher Ramsden, Millstone Medical CEO. “The new facility is specifically designed to enable Millstone to scale with medical device manufacturers and solve specialized inspection, packaging, and distribution challenges.The new facility’s inspection cell features state-of-the-art equipment, including optical comparators, coordinate measuring machines, vision systems, and microphites.

The clean room incorporates ultra sonic clean lines within environmentally controlled areas. And the entire facility can be monitored remotely for particulate and environmental conditions. The company, which provides outsourcing services to the medical and dental device industries, held a ribbon-cutting ceremony and open house at the new facility on April 24. Fall River Mayor Robert Correia and U.S. Rep. Barney Frank (D-Mass.) attended the event.

•••

ISO CERTIFICATIONS:



• Software developer CSOFT International Ltd. has received ISO 13485:2003 certification. The Beijing, China-based firm provides multilingual localization, testing and outsourced software development to the medical device, manufacturing, life sciences, financial services, chemical, energy, and information technology markets. “Being awarded ISO 13485:2003 certification further validates the depth and maturity of our quality management system (QMS) for medical translation…” said Shunee Yee, CSOFT’s president and CEO.
• Foresight Imaging, a company that designs video streamers, frame grabbers, and PACS connectivity hardware and software for the medical imaging market, has received ISO 13485:2003 and ISO 9001:2000 certification. The 10-year-old firm is based in Chelmsford, Mass.
• Franek Technologies Inc., a supplier of battery backup power protection systems, has received ISO 9001:2000 certification. The 35-year-old company is headquartered in Tustin, Calif., and serves the analytical, research, diagnostics and medical instrumentation markets.
• ISO 13485:2003 certification has been awarded to HydraBrush Inc., an Escondido, Calif.-based manufacturer and distributor of powered toothbrushes. “The certificate conveys to our customers and the financial community that we have a system in place that demonstrates our commitment to the highest standards of quality control,” said Ken Hegemann, HydraBrush president and CEO.
• Forceps manufacturer Scholten Surgical Instruments Inc. has received ISO 13485:2003 certification. The Lodi, Calif.-based firm is credited with developing endomyocardial biopsy forceps known as the Scholten or Stanford Bioptome.
• ISO 13485:2003 certification has been awarded to SterlingTech Software of Rochelle Park, N.J. The company provides software development, testing and validation services for the medical device industry. President Dan Sterling said the certification is the “next step in our growth as a company.”
• Outsource provider Teleflex Medical OEM has received ISO 13485:2003 certification for its catheter fabrication and assembly facility in Plymouth, Minn. The Plymouth site is the last of the company’s four facilities to be ISO certified. Teleflex’s other plants are located in Jaffrey, N.H.; Mansfield, Mass.; and Limerick, Ireland.
• Wedge Manufacturing Inc., a precision machining, engineering and contract manufacturing firm based in Birmingham, Ala., has received ISO 13485:2003 and ISO 9001:2000 certification. During the certification process, the company was subjected to three audits by the British Standards Institute.

•••

Vesta Completes ExtruMed Buy

A new tubing company has entered the medical device market.

Vesta Inc. has acquired ExtruMed LLC to create a company that can offer both silicone and thermoplastic tubing for cardiovascular, neurological and other intravenous catheter markets.

The new company will have five production facilities that can manufacture more than 60 million medical device components annually.

Vesta, a silicone tubing manufacturer headquartered in Franklin, Wis., has an ISO 13485:2003-certified facility in Franklin and a plant in Portage, Wis., that is ISO 9001:2000-registered. ExtruMed, a maker of precision thermoplastic tubing, operates out of Placentia, Calif.

It has ISO 13485-certified plants in three California cities: Placentia, Termucula and Livermore.

Terms of the acquisition were not disclosed. GE Healthcare Financial provided an $89 million credit line to Vesta to help close the deal.

“We are excited about the combination of ExtruMed and Vesta,” said Phil Estes, Vesta CEO. “The two businesses offer complementary services to our customers. I look forward to working with the ExtruMed management team and its employees to fulfill the combined company’s growth potential. We are also pleased to have the support of RoundTable to complete this acquisition and to show continued commitment to investing in Vesta’s future.”

Other executives at Vesta said the merger would broaden the company’s outsourcing capabilities.

“We are attracted to ExtruMed’s capabilities in high-precision thermoplastic tubing extrusion and its strong reputation for quality and customer service,” said Joseph F. Damico, founding partner of RoundTable Healthcare Partners and Vesta board chairman. “Adding ExtruMed’s capabilities in thermoplastics to Vesta’s core competencies in silicone component manufacturing broadens the outsourcing capabilities we can provide to our customers.

Roundtable Healthcare Partners, a Lake Forest, Ill.-based private equity firm, has owned a majority stake in Vesta since August 2007.

Bill Ellerkamp, ExtruMed’s CEO, said the merger would benefit both companies.

“Vesta and RoundTable are ideal partners for ExtruMed and its employees,” he said. “We are very excited to join the Vesta team, and we believe that RoundTable and Vesta will be able to enhance our market position through their operational, sales and marketing expertise as well as their relationships with medical device OEMs.”

•••

Q&A with Jim Fitzgerald, VP of sales and marketing

Medical Product Outsourcing spoke with Jim Fitzgerald, Vesta’s vice president of sales and marketing, about the merger. His responses provide some insight into the reasons behind the acquisition and the role ExtruMed is expected to play in Vesta’s future growth:

MPO: What were the reasons behind the acquisition?

Jim Fitzgerald: Vesta was attracted to ExtruMed because of its reputation for high-quality manufacturing and its ability to manufacture difficult extrusion profiles in a variety of materials. Vesta has continued to have its customers approach us about our ability to work with materials other than silicone, and we believe that the partnership with ExtruMed will allow us to offer more value to our customers. We also are excited about the fact that our companies are 100 percent complimentary in our offerings (no duplication of resources or efforts), and we share a similar model of collaborating with our customers to develop and manufacture custom medical device components. The great thing about both companies is that both have been very focused on executing their strategies. Today, both Vesta and ExtruMed remain 100 percent focused on providing medical product manufacturing, and both are 100 percent committed to being an effective contract manufacturer, not a company that does both contract manufacturing while also maintaining services as an OEM.

MPO: How will Vesta benefit from the acquisition?

Jim Fitzgerald: Vesta will benefit from the acquisition because of the additional value we can bring to our customers beyond working with silicone. We also expect to generate new business opportunities for the silicone platform from loyal ExtruMed customers who may be looking to source silicone components, but who may not be currently working with Vesta.

MPO: Are the two companies merging operations and/or names? If not, why?

Jim Fitzgerald: The two companies are not merging operations. Each company has built a strong, focused manufacturing environment with talented and committed employees, and we do not see a business reason to combine operations. We are expecting to align our focus and expand the service offering at ExtruMed by sharing some of the manufacturing practices on secondary services that Vesta is offering today. No decisions have been made to impact the names of either organization, as both companies have a strong brand awareness today.

MPO: What kind of role do you expect ExtruMed to play in the future growth of Vesta?

Jim Fitzgerald: ExtruMed’s role in Vesta’s future growth will be to enlist the input and support of ExtruMed’s talented management team. Our business models are very similar. Both companies work hard to support their customers during their product development efforts to provide inputs to ensure that they are designing for manufacturability, while remaining cost competitive. Colletively, the two companies will produce more than 60 million medical device components annually, and we anticipate discovering improvements in our manufacturing processes and capabilities, which will allow us to bring new sources of value to our combined customer base. One last point. I would strongly encourage a customer who has an application requiring both platforms to consider the value of working with a company like ours. Customers are under increasing pressure to reduce time to market, and to lower their expense structure.As economic pressures continue to lead to workforce reductions, we believe customers will require partners who can offer more services to help them offset their workloads through smart outsourcing decisions, and we are excited about the value that Vesta and ExtruMed can play to assist our customers complete their projects on time, and under budget.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters

Topics