Contract research organization NAMSA is on the fast track to expanding its global reach. After establishing offices in Frankfurt, Germany, the Northwood, Ohio-based company has announced an alliance with The Integra Group, a preclinical and clinical research company in Brooklyn Park, Minn. The partnership, the companies claim, will help medical device manufacturers get their products on the market faster.
The firms jointly will market services to medical device manufacturers throughout the United States and will coordinate projects for clients undergoing safety and efficacy evaluations for innovative medical technologies.
Company executives highlighted the benefits of having access to each other’s expertise. NAMSA claims strength in research and development, biocompatibility and clinical research while The Integra Group claims proficiency in both non-clinical and clinical research. NAMSA recently opened new offices near Frankfurt, Germany, intended to provide clinical trial and regulatory support, so the benefits of having Integra by its side are clear.
“Aligning the expertise of our people can facilitate medical device development through material selection, prototyping, non-clinical testing, and clinical research faster than other service providers,” said John Gorski, NAMSA president and CEO.
Roy Martin, M.D., chief medical officer of The Integra Group said, “Combining our research models in non-clinical and clinical research with NAMSA’s strength in biocompatibility and breadth of services makes us a stronger team together for the benefit of clients.”
In addition to laboratory testing, NAMSA provides a range of services to prove efficacy, non-clinical and clinical safety of medical devices, in-vitro diagnostics and combination products.
The Integra Group provides preclinical and clinical services, and helps clients navigate the process of product development, clinical trials, U.S. Food and Drug Administration submissions, and post-market studies.
MRPC Acquires ETI
MRPC recently made its first acquisition since the 1980s, welcoming ETI Inc. into its corporate family. Butler, Wis.-based MRPC is a single-source provider of innovative medical device components and assemblies, specializing in clean room molding with a focus on silicone molding, two-material molding and micromolding. ETI is in the same market, specializing in custom silicone injection molding for the medical, infant care, commercial, industrial, consumer dispensing and electronic products markets. The former ETI location in Largo, Fla., now will become the MRPC–ETI Division office, according to MRPC executives.
MRPC employs more than 115 people in its home state, while the smaller ETI employs approximately 25. Prior to the acquisition, ETI was wholly owned by its employees. Now one company, MRPC expects to add between 10 and 20 positions over the next two years.
MRPC has been preparing for expansion for some years now, adding clean rooms and making strategic investments into its facilities. Between the two companies, MRPC-ETI now has a total of five cleanrooms, from Class 10,000 to 100,000.
Jim Smith will continue in his position as general manager of ETI, but he now will oversee the MRPC–ETI location in Florida. “We are thrilled to be a part of this growing enterprise, knowing that it brings enhanced capabilities and versatility to our customers,” he said. “The combination of MRPC and ETI, with our shared commitment to excellence and complementary skill sets, creates a strategic advantage and elevates the national profile of both companies.”
MRPC executives said increased demand for silicone products led to the merger. “We are . . . thrilled to bring our customers even more horsepower in liquid silicone molding, while providing the security and convenience of multi-location production facilities,” said Greg Riemer, president of MRPC.
The two locations will serve as home bases for the northern and southern United States, respectively.
Value Plastics Expands Presence in Oceania
Fort Collins, Colo.-based Value Plastics, owned by Nordson Corp., has signed John Morris Scientific Pty. Ltd. (JMS) as a distributor to widen its presence in Australia and New Zealand. JMS, based in Chatswood, New South Wales, Australia, is a scientific instrument supplier.
Oceania, comprised of Australia, New Zealand, and its surrounding island states, is home to more than 100 companies served by Value Plastics’ home offices in Colorado, so JMS will allow the company to offer its customers local service. JMS has 12 offices throughout the region.
Value Plastics manufactures fluid fittings and other fluid management components used with the flexible tubing employed in healthcare and biopharmaceutical applications. JMS will carry all of Value Plastics’ products as well as provide local sales and technical support to customers. Another benefit of the distribution agreement is the ability of customers to purchase products in local currency.
“Australia is a key market for medical, biotech, and pharmaceutical companies,” Value Plastics vice president Chuck Philipp said in a prepared statement.
While global companies have established a presence there, the Medical Technology Association (MTAA) of Australia categorizes the medtech industry in the country as emergent. Because local industry is young, there is a high level of innovation and, thus, a short average lifespan for medical products, according to the MTAA.
Nordson Corp., based in Westlake, Ohio, manufactures products and systems used for dispensing adhesives, coatings, sealants, biomaterials and other materials, fluid management, test and inspection, ultraviolet curing and plasma surface treatments. Nordson acquired Value Plastics in June 2011.
MedPlast Acquires UPG
Tempe, Ariz.-based medical device manufacturer MedPlast Inc. has completed the purchase of United Plastics Group Inc. (UPG), headquartered in Oak Brook, Ill. Both companies develop plastics for use in medical devices.
With the acquisition, MedPlast gains a global presence through UPG’s locations in Mexico, the United Kingdom, and China; between the two companies they now have nine United States locations. President of UPG China Tom Opielowski noted, “Having state-of-the-art facilities in China, including precision mold making, will increase options for MedPlast customers.”
“The combination of MedPlast and UPG represents tremendous opportunities for both firms and for customers,” MedPlast CEO Harold Faig said. “MedPlast’s enhanced global footprint and added technical capabilities will bring synergies to customers looking for solutions to their design, development and manufacturing challenges.” From MedPlast’s vantage point, expanded global presence is the clear driver behind the acquisition.
UPG also highlighted the companies’ complementary technologies: “UPG brings a wide range of value-added capabilities to the table, including partial- and full-assembly, contract sterilization, lab services as well as global supply chain and logistics management,” said UPG vice president of sales and marketing Matt Langton.
MedPlast was conceived in founder Robert Piccoli’s mother’s garage in 1969. There, Piccoli launched a mold-making business called Dual Machine Tool, which by 1984 became Modern Plastics Techniques, a custom injection molding company. After many acquisitions and mergers, MedPlast Inc. was born in 2008. Piccoli is now vice president and general manager of MedPlast Berlin.
Arteriocyte Partners with Military for New Technology
Arteriocyte, a medical device company with offices in Cleveland, Ohio, and Hopkinton, Mass., has received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial for its Magellan MAR01 technology for the treatment of compartment syndrome. The technology already has received 510(k) clearance.
Compartment syndrome is the compression of nerves, blood vessels and muscle inside an enclosed muscle compartment in the body. This can lead to tissue death and amputation if the pressure is not released because the compression prevents blood from flowing through the affected area. The syndrome can occur after severe physical trauma or inflammation. Ateriocyte’s Magellan technology has been developed in partnership with the United States Army Institute of Surgical Research (ISR), San Antonio Military Medical Center at Fort Sam, Houston, Texas, and Ohio State University as part of Arteriocyte's Cellular Therapies for Battlefield Wounds Program.
The Magellan system produces autologous platelet rich plasma from a patient’s blood and bone marrow that can be applied to a surgical site as surgeons deem necessary. Arteriocyte has partnered with the U.S. military to develop the system for clinical use across three trauma platforms: extremity trauma, burn wounds and infection prevention. The company already actively is enrolling patients in a separate clinical trial for MAR01 treatment in critical limb ischemia (CLI) under an FDA approved Investigational Device Exemption. CLI is a severe blockage of blood with the patient experiencing extreme pain as well as possible ulcers or sores.
The U.S. military has a vested interest in the Magellan clinical trial.
“Compartment syndrome and the associated complications are a major challenge in combat casualty care, resulting in elevated rates of amputations,” said retired Army Col. John Kragh, M.D., an orthopedic surgeon and researcher at ISR, and Arteriocyte’s program officer. “This treatment represents an important potential tool to improve the success of limb salvage for these patients.”
Enrollment in the compartment syndrome clinical trial is expected to begin immediately following final approval by the Army’s Human Research Protections Office. The study will be performed at the Ohio State University Wexner Medical Center, led by Jason Calhoun, M.D., chair, Department of Orthopedics, and Frank J. Kloenne, chair of Orthopedic Surgery.
Arteriocyte produces stem cell related medical devices. The Magellan technology was built upon the foundation laid by Medtronic Inc.’s blood component therapies, according to company website.
Stem-Cell Startup Receives Funding
SynGen Inc., a medical device startup in Sacramento, Calif., that develops stem cell harvesting systems, has completed a $5 million stock financing round with Bay City Capital LLC (BCC).
San Francisco, Calif.-based BCC will appoint two representatives to SynGen’s board under the terms of the transaction.
The money is intended to fund the platform system SynGen-1000 and market it to cord blood banks, a facility that stores umbilical cord blood for future use. Cord blood contains stem cells that can be used to treat hematopoietic and genetic disorders.
Phil Coelho, SynGen’s president and CEO, said, “These banks value the substantially improved cell recovery and high purity of stem and progenitor cells that the product provides, in addition to its ease-of-use, reduced costs and improved data recording standards for automated cGMP (current good manufacturing process) cell processing. We expect to file for 510(k) clearance with the FDA (U.S. Food and Drug Administration) and to achieve CE marking for the SynGen-1000 in the near future.
Subsequently, our advanced designs target emerging markets including stem cell research centers, hospitals practicing cell therapy in surgical suites and stem cell clinical trials.”
The SynGen-1000 is a battery operated, single-use device designed to harvest white blood cells from normal or cord blood, bone marrow aspirate, stromal vascular fraction cells from adipose tissue, and reamer/irrigator/aspirator bone marrow cell solution.
Okay Industries Expands to Costa Rica
Responding to continued business growth and the need for increased capacity and additional capabilities, Okay Industries Inc. reports a 60-percent expansion in the United States, as well as its entry into the Latin American market. The move comes just in time to celebrate the firm’s 100th anniversary; the company started its journey as the B. Jahn Manufacturing Company.
Okay is developing a 63,000-square-foot medical engineering and manufacturing facility to consolidate and grow its medical components business in Berlin, Conn.
The new facility will complement Okay’s 100,000-square-foot headquarters in New Britain, Conn., company officials said.
“The medical market’s reliance on innovation and its unique need for repeatable quality make it a great match for the engineers and manufacturing professionals at Okay,” said President Jason Howey. “By adding a standalone medical facility to our capabilities, we’ll have the focus and resources to develop the applications that help our medical customers redefine how they treat patients.”
Okay specializes in stamping and machining metals, laser welding, automated assembly, design engineering and supply chain management.
In addition to new facility space at home, the expansion also includes a 14,000-square-foot facility in Alajuela, Costa Rica.
“Working closely with customers so that we understand both their manufacturing needs and their business needs is one of the keys to Okay’s superior output,” said Mario Chaves, a local manufacturing veteran who will serve as general manager of Okay Industries Costa Rica S.R.L. “Our Costa Rica operation will keep Okay engineering and expertise close to our customers who are growing there.”
The move to Costa Rica was a customer-driven decision, executives noted.
“We listen to our customers and we listen to our employees to help guide our decisions. That keeps us focused on market needs and the best ways to use our skills to meet those needs,” said Donna Lasher, Okay’s vice president. “As we continue to grow in the U.S. and into Costa Rica, we’re building an infrastructure for flexibility and performance that will lay the foundation for our next hundred years of success.”
Okay Industries engineers and manufactures components and subassemblies for OEMs in the medical, automotive, defense/firearms, and industrial markets.
GCMI Opens Medtech Product Development Center
The Global Center for Medical Innovation (GCMI) officially opened its doors on April 18. GCMI, a partnership between Georgia Institute for Technology (Georgia Tech), Saint Joseph’s Translational Research Institute, Piedmont Healthcare and the Georgia Research Alliance (GRA), was granted $2.6 million to build the Southeast’s first comprehensive medical device innovation center in mid-2010. Half of the funding came from the U.S. Economic Development Administration (EDA), and the rest was matched by the GRA. The EDA is a branch of the U.S. Department of Commerce.
According to GCMI’s website, the center is an independent, not-for-profit, full-service product development organization that will help new-product teams enhance their product development, shorten time to market, and achieve significant cost savings throughout the process.
“GCMI has built and equipped a prototyping design and development facility that will accelerate the commercialization of next-generation medical devices and technology,” said H. Wayne Hodges, GCMI’s executive director. “The center has the equipment, clean room facilities, engineering expertise and partner network needed to help bring ideas from concept to market.”
Acting assistant secretary of economic development at the EDA, Matt S. Erskine, flew in from Washington, D.C., to speak at the official opening.
“We believe GCMI will help Atlanta and the entire Southeast accelerate development of the next generation of medical devices,” he said. “We have had to rethink economic development. There is a new economic reality, and communities can’t thrive by returning to the status quo. We have to find new ways to create jobs, and that growth is coming from entrepreneurs. Supporting regional resources like GCMI offers the best return on investment by driving innovation and increasing exports.”
GCMI General Manager Doug Schumer, Ph.D., said the facility’s role as both a technology incubator and facilitator is perhaps its most exciting.
“The greatest thing GCMI will do is to help bring to life devices that otherwise might never see the light of day. There are many doctors out there with good ideas, but who don't know how to bring that idea to commercial fruition. GCMI will be able to help,” Schumer said.
Located in Atlanta, Ga., the GCMI center features engineering and computer aided design spaces, clean assembly and sterile packaging, a physical testing lab and a training area.