Millstone Medical Outsourcing Expands Mechanical Inspection Cell

ATEK Medical Group Adds to its International Stable of Resources

A Q&A with company president Chris Oleksy.

MPO: ATEK Medical Group has announced an expansion.

Can you tell us more?

Oleksy: The ATEK Medical Group includes two organizations—ATEK Medical and ATEK Plastics. We are adding additional capabilities in both our Medical locations in Grand Rapids, Mich., and San Jose, Costa Rica. The additional space we have secured in these locations significantly increases square footage, allowing us to offer a variety of services. The proximity of these locations will create a campus atmosphere, better enabling us to leverage our talent, business processes and Medical Group capabilities.

MPO: What does this expansion mean to our readers in terms of added services?

Oleksy: ATEK Medical Group will now have significant space to enhance our current offering while adding new capabilities for our customers. New “Lean/3P (production, preparation, process) Solution Centers” is a collaborative working environment between ATEK and our customers. A collaborative customer/ATEK work environment ensures a solution that encompasses the needs and thoughts of both organizations for optimized results across the value chain. In addition, the expansion of the packaging center in Grand Rapids will leverage our capabilities, and, coupled with our plastics and assembly capabilities, ATEK can offer “one-stop” solutions for our customers. Other capabilities, driven by the needs of our customers, will be established as needed.

MPO: Is your expansion driven by existing business, newpartnerships, or both?

Oleksy: Both. Most of the products we manufacture are the market leaders in our customer’s spaces. Therefore, supporting our customer’s needs to either achieve or maintain market domination is imperative to their success and ours. ATEK’s successful relationships with its customers allows us to continually secure projects. In addition, that success has translated into being awarded other projects from new customers who want to form a lasting partnership with ATEK as well. The medical device industry is in a constant state of change. Continually offering our customers new and enhanced capabilities is an important part of our strategy so that we can better help them meet their goals.

MPO: Where/How else do you see ATEK expanding?

Oleksy: Our customers are asking us to support them intra-regionally and with expanded capabilities.Therefore, we will continue to explore locations around the world where we can take our business model and add new capabilities. ATEK meets with its customers regularly for strategic conversations in regards to locations and capabilities. The expansions currently taking place are a direct result of those discussions and partnerships. We are excited about our current expansions and see these as the beginning of other things to come. —Laura Sassano

ISO CERTIFICATIONS

• OrthoSensor Inc., a Sunrise, Fla.-based intelligent orthopedic device developer, has received ISO 13485:2003 certification. The company has partnered with Stryker Corp. on an “intelligent” disposable insert that provides evidence of proper soft tissuebalance during knee replacements.

• Five Star Manufacturing Inc. of New Bedford, Mass., an OEM contract manufacturer, has received ISO 13485:2003 certification. “As we grow our customer base in new areas of the medical device market, the attainment of ISO 13485 strengthens our relationships and provides new opportunities with customers requiring higher and more stringent standards,” read a news release issued by the company’s management.

• Fort Wayne Metals Research Products Corp., a manufacturer of high-quality precision wire, strands and cables, and component assemblies for medical devices and other applications, has achieved ISO 13485:2003 certification. “This certification gives our customers additional assurance of our quality system,” explained John Arnold, director of Quality for Fort Wayne Metals.

• Verisante Technology Inc., a Vancouver, Canada-based company, has received ISO 13485:2003 certification. “We have achieved a significant regulatory milestone on our pathway to the commercialization of Verisante Aura,” said President and CEO Thomas Braun. “ISO certification as a medical device manufacturer means our customers can be confident about the quality of our products and processes. It is a major hurdle in the requirements for obtaining regulatory approval of Verisante Aura in Canada,Europe and Australia.”

• BG Medicine Inc., a Waltham, Mass.-based company focused on the development and commercialization of novel, biomarker-based diagnostics, has received ISO 13485:2003 certification. “Receipt of ISO 13485 certification demonstrates BG Medicine’s commitment to stringent quality systems and practices in the development and manufacturing of our diagnostic products,” said Pieter Muntendam, M.D., president and CEO.

• Resinlab, a Germantown, Wis.-based subsidiary of Ellsworth Adhesives, has received ISO 9001:2008 certification.“Obtaining this certification shows our commitment to quality and continual improvement,” said Roland Chaloupka, quality manager of Ellsworth Adhesives.

• American Bioanalytical Inc., a supplier of high quality biochemicals and reagent products for life science research and manufacturing applications, has achieved ISO 13485:2003 certification. “The mission of American Bioanalytical is to offer the highest quality components, solutions and reagent products to our clients and ISO 13485:2003 and ISO 9001:2008 certifications help support that commitment,” said Wayne Gagnon, vice president of American Bioanalytical. “Achieving these certificates validates our commitment to quality and strengthens our ability to compete in this global marketplace.”

• Mass Design Incorporated, a Nashua, N.H.-based company that fabricates printed circuit boards for OEMs and produces fully-assembled printed circuit boards, has received ISO 13485:2003 certification. “Gaining this latest ISO certification is an affirmation of the quality we have been delivering to the medical device industry for over a decade,” said Paul Boduch, vice president and cofounder of the company.

• Sierra Circuits Inc., a Sunnyvale, Calif.-based company that specializes in HDI, fine line and flex technologies, has achieved ISO 13485:2003 certification. “Our ISO 13485 certification enables us to provide capabilities under the strict quality management procedures required for medical devices. In particular, product traceability through rigorous record keeping is a critical requirement in the medical device manufacturing community,” said Amit Bahl, marketing director at Sierra Circuits.

The Medtech World Descends on Deutschland

Medica and Compamed trade fairs draw hundreds of thousands of attendees from across the globe.

The world is shrinking—faster as years pass. Generations of inventors and their innovations have taken a bite out of the distance and time that separate the world’s inhabitants. Ocean sailing ships, jet aircraft and the Internet, for example, all have served to make our world increasingly smaller. But closing the distance and technology gaps, however, have increased opportunity in global markets.

The medical device industry continues to be an example of this trend—as is one of the industry’s largest trade events:

Medica 2011.

Officials at Messe Düsseldorf, organizers of the international medical product trade show and conference, say that current overall positive conditions in the medtech market have resulted in an uptick in exhibitor registrations for their upcoming annual event.

So far, more than 4,500 exhibitors have booked about 1.2 million square feet of space, an increase compared to last year (there were 4,400 exhibitors in 2010, organizers reported). Two-thirds of the exhibitors are from countries other than Germany and more than 60 countries will be represented, according to organizers. Of the total number exhibitors, more than 600 companies will exhibit at Compamed, which focuses on medical technology manufacturing services. Medica exhibitors showcase a complete range of medical products—everything from hospital beds and braces to the most complex implants and instrumentation. Both programs occupy all 19 halls of the Messe Düsseldorf fairgrounds. This combination reflects the entire process chain and the full range of medical products, devices and instruments, organizers said. Medica will be held Nov. 16-19 in Düsseldorf, Germany, while Compamed runs from Nov. 16-18.

Key exhibit categories at Medica 2011 will include electro-medicine/medical technology, laboratory technology/diagnostics, physiotherapy/orthopedic technology, medical products (devices and consumables) as well as information and communication technology, medical furniture and furnishings. There also will be a number of international pavilions, including one where U.S. device makers will be located.

A new event this year will be the Medica Wound Care Forum in Hall 6, organized in cooperation with the German Institute for Wound Healing. On each day of the trade fair, this forum will provide information about current trends and new approaches for chronic wound treatment. The Medical Tech Forum, which was launched last year, will continue in Hall 11. This event focuses on innovations in medical technology and initial experiences with them in medical use. The topics covered by the seminars at Medica 2011 will include new products and current trends in the areas of intensive care, disaster and emergency medicine, and computer-assisted surgery.

Medica also will host the 34th German Hospital Conference, the largest communication platform for German hospital managers. This conference will deal with various political, medical and economic issues in hospital care, ranging from new billing systems and the optimization of patient care to various organizational topics.

Compamed exhibitors are expected to book about 107,600 square feet of space in Halls 8a and 8b at the convention center. The show will cover the entire medical technology supply chain—from individual components to measuring techniques and quality testing to end products that are packaged sterile. Of the 137,200 visitors that attended Medica last year, 16,000 were focused on Compamed, which originally debuted in 1992. While most visitors attending Medica are users of medical technology, the majority of visitors attending Compamed are engineers, developers and buyers from the medical technology industry.

The full range of products and services presented at Compamed includes production (assembly, automation and production technology, process technology and packaging), materials, micro- and nanotechnology, inspection and testing systems as well as components (electronics, parts, pipes and hoses, filters, pumps and valves).

In addition to the topics presented by exhibitors, two educational forums will be available—one on micro-systems technology and the other on supplier technology. Leading experts from the medical supplies industry will give informative lectures on new developments in the fields of materials, production techniques and nanotechnology as well as process control and global sourcing.

Attending the Show

An app for the iPhone, iPad and iPod touch is available providing an interactive map of th­e trade fair center, allowing users to jump from one hall to another and zoom into each exhibitor’s booth or search the exhibitor and product database. The app is available free of charge from the Apple iTunes Store, with special versions optimized for the different screen sizes of the iPhone, iPod touch and the iPad.

This year, visitors again will be able to visit both Compamed and Medica with one entrance pass. E-tickets bought online can be printed out immediately after purchase and are less expensive than tickets purchased onsite, according to organizers.

Detailed information about pricing, attendance, travel and more is available at www.compamed.de, www.mdna.com and www.medica-tradefair.com. — MPO Staff Report