Companies should employ an open business model to maximize success with regard to outsourcing, according to Marco Befan, lead analysis for Nerac. He spoke today at the conference session "Collaborative Outsourcing: Building and Maintaining Provider Partnerships that Work" at MD&M West. An open business model is based on being more flexible with incorporating external ideas and technologies and making the company's own technologies available to other companies. If companies don't operate with an open business model, they run the risk of not utilizing all of their intellectual property assets. In addition, companies with a more closed model tend to resist external technologies that could complement their own products. Open business models, by contrast, allow companies to increase their revenues and reputation by licensing their technologies to other companies.
February 14th, 2007
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The generics concept has existed in pharmaceuticals for about 30 years. Given the spiraling costs of healthcare in the United States and around the world, it's surprising no one had thought to try it for medical devices until Richard P. Kuntz had a revelation while at a pharmacy a year and a half ago. In August, Generic Medical Devices (GMD), with Kuntz as CEO, opened its doors in Gig Harbor, WA. And last month, it received FDA approval for its first product, a circumcision clamp. A surgical mesh should be approved soon, and seven more products are in development. Some of the MD...
February 14th, 2007
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To improve cost efficiency of tubing used for catheters and other implants, Creganna Medical Devices has launched a new material that joins nitinol with stainless steel. The innovation has garnered quite a bit of attention at MD&M West, where it is being introduced. The company estimates that for a typical catheter, only 12% needs to be made of nitinol. However, the material is notoriously difficult to bond with dissimilar materials, such as stainless steel, and it is expensive. To make catheter building more cost effective, the company has created a patented material that can bond to both nitinol and stainless steel. What this material is is secret, but the company spokesperson did mention that it is a commonly used material that is safe for use in medical implants.
February 14th, 2007
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Eastman Chemical Co. (Kingsport, TN) has been working with medical product manufacturers to inspire designers and engineers through its Innovation Lab. The online tool serves as a way to reach out to designers and provoke ideas that manufacturers can use during the design process. According to Glenda Eilo, global industry leader of medical specialty plastics marketing at Eastman, the company is constantly looking for ways to improve patient care and help introduce designer input into the healthcare arena. If you're involved in the design process at your company, take a look at Eastman's online lab. Perhaps it'll help conjure up new ideas on what materials could work best with your product's potential applications.
February 14th, 2007
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At an MD&M West conference session yesterday, Bill Evans, president of Bridge Design, and David Maltz, product development professional for Nektar Therapeutics, addressed how to get by the roadblocks that can get in the way of innovative medical product design and development. The roadblocks, Evans said, come primarily in three categories: product definition, resources, and culture. (Of course, regulatory issues can also put up roadblocks, but device companies don't have much control over those.) Evans' top four tips are: Create a culture of innovation and reinforce it, spend more time on "what" and not so much on "when" (that is, let the process take its course, and don't shoehorn it around a marketing deadline), prototype early and often, and build a team of an appropriate size (if too large, nothing gets done; if too small, changes may have to be made later.) Maltz' top four tips: Share information widely across the team, adopt a "fast fail" attitude (that is, identify and kill...
February 14th, 2007
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Canon Communications LLC, publisher of MD...
February 14th, 2007
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United Plastics Group Inc. has changed its name to UPG. The company exhibited under the new name at MD&M West. The full-service contract manufacturer, headquartered in Oak Brook, IL, says the name change reflects the company’s broad services and global reach. The company has evolved from molding components to providing a full range of product development and manufacturing services. It has also opened manufacturing facilities in Mexico, China, and Europe. UPG’s services include application design, tooling engineering, processing, manufacturing, program management, and supply-chain management for projects that range from injection-molded plastic components to subassemblies and finished...

February 14th, 2007
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Apec (Baldwin Park, CA), which offers injection molding and assembly for the medical device industry, will open a new manufacturing facility in Guangdong, China. Although the new facility (Apec Asia) will support the company's existing customer base, the facility was also created to cater to the burgeoning Asian market. The 35,000-sq-ft facility is scheduled to open in mid-March and will offer a Class 100,000 cleanroom. However, Apec Asia employees are currently at company headquarters in Baldwin Park for training, according to sales manager Felix Rozuk. The new facility will mirror the company's U.S. manufacturing operations. Several other companies have set up shop in Guangdong, including GW Plastics and Loparex, which recently expanded its production portfolio. The region has seen an increase in activity because of its proximity to the shipping ports of Hong Kong and its large technical workforce.
February 13th, 2007
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When developing processes and designs for medical devices, risk is a key factor to keep in mind at all times, according to Tom Wrobel and John Blix of Boston Scientific. They spoke at the MD...
February 13th, 2007
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There are numerous details that OEMs must consider when seeking market clearance. One significant principle that is often forgotten is that FDA should be treated as a customer. This was the advice of Michael Barile of Barile & Associates in his talk, "Anticipating and Avoiding Regulatory and Compliance Hurdles," at the conference session, "Manufacturing for Innovation," at MD&M West. Barile stressed the importance of approaching premarket approvals or 510(k)s by anticipating the reviewers needs and identifying with their point of view.  He also reiterated the need to use checklists and cover sheets provided by FDA. The most important thing, he said, is to organize the information and make it as easy to understand. FDA rewards organization and it is critical to jumping hurdles to gain market access. "FDA may not be paying you for your product like a regular customer," he said. "But you need them to become part of the market."
February 13th, 2007
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