Bayer Debuts New Medical Materials

Applications can include catheters, tubing, connectors, and fabric coatings.

Two-Shot Process Improves Bonding

Generics Model Comes to Medical Devices

A surgical mesh should be approved soon, and seven more products are in development. Some of the MD&DI staff met with Kuntz at MD&M West to learn about GMD's business model. It sounds like it would simply consist of reverse engineering, but it's much more than that. First, the firm has to find products that could be sold as generics. They must be off patent, have reimbursement, still be the state of the art for their fields, and have no safety issues. Given the short product life cycles in the device industry, such products are difficult to find. Then, the firm sends its engineers into operating rooms to observe how the product is actually used. From there, engineering and human factors specialists design the product, with improvements if necessary -- the generic device is not necessarily an exact copy of its predicate branded device. Then it is sent for regulatory approval and priced. Manufacturing is done by contract manufacturers. Kuntz says the manufacturers of the predicate devices raise their prices each year despite the devices having been on the market for 20 years or longer in some cases. He estimates that the company's first three products will bring an immediate savings of $360 million to the healthcare system. It appears that GMD's model is in fact a mixture of the pharmaceutical generic model and the medical device 510(k) "me too product" model. But it has enormous potential, as evidenced by doctor reaction. Many of the surgeons who are approached about using GMD's devices are so impressed with the concept that they want to invest in the company.

Outsource with Open Minds, Business Models

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.

A Valentine's Day for Bonding

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.

Eastman Chemical Provokes Design Ideas

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.

How to Overcome Barriers to Innovative Product Development

(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 early on designs that won't succeed), reward good decisions as opposed to good outcomes, and look at ways for design and development processes to move in parallel, both internally and externally.

Canon, SPI Align Plastics Trade Shows

Canon will also be an official partner for the NPE Advisor, a digital newsletter delivered before and during SPI's NPE plastics exposition, held every three years. The arrangement could benefit medical device manufacturers whose products have plastic parts. "This agreement will enable SPI to focus more closely on NPE," said SPI President and CEO William Carteaux. He noted that the event has experienced tremendous growth recently and new digital products related to it are in the works. He said SPI chose Canon to run the regional show because of its success in hosting co-located regional shows. (For example, MD&M West is co-located with PLASTEC West, WestPack, Pacific Design & Manufacturing, Electronics West, and ATX West.) "This acquisition expands our position as a leading provider of trade shows, publications, and digital media for the plastics industry," said Charles G. McCurdy, Canon's president and CEO. "While Canon has had a working relationship with SPI for some time, it was often on a case-by-case, show-by-show basis. We will now have in place a cooperative alliance with the premier trade association representing the dynamic U.S. plastics industry."  

Name Change Reflects New Face of Contract Manufacturer

The full-service contract manufacturer, headquartered in Oak Brook, IL, says the name change reflects the companyâEUR(TM)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. UPGâEUR(TM)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 devices. The name change is concurrent with the official grand opening of the companyâEUR(TM)s third Mexican manufacturing location. The new 62,000-sq-ft facility in Tijuana includes a Class 100,000 cleanroom. The facilities are ISO 9001 and ISO 13485 certified and FDA registered.

China Becomes Hot Spot for Suppliers

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.