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Articles from 2008 In October

Teaching An Old Device New Tricks

But then these devices came under fire in the 1980s after medical waste washed ashore on several beaches. (Even as recently as two months ago, several hundred syringes washed ashore in Avalon, NJ.) But Kalorama's market research report indicates that the market for reusable medical devices should grow about 13% annually for the next few years. Industry can credit the orthopedic and general surgery segments for the boostâEUR"nearly 70% of the sales generated in 2007 came from these areas. The orthopedic sector continues to outpace others, and it is expected to have sole domination of market shares by 2012.

Are 510(k)s Overused?

Now, however, it is the most popular form FDA receives by a margin of thousands. However, author Reed Abelson seems to be forwarding a theory of mass conspiracy against patients, to fool them into using medical technology that does not work and could harm the most innocent of consumers. For example, the author uses radiation delivery through brachytherapy as an example of âEURoeexperimentalâEUR surgery that enables surgeons to get more money. But donâEUR(TM)t worry, according to Abelson, there is plenty of blame to go around. The new technology is used at the expense of âEURoethe gold standardâEUR of conventional radiation because reimbursement facilities reward hospitals for using the technology. He points out that conventional radiation has 30 years of use, while brachytherapy, which came out in the mid 1990s, logically does not have such venerable evidence. And while he does explain that brachytherapy enables patients to receive treatment in a much shorter time and recover faster (five days versus six weeks) with fewer complications, he doesnâEUR(TM)t make the logical leap that it ultimately saves hospitals money and is more convenient and represents less risk for patients than traditional radiation. So, according to Abelson, all players involved are to blame. FDA does not properly vet devices put forth by greedy medical device firms, who trick FDA into giving them market approval without having to prove efficacy. Medicare enables this system by rewarding greedy surgeons who embrace the new technologies. WonâEUR(TM)t someone please think of the patient?

Medtech Industry Proves Hardy—At Least in Minnesota

The state attracted $220.8 million in the third quarter, the first time it has done so since 1999, according to the article. Seven medical device firms, led by CVRx Inc. and Cardiac Concepts Inc., captured $130 million, or 59% of overall investment. What it proves is that as long as companies are developing innovative technologies that fill unmet needs, the funding will be there.

Boston Scientific's Carotid Artery Stent Approved

The product, which has already received a CE Mark from the European Union, will be sold in the United States immediately.

Boston Scientific's Corporate Warning Letter Completely Lifted

Tobin said the move will allow the firm to introduce stents to treat blockages in the carotid artery and kidney, as well as a balloon catheter for unclogging blood vessels. Its newest heart stent, Taxus Liberte, was approved Oct. 10 after some of the restrictions were lifted.

Earnings Up for St. Jude and Edwards, but Down for Boston Scientific

Edwards' profits were up 13% over the same period a year ago, thanks to strong sales numbers in heart valves, critical care products, and cardiac surgery systems. Meanwhile, Boston Scientific lost $62 million in the third quarter, though that is better than the $272 million loss it took for the same period a year ago. Most of the difference was due to fewer one-time charges. But its stent sales are down 11% from a year ago, as Abbott and Medtronic introduced new drug-eluting stents into the U.S. market in the interim.

FDA Issues Public Health Notice on Surgical Mesh

There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA has not yet determined whether particular types of patients are at increased risk for these types of complications. The agency recommends that surgeons be aware of these issues and be specially trained for each mesh placement technique. They should also watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. And they should tell patients that surgical mesh implants are permanent and can bring complications -- and provide them with a copy of product labeling, if possible. The agency has also posted consumer information documents on surgical mesh for hernias and pelvic organ prolapse/stress urinary incontinence. It has not issued a public health notice on hernia applications because it does not yet have specific recommendations for physicians regarding hernia repair.

Firm Tests Non-Invasive Stomach Stapler

Satiety is conducting a trial in hopes of getting FDA approval; the Times article chronicles one of the procedures during the trial. Early indications are that the Toga procedure offers "a drastic reduction in side effects and risk" compared to conventional bariatric procedures. First, a dilator is pushed down the throat to widen the esophagus. Then a two-foot-long tube containing the stapler is inserted. The patient's stomach is inflated with carbon dioxide to create more working space. Then the stapler is positioned and the tube is opened. A wire emerges from the stapler to push aside the folds of the stomach, then a vaccum pump draws in the front and back walls of the stomach into the device to be stapled together. The stapler only holds one row of staples, so for each additional row needed, the stapler is withdrawn, rinsed, reloaded, pushed back down the patient's throat, and repositioned.

Smith & Nephew to Open Biologics & Spine Unit

It selected Durham because it wanted access to the area's many universities and research organizations.

Microtool Maker Markets Tiny Tools to Big Industry


Microtool Maker Markets Tiny Tools to Big Industry
Bob Michaels
Midwest Industrial Tool Grinding supplies microtooling to medical device manufacturers.

At its founding in 1993, Midwest Industrial Tool Grinding Inc. (MITGI; Stewart, MN) was a one- or two-person custom manufacturer and regrinder of cutting tools. Today—13 years and a major capital expansion later—the company has become a round-the-clock operation that supplies microtooling, developing products, and customer specialty tools to medical device manufacturers in Minnesota, the United States, and beyond.

MITGI began primarily as an industrial tool grinding company, regrinding drill bits and end mills, which are similar to router bits. The company focused on the precision metals industry, supplying such customers as 3M, Hutchinson Technology, and other metal shops. Meanwhile, the firm branched into the medical device manufacturing area.

“We began making prototype tooling for customers through word of mouth,” remarks Jeff Streich, MITGI’s customer service representative. “Our quality impressed people, and we continued to get more work in this field and more referrals through word of mouth. In 2003, we began a concentrated effort to move more of our work into this area, as we were having success and doing well in the medical field. This sector has continued to grow and is doing very well for us.”

As part of its drive to expand into the medical device manufacturing industry, the company will exhibit at MD&M Minneapolis for the first time, highlighting its entire line of customer specialty products, including medical tooling. Specializing in microtooling, the company offers all types of micro end mills and micro drills, including extended-reach and special-geometry models. It manufactures end mills as small as 0.003 in. in diameter.

Providing tooling for arthroscopic surgery instruments, for modifying implants such as pacemakers, and for other medical devices, MITGI manufactures tools with tight tolerances and repeatability. Tool consistency, in turn, translates into reduced setup times for operators manufacturing parts. By visiting customer facilities and understanding customers’ manufacturing goals, the company helps design tools that can meet their needs. It maintains complete documentation, including in-house prints, for all the tools it ships, enabling the company to correct problems that may arise and address customer concerns.

The company’s pursuit of precision manufacturing has paid off. In 2005, founder Jim Schaufler more than doubled the size of his facility, adding three CNC robotic tooling machines to the two that were already in operation. He also widened his customer base and began to increase the firm’s workforce. For his efforts, Schaufler was honored with the Southwest/Central Minnesota Entrepreneur of the Year award in 2006.

“We’ve really gotten into the medical field,” notes Schaufler. “I don’t think there is anyone in the state doing what I am doing.”

Booth #856

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