November 2006

This month’s headlines
Mark your calendar for the 2007 Annual Conference and Manufacturers Forum, to be held at the beautiful Coeur d'Alene Resort in Coeur d'Alene, Idaho, June 3-5.

New wrinkle to vendor access. If you provide health insurance to your employees and you sell products to Baptist Health South Florida, you’ll have a leg up on the competition.

Sudden Impact. The FDA lists 14 devices and products approved or cleared during the past fiscal year that it believes will have the most impact on patient care.

Rocky road. If you want to see the future of medical technology, check out your local university.

Measure your relationships with customers. Can hospitals and suppliers objectively evaluate their relationship and move it in a positive direction? Maybe, if they have the tool to do so.

VOIP in your future? Internet phone services are starting to target small businesses.

Return to top

 

New wrinkle to vendor access

If you provide health insurance to your employees and you sell products to Baptist Health South Florida, you’ll have a leg up on the competition. The Coral Gables, Fla.-based system has gone on record saying it will give preferential status to suppliers with employee health plans, according to a recent report in the Miami Herald. The decision is the first of its kind in South Florida and one of the few in the nation by a nongovernmental body, according to the newspaper. It also adds a wrinkle to the issue of vendor-access policies. (See October 2006 IMDA Update.)

“It’s not going to change the world,” Baptist Health CEO Brian Keeley was quoted as saying. “But it’s going to make a philosophical statement: Treat your employees well. We need to take care of the people of South Florida.” Baptist Health comprises five hospitals and has an estimated 10,000 vendors.

''The whole idea is to be socially responsible,'' spokeswoman Jo Baxter was quoted as saying. “All things being equal, the vendor providing insurance will be selected, but in selected instances, on a case-by-case basis, we might actually pay a higher price to a vendor if there wasn't a huge disparity, because [Keeley] wants to make a statement.''

Baptist Health undoubtedly has its own interests at heart as well. Although the system had a strong financial statement last year, reflecting a net surplus of $193 million, it had to write off $363 million in gross charges for charity care and uncompensated services that same year. In fact, 26.8 percent of the population in Miami-Dade County are without health coverage; in nearby Broward County, 16.6 lack insurance.

“You look at the growing number of uninsured, and there is no light at the end of the tunnel,” said Keeley.

Return to top

 

Sudden Impact:  FDA lists top devices of 2005

The U.S. Food and Drug Administration’s Office of Device Evaluation reviews and clears for marketing thousands of medical devices every year. In its Annual Report Fiscal Year 2005, the agency listed the 14 devices and products approved or cleared during the past fiscal year that it believes will have the most impact on patient care. They are:

IMDA announcement

Missed the 2006 Manufacturers Forum?

Go to the "Members Only" section of the IMDA website (www.imda.org) to check out which manufacturers were there, and how you can contact them.

While you’re at "Members Only," check out the "Membership Listing," an up-to-date listing of all IMDA members.

New technology for the destruction of uterine fibroids.
The ExAblate 2000 System by InSightec Ltc. uses magnetic-resonance-imaging-guided, focused ultrasound to target and destroy uterine fibroids. It is intended to treat women who have completed childbearing or who do not intend to become pregnant. The ExAblate combines two systems: 1) an MRI device to visualize patient anatomy, map the volume of fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating; and 2) a focused ultrasound beam that heats and destroys the fibroid tissue using high frequency, high-energy sound waves. The procedure can last as long as three hours. Insightec is based in Tirat Carmel, Israel, with U.S. offices in Dallas.

Sealant system for neurosurgical procedures.
The DuraSeal Dural Sealant System by Confluent Surgical Inc., Waltham, Mass., is the first material approved for sealing leaks in the dura mater during neurosurgical procedures. The sealant is composed of two solutions -- a polyethylene glycol ester solution and a trilysine amine solution. When mixed together, the solutions provide rapid polymerization to form a hydrogel that seals the dura mater. The sealant is intended to aid in preventing cerebrospinal fluid leakage through suture-approximated wound edges.

Artificial spinal disc
The CHARITÉ™ Artificial Disc by DePuy Spine Inc., Raynham, Mass., is the first non-fusion device intended to replace a diseased or damaged intervertebral disc to treat pain associated with degenerative disc disease. The disc consists of two metal (cobalt-chrome alloy) endplates, which are anchored to the top and bottom surfaces of the vertebrae, and a plastic (ultra-high molecular weight polyethylene) core, which fits between the two endplates. The plastic core and endplates help restore the natural distance between the two vertebrae. The endplates can slide over the domed parts of the core, which can allow movement at the level where it is implanted.

New lead wire for pacemakers
The SelectSecure™ Lead Model 3830 from Medtronic Inc., Minneapolis, Minn., is a surgically implanted wire that connects the heart to an implanted pacemaker. The lead wire, in conjunction with the pacemaker, treats irregular or slow heart rhythm (bradycardia), and it allows the pacemaker to monitor and pace the heart. It slowly releases a steroid (Beclomethasone Dipropionate) into the body to improve healing of the lead attachment site after implantation. The lead wire is used when implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated.

Endovascular graft for treatment of aneurysms
The GORE TAG Thoracic Endoprosthesis (a prosthetic endovascular graft) by W.L. Gore & Associates, Newark, Del., is the first endovascular grafting system used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The endoprosthesis is made of ePTFE (expanded polytetrafluoroethylene) with a metallic support structure known as a stent. The graft is placed inside the weakened artery to prevent further growth and rupture of the aneurysm.

Stent for prevention of future strokes
The Xact® Carotid Stent System by Abbott Vascular Devices, Abbott Park, Ill., is an alternative to carotid endarterectomy, and is intended to open blockages in the carotid blood vessel in order to prevent future strokes. It is used in high-risk carotid disease patients with either symptomatic carotid vascular disease and greater-than-50-percent carotid blockage, or in patients with a very tight blockage (over 80 percent) in the carotid artery. The stent system has two components: the stent and delivery catheter system; and an embolic protection device, which is intended to capture debris that may be dislodged during placement of the stent.

New prosthetic jaw joint
The Total Temporomandibular Joint Replacement System by Walter Lorenz Surgical Inc., Jacksonville, Fla., is a prosthetic jaw joint. It is designed for use by patients who need a total jaw replacement due to one or more of the following conditions: severe arthritic conditions, fused joints, previous multiple surgeries, severe fractures, tumors and severely degenerated joints. The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head in front of the ear. A surgeon implants the joint after removing any old devices, unsuccessful grafts, and badly damaged bone. It may reduce jaw pain, reduce interference with eating and increase the ability to open the mouth.

Catheter to treat cerebral ischemia
The NeuroFlo™ Catheter by CoAxia Inc., Maple Grove, Minn., is used to treat cerebral ischemia, a condition that occurs when the brain does not receive enough blood flow to maintain normal neurologic function, such as speech, movement and understanding. The catheter is a long, flexible tube with two small balloons on one end, which are used to partially block blood flow in large blood vessels. It is used for the treatment of cerebral ischemia resulting from symptomatic vasospasm in patients who have not responded to other forms of treatment. Symptomatic vasospasm is the squeezing down of a blood vessel in the brain, which results in symptoms similar to stroke, such as difficulty in speaking, movement, or understanding.

Monitoring leaks of vascular graft
FDA approved, through the de novo process, is the CardioMEMS (Atlanta, Ga.) device intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm repair. The device is intended to be used as an adjunctive tool in the detection of intraoperative endoleaks. It is designed to be implanted in the abdominal aortic aneurysm sac during the deployment of a stent-graft. It senses the pressure in the sac, so that information regarding possible endoleaks or rupture can be collected.

Surgical laser for use in assisted-reproductive procedures
FDA approved, through the de novo process, is the Infrared Laser Optical System (ZILOS-th®) from Hamilton Thorne Biosciences Inc., Beverly, Mass. The device is used to drill a small tangential hole in the zona pellucida of embryos to facilitate embryo hatching prior to implantation, and has been shown to increase implantation rates in older women (over 37 years), and patients using frozen embryos.

Laser scanning technology for confocal microscopy of the cornea
The Heidelberg Engineering HRT II laser scanning technology combined with the Rostock Cornea Module is the first FDA-cleared ophthalmic confocal laser scanning microscope for directly imaging a patient's cornea and anterior segment. It can be used to obtain high-resolution images and 3-D reconstructions of thick specimens at various depths. Images are taken point-by-point and reconstructed with a computer, rather than projected through an eyepiece. The microscope allows for imaging at different depths inside the cornea, as well as the front of the eye, with high resolution.

Patient -administered analgesia control
The Patient Therapy Manager accessory to the SynchroMed Implantable Infusion System by Medtronic Inc. is the first device for patient-administered analgesia control for an implantable infusion pump. It allows a patient to self-administer a bolus of pain medication based upon parameters programmed by a physician.

Technology for maintaining patient data
The VeriChip™ Health Information Microtransponder System from VeriChip Corp., Delray Beach, Fla., allows a caregiver to retrieve a unique patient identifier and patient medical information from a prescription website when the patient is otherwise unable to provide this information. The medical information on the website is supplied by the patient and can only be accessed with appropriate authorization. The system consists of an implantable chip, an introducer, and a reader.

Oral rinse for gingivitis.
FDA approved, through the de novo process, Decapinol from Sinclair Pharmaceuticals plc (Godalming, Surrey, UK, with U.S. offices in Carrollton, Texas) is a prescription oral rinse used to reduce the adhesion of dental plaque. It was cleared by the agency as a medical device for the treatment of gingivitis because of its mechanism of action. Decapinol works by preventing attachments of bacteria to tooth surfaces rather than being bactericidal. Gingivitis, the earliest stage of gum disease, is an inflammation of the gums caused by a build up of bacteria that grow in the coating (plaque) that forms on teeth between brushings. It is intended to be used twice daily for one minute after brushing and flossing.

Return to top

 

Rocky road to tomorrow's ideas

New devices take an often tortuous path from university lab to patient's bedside

If you want to see the future of medical technology, check out your local university. In fact, universities are filing patents (though not, of course, all medical-product-related) at a furious pace. According to the Association of University Technology Managers, Northbrook, Ill., between fiscal year 1991 and 2004, annual invention disclosures increased more than 290 percent, new patents filed increased nearly 450 percent, and new licenses and options executed increased 510 percent.

Despite all the activity, however, some of those great ideas never make it to market. That’s because universities have to rely on private companies to license, manufacture and market their innovations. And sometimes, universities and private companies don’t see eye to eye.

Often, academics and marketing professionals disagree on the value of the innovation, says William R. Brody, president of Johns Hopkins University, in a recent interview in the New York Times. “If universities have a patent, they think it’s worth a lot,” he says. “But companies feel a patent isn’t worth a lot because they’re going to have to invest a ton of money to bring it to market. So the question is, what is the actual value?”

Universities and private companies sometimes have divergent goals for innovative technology. “On one hand, universities would prefer, in keeping with the intent of the federal government, not to license something to one company exclusively,” says Brody. “Our intention is to make technology as broadly available as possible. Companies, on the other hand, want exclusive licenses. That’s one bone of contention.”

Rich tradition

Universities have a rich tradition of medical device innovation. Johns Hopkins, for example, was responsible for developing technology for magnetic resonance imaging inside blood vessels, as well as an inflatable vest for cardiopulmonary resuscitation, says Brody. But for some, innovation is a losing proposition.

In the year 2000, universities had about 21,000 active licenses with industry, but only 125 generated more than $1 million in licensing and royalty income, says Brody. “Unless you have a big hit like Gatorade, which came out of the University of Florida, or a drug that the University of Wisconsin had many years ago to prevent blood from clotting, or the recombinant DNA patent that the University of California at San Francisco and Stanford share, the aggregate income doesn’t cover the expenses.”

One organization that attempts to promote the commercialization of university research is the Association of University Technology Managers. Founded in 1974, the organization comprises more than 350 universities, research institutions, teaching hospitals and government agencies, as well as companies involved in managing and licensing innovations derived from academic and nonprofit research.

Despite the challenges universities face in turning their ideas into reality, the news isn’t all bad. In fiscal year 2002, AUTM members reported 569 new product introductions. Nearly 23 percent of their 26,086 active license agreements were associated with product sales by their licensees.

“[R]esearch is about planting seeds and watering them and occasionally pulling the weeds out,” says Brody. It would appear that commercializing that research calls for some weeding of its own.

Return to top

 

Measure your relationships with customers

By Laura Thill

Can hospitals and suppliers objectively evaluate their relationship and move it in a positive direction? Maybe, if they have the tool to do so. Strategic Marketplace Initiative (SMI), a Scituate, Mass.-based forum for medical products vendors and providers’ contracting executives, believes it has developed such a tool.

Introduced at the annual conference of the Association for Healthcare Resource & Materials Management, the electronic “Tool for Measuring Effective Relationships” provides food for thought for both buyers and sellers. The software was the product of a yearlong process in which a team of suppliers and providers identified methods for measuring and monitoring the effectiveness of business relationships. The team focused on six aspects of such relationships:

  • Financial.

  • Relationship.

  • Quality.

  • Safety.

  • Service.

  • Technology.

“We were trying to create a process whereby business partners could communicate about – and monitor – their relationship,” says SMI project manager Dennis Orthman. “This is a collaborative tool that enables both the supplier and provider to come together and evaluate their relationship.”

To work most effectively, the software tool calls for hospital and provider business partners to review each of the six elements (and the subsets within them) and determine which are the most important to the relationship. “This in itself promotes communication, as one party may [value] something that the other party is unaware of,” says Orthman.

Once both parties agree on the importance of the different elements of their relationship, they can rate their collective performance on a scale of 1 to 5. “In this way, the tool attempts to quantify a subjective process,” explains Orthman. “Sharing information is critical to developing long-term relationships between business partners. This tool takes a business relationship beyond the traditional transaction, where [one party] orders a product and the other party ships it.”

The software is free and can be downloaded from the SMI website.

Return to top

 

VOIP in your future?

Internet phone services are starting to target small businesses. After catering primarily to large companies or consumers, vendors of voice over Internet protocol, or VOIP, are creating packages of services for entrepreneurs, according to a recent article in The Wall Street Journal.

Last year, small- and medium-size companies spent $2.1 billion on Internet phone systems, equipment and services, compared with $4 billion for large businesses, according to the report. By 2010, however, small-business spending should climb to $8.9 billion, according to Terry White, analyst for market-research firm InfoTech, Parsippany, N.J.

Small firms don’t get a lot of features, usually just basics, such as voice mail, according to the article. Providers cut costs by routing calls over their private data networks instead of traditional copper phone lines.

Providers of basic VOIP services for small businesses include XO Communications, a unit of XO Holdings Inc., Reston, Va.; Cbeyond Inc. of Atlanta; and M5 Networks Inc., of New York. As interest grows, larger companies such as AT&T, Verizon Communications Inc. and Qwest Communications International are also targeting more small businesses. Vonage, the nation’s largest provider of VOIP to consumers, has reportedly been vocal about its desire to expand into the business market. The company offers two plans. The first, priced at $40 a month, includes 1,500 minutes of call time; the second, at $50 a month, offers unlimited minutes and the ability to contact more countries overseas.

Next year, cable companies are expected to get into the small-business market, just as they have with the consumer market.

“[Small business] really is the remaining battleground for all of these service providers,” John Macario, president of the Boston-based consulting company Savatar Inc., is quoted as saying. "We're watching closely to see if these emerging companies can keep the momentum up and become established players, if the phone companies can step up their game, or if cable companies can get in through the side doors."

Return to top

 

 

IMDA Update

Published by IMDA
5204 Fairmount Ave., Downers Grove, IL 60515
Phone:  (630) 655-9280
(866) IMDA-YES (866-463-2937)
Fax: (630) 493-0798
Website: 
www.imda.org
E-mail: 
imda@imda.org
 

Staff

Katie Swartz: Executive Director
Judy Keel: Executive Vice President
Patti Perillo:  Database & Finance Admin.
Mary Moran:  Chief Financial Officer

Mark Thill, Editor (847) 255-0716
Laura Thill, Associate Editor (847) 255-4854

Mitchell Kramer, Legal Counsel (800) 451-7466

 

2007-2008 Directors

President
Shawn Walker, Bay State Anesthesia (978) 682-6321

President-Elect
Kevin Trout, Grandview Medical Resources (412) 914-0950

Secretary/Treasurer
Leo Mindick, Med-Tech Consultant Partners, LLC
(516) 708-1111

Chairman of the Board
Dave Campbell, Vital/Med Systems (303) 660-0888

Directors-at-Large
Hal Freehling, O.E. Meyer (419) 609-1633
Tom Birmingham, Bay State Anesthesia (978) 682-6321
Tony Marmo, Martab Medical (201) 512-1100

Past-President
Ed Boracchia, Boracchia + Associates (707) 765-3100

Manufacturer Representative to Board
Rick Pfahl, Bovie Aaron Medical (727) 384-2323

The ideas presented in this newsletter may or may not be applicable to your particular situation.  Always consult your tax advisor, attorney or CPA before putting them into effect.