This month's headlines

The Hyatt Lodge, site of the 2008 IMDA Annual Conference

Joint Commission to participate on Conference panel. If there’s one voice IMDA members are eager to hear in the vendor-credentialing debate, it’s that of the Joint Commission. Now they’ll have their chance, at the upcoming Annual Conference and Manufacturers Forum in Oak Brook, Ill.

Customers for life. Capturing customers is good. Keeping them is better. Keeping them for a lifetime is best. Scott Fanning, founder and principal of 95% Share Marketing, believes there’s only one way to do it: Own ’em. And he’s going to show IMDA members how to do just that at the upcoming Annual Conference.

Supreme Court decision could affect IMDA members. A recent U.S. Supreme Court decision spells good news for manufacturers of innovative medical devices. But IMDA members should hold their applause,

Worldwide Innovations case study posted on Web. In its continuing efforts to spread the word about specialty sales and marketing to both manufacturers and prospective members, IMDA has posted its third case study on the Website.

Hospitals will test new technologies. Premier Inc. has launched a program which, it says, will accelerate hospitals’ access to medical technologies proven to be safe and effective.

                                                                                                                                                         

Annual Conference Joint Commission to participate on Conference panel

IMDA Announcement 2008 Annual Conference & Manufacturers Forum June 8-10, 2008 The Hyatt Lodge Oak Brook, Ill. (Just 12 miles from the Frank Lloyd Wright Home and Studio in Oak Park.) Book it!

If there’s one voice IMDA members are eager to hear in the vendor-credentialing debate, it’s that of the Joint Commission. Now they’ll have their chance, at the upcoming Annual Conference and Manufacturers Forum in Oak Brook, Ill.

Laura Smith, associate project director of the Joint Commission’s Division of Standards and Survey Methods – and the organization’s point person on vendor credentialing – will participate on a panel at the upcoming Conference. She will join Peter Sheehan, a founder of REPtrax, a vendor credentialing company; Michael Carey, director of purchasing for the University of Chicago Hospitals; and IMDA member Bob Byers, president and CEO of Tri-anim.

At the Joint Commission, Smith is responsible for the Accreditation Manual for Hospitals and the Accreditation Manual for Critical Access Hospitals, and she is the subject-matter liaison for the organization’s “Management of Human Resources” chapter. She has also been responsible for the standards research and development activities related to credentialing of health care industry representatives.

The Joint Commission has been considering proposed standards for vendor credentialing for quite some time. As it stands, the organization is deciding whether more research is needed before going forward with a field review. In the field review process, the Joint Commission conducts surveys on selected topics, then uses that input to establish policies. The organization conducts about 10 such reviews annually.

Smith will be on hand to answer IMDA members’ questions about where the Joint Commission stands in the process, and what aspects of vendor credentialing it is most interested in. Industry observers expect the Joint Commission to focus on the patient-safety aspects of credentialing, leaving the economic argument to others in the market.

Smith has been with the Joint Commission for 18 years and has held various positions, such as analysis specialist for hospital and behavioral health, organization liaison, and senior research associate. Prior to joining the organization, she served as a job placement counselor for Southwest Community Services in Tinley Park, Ill., a Chicago suburb. She developed a competitive employment skills course and taught the course to individuals with mental disorders. She also assisted these individuals with obtaining jobs in the community.

For more information on the Annual Conference, go to www.imda.org. 

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Capturing customers is good. Keeping them is better. Keeping them for a lifetime is best. Scott Fanning, founder and principal of 95% Share Marketing (www.95share.com), believes there’s only one way to do it: Own ’em. And he’s going to show IMDA members how to do just that at the upcoming Annual Conference in Oak Brook, Ill.

Fanning knows what he’s talking about. As vice president of sales for Midmark Corp., he took that company from less than 10 percent market share to more than 95 percent share in three core product lines. What’s more, he and his team were able to grow the market for those product lines three times, all the while maintaining more than 95 percent market share.

“Most companies just ‘have a relationship’ with their customers,” says Fanning. “After our session, you will know exactly what needs to be done to ‘own the relationship’ with your customers and to create relationships with them so deep that they, in turn, will show you extreme loyalty. They will look for ways to give you not just some of their business, but all their business. Best of all, they will become walking PR machines for you and your company to everyone they meet.”

IMDA members will find out that Fanning’s approach is as unorthodox as it is entertaining. “Our presentation will encompass how important it is to be creative, always making it fun for you and your customers, and finally making sure every time you touch the customer it’s done in a memorable way. When completed, not only will you be energized, but you will also know how to delight your customers, how to clearly differentiate yourself in the marketplace, and how to build the environment to get customers for lifetime, to buy all your products and services, and brag about you to all their friends.”

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By Barbara H. Kramer

A recent U.S. Supreme Court decision spells good news for manufacturers of innovative medical devices. But IMDA members should hold their applause, because in this case, what’s good for manufacturers could spell trouble for specialty sales and marketing organizations – unless they take some common-sense steps to protect themselves.

Charles Riegel underwent a coronary angioplasty in 1996. During the surgery, his surgeon overinflated a Medtronic Evergreen Balloon Catheter, which burst in Riegel’s artery and caused permanent injury. The Medtronic device is a Class III device that had premarket approval. Riegel sued Medtronic, alleging claims involving alleged negligent manufacturing and defects with the design, manufacture, and labeling of the device.

On February 20, 2008, the United States Supreme Court decided Riegel v. Medtronic, Inc. The Court held that once a medical device has premarket approval by the FDA, federal law bars many types of claims by users of medical devices that challenge the safety or effectiveness of the device, its design or its label. The claims brought by Mr. Riegel and his wife were thrown out on the basis that they were “preempted” by the FDA’s approval of the device.

In 1976, the federal government began premarket regulation of medical devices and enacted the Medical Device Amendments of 1976. These amendments charge the FDA with overseeing the safety and efficacy of medical devices. The amendments also included a “preemption clause” designed to make the federal regulations preempt or “trump” state regulations governing medical devices.

The Supreme Court’s recent decision leaves open the possibility of device users bringing limited types of claims against manufacturers based on violations of federal law, but it makes it very difficult to bring such claims. (In addition, the decision does not necessarily address claims that involve products that have only 510(k) approval but have not undergone the extensive premarket approval, or PMA, process.)

IMDA Announcement Stay in touch. . . with IMDA's listserv. Now it's easier than ever to electronically communicate with your fellow IMDA members. It's called a listserv, and it's up and running now. It replaces the electronic bulletin board. Simply write your message, address it to the IMDA listserv address (found in the "Members Only" section of www.imda.org) and click "send." All your colleagues will receive the message. Plug into the power of IMDA through IMDA's listserv.

Impact on IMDA members

While a decision limiting patients’ rights to bring lawsuits may seem good for the medical device business, IMDA members shouldn’t cheer too fast. Of course, device failures are generally bad for business, and make patients and doctors reluctant to try new technologies. But the inability of patients to sue manufacturers increases the vulnerability of sales representatives and distributors to being sued. In other words, manufacturers’ gains could be your loss. The Supreme Court’s decision, which gives manufacturers extraordinary protection against lawsuits, may leave sales representatives open to increased risk. If a patient is seriously injured due to medical device failure, patients may look to the agent or distributor as a potential defendant in a suit alleging misrepresentation or negligence.

How do you protect yourself? In addition to having a well-trained sales force, the most important thing is to ensure that you have strong contracts with the manufacturers your company represents. Those contracts must include broad, sturdy indemnification clauses. Many of the clauses we see in standard contracts provided by manufacturers are not broad enough to protect you in the event of litigation. Fortunately, reputable manufacturers are usually willing to negotiate these clauses to ensure that sales agents and distributors are protected in the event of litigation. Few distributors or sales agents carry product liability insurance, so it is imperative that you ensure that your manufacturers have your back, before you walk into surgery with their products.

Barbara Kramer is a partner in Kramer & Kramer, LLP, IMDA legal counsel. She may be reached at (734) 930-5452 or bkramer@kramerandkramer.com.

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In its continuing efforts to spread the word about specialty sales and marketing to both manufacturers and prospective members, IMDA has posted its third case study on www.imda.org. Following is the story of Worldwide Innovations and Technologies.

Interventional radiologists face a tough choice. They wear lead aprons and vests, and use table skirts, to protect themselves from radiation that “scatters” throughout the procedure room. But the fact is, irradiated patients themselves emit radiation. As a result, clinicians’ faces, hands, arms and legs can be exposed to radiation in harmful doses. In fact, by April or May, many interventional clinicians often have been exposed to the maximum annual allowable amount of radiation. Here’s their choice: They can either 1) quit working for the rest of the year or 2) remove the badge that tells the radiation safety officer how much radiation they have been exposed to. Most choose Option No. 2.

IMDA Announcement Looking for lines? View a list of all medical devices receiving FDA marketing clearance in April by visiting the FDA Website at:  http://www.fda.gov/cdrh/ 510k/sumapr08.html. You might find a company in need of your expertise.

William Orrison, M.D., an interventional neuroradiologist in Las Vegas, Nev., decided there had to be a better way to deal with radiation scatter. So he developed the RADPAD®, a disposable “blanket” or “shield” which, when draped over the patient, blocks the emission of radiation during procedures anywhere from 50 percent to 95 percent. With the RADPAD, hospitals could comply with ALARA, an industry term that stands for radiation levels “as low as reasonably achievable.” He received 510(k) marketing clearance from the U.S. Food and Drug Administration in 1998.

Then he began the tough task of building a market for his product. “Tough” because, after all, innovative technologies – no matter how beneficial – don’t sell themselves. He was joined by John Cadwalader, a Kansas City native who, after a 16-year career in the pharmaceutical industry, was ready for a new challenge. “We started selling RADPAD out of the house,” recalls Cadwalader, who today is the CEO of Worldwide Innovations and Technologies Inc. (www.radpad.com). Cadwalader, his wife (who is an integral part of the business) and a colleague began traveling to medical meetings to show the product. “Doctors liked it and started buying it,” he says.

But growth was slow. After all, there are only so many doctors that three people can personally visit with. The young company was ready to try something new. At that point, a contract manufacturer put Cadwalader in touch with a specialty distributor.

“The considerations weren’t that difficult,” recalls Cadwalader, recounting the thought process that led him to take on specialty distributors. “Yes, they would have to be paid for their work. But they could service the customers onsite much better than we could. We couldn’t go all over the country. They were in the hospitals a lot more than us. It just made sense.” Especially for a product such as the RADPAD which, while relatively simple, is not intuitive. “You can’t just sell it and walk away,” he says. Doctors must be trained on how to use it properly.

Since those first days selling products out of the house, Worldwide has developed more than 100 RADPAD products, not only to protect interventional radiologists, cardiologists and electrophysiologists from radiation exposure, but patients as well.

The company now has specialty distributors around the country, and in 2007, introduced the products into the European marketplace. “We couldn’t have gotten as far as we have without specialty distributors,” says Cadwalader. The company shares tradeshow booths and costs with its distributors. “We see it as a partnership,” he says. “As long as there’s a strong trust factor and everyone is committed to growing the business, we work well together and the business grows. Over time, the trust and commitment factors have been the key issues.”

The experience of Worldwide Innovations and Technologies Inc. demonstrates one of IMDA’s recurring messages to manufacturers: If you make commodity products, seek out a general-line distributor. But if you make an innovative technology that calls for an educated, technical, and even missionary sell, consult a specialty distributor. Consult IMDA.

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Premier Inc., the Charlotte, N.C.-based GPO, has launched a program which, it says, will accelerate hospitals’ access to medical technologies proven to be safe and effective. The program, called the QUEST Supplier Innovation Program^TM, will test the effectiveness of new healthcare technologies through Premier’s “QUEST: High Performing Hospitals” initiative. Measurement criteria include harm avoidance, efficiency and mortality reduction.

The QUEST Supplier Innovation Program is open to all suppliers, medical device manufacturers, pharmaceutical manufacturers and service providers, even those without Premier contracts. But manufacturers have only until May 30 to be considered for the initial phase of the program.

Interested suppliers are asked to submit specific details on their innovations, including product attributes, performance measurement criteria, previously completed research and data analysis, testimonials, and an overview of how they anticipate their concept would positively impact the QUEST performance measures. Chosen suppliers will have an opportunity to present their concepts during the 2008 Premier Annual Breakthroughs Conference and Exhibition, June 10-13 in Nashville, Tenn. After concepts have been selected, a subset of the QUEST charter member hospitals will test, validate and substantiate them.

QUEST is a three-year, collaborative program among more than 150 hospitals, which has established a set of measures and benchmarks for five dimensions of hospital performance:

• Risk-adjusted mortality ratio.
• Evidence-based care (percentage of patients receiving "perfect care,” using nationally recognized evidence-based quality measures).
• Efficiency (total inpatient cost per case mix adjusted discharge, including all of the costs associated with each episode of acute care).
• Patient experience (based on the patient satisfaction measures of the CMS Hospital Consumer Assessment of Healthcare Providers and Systems.
• Harm avoidance (that is, the prevention of such things as healthcare-associated infections and adverse drug events).

To participate, manufacturer must submit an application by May 30 on the following URL: http://www.premierinc.com/quality-safety/tools-services/quest/suppliers/form.jsp.

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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.