New allied member Intersurgical Inc. is looking forward to strengthening its relationships with IMDA members and engaging in mutually beneficial networking. The company also looks forward to sharing its unique perspective and experience in the marketplace with the members of IMDA.

Based in the United Kingdom, Intersurgical -- a manufacturer of anesthesia and respiratory care products -- was formed in 1982 and entered the U.S. market in 1991, explains Mary Sweeney, North American marketing manager. "We have established an outstanding reputation for manufacturing only the highest quality disposable products and offering excellent customer service to all our business partners in the United States, Canada and Mexico," she says. "Our products are engineered with the user in mind - easy to use, technologically advanced, innovative and of the highest quality."

With production sites in Liverpool, N.Y., Guernsey Channel Islands and Lithuania, the company's products are manufactured to the highest industry standards, she says. "ISO 13485 is just as much a part of our daily production as the strictest adherence to the FDA Quality System Regulation. [Our production sites] are experts in extruding, injection molding and blow molding the most difficult disposable medical products."

Specialty distribution

Specialty distributors have access to Intersurgical's full range of products, says Sweeney. "We do have exclusive agreements with some specialty distribution channels." In fact, it was through its specialty dealers that Intersurgical learned of IMDA.

Why specialty distribution? "Our product line is most successfully promoted by sales professionals who can effectively communicate the unique features and clinical benefits of a particular product or products," says Sweeney. "Specialty distribution sales forces tend to possess the necessary skill sets and clinical knowledge."

If Intersurgical has faced challenges in working with specialty sales and marketing companies, it is the difficulty of putting together a network that will allow for complete national coverage, says Sweeney. "We have also found that the limited number of specialty distributors leads to an environment where there is intense competition among manufacturers for the time and attention of dealer sales representatives."

IMDA members interested in learning more about Intersurgical can visit the company's Website at www.intersurgical.com, or by contacting Mary Sweeney at (315) 451-2900 x203 or (800) 828-9633 or by e-mail.

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KEYSTONE, COLO -- Drawing up five- and 10-year business plans used to be standard operating procedure among American business owners. But given the rapid pace of change these days (technological, economic and otherwise), few owners are willing to hazard a guess further out than 24 months. Nor should they, said Gerry Layo, Sales Coach International, Granite Bay, Calif., speaking at the recent IMDA Annual Conference and Manufacturers Forum. "But you do need a plan," he said.

A good place to start is asking yourself and your team a simple question: "What would we dare to define and design if we knew we could not fail?" Layo said. Here are some of his tips on coming up with a 24-month plan you can rally around.

Begin with the end in mind. Envision what your company will look like in two years. What will your sales figures be? Revenues? Profits? How will you make decisions? How will you create what Layo calls a PPOD -- or positive perception of differentiation -- in the market?

What will your pre-call preparation look like in 24 months? Will you -- as Layo urged IMDA members to do -- push your sales reps to continually asking themselves, "What is the purpose of this call?" before each and every call they make?

What will your brand be in 24 months? What will make you stand out from your competitors? Try to synopsize it in one sentence.

How do you intend to make that brand visible? Will you be strategic about the trade shows you attend, and how you approach each show? How will you get people into your booth? What will you tell people you do? What is your "known-for-ness?" Imagine meeting someone who is about to meet with 100 of your potential customers. What do you want him or her to say to them about your company?

What will define and differentiate you? Consider this: If you want to get more from your market, give more to your market. Join trade associations and get involved in your customers' activities.

How will you add value for your customers? If the only thing you bring to your customers are products, chances are your conversations will revolve around product features and price. How about training? Financing? Service? Find out your customers' mandates, and help them achieve them, suggested Layo.

Imagine what referral streams will look like 24 months from now. Based on that, figure out whom you should be meeting in the hospital today. By building a good reputation, one that establishes the trustworthiness of your company, you will diminish the urgency of two questions on the part of your customers: "Will this product work?" and "Am I paying too much for it?"

In 24 months, will yours be a company that gets -- and acts on -- referrals? Don't be afraid to ask a satisfied customer for a referral…or two, said Layo. And when you get one, follow up immediately. Don't forget to thank the customer who gave you the referral.

Ask yourself the tough question: Will my current team be the ones to drive me to success 24 months from now, or do I need to replace some people today? "It's easy to keep some people rather than [fire] them," he said. "But I'm not talking about what's easy."

Ask yourself, "Am I willing to do what's necessary to be the company I envision 24 months from now, or is good enough good enough?" And keep in mind that you might need to change yourself as much as anyone else on your team. Are you willing to make those changes in order to be successful two years from now?

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KEYSTONE, COLO -- Thinking about expanding into a new product area, new specialty or even new market (e.g., physicians offices)? Who isn't? Most IMDA members are always thinking about change. And that's a good thing, said Rick Davies, Vector Resources, Midvale, Utah, and a speaker -- along with son and partner Chris Davies -- at the recent IMDA Annual Conference. "Nature has a name for when things cease to change," he said. "It's called death."

But change for the sake of change might not be the best way to go, said Davies, who is the former vice president of planning and business development for Kendall Healthcare (now Covidien). Rather, a move into new markets should meet three criteria, he suggested: It should be contiguous, strategic and accessible.

Contiguous

The word "contiguous" means "attached to something, sharing a common border or boundary," said Davies. "At Kendall, if we lacked presence in a market, a technology link, or a sales force that was part of the call pattern, it was not an area allowable for expansion. Moving from where we were to where we wanted to be had to be by connected steps."

The title of Davies' presentation, "One Degree of Separation," underscored the point. "Six degrees of separation" is the theory that none of us are more than six people away from anyone else on Earth.

IMDA Announcement Looking for lines? View a list of all medical devices receiving FDA marketing clearance in April by visiting the FDA Website. You might find a company in need of your expertise.

Strategic

A strategic relationship goes beyond the obvious financial considerations, said Davies. For example, a new product might not reap huge profits, but it might get the distributor's foot in the door of a new department. That said, any new product must meet what Davies called the "medical device triad." It must be needed, wanted and cost-effective. Today, to be needed means it must yield improved clinical outcomes. For clinicians to want a product, it must be easy to use, and it doesn't hurt if it also makes the clinician look good. And it goes without saying that the product's cost to the provider must be reasonable.

"How many products have you come across that the market doesn't need or want, or that cost too much?" he asked. "Yet manufacturers put all their horses behind it, trying to convince everyone that they do need it and want it." Those are horses to stay away from, he said.

Accessible

"How accessible is the opportunity you're contemplating?" Davies asked conference attendees. Is it close to what you're already doing? If the technology you're thinking about targets a specialty that you don't currently call on, but which is in the hospitals you already serve, it might be a good opportunity. But if the technology is used in non-acute-care settings, you might want to stay away from it, unless you're prepared to service those facilities on a regular basis.

Some final thoughts:

• First, the ER is the gateway to the hospital, according to Davies. Most products that IMDA members sell can be used there. "If you have an excuse to walk into the ER with a product, then you can walk anywhere in the hospital with it."
   

• Second, leverage your contacts. All of them. Your kids might be on the same soccer team as the son or daughter of an influential physician or department head. An IMDA colleague might be carrying products in a non-competing territory that would round out your portfolio too. And your sales reps might have valuable contacts or expertise gained on their last job. Tap into it.

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Newly posted changes to the IMDA Website (www.imda.org) reflect news from the recent Annual Conference in Keystone, Colo., as well as some of the wishes expressed by IMDA members at various breakout sessions during the Conference. Highlights include:

• An updated "List of companies taken to market." The old list was compiled more than 10 years ago. The new one isn't intended to list every company taken to market by IMDA members since the association's founding in 1978, but it does reflect the impact specialty sales and marketing organizations have had on the market through the years. The list was compiled with input from the entire IMDA membership, and is designed to demonstrate to manufacturers visiting the web the effectiveness of specialty sales and marketing. To view it, go to http://www.imda.org/manufacturers/companies_taken_to_market.htm.
   

• A new section for providers, which can be accessed from the home page. The section not only lists IMDA members as well as the companies taken to market, but two short pieces discussing the important role of technology in healthcare, and the role of specialty distributors and reps in bringing that technology to providers.
   

• A comprehensive review of the 2010 Conference (http://www.imda.org/documents/2010ConferenceSummary.pdf). This review is open to the public and is intended to demonstrate the value that potential members and manufacturers can derive from IMDA's conference.

More changes are coming. For example, work is being done to update the ROI calculator, designed to help manufacturers of innovative technologies compare the cost of selling direct vs. outsourcing sales and marketing to IMDA members.

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The Food and Drug Administration reports it is on track to release a report in several weeks on suggested changes to the 510(k) marketing clearance program. After the report has been released, the agency's Center for Devices and Radiological Health -- which oversees the program -- will solicit public comment on it. Meanwhile, the industry was buzzing about what changes might be in store.

"There's a lot of rumor mill about what we're going to do, but we've not said we're doing A, B, C or D, specifically," CDRH Director Jeffrey Shuren, MD, told Massachusetts Medical Devices Journal, following a second "town hall" meeting on the subject in Woburn, Mass., in June.

Bad press brings on storm

The 510(k) process came under attack most recently in March 2009, when the Wall Street Journal published a damaging article titled "Political Lobbying Drove FDA Process." The article explained in detail how ReGen Biologics obtained 510(k) marketing clearance for its meniscus-repair product. Clearance came only after years of a bitter struggle with the FDA, as well as charges that Congressional representatives and others had bullied the FDA into granting 510(k) clearance.

The 510(k) process calls for the manufacturer of a new device to demonstrate that the device is substantially equivalent to one already on the market. Critics have charged for some time that the FDA is too lax in allowing manufacturers of Class III devices -- those deemed highest-risk -- access to the market through the 510(k) process. The ReGen Biologics debacle may well have been the straw that broke the camel's back.

Following ReGen Biologics, the FDA commissioned the Institute of Medicine to study the 510(k) process. The agency also announced that its own Center for Devices and Radiological Health would convene an internal working group to "evaluate and improve the consistency of FDA decision-making in the 510(k) process."

In his most recent comments, Shuren said it was premature to speculate on what the FDA would propose. "The real test of the program is whether or not, when we're making a decision for a device to go on the market, there are truly reasonable assurances of safety and effectiveness," he said. He did offer one clue, saying that manufacturers applying for 510(k) clearance would probably be required to submit more clinical data than in the past.

Watch IMDA Update for developments.

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Premier Inc., the Charlotte, N.C.-based group purchasing organization, recognized 23 medical technologies in its second annual "Innovation Celebration," held in conjunction with the GPO's recent annual Breakthroughs Conference and Exhibition in June.

Though preference was given to Premier's contracted suppliers, non-contracted suppliers were free to apply to exhibit at the event. If selected, non-contracted suppliers were expected to begin discussions with Premier about adding the technology to Premier's contract portfolio. The number of technologies was limited to 30. No application or registration fee was required.

The technologies recognized in the Innovation Celebration were selected by a committee of Premier members. To be considered, technologies had to meet these criteria:

• Recently launched or soon-to-be launched.

• Unique.

• Has an impact on an unmet medical need.

• Is marketable.

IMDA Announcement Spread the word about your association At the next clinical meeting you attend, let other specialty distributors and reps know about your association. IMDA has prepared a simple, one-page flyer describing five benefits of joining the association. Before your next clinical meeting, print out a few, then hand them out to prospective members. Go to "Let Others Know about IMDA" in the "Members Only" section of imda.org. Remember: IMDA's strength lies in numbers. Help us keep them up, and keep us strong.

The technologies selected for 2010 (with descriptions provided by manufacturers) were:

• Double Black Imaging DBI2110MP-PP, a 10-megapixel high bright monochrome LCD designed for mammography.

• Trinova Medical Waste Solutions infectious waste system, which shreds waste, reducing it by 80 percent, then treats remaining waste with chlorine dioxide for landfill.

• ReavillMED catheter (ReavillMED LLC), a completely enclosed method of central line insertion that starts as a peripheral IV and can be quickly transformed into a larger catheter for volume resuscitation and/or a central line.

• Rainbow Flex Procedure System (NeoForce Group), a two-piece warmer and surgical platform for premature babies or newborns who must undergo clinical procedures.

• Griggs™ Percutaneous Dilation Blue Line® Ultra® tracheostomy kit (Smiths Medical), designed to allow surgeons to achieve bedside placement of a tracheostomy tube without the risk of damaging tracheal structures via anterior to posterior compression.

• Sorbaview Shield (Centurion Medical Products Corp.), hybrid dressing employing a shield designed to yield a seven-day catheter dressing with built-in securement.

• HemCon antimicrobial IV dressing (HemCon Medical Technologies Inc.), indicated for the control of surface bleeding from vascular access sites and percutaneous catheters.

• AirStrip OB (AirStrip Technologies), mobile software solution for remote patient monitoring, transmitting medical information from hospital monitors to physicians' smart phones.

• KimVent multi-access port closed suction catheter (Kimberly-Clark), designed to maintain the closed circuit while allowing the care provider to perform diagnostic procedures or change the closed suction catheter.

• Symbiq-EndoTool integration software (Hospira), designed to allow hospitals to move to software-based protocols integrated with the infusion pump delivering IV medications, e.g., insulin.

• Carestream DRX-1 system (Carestream Health Inc.), a wireless, cassette-sized, battery-powered, flat-panel digital radiography (DR) detector.

• UltraSonic cardiac output monitor (Spacelabs Healthcare), Doppler ultrasound device designed for non-invasive assessment and management of circulation.

• LodgeNetRX interactive patient television system (LodgeNet Healthcare), said to transform patient room TV into a two-way communication device.

• Power Pole (NK Medical Products), an infusion stand designed to elevate four 10-pound bags with one hand, without cords, plugs or batteries.

• AccuCirc (Clinical Innovations), single-action circumcision device.

• CORTRAK® enteral access system (CORPAK MedSystems), said to use computer technology to guide clinicians in placement of feeding tubes.

• Navigator BioNavigator system (CORPAK MedSystems), an external, handheld, battery-powered electronic PICC-tip-locating device for adults and neonates.

• Opticath ScVO2 advanced sensor probe and catheter (ICU Medical), indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system.

• QED-100 anesthesia recovery device (Sagent), designed to actively remove residual inhaled anesthetics at the end of surgery.

• Hand hygiene compliance solution (Dynamic Computer Corp.), a system of badges, ceiling sensors and soap/sanitizer dispensers retrofitted with sensors.

• Alaris glycemic control (CareFusion), a glycemic control feature for the Alaris System that uses GlucoTec's algorithm.

• iCOMPEL (Black Box Network Services), a digital signage solution, allowing users to create, distribute and manage digital signage.

• Thopaz (Medela Healthcare), said to promote mobility for chest drainage patients through an integrated suction pump.

IMDA members can alert their manufacturers to apply for Premier's 2011 Innovation Celebration by sending an e-mail to innovationcelebration@premierinc.com.

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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:  Senior Administrator Mary Moran:  Chief Financial Officer Mark Thill, Editor & Communications Director (224) 735-3297 Mitchell Kramer, Legal Counsel (800) 451-7466 Barbara Kramer, Legal Counsel (734) 930-5452 George Ayd, Jr., Insurance Administrator (703) 652-1309         2010-2011 Directors President Kevin Trout, Grandview Medical Resources, Inc. (412) 914-0950 President-Elect Anthony Marmo, Martab Medical (201) 512-1100 Secretary/Treasurer Hal Freehling, Jr., O.E. Meyer Company (419) 609-1633 Chairman of the Board Dave Campbell, PhD, Vital/Med Systems Corporation (303) 660-0888 Directors-at-Large Tom Birmingham, Bay State Anesthesia, Inc. (978) 682-6321 George Howe, Mercury Medical (727) 573-0088 John Kasberg, Genesis Medical, Inc. (317) 347-2000 Philip M. Reilly, KOL Bio-Medical Instruments, Inc. (703) 378-8600 Don Reiter, SRC Medical (818) 717-8807 x19 Bill Schultz, IPV Medical, LLC (760) 212-2769 Don Sizemore, D&D Medical, Inc. (615) 859-2337 Past-President Shawn Walker, Bay State Anesthesia, Inc. (978) 682-6321 Manufacturer Representative to Board Tim Beevers, Beevers Manufacturing & Supply (503) 472-9055 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.