February 2007

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.

Conference takes shape. Conference Chairman Tom Birmingham promises a substantive, provocative and entertaining mix of formal presentations and interactive sessions.

In Focus. The word “acuity” means acuteness of vision or perception. It was vision that led sales and marketing veteran Mark Tomchik in 2003 to purchase a high-quality independent rep firm and remold it into a full-service specialty sales and marketing organization.

Vapotherm reintroduces 2000i. The U.S. Food and Drug Administration gave Vapotherm Inc., Stevensville, Md., the green light in January to reintroduce its 2000i High Flow Humidification Device to the market.

IMDA members can attend commercialization workshop. IMDA members get a break when they attend the Medical Device Manufacturers Association’s upcoming workshop on “Commercialization of Medical Devices,” to be held Mar. 22 in Washington, D.C.

‘Ask your doctor’ about medical devices. Tired of seeing actor Mandy Patinkin suggesting that you “ask your doctor” about CRESTOR®, AstraZeneca’s cholesterol drug? Brace yourself. Device manufacturers are beginning to follow in the footsteps of their Rx counterparts by advertising their products directly to consumers.

Venture capitalists high on medical devices. VCs’investments in medical devices saw a record year in 2006, both in the number of deals and dollars invested.

Are universities getting greedy? University technology-transfer offices, which are responsible for helping university researchers bring their discoveries to the commercial market, are under fire from companies, venture capitalists and researchers themselves for presenting more roadblocks than assistance.

Coach your team to WIN! The word "coaching" is starting to be used so often these days that it is truly losing its meaning and effectiveness. IMDA keynote speaker Gerry Layo shows how to replace the talk with the walk.

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2007 Annual Conference

Conference takes shape

Annual Conference organizers are refining the agenda for the 2007 Conference and Manufacturers Forum, to be held June 3-5 in Coeur d’Alene, Idaho. Conference Chairman Tom Birmingham promises a substantive, provocative and entertaining mix of formal presentations and interactive sessions.

Sunday, June 3

Golfers will assemble at Coeur d’Alene’s award-winning (that means challenging) course at 8 a.m. on Sunday, for IMDA’s Annual Golf Tournament.

At 3 that afternoon, IMDA President-Elect Shawn Walker will facilitate the First-Time Attendee Orientation. This year, program organizers intend to make sure that newcomers feel welcome and become quickly oriented to IMDA. Manufacturers will learn more about the organization as well.

The Welcome Reception for all attendees will take place from 4 to 6. Dinner is open. (Note: In response to input from manufacturers, the Manufacturers Forum will not begin until Monday.)

Monday, June 4

As reported in last month’s IMDA Update, Gerry Layo, noted speaker and business coach, has agreed to deliver the keynote address on Monday morning, June 4. His topic: “Building a World Class Organization. (See Layo’s article on the same topic at the end of this month’s IMDA Update. Or click here.)

The Manufacturers Forum will open at noon and continue until 2 p.m. IMDA members are encouraged to tell their manufacturers about the event, which is the industry’s only meeting place for manufacturers of innovative medical devices and specialty sales and marketing companies. (A complete packet of information is available on the IMDA website at www.imda.org.)

Several compelling breakout sessions – in which smaller groups of attendees gather to engage in constructive give-and-take -- will be held Monday afternoon. Topics include how to draw up equitable contracts and how to guarantee selling success in your company.

A general session will follow, focusing on how to build sound exit strategies into your contracts.

The Manufacturers Forum & Reception will be held from 5:30 to 7:30, followed by the annual Awards Dinner.

Tuesday, June 5

Tuesday begins with the specialty breakouts, during which members in the same specialty can discuss the most pressing business issues facing them.

At 9:30, IMDA members will gain insight into some of the most important issues affecting medical device manufacturers, hospital customers and themselves. IMDA member Dave Campbell will moderate “Healthcare Policy and Practice in 2007,” in which a panel of experts will discuss medical device safety, the cost-effectiveness of new medical devices, barriers to vendors’ access to customers, group purchasing, patient safety and other issues. Confirmed is Megan Ivory, executive vice president of government affairs for AdvaMed, an association of medical products manufacturers.

Breakout sessions will follow. Already confirmed is a session on establishing quotas, moderated by IMDA allied member Rick Pfahl of Aaron Medical.

Lunch and the Annual Business Meeting will be held at 12:15, followed by a closing session.

For die-hard golfers, an extra golf outing will be held on Tuesday afternoon.

Plan on being at Coeur d’Alene. It’s your opportunity to network with peers who understand your business, and to meet manufacturers who are looking for companies that do what you do. Besides that, Coeur d’Alene is absolutely beautiful. Watch the IMDA website for continuing developments.

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New member

In Focus
Acuity Medical owner Mark Tomchik builds upon an outstanding legacy

The word “acuity” means acuteness of vision or perception. Indeed, it was vision that led sales and marketing veteran Mark Tomchik in 2003 to purchase a high-quality independent rep firm, Acuity Medical, and remold it into a full-service specialty sales and marketing organization. Based in Annapolis, Md., Acuity Medical is IMDA’s newest member.

Born in Pittsburgh and raised in Baltimore, Tomchik is no stranger to selling and marketing innovative medical products. He spent close to 20 years with a number of start-up medical-products manufacturers, including Thermoscan (tympanic ear thermometers), Optiva Corp. (sonicare® sonic toothbrush) and, most recently Vapotherm, for whom he served as vice president of sales and marketing. In fact, at Vapotherm, he helped develop and execute the original sales and marketing plan for the Vapotherm 2000 respiratory-airway therapy system. It was while working for Theromscan and Vapotherm that Tomchik became aware of the capabilities of specialty sales and marketing companies, particularly those in IMDA.

Tomchik bought Acuity Medical with the intent of building on its already high reputation in the market. Speaking of former owner Bob White, Tomchik says, “[He knew that] if he could offer a documented track record of high sales achievement and surround himself with other high sales achievers in the organization, quality manufacturers would outsource their business development efforts to his company. This is still our business model today, as we validate our consistent results-oriented focus on a daily basis for our manufacturing partners.

“We want to over-perform with any line we have, whether from the distribution or sales agency side. That’s our core goal. And if we’re not doing that right, there’s a breakdown somewhere.”

To eliminate such breakdowns, Tomchik has rebuilt Acuity Medical’s sales team and expanded its geographical coverage, so the company now services North and South Carolina, West Virginia, New York City, Maryland, the District of Columbia, Delaware, Virginia, New Jersey and Pennsylvania. Acuity Medical also offers a skilled customer service and technical service team to support is field sales force of six people.

Tomchik looks forward to identifying profitable new modalities that can improve outcomes and reduce costs. He hopes that by joining IMDA, he will be able to network with others who share the same vision. He also hopes to leverage IMDA’s resources to make Acuity Medical more efficient, and to become more engaged with others in the industry and at a higher level.

Mark Tomchik lives with his wife, Susan, and his three children in Annapolis, Md. Welcome him to IMDA by calling him at (410) 280-3880 or by e-mailing him at swtomchik@aol.com. Visit Acuity Medical’s website at www.acuitymed.com.

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Vapotherm reintroduces 2000i

The U.S. Food and Drug Administration gave Vapotherm Inc., Stevensville, Md., the green light in January to reintroduce its 2000i High Flow Humidification Device to the market. The units deliver heated, humidified nasal flow to people with chronic lung and acute breathing disorders. They were recalled in December 2005 after reports that they were associated with Ralstonia ssp., which are gram-negative bacilli that grow in moist environments and infrequently cause infections in people.

The company was returning the devices to customers with revised instructions for use and reprocessing. (A revised Operating Instruction Manual can be viewed on Vapotherm’s website at www.vtherm.com/customers.) The changes recommended by the manufacturer include:

  • Instructions for a new accessory, the single-patient-use Vapotherm Spike Set, and a recommendation that the device be used with USP water (sterile water) for inhalation in a “closed system.”

  • A modified disinfection procedure that uses cartridge-bypass tubes and allows for the use of Control III® (Maril Products, Tustin, Calif.) or Minncare® (Minntech, Minneapolis, Minn.) disinfectant solutions.

  • Additional recommendations and warnings about using standard precautions and aseptic technique.

  • A recommendation that the cartridge be used on a single patient basis until a reprocessing procedure can be validated and cleared for use.

  • The Centers for Disease Control and Prevention tested the device and reported that its tests:

  • Failed to recover any gram-negative organisms (including Ralstonia species) from the unopened gas transfer cartridges that were tested.

  • Failed to recover Ralstonia from the samples of the water circulating through the machine following application of the revised disinfection protocol.

  • Failed to recover any microorganisms in the vapor cultured from the Vapotherm machine following routine disinfection.

“Vapotherm is pleased to return the 2000i and High Flow Therapy to our users,” Vapotherm President and CEO Robert Storey said in a statement. “During the recall period, we received a tremendous outpouring of support from health care practitioners, patients and their families, all voicing the importance of this technology in providing non-invasive respiratory support. We extend our sincere appreciation to our customers and partners for their patience and support during this period.”

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IMDA members can attend commercialization workshop

IMDA members get a break when they attend the Medical Device Manufacturers Association’s upcoming workshop on “Commercialization of Medical Devices.” IMDA members pay only the MDMA member price -- $195 – for the one-day workshop, to be held Mar. 22 in Washington, D.C.

The workshop will be presented by MDMA in cooperation with Vector Resources, whose two partners – Rick Davies and Chris Davies – are frequent IMDA speakers. It is the third event of its kind, the first one having been held in Burlington, Mass., in March 2006, and the second in Los Angeles in September. (IMDA member Dave Campbell represented IMDA on the faculty of both prior workshops.)

The workshop is designed to help manufacturers of innovative technologies choose the best way to bring their products to market. Topics include how to profile your company, working with the military medical community, and selecting a product commercialization strategy that fits your company’s profile. In addition to Rick and Chris Davies, speakers include IMDA allied member Rick Pfahl, vice president of marketing and sales for Bovie Aaron Medical; Warren Grundfest, M.D., professor of bioengineering, electrical engineering and surgery, UCLA; and David Hood, senior advisor for the principal advisor for acquisitions, telemedicine & advanced technology research, U.S. Army Medical Research & Material Command.

For more information, visit the MDMA website at www.medicaldevices.org, or phone MDMA at (202) 349-7172.

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'Ask your doctor' about medical devices

Tired of seeing actor Mandy Patinkin suggesting that you “ask your doctor” about CRESTOR®, AstraZeneca’s cholesterol drug? Brace yourself. Device manufacturers are beginning to follow in the footsteps of their Rx counterparts by advertising their products directly to consumers.

According to an article in the Chicago Tribune (“Medical ads aim straight for the heart,” Jan. 23, 2007), Medtronic Inc. recently launched a national $100 million campaign to raise awareness of sudden cardiac arrest – and to tout its $30,000 implantable defibrillator. The blitz includes marketing materials for physicians, as well as print and TV ads directed at consumers.

To be sure, Medtronic is not the first medical device manufacturer to pedal its products directly to consumers. Three years ago, Stryker Corp. commissioned golfer Jack Nicklaus to extol its titanium hips on TV. Johnson & Johnson’s Cordis Corp. has run ads for drug-coated stents in national newspapers, and Boston Scientific Corp. has done the same for its products, including Enteryx, a liquid injected into the lower esophagus to treat acid reflux (which was recalled by the manufacturer in September 2005).

Medtronic Vice President and Medical Director David Steinhaus, M.D., is quoted in the Tribune article as saying the company’s ad campaign is “about trying to save more lives.” But critics contend that ads such as those from Medtronic could lead to a new burst of spending on medical care. Indeed, spending on brand-name drug advertising now stands at $4 billion a year and shows no signs of abating.

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Venture capitalists high on medical devices

Venture capitalists’ investments in medical devices saw a record year in 2006, both in the number of deals and dollars invested, according to a report by Reuters. According to a year-end summary from Ernst & Young LLP and Dow Jones VentureOne, investments in medical devices grew 20 percent to $2.63 billion last year. Despite the big numbers, medical devices still took a back seat to biotech and pharmaceutical firms, which lured $4.72 billion in investments last year.

Medical devices, biotechnology Internet services and alternative energy start-ups fueled most of the industry’s growth. In fact, overall U.S. venture capital investments rose 8 percent to $25.75 billion in 2006, the highest level in five years.

“I think 2006 proved that the U.S. venture capital industry has entered a new cycle with many investors renewing their commitment to the entrepreneurial spirit by focusing attention and capital on companies that affect our health, the way we communicate, and the environment,” Stephen Harmston, director of global research for VentureOne, was quoted as saying. “The data also shows that investors are recognizing the economic reality for start-ups today and are willing to sustain them with round sizes that are at the highest levels in six years.”

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Are universities getting greedy?

University technology-transfer offices, which are responsible for helping university researchers bring their discoveries to the commercial market, are under fire from companies, venture capitalists and researchers themselves for presenting more roadblocks than assistance.

A recent article in Science magazine (“The Trouble with Tech Transfer, Vol. 21, Issue 1) discusses allegations that university technology-transfer offices have become overly concerned with economics, to the point of being downright greedy, since the passage of the 1980 Bayh-Dole Act, which allowed universities to retain ownership of any patents that are developed using federal funds. Some critics contend that even if the tech transfer offices aren’t greedy, they are incompetent, bureaucratic, and unable to perceive the true value of the inventions and discoveries brought to them by their own faculty. Others believe that the offices are simply responding to companies that are driving harder bargains than ever before.

“The list of accusations from industry officials, academics, and others ranges from incompetence to greed: TTOs [technology-transfer offices] allegedly employ poorly trained staffers who fail to understand what companies are seeking or are simply unresponsive to their own ambitious professors,” according to the article. “At the same time, TTOs are being chastised for setting conditions for preliminary technology reviews that make it difficult for a company to assess commercial viability. A more common complaint is that tech transfer officials simply bargain so hard over royalties that some companies find the terms onerous and withdraw, leaving US universities with lost opportunities.”

Indeed, the number of universities filing up to 10 patent applications in a year dropped by roughly 25 percent from 2003 to 2004, the last year for which data is available, according to the article.. There was also a slight overall drop in the number of invention disclosures and startup companies formed.

Some observers believe the recent push to bargain harder “amounts to a belated recognition that their [technology-transfer offices] weren’t always extracting the best possible terms,” according to the article. “Now, the tech transfer offices are learning to negotiate smarter terms,” such as demanding stock in startup companies.

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Coach your team to WIN!
Key elements of outstanding sales leadership

By Gerry Layo

The word "coaching" is starting to be used so often these days that it is truly losing its meaning and effectiveness. Too many leaders/managers are using the word in an attempt to separate themselves. Words and phrases, however, do nothing to separate those who can't from those who can AND do! ACTION is the thing that does that! Below are several actions that you as a business leader can do to stop talking it and to start walking it. Become a coach to your people and they will be your people for long, long time.

Draft top talent

As a coach, you want to give your team the right staff of players so that they can consistently win in the marketplace. The best coaches realize that they must always be looking for and recruiting new stars to their teams. New players keep the team fresh and on their toes. New players to the team may replace existing non-productive players or may help to drive those existing players to new levels of productivity. A coach is always looking for the key players to add to his team to help bring the team to the next level. A good coach also realizes that players DO leave and go to other teams. It is not a matter of if they do, often it's just when. It is because of this that the coach always has a list of potential new recruits that he has had communication with. There are always new stars in the recruiting basket of the coach. He is always looking for talent. He realizes that recruiting is a process, not an event.

Set expectations up front

The coach brings every member onto his team with open eyes. He works very hard to set mutual expectations up front with his new players. He makes sure that his players know that he will expect big things from them and that they will work harder on his team than they ever have anywhere else in the past. They will know that they will be measured and held accountable to constant improvement and that they will be held to the highest standards of professionalism.

A clear plan for every player

The best coaches always make sure that every player on their team has a very clear and defined game plan to success. The realize that focus precedes success, and if they can keep their players focused on their key roles in the outcome for the team, than each player will have a much better chance of winning. The teams that consistently win do so because they have a very clear plan that is broken into individual responsibilities. A good coach leaves nothing to chance. A good coach works with his people individually on their game plans so that he can improve his players’ skills. A good coach realizes that a player without a plan has no way to mark his/her successes as they come.

Never, ever stop

The essence of a coach should be in being a teacher, a mentor, a leader. The best coaches are the ones who are in the game with their players every day, working with them on their skills. The best coaches schedule time every day for training of their people. The skills necessary for success must be taught and practiced regularly. People do not learn these things intuitively. Coaches realize that, given the choice, most players would rather not practice their skills. This is not to say that they do not want to succeed. They merely will take the past of least resistance most times. (It is human nature.) The best teams in history did not stop practicing because they started winning. They did not stop practicing because they got some good players. Solid coaching requires a discipline towards constant improvement and the catalyst for that is the coach.

Strengthen relationships

Even the best players do not respond if there is no trust. A good coach realizes that it may take months -- even years -- to build a solid foundation of trust, but only moments to destroy it. Coaching sometimes requires tough choices. Good coaches always make sure that the choices they make do not compromise the trust that they have built. Good coaches realize that it isn't always about being the nice guy; but it is about being fair and honest with the entire team.

Solid relationships are built on communication. Taking the time to forge solid relationships with his people is one of the things that a great coach does best. People will walk through fire for a leader they believe in. People tend to trust and believe in those who trust and believe in them. This goes beyond words. Again, it comes down to the actions of the coach.

There are indeed many things that are necessary when one attempts to become a solid leader, that is, a coach of a winning team. Focus on a few of those mentioned above and your results will be outstanding.

Gerry Layo will be the keynote speaker at the IMDA 2007 Annual Conference, Monday morning, June 4, Coeur d’Alene, Idaho. He is recognized as one of the nation’s most dynamic and sought after speakers, trainers, authors and coaches. IMDA Conference Chairman Tom Birmingham has seen Layo speak and sought him out for the 2007 Conference., Layo is the author of Smart Selling-Strategies to Reinvent the Sales Process. For more information visit: www.gerrylayo.com or call (866) 979-LAYO (5296).

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IMDA Update

Published by IMDA
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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.