IMDA Update
Jan/Feb 2002
The nation’s premier providers of specialty medical sales, service and education
In This Month’s Issue… Click on any of the following headlines
to read stories from this month’s newsletter.
Don’t stop thinking about tomorrow. Max Carey to speak at IMDA Annual
Management Conference on the art of long-term thinking.
Innovation vigilantes. Local Innovation Councils press lawmakers and others to grease
the wheels for the introduction of new medical technologies.
Time to renew insurance. The products liability policy developed exclusively for
IMDA members renews on April 1. Get your application in now.
You’re in the people business now. You can take this to the bank: As your company
grows, you’re going to find yourself running two businesses -- the one you started or took
over, and the employee business. Ever consider outsourcing human resources?
Face your fears. Talk about lions and tigers and bears. The small-business owner faces
a multitude of scary things, from fire to the loss of a major client to sabotage at the hands
of a disgruntled employee. Read about a new book that tells you how to face these things
head-on.
Distributors Wanted. Companies that are actively seeking specialty distributors.
Awaiting your call. Here’s a list of companies and products receiving recent 510(k) and
PMA approvals from the FDA. All have been sent an IMDA information packet.
Find FDA listings. Instructions on how to track down recent 510(k) and PMA
approvals on the FDA website.
Technology Briefs. New technologies and companies you should be aware of.
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2002 Annual Conference
Max Carey added to agenda
Short-term thinking never adds up to long-term success. Yet, given the pressures we
face today, it’s hard to look beyond the next bump in the road. Max Carey offers this
piece of advice: “Do it anyway.”
Carey, founder of Atlanta-based Corporate Resource Development, has just been added
to the agenda for IMDA’s 2002 Annual Management Conference and Manufacturers
Forum. He will speak during the two-hour session entitled “TEC: Your ‘Informal Board
of Directors,’” Friday morning, June 21. (For a complete agenda of the Conference, see
http://www.imda.org/meetings/imda_meetings.htm.)
Carey knows what it’s like to win in adversity. He attended Columbia University on a
full academic scholarship, and while there, played football and set five school records
and one NCAA record for punt and kickoff returns. Later, as a Naval carrier-based fighter
pilot in 1972, he flew 110 combat missions over North Vietnam. In 1986, he was named
Vietnam Vet Small Business Person of the Year by Bob Hope. His company, Corporate
Resource Development, helps firms deal with strategic and tactical marketing and sales
pressures. He is speaking at the Annual Conference courtesy of TEC (www.tecceo.com),
an organization founded in 1957, which every month brings together on a local basis
groups of CEOs from all industries.
According to Carey, business owners have to replace traditional sales and marketing
strategies with new ways of thinking. They must move from a short-term to a long-term
focus, and they must be willing to make commitments of greater magnitude than ever
before, he says. Furthermore, they must leverage greater expertise into their first-tier
accounts to gain proprietary value in the eyes of their clients and customers.
Carey’s presentation fits neatly into the theme of the conference, “Strategic Planning
for Specialty Sales and Marketing Organizations.” The program has been drawn up by
IMDA member Ed Boracchia with help from distribution industry expert Ron Stephenson
of Indiana University (who will facilitate the Conference). It will be held June 19-23,
2002, at the Omni Tucson National Golf Resort and Spa in Tucson, AZ. Among the
topics to be discussed are:
 What is strategic planning, and why should I worry about it? Some things to
think about: What are my financial goals and drivers? What are my specific
goals (for example, territory, product mix, etc.)? What specific tactics can I
employ to achieve my plan? What major industry issues are likely to affect my
plan? How will I finance my plan?
 Should my family-owned firm have an outside board of directors? Joining
IMDA members at the conference will be Jeff Beischel, CEO of The Brewer
Company, a family-owned manufacturer of medical furniture in Menomonee
Falls, WI. Beischel is a non-family member who, together with an outside board
of directors, runs the company. He’ll talk about his experiences in this position.
 How can I tap into the planning experience of executives and business owners
outside the medical specialty distribution business? One answer is TEC. Carey
will be joined by someone from TEC to talk about how the organization can
help business owners get a broader perspective on their businesses.
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Am I prepared to handle the unexpected? Fire? A lawsuit? The loss of my No. 1
vendor? Defection by my top sales reps? IMDA Legal Counsel Mitchell Kramer
will lead a panel of IMDA members who share how they turned adversity into
opportunity.
Continuing a tradition begun at last summer’s Annual Conference, IMDA members
will have an opportunity to meet with others in their specialties, to talk about common
concerns and opportunities. This was one of the most popular features of last summer’s
conference, according to many who attended.
Manufacturers Forum
Manufacturers of innovative medical devices will be invited to exhibit their products at
the Manufacturers Forum, scheduled for 5 to 7 p.m., Thursday, June 20. The Forum held
at last June’s Conference was the most successful thus far, attracting 15 manufacturers of
innovative technologies.
Manufacturers who exhibit at the Forum will be welcome at most Conference sessions.
“We think they have as much to learn as we do about strategic planning,” says IMDA
President Richard Manley of Arlington, TX-based CVC. “And we’ve found that the
interaction between our members and manufacturers at the educational sessions is
invaluable.”
Tucson in June?
Just 18 miles from Tucson International Airport, the Omni (www.omnihotels.com) is
nestled in the foothills of the Santa Catalina Mountains. It features a full-service spa and
a 27-hole championship golf course, which has been home to the PGA Tour’s Tucson
Open since 1976.
The Annual Conference was shifted from its traditional January slot to June in 2001, in
response to requests from IMDA members to make the event more affordable. “At the
same time,” says Manley,” we kept hearing that our members wanted to enjoy
comfortable accommodations, with plenty of opportunities for recreation and relaxation.
We’re hoping that many of our members will bring their families along.”
Indeed, the Omni is:
 Ten minutes from Saguaro National Park, one of the finest saguaro cacti forests
in the world.
 Twenty-five minutes from Sabino Canyon, a desert oasis, complete with
waterfalls, a swimming hole and picnic areas.
 Thirty minutes from Biosphere-2, a world-renowned experiment in creating a
closed ecosystem, operated by Columbia University.
 Thirty minutes to Pima Air & Space Museum, the largest privately funded air
museum in the world, located just southwest of Davis-Monthan Air Force Base.
 Thirty minutes from Old Town artisans, located in the Presidio District, a
historic city block lined with shops rich with Southwest flavor.
 Thirty-five minutes from Mission San Xavier del Bac, the “white dove of the
desert,” a graceful mission church on the southwest side of town still serving the
Tohono O’Odham Indian community for whom it was established in the late
1600s.
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Forty minutes from Old Tucson Movie Studios, known as “Hollywood in the
Desert.” More than 200 movies, commercials and feature films have been
filmed here since it was built in 1939.
Forty-five minutes from the Arizona-Sonora Desert Museum, a “living
museum” of the desert displaying 300 different animal species and more than
1,300 plants indigenous to the Sonoran Desert.
One hour from Tubac, an artist community with art galleries and seasonal street
fairs.
One hour from Kartchner Caverns, one of the world’s most pristine caverns,
now open to the public. Camping facilities, hiking trails, a bird sanctuary and a
visitor’s center are located nearby.
One and a half hours from Kitt Peak Observatories, world-famous center of
astronomical study and the world’s largest optical observatory. Home to three of
the largest high-powered telescopes in the world.
Call IMDA headquarters for more information, at (800) 398-5632.
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Innovation vigilantes
Breaking in the market for new medical technologies is never easy. Call it inertia, red
tape or plain old fear of the unknown, providers are often reluctant to embrace what is
new. And more often than not, the government’s review processes and reimbursement
policies only reinforce their reluctance. That’s why AdvaMed (formerly HIMA)
established its Innovation Councils two years ago.
These groups, established on a local basis, comprise manufacturers, academics and
others with a keen interest in advancing new medical technologies. On a regular basis,
they visit Congresspeople and Senators to talk about how the government can facilitate
instead of obstruct the introduction of new medical technologies into the market.
Based in Washington, DC, AdvaMed (the Advanced Medical Technology
Association) represents more than 1,100 manufacturers of medical devices,
diagnostic products and medical information systems. Michael Reilly heads up
the Innovation Councils.
“Generally speaking, [the Councils] are focused on making sure that both from the
FDA and Medicare side of things, new technologies – and technologies in general – are
available for patients,” says Reilly. “There are a lot of logjams that delay them from
effectively getting to patients when they need them.” The two main logjams are the FDA
review process and Medicare reimbursement.
FDA issues
AdvaMed and its Innovation Councils helped push a bill, known as the “Preparing FDA
for 21st Century Medical Technology Act” (H.R. 3580), onto Congress’s agenda just
before Christmas 2001, says Reilly. The bill was sponsored by Reps. Jim Greenwood (R4
PA) and Anna Eshoo (D-CA). Given the imminence of the holiday break and the
slowdown of new legislation following Sept. 11, the fact that the bill was introduced and
co-sponsors recruited in short order signaled the Innovation Councils’ effectiveness, says
Reilly.
The bill reflects some of AdvaMed’s major concerns surrounding new medical
technologies. For example, it calls for:
 Improving the timeliness of PMAs [premarket approval applications] for new
technologies. AdvaMed says that despite recent improvements, FDA review
times for breakthrough technologies, which typically require a premarket
approval application, have remained twice the statutory 180-day deadline.
 Allowing for a greater number of third-party reviews of 510(k) applications,
instead of jamming up applications at FDA.
 Establishing an Office of Combination Products within the FDA, to focus on
those technologies that are part drug, device and biologic.
Reimbursement
On the Medicare side, the Innovation Councils will continue to hammer on
reimbursement. “The general theme is how to make sure we can improve coding
coverage and the payment process for Medicare, with regard to advanced medical
technology,” says Reilly. The issue is critical, because most private payers follow
Medicare’s lead. If Medicare drags its feet on reimbursing new technologies, private
payers will most likely do so as well.
The Innovation Councils and AdvaMed at large will continue to insist that coverage
decisions be predictable and understandable, says Reilly. H.R. 3580 includes provisions
addressing both points. In addition, the Councils will continue to press for full and rapid
reimbursement for innovative technologies used in hospital outpatient procedures.
“The state of the union has never been stronger,” says Reilly, speaking about
AdvaMed’s efforts to stimulate the environment for new medical technologies. The
Innovation Councils continue to grow and build relationships with key legislators around
the country. Councils have been established in Orange County, CA; San Diego; Palo
Alto, CA; Seattle; Cincinnati; Cleveland, OH; Memphis; Nashville; Atlanta; Miami;
Chicago; Erie, PA; Philadelphia; Dallas-Fort Worth; Denver; Salt Lake City; and
Connecticut and Michigan. For more information, contact Michael Reilly at
202·783·8700.
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Time to renew insurance
By Debbie Kielman
Schifman, Remley & Associates
The products liability policy developed exclusively for IMDA members renews on
April 1. As in the past, applications must be completed in detail and returned to the
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attention of Debbie Kielman of Schifman, Remley & Associates, IMDA’s insurance
administrator. Include brochures from your manufacturers representing your major lines
of distribution.
Insurance prices have been on an upswing for the past 12 months, and after September
11, costs have risen dramatically. The scope of the losses facing the insurance industry is
unprecedented, resulting in more restrictions on coverage than ever before. A number of
carriers who formerly provided coverage for medical supply distributors are nonrenewing
policies that include product liability.
If you don’t participate in the IMDA Product Liability Program, now is an excellent
time to check it out, for several reasons: It offers valuable protection for the assets of
your company; and it allows more bargaining power for your organization (one of the
reasons your company joined IMDA in the first place).
Membership in IMDA is required in order to participate in the program. Keep in mind
that negotiations on the April 1 renewal will begin only after we receive your application
and product brochures, so time is of the essence.
It is vitally important that the underwriters be given ample time to examine each
application, so we need your application as soon as possible! If you have any questions as
you complete the form, or if we may be of assistance, please call us at (800) 304-9852.
We support and promote the IMDA organization for the benefit of all involved.
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You’re in the ‘people business’ now
You can take this to the bank: As your company grows, you’re going to find yourself
running two businesses -- the one you started or took over, and the employee business.
When a company reaches about 10 employees, the owner typically finds himself or
herself at a crossroads, says Administaff Vice President Roger Gaskamp. On the one
hand, he or she can stop doing what attracted him to the business in the first place (like
selling innovative medical devices) in order to handle employee matters full-time. Or he
or she can squeeze in employee matters after hours, giving up personal time or the time
needed to help grow the company.
Administaff caters to business owners in just this predicament. A “professional
employer organization,’ the Kingwood, TX-based company provides its clients an
outsourced human resources department. “Our clients retain the ability to direct people to
grow their business,” says Gaskamp. “What they get rid of is the administration – the
benefits administration, safety administration and other human resources aspects that,
one, they never thought about; two, don’t know how to do; and three, have no desire to
do.” Administaff is a publicly owned company with revenues in excess of $3.7 billion.
Administaff and IMDA recently signed a “Center of Influence” agreement, which
entitles IMDA to a finder’s fee for every member who signs up. One IMDA member –
Vital/Med Systems in Castle Rock, CO – is an Administaff client. Vital/Med President
Dave Campbell arranged for Administaff to speak at the 2001 Annual Management
Conference, and was a key driving force behind the IMDA agreement.
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How far?
How involved does Administaff get in its client’s employee affairs? As much or as little
as the client wants, says Gaskamp. “Think of a human resources department in a big
company,” he says. “It can be as involved as the manager wants it be in things like hiring
and firing.”
For example, the company can go so far as to screen resumes, test and interview
candidates, then present the best ones to the client. When an employee must be
terminated, Administaff can help the client make sure the termination is done properly,
says Gaskamp, noting that 90 percent of small businesses involved in EEOC lawsuits fail,
because of the time and energy required of such lawsuits.
Other services Administaff provides:
 Onsite training in such issues as sexual harassment.
 Assistance with the writing of employee handbooks.
 Training in leadership, teamwork, management and other topics, via the
Internet.
 Discount programs for employees and their families from such companies as
Dell Computers, IBM, real estate companies, apartment locators, etc.
 Access to bigger-company insurance programs,
such as medical, dental, vision, disability, life and
accidental death.
 Employee assistance programs.
 401(k) programs.
Prices are based on the client’s size and needs.
For more information on the Administaff program, call IMDA headquarters at (800)
398-5632. Check out the Administaff website at www.administaff.com.
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IMDA Book Review
Face your fears
The Small Business Owner’s Guide to a Good Night’s Sleep
Talk about lions and tigers and bears. The small-business owner faces a multitude of
scary things, from fire to the loss of a major client to sabotage at the hands of a
disgruntled employee. In her book, The Small Business Owner’s Guide to a Good
Night’s Sleep (Bloomberg Press, 2001), author Debra Koontz Traverso says that the key
to a good night’s sleep is prevention and preparation – prevention of as many crises as
possible, and preparation for the very worst.
“Nobody wants to think or talk about these unpleasant realities,” says Traverso, who
teaches crisis management and prevention, and who is a member of the adjunct faculty at
Harvard University. “They know it’s something they should do and intend to do. They
know they ought to plan ahead. They know it’s just a matter of time….Yet people seem
to think that death won’t come if they don’t plan for it. And business managers think that
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bad things won’t happen if they don’t think about them.” That would be hard to do after
reading this book, which is enough to scare anyone into action.
(Strategic planning and crisis management will be topics discussed at the upcoming
IMDA Annual Management Conference. Click here for more information on the
Conference.)
Where is my company vulnerable?
A crisis is, simply, “any situation that takes your focus away from serving your
customers and turning a profit – the primary reasons you are in business,” says Traverso.
Looked at that way, dealing proactively with crises makes all the sense in the world.
Answering the question, ‘Where is my company vulnerable?’ can identify deficiencies
and lead to strategic thinking and creative ways of doing business, says Traverso. So, in a
way, addressing risks before they become disasters strengthens your management
practices, she says.
The small-business owner can begin the process by listing all the potential risks he or
she faces. And there are plenty: suicide on the premises; computer viruses; promotional
errors; workplace violence; supplier loss; natural disasters; and a host of subtler but
equally crippling calamities, such as the erosion of your customer base, poor cash flow or
an industry recession.
Obviously, listing the potential hazards doesn’t accomplish anything if the smallbusiness owner doesn’t also develop checklists of action steps to take. Involving
employees in the planning process enhances their understanding of the business and gives
them a better sense of the company’s responsibilities and contractual agreements, says
Traverso. But in a time of crisis, most business owners – especially those who run small
businesses – will have to rely on outside organizations for help, such as temporary
employment agencies, attorneys, public relations firms, insurance carriers, trusted
consultants, even off-duty police officers. The only catch is that the small-business owner
should be lining them up before trouble strikes, says Traverso.
Self-audit
Although companies need to plan how they will respond to potential disasters, they
should spend even more time figuring out how to avoid them, says Traverso. They can
begin by identifying them in what Traverso calls the small-business self-audit. Ask
yourself these questions, she suggests:
 Do you have a clear mission statement, and are you carrying it out?
 Do you have a written business plan? Is it thorough enough to share with loan
officers, in case you need access to capital?
 Do you have a realistic annual budget? Do you adhere to it?
 Do you have a good bookkeeping system?
 Do you have a written sales plan, with realistic goals, target markets, etc?
 Is your pricing justified?
 Do employees know what is expected of them, and have they been trained to
deliver it?
 Have you identified two or more suppliers for each product you sell?
 Do your employees handle customers courteously?
 Is your location appropriate for your business?
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Are employees adequately trained to operate company equipment and vehicles?
Do you have access to legal advice when you need it?
Do you know what to do if your facility is damaged and must be closed for a
period of time?
The point is, sometimes the least expected – but most damaging – crisis to affect your
business is the one that could have been avoided had management changed the way they
operate, says Traverso.
Common management missteps
Small businesses often fail because of poor policies, supervision or planning, she says.
“Then, to add gasoline to the fire, when the adverse situation is identified, the business
owner or manager refuses to recognize the situation as critical, or refuses to learn from
the incident, which allows the mistakes to grow.”
How do you become a better manager? You can take courses at school, or, barring that,
study the success of others, study your competition, solicit suggestions from employees,
and give your employees what they need to do their jobs, says Traverso. What’s more,
you should:
 Be a boss, not a buddy.
 Develop a good relationship with your banker.
 Learn to network.
 Learn how to compile and interpret financial reports.
 Concentrate on your niche.
 Eliminate waste.
 Know when it’s time to make a change, either within yourself or your business.
Scores of dangers can emerge which, in the absence of astute management, can destroy
your business. For example, if you’re losing customers, it’s imperative to find out why.
Could it be that they note an attitude of indifference on the part of your company’s
representatives? If you suspect so, training is in order. Perhaps your company is suffering
from poor cash flow. If so, improve your accounts receivable process, find less expensive
suppliers, postpone equipment purchases, cut waste (including unproductive employees),
or establish good credit (something you should think about long before you run into a
cash flow crunch). In short, do something.
And always, always think ahead, says Traverso. For example, “When you are at your
busiest serving clients is exactly the time when you should be beefing up your marketing
efforts,” she says. “Your promotion should always be in motion. Why? Because all good
things come to an end eventually.” Contracts expire, clients redirect their attentions, the
industry changes, etc. “Being too busy today to market for tomorrow will come back to
haunt you.”
Sure, businesses can fail overnight due to acts of God (fire, flood, etc.) or other events
that are difficult to predict. But most crises are neither accidental nor sudden, says
Traverso. They fester for months or years, and frequently involve questionable, illegal,
unethical or irresponsible activity by someone in the company. In many cases, someone
in the organization is aware of this activity or has neglected its symptoms. “So the crisis
comes not from lack of knowledge, but from unwillingness to report or deal with
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unpleasant realities,” says Traverso. “Much of the problem, then, can be attributed to
management,” specifically, management’s ineptness at dealing with employees.
The personnel touch
Just as employees are the key to a company’s growth, they can also pave the way to its
downfall, particularly when mixed with poor management. “Statistically, small
companies are less likely to experience sabotage or strikes than their larger competitors,”
says Traverso. “But it’s the smaller incidents – such as employee theft, poor customer
service, and improper hiring practices – that can put a small company under or damage its
reputation.”
In fact, poor management of people causes more problems for small businesses than
employee maliciousness, says Traverso. And she’s not just talking about the subtle
psychological side of things. For example, do you know where each of your employees is
at all times? Such knowledge is invaluable should you have to evacuate your building
because of an accident or other disaster. Do you provide your employees a safe
environment in which to work? Have you trained them properly? Do you keep names and
phone numbers of temporary employees, in case your staff becomes sick or injured, or
you receive a big order? Do your people know what is expected of them? Have you laid
down the law on sexual harassment and discrimination? Have you drawn up and
communicated a succession plan in the event of your illness or death? If you run your
business out of your house, have you established limits on your employees’ use of and
access to your home?
The computer threat
Like employees, computers can help you build your company or lead to its destruction.
Hardware breakdowns, corrupted software, hackers, customers with fraudulent credit
cards, disgruntled employees, or the loss of your star IT guy can grind your business to a
halt. Have you taken steps to soften the blow if any of these should occur? Here are some
you might try:
 First of all, understand that computer crashes are inevitable, says Traverso. With
that in mind, consider backups to be a must, not a maybe.
 Second, be aware that 26 percent of all notebook computer losses and 25
percent of all desktop computer losses were due to theft. Is your computer
secure?
 Third, understand that e-mail brings potential liabilities along with its
conveniences. For example, an employee could forward a message that contains
racist or sexist comments, or send information to a competitor that contains
confidential information. Does your liability insurance include coverage for
electronic messages? Have you established policies regarding what is and what
is not appropriate regarding e-mail?
Like e-mail, the Internet opens a Pandora’s box, along with all of its incredible value.
Employees find it difficult to resist surfing the Web for personal purposes during office
hours. Worse, they (or people on the outside) can post harmful or offensive content on
your home page. Worse still, companies can find themselves the victims of lies posted on
the Internet. Some of this will inevitably happen. Still, make it known to your employees
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from Day One that you monitor computer activity closely, and have them read and sign a
security policy, advises Traverso.
Assign someone to monitor newsgroups and search engines at least once a week, in
order to scout out malicious information about your company. If you do find postings in
newsgroups, you’ll have to decide whether it’s best to respond or to let the issue die. In
some cases, you can contact the source directly and see if you can work out the problem.
In all cases, copy the offensive pages onto your computer and print them out on paper;
they are your evidence.
Insurance
Traverso ends her book with a fresh perspective on insurance, perhaps the ultimate
preventive medicine.
“I know firsthand that most small-business owners don’t like researching, reviewing,
and buying insurance,” she says. “To them, it’s like a tax – a necessary but burdensome
expense that should be kept to a minimum.” But that’s not what insurance is.
“Besides reducing the uncertainties under which you do business – which in itself
generally provides a better night’s sleep – insurance can reduce employee turnover, make
you more attractive to potential investors, enhance your credit rating at the bank, and
convince wary customers that you’re worth doing business with. So if you can begin to
look at insurance as an investment in your business and its future, then the task of
identifying and shopping for insurance becomes a little less burdensome and annoying.”
Will all this advice get you that elusive good night’s sleep? Definitely not, at least at
first. As Traverso says, few of us like to anticipate bad news. But once danger and the
potential of danger is faced head-on, good things can happen.
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Distributors Wanted
World of Medicine
4531 36th St.
Orlando, FL 32811
Contact: John Klostermyer
(407) 438-8810
Fax: (407) 859-2425
Email: john.klostermyer@womcorp.com
Product: Shockwave lithotripsy laser for intracorporeal stone treatment in
urology/gastroenterology. Patented FREDDY technology protects soft tissue.
Territory: All United States
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Awaiting your call
IMDA members might consider following up with any of the following companies, all
of whom recently received FDA 510(k) or PMA marketing clearance for the devices
listed. They were mailed information from IMDA on our association and specialty
distribution.
510(k)s
Ackard Laboratories
70 Jackson Dr.
P.O. Box 1085
Cranford, NJ
(908) 276-6290
Device: H/S Elliptosphere Catheter Set, Model 61-4005 (for conducting either
hysterosalpinogography (examination of the uterus and fallopian tubes using X-rays) or
hysterosonography (examination of the uterus and fallopian tubes using ultrasound
sonography).
Atlantech Medical Devices
38 Freemans Way
Harrogate, North Yorkshire, UK
44 142 388880 6
Device: Endoflip (graft fixation device for femoral fixation of hamstrings grafts in
cruciate ligament reconstruction).
Autogenesis
8700 Old Harford Rd.
Baltimore, MD 21234
(410) 665-2017
Device: Autogenesis™ Automator (motorized device used to accomplish precision
distraction for the purpose of bone and soft tissue (re)generation).
Bioplate Inc.
6911 Melrose Ave.
Los Angeles, CA 90038
(323) 549-9500
Device: Bioplate® ZIP™ Craniotomy Fixation System (to reattach a cranial bone flap
to the surrounding cranium after a craniotomy procedure).
Bonutti Research Inc.
2600 South Raney
P.O. Box 1367
Effingham, IL 62401
(217) 342-3412
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Device: Multitak Suture Snap System (for approximating and securing soft tissue in
arthroscopic and open surgical procedures).
Bypass Ltd.
555 Thirteen Street NW
Washington, DC 20004-1109
(202) 637-5910
Device: ByPass CorLink™ Automated Anastomotic Device (to create the proximal
graft-aorta anastomosis during a CABG procedure).
Cardiofocus Inc.
10 Commerce Way
Norton, MA 02766
(508) 285-1700
Device: Malleable Surgical Lightstic™ 180 (for coagulation of soft tissue in
conjunction with or without endoscopic equipment, in the contact or non-contact mode in
both open or closed surgical procedures).
Clarus Medical
1000 Boone Ave. North
Minneapolis, MN 55427
(763) 525-8401
Device: Model 2180 Spinescope (for intraoperative or percutaneous accessing and
visualizing spinal nerve roots and surrounding tissue in the cervical spine).
Cook Vascular Inc.
Rt. 66 River Rd.
P.O. Box 529
Leechburg, PA 15656-0529
(724) 845-8621
Device: Vascular Shapeable Doppler Flow Probe (for monitoring blood flow through
vessels in patients intraoperatively and during intraoperative neuro-vascular procedures).
Designs for Vision Inc.
760 Koehler Ave.
Ronkonkoma, NY 11779
(631) 585-3300
Device: Daylite Xenon Light Source (for use in surgery and medical applications where
high-intensity illumination is required).
Drager Medizintechnik GMBH
3135 Quarry Rd.
Telford, PA 18969
(215) 721-5400
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Device: Oxylog 1000 (time-cycled, constant-volume, transport and emergency
ventilator for patients requiring a minute volume ventilation of at least 3 liters per
minute).
Gimmi GMBH
Amstel 320-1
Amsterdam, Netherlands 1017AP
312 042 89591
Device: “Alpha” endoscopes and accessories.
H.S. Hospital Services S.P.A.
10147 Umberland Place
Boca Raton, FL 33428
(561) 477-1671
Device: Biospeed™ Spring Loaded Biopsy Needle (for use in fluoroscopic, CT,
mammographic and laparoscopic procedures to obtain biopsies of various tissues,
including those from breast, kidney, liver and prostate).
Imagyn Medical Technologies
8850 M-89
Richland, MI 49083
(616) 629-2787
Device: Imagyn isosleeve/isostar Needle System (for delivery of isostar Iodine 125
interstitial brachytherapy seeds and spacers during implantation of radioactive seeds in
selected localized prostate tumors).
Mentor Corp.
201 Mentor Dr.
Santa Barbara, CA 93111
(805) 879-6304
Device: Contour Profile Tissue Expander (for breast reconstruction after mastectomy,
correction of an underdeveloped breast, scar revision and tissue defect procedures).
Minrad Inc.
555 Thirteenth St. NW
Washington, DC 20004-1109
(202) 637-5600
Device: Light Saber™ Introducer Needle (disposable introducer needle/cannula
intended for precise placement of guidewires in non-vascular procedures).
Neo Metrics Inc.
15301 Highway 55 West
Minneapolis, MN 55447
(763) 559-4440
Device: Selectiva™ guidewire (to facilitate the placement of devices for diagnostic and
interventional procedures. Not for PTCA use.)
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Orthopedic Source Inc.
P.O. Box 307
Loomis, CA 95650
(800) 500-0381
Device: Avalon Cup System (for use in total hip arthroplasty for reduction or relief of
pain and/or improved hip function in skeletally mature patients).
Porex Surgical
15 Dart Rd.
Newnan, GA 30265
(678) 479-1610
Medpor® Coated Tear Drain (An implant to bypass the obstructed lacimal drainage
system for the treatment of chronic epiphora.)
Rennels Medical Corp.
P.O. Box 3626
Morganton, NC 28680-3626
(828) 437-1085
Contami-Shield™ Breathing Circuit Sleeve (for use with mechanically ventilated
patients, to reduce the gross external contamination of the breathing circuit during use).
USA Instruments
1515 Danner Dr.
Aurora, OH 44202
(330) 562-1000
Device: Shoulder Coil (A receive-only phased array RF coil, used for obtaining
diagnostic images of the shoulder and adjacent regions in MRI systems.)
Vascumetrix LLC
2824 N. Power Rd.
Suite 113-278
Mesa, AZ 85215-1674
(480) 807-6300
Device: Gelbish™ Vascular Dilator (to be used over a guidewire to dilate or calibrate
blood vessels).
PMAs
AGA Medical Corp.
682 Mendelssohn Ave.
Golden Valley, MN 55427
(763) 513-9227 or (888) 546-4407
www.amplatzer.com
Device: The AMPLATZER® Septal Occluder device (for the occlusion of atrial septal
defects in secundum position.)
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Nitinol Medical Technologies
27 Wormwood St.
Boston, MA 02210
(617) 737-0930
www.nmtmedical.com
Device: CardioSEAL® Septal Occlusion System with QwikLoad™ (for use in patients
with complex ventricular septal defects of significant size to warrant closure who are
considered to be at high risk for standard transatrial or transarterial surgical closure based
on anatomical conditions and/or based on overall medical condition.)
American Medical Systems
10700 Bren Rd. West
Minnetonka, MN 55343
(800) 328-3881 or (952) 933-4666
Device: Acticon Neosphincter System (to treat severe fecal incontinence in males and
females eighteen years and older who have failed, or are not candidates for, less invasive
forms of restorative therapy.
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Find FDA listings
Every month, the U.S. Food and Drug Administration publishes on its website a list of
manufacturers receiving 510(k) clearance and approved PMAs (premarket approval
applications). Companies that receive either designation are free to market their devices.
Here’s how to find this month’s listings:
1. Go to the FDA website at www.fda.gov.
2. In the “FDA News” box, click on “Other Recent Approvals,” which appears under
the green “Product Approvals” bar.
3. In the blue box on the left, you will find a “Medical Devices” heading. You have
two choices: “Latest” or “Archives.” If you click on “Latest,” you’ll find a
summary of the latest approvals.
4. If you click on “Archives” under “Medical Devices”, click on the words
“Searchable database,” which is the second bulleted item. You can then select
whether you want to review 510(k)s or PMAs.
5. Contact companies in whom you’re interested, demonstrate the value of working
with specialty distributors, and start selling!
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16
Technology Briefs
Aspect Medical Systems (Newton, MA), manufacturer of technology that measures the
effects of anesthetics and sedatives on the brain, featured the latest advances in BIS
technology and BIS-related critical care research at the Society of Critical Care Medicine
(SCCM) meeting in San Diego in January. The company highlighted its BIS® Extend
sensor designed to monitor for patients for an extended period of time in the critical care
environment. In the past, sedation assessment in the ICU has been guided primarily by
vital signs or sedation assessment scales, says the company. But these approaches can be
unreliable. Under-sedation can cause agitated patients to harm themselves by pulling out
tubes or drains, while too much medication can cause dips in blood pressure and prolong
the need for mechanical ventilation, says Dr. Gerald Fulda, director of surgical critical
care at Christiana Hospital in Newark, DE. The technology works by placing a BIS
sensor on a patient's forehead to obtain information from electrical brain activity, or EEG.
(http://www.aspectms.com.)
Cook Inc. (Bloomington, IN) received conditional approval from the U.S. Food and
Drug Administration to enroll 200 patients at 20 sites in the U.S. clinical trial of its new
paclitaxel-eluting coronary stent to combat restenosis. The company is planning to
launch the Logic™ PTX™ stent in the United States in 2003. In addition, the FDA gave
Cook approval to enroll 100 patients at 10 institutions in a randomized pilot study using
its paclitaxel-eluting coronary stent to treat in-stent restenosis, a condition created when
restenosis occurs at the site of a previously implanted stent. Paclitaxel acts to prevent
excessive cell regrowth at the site of the angioplasty, which human clinical research has
shown may reduce or eliminate restenosis. Cook's polymer-free, paclitaxel-eluting
coronary stents are investigational devices not approved for sale in the United States at
this time (www.cookgroup.com/)
Intuitive Surgical Inc. (Mountain View, CA), manufacturer of operative robotic
surgery, said that on Jan. 15, a team of cardiac surgeons at New York-Presbyterian
Hospital's Columbia Presbyterian Medical Center completed the first-ever closed-chest,
totally endoscopic coronary artery bypass surgery in the United States. The procedure
was performed using Intuitive Surgical’s da Vinci Surgical System, and it begins the
company’s FDA clinical study that will involve several major medical centers in the
United States. The procedure requires that three or four pencil-sized holes -- or ports – be
made between the ribs. Through these ports, two robotic "arms" and a camera system
gain exposure to the heart, allowing the surgeon to perform surgery without opening the
chest. Although this is the first such procedure to be performed in the United States, more
than 200 have been performed in Europe, according to the company.
Eunoe Inc. (Redwood City, CA) initiated a multicenter clinical trial to investigate the use
of its COGNIShunt™ System in Alzheimer's disease patients. The device is designed to
increase the flow of cerebrospinal fluid and improve clearance of neurotoxins from the
fluid, which are believed to contribute to the progression of Alzheimer's disease. Phase
I/II feasibility study results, reported at the American Association of Neurological
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Surgeons Conference in July 2001, indicate that COGNIShunt may slow or stop the
progression of Alzheimer's disease symptoms. The procedure involves placing a narrow
catheter into the fluid-filled cavity of the brain, allowing the controlled drainage of a
small quantity of fluid into the abdomen. The surgery is conducted under general
anesthesia, and patients typically go home the next day or the day of the surgery.
(www.eunoe-inc.com)
Innomed Technologies Inc. (Boca Raton, FL) introduced the FDA-approved Nasal
Aire™ interface for sleep apnea. According to Innomed, the device requires no
headgear, virtually eliminates all pressure points on the face and bridge of the nose, has
one of the highest CO2 washouts, contains virtually no parts that can break from the
device, and wears like an oxygen cannula. (www.innomedinc.com)
Kensey Nash Corp. (Exton, PA) received approval to apply the CE Mark to its
TriActiv™ Balloon Protected Flush Extraction System, allowing sale of the product
throughout the European Union. The system is designed to prevent heart attacks during
the interventional treatment of saphenous vein grafts in patients who previously received
coronary bypass surgery, but now have blockages in the grafts. According to the
company, it incorporates three features to address the common problem of distal
embolization: a protection balloon guidewire, which creates a protected space; a flush
catheter, which washes the graft; and an extraction system, which removes the debris
found in the grafts. A U.S. randomized trial, the PRIDE trial (PRotection during
saphenous vein graft Intervention to prevent Distal Embolization), commenced in
December 2001. It will take place at up to 50 sites and will involve up to 800 patients.
(www.kenseynash.com)
Lifecor Inc. (Pittsburgh, PA) received FDA clearance for its wearable defibrillator for
patients who may be at a temporary but high risk for sudden cardiac arrest, or those who
may not be indicated for an implanted defibrillator. Defibrillators deliver electrical
shocks to jolt a heart following detection of irregular heart rhythms (arrhythmia) or other
symptoms of sudden cardiac arrest. The Lifecor device continually monitors the patient's
heart activity from outside the body. If it senses an abnormal heart rhythm, it gives a
series of alarms and delivers a shock to return normal heart rhythm if the wearer does not
respond to the alarms. It is designed to deliver the shock within 30 to 50 seconds.
(www.lifecor.com)
Medivance Inc. (Louisville, CO) said that it launched sales of its Arctic Sun
Temperature Management System, a non-invasive temperature management system
designed to monitor and regulate a patient's core body temperature during complex
surgical procedures, such as beating-heart off-pump coronary artery bypass, as well as
during other critical medical situations where achieving and maintaining normothermia is
vital to a patient's well-being. In addition to being used to prevent hypothermia during
complex surgical procedures, the system is being used in clinical investigations as a tool
to induce and sustain mild hypothermia in stroke patients and to reduce fevers in
intensive care patients, said the company. The system consists of the intuitive Arctic Sun
Control Module and the Arctic Sun Energy Transfer Pads™, which are applied on
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various areas of the body. Once the Energy Transfer Pads are in place, the system is
capable of achieving rapid and precise body temperatures in the range of 33 degrees to 37
degrees C and maintaining desired core body temperature, according to the company.
(www.medivance.com)
Meridian Medical Technologies Inc. (Columbia, MD) said it will seek clearance to
market its TelePulse™ oximeter in the United States. The device, which allows the
transmission of the blood oxygen levels and heart rate of heart patients to medical
personnel by telephone, is currently available in Europe and Israel. It is used in
conjunction with the company’s TeleWeight and TelePres products to monitor congestive
heart failure patients at home. (www.meridianmeds.com)
Oakwood Annapolis Hospital (Wayne, MI) said it is the first hospital in the world to
begin using the Niagara PVP™ laser photo-selective vaporization procedure for benign
prostatic hyperplasia. The system was developed by San Jose, CA-based Laserscope. In
the 20-minute procedure, laser pulses -- delivered through a fiber the thickness of a hair
inserted in the urinary passage -- completely vaporize obstructive prostate tissue. The
laser seals the surrounding area, creating a virtually bloodless procedure, according to the
company. The procedure generally takes around 20 minutes and is generally done under
local anesthetic. Recovery time is reduced from three weeks to two days. Patients can
return to work the day after the operation.
Orqis™ Medical (Lake Forest, CA) said that it was awarded its second key patent for
the development of a Cardiac Recovery System for the treatment of Class III and IV
congestive heart failure patients. The company has initiated clinical trials in Europe with
Cancion™, its first device for minimally invasive treatment of congestive heart failure,
which affects nearly 7 million people in North America. (www.orqis.com)
Prosurg Inc. (San Jose, CA) said that it has developed an RFGel – RF electrosurgical
technology platform for microinvasive, image-guided, endoscopic treatment of
controlled tissue ablation in urological, gynecological and general surgical disorders. The
conductive RFGel is said to be safe, biocompatible and visible under ultrasound, CT and
MRI imaging. Physicians can create a three dimensional, interactive RFGel electrode of
any shape and size under "real time" image guidance to achieve desired tissue ablation
zone, by controlling injection volume of conductive RF Gel. The RFGel device consists of
18 Ga needle probe with proximal RF connector and delivery port for RFGel. The RFGel
electrode is said to enhance the conduction of RF energy and create a controlled zone of
necrosis in the target tissue for optimum clinical outcome and patient safety. The RF Gel
device is compatible with all of the commercially available RF generators, including
Valley Lab, Conmed, Bard, ERBE and others. (www.Prosurg.com)
Raymedica Inc. (Minneapolis) received marketing approval for the sale of its PDN®
prosthetic disc nucleus device in Argentina, Brazil and Mexico. Previously, the
company had received marketing approval for the PDN device in the smaller Latin
American countries of Chile and Venezuela. The device is comprised of a hydrogel
material designed to replace the function of a failed spinal disc nucleus. To treat low-
19
back pain, a pair of PDN devices is implanted in the center of the spinal disc. (In smaller
patients, a single PDN device is sufficient.) The devices are designed to support the bones
of a patient’s spine while allowing for more normal flexibility and movement than spinal
fusion, the current established surgical treatment, in which adjacent vertebrae are fused
together. Raymedica is pursuing marketing approval from the U.S. FDA and recently
received approval to begin a second round of U.S. clinical evaluations.
(www.raymedica.com)
Response Biomedical Corp. (Burnaby, BC) received FDA clearance to market its
RAMP™ Reader and RAMP Myoglobin Test, used for the rapid diagnosis of heart
attacks. The RAMP System is said to deliver results in less than 15 minutes, enabling
immediate decision-making in hospitals, clinics, emergency rooms and doctors' offices.
(www.responsbio.com)
TherOx Inc. (Irvine, CA) received FDA permission to initiate a Phase II clinical study in
the United States with the TherOx® AO system, which hyperoxygenates a patient's
blood with aqueous oxygen, and then delivers the hyperoxygenated blood to oxygendeprived areas of the heart following heart attack. David O. Williams, M.D. at Rhode
Island Hospital will serve as Principal Investigator. In addition to the initial heart attack
application, TherOx is exploring the application of AO technology to stroke, cancer
therapy, wound treatment, and skin care. ( www.therox.com)
Closure Medical Corp. (Raleigh, NC) received FDA approval to include in its device
labeling that DERMABOND adhesive acts as a barrier to microbial penetration.
Clinically, this provides for the potential reduction of infection rates, as long as the
adhesive remains intact, when closing incisions and lacerations with DERMABOND
adhesive vs. the traditional use of sutures and staples, which have not been shown to
protect against microbial penetration.
New practice guidelines to assist physicians in evaluating and managing the risk of
cardiovascular complications in heart disease patients immediately before and after
they undergo non-heart-related surgery are now available from the American College of
Cardiology and the American Heart Association. The guidelines (“ACC/AHA Guidelines
for Perioperative Cardiovascular Evaluation for Noncardiac Surgery”) update an earlier
version published in 1996. The document outlines a stepwise approach to assessing a
patient's cardiac health before surgery, guiding the physician in balancing the patient's
clinical condition and physical fitness against the risk of a specific surgery. It also
encourages wider use of beta blockers -- medications that slow the heart rate, lower blood
pressure, and protect the heart during stress. Another important change in the guideline
cautions physicians against performing surgery in a patient who has recently had a
narrowed coronary artery opened with a stent. Fresh stents can increase the risk of
developing a blood clot in the coronary artery, while the anti-clotting drugs set the patient
up for the possibility of more bleeding from the surgical wound. The guidelines also offer
new information on safely performing surgery in patients with pacemakers and implanted
defibrillators and goes into detail on how to care for patients who have a heart attack
during or shortly after surgery. Each year, of approximately 8 million Americans who
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have or are at substantial risk for heart disease, at least 1 million suffer a significant
cardiac complication, including 50,000 who have a heart attack, while undergoing
surgery. The guideline update can be viewed on the Web sites of the ACC (www.acc.org)
and the AHA (www.americanheart.org).
IMDA Update
©2002 IMDA
5800 Foxridge Dr., Suite 115
Mission, KS 66202-2333
(800) 398-5632
www.imda.org
Executive Director: Frank Bistrom, imda@imda.org
Membership Services Director: Betchie Bistrom, imda@imda.org
Legal Counsel: Mitchell Kramer, krameresq@aol.com
Insurance Administrator: Schifman Remley & Assocs (Mike Fate, m_f@srains.com)
Editor and Communications Director: Mark Thill, markthill@attbi.com
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