Welcome to Compliance Consultants...
...the more you learn...the more you will want us for FDA!
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Welcome to Compliance Consultants...
...the more you learn...the more you will want us for FDA!
C2 will conduct a marketing
fact finding project as an adjunct to launching new medical devices in the U.S.
to focus on new high technology medical marketplaces. You receive information
about what is going on in the marketplace right now not what happened. A
typical project can be summarized as follows. Definitions
& Who's Who C2 will establish detailed
definitions to identify the marketplace.
These definitions would consist of: who purchases similar systems, who
uses it in the field, which regulates products, who delivers the services, and
what performance or accuracy are required. C2 will identify all
major influences in the marketplace including both the formal and informal
influences in the marketplace including:
a) Competition
b) Potential
Purchasers c)
Population, industries, regions at risk, d) related
demographics. Marketplace All aspects will be included to define the marketplace, who
buys, the size of the markets, age of the markets, past / future history of the
market, impact articles {recently published to identify trends in the
marketplace} print articles, trade shows, primary competitors, shadow
competitors {who is likely to be deprived of income due to the success of your
product} or who is likely to actively compete for the equipment or service
which would result in lower sales. C2 will define the
current marketplace in detail with all appropriate listings. We include all
forecasts and trends, which may have a significant effect on the market. Physicians We will identify competing treatments currently used by
physicians, demographics of the prescribing physicians and specific products
for treatment. Patients We define patient demographics, population, and the most
likely regions to need the service, current diagnostic efforts, etc. Pricing C2 defines the cost
elasticity for the product, The mark up chain citing actual manufacturers, distributors,
and wholesalers to establish the price structure. This structure may be complex
involving multiple structures and various products. Product We assemble information to establish the expected service
and performance of your therapeutic or treatment device. Potential
Purchasers C2 provides a list of
potential purchasers (accumulated from many different sources). These potential
purchasers could be actively solicited as well as potential OEM distributors as
part of the product launch. We can even provide sources from which to derive mailing lists. Personalities We identify leading advocates, political action committee,
legislative review bodies, etc. which would be of interest. These groups or
personalities would have had some notoriety or public reaction the concept they
advocate. Competitive
Manufacturers We identify current and similar products for competing
technology that could affect sales. Of these manufacturer's we can detail their
product costs including: industries, R
& D and manufacturing costs. We would also identify current providers of
services who may purchase or use your device. Regulatory
Controls We identify what agencies {both mandatory and participatory}
regulate your product such as: FDA, OSHA, EPA, etc. We identify those
institutions who govern activities related to the market, processes, health
risk, equipment, etc. C2 will identify
authorities, trade unions or standards that regulate the performance of the
product with agencies such as: FDA, UL,
OSHA, EPA, Red Cross, or AMA We also identify accepted accuracy for related
test data. Data
Collection and presentation We collect data empirically. All sources are personally
contacted by phone to verify the information which applies. Usually over 100
conversations with various significant personalities and challenges are
conducted. We maintain a log of conversations and as data arrives we organize
and build the data into appropriate volumes for presentation. You receive: Customer
Publications, Trade
Publications, Scientific
Journals, Institutional
Bodies, Trade Shows, Lobby
Organizations, Patient
Support Groups, sample
magazines, trade show
announcements, magazine
articles, journal
publications, etc. product
brochures from competitors, complete
prices media reviews
or reactions concerning available
products. current
magazines & trade shows. We collect information packages from related institutional
governing bodies who police or organize other users or manufacturers and may
issue specifications or standards. All data would be researched & authenticated prior to
presentation. We verify all phone numbers, data, and accuracy of data. Significant
Legal / Legislative Activities We identify any significant legislation or legal activities,
which could have a significant effect on the product or on the regulatory
environment in the marketplace. Merchandising
Structure As part of defining the merchandising structure, we define
the overall price, distribution, inventory turns, competitive point of sale
promotions, point of sale incentives and mark up chains. Our analysis follows a
competitor's product from the time the product leaves their shipping dock until
it is used by the patient. Where applicable, we can research various accepted insurance
re-reimbursement rates for the product.
marketing investigations
Marketing
Investigations
copyright by Compliance Consultants, Stamford, CT USA, September 2001
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Compliance Consultants
1151 Hope Street
Stamford CT 06907 USA
voice 203 329 2700
fax 203 329 2345