U.S. patent application number 11/415368 was filed with the patent office on 2006-11-30 for method of manufacturing a multiple component device.
Invention is credited to George A. Lopez.
Application Number | 20060271228 11/415368 |
Document ID | / |
Family ID | 22620776 |
Filed Date | 2006-11-30 |
United States Patent
Application |
20060271228 |
Kind Code |
A1 |
Lopez; George A. |
November 30, 2006 |
Method of manufacturing a multiple component device
Abstract
Disclosed are methods of manufacturing a product from individual
components comprising the steps of providing data regarding
components to a customer; permitting the customer to request a
product comprising the combination of the components; transmitting
the request to a first location remote from the customer; receiving
one of the components at a first location; transporting the
components from a first location to a second location; assembling
the components into the desired product at the second location; and
transporting the assembled product to the customer.
Inventors: |
Lopez; George A.; (Laguna
Beach, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
22620776 |
Appl. No.: |
11/415368 |
Filed: |
May 1, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10398432 |
Apr 26, 2004 |
7099731 |
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PCT/US00/34124 |
Dec 14, 2000 |
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11415368 |
May 1, 2006 |
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60170659 |
Dec 14, 1999 |
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Current U.S.
Class: |
700/117 ;
700/97 |
Current CPC
Class: |
A61M 39/12 20130101;
G06Q 30/0601 20130101 |
Class at
Publication: |
700/117 ;
700/097 |
International
Class: |
G06F 19/00 20060101
G06F019/00 |
Claims
1. An assembly method for multiple-component kits comprising:
providing a selection of components; providing data in a database,
said data comprising data regarding characteristics of each of said
components in a database, data regarding availability of said
components, and data regarding combinations of said components;
allowing a potential customer to access data from the database
(dep: directly) permitting a customer to select a combination of
components; approving a combination of components using a program
to create an approved combination; permitting the customer to place
an order for the approved combination; transmitting data regarding
the approved combination to a first location; transmitting data
regarding at least one component in an approved combination from
the first location to a second location; receiving components in
the approved combination at a third location; assembling components
in the approved combination to form an assembled product; and
sending said assembled product to a customer.
2. The method of claim 1, wherein allowing a potential customer to
access data from the database comprising allowing a potential
customer to access data relatively directly from the database over
the world wide web.
3. The method of claim 1, wherein the second location is the same
as the third location.
4. The method of claim 1 wherein providing data in a database
further comprises providing data relating to compliance with
government regulations.
5. The method of claim 4, wherein providing data relating to
compliance with government regulations further comprises providing
data relating to compliance with FDA regulations.
6. The method of claim 1, wherein providing a selection of
components further comprises providing a selection of at least two
components selected from the group consisting of the following: an
IV drip bag, medical tubing, a needleless injection site, a Y-site,
and a luer connector.
Description
PRIORITY INFORMATION
[0001] This application is a continuation of, and claims priority
to, U.S. patent application Ser. No. 10/398,432, titled "METHOD OF
MANUFACTURING A MULTIPLE COMPONENT DEVICE," for which the last of
the 35 U.S.C. 371 (c)(1), (c)(2), and (c)(4) ere received in the
United States Patent and Trademark Office on Apr. 26, 2004, which
is a National Stage of International Application No.
PCT/US2000/34124, filed Dec. 14, 2000, which claims priority to
U.S. Provisional Patent Application No. 60/170,659, filed Dec. 14,
1999. The entirety of each of the above-referenced is hereby
incorporated by reference and made part of this specification.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to methods of manufacturing
devices, and specifically to methods of manufacturing devices
comprised of multiple component products.
[0004] 2. Description of the Related Art
[0005] Many manufacturers produce a comprehensive line of component
products which are designed to interconnect and function together.
It is often desirable for such manufacturers to sell their
components separately because the varying needs of their customers
would not be readily satisfied by any single combination of
components, and it is frequently not economically feasible to
assemble the components in accordance with the individual needs of
every customer at the manufacturing site. In addition, in some
industries, manufacturers make individual components which are
capable of being used in combination with the components of other
manufacturers in the industry.
[0006] As a consequence, the customer usually is faced with the
inconvenient task of obtaining the desired component parts from one
or more manufacturers and then combining them in the desired
configuration. When a customer has a continuous need for such a
combination of components, the burden of ordering the components
and putting them together may become very time-consuming and
expensive.
[0007] The problem is especially evident in the medical device
industry. For example, medical practitioners often require a
variety of components to create a desired intravenous (IV) set. The
components of an IV set may include IV drip bags, medical tubing,
needleless injection sites, Y-sites, luer connectors, etc. Many of
these components are repeatedly used together in certain
configurations for specific applications at a given hospital or
other care center, but the components are generally sold separately
by separate manufacturers.
[0008] Some medical device manufacturers have permitted their
customers to order combinations of such components pre-assembled.
However, as described below, the expense and delay heretofore
associated with pre-assembled combinations has often been
prohibitive, especially in view of the increasing cost constraints
placed upon medical practitioners and medical device companies by
insurance companies and the consuming public. Thus, despite the
recurrent use of a certain combination at a facility, many medical
practitioners have still been forced to order the components
separately and then assemble them on site.
[0009] An example of a combination of IV set component parts that
might be desired at a given hospital is shown in FIG. 1. In this
example, a first end of a section of medical tubing 20 is inserted
into a first inlet 22 of a Y-site 24. A female luer 26 and a CLAVE
28 fluid connector (manufactured by ICU Medical, Inc. of San
Clemente, Calif.) are attached in series to the opposite end of the
medical tubing 20. A PIGGY LOCK connector 30 (also available from
ICU Medical, Inc.) is attached to a second inlet 32 of the Y-site
24, and a section of medical tubing 36 is coupled to the outlet
port 38 of the Y-site 24. The PIGGY LOCK connector is attached to
tubing 37 which is attached to a spike 35. The tubing 36 is
connected to a luer lock 39 at its opposite end.
[0010] The typical prior art procedure for providing a
pre-assembled combination of such an IV set is outlined below. A
customer first contacts a manufacturing representative of a company
which offers one or more of the components of the desired
combination. The manufacturing representative then informs the
manufacturer of the request and an employee of the manufacturer
must then determine whether the requested combination can be
provided in view of applicable governmental regulations.
[0011] Assuming the combination is permitted by such regulations,
the manufacturing representative then arranges for another employee
to put together a sample of the desired combination from the
component parts. The sample is then sent to a facility for medical
sterilization and packaging, returned from the sterilization
facility, and then sent to the customer.
[0012] In this process, if the manufacturer does not make all of
the components of the desired combination, the manufacturer may
need to obtain one or more of the components from another
manufacturer.
[0013] It typically takes about ten days from the time the customer
originally requests the sample to the time the customer receives
the sample. The customer then evaluates the sample to determine
whether it is satisfactory. If the customer approves of the sample,
the customer must generally place a minimum bulk order of the
combination with the manufacturing representative. In most cases,
the customer does not have the option of ordering the desired
combination in small quantities.
[0014] Bulk orders are usually required because the process of
assembling and packaging a specific combination requires
reconfiguration of the assembly process and special attention by
the manufacturing and distribution personnel, entailing additional
expenses which are only compensable by the profits resulting from
an order of substantial size.
[0015] The assembly process usually takes an extended period of
time. After assembly, the products must be sterilized and packaged.
The process of sending the products to the sterilization facility,
performing the sterilization and packaging, and then sending them
back to the manufacturer takes more time. As a consequence of the
various delays and inefficiencies, the complete process takes
approximately four to six months from the time the customer first
contacts the manufacturing representative to the time the customer
receives the first bulk order.
[0016] Another problem associated with this procedure relates to
the end cost of the product. As may be appreciated, the cost of
labor is the primary cost associated with producing the product. In
this process, a substantial number of man hours are spent in this
process preparing the sample product. More man hours, and capital
expenditure, are required to produce the minimum order of the
product. Because of the substantial man-hours associated with the
preparation of the product, the cost of the product is very high.
This is especially true when viewed in relation to the number of
products produced. This cost is passed on to the consumer, after
application of a profit margin by the medical device supplier and
hospital. In addition, they often produce several times the amount
of the product ordered and keep the remaining product in inventory
so that subsequent orders can be filled more quickly.
[0017] There is thus a need for an improved method of manufacturing
pre-assembled combinations of component parts.
[0018] It is an object of the invention to provide a method in
which the customer is given more information at the beginning of
the ordering process and the assembly process and wherein the
assembly and transportation are efficiently controlled in a manner
which provides the product more quickly and at a significant
reduction in cost.
SUMMARY OF THE INVENTION
[0019] The present invention is a method of manufacturing a product
from at least two individual components. In general, this method
comprises the steps of providing data regarding at least a first
and a second component to a customer; permitting said customer to
request a product comprising the combination of at least said first
and said second component; transmitting said request to a first
location remote from said customer; receiving at least on of said
first and second components at said first location; transporting
said first and second components from said first location to a
second location ; assembling said first and second components into
the desired product at said second location; and transporting said
assembled product to said customer.
[0020] Preferably, data regarding each individual component and
combinations of multiple components is available on a database. The
customer accesses this database to determine the availability of
particular combinations of components.
[0021] The database is associated with a program which permits the
customer to place an order for an approved combination of
components.
[0022] In the preferred embodiment, the method is used to create a
multi-component medical device, such as an IV set.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a plan view of an example of a combination of
medical device component products;
[0024] FIG. 2 is a flowchart illustrating the steps of the method
of the present invention;
[0025] FIG. 3 is a schematic illustrating the interrelationship
between the various locations and activities associated with the
method of the present invention; and
[0026] FIG. 4 is a schematic illustrating the method of the present
invention as used to create the product illustrated in FIG. 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] The present invention overcomes the expense and delay
previously associated with providing customers with combinations of
component products by using a novel method of bringing all of the
components together for assembly, performing the assembly process
in an efficient and economical manner, and delivering the assembled
components directly to the customer.
[0028] The method of the present invention is broadly illustrated
in FIG. 2. In a first step S1, a number of component parts are made
generally available to a customer by a vendor. These components may
be provided by a number of suppliers or manufacturers. In step S2,
a customer places an order with the vendor for a product comprising
at least two of the assembled components which are available.
[0029] In step S3, the vendor requests each of the assembled
components required to produce the combination from the individual
suppliers or manufacturers. In step S4, these individual components
are delivered to a single location where they are combined in bulk.
These unassembled but amassed components are then delivered to an
assembly location, where in step S5 they are assembled into the
desired combination of the components.
[0030] In an optional step S6, the assembled combinations are
subjected to post-production processing, such as packaging or
sterilization. This processing may take place in a remote location
from the location of assembly.
[0031] Finally, in step S7, the completed products are shipped
directly to the consumer which placed the order in step S2 or an
address to which the consumer wishes the products to be
delivered.
[0032] In accordance with the present invention, the method
illustrated in flowchart form in FIG. 2 preferably occurs at
several locations and involving several parties, the
interrelationship of which is illustrated in FIG. 3.
[0033] As illustrated in FIG. 3, according to the present invention
a vendor preferably provides a customer 40 with means for
ascertaining all possible combinations of available components.
Preferably, this means provides the customer with information
regarding each individual component, as well as combinations
thereof. In addition, the customer is provided with information
regarding which combinations are prohibited by applicable
government regulations.
[0034] This means may include a catalog, a telephone system, or
preferably, a computer program with a comprehensive database. This
database includes information regarding each component, such as the
specifications of the component and the like. In the case of a
computer database, an illustration of the component is provided on
a viewing screen.
[0035] A program associated with the database permits the customer
to obtain information regarding proposed combinations of individual
components. In this arrangement, a customer may utilize a computer
at a remote location to access a main computer associated with the
vendor which contains the database. The customer's computer
communicates with the main computer via the Internet, a telephone
link or other means well known in the art. Of course, one or more
access computers may be provided at the location of the vendor
which the customer may use to obtain the same information. This
arrangement is less desirable, however, since the customer must
travel to the vendor's location to obtain the information.
[0036] Preferably, the program is arranged so that the customer
selects individual components from the database and requests their
combination. In response, the computer instantly displays the
desired combination and indicates whether it is acceptable. For
example, in the medical area, the computer database would contain
information regarding whether a particular combination of
components meets FDA approval.
[0037] The means for ascertaining the combination components
preferably allows the customer to choose products made by a wide
variety of manufacturers. In this way, the customer may, if
desired, choose components from different manufacturers to include
in the combination. In this arrangement, the database simply
includes the necessary information regarding the individual
components, regardless of their source, and combinations
thereof.
[0038] According to a preferred embodiment, once the customer has
put together a given combination of products on the computer screen
and the computer program has determined that the combination is
acceptable, the customer is then permitted to place an order.
Preferably, this order is placed directly through the computer
which is being used to determine the proposed combinations of
components.
[0039] When the customer places an order through the main computer,
the main computer transmits the customer's order to a control
office 42. Depending on the location of the main computer and the
control office, this transmission may be through a direct
connection, or when the computer and control office are far apart,
through an electronic connection such as the Internet or via fax,
etc.
[0040] As stated above, desirably a computer program forms an
integral part of the method, facilitating access to the component
and component combination data, as well as permitting ordering.
[0041] As one aspect of the invention, a printer or similar device
is preferably provided at the kit factory 50 for printing out the
order and instructions which are to be provided with the components
are to be assembled at the assembly location 52. The instructions
may be arranged to include pre-printed address labels for the
assembly location 52 and customer 40 which are used to label the
packages to each of these locations.
[0042] Most importantly, the method of the present invention
permits the customer to order any number of products.
[0043] Thus, the customer is not required to order a bulk order. As
detailed below, the present invention is so efficient that bulk
orders are not required to recoup assembly and administrative
costs.
[0044] The control office 42 is preferably a small, stream-lined
facility. There need not be many employees or extensive building
space because the fundamental role of the control office is merely
to receive electronic orders from the customer, send electronic
instructions and receive status reports from other locations
involved in the steps of the present invention.
[0045] In fact, much of the order processing may be carried out by
a computer system in the control office without the need for a
great deal of employee involvement.
[0046] At or after the same time the order placed by the customer
is transmitted to the control office 42, a corresponding order is
transmitted to each supplier of the components comprising the
desired assembled product. The orders which are transmitted to the
suppliers or manufacturers of the components may be transmitted
with the request to the control office 42, such as in the same or
substantially-the same step performed by the computer program or
other protocol.
[0047] Preferably, when the control office 42 receives the
customer's order, the control office immediately transmits the
order. In the arrangement illustrated, a corresponding request or
order is transmitted to three manufacturers 44, 46, 48.
[0048] The order is also transmitted to a kit factory 50 associated
with the vendors 44, 46, 48. This transmission is also preferably
via a computer network.
[0049] The manufacturers' 44, 46, 48 involvement may be limited to
just receiving orders and sending individual components, a task to
which they are already well adapted. In that regard, the orders
transmitted thereto are preferably for the manufacturer to deliver
or transport the desired components to the kit factory 50.
[0050] In this arrangement, the kit factory 50 is a facility which
desirably has very little storage capacity for component parts. The
reduction in total inventory contributes to a lower cost of
production.
[0051] Instead, the kit factory 50 simply serves as a location
where orders are received and to which component parts from the
manufacturers are amassed and then sent to an assembly location. As
a result, the kit factory operates as economically as possible.
[0052] In a preferred arrangement, the kit factory 50 has some
inventory, permitting immediate amassing of the necessary parts for
forwarding to the assembly location 52. In this arrangement, the
orders are placed with the manufacturers 46,48,50 to provide
immediate replacement of the depleted minimal inventory.
[0053] The respective manufacturers 44,46,48 transport their
requested components to the kit factory 50. The components may be
transported by truck, airplane or any means known to those of skill
in the art.
[0054] The components arrive at the kit factory a short time,
preferably the same day, or within a few days after the customer's
order is first received. In that event, if insufficient inventory
existed, the time to receive additional components is minimal, and
used inventory is immediately replenished. To reduce the cost
associated with transportation, the kit factory 50 is desirably
located close to the manufacturers 44,46,48, but also close to an
assembly location 52, described below.
[0055] An employee at the kit factory 50 then rapidly amasses the
separate components from the manufacturers together with assembly
instructions regarding how the components are to be combined. In a
preferred embodiment, the description consists of a simplified
schematic picture generated by the computer system of the combined
components. The picture is desirably included in the package
containing the separate components and the package is then sent to
the assembly location 52. The picture or other instructions may
contain a bar code which is read at each step of the process so
that the computer will record exactly where any particular order
is. A customer may be given access to the bar code system to
"track" the progress of the customer's orders.
[0056] Of course, in alternative embodiments, any of the locations
where the method steps are performed may be combined, or the
locations may be very close to each other, such as different rooms
in the same building.
[0057] In order to further limit the total cost of producing the
desired combination of component products, the assembly location 52
is preferably situated in a place where labor costs are
substantially lower, such as a foreign country (such as Mexico),
thereby significantly diminishing the cost of assembly. The
components are quickly combined into the desired combinations by
the personnel at the assembly location 52 with reference to the
schematic picture or other assembly instructions which are
conveniently provided along with the bulk components.
[0058] After assembly, the products may be sent to a
post-production location 54. In the case of medical devices, this
location comprises a sterilization and packaging facility. In that
arrangement, the assembled combinations are therefore sent from the
assembly location 52 to a sterilization plant 54. After
sterilization and packaging, the products are then preferably sent
directly to the customer 40. Alternatively, the products may be
sent to a hub which then distributes the products to customers, as
will be understood by those of skill in the art.
[0059] In the preferred embodiment, the method of manufacture is
utilized to create medical devices from individual components. An
example of the method is utilized to create a medical device will
be described with reference to FIGS. 1 and 4.
[0060] A customer is interested in obtaining the assembled product
illustrated in FIG. 1 and described above. The customer accesses
the vendor's main computer containing the above-referenced
database. The customer locates each of the individual components of
the product in the database. In this case, the components include a
standard CLAVE connector 28, tubing 20, Y-site 24, adapter 26 and
PIGGY LOCK'D connector 30. (The remaining components shown in FIG.
1 will not be described for simplicity.) The customer instructs the
main computer to create a "cyber" version of these components
assembled into the desired product configuration 98. This product
configuration is illustrated on the screen of the customer, as
illustrated in FIG. 4 at 100. The screen preferably displays data
regarding the cost per unit of the product 102 and whether the
combination can be produced in light of governing regulations
104.
[0061] If the combination is approved, the customer orders a
quantity of the product. This order is received at the control
office 42. Either simultaneous with the customer's order, or at or
near the time of receipt thereof at the control office 42, an order
is sent to the manufacturer or supplier of each of the individual
components, requesting their delivery to the kit factory 50.
[0062] Upon receipt of the individual components, an employee at
the kit factory 50 prepares a package containing the raw materials,
i.e. components, necessary for assembly of the final product. In
this case, if 100 of the product illustrated on the customer's
computer screen have been ordered, at least 100 of each of items
20, 24, 26, 28 and 30 are placed into the package. In addition, an
instruction and data sheet is provided with this package. This
sheet preferably contains data regarding the order, the customer
and how the individual components are to be assembled to complete
the combination.
[0063] The assembly instructions preferably include a pictorial
representation of the assembled product which may be used as a
guide in the assembly process.
[0064] This package is delivered to the assembly location 52. At
this location, the instructions are utilized to assemble the
completed product from the individual components. The assembled
products are then placed into a package and delivered to the
sterilization facility 54. At this facility, each product is
sterilized and/or packaged. The products are then delivered to the
customer 40 or a distribution hub.
[0065] Many advantages are realized using the above-described
invention. First, the method of the present invention provides
products to customers much faster than conventional methods. In
fact, customers may receive the products ordered in a few days as
opposed to weeks or months later. In addition, the cost to
manufacture the products is dramatically reduced. Samples do not
need to be produced, and inventory is kept to a minimum as
described above.
[0066] The above is a description of the application of the method
of the present invention to a single product. Those of skill in the
art will appreciate how the method may be applied to create a wide
range of products from individual components.
[0067] Of course, the foregoing description is that of preferred
embodiments of the invention, and various changes and modifications
may be made without departing from the spirit and scope of the
invention, as defined by the appended claims.
* * * * *