`
`
`
`
`
`2010 ENTRY QUESTIONNAIRE
`
`Entrants must provide their responses to this questionnaire in both electronic (e-mailed or CD-
`ROM) and hard-copy (signed) forms. E-mail forms to mdea@cancom.com. Mail CD-ROM and
`hard copies together with other required entry materials to:
`
`
`Medical Design Excellence Awards
`c/o Sherrie Conroy, Editor-in-Chief
`Canon Communications LLC
`11444 W. Olympic Blvd.
`Los Angeles, CA 90064-1549
`Phone: 310/445-4280
`
`
`Entrants who choose to generate their own form must include the questions as listed below. The
`downloadable Entry Questionnaire is provided as an unlocked Word document; when completed,
`it should be submitted in the same format. Do not lock the document or convert it to a portable
`document format (PDF) file. Do not alter the formatting of the questionnaire by changing type
`size or color or by resetting margins. The total length of answers to questions 10 through 16
`should not exceed seven single-spaced pages.
`
`Entrants are encouraged to support their responses to this questionnaire by providing additional
`photographs, figures, and other exhibits. Such materials should be referenced at the appropriate
`places in the responses to this questionnaire (e.g., see figure 1; see exhibit 4). In the hard copy
`format of the entry, such materials should be clearly numbered in the bottom margin and placed at
`the end of the questionnaire. In the electronic format of the entry, such materials should be
`provided as separate files with clear filenames (e.g., productname-image01; productname-
`figure02; productname-exhibit04, etc.).
`
`The MDEA Entry Instructions provide detailed information about the formatting of electronic
`files and hard copy materials. Please review and follow these instructions when compiling
`entries. Do not embed photos or other documents within the responses to this questionnaire.
`
`For complete competition rules and entry instructions, visit the awards Web site at
`www.MDEAwards.com.
`
`
`
`
`1
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 1 of 11
`
`

`

`PRODUCT AND ELIGIBILITY INFORMATION
`
`1. MANUFACTURER NAME (the single corporate entity holding regulatory approval for marketing
`the product).
`Medline Industries, Inc
`
`2. PRODUCT BRAND NAME.
`ERASE CAUTITM Foley Catheter Management System
`
`3. REGULATORY APPROVALS granted to the product (provide name of approving body,
`identification number, and date of issuance).
`None. This product is considered a convenience kit, so regulatory approvals are not necessary.
`
`4. DATE FIRST COMMERCIALLY AVAILABLE.
`September 1, 2009
`
`5. COUNTRIES WHERE COMMERCIALLY AVAILABLE.
`United States of America
`
`6. DIMENSIONS AND WEIGHT.
`Tray Dimensions:
`Length: 10.25 inches
`Height: 9.25 inches
`Width: 1.75 inches
`Weight: 12.8 ounces
`
`7. SUGGESTED RETAIL PRICE.
`MSRP: $38.52 – $52.63
`
`8. A CAPTION describing the product and its intended use (255 characters maximum, including
`spaces).
`Medline’s revolutionary patent-pending Foley Catheter Management System features a re-
`engineered tray that uses evidence-based solutions to help improve the insertion process and
`minimize the risk of urinary catheter-associated infections.
`
`9. SELECT AN ENTRY CATEGORY from the list below. Entrants may choose only one category
`per entry. (Jurors may move an entry into a more appropriate category.)
`
`
`_____ Critical-care and emergency medicine products
`_____ Dental instruments, equipment, and supplies
`_____ Finished packaging
`__X__ General hospital devices and therapeutic products
`_____ Implant and tissue-replacement products
`_____ In vitro diagnostics (biochemicals for diagnostic use, related instrumentation, and
`home-use devices)
`_____ Over-the-counter and self-care products
`
`
`
`2
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 2 of 11
`
`

`

`_____ Radiological and electromechanical devices (diagnostic imaging devices, energy-
`emitting therapy devices)
`_____ Rehabilitation and assistive-technology products (healthcare furnishings, patient-
`transfer equipment, and home-use medical equipment and supplies)
`_____ Surgical equipment, instruments, and supplies
`
`
`JUDGING INFORMATION
`
`
`MDEA jurors will use responses to the following questions (and additional exhibits provided) to
`evaluate each entry. Answer each question fully and directly, referring to supporting documents
`as necessary. Do not exceed seven single-spaced pages.
`
`Additional photographs, figures, and other exhibits should be referenced at the appropriate
`places in the responses to this questionnaire (e.g., see figure 1; see exhibit 4). In the hard copy
`format of the entry, such materials should be clearly numbered in the bottom margin, and placed
`at the end of the questionnaire. In the electronic format of the entry, such materials should be
`provided as separate files with clear filenames (e.g., productname-figure 1, productname-exhibit
`4). Do not embed photos or other documents within the responses to this questionnaire.
`
`
`10. PRODUCT OVERVIEW. In a single paragraph, describe the product and its intended use. This
`paragraph should define what the product is, who should use it, the medical purposes of the
`product, and what settings it may be used in.
`
`The ERASE CAUTITM Foley Catheter Management System should be used at healthcare
`facilities as a quality improvement program to enhance appropriate use of indwelling Foley
`catheters and to reduce the risk of infection due to an indwelling catheter (see Exhibit 1). The
`medical purpose for the product is to allow a patient’s urine to drain freely from the bladder.
`The ERASE CAUTI™ education program is reinforced at the patient bedside with a completely
`redesigned 1-layer closed system tray (see Exhibits 2 and 3). The Foley Catheter Management
`System tray incorporates the ERASE acronym into the design of the tray which triggers the next
`step in the proper use of the tray and promotes the recommended guidelines from leading
`industry experts (see Exhibit 4). On the outer package of every tray is a checklist which verifies
`that the patient has a valid clinical reason for a Foley catheter (see Exhibit 5). Every tray also
`includes a step-by-step instructional guide which can be used as a training tool for new staff
`throughout the facility (see Exhibit 6). Once it has been validated that the patient does indeed
`need a catheter, the tray has been redesigned to make it hard for the clinician to do the wrong
`thing. The sequencing of the 1-layer tray moves you from left to right and allows you to
`visualize all of the components available to you to complete the procedure. Unique features of
`the tray include pre-saturated PVP swab-sticks to facilitate proper patient prep and a CSR wrap
`that allows for a 56% increase in workable sterile field. A "lubrication well" has also been
`designed as a place to keep the catheter in place and prevent it from moving outside the sterile
`field. Once the catheter has been properly inserted, a securement device has been included to
`encourage proper catheter securement (see Exhibit 7). The tray also includes a Foley
`InserTag™, which can be used to track when the catheter was inserted (see Exhibit 8). Once the
`
`
`
`3
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 3 of 11
`
`

`

`procedure has been completed, a patient education (bi-lingual in Spanish and English) card is
`available (see Exhibit 9).
`
`11. MATERIALS AND COMPONENTS. What types of materials, components, and processes are
`used to fabricate the product? Be specific (e.g., polystyrene exterior case, EPROM circuitry, RS-
`232 communications ports, automated subsystem assembly, E-beam sterilization).
`
`The base of the Foley Catheter Management System tray is fabricated using recyclable,
`polypropylene and is injection molded with the labeling pad printed along the top of the tray.
`The kit assembly is done by hand, placing each component in a strategic position and order. The
`exterior components include a paper poly CSR wrap, paper poly under buttocks drape, Medline’s
`Aloetouch 3G stretch synthetic vinyl latex-free gloves, Aplicare antiseptic gel hand sanitizer,
`filled sterile water syringe, water soluble lube jelly syringe, polypropylene specimen container,
`triple-pack of pre-saturated povidone-iodine swabsticks, the adhesive backed Foley InserTag™
`and the latex-free adhesive fabric Medline Foley Catheter Securement Device. Also included in
`the tray is a Foley catheter pre-connected to a vinyl, latex-free urinary drainage bag. The entire
`tray is wrapped in a plastic peel pouch and ETO sterilized.
`
`12. TECHNOLOGICAL CHALLENGES. In relation to the clinical objectives of the product, describe
`the principal design and engineering challenges and how the product overcomes them. Pay
`particular attention to design and engineering innovations unique to this product.
`
`The initial design challenge was initiated by clinicians and their concerns about the deficiencies
`with the current products in the market used during the Foley catheterization procedure. The
`typical Foley catheter insertion tray is two layers, with the base of the tray holding the drainage
`bag and catheter while the upper level of the tray holds all of the patient preparation components.
`This traditional design made it difficult to maintain a sterile field and keep the catheter clean
`while undergoing the procedure. The changes for the design of the tray were identified based on
`interviews and focus groups attended by clinicians in varying positions within an acute-care
`setting. Based on their suggestions and ideas, we completely re-imagined the tray design and
`created one which made the Foley catheter insertion process intuitive. A revolutionary one-layer
`tray design was initiated by Deborah Adler, allowing the user to visualize all of the components
`at once, and minimizing the risks of contaminating the catheter. Once the one-layer design was
`agreed upon, it was a challenge to minimize the size of the tray and package in order to
`efficiently sterilize and ship the product, while maximizing the space to hold all the components.
`It was also a challenge to design the syringe slots in order to keep the sterile water and
`lubricating jelly syringes easily accessible while keeping them in place during transport. After
`the concept design, the slots which hold the flange of the syringe needed to be deepened in order
`to keep the syringes in place during shipment. The cut out along the inner portion of the tray
`was placed in a strategic position in order to allow the catheter to be easily placed in the
`lubricating jelly trough.
`
`13. USER-RELATED FEATURES. In relation to actual use of the product, describe how the design
`and engineering features of this product reflect functional innovations that improve healthcare
`delivery. Pay particular attention to features that broaden the scope of users (e.g., turning a
`professional-use device into a home-use device), change traditional medical attitudes or
`
`
`
`4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 4 of 11
`
`

`

`practices, or offer significant use-related improvements (e.g., simplified training, easier use,
`intuitive user interfaces).
`
`The Foley Catheter Management System tray was designed in a way which would make it not
`only intuitive to use, but difficult to vary from the proper aseptic insertion process. Current
`product design left it up to the healthcare worker to find their way through the process and made
`it easy for contamination of the catheter to occur. The innovative new design not only simplifies
`the Foley catheter insertion process for the healthcare worker, but unifies the process across all
`facets of nursing practice. The placement of the tray components lead the clinical from one step
`to the next, and allow them to reach the ultimate goal on inserting the catheter aseptically and
`properly every time. The new design also clearly and pictorially displays all of the components
`of the tray, so the nurse can quickly see what is included in the tray and can grab any extra
`supplies needed. This eliminates the chance that a nurse will begin the procedure, realize they
`need another supply, and break aseptic technique by leaving the patient bedside to get what they
`need. The inserts are also color coordinated by type of catheter (Silvertouch, 100% Silicone and
`Silicone-Elastomer Coated Latex) so that a nurse can easily and clearly identify which catheter
`tray they are pulling from the shelf so they use the proper catheter on the patient.
`
`The design change starts with the packaging, which uses a checklist (widely visible and eye
`catching) to verify if the patient has a valid clinical reason to insert the catheter. We are trying
`to change the learned behavior that every patient needs a Foley catheter (which guidelines
`indicated is not necessarily the case) and are providing the nurse with the tools he or she needs
`before arriving to patient bedside to determine if an alternative to a Foley catheter should be
`used. Inside every tray is a step-by-step instructional guide book for proper Foley insertion. The
`process flow of the tray has also been altered, where the under buttocks drape is now on the
`outside of the packaging. Using the drape first allows the nurse to complete the process without
`contaminating the sterile field. Placement of the sterile gloves has also been altered so that the
`nurse can grab the gloves without contaminating the tray. A packet of hand sanitizer has also
`been added to reinforce the idea of proper hand hygiene. Tray components are positioned in a
`way where the clinician can move from left to right on the tray and so they will complete the
`catheter insertion process correctly, each and every time. The new positioning guides a change
`in traditional nursing practice for how a Foley catheter is inserted and ensures that aseptic
`technique is maintained each time the procedure is performed. A securement device has been
`added to the tray to encourage proper Foley catheter securement.
`
`
`14. PATIENT BENEFITS. In relation to the clinical effectiveness of the product, describe how the
`design and engineering features of this product provide enhanced benefits to the patient (e.g.,
`comfort, fit, service access, safety, appropriate aesthetics, overall improvement of healthcare).
`Provide documentation (e.g., research reports or user studies) to support your findings.
`
`
` A key benefit to the patient includes a competent and well-educated healthcare
`professional. Upon insertion, the caregiver has step-by-step training so that they can
`more accurately describe the procedure to their patient and be more confident in inserting
`the catheter. The tray has also been designed to include all of the components a nurse
`would need in order to complete the procedure. This will prevent a nurse from having to
`
`
`
`5
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 5 of 11
`
`

`

`leave the room during the procedure in order to grab a component they may have
`forgotten.
` Often times, the catheter becomes contaminated before it is inserted into the patient. The
`new tray design will minimize the risks of contaminating the catheter upon insertion.
`This was done by eliminating the two-level tray design and making is a one-layer tray
`with a lubricating jelly well. This keeps the catheter on the sterile field while properly
`preparing the patient. The sterile field is also increased by 56%, making it easier for the
`nurse to keep aseptic technique and minimize contamination during insertion.
` The number one cause for CAUTI is the duration of catheterization. By minimizing the
`amount of time a Foley catheter is in place, we can reduce the direct risk to the patient.
`The Foley Catheter Management System provides the clinician the opportunity to utilize
`the Foley InserTag™. This visual cue reminder system is meant to remind the healthcare
`worker how long the catheter has been in place and evaluate the patient on a daily basis
`to determine if the catheter is still needed. The tag is also beneficial when nurses change
`shifts and new nurses can easily check and be reminded of when the catheter was
`inserted.
` Another direct benefit to the patient may be avoiding catheterization altogether. By
`utilizing the clinical reason for catheterization checklist found on every Foley Catheter
`Management System, the clinician is mandated to verify if there is a valid clinical reason
`for Foley catheter insertion. If not, an alternative such as an underpad, brief, or
`intermittent catheter may be used, thus increasing the standard for patient care.
` The patient will also benefit from the use of the securement device to hold their catheter
`in place. This will minimize urethral traction which can cause irritation and discomfort.
`The securement device is also gentle on the patient’s skin and is able to be easily
`removed when the catheter is no longer needed.
` The detachable patient education card is also a benefit to the patient. Here the patient can
`learn more about the procedure, why they have a catheter, how to care and maintain for
`their catheter, and signs and symptoms to be aware of for an infection. In addition to
`providing the opportunity to discuss the procedure with a clinician, the card also provides
`the opportunity for the patient to obtain their physician’s contact information in case they
`were to have any further questions.
`
`
`
`15. COMPANY BENEFITS. Explain how the design and engineering aspects of the product
`improved the manufacturer’s profitability (e.g., reducing cost of development or manufacture,
`enhancing existing product lines, improving distribution, opening new market segments,
`increasing speed to market).
`
`Medline’s ERASE CAUTITM program, supported by the ERASE CAUTITM Foley Tray, has
`opened opportunities in the marketplace that previously were not available. While our earlier
`product offering was comparable to other market players, there was not an overwhelming
`impetus for customers to go through the effort of making a change for a parity product. The
`ERASE CAUTITM program and Foley Tray are in direct response to clinician-identified market
`and product deficits; customers that were looking to fill those gaps have responded very well to
`the new program and product and have become champions for the change.
`
`
`
`
`6
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 6 of 11
`
`

`

`As awareness grows and demand grows, our line of ERASE CAUTITM offerings is being
`expanded to include Urine Meter Foley Trays, Temperature Sensing Foley Trays and Pediatric
`Foley Trays. We also are expanding the patient education component of the program to be
`bilingual, printed in both English and Spanish. These line extensions and enhancements have
`been suggested and driven by decision-making clinicians. More clinicians in these roles are
`seeking us out and carving-out time for us, knowing that we have listened and responded with
`the ERASE CAUTITM program and tray, and they want to be a part of other developments and
`enhancements that we are considering. This market input is invaluable to our ability to make
`meaningful changes and additions to our product lines.
`
`16. BENEFITS TO THE HEALTHCARE SYSTEM. Explain how the design and engineering aspects
`of the product improved the delivery of healthcare (e.g., making the device or related treatments
`more accessible to patients, improving safety or efficacy, increasing cost-effectiveness).
`
`Catheters are a common feature of hospital care, used by over four million hospital patients a
`year some time during their stay. Another, but seldom-discussed reality is that the chances of a
`patient getting a UTI from a catheter are pretty high. In fact, the daily risk for patients acquiring
`a urinary infection is as high as seven percent when indwelling urethral catheters remain in their
`original position. Overall, such infections account for more than a third of all hospital-acquired
`infections.
`
`The cumulative impact of these catheter-associated infections, or CAUTIs, is significant, as they
`raise hospital costs, increase a patient’s stay and complicate their recovery. CAUTIs are a major
`drain on hospital resources, increasing length of stay by one to three days. Such infections add
`approximately $675 per patient to the costs of hospitalization. When bacteremia develops, this
`additional cost increases to at least $3,800. CMS reported that in 2007 patients with CAUTI had
`an average cost of $44,043 per hospital stay.
`
`Yet despite this, clinicians often pay little attention to the decision to insert an indwelling
`catheter, its optimal management or its timely removal. Supporting data also suggests that many
`times a urinary catheter is inserted without physician’s order, and that at times patients are not
`assessed appropriately for alternatives to catheterization.
`
`
`With that in mind, we based the ERASE CAUTITM tray on the same criteria the CDC used in
`developing their new CAUTI prevention guidelines: a targeted systematic review of the best
`available evidence, with explicit links between the evidence and recommendations.   The result is
`a new tray design that:
`
`
`
`Is intuitive and helps staff follow the correct technique and recommendations.
` Minimizes the risks of contaminating the catheter upon insertion by making it easier for
`the nurse to keep aseptic technique and minimize contamination during insertion.
` Provides the clinician the opportunity to utilize the Foley InserTag™ as a visual cue to
`remind the healthcare worker how long the catheter has been in place and evaluate the
`patient on a daily basis to determine if the catheter is still needed.
` Help determine if catheterization is truly necessary in for the patient by utilizing the
`clinical reason for catheterization checklist found on every Foley Catheter Management
`
`
`
`7
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 7 of 11
`
`

`

`System, the clinician is mandated to verify if there is a valid clinical reason for Foley
`catheter insertion.
`
`
`
`Exhibits:
`1. ERASE CAUTITM Foley Catheter Management System Video Overview
`2. ERASE CAUTITM FCMS Tray
`3. FCMS Item Numbers
`4. ERASE CAUTITM Brochure
`5. Indications Checklist
`6. Directions Inserts
`7. Securement Device
`8. Foley InserTagTM
`9. Patient Education Card
`
`CONTACT INFORMATION
`
`
`17. SUBMITTER CONTACT. Provide full contact information for the individual who is responsible
`for the accuracy and completeness of this submission and will act as the contact for all
`correspondence throughout the competition.
`
`Contact name: Jennifer Downey
`Title: Program Manager
`Company: Medline Industries, Inc
`Street address: One Medline Place
`City, State Zip/postal code: Mundelein, IL 60060
`Country: USA
`Telephone: 847-837-2869
`Fax: 847-949-3073
`E-mail: jdowney@medline.com
`
`Has this company entered the MDEA program in previous years? No
`
`18. MANUFACTURER CONTACT. The manufacturer of record is the single corporate entity
`holding regulatory approval for marketing of the product. Provide full contact information for an
`authorized representative of the manufacturer who has provided consent for this entry. If the
`submitting company is the same as the manufacturer, please write “same as submitter.”
`
`Same as submitter
`
`Other team members employed by the manufacturer:
`Jennifer Tomes
`Director of Marketing – Urology
`847-949-3098
`jtomes@medline.com
`
`
`
`
`
`8
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 8 of 11
`
`

`

`
`Sarah Zyburt
`Product Manager – Urological Products
`847-643-4161
`szyburt@medline.com
`
`David Russo
`Sales Specialist – Urological Products
`847-643-4757
`drusso@medline.com
`
`Lorri Downs
`VP Infection Prevention
`847-643-4211
`ldowns@medline.com
`
`Jack Maze
`VP of Manufacturing - Dynacor
`847-949-3067
`jmaze@medline.com
`
`Jerreau Beaudoin
`Director of Public Relations
`847-643-3011
`jbeaudoin@medline.com
`
`19. DESIGN AND SUPPLY CREDITS. Provide full contact information for one representative of
`each company that contributed significantly to the development of this product. Companies may
`include design and engineering firms as well as suppliers of materials, components, or other
`contract services. (Copy the lines below as required for each contributing company.)
`
`Contact name: Deborah Adler
`Title: Principle
`
`Company: Deborah Adler Design
`Street address: 60 East 8th Street, Suite 4H
`City, State Zip/postal code: New York City, NY 10003
`Country: USA
`Telephone: 212-217-6229
`Fax: 646-395-1371
`E-mail: studio@deborahadlerdesign.com
`
`Other team members employed by this company:
`Name
`
`Title or role
`
`
`Phone
`
`Contact name: John Kutsch
`Title: Principle
`
`E-mail
`
`
`
`
`
`9
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 9 of 11
`
`

`

`
`
`E-mail
`
`Company: Whole World
`Street address: 107 W. Front St.
`City, State Zip/postal code: Harvard, IL 60033
`Country: USA
`Telephone: 815-943-0714
`Fax: 815-943-7072
`E-mail: worldone@mc.net
`
`Other team members employed by this company:
`Name
`
`Title or role
`
`
`Phone
`
`PAYMENT AND AUTHORIZATION
`
`
`20. FORM OF PAYMENT. Declare form of payment. If form of payment is a check, include the
`check with the hard-copy portion of your entry that is mailed.
`
`Check ___
`Credit card _X__
`
`If the entry fee will be paid with a credit card (VISA, MasterCard, or American Express), please
`complete the following:
`
`Per email conversation with James Costigan, please call Sarah Zyburt at 847-643-4161 to
`process payment information.
`
`
`Amount: $700.00
`
`Account number:
`
`Expiration date:
`Name of cardholder: Sarah Zyburt
`Signature _____________________________________________________________________
`
`Entrants are responsible for payment of all fees related to the delivery of their entry materials
`and sample products, including customs tariffs, brokerage charges, and other shipping costs.
`Delivery-related invoices received by Canon will be forwarded to the submitter for payment.
`
`
`21. AUTHORIZATION. The following statement must be included on the hard-copy version with
`submitter’s signature and date:
`
` I
`
` attest to the accuracy of the information provided in this submission to the 2010 Medical
`Design Excellence Awards. I have determined that this product, in the form presented here, is
`commercially available now or will be by December 31, 2009.
`
`
`Submitter’s signature __________________________________________________________
`
`
`
`10
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 10 of 11
`
`

`

`
`Date _______________________________________________________________________
`
`
`
`11
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2101
`Page 11 of 11
`
`