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					                             DREXEL UNIVERSITY




Senior Design Progress Report
            Final
Title: Dual Chamber Syringe Design for Storage, Integration, and Administration
      of Medications Requiring Reconstitution for Hospital and Home Use




                                     Team 9


                    Lawrence Benedict – BMES - Biomechanics

                    Allison Lloyd – BMES – Tissue Engineering

                     Misha Mehta – BMES - NeuroEngineering

                    Megha Vadher – BMES – Tissue Engineering

                       Tom Ward – BMES - BioInformatics

                      Team Advisor: Dr. Elisabeth Papazoglou



                                    3/2/2010




                                                                                  1
Executive Summary
       The proposed design consists of a dual chamber syringe, intended to allow for the storage
and eventual integration and administration of NovoSeven RT. NovoSeven RT is a haemostatic
medication that is prescribed in the form of a lyophilized (freeze dried) powder consisting of
blood components and a separate diluent. The two components must be mixed prior to
administration. Immediately after the components are mixed, the solution begins to degrade and
within 3 hours of mixing degrades to a point at which it is no longer usable.

        Currently patients receive the medication in the form of two glass vials. The patients
must utilize a mixing kit consisting of 8 components to mix the medication via manufacturer
recommended practices. Furthermore, the manufacturer has published recommended integration
guidelines, which consist of 9 unique steps and require 2-5 minutes to integrate the medication
and diluent, prior to administering the medication. The excess time and number of steps required
stem primarily from the need to interact with multiple individually packaged components and
ensure that said components are appropriately disinfected prior to use. The proposed design aims
to reduce the number of steps and amount of time to less than a minute, required to integrate the
medication by reducing the number of components necessary and reducing the number of
components that require disinfection.

        The proposed design also aims to address several currently unmet needs in the market
place. Transportation of haemostatic agents is currently difficult due to the number of
components and the expertise required for reconstitution of the medication. The ability to easily
transport such agents and allow for simple reconstitution could enable such agents to be used in
emergency situations such as on the battlefield. Also, to increase the functionality maintained for
minimum of two years at standard ambient temperature and pressure as defined by the EPA. The
current involvement of multiple components presents an opportunity that may be met by the
single syringe design. Though an initial capital investment would be required the development of
a process for filling and packaging the dual chamber syringes, the investment should be recouped
through cost savings by reducing the number of components and associated packaging.

        Current methods for transporting, storing, and reconstituting medications requiring
reconstitution require multiple steps and components. These configurations present additional
risks to patients, which can be mitigated via the use of single assembly, multi-chamber syringes.
The proposed design aims to address the unmet needs in the lyophilized medication arena while
maintaining the mechanical properties of currently available syringes. Future iterations of the
design may allow for extra durability to account for battle field use, however the current
proposed solution is aimed at easing the issues associated with home and hospital use of
recombinant medications.




                                                                                                 2
Table of Contents

Introduction..........................................................................................................................................................................................4

     Solution Criteria.............................................................................................................................................................................4

     Constraints .......................................................................................................................................................................................6

Solution ...................................................................................................................................................................................................7

Prototype to Date ...............................................................................................................................................................................8

     Major Components of the current prototype include (refer to figure 1): ............................................................8

     Preparation for prototyping ................................................................................................................................................. 10

     Testing ............................................................................................................................................................................................. 10

Problems and Issues......................................................................................................................................................................11

Plan of action for winter/spring term..................................................................................................................................12

Societal and Environmental Impacts ....................................................................................................................................13

Schedule ...............................................................................................................................................................................................16

References ..........................................................................................................................................................................................17

Appendix A: Initial Prototypes.................................................................................................................................................18

Appendix C: Comparison of Steps ..........................................................................................................................................20

Appendix D: Testing Schedule..................................................................................................................................................21

Appendix E: Current Infusion Kits .........................................................................................................................................22

Appendix F: Resumes of Team Members ...........................................................................................................................23




                                                                                                                                                                                                          3
Introduction

       The ideal and sometimes only method of storage of medications is in a lyophilized form,

where the medicine is freeze-dried and must be dissolved in a saline-like solution, in order to be

usable. This process is called reconstitution. Premature reconstitution reduces shelf life from

years to hours, at which point the medicine loses functionality. Thus, maintaining the separation

of these components until the time of use is crucial. This is typically accomplished by complex

kit systems involving many steps and components. Such configurations present additional risks

to patients, which can be mitigated via the use of single assembly, multi-chamber syringes,

specifically for the application of this concept to the hemostatic agent, NovoSeven RT.


Solution Criteria

           1. Maintain seal with rubber sealing layer less than 0.05" thick

                    Maintaining the seal is cruicial for preventing premature reconstitution of the

                    lypholized drug and diluent. For this to be successful, sufficient rubber

                    material must be applied to the smooth surface of the sealing support

                    mechanism, which is currently represented by an aluminum washer. However,

                    minimizing the thickness of this layer aids in reducing the compression of

                    diluent and turbulence of the diluent into the medicinal chamber. This is

                    accomplished by reducing the length of the flow path of the diluent around the

                    sealing mechanism, and the volume of material moving through the diluent.

       2. Functionality maintained for minimum of 2 years at standard ambient temperature

           and pressure as defined by the EPA




                                                                                                 4
           The maximum shelf life of the NovoSeven RT medicine is 2 years at ambient

           temperature and pressure as defined by the EPA. Therefore, making this the

           minimum shelf-life for the proposed design ensures that by the closest time

           frame, the device will not fail before the drug expires.

3. The use of the device must require less than or equal to 1 minute

           The current advertised time for the preparation of the NovoSeven RT

           medicine using the current complex method is 2-5 minutes. Therefore,

           reducing the average preparation time as determined by a rough experiment

           with senior undergraduate and graduate engineering student volunteers, will

           be a great and marketable improvement. This will serve as an indication of

           improved ease of use.

4. Half as many separate parts as the current method (4-5 separate parts or less)

           Fewer separately packaged parts will aid in reducing the time required to

           prepare the medicine, and reduce the complexity of the process, while

           reducing the risk of contamination. This serves as another indicator of

           improved ease of use. The current method involves 9 individually packaged

           parts which must be unpackaged, put together, and/or taken apart during

           preparation.

5. Half as many separate steps as the current method (8-9 steps or less)

           Fewer steps will reduce complexity of the preparation process and improve

           ease of use. The current method requires 17 steps, excluding the preparation

           and attachment of the needle.

6. Must be 8oz, 6" long



                                                                                     5
                  A small, lightweight device will be more accessible for use in applications

                  which may require swift and easy transport of the drug for immediate use.

                  Such applications may include the hospital, home, transport with emergency

                  responders and in the battlefield. A device of smilar proportions to the epipen

                  would fit more easily in a glovebox, handbag, or first aid kit, etc.

       7. Force to push plungers less than 1 lbf

                  The force to move the plungers for both the reconstitution, and the

                  administration of the medicines must be easily manuverable. Potential users of

                  the device may include elderly or injured persons, for which the application of

                  much physical force may be difficult. Therefore, minimizing this value is

                  ideal. However, too little force on the secondary plunger may compromise the

                  sealing mechanism.


Constraints

1. Must completely separate diluent from medicine until deliberately mixed by user

          This prevents premature reconstitution and resulting premature expiration of the

          NovoSeven RT medicine.

2. Must hold 84mg of lypholized medicine and 2.1ml of diluent

          This is the middle dose level of the three options provided commercially by Novo

          Nordisk, the producing company of NovoSeven RT. The sizes are a 1ml, 2ml, and

          5ml dose.




                                                                                               6
Solution

       The intended final prototype willconsist of a specialized syringe possessing two

chambers. One chamber will contain a lyophilized drug and the other chamber will contain a

diluent. Upon user activation of the device, the diluent will be introduced into the medication

chamber, allowing for mixing.

       The most critical design feature of the device is the seal between the medication chamber

and the diluent chamber. The medications intended to be utilized with this device rapidly

degrades when exposed to liquid solutions. As such, the integrity of the seal must be maintained

for the shelf life of the unit and through various environmental factors (vibration, accidental

impacts, etc.) to ensure the viability of the product. To achieve an effective seal, the components

will be constructed from annealed silicone rubber compressed between two rigid components.

Silicone was chosen for the seal medium because annealed silicone essentially has a porousity of

0. This mechanical property of the rubber compound means that silicone possesses the ability to

prevent seepage through the seal, so long as sufficient pressure is maintained. The device will

utilize a quarter-turn sloped locking mechanism to maintain pressure on the seal so as to prevent

seepage due to environmental stressors. In this design, the compression of the silicone will act as

the spring for maintaining the seal.

       To ensure patient safety in the event that the seal is broken, the design will be transparent,

so that if the seal does become compromised, the end user will be able to see that he lyophilized

medication has been contaminated. In addition to the transparent nature of the design, the sloped

lock will prevent the seal from unintentionally being re-integrated. Other potential safety

mechanisms were proposed during the design process, however this was deemed to be the most




                                                                                                   7
practical and economically feasible method due to the size and cost of components used in this

design.


Prototype to Date

          As of this writing, two “proof of concept” prototypes have been fabricated. The

prototypes were crafted from 6061-T6 aluminum, buna-N rubber o-rings, adhesive backed

silicone, and syringe bodies. These materials and components were selected for the initial build

because they are inexpensive and relatively easier to fabricate than the intended final materials,

in which the aluminum components will be replaced with clear polycarbonate. Such decisions

allowed for identification and compensation for various fabrication errors. The knowledge

obtained during this process will allow for a more precise build for future iterations.


Major Components of the current prototype include (refer to figure 1):

                1. Secondary Plunger

                       a. The secondary plunger was fabricated from .25” diameter precision

                           ground 6061-T6 aluminum. Due to the tolerance held on the raw

                           material, only three operations were required to complete this

                           component.

                                           i. The part was cut to size

                                          ii. A hole was drilled and tapped into one end to allow

                                              for thumb cap attachment

                                         iii. Slots were turned into the other end using a lathe to

                                              allow for o-ring insertion.




                                                                                                 8
      b. This component seals the medicine chamber against the interior of the

          primary plunger and against the plunger seal, which allows for

          separation of the medication from the diluent.

      c. Activating this component (depressing the thumb cap) allows for

          mixing of the components



2. Primary Plunger

      a. The primary plunger was fabricated from a 5/8” diameter 6061-T6

          aluminum rod. The rod was turned down to .5” along most of the part

          after being cut to size. The piece was then center drilled with a .25”

          drill to allow for insertion of the secondary plunger. Slots were also

          turned into the piece to allow for o-ring insertion.

      b. This component seals against the inside body of the syringe

      c. This is utilized for “pushing” the medication out of the device after

          mixing

3. Plunger Seal

      a. This component was crafted from 6061-T6 aluminm to make a disc.

          Adhesive backed silicone was then attached to the disc to create a

          sealing surface.

      b. This component attaches to the secondary plunger and seals against the

          primary plunger




                                                                              9
              Figure 1 – Major Components of the “proof of concept” Prototype




          2. Primary Plunger                      3. Plunger Seal

                          1. Secondary Plunger                              Syringe body
                                                                            bodybodyBody




    Spring


 Figure 1 displays important components in graphical form. For a more accurate display of the

                               prototypes, refer to Appendix A.


Preparation for prototyping

                  i. Mechanics research into the underlying physical properties of sealing and

                     pressures has resulted in a set of modeling equations to describe the

                     syringe actions (refer to Appendix B)

                 ii. Individuals in the team unfamiliar with rudimentary machining processes

                     have taken steps to allow themselves to assist with prototype fabrication in

                     the machine shop


Testing

                  i. Initial testing indicated the role of free air in a mixing procedure

                 ii. Future research into the compressibility of air and how it will affect the

                     design is required




                                                                                              10
Proposed Future Prototype:

   The proposed future prototype will replace the spring mechanism with a “sloped locking

mechanism” as shown in figure 2 (refer to appendix for technical drawings).



                           Figure 2 – Proposed Plunger Configuration




     Figure 2 displays the proposed configuration in the sealed (left) and unsealed (right)

                                          configurations.


Problems and Issues

       During the construction of the prototype, there were a few minor setbacks that impeded

progress. Overall these problems were not major and the prototype was able to be built in

accordance with our term schedule.

       The first complication was during the building of the outside plunger; the inside was

centered and not reamed. This meant that the inside surface had a degree of roughness to it that

would interact with the rubber o-rings, on the inner plunger, that form a seal with the surface.




                                                                                             11
The inside should be smoother so for future prototyping, the hole would be reamed instead of

centered.

       The second complication involved the grooves for the o-rings on the inside plunger. The

grooves on the plan were proscribed to be a depth making the o-ring flush with the outside

surface of the plunger. This impeded the seal with the outside plunger since the o-ring could not

accurately interact with inside surface. The inside plunger had to be made with shallower o-ring

grooves allowing them to be just above the surface of the plunger to interact with the surface.

       The washer that went on the end of the inside plunger to hold the seal with the outside

plunger was originally designed to be too thin. This only allowed for 1 screw thread which was

too weak. In the final version the washer is thicker and there are 4 full threads in the washer

allowing strength to perform its task of holding a pressure seal.

       It was discovered that for future prototypes that using a 4-40 stud in place of dying a

thread to the end of the inside plunger will make manufacturing parts less complicated. Future

versions will likely feature a 4-40 thread tap with a 4-40 stud in place of a dyed screw thread.

       Finally, the current size spring and washer do not work well together. The washer is not

wide enough to catch the spring and the spring does not hold its shape accurately. In the future

prototypes, the spring will be more rigid and the washer will be a larger size.


Plan of action for winter/spring term

   Some prototype modifications will have to be done in the coming weeks and spring term.

The initial prototype has been constructed out of aluminum because of the material’s “forgiving”

nature when machining. The subsequent prototypes however are intended to utilize polyethylene

or polycarbonate, as these are structurally sound, inert, transparent plastics used for syringe

construction. Fabrication using these materials will not commence until sufficient skills in



                                                                                                   12
fabricating aluminum prototypes are acquired. And if issues regarding compressibility of

air/water arise, the design can be modified for its betterment. A small motor mechanism may be

installed into the design if issues regarding mixing of the diluent and medication arise.

Testing would include both mechanical and subjective testing. (Schedule in appendix A)

Mechanical testing will be done by a drop test during which the prototype will be dropped from

5 feet to check for any mixing. There will be use of a powder dye in the medicine chamber to

check that the seal maintains its integrity. A test to check plunger pressure using water is

scheduled to ensure correct syringe’s pressure when applied. Quantification using mechanical

testing to see how much force it takes to push the plunger down.


    A vibratory test will also be done by utilizing test tube shakers and/or vibratory tables to

ensure if seal integrity is maintained during shipping and handling etc. Force testing will occur to

make sure that the operation of plungers requirs less force (<2lbf). Under subjective testing of

the syringes, the prototypes will be tested by each team member and sample of people familiar

with the use of syringes. This kind of testing will focus on two aspects

   a. Speed – the amount of time required for complete reconstitution

   b. Usability – a subjective measure of the efficacy of the assembly

[If time and funding permit, the testing will also employ current competitive designs to allow for

effective comparison]


Societal and Environmental Impacts


       Our idea of developing a dual-chambered syringe is a way to upgrade current use of

syringes for two component drug delivery. With the help of a dual-chambered syringe, the

intricate process of mixing the drug and then injecting can be simplified to large extent. The aim


                                                                                                 13
is to promote our design so that people who are in high- risk of severe bleeding can use the drug

as swiftly as possible. Such a market would include soldiers and other personnel who are in the

line of fire or even institutions for example, schools and workplaces to help severe bleeding at

least till the time the injured individual waits to reach the hospital or clinic. This will surely have

a positive impact on the society as a whole as it would reduce the deaths that occur due to severe

bleeding or unsterilized administration of the injection. We would also have different packaging

such as 1mg and 5 mg doses to make it easy to use for people suffering heavy bleeding needing

instant cure.


       The sterilizable syringe is probably a cheaper and more environmentally-friendly

alternative to the hypodermic needle. These are re-usable up to 50 times and can be sterilized in

steam after each injection at a temperature of 121°C for 20 minutes. However, healthcare

workers must have access to sterilization equipment and proper training since inadequate

sterilization can result in the transmission of disease. We plan to omit any such risk with syringe

administration by having our syringe non-reusable. We would be using low cost of materials

such as propylene and rubber used for the syringe. It has been seen that the manufacturing

process of polypropylene and other low cost plastics has reduced factory emissions and energy

consumption when compared to glass and metal construction. There is little scope of misusing

our syringe in the sense of being able to overdose. The use of contaminated syringe for second

use without a sterilizing process could be another risk present but it is important to understand

that these risks are present for all syringes.


        The small overdosing potential might cause kidney and liver damage. 3 Our design will

aim for no minimal chance of the two components mixing before required causing degradation of




                                                                                                    14
the drug. A transparent plastic would be used so as to avoid usage of such syringes. The final

prototype is intended to be constructed from commonly used syringe plastics. This plastic

materials can be recycled, provided that they are appropriately handled regarding bio-

contamination procedures. This design could allow for use in emergency medicine situations,

which could decrease mortality rates with regards to severe trauma. Thus being a boon to many

situations when people die from excessive bleeding.




                                                                                           15
Schedule

           a. We are currently on schedule as we have finished building the primary prototype.

           b. Testing will be performed till the end of this term (winter)

           c. Gantt chart below.




                                                                                            16
References
(2009). Administering treatment: Novo Nordisk - NovoSeven RT. Retrieved November 20, 2009
from NovoSeven RT website: http://www.novosevenrt.com/administration-hemophilia-
treatment/administration.html

(2009). Single blue epipen holder, epipen pouch, epipen case, for carrying auto Injectors.
Activeaide. Retrieved November 24, 2009 from http://www.activeaide.com/us/single-auto-
injector-pouch-blue.html

Novo Nordisk (2008). FDA Approves NOVO NORDISK's NovoSeven(R) RT (Coagulation
Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors.
PR Newswire. Retrieved November 20, 2009, <http://www.bio-medicine.org/medicine-news-
1/FDA-Approves-NOVO-NORDISKs-NovoSeven-28R-29-RT--28Coagulation-Factor-VIIa--
5BRecombinant-5D-Room-Temperature-Stable-29-for-Hemophilia-Patients-With-In-19262-3/>

Novo Nordisk (2009). Novo Nordisk - NovoSeven RT. Novo Nordisk, Inc. Retrieved November
21, 2009 from NovoSeven RT website:
http://www.novosevenrt.com/index.aspx?aspxerrorpath=/novoseven-rt-
difference/simplicity/using-novoseven-rt.aspx#

Reynolds, G. (2007). Drug Reconstitution: Market Needs and Technical Challenges, Graham
Reynolds, March 2007. Controlled Environments Magazine®. Retrieved November 21, 2009
from http://www.cemag.us/articles.asp?pid=662




                                                                                          17
Appendix A: Initial Prototypes




                                 18
Appendix B: Calculations




                           19
Appendix C: Comparison of Steps
The Current Method (17 steps)
   1. Remove the appropriate medicine vial, the matching diluent vial, 1 vial adaptor, the appropriate
       syringe, 1 butterfly needle, and 2 alcohol swabs from the main package
   2. Uncap the vials
   3. Unwrap the alcohol swabs
   4. Swab the tops of the vials (one alcohol swab per vial)
   5. Unpack the vial adaptor
   6. Place the vial adaptor with the spike down, on the top of the diluent vial taking care not to touch
       the spike
   7. Unpack the syringe
   8. Pull air into the syringe to a volume matching the volume of diluent in the diluent vial
   9. Screw the syringe into the exposed end of the vial adaptor
   10. Empty the syringe of air into the vial
   11. Tip the vial upside-down and pull the plunger down slowly to remove the diluent from the vial
   12. Remove the syringe and vial adaptor (keeping them attached to each other) from the diluent vial
   13. Clip the removed vial adaptor and syringe onto the medicine vial (do not touch the spike)
   14. Tilt the syringe, adaptor, and vial slightly with the vial facing downward
   15. Slowly push the plunger to eject the diluent along the inner wall of the vial, and into the
       medicine, and to avoid foaming
   16. Gently swirl the syringe, adaptor, and vial to mix the components until the solution is clear and
       colorless.
   17. Once mixed, remove the syringe from the vial adaptor


Proposed Method (9 steps)
   1. Unpack the syringe device
   2. Check that no mixing of diluent and powder has occurred (powder should be viewable withing
      the inner chamber of the syringe)
   3. Flip open the cap on top of the primary plunger
   4. Depress the secondary plunger and hold it down
   5. While holding the secondary plunger down, gently tilt the device from side to side to mix the
      components until the solution is clear and colorless
   6. Once mixed, hold the device vertically, with the plunger facing upward and release the secondary
      plunger
   7. Replace the cap on the top of the primary plunger
   8. Remove the locking collar from the primary plunger
   9. Uncap the needle to inject




                                                                                                        20
Appendix D: Testing Schedule
 No.       Date      The Tests                  Test Duration           Purpose of test          Course of action
       1             5 ft drop test of          20 drops minimum        to ensure that seal      no red dyed diluent
                     completed assembly                                 remains intact           intrudes into the
            17-Mar                                                                               medication
                                                                                                 chamber

       2             Vibratory table testing    4 trials of varying     to ensure if shipping    no red dyed diluent
                     of completed               level frequencies of    or battlefield           intrudes into the
                     assemblies (multiple       vibrations at           situations does not      medication
            17-Mar   syringes in a box)         15minutes per trial     cause any leakage        chambers



       3             Completion of steps        20- 50 trials at        to determine air         less than X ml of
                     for integration of         different speeds        present in injection     air based on visual
            23-Mar   compounds                                          chamber                  inspection through
                                                                                                 clear syringe

       4             Testing of force           10 bend test for each   to determine the         subjective feel that
            24-Mar   required to actuate        trail                   force the material       force is not "too
                     secondary plunger                                  can withstand            much"
                     note: this is for
                     potentially increasing
                     spring force after drop
                     testing

       5             Force Injection test       5 trial for different   to check the
            24-Mar                              syringes                working of the
                                                                        syringe
       6             Vertical storage testing   20 trials- 48 hours     to ensures the           no red dyed diluent
                     (several weeks)            per trial               syringe is sealed well   leaks into the
            30-Mar
                                                                                                 medication
                                                                                                 chamber




                                                                                                                        21
Appendix E: Current Infusion Kits




                                    22
Appendix F: Resumes of Team Members
                                                      Lawrence Benedict
                                                      1805 Arrowtrail Dr.
                                                     Williamstown NJ 08094
                                                        (856) 649 - 3906
                                                      Lmb69@drexel.edu
Education
Drexel University, Philadelphia, PA
Bachelor of Science in Biomedical Engineering, Anticipated Graduation - June 2010
Cumulative GPA - 3.15
Academy of Engineering Science at Williamstown High School, Williamstown, NJ
High School Diploma, Graduated with Honors June 2006

Relevant Coursework
Calculus I, II, IV Linear Algebra Differential Equations
Engr. Living Systems I, II Physics I, II, III Introduction to Materials
Engineering Design Thermodynamics Basic Engr. Circuit Analysis
Human Physiology I, II Biomechanics I Biodynamics
The Body Synthetic Modern Medicine Biomed. Engr. Lab I, II, III, IV
Chronoengineering I,II Economics I,II

Experience
Solvay Solexis North America, Thorofare N.J.
Maintenance Coop, September 2008 to April 2009
Maintained equipment database
Updated P&IDs and drawings in AutoCAD
Created an Access database for maintaining schedule of safety valves
Long Architecture and Engineering, Williamstown, NJ
AutoCAD Technician, July 2005 to August 2006
• Used AutoCAD to draw architectural plans
• Designed minor components of architectural plans
B'nai Tikvah, Sewell, NJ
Tutor, September 2004 to June 2006
• Tutored special needs students and bar and bat mitzvah students

Computer Skills
Microsoft Word, Excel, and PowerPoint
AutoCAD, Inventor 3d Modeling Software

Honors and Awards
Dean's Scholarship, Drexel University, June 2006
Williamstown High School Most Dedicated Student Scholarship, June 2006

Senior Engineering Design Project

Team is currently developing a system for the delivery of a reconstituted medication.




                                                                                        23
                                                    ALLISON LLYOD

281-772-6036                                                                              150 E. Wynnewood Rd.
lloyd.allison.l@gmail.com                                                                        Apt 28A
                                                                                         Wynnewood, PA 19096
Education
      Drexel University, Philadelphia, PA
      Bachelor of Science in Biomedical Engineering, June, 2010
      Concentration in Tissue Engineering

Publications
       US Patent Number 20090105670; Thin Film Wound Cover, Suction Assisted Wound Treatment System Using the Same,
Method of Using the Thin Film Wound Cover and Method of Making the Same 04-23-2009

Honors and Awards
      Jacobs Management Group, "Employee of the Month" September 28, 2006 to November 28, 2006.
      International Science and Engineering Fair, "Simplifying the Preparation of Haemostatic Agents,"
         Drexel Presidential Scholarship, Spring 2004.

Work Experience
      Boehringer Laboratories, Inc., Norristown, PA
      Project Engineer, September 2007-April 2008; September 2008-March 2009
              Projects
                     o Designed, developed, produced and tested prototype pipeline products
                     o Designed, constructed and tested functional machine determining the durability of battery packs used
                          in one current product
                     o Designed, constructed and tested a functional machine determining the durability of various
                          connectors used in a current product
                     o Conducted machine work finalizing production-ready parts prior to assembly
                     o Created wound models mimicking the flexibility and compressibility of human tissue
              Experiments
                     o Designed and performed accelerated aging tests on pipeline products
                     o Performed infection control experiments on existing and competitive products
                     o Researched and tested a number of materials for use in pipeline products
              Documentation
                     o Updated SolidWorks drawings for existing products and tools
                     o Edited and created SolidWorks drawings for parts, tools, and pipeline products
                     o Designed, arranged, and produced a number of documents outlining the benefits and usage of existing
                          products and comparing these to competitive products
                     o Drafted Instructions for use for pipeline products
                     o Produced several evaluation forms for field testing of prototype pipeline products
                     o Drafted a patent application for a pipeline product and am listed on one more published patent
                          application (Number 20090105670)
                     o Designed, developed and produced a series of marketing deliverables for current products including
                          instructional videos, descriptive pamphlets and instructional brochures
                     o Filed paperwork including engineering change notice forms, PO order slips, and scrap reports

                     o      Conducted and reported inspections of produced parts and products for compliance with
                            specifications

       Jacobs Management Group, Inc., Philadelphia, PA
       Telephone Interviewer/Researcher, August 28, 2006 to March 20, 2007
              Marketed job opportunities to potential candidates
              Screened potential candidates for applicability to a number of positions offered by healthcare companies
                nationwide
              Cold called managers and HR for job openings




                                                                                                                       24
Project Work
       Senior design, 2009, September-Present
              Designing and developing, and prototyping a product to simplify the preparation and administration of binary
                medicines requiring reconstitution prior to use
              Drafting and producing a detailed proposal for this product, including executive summary, introduction, method
                of solution, societal and environmental impact analysis, budget outline, and product development schedule
              Giving an oral presentation of the prototyped design, background, market analysis, societal and environmental
                impact, and business model for suggested production and release of product

       Junior Design Project, 2009, April-September
              Researched potential solutions to better drug preparation and administration
              Drafted a preliminary marketing document defining the need and target market for a proposed solution to a
                healthcare problem
              Developed a business model outlining product development and launch strategies and scheduling
              Created a competitive matrix comparing similar existing products to that proposed

Technical Skills
      Computer software (all Microsoft Office programs, Auto Desk Inventor, SolidWorks, Auto CAD)
      Manual drafting
      Construction of wood or foam models
      Machine work (Mill, Band Saw, Drill Press, Router, Dremel, Grinding Machine)
      Soldering

Activities
        Drexel Student Ambassador (May 2006-Present)
        Drexel String Ensemble-Violin (January 2006-Present)
        Member of the Society of Women Engineers (SWE) (November, 2005-Present)
        Robotics Club (BEST competition) (2002)
        Technology Students Association (2002-2005)
        Independent Study and Mentorship (2004-2005)
        Katrina Volunteer at the Houston George R. Brown Convention Center (12+ hours)

References
      Available upon request




                                                                                                                        25
                                                         Misha Mehta
                                                 3410 Race Street Apartment 3F
                                                    Philadelphia, PA 19104
                                                         215-866-6515
                                                   mehta.misha@gmail.com
Education
Drexel University Philadelphia, PA
Bachelor of Science in Biomedical Engineering Anticipated Graduation - 2010
Master of Science in Neuro- Engineering GPA: 3.0

International Centre for Applied Sciences-MAHE Manipal, India
Pursued Bachelor of Science in Biomedical Engineering September 2005 - August 2007

Internship
 ICON Clinical Reasearch North Wales, PA
Clinical Data Coordinator October 2008- March 2009
1) Reviewed Clinical data and queried the study coordinator whenever required.
2) Maintained and updated the discrepencies as per Company's conventions.
3) Participated in Management meeting to enforce efficient ways of handling clinical data.

Research Experience Drexel University Philadelphia, PA
Research Assistant August,2008- January,2009
Team responsibilities in the "Smart Surgical Tool Project" under Bio-NanoSensor Research. Performed required experiments and
presented the data with analysis of experimental sources of error.

Project Experience
Engineering Design (2007) -Team project on our innovation of the 'Eazy Closet'.
G.gallus Project (2005) -Dissected domestic chicken to study its skeletal system.

Coursework
Linear Algebra Cells and Genetics Organic Chemistry I
Electric Circuits, Statics Biosimulation I,II Ultrasound Imaging
Biomedical Ethics and Law
Honors
• CEO leadership certificate at Drexel University, 2008
• Dean's Scholarship, Drexel University, 2007-present
• Certificate of Merit, Drexel University, 2007
• Sanskrit Scholarships, Delhi Public School Vasant Kunj, 2000-2003
• Scholar Tie, Delhi Public School Vasant Kunj, 1998-2003

Volunteer Experience
International Centre for Applied Sciences-MAHE Manipal, India
Volunteer 2005-2006
Coordinated events and attended to visitors at the front desk.
Gnomon Educational Services New Delhi, India
National Level, Member 2003-2004
Participated in activities in the Vamna Project-Venus Transit in this astronomy club.
Anti-Tobacco Organization New Delhi, India
Volunteer 2002
Participated in events like plays and skits to spread awareness amongst teenagers and people of other age groups.

Computer Skills
Microsoft Office                                  ORACLE
MATLAB                                            LABVIEW

Activities
Journal Club at Drexel University, 2010
Dance performance at Drexel University (NASHA), 2008
Vocal performances at School and College, 1996-2007
Peer tutor, New Delhi, India, 2003-2005
Awarded for performances in group dances, 2005-2006
Prefect in Delhi Public School Vasant Kunj, 1999-2001



                                                                                                                         26
                                                       Megha Vadher
                                                      5633 Cricket Lane
                                                     Bensalem, PA 19020
                                                        215-833-9203
                                                  megha.s.vadher@drexel.edu
——————————————————————————————————————————
Education
Drexel University                                                                       Philadelphia, PA
Bachelor of Science in Biomedical Engineering                            Anticipated Graduation - June, 2010
Experience
Estee Lauder                                                                                     Philadelphia, PA
Co-op (Production Supervisor)                                                              September 2008 – March 2009
          Supervised a team of 30 employees to ensure that production was exceeding or at least 95% of company standard
          Completed a series of paperwork to document the amount of daily production completed
          Participated in team meetings which discussed goals and strategies for improving production
          Trained new employees in using process and equipment
          Mediated conflicts tat occurred between employees on the production floor
University of Pennsylvania Hospital                                                        Philadelphia, PA
Co-op (Nuclear Medicine Junior Engineer Research Assistant)                        September 2007 – July 2008
          Conducted literature review through online journals such as PubMed, ScienceDirect, Engineering Village, and
              Web of Science
          Analyzed data on hip prosthesis, melanoma, mesothelioma, lung cancer, esophageal cancer which lead to future
              publications in the Journal of Nuclear Medicine
          Determined the efficacy of Positron Emission Tomography (PET) imaging in the detection and monitoring of
              these particular disorders
          Created a data base on Microsoft Excel used to analyze numerous amounts of patient data
Carpenter Technology, Corporation                                                                     Reading, PA
Co-op (Bar Products Engineer)                                                              September 2006 - March 2007
          Completed a two year project conducted on the variation in tensile testing
          Facilitated the processing of material through the mill by ensuring that orders were not held up
          Created an in depth report concluding tensile testing project
          Presented research and experiments that were carried out to improve the straightness of bars
Publications

             Slotcavage, R; Vadher, M; Parvizi, J; Zhuang, H; Torigian, D; Alavi, A. (May 2008). “Detection of infected hip
              arthroplasty using FDG-PET”. The Journal of Nuclear Medicine 49: 269P.
             Slotcavage, R; Vadher, M; Parvizi, J; Zhuang, H; Torigian, D; Alavi, A. (May 2008). “Detection of infected knee
              arthroplasty using FDG-PET”. The Journal of Nuclear Medicine. 49: 10P.
             Moghadam-Kia, S; Parsons, M; Vadher, M; Cucchiara, A; Torigian, D; Alavi, A. (May 2008). “The role of dual
              time point FDG PET imaging in identifying malignant pleural mesothelioma”. The Journal of Nuclear Medicine.
              49 (1):362P.
Skills
             Software: Matlab, AutoCAD, Maple, Microsoft Office (Word, PowerPoint, Excel, Access, Outlook, Publisher)
             Operating Systems: Windows 98, ME, XP, Vista, Windows 7, Macintosh
             Laboratory Skills: Western Blots, Real-Time PCR, Gel Electrophoresis, Recrystallization, DNA Synthesis,
              Bacterial Cloning, Chromatography, Caffeine Extraction, Bone Mechanics, Hydrogels
             Language Skills: English, Hindi, Gujarati, Urdu, Punjabi




                                                                                                                           27
                                                         Tom Ward
                                                    2265 N Providence Rd
                                                       Media, PA 19063
                                                        610-405-2398
                                                      tfw25@drexel.edu

Education
Drexel University, Philadelphia, PA
Bachelor of Science in Biomedical Engineering, Anticipated Graduated - June, 2010
Cumulative GPA: 2.97

Thomas Jefferson University, Philadelphia, PA
EMT-B, February - May, 2007

Honors and Awards
• AJ Drexel Academic Scholarship, 2005 to Present
• National Society of High School Scholars, 2002 to 2005
• National Honor Society, 2002 to 2005
• AP Scholar with Distinction, 2005

Relevant Skills
Microsoft Word, PowerPoint, Excel, Visual Basic, Maple, MATLab, LabView, AutoCAD, SolidWorks, C++, HTML, Manual
and CNC Milling, Lathe Experience, General Machine Shop Experience

Relevant Coursework
ChronoBioEnginering, Fundamentals of Computer Aided Design, Computational Bioengineering, Biomedical Ethics and Law,
Business Law, Modern Medicine, Digital Logic and Design

Work Experience
Boehringer Laboratories, Norristown, PA
Project Engineer, September 2009 to Present
Engineering Intern, September 2007 to September 2009
          Interacted with customers in healthcare and informal settings to determine unmet clinical needs
          Developed clinical products from pencil sketches to complete medical devices that are currently sold in the United
          States
          Interacted with vendors to ensure quality of outsourced products
          Aided with the completion of marketing materials and various regulatory reports including but not limited to FDA, ISO
          9001, ISO 13485, and CE compliance
          Worked on a variety of projects both in individual settings with minimal direct supervision and in group settings

Drexel University, Philadelphia, PA
Co-op Engineering Aide, September 2006 to April 2007
        Oversaw six labs in the electrical engineering department
        Aided students with lab equipment and technical questions
        Developed a working knowledge of many fundamental electrical components

Published Research
John Karpowicz, Kevin Klocek, Tom Ward. Evaluation of Negative Pressure Wound Therapy (NPWT) Dressings in a
Hyperbaric Oxygen (HBO) Environment. Session D, Annual Undersea and Hyperbaric Medical Society 41st meeting. June 2008.




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