SOCIETY OF PLASTICS ENGINEERS

Medical Plastics Division2011 – 2012 OFFICERS

ChairSteve McCarthyUMASS Lowell

First Quarter 2012

Letter from the Chair:Chair-ElectJill MartinDow Plastics

SecretaryDan FuccellaApplied Technologies

fDear Medical Plastics Division Members,

ANTEC will take place in Orlando in conjunction with NPE from April2 to 4, 2012. Our Board of Director’s meeting will take place onMonday April 2 at 7 PM in the Convention Center. Our Annual DivisionApplied Technologies

TreasurerPaul GermanKruger Plastics

CouncilorMargie HannaC b E i I

Monday April 2 at 7 PM in the Convention Center. Our Annual DivisionBusiness Meeting will take place on Tuesday April 3 at 5 PM in RoomS310AB in the Convention Center. We have a full day of presentationstaking place on Tuesday starting at 8 AM and going until 5 PM in RoomS310AB. I would like to encourage attendance at the Medical Plasticssessions and the Business Meeting on Tuesday at ANTEC.

Czuba Enterprises, Inc

Past ChairLen CzubaCzuba Enterprises, Inc.

Board Membersex officio

Two days of Medical Plastics presentations by the Medical PlasticsDivision took place at the MD&M West show on February 13 and 14th

in Anaheim, California. The MD&M Show East is scheduled inPhiladephia from May 21 to 24. The Medical Plastics Division isscheduling two days of presentations there. Plastics News is holding aconference on Plastics in Medical Devices from June 12-13, 2012 inex officio

Glenn BeallBrent StrongGerry McNallyDavid HowardAustin Coffeythrough ANTEC 2012Ken PawlakM R i

Westlake, Ohio and the Medical Plastics Division will have a booththere. Plans are underway for an ANTEC in Mumbai, India inNovember 2012.

Thank you to all of the Medical Plastics Division Board members andspeakers who have volunteered their time to make this a success. Jim

Maureen ReitmanPeter Colburnthrough ANTEC 2013Mark BonifacioVipul DaveVinny SastriHenk BlomEd Fewkes

Madenjian has a list of speakers appropriate for a traveling MiniTecRoad Show. If any SPE sections are interested, let us know.

As members of this Division, I would encourage each of you to vote forour Board of Directors and Councilor. I also would like to encourageparticipation through suggestions you may have on ways to bring valueEd Fewkes

through ANTEC 2014Norris TollefsonJim MadenjianHarrison YuJordan Freedman

to our members. Please contact me or any of the Board members withthese ideas.

Steve McCarthy2011 – 2012 Chair

Inside Upcoming Conferences for 2012

G l d Obj i Goals and Objectives 2011 – 2012

Election for TheBoard of Directors

ANTEC 2012 Conference 6 - 7

Nominations for Board of Directors

8 - 9

U i C f d 10

In This IssueMessage from the Chair 1

Inside: Table of Contents 2

Board of Directors

Upcoming Conferences and Activities

10

MDM West – Report 11 – 12

MDM East – Upcoming Conference

13

Technical Presentation 14 18

From The Editor 2

Medical Plastics Division Mission Statement

3

Goals and Objectives 3 - 4Technical Presentation 14 – 18

BOD Meeting Minutes 19 – 22

From The Editor:

Board of Directors 2012 5

Treasurer’s Report 5

In my last message, when I said “ANTEC 2012 is earlier than usual,” today I find myself themaster of understatement. ANTEC is here. Already! Just a few weeks away and no AprilFool’s Day.

ANTEC 2012 is being held concurrently with NPE so there is plenty to see and do. I findmyself always trying to balance the things I want to do, the programs I want to attend, andthe things I need to do. As much as I want to, I cannot do it all and I am thankful that I haveg ,the conference proceedings to use as reference in the future. I try to go through theExhibition at least twice, to make as many useful contacts as I can on the supplier side ofthe plastics industry. With NPE being held at the same time, the “Exhibition” is much muchbigger, meaning there will be more to cover. There is always a lot to do and rarely enoughtime to do it.

There is also the temptation of having the Magic Kingdom and SeaWorld across the streetThere is also the temptation of having the Magic Kingdom and SeaWorld across the streetfrom the Conference Center. I hope you can arrive early or stay late to visit one of the parksso you will not have that temptation during the conference!

I hope and expect to see you at ANTEC and NPE!Norris M. Tollefson

Mi i St t tMedical Plastics Division

Mission StatementTo provide a forum for technical, quality systems,

and Regulatory information exchange on polymers and polymer processing for the medical

and healthcare industries focusing on new

Goals and Objectives 2011 - 2012Technologies, applications, and delivery methods.

OfficersSteve McCarthy – Chairman Jill Martin – Chair - ElectDan Fuccella – Secretary Paul German – TreasurerDan Fuccella Secretary Paul German TreasurerMargie Hanna – Councilor Len Czuba – Past Chair

•The officers are responsible for MPD board operations to comply with SPE Division guidelines and policies. This includesmaintaining an active Board of Directors with appropriate officers and chairs. The officers challenge each member withbringing new enthusiasm to the board and their assigned area of responsibility. This will include identifying new boardprospects, mentoring those new to the board and initiating new programs that will make MPD of more benefit tomembers and to prospective members of SPE. The officers shall be responsible for attendance and active participation atall SPE Council and Division Committee meetings as well as holding an annual business meeting.all SPE Council and Division Committee meetings as well as holding an annual business meeting.•The Medical Plastics Division shall plan to win the Pinnacle Gold and strive to win the Communications Award.•Board members are expected to attend board meetings or advise chairman when unable.

Technical Program CommitteeHenk Blom – ANTEC Technical Program Chair Vipul Dave – CommitteeEd Fewkes – Committee Jordan Freedman – CommitteeKen Pawlak – Committee Joe Fox – Committee / Webinars

•The ANTEC Technical Program Committee is responsible for our ANTEC involvement with two days of papers includingjoint sessions with other divisions.•The Technical Program Committee is responsible for managing the partnership with Canon for MDM shows, developingwebinars, and managing a traveling MiniTec Road Show which can be offered to Sections interested in partnering withMPD for a medical themed half or full day conference event. The Technical Programming Committee shall providetechnical programming that drives diverse member participation and networking opportunities, as well as technicalprogramming that addresses participation in under-represented areas. The Technical Program Committee shall supportnew SPE technical products and support Student Activities and Programming.p pp g g•Other activities include preparing a speakers list and making it available to Sections for monthly dinner type meetings,and supporting the Eurotec and AsiaTec conferencing efforts.

Communications CommitteeDan Fuccella – Secretary – Chair Norris Tollefson – Newsletter EditorJim Madenjian – Social Co-Chair Harrison Yu – Website / Pinnacle

•The Communications Committee is responsible for effectively communicating with members about SPE offerings ande Co u cat o s Co ttee s espo s b e o e ect e y co u cat g t e be s about S o e gs a devents to foster a sense of community and to allow them to respond. This includes providing financial reports andminutes of the Board meetings to membership, offering a social event annually, and providing SPE Headquarters withbest practices for member communications. In addition the Communications Committee will prepare and send out atleast 3 and possibly 4 newsletters of high quality with news of activities and interest to our members, participate in theCommunication Excellence Award contest, effectively use the website for better communication about MPD activities aswell as a support mechanism to answer members’ technical questions, and to reach out to members with monthly emailblasts to promote activities.

Goals and Objectives 2011 – 2012(con’t.)

Finance CommitteeLen Czuba – Finance Committee Chair Paul German – TreasurerJill Martin – Member Mark Bonifacio - MemberSteve McCarthy - Member

•The finance committee is responsible for proposing the effective use of division funds as well as proposing an operatingbudget for best use of funds for member programs and benefits.•The finance committee also develops a long-range plan for the use of funds including an annual budget and plans toraise income, and submission of the SPE Annual Financial Report and IRS 990 Form.

Membership CommitteeVinny Sastri – Membership Chair

•The membership committee is responsible for providing SPE Headquarters with names, addresses, phone and emailaddresses of prospective members acquired by the Medical Plastics Division.•In addition the membership committee will develop communication programs and efforts to both recognize newmembers but to reach out to lapsed members, work with communication tools (newsletter and website) to reachprospective new members through the MGM program, to develop and implement at least one new service that offersmember value, and try to increase division membership by 10%.

Recognition CommitteeLen Czuba – Nominations Maureen Reitman – AwardsPeter Coburn - Awards

•The Recognition Committee is responsible for utilizing the awards program to recognize contributions from conferencespeakers to student papers, working with the programming committee to identify and recognize best speaker at eachconference.•In addition the Recognition Committee will nominate and sponsor at least one member for either HSM or Fellow fromour division, implement a Medical Plastics Division member recognition program, and use division awards to recognizesignificant contributions.

Medical Plastics Division - SPEBoard of Directors for 2011 - 2012

Name 2011-2012 Position Email CompanyOfficersSteve McCarthy Chairman stephen_mccarthy@uml.edu UMass LowellJill Martin Chair-elect jmmartin@dow.com Dow Plastics

Paul German Treasurerpgerman@krugerplasticproducts.com Kruger Plastics

Margie Hanna Councilor m hanna@yahoo com Czuba Enterprises IncMargie Hanna Councilor m_hanna@yahoo.com Czuba Enterprises, Inc.Len Czuba Past Chair/TPC lczuba@aol.com Czuba Enterprises, Inc.Dan Fuccella Secretary dan@ati-engineers.com Applied Technologies, Inc.Board MembersClass ending ANTEC 2012Ken Pawlak Technical Program Committee k.pawlak@comcast.net Pawlak PlasticsMaureen Reitman Technical Program Committee mreitman@exponent.com ExponentPeter Colb rn A ards peter colb rn@e onik com C ro E onik Ind striesPeter Colburn Awards peter.colburn@evonik.com Cyro Evonik IndustriesClass ending ANTEC 2013Mark Bonifacio Finance / Social Co-chair mbonifacio@ymail.com Bonifacio Consulting Vipul Dave Technical Program Committee VDave1@its.jnj.com Cordis Johnson & JohnsonVinny Sastri Membership Chair vsastri@winovia.com Winovia, LLCHenk Blom ANTEC TPC hpb1517@yahoo.com RollprintEd Fewkes Technical Program Committee fewkesej@corning.com CorningCl di ANTEC 2014Class ending ANTEC 2014Norris Tollefson Newsletter Editor norris.tollefson@cibavision.com CibaVision Corp.

Jim MadenjianCommunications/Social Co-chair jmplastics@aol.com J.M. Engineering Associates

Harrison Yu Website / Pinnacle harrisonyu@comcast.net Bondable BiopolymersJordan Freedman Technical Program Committee jordan.freedman@biomet.com Biomet Orthopedicsex officioGl B ll Hi t i l b ll l @ Gl B ll Pl tiGlenn Beall Historian glennbeallplas@msn.com Glenn Beall PlasticsTricia McKnight SPE Liaison tmcknight@4spe.org Society of Plastics EngineersBrent Strong EC Liaison stronglblb@aol.com Harris Precision MoldGerry McNally EMPD TPC g.mcnally@Qub.ac.uk Queen's University BelfastDavid Howard EMPD Chairman dhoward@ncc.ie National Chemical Company

Austin Coffey EMPD Councilor acoffey@wit.ieWaterford Institute of Technol.

Balance as of November 7, 2011 $11,000.83

INCOME

INVESTMENT ACCOUNTSPE - Investment Fund 9/2011 [$15,231.48]

MEDICAL PLASTICS DIVISION-S.P.E.Treasurers report as of January 19, 2012

INCOMESPE 4th Qtr rebate $406.71

EXPENSESSPE-Euro Banner (1/2 ) $104.39 Council Exp. $1,477.36

Cash available as of January 19, 2012 $9,825.79

PAUL G. GERMAN, TREASURER19-Jan-12

The Medical Plastics DivisionThe Society of Plastics Engineers

ANTEC 2012ANTEC 2012 will be held on April 2-4, 2012 at the Orange County Convention Center in Orlando, FL, USA (co-locating with NPE)

Session T29 – Advances in Medical Plastics – Tuesday AfternoonM d Vi l D é

2011 Technical ProgramModerator – Vipul Davé

Time Speaker Title1:30 pm Gerry McNally

Queen’s University Belfast2012 Annual Education Award winner

Reflections and Encouragement from the 2012 SPE Annual Education Award Winner

2:00 pm Graciela Terife Increasing Drug Release Rate Through2:00 pm Graciela TerifeNew Jersey Institute of Technology

Increasing Drug Release Rate Through Foamed Structures

2:30 pm Mark SannerSABIC

A New Sterilizable High Temperature Polyetherimide Blend for Healthcare Applications

3 00 h l B fit f S Ult i W ld t3:00 pm Kenneth HoltDukane Corporation

Benefits of Servo Ultrasonic Welders to Medical Industry ‐ A Case History

3:30 pm Tadashi OtsukaSenju Pharmaceutical Company, Ltd.

Adsorption and Barrier Properties of PET/PP Blend in Injection Molding

4:00 pm Ken Kelly Bio‐compatible Fluoropolymers and Advances4:00 pm Ken KellyPerformance Plastics Ltd.

Bio compatible Fluoropolymers and Advances in Injection Molding These Materials for Medical Devices, Drug Delivery Systems and Storage Components

4:30 pm Peter Röstel Injection Molds in Cleanroom EnvironmentsFachhochschule Schmalkalden

5:00 pm Medical Plastics Division Annual Business Meeting            Open to all

The Medical Plastics DivisionThe Society of Plastics Engineers

Other Activities

ANTEC 2012Other Activities

New Technology Forum

Polymer Applications in HealthOrganizers – Sadhan C. Jana, Prithu Mukhopadhyay, Len Czuba

Time Speaker Title8:00 am Andreas Lendlein

Univeristy Potsdam FU Berlin

Mulitfunctional Polymer Networks and Their Application Potential in Medicine

8:30 am Arindam DattaBiomerix Corporation

A Family of Novel Reticulated Elastomeric Biostable and Biodegradable Polyurethane Biomaterials – Achieving Biointegration forBiomaterials  Achieving Biointegration for Tissue Growth and Enhanced Healing

9:00 am R.T. MatherI.U. OnyejekweSyracuse University

Drug Release from Biomimetic Shape Memory Elastomeric Composites (SMEC)

l f l9:30 am Vipul DavéJohnson & Johnson

Application of Polymers to Treat Cardiovascular Disease

10:00 am Steve KurtzExponent

Advances in PEEK Biomaterials for Implant Applications

10:30 am Dinesh V Patwardhan Medical Devices & Biomaterials:

Date Time Event Location

April 2, 2012 7:00 p.m. MPD Board Meeting Convention Center

10:30 am Dinesh V. PatwardhanCDRH/FDA

Medical Devices & Biomaterials:An FDA Perspective

April 2, 2012 8:00 p.m. MPD Dinner TBD

April 3, 2012 7:00 am Past Chair’s Breakfast TBD

April 3, 2012 5:00 pm MPD Business Meeting Session T9 Room

NominationsBoard of Directors for the Medical Plastics Division

Th B d f Di t i d f i t l 20 l t d b th t llThe Board of Directors is made up of approximately 20 elected members that generallyserve three year terms in a staggered fashion so that each year we elect five new boardmembers. Officers serve one or two year terms with the exception of our Councilor to theSPE who serves a three year term. See the list of the Board of Directors on page 5 of thisnewsletter.

The Ballot for voting will be sent separately. Biographies for the candidates are shown belowto help you make your selections.

Candidate for Councilor:

Margie Hanna is the Director of Business Development for CEI, a product developmentconsulting firm. She has a degree in Psychology from the University of Illinois Chicago andhas more than 20 years of experience in education sales and marketing roles She hashas more than 20 years of experience in education, sales and marketing roles. She hasserved the Medical Plastics Division by assisting with the MDM programming, was anappointed board member serving as Social Chair. She has coordinated severalmembership recruitment efforts including arranging the MPD receptions at ANTEC. Thepast three years she has served as MPD Councilor. She serves on the Student ActivitiesCommittee and the Communications Committee. Margie Hanna would like to continue toserve the membership of MPD by re-election to Councilor for a second term.

Dr. Ali Ashter is currently a Development Engineer with EMD Millipore Corporation inBedford, Massachusetts. He earned a B.S from Aligarh Muslim University, Aligarh, India,and M.S and Ph.D. from UMass Lowell and worked as a post-doctoral research fellow atMcMaster University in Hamilton, Ontario, Canada. Dr. Ashter has been a member ofSPE since 2000 when he was student at the University of Massachusetts Lowell. He also

Candidates for Board of Directors:

yserves as a member of American Society for Testing Materials (ASTM).

Kenneth E. Breeding, Jr. is a Technical Platform Manager for Molding ApplicationResearch and Development lab with Eastman Chemical Company, based in Kingsport,Tenn He has been with Eastman chemical since 1985 Breeding holds a Bachelors ofTenn. He has been with Eastman chemical since 1985. Breeding holds a Bachelors ofScience Degree in Chemistry from East Tennessee State University in Johnson City,Tenn.

Jodie Laughlin's experience in plastics and manufacturing includes medical devices,g p p g ,automotive components, electronics, consumer products, industrial applications. She hasserved as membership chair and proxy councilor for the Chicago Section and currently isVice President of the Chicago SPE Educational Foundation Board of Directors. Jodiehas been a member of SPE for 13 years and welcomes the opportunity to serve on theSPE Medical Plastics Board of Directors.

Dr. James Oberhauser received his B.S. from the University of California, Davis (1992),M.S. from Stanford University (1993), and Ph.D. from the University of California, SantaBarbara (2001), all degrees in chemical engineering. Subsequently, Dr. Oberhauserperformed postdoctoral research on flow-induced polymer crystallization at the CaliforniaInstitute of Technology. In 2001, he joined the faculty of the Department of ChemicalEngineering at the University of Virginia and, in 2007, joined Abbott Vascular managing thePolymer R&D group’s investigation of bioresorbable vascular scaffolds. He has been amember of the Society of Plastics Engineers since 2001.

Dr. Maureen Reitman is a Principal and the Director of the Polymer Science andMaterials Chemistry practice at Exponent, a scientific and engineering consulting firm.Dr. Reitman received both her Bachelor and Doctor of Science degrees from MIT. Shehas been practicing in the field of polymer science and engineering for more than 20years as a researcher at MIT, in a variety of technical roles at the 3M Company, and asa consultant with Exponent. Dr. Reitman has been a member of the Board of Directorsof the Medical Plastics Division since 2006, serving as Secretary, President, andMember at Large. If elected Dr. Reitman will continue to support Division objectives,especially as it relates to technical programming. Dr. Reitman will be speaking on thetopic of Medical Plastics as part of the 2012 ANTEC Fundamentals Forum.

Andy Sagcal is the Medical Device Specialist for Network Polymers Inc., a styrenicsy g p y , yresin manufacturer and specialty compounder in Akron, OH. He leads their Sales &Marketing and New Business Development efforts, and works directly with Medicaland Electrical OEMs to develop material solutions to complex problems. He earnedhis B.S. in Chemical Engineering from Florida State University. He has over twentyyears of experience with amorphous and semi-crystalline engineering polymers.

►Board members are expected to assumeibilit f ifi d ti h S t

►Candidates for the SPE Medical Plastics DivisionB d f Di t t b ti b f th

Requirements and Responsibilities of Board Membersfor the Medical Plastics Division

responsibility for specific duties, such as Secretary,Newsletter, Web-Site, Social Activities, TechnicalProgram Chair, Membership, Student Activities,Treasurer and SPE-Council Representative.

►Board members are expected to participate incommittees in some capacity to support activitiessuch as Technical Conferences Membership Group

Board of Directors must be active members of theSociety of Plastics Engineers and of the MedicalPlastics Division.

►Members of the Board should be involved in orhave interest in some aspect of the Medical PlasticsBusiness or a related academic field.

such as Technical Conferences, Membership GroupActivities, Financial oversight, BOD nominations, etc.

►We encourage an active membership so any oneindividual doesn't carry too much of a load.

►Board members are expected to participate inmonthly 1-hour teleconference meetings and annualin-person Board of Directors and Business meetingsat SPE's Annual Technical Conference (ANTEC).

Upcoming Conferences and Other Activities

April 2-4Orange County Convention Center

Orlando, Florida USA

Recent Conferences and Activities

For more information, visit the SPE website at www.4SPE.org and look for

events under Technical Groups

Programs Sponsored by The Medical Plastics Division of the Society of Plastics Engineers

Advances in Medical Polymers and NewAdvances in Medical Polymers and New Processing Technologies for Medical Devices

Session 104 - Advanced MaterialsMonday, February 13, 2012Moderators: Margie Hanna – Czuba Enterprises, Inc.

Peter Colburn – Evonik Cyro LLC

The Medical Plastics Division of SPE sponsored twofull days of conference programming at the MD&MWest Conference and Exhibition. The Board ofDirectors of MPD was well represented with four

•Polyolefins for Blow-Fill-Seal Pharmaceutical Packaging: A Case StudyJill Martin Dow Chemical Company

•Processing Considerations for Bioresorbable Polymers in Medical ApplicationsLothar Kleiner Abbott Cardiovascular

E iti N E t d d T bi M t i l

Directors of MPD was well represented with fourboard members giving presentations. Day Onefocused on Advanced Materials while Day Two wasprimarily on Advanced Processing, all related tomedical devices.

Topics in new materials included new olefins,resorbable materials, new polyesters, fluoropolymer

•Exciting New Extruded Tubing Materialsfor Medical ApplicationsEd Boarini Teleflex Medical OEM

•Device Related Hospital Acquired Infections (HAIs) and A Novel Next Generation Antimicrobial TechnologyGertrude Gutierrez Innova Dynamics

•The Production and Use of Supported Nano Silver Particles in

multi-layered tubing, and several papers on materialswith added antimicrobials or active pharmaceuticalingredients.

During the Day Two session on processing, weheard novel topics such as injection molding offluoropolymers, design and selection of devicematerials new packaging materials and •The Production and Use of Supported Nano-Silver Particles in

Polymer SystemsMatt Gande BASF

•Responsible Approach to Antimicrobials and MaterialsPeter Colburn Evonik Cyro LLC

•Modification of Silicone Chemistry and Its Influence on Release Rates of Active Pharmaceutical Ingredients (APIs)

materials, new packaging materials, andmicromolding combined with robotics and a new wayto assure sterilization of product.

See full program detail provided in newslettershowing presenters names, company affiliation andthe title of their presentation. The Medical PlasticsDivision also hosted a gathering of attendees at the Release Rates of Active Pharmaceutical Ingredients (APIs)

Brian Reilly NuSil Technology

•Fabrication of Silicone-Based Combination ProductsMark Paulsen Specialty Silicone FabricatorsMel Toub Momentive Performance Mat’ls

•Trends in Medical Device Materials and An Introduction to Novel Copolyesters

House of Blues for after-session beverages,networking and dinner in Downtown Disney to cap afull day in the conference session.

For anyone that missed this session in Anaheim, CA,MPD will be sponsoring a repeat program at theMDM East on May 22–24, 2012 in Philadelphia,PA Please plan to join us for the latest from experts

Ken Breeding Eastman Chemical Company

•Bioresorbable Polymers for Medical Devices – A (Still) Emerging FieldRichard Meyst Steve CoulterFallbrook Engineering

PA. Please plan to join us for the latest from expertsin some of the leading companies of our industry.

Medical Plastics Division session coordinator Len Czuba 630.632.3560 lczuba@aol.com MDM 2012 MPD

Session 204 – New Processing TechnologiesTuesday, February 14, 2012Moderators: Mark Bonifacio – Bonifacio Consulting Services

John Czuba - CEI•Advances in Injection Molding of Biocompatible FluoropolymersKen Kelly Performance Plastics Ltd.

•Role of Mechanical Properties in Design Control and ValidationSiddharth Desai Gary AurinI Flow Division of Kimberly Clark Corporation

Moderator Margie Hanna with speaker Brian ReillyI Flow Division of Kimberly Clark Corporation

•The Importance of Design and Material Selection for Successful Medical DevicesPhil Anthony Design Integrity

•Qualification of Components for Use in Medical DevicesScott Young West Pharma

•Medical Grade Polyurethanes from Wound Care to Permanent ImplantsTony Walder Lubrizol, Inc

•New Developments in Medical Packaging MaterialsDhuanne Dodrill Rollprint Packaging Products

•New Developments in Medical MicromoldingM k B if i B if i C lti

Speakers Dick Mest, Steve Coulter,Ed Boarini, and Len Czuba

Mark Bonifacio Bonifacio Consulting Services

•Hardware Developments for Machine and Robotic Transfer SystemsStu Kaplan Makuta Technics

•The Challenges of Choosing the Right Polymeric Material for Today’s Medical Devicesfor Today s Medical DevicesLen Czuba Czuba Enterprises, Inc.

•Process Challenge Device – A Sterility Assurance Validation ToolR. Daniel Webster Process Challenge Device

Moderator Margie Hanna with speakers Mark Paulsen and Mel Toub

Programs Sponsored by The Medical Plastics Division of the Society of Plastics Engineers

Advances in Medical Polymers and New P i T h l i f M di l D i

Advanced Materials

Processing Technologies for Medical DevicesPlanned Program

Advanced Materials Polyolefins for Blow-Fill-Seal Pharmaceutical Packaging: A CaseStudy Jill Martin Dow Chemical Company Medical Grade Polyurethanes from Wound Care to PermanentImplants Tony Walder LifeScience Polymers, Lubrizol, Inc.

New Processing Technologies Exciting New Extruded Tubing Materials for Medical ApplicationsEd Boarini Teleflex Medical OEM Device Related Hospital Acquired Infections (HAIs) and a NovelNext Generation Antimicrobial Technology Gertrude Gutierrez Innova Dynamics Responsible Approach to Antimicrobials and Materials Peter Colburn Evonik Cyro LLC

The Importance of Design and Material Selection for Successful Medical Devices Phil Anthony Design Integrity Qualification of Components for Use in Medical Devices Scott Young West Pharma Role of Mechanical Properties in Design Control and Validation Gary Aurin I Flow Division of Kimberly Clark

Peter Colburn Evonik Cyro LLC Bioresorbable Materials Michiel van Alst Purac Biomaterials Processing Considerations for Bioresorbable Polymers in MedicalApplications Lothar Kleiner Abbott Cardiovascular Bioresorbable Polymers for Medical Devices - A (Still) EmergingFi ld

New Developments in Medical Packaging Materials Dhuanne Dodrill Rollprint Packaging Products Biomedical Textiles in Implantable Medical Devices Jeffrey Koslosky Secant Medical, LLC Advances in Injection Molding of Biocompatible Fluoropolymers Ken Kelly Performance Plastics Ltd.

Field Steve Coulter Fallbrook Engineering Modification of Silicone Chemistry and its Influence on ReleaseRates of Active Pharmaceutical Ingredients (APIs) Brian Reilly NuSil Technology Fabrication of Silicone-based Combination Products Mark Paulsen Specialty Silicone Fabricators Mel Toub Momentive Performance Materials

New Developments in Medical Micromolding Mark Bonifacio Bonifacio Consulting Services Hardware Developments for Machine and Robotic Transfer Systems Stu Kaplan Makuta Technics The Challenges of Choosing the Right Polymeric Material for Today’s Medical Devices Len Czuba Czuba Enterprises IncLen Czuba Czuba Enterprises, Inc. Trends in Medical Device Materials and an Introduction to Novel Copolyesters Ken Breeding Eastman Chemical Company

Technical Presentation: From EUROTEC 2011

Approved Meeting Minutes: Only approved meetingminutes are published. Minutes from recent meeting for the Board ofDirectors are not yet approved.

November 21, 2011 Teleconference Board of Directors Meeting November 21, 2011 Teleconference Board of Directors Meeting of the Medical Plastics Division of the Society of Plastics Engineers

(title corrected 01/09/2012)

Meeting was called to order by MPD Chairman Steve McCarthy at 11:05 am (ET)

Attendance:-Attended: Steve McCarthy, Jill Martin, Margie Hanna, Len Czuba, Dan Fuccella, Maureen Reitman, Mark Bonifacio, Vipul Dave Ed Fewkes Norris Tollefson Jim Madenjian Jordan Freedman Glenn Beall Tricia McKnight Brent StrongVipul Dave, Ed Fewkes, Norris Tollefson, Jim Madenjian, Jordan Freedman, Glenn Beall, Tricia McKnight, Brent Strong-Excused Absence: Paul German, Harrison Yu, Austin Coffey-Absent: Ken Pawlak, Peter Colburn, Vinny Sastri, Henk Blom, Gerry McNally, David Howard-Guest: Emmitt O'Brien

Note: Some members of the Board received an MS Outlook meeting Cancelation Notice prior to the meeting.

Approval of minutes of Board meeting of September 12, 2011: Moved Dan Fuccella, Second Margie Hanna, Motion carried.

Finance committee – Len Czuba-Joe Fox has had to relinquish his post on the Finance Committee and on the MPD BOD. For now, he will not be replaced on the finance committee.

-Moved Len Czuba, Second Norris Tollefson: to donate $2,500 to the 2012 ANTEC Student Activities committee. Motion carried.

-Finance Committee is soliciting new ideas from the Board regarding how best to use funds (e.g.: membership activities, student support, etc.)-Treasurer’s Report –

Cash on Hand: $11,000.83SPE Investment Fund; $15,231.48

Technical Program CommitteeANTEC Report – Vipul Dave / Henk BlomVipul reported:-Seven papers submitted Hope to have initial reviews completed by 11/26/11

Also disc ssedAlso discussed:•Board encouraged to contact colleagues who are doing some interesting work to be potential presenters

•Try to encourage invited speakers (no paper required)-New Technology Forum: will feature frontier pushing topics; speakers needed - send to inquiries to Len Czuba

MDM 2011 update – Len Czuba / Maureen ReitmanHave acquired enough papers to fill two full days of the program

EuroTec Barcelona Spain; Nov 14th and 15th 2011 – Austin Coffey / Len CzubaEuroTec Barcelona, Spain; Nov 14 and 15 , 2011 – Austin Coffey / Len CzubaLen reported:-15 papers presented by the European Medical Polymers Division, our sister division.

-200 total papers presented-250 attendees – good participation globally

-Moved Len Czuba, Second Margie Hanna, Motion carried; to provide USB flash drives to the MPD presenters at the EuroTec

-Papers will be available for download by attendees in DecemberTravelling MiniTec Outreach Speaker’s list – Jim Madenjiang p j-Have received several requests for MPD speakers -Minneapolis would like to hold a program early in 2012-Will continue to work on this outreach and programming concept.Webinar Len Czuba speakers needed and the invite is open; so contact us when there is interest.

Membership – Vinny Sastri: -No new action

Communications-Newsletter – Norris Tollefson:-Soliciting technical papers and pertinent articles; Len to provide one paper from the EuroTec for one of our future issues.

-Will include the program from the EuroTec-Can make up for newsletter shortfall for the Pinnacle Award with LinkedIn communications, etc.

-Len mentioned the Medical Plastics News e-news edition, based in London, will be publishing 4 issues per year. Send editorial copy to submissions to Len

Website – Harrison Yu: Excused absenceNo report

Social Committee: Mark Bonifacio and Jim MadenjianNo new action

Recognition – Peter Colburn:Len reported:

Gerr McNall as a arded the SPE International Ed cation A ard-Gerry McNally was awarded the SPE International Education Award

Pinnacle – Harrison Yu: Working on Pinnacle Award documentation-Assigned sections of the report are due to Harrison by the end of November

Councilor report – Margie HannaNew Officers

President-elect Jon RatzlaffSenior Vice President Dick CameronSenior Vice President Dick CameronVice President Gregory CampbellCouncil of the Whole Chair Monika Verheij

Search for a new SPE Executive Director is targeted for completion in about on a month

Presented a $2,500 check from MPD to be used by the Student Activity's Committee at the 2012 ANTEC

We will have a registered office in Brussels, Belgium starting December 1, 2011. It will have a phone manned for questions and problems.

November 29 & 30, 2012 we will have the first ANTEC in Mumbai. Any support will be appreciated for the new venture.

Currently, our society is 15,186 members strong.

Budget:Project a $70K surplus for 2011 vs. planned budget surplus of $30K. Thanks to tight cost control, good performance of conferencing especially ANTEC in Boston, and the relationship with Wiley, Executive Director Susan Oderwald and staff have been able to head into 2012 with sound financial footing. 2012 is expected to be challenging year with ANTEC co-located with NPE in Orlando and membership is projected to be flat. However, rebates are expected to return to full rebates ($300K) back to Sections and Divisions which end up from 2011 ($100K). Next Council will meet in February and will be a Teleconference and Web-based meeting.

LiaisonsE ropean Medical Pol mers Di ision Gerr McNall / A stin Coffe No report-European Medical Polymers Division – Gerry McNally / Austin Coffey: No report

-SPE Staff – Tricia McKnight:•Headquarters is implementing an online daily activities reporting system

•Still identifying an Executive Director

Executive Committee Liaison – Brent Strong: -Nothing new to add or report

New BusinessJoe Fox has had to relinquish his post on the MPD Board; Emmitt O’Brien of Eastman will be filling the position-Joe Fox has had to relinquish his post on the MPD Board; Emmitt O Brien of Eastman will be filling the position.

Unfinished business: None reported

The next MPD Board of Directors teleconference meeting is scheduled for 11:00 am (ET), January 9, 2012

Meeting adjourned 11:39am ET Moved Jim Madenjian, Second Margie Hanna, carried

Submitted by:Daniel C Fuccella,Secretary, MPDDecember 5, 2011

Medical Plastics Division of the Society of Plastics Engineersy g

Minutes of the September 12, 2011 Board of Directors teleconference meeting

Meeting was called to order by MPD Chairman Steve McCarthy at 11:10 am (ET)

Attendees: List attached

Approval of minutes of Board meeting of July 18, 2011: Moved: Dan FuccellaSecond: Len Czuba

Finance committee – Len Czuba-Joe Fox and Dan Fuccella recently joined the Finance Committee

-Will continue to emphasize student support particularly at ANTEC -Finance Committee is soliciting new ideas from the Board, e.g.:

oSeek sponsors for the MPD newsletter oProvide financial incentive to new/prospective MPD members

Id f l l i di f d i i d th/i t t idoIdeas for long range planning regarding fund raising and growth/investment ideas-Copies of September Meeting Notes, Long Range Plan and Budget Update will be sent to all board members.

Treasurer’s Report – Paul GermanCopy attached

Technical Program CommitteeANTEC Report – Vipul Dave / Henk BloomHenk reported:Henk reported:-No papers submitted as of yet - will send out another email blast

-Seeking volunteer reviewers (paper submission closes October 19th)-Will be looking into Joint Sessions based on papers that get approved

Also discussed:-Board encouraged to contact colleagues who are doing some interesting work to be potential presenters

-Seek an invited speaker-New Technology Forum: will feature frontier pushing topics; speakers needed - send to Len

MDM 2012 update – Len Czuba / Maureen ReitmanLen reported:-Conveyed Intent to Participate-Looking for speakers (no paper required) for one to two days of programming

EuroTec – Austin Coffey / Len CzubaLen reported:-Barcelona, Spain; Nov 14th and 15th, 2011

-14 papers submitted and reviewed waiting for final approval-Popular topics: Nano composites and resorbable materials

Travelling MiniTec Outreach Speaker’s list – no report

Webinar speakers needed – Len Czuba for Elizabeth Reagan: in process

Membership – Vinny Sastri: -Discussed sending welcome notice and recognizing new members

C i tiCommunicationsNewsletter – Norris Tollefson:-Summer 2011 MPD newsletter posted on the SPE website

-Next issue scheduled for late October/early November – need technical papers or articles-Asked to include info on newsletter sponsorship, membership campaigns, and EuroTech

Website – Harrison Yu:Commented on redundancy between newsletter and website

Social Committee: Mark Bonifacio and Jim MadenjianNo new action

Recognition – Peter Colburn:Len reported:-Must submit applications for Honored Service Members by September 20th

-MPD Most Valuable Member voted on just before ANTEC-Think about other forms of membership recognitionp g

Pinnacle – Harrison Yu: Working on Pinnacle Award documentation-Sent sections of the application to appropriate persons-Needs responses during November for December submission to Headquarters (tech program, communication, organization.)

-Needs goals and plans for membership growth.

Councilor report –Margie Hanna:-Nov 12 next council meeting send questions to Margie

LiaisonsEuropean Medical Polymers Division – Gerry McNally / Austin Coffey: No report

Executive Committee – Brent Strong: -No Report

SPE Staff – Tricia McKnight:Fi i l t d IRS f d N b 15 2011-Financial report and IRS forms are due November15, 2011

Unfinished business: None reported

Note: Len mentioned the Medical Plastics News e-news edition, based in London, will be publishing 4 issues per year. Send editorial to submissions to Len

The next MPD Board of Directors teleconference meeting is scheduled for 11:00 am (ET) 2011. November 21, 2011

Meeting adjourned 11:58am ET

Submitted by:Daniel C Fuccella,Secretary, MPD