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www.mediplastconference.com




The theme for this year’s 2-day conference on “Polymers & Plastics in Medical Applications” is to bring the
participants up to speed on the newest trends and technical advances in the field of Medical Devices as it
relates to Polymeric Materials.

The target audience is Medical Device producers, Molders of Sub-Assemblies, Plastic & Additive suppliers,
Equipment & Prototype Designers, Regulatory professionals, Sales, Marketing, and Business Development
leaders throughout the entire supply chain of the Health-Care industry. The conference has been structured to
provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the
value chain.

Conference Chairs
Dr. JaiPal Singh, CSO / VP-Research, Saint Joseph’s Translational Res., Institute, Atlanta, GA 30313

Dr. Daniel Bolton, Market Develop Mgr., Eastman Chemical, Kingsport, TN 37662




       FEBRUARY 29 - MARCH 2, 2012
        CAESAR’S PALACE
                      LAS VEGAS, NV, 89103, USA
CONFERENCE SCHEDULE

Optional Pre-Conference Course
9:00-12:00                                                            Conference Schedule
               High Growth Strategies for Medical Start ups: Creating the Next Blockbuster
               Prof. Gary Lynn, Distinguished Service Professor Stevens Institute of Technology, USA
               Named One-of-Ten Top Management Gurus in the World ………….Business 2.0 Magazine
               Named One-of-Seven Leading Thinkers in Technology Innovation Management……IAMOT
               Author of Blockbusters: Five Keys to Developing Great New Products
Over 60% of new technology ventures fail. There are five(5) critical practices that separate the high-growth companies
from the rest. You will learn these tested strategies that will help you develop new medical products more success-
fully, for less investment – and do it faster. Topics covered will include (i) identify your ideal customer (ii) articulate
your customer value proposition - clearly and succinctly (iii) size your market - accurately and believably (iv) identify
and secure channel partners (v) create an accurate growth schedule, (vi) value your company, and (vii) raise external
funding faster and easier.

2:00-5:00      Regulatory Considerations for Selecting Materials for Medical Devices
               Dr. Linda Braddon, President, Secure BioMed Evaluations, USA

All too often in the design of a new medical device, regulatory considerations do not come to the forefront until
after the device is designed. By performing a regulatory impact review of your material choices very early in
the design process, a new medical device company can expedite their time to market and reduce the regulatory
burden. By performing simple activities early in the process, such as identification of FDA friendly materials,
manufacturers can reduce the burden of proving safety of their medical devices and decrease the time to prod-
uct launch. An overview of materials selection in the light of regulatory approval, will be presented.




7:30-8:15        Registration and Continental Breakfast

8:15-8:30        Welcome and Opening Remarks

8:30-9:15        Keynote Address
                 Plastics in Medical Technology: Highlights, Challenges & Opportunities
                 Prof. Aman Mahajan, M.D., Ph.D., FAHA
                 Chief of Cardiothoracic Anesthesiology
                 Director- Interventional Cardiology Operations
                 Director - PeriOperative Echocardiraphy
                 Ronald Reagan UCLA Medical Center, Los Angeles, CA 90095, USA

Polymeric Materials represent one of the greatest innovations in science & biotechnology that have led
to advancement in almost every field of medicine. This keynote presentation will discuss the parallel
growth in plastics and medical technology and how several landmark technological advances in
different fields of medicine were made possible by use of plastics. Topics will include how innovations
in the field of plastics have contributed to the advancement of surgical equipment and techniques, criti-
cal care and life support hardware, and radiologic evaluation with the advent of MRI and how changes
in these fields have shaped the current practice of medicine. Presentation will also address how the
evolution of plastic technology in and out of the hospital have lead to decreasing rates of infection and
medication-related error. Furthermore, challenges & opportunities for medical devices of the future will
be mentioned.
9:15-9:30   Coffee break

            Session I: Polymers in CARDIOVASCULAR Devices
            Polymeric Materials in Medical Devices: Challenges & Opportunities
            Dr. Patricia Davis-Lemessy, Manager-Polymers, Cordis-a Johnson & Johnson Company, USA

            Assessment of Polymer Coatings for Drug Eluting Stents
            Dr. Barbara Huibregtse, Director-Preclinical Sciences, Boston Scientific, USA

            The Importance of Polymer Biocompatibility for Long-Term DES Outcomes and Safety
            Dr. Josiah (Cy) Wilcox, Chief Scientific Officer, Medtronic Cardiovascular, USA

            Novel BioResorbable Polymer based Drug Eluting Scaffolds
            Dr. Joanzy Zeltinger, VP-Scientific Affairs, Reva Medical, USA

            Role of BioResorbable Polymeric Scaffold in Vascular Systems
            Dr. Syed Hossainy, Director-Innovation Incubator & Volwiler Fellow, Abbott Vascular, USA

            Self-Expanding BioResorbable Scaffolds for Peripheral Artery Disease
            Dr. Maria Palasis, Exe VP & Chief Technology Officer, Arsenal Vascular, USA

            New Approaches to Define Biological Response of Biopolymers and Drugs used in Vascular Stents
            Dr. JaiPal Singh, Chief Scientific Officer, Saint Joseph’s Trans Res. Institute, USA

            Innovative Plastic for Cardiovascular & Renel Devices
            Dr. Brock Thomas, Sr. Appl. Development, Eastman Chemical, USA
            Gopal Saraiya, Global Segment Leader-Med Devices, Eastman Chemical, USA


            Session II: Polymers in ORTHOPAEDIC Devices

            High Strength Collagen Polymers for Orthopaedic Applications:
            Creating Biomimetic Tendons
            Dr. Thomas Koob, Chief Sci. Officer & Exe VP, MiMedx Group, USA

            Biomaterial Innovation Takes Shape: Drug Delivery Device Forming Possibilities
            Utilizing Extrusion Technologies
            Anthony Listro, Managing Director-Delivery Science, Foster Corp, USA

            High Performance Biocompatible Implantable Plastics
            Michael Wallick, Technical Support Manager, Invibio, UK

            Failure Modes in Polymers for Orthopaedic Applications:
            Material Requirements/Design Constraints
            Dawn Lissy, President & CEO, Empirical Testing Corp., USA
Session III: Advances in MATERIALS & COATINGS
Controlling Polymer Surface Properties for Tailored Biological Interactions
Dr. Theresa Hermel-Davidock, Manager-R&D, Beckton Dickinson, USA

Diagnostic Devices: Addressing Chemical Resistance of Plastics in Clinical
Environments
Matt Sauers, Principal R&D Engineer, Roche, Diagnostics Operations, USA

Novel Approaches to Address Chemical Resistance & Toughness:
Advances in Thermoplastic Alloys & Design
Dr. Steve Blazey, Technical Director, Diamond Network Polymers, USA

AntiMicrobial Acrylic: A New Medical Polymer Compound for Medical Device
Applications
Dr. Zhen Zhu, R&D Manager, Evonik Cyro, USA

AntiMicrobial Solutions for Next Generation Medical Devices
Troy Mohr, VP-Business Develop, BioMerics, USA

Alternative to PVC Plasticizer DEHP in Medical Applications: Eastman 168™
Dr. Mark Holt, Manager-Plasticizers Market Develop, Eastman Chemical, USA

Session IV: Advances in MANUFACTURING: Devices & Materials

State-of-the-Art Additions to Molding Machines for Medical Applications
Dr. Juergen Giesow, Regional Manager, Arburg, USA

Process Monitoring & Control for Medical Molders
Shane Vandekerkhof, Business Develop Mgr, RJG Inc., USA

Medical Devices & Packaging: Pushing the Boundaries of Conventional Thermoforming
Andy D’Esposito, Tek Packaging, USA


Session V: REGULATORY Requirements for Medical Polymers
FDA Medical Device Approval Process: An Overview
Dr. Linda Braddon, Secure BioMed Evaluations, USA

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Medical Device-Polymers & Plastics

  • 1. www.mediplastconference.com The theme for this year’s 2-day conference on “Polymers & Plastics in Medical Applications” is to bring the participants up to speed on the newest trends and technical advances in the field of Medical Devices as it relates to Polymeric Materials. The target audience is Medical Device producers, Molders of Sub-Assemblies, Plastic & Additive suppliers, Equipment & Prototype Designers, Regulatory professionals, Sales, Marketing, and Business Development leaders throughout the entire supply chain of the Health-Care industry. The conference has been structured to provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the value chain. Conference Chairs Dr. JaiPal Singh, CSO / VP-Research, Saint Joseph’s Translational Res., Institute, Atlanta, GA 30313 Dr. Daniel Bolton, Market Develop Mgr., Eastman Chemical, Kingsport, TN 37662 FEBRUARY 29 - MARCH 2, 2012 CAESAR’S PALACE LAS VEGAS, NV, 89103, USA
  • 2. CONFERENCE SCHEDULE Optional Pre-Conference Course 9:00-12:00 Conference Schedule High Growth Strategies for Medical Start ups: Creating the Next Blockbuster Prof. Gary Lynn, Distinguished Service Professor Stevens Institute of Technology, USA Named One-of-Ten Top Management Gurus in the World ………….Business 2.0 Magazine Named One-of-Seven Leading Thinkers in Technology Innovation Management……IAMOT Author of Blockbusters: Five Keys to Developing Great New Products Over 60% of new technology ventures fail. There are five(5) critical practices that separate the high-growth companies from the rest. You will learn these tested strategies that will help you develop new medical products more success- fully, for less investment – and do it faster. Topics covered will include (i) identify your ideal customer (ii) articulate your customer value proposition - clearly and succinctly (iii) size your market - accurately and believably (iv) identify and secure channel partners (v) create an accurate growth schedule, (vi) value your company, and (vii) raise external funding faster and easier. 2:00-5:00 Regulatory Considerations for Selecting Materials for Medical Devices Dr. Linda Braddon, President, Secure BioMed Evaluations, USA All too often in the design of a new medical device, regulatory considerations do not come to the forefront until after the device is designed. By performing a regulatory impact review of your material choices very early in the design process, a new medical device company can expedite their time to market and reduce the regulatory burden. By performing simple activities early in the process, such as identification of FDA friendly materials, manufacturers can reduce the burden of proving safety of their medical devices and decrease the time to prod- uct launch. An overview of materials selection in the light of regulatory approval, will be presented. 7:30-8:15 Registration and Continental Breakfast 8:15-8:30 Welcome and Opening Remarks 8:30-9:15 Keynote Address Plastics in Medical Technology: Highlights, Challenges & Opportunities Prof. Aman Mahajan, M.D., Ph.D., FAHA Chief of Cardiothoracic Anesthesiology Director- Interventional Cardiology Operations Director - PeriOperative Echocardiraphy Ronald Reagan UCLA Medical Center, Los Angeles, CA 90095, USA Polymeric Materials represent one of the greatest innovations in science & biotechnology that have led to advancement in almost every field of medicine. This keynote presentation will discuss the parallel growth in plastics and medical technology and how several landmark technological advances in different fields of medicine were made possible by use of plastics. Topics will include how innovations in the field of plastics have contributed to the advancement of surgical equipment and techniques, criti- cal care and life support hardware, and radiologic evaluation with the advent of MRI and how changes in these fields have shaped the current practice of medicine. Presentation will also address how the evolution of plastic technology in and out of the hospital have lead to decreasing rates of infection and medication-related error. Furthermore, challenges & opportunities for medical devices of the future will be mentioned.
  • 3. 9:15-9:30 Coffee break Session I: Polymers in CARDIOVASCULAR Devices Polymeric Materials in Medical Devices: Challenges & Opportunities Dr. Patricia Davis-Lemessy, Manager-Polymers, Cordis-a Johnson & Johnson Company, USA Assessment of Polymer Coatings for Drug Eluting Stents Dr. Barbara Huibregtse, Director-Preclinical Sciences, Boston Scientific, USA The Importance of Polymer Biocompatibility for Long-Term DES Outcomes and Safety Dr. Josiah (Cy) Wilcox, Chief Scientific Officer, Medtronic Cardiovascular, USA Novel BioResorbable Polymer based Drug Eluting Scaffolds Dr. Joanzy Zeltinger, VP-Scientific Affairs, Reva Medical, USA Role of BioResorbable Polymeric Scaffold in Vascular Systems Dr. Syed Hossainy, Director-Innovation Incubator & Volwiler Fellow, Abbott Vascular, USA Self-Expanding BioResorbable Scaffolds for Peripheral Artery Disease Dr. Maria Palasis, Exe VP & Chief Technology Officer, Arsenal Vascular, USA New Approaches to Define Biological Response of Biopolymers and Drugs used in Vascular Stents Dr. JaiPal Singh, Chief Scientific Officer, Saint Joseph’s Trans Res. Institute, USA Innovative Plastic for Cardiovascular & Renel Devices Dr. Brock Thomas, Sr. Appl. Development, Eastman Chemical, USA Gopal Saraiya, Global Segment Leader-Med Devices, Eastman Chemical, USA Session II: Polymers in ORTHOPAEDIC Devices High Strength Collagen Polymers for Orthopaedic Applications: Creating Biomimetic Tendons Dr. Thomas Koob, Chief Sci. Officer & Exe VP, MiMedx Group, USA Biomaterial Innovation Takes Shape: Drug Delivery Device Forming Possibilities Utilizing Extrusion Technologies Anthony Listro, Managing Director-Delivery Science, Foster Corp, USA High Performance Biocompatible Implantable Plastics Michael Wallick, Technical Support Manager, Invibio, UK Failure Modes in Polymers for Orthopaedic Applications: Material Requirements/Design Constraints Dawn Lissy, President & CEO, Empirical Testing Corp., USA
  • 4. Session III: Advances in MATERIALS & COATINGS Controlling Polymer Surface Properties for Tailored Biological Interactions Dr. Theresa Hermel-Davidock, Manager-R&D, Beckton Dickinson, USA Diagnostic Devices: Addressing Chemical Resistance of Plastics in Clinical Environments Matt Sauers, Principal R&D Engineer, Roche, Diagnostics Operations, USA Novel Approaches to Address Chemical Resistance & Toughness: Advances in Thermoplastic Alloys & Design Dr. Steve Blazey, Technical Director, Diamond Network Polymers, USA AntiMicrobial Acrylic: A New Medical Polymer Compound for Medical Device Applications Dr. Zhen Zhu, R&D Manager, Evonik Cyro, USA AntiMicrobial Solutions for Next Generation Medical Devices Troy Mohr, VP-Business Develop, BioMerics, USA Alternative to PVC Plasticizer DEHP in Medical Applications: Eastman 168™ Dr. Mark Holt, Manager-Plasticizers Market Develop, Eastman Chemical, USA Session IV: Advances in MANUFACTURING: Devices & Materials State-of-the-Art Additions to Molding Machines for Medical Applications Dr. Juergen Giesow, Regional Manager, Arburg, USA Process Monitoring & Control for Medical Molders Shane Vandekerkhof, Business Develop Mgr, RJG Inc., USA Medical Devices & Packaging: Pushing the Boundaries of Conventional Thermoforming Andy D’Esposito, Tek Packaging, USA Session V: REGULATORY Requirements for Medical Polymers FDA Medical Device Approval Process: An Overview Dr. Linda Braddon, Secure BioMed Evaluations, USA