Conference — Session 204TUESDAY, FEBRUARY 14
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About the Moderators
Mark Bonifacio, President, Bonifacio Consulting Services, LLC
Mark Bonifacio is the president and founder of Bonifacio Consulting Services, LLC (BCS), a medical device manufacturing consultancy focused on helping medical device firms with the manufacturing of plastic medical device components and assemblies across several therapeutic disciplines. BCS specializes in precision injection molding and assemblies, LIM/silicone molding, micromolding and all manufacturing aspects of plastic medical devices and disposables.
Bonifacio has been working for and with various medical device OEMs and contract manufacturers for more than 25 years. He has held leadership positions in engineering, business development, sales and operations. Before BCS, Bonifacio co-founded APEC (now Helix Medical), a leader in plastics medical products injection molding and manufacturing. He began his career as an engineer with Elkay Products and Baxter Healthcare (now Cardinal Health). He holds a Bachelor of Science degree in plastics engineering from the University of Lowell (now UMASS - Lowell).
John Czuba, Director of Quality, CEI
Having worked in tooling design and manufacturing, the move to Quality was a natural in the Medical Products area. Some of the more interesting projects recently included material selection, validation documentation, and product delivery systems.
Advances in Injection Molding of Biocompatible Fluoropolymers
About the Presentation
Difficult bio-compatibility requirements for the storage and delivery of next generation drug technologies and demanding performance requirements of new medical devices can be addressed with injection molded fluoropolymers.. In the past, fluoropolymers were not often considered for high volume parts with complex geometries due to material processing challenges. The caustic nature of the byproducts generated during the injection molding process accelerated tooling degradation severely limiting production. Sintering or machining of individual parts was considered the only reliable production method. Concerns about dimensional limitations, melt fracture, delamination issues and scrap rates still persist but no longer valid. Developments over the past 10 years in mold designs and tooling steels combined with specialized hot runner systems and direct gating techniques have eliminated all traditional processing and material waste allowing for complex geometries, tight tolerances and high volume production at significantly reduced per piece price. These manufacturing advances allow the use of bio-compatible fluoropolymers as price competitive alternatives for high volume medical device, drug delivery and storage components that need a combination of chemical and organic resistance, low surface adhesion and high temperature attributes to address critical performance requirements.
Presentation objectives:
Plastics used in current medical and pharmaceutical applications will not meet increased physical, environmental, chemical resistance, cytotoxicity and bio-compatibility requirements of the next generation medical devices and drugs.
Because of fluoropolymers natural temperature, friction and barrier properties, secondary coatings like silicone used with traditional plastics are not required. These characteristics offer performance advantages for liquids, sprays and powders during manufacturing, testing, storage, packaging and delivery.
Direct gating, hot runner technology specifically developed for PFA, FEP and other fluoropolymer materials eliminates waste associated with conventional molding techniques to significantly reducing material usage.
Advances in materials, tooling, injection molding equipment and processes has overcome traditional obstacles allowing high volume manufacturing of fluoropolymer components with complicated geometries and tight tolerances at competitive costs.
Ken Kelly, General Manager, Performance Plastics Ltd.
Ken has been with Performance Plastics since 2000. He has 17 years of experience in the plastics industry. Prior to his role as General Manager, Ken held the position of Engineering Manager. His areas of expertise include plastic part design, tool design and material selection. Ken holds a BS in Plastic Engineering from Shawnee State University and an MBA from Xavier University.
Qualification of Components for Use in Medical Devices
About the Presentation
Ultra high-quality plastic syringe systems provide a compelling alternative to glass syringe systems. Through simplified usage, support for new classes of biopharmaceutical products, reduced waste, break-resistance, dosage precision and the virtual elimination of extractables and leachables, plastic prefillable syringes present attractive benefits that are gaining increased attention from manufacturers seeking new answers to today’s and tomorrow’s drug-delivery and administration challenges.
Additionally, rapid growth of injection devices has become increasingly prevalent in pharmaceutical drug delivery. There is an emerging need to minimize or eliminate protein aggregation due to silicone oil interaction, reduce contamination due to extractables and minimize drug loss due to adsorption. Choosing the right injection system can mitigate these protein aggregation and instability issues. This session will discuss key attributes of a silicone-free prefillable syringe system, including syringe functional performance attributes, ideal for biopharmaceutical drug delivery applications.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
- Requirements of pharmaceutical delivery systems
- Current issues with traditional glass packaging
- Testing and performance of syringe systems
- Design flexibility of plastics
About the Speaker
Scott Young, Ph.D., Senior Director, West Pharmaceutical Services, Inc.
Dr. Young has more than 20 years of extensive expertise in the area of medical device design and materials development. Previous industrial experience includes employment at American Cyanamid, Shell Chemical Company, and WL Gore.
Currently responsible for the development and commercialization of the Daikyo Crystal Zenith Platform including syringes, vials, API containers, and novel delivery systems.
Dr. Young holds a B.S. degree in Chemical Engineering from West Virginia University, a M.S. and Ph.D. degree in Chemical Engineering from University of Pittsburgh, and an M.B.A. from the University of Delaware.
Dr. Young is an active member of the American Chemical Society and the Society of Plastic Engineers, and has authored more than 20 publications and conference presentations. s
The Importance of Design and Material Selection for Successful Medical Devices
About the Presentation
As medical devices evolve and become more technically challenging and prevalent in healthcare environments as well as in the home, the design of the products and the selection of the right materials are just as important as ever. The design of medical products has always included proper engineering and verification testing, but usability has become a critical aspect of all medical product design programs. The material selection process can range from short and simple to complex and burdensome on any given project, but the process is generally more involved when it comes to medical devices and equipment. During this session, key insights into medical device design will be presented. In addition, the typical material selection process will be reviewed along with key material selection guidelines for medical products. Related case studies will be presented as examples.
- Presentation of key insights into medical device design
- Review of material selection guidelines common to all products
- Key material selection guidelines for medical devices and equipment
- Case studies of related examples
About the Speaker
Phil Anthony, President, Design Integrity, Inc.
Phil Anthony is the founder and president of Design Integrity, Inc., a new product design and development consulting firm located in Chicago. Over his 25 years of design experience, Phil has developed several innovative and successful new products in various markets including industrial equipment, medical devices, and consumer products. His clients include Snap-on, Illinois Tool Works, Baxter Healthcare, SRAM, S.C. Johnson, and Abbott. Phil received his BSME from Lehigh, his MSME from Northwestern, and his MBA from the Kellogg Graduate School of Management. He has earned 12 US utility patents and several major design awards throughout his career in design.
Physical Properties and Its Implications on Design Control
About the Presentation
This presentation will describe the method of treatment for Physical Properties in Design and Development for robust design Control.
Design Requirements
A specific physical parameter can not be observed in isolation by itself. It is important to understand the significance of the parameter on the fundamental device performance requirement. In the DFSS approach, the Critical to Quality criteria is determined through the fundamental understanding of the product function.
Methodology
A case study is provided here to develop a method for robust Design Control.
- Review basic product requirements including Customer, Marketing and Engineering. Thoroughly understand the functionality of the product requirement.
- Define design input requirements for the product from the product requirements.
- Develop a complete Assembly Process Diagram; from component to finished device.
- Complete the cascade diagram; from component to the finished device that focuses on critical to quality (CTQ) parameters.
- Review CTQ parameters at the component level. Cascade this upwards to the finished device. CTQ parameters for component may be Durometer, Tensile Strength, Modulus of Elasticity, Impact Strength.
- Thoroughly define CTQ at the physical property level for the components.
- Complete tolerance stack-up analysis and develop design of experiments to assess criticality of each parameter.
- Develop design of experiments to define significance of the physical property at the component, subassembly, assembly and finished device level.
- Validate through systematic scientific processes.
- Complete Design Input to Design Output trace matrix with emphasis on the CTQs. Ensure that the trace matrix reflects complete cascade including component characteristics to finished device.
Strategic Drivers for the Process
- FDA and Other Regulatory mandated Design Control
- Robust Design and Process Development
- Validation and Verification optimization
- Converting science into comprehensive practical language
- Better products
About the Speakers
Siddharth Desai, VP R&D, I Flow Division, Kimberly Clark Corporation
Siddharth Desai is a seasoned technical leader with a focus on Strategic Product Planning, New Product Development, and Operations Engineering.
He has over 21 years of experience in the Medical Device Industry. His career has been in diverse areas of healthcare including Anesthesia, Drug Delivery, Infusion Systems, Ophthalmic Devices, Orthopedics and Plastic Surgery.
He has multiple patents and publications in the areas of Product and Process Development, among them are Flow Indication and MEMS devices. Among the products he has launched include Wound Drainage System, Antimicrobial Wound Dressing, Varieties of Infusion Pumps, Intra Ocular Lenses, Phaco-Emulsification Equipment, Regional Anesthesia Nerve Block products.
He has managed manufacturing operations and engineering and supported multiple plants. He is expert in the areas of Design Control, Process Validation, and Process Control. He has worked with variety of regulatory agencies and launched products in various parts of the globe including North America, Europe, Canada, Japan, Australia, Korea, and China.
He has presented papers to the industry in New Product Development, Healthcare Law and Impact on Medical Device Innovation and Creating Strategic Alliances. His education background includes a B.S. and an M.S. in Engineering, and an Executive MBA.
Gary Aurin, Technical Leader, Kimberly Clark Corporation
Gary Aurin is a seasoned technical leader with a focus on New Product Design, Development, and Operations Engineering.
He has over 21 years of experience in the Medical Device Industry. His career has been in diverse areas of healthcare including Infusion Systems, Drug Delivery Systems.
Among several areas of expertize, Gary specializes in Design Control, Validation and FDA compliance. He is also well versed in Statistics and Design of Experiments.
He has worked with variety of regulatory agencies and launched products in various parts of the globe including North America, Europe, Canada, Japan, Australia, Korea, and China.
His education background includes a B.S. in Industrial Engineering from Iowa State University and MBA from University of Iowa.
Medical Grade Polyurethanes from Wound Care to Permanent Implants
About the Presentation
Polyurethanes have been used in medical applications for many years. The versatility in the chemistries allows the polyurethane to have different physical and chemical properties. The versatility also allows polyurethanes to be processed using a variety of methods. The polyurethane family of materials can be used in a multitude of application such as the films for wound care to permanent implants pacemakers.
- Polyurethanes can be made from a variety of monomers resulting in materials from elastic characteristics to materials with stiffness reviling metals.
- Variety of monomers used to make polyurethanes results in materials with various properties such as moisture transportation rates, hydrolytic and oxidative characteristics.
- Thermoplastic Polyurethanes can be processed by extrusion to produce film or sheet or into single lumen tubing to complex profiles.
- Thermoplastic Polyurethanes can be processed by injection molding to produce complex components.
About the Speaker
Tony Walder, Manager of Technology, LifeScience Polymers / The Lubrizol Company
Anthony Walder has worked more than 20 years developing thermoplastic polyurethanes for medical and specialty non-medical applications. He received a B.S. in Chemistry from the University of Wisconsin-Stevens Point in 1983 and in 1989 he received a Ph.D. from the University of Tennessee-Knoxville in the area of polymer chemistry. Work history includes 1988 to 1994 at Becton, Dickinson and Company developing novel polyurethanes and devices for medical application. Since 1994, he has worked for ThermedicsT Polymer Products developing new polyurethanes and supporting technologies. He is presently Global Technology Manager - Medical at The Lubrizol Corporation.
New Developments in Medical Packaging Materials
About the Presentation
Many of the advances in medical packages materials have been in response to the needs of the end-users: the hospitals, nurses, and patients using the products. The exciting new material solutions that are available to address these needs will be discussed. New peelable sealants for holding concentrated alcohol were necessitated by the focus on reducing hospital-acquired infections. Efficiency initiatives have resulted in a desire to see the product requiring new ultra-high barrier clear solutions. New peelable options for uncoated Tyvek were driven by the demand for cost-savings. As hospitals begin to look at their waste stream and develop sustainability programs, recyclable packaging solutions are gaining in interest.
- Peelable sealants for concentrated alcohol applications
- Ultra-high clear barrier materials
- The status of form-fill-seal solutions for uncoated Tyvek
- Recyclable lidding options
About the Speaker
Dhuanne Dodrill, President, Rollprint Packaging Products
Dhuanne Dodrill is the President of Rollprint Packaging Products, a flexible packaging converter specializing in technically innovative products for the healthcare, food, and, industrial markets. With over 25 years of experience in the flexible packaging industry, Dhuanne has worked in a variety of technical, quality assurance, and management positions. She is the chair of ASTM's Committee F02 on Flexible Barrier Packaging, a member of the Flexible Packaging Association's Sterilization Packaging Manufacturers Council and is active with IoPP's Medical Packaging Task Group and AAMI Technical Committee 198, Sterilization, Working Group 7. Dhuanne has a B.S. in Chemical Engineering (with honors) from the University of Illinois Urbana-Champaign.
New Developments in Medical Micromolding
About the Presentation
We will be presenting the some of the latest advances in materials, technologies and other advancements in medical micromolding applications. Case study examples and samples will be presented to show some of the latest trends and developments in this fast growing field. Some new markets and current areas or applications will also be discussed and presented, as well as some of the economic factors to be considered on micromolding projects.
We will cover:
- New materials for micromolding applications
- Downstream technologies and new technologies.
- New Markets for medical micromolding.
- Tooling developments.
- Economic considerations
About the Speaker
Mark Bonifacio, President Bonifacio Consulting Services, LLC
Mark Bonifacio is the president and founder of Bonifacio Consulting Services, LLC (BCS), a medical device manufacturing consultancy focused on helping medical device firms with the manufacturing of plastic medical device components and assemblies across several therapeutic disciplines. BCS specializes in precision injection molding and assemblies, LIM/silicone molding, micromolding and all manufacturing aspects of plastic medical devices and disposables.
Bonifacio has been working for and with various medical device OEMs and contract manufacturers for more than 25 years. He has held leadership positions in engineering, business development, sales and operations. Before BCS, Bonifacio co-founded APEC (now Helix Medical), a leader in plastics medical products injection molding and manufacturing. He began his career as an engineer with Elkay Products and Baxter Healthcare (now Cardinal Health). He holds a Bachelor of Science degree in plastics engineering from the University of Lowell (now UMASS - Lowell).
Hardware Developments for Machine and Robotic Transfer Systems
About the Presentation
Micro molding requires unique methods for handling products and for the elimination of cross-contamination by material from one manufactured product to another.
The ability to design "part unique" material handling systems is of the utmost importance, given the size and requirements of micro molded components. Robot development, in a cost effective manner, that allows for the flexible extension of the life of the mold and takes into account the life cycle of the program is very important. Part handling systems and the development of quick change screw and barrel systems has enabled Makuta to minimize material contamination while maintaining rapid changeover times.
Presentation Objectives:
- Video(s) of part handling systems
- Pictures of the development of end of arm tooling (EOAT) systems
- Pictures of screw and barrel systems
- Pictures of the wiring of the screw and barrel systems
- Video of the quick change system developed by Makuta
About the Speaker
Stuart P. Kaplan, President, Makuta Technics, Inc.
Stu Kaplan is President of Makuta Technics, Inc. Makuta has been manufacturing micro molded plastic components and assemblies for the medical and pharmaceutical industries; automotive industry; and the office automation industry since 1996.
Makuta is a member of the Sansyu Group of micro molders, the largest and oldest producer of micro molded components and assemblies in the world. Stu's family has been in manufacturing since 1909 and his knowledge and background in micro manufacturing technology comes from having lived and worked in Japan. Stu is a board member and a past president of the Mid America Plastic Partners (MAPP).
The Challenges of Choosing the Right Polymeric Material for Today's Medical Devices
About the Presentation
Regulatory oversight and increasing scrutiny require the careful selection and testing of materials of construction for all medical devices. This paper presents a few guidelines that should be used in choosing and qualifying new materials for your devices. This same process can simplify the replacement of a material already cleared for use.
We will discuss:
- FDA "approval"
- Biocompatibility - what is it?
- How to get started in selecting a material Sorting through the available data
- Testing requirements overview
About the Speaker
Len Czuba, President, Czuba Enterprises, Inc.
Len is the President of his own product development firm, Czuba Enterprises, Inc. headquartered in the greater Chicagoland area. He uses his new product development experience and polymers expertise in working with partner firms to take products, especially medical devices, from concept to market.
He has a Bachelor's degree in BioSciences from Southern Illinois University. He has more than 30 years of experience in polymer synthesis, compounding and material development in the medical device industry.
Prior to the formation of CEI, he was with Baxter Healthcare Corporation in the 70's, 80's and 90's, where he was involved in device engineering, blood and IV container work and new product development. He was responsible for several new material replacements for PVC and holds 15 US patents for his work. He has worked on a wide variety of devices, both implantable and external accessories, used in the health care industry.
In 2004, Len Czuba was honored as one of the 100 MD&DI Notable Persons in the medical device industry. He also is a frequent seminar instructor throughout the country and has given seminars around the globe.
Mr. Czuba is a long time member of the Society of Plastics Engineers. A member since 1975, is active in Chicago, has been on the board of directors of the Medical Plastics Division since 1985 and has thrice served as the Division Chairman. In May of 2000, Mr. Czuba was inducted to the ranks of Honored Service Member and was the Society's President for SPE's 2005 - 2006 year. He is now a Distinguished Member of the SPE.
Process Challenge Device - A Sterility Assurance Validation Tool
About the Presentation
A presentation describing a novel family of devices developed for validation and routine monitoring of EO and other gas sterilization processes. The presentation will give a short history of the device and how it is typically used in the Medical Device Industry. A description of the benefits and regulatory aspects will also be provided.
- Definition of Terms
- Description of Product Components and Function
- Benefits to the User
- Validation Requirements
- Questions and Discussion
About the Speaker
R. Daniel Webster, CEO, Process Challenge Devices
Dan has had 37 years experience in the Pharmaceutical / Medical Device industry as a Packaging development engineer, project manager, consultant and entrepreneur. His work experience has included 14 years at Baxter Healthcare developing and qualifying high barrier packaging systems for blood storage products and IVs. He co-founded an In-Vitro Medical Device company, BioMed Diagnostics and currently serves on it's scientific advisory board. Dan was also manager of Packaging at Laserscope for five years. Additionally, he has been a consultant to numerous Bio-Tech, Medical Device and Pharmaceutical companies over the past 24 years. His specialized experience is the design, development and validation of sterile barrier packaging systems and high barrier packaging materials. Dan has ten (10) patents issued with additional ones pending. He currently is founder and CEO of Process Challenge Devices.
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