Bruce Arntzen is the executive director, MIT Supply Chain Management (SCM) Program where he oversees SCM curriculum, student admissions, faculty selection, and student job placement. He also leads the MIT Hi-Viz supply chain project which is developing automated board-ready visualizations of the supply chain and its critical risk pathways. For more than 20 years he has managed a corporate industrial engineering group, founded two supply chain consulting firms, lead numerous supply chain process and network modeling projects, and served as an economic analyst at The World Bank. A frequent speaker at industry conferences and three-time president of the New England Roundtable. Arntzen holds an MSE from Johns Hopkins and a Ph.D. from Massachusetts Institute of Technology.

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).

Keith Checca, recently joining Boston Scientific (Nov-2010) to support growth in the endoscopy R&D division, has more than 15 years experience in medical device development and operations. His core experience has been in process development, product transfer, and ongoing operations for both low-cost disposables and high-risk, long-term active implantable devices. Significant portions of this experience were in managing integrated systems between internal and sub-contracted operations.

Prior to joining BSC, Checca was with CIRTEC Medical Systems, a contract design and manufacturing company with primary focus on minimally invasive systems, active and passive implants, medical electronics, and instrumentation. Checca served as director of business development and engineering manager within CIRTEC, both roles focused on a blend of business and technical customer interaction and project management.

Checca previously served in broad engineering roles at NMT Medical, MediSystems Corporation, and Quinton Instruments. He has a Bachelor of Science in mechanical engineering from Worcester Polytechnic Institute in Massachusetts.

Dr. Christopher Joseph Devine is the president of Devine Guidance International, Inc., a consulting firm specializing in providing solutions for compliance, regulatory, quality, supplier management and supply chain management issues facing the medical device industry. Prior to launching his own consulting firm, Devine spent 14 years with Boston Scientific Corporation. Additionally, he is the author of Devine Guidance, a weekly blog focusing on the understanding of regulations mandated by the FDA and other regulatory bodies. Devine has more than 32 years of experience in quality assurance, regulatory affairs and program management. He is a senior member of the American Society of Quality, a member of Regulatory Affairs Professionals Society, a member of the Project Management Institute and resides on several technical and corporate advisory boards. He received his doctorate from Northcentral University. Devine also holds a graduate degree in organizational management and an undergraduate degree in business management.

Jeffrey DiNardo has been interfacing and managing contract manufacturers for more than seven years at Medtronic. He has managed through supplier selection and due-diligence approaches regarding manufacturing capability and quality system analysis. DiNardo has extensive experience with developing oversight approach to suppliers and their suppliers to ensure quality, service level and cost are attained. DiNardo mostly manages low-cost provider located in strategic global locations that drive bottom-line growth. His virtual communication skill sets and business acumen ensures he builds strong relationships and trust along the partnership.

Ben Dunn is a managing director and head of healthcare investment banking with Covington Associates LLC, a specialty investment banking firm focusing on middle market M&A advisory services. Since joining Covington Associates in 1996, Dunn has orchestrated, negotiated and structured more than 100 transactions for both public and private companies. Successfully completing deals with companies such as Memry Corp., Polymedix, Bard, Boston Scientific, Johnson & Johnson, Medtronic, Cerner, GE and Siemens, Dunn's area of specialty is advising medical technology, manufacturing, and services firms on a range of strategic transactions.

Dunn received his undergraduate degree from the University of Vermont and his MBA and master's degrees from the University of New Mexico. Dunn is a frequent speaker at healthcare conferences and author of numerous articles, including a recently published white paper on "A Strategic Review of Outsourced Manufacturing for Medical Devices."

Arthur G. Erdman, P.E., is the Richard C. Jordan Professor and a Morse Alumni Distinguished Teaching Professor of Mechanical Engineering at the University of Minnesota, specializing in mechanical design, bioengineering and product design. In July 2007 he was selected as the Director of the Medical Devices Center at the U of M. He received his Bachelor of Science degree at Rutgers University, his Master of Science and Ph.D. at Rensselaer Polytechnic Institute. Erdman has published more than 325 technical papers, three books, holds more than 30 patents, and shares with his former students nine Best Paper Awards at international conferences. He has received a number of awards including ASME Machine Design Award and the ASME Outstanding Design Educator Award. Erdman is a Fellow of ASME and a Founding Fellow of AIMBE.

Ken Fine has more than 22 years experience in the design and development of Class II and critical Class III electro-mechanical medical devices and equipment. His major areas of expertise include electrical and software design for medical systems; high-reliability, low-power medical electronics; implantable device and ancillary equipment; real-time control software; medical software development processes and quality systems; international and domestic quality standards; FDA GMP, new product development and product improvement management. Ken holds an MS in electrical engineering from Northeastern University and a BS in biomedical engineering from Boston University.

C. Peter Harris, Jr., became president and CEO of Cadence, Inc., a contract manufacturer of medical device and diagnostics products, in January 2003, following five prior years of employment with the company. Since 2003, Cadence has undergone a substantial transformation, growing from an $8 million, and 80 percent industrial product company to a $45 million and 85 percent life-sciences company.

In addition to being a director of Cadence, he has served on the boards of the Shenandoah Valley Partnership, the alumni board of the Darden School, the Virginia Manufacturers Association, Mountain Lumber Company, KMT Water Jet and Tele-Works, Inc. and teaches whenever he can at Darden. Harris began his career trading fixed income securities for Montgomery Securities and spent a few years working with large multinationals on China market entry strategies with Pacific Rim Resources, both in San Francisco. He has a Bachelor of Arts in mathematics from Middlebury College and a master's degree in business from the Darden Graduate School of Business at the University of Virginia.

Steve Introne is the director of global engineering services for the medical supplies business unit within Covidien. Introne recently took this position, and is responsible for the program strategy and deployment of partnering with emerging market engineering service providers to enhance the R&D/engineering functions. His role includes ESP identification, audit, selection, contract negotiations, monitoring and management. Prior to this role, Introne created and developed an advanced supplier development team. This team was comprised of all quality, sourcing, and OpEx/Mfg functions responsible for supplier identification, selection, and development for all large growth NPD projects.

Introne has 17 years of problem solving, management, product and process development, and technical engineering expertise in the medical device and automotive industries (Covidien, Ford and Michelin). He has developed, led, and institutionalized business-level processes and teams in new product development, advanced supplier development and OpEx.

Ron Jellison is executive director of business development at KMC Systems, Inc., a leading provider of contract services for development and manufacture of medical instrumentation. For more than 30 years, KMC has partnered with companies to successfully bring in-vitro, diagnostic, surgical, therapeutic and laboratory automation applications to market. KMC Systems is an ISO 13485-certified and FDA-registered firm with expertise in all aspects of product development, verification, design for and transition to production.

Jellison is responsible for all business development and marketing activities regarding new customer programs for both design and manufacturing programs. He is also responsible for maintaining and growing existing customer relationships.

Sarah O. Kalil is the vice president of manufacturing operations with Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Kalil was the chief operating officer of Interlace Medical, acquired by Hologic in January of 2011. Kalil has been responsible for the integration of the Interlace product line and personnel into Hologic. Additionally Kalil participates in the women's leadership initiative within Hologic.

Kalil brings more than 20 years of experience from within the medical device industries. Her roles have included responsibility for R&D, clinical and regulatory affairs, quality assurance and manufacturing. Kalil recently served as the president of Boston Endo-Surgical Technologies and has worked start-up operations as well as large multi-national device design and manufacturing companies. Kalil's experience brings a unique perspective having worked on both sides of the outsource partner relationship.

Steven Liu is the director of global supply management for Smith & Nephew. He is responsible for leveraging Smith & Nephew's product raw material and component spend to achieve sustained competitive advantage in product component cost, quality and delivery. Additionally, Steven is responsible for indirect general procurement activity and for all supplier quality and supplier development functions.

Liu brings more than 20 years of engineering, operations and supply management experience from within the aerospace and commercial industries. He began his career as an engineer with General Dynamics Ft. Worth, now Lockheed Martin. In 1996, Liu joined United Technologies Corporation and has held positions of increasing responsibilities in operations and supply management within UTC's divisions of Pratt & Whitney, UTC Corporate, and Carrier.

Steven earned his MBA from Yale University's School of Management, as well as, a Master of Science in global supply chain management from Indiana University's Kelley School of Business. He holds a bachelor of science in materials engineering from Rensselaer Polytechnic Institute.

Brian Matachun joined MTD Micro Molding in 2008, leading and developing its customer-oriented and technical sales force. Matachun brings nearly 15 years of business management, polymer development and plastic processing expertise to MTD Micro Molding, and uses his extensive experience and education in plastics engineering to lead our dedicated sales force.

Linda Meloro is a principal in the healthcare business group at PRTM Management Consultants specializing in operational and supply chain optimization and innovation in the medical device industry. She has more than 18 years of consulting and industry experience and has led numerous teams in the design and implementation of operations and supply chain strategy and process improvement projects. Her recent project work has ranged from helping several global medical device companies redesign their manufacturing and distribution networks to conducting a strategic sourcing engagement for a major medical equipment manufacturer. Linda led the development of the "PRTM 2009 Medical Device & Diagnostics Direct Material Sourcing Benchmark".

Linda earned a Master of Business Administration from Carnegie Mellon University and also holds a Bachelor of Science and Master of Science in materials engineering from Rensselaer Polytechnic Institute.

Throughout the first half of his working career, Larry Nichols owned and operated various business that included a locksmith shop, four ice cream stores and a small chain of retail cartoon stores. During the dot-com era, he was the vice president of procurement for ActionAce until the dot-com bust. For the past 15 years he has been in the medical device industry at NUTEK Corporation where he started as the business manager. Over the years he has rounded out his medical device experience as the manager of different department within the company that include quality, operations and business development before being promoted to CEO.

Larry earned his Bachelor of Science in business management at Cal Poly in San Luis Obispo California.

Kevin P. Pelletier has more than 25 years of experience in the field of materials testing and failure analysis. He is presently the sales and marketing manager at Massachusetts Materials Research, Inc., which is an employee owned independent materials testing and materials engineering laboratory serving a variety of industry sectors. He has a technical degree in Materials Technology from Worcester Industrial Technical Institute and a BSBA with a minor in Marketing from Nichols College. He started his career as a metallurgical technician involved in materials testing and failure analysis in a variety of different companies. This was followed by fourteen years as a metallurgical laboratory section leader at an independent materials testing laboratory that served the aerospace and commercial manufacturing industries. Throughout his career, he has been actively involved in the American Society for Materials (ASM), of which he is a 25-year member and has served as the treasurer, vice chairman, and chairman of the Worcester Chapter. He is presently serving on the American Society for Testing and Materials (ASTM) Committee F04- Medical and Surgical Materials and Devices and has served on the ASTM F40 Committee- Declarable Substances in Materials which was formed to address the European Union RoHS directive. He is an active member of Medical Development Group (MDG) Boston Forum and serves as the co-chairman for the MDG Product Development & Manufacturing Outsourcing Special Interest Group.

Dean Petrella began his medical device manufacturing career in 1992 as the first employee of Accu-Met Laser in Cranston, R.I. which later became Tegra Medical in 2007. Over his 19 year career, Petrella's titles and roles have ranged from: laser tech lead, quality manager, process development engineer, operations manager, and engineering manager to his current role as a program manager. In his current position, Petrella works closely with the customers on new projects and products. He oversees most of Tegra's rapid response prototyping and select programs that require laser processing and validations. His proficient background in process validations allows him to accurately steer customers down the appropriate path of development as new projects arise. Petrella is also a hands-on contributor to process development. This program management role allows him to marry the two critical components of successful product development: customer service and technical applications expertise.

Jim Rancourt has been working in the polymer industry for more than 30 years. He is a 1981 graduate of the University of Lowell, majoring in chemistry and a 1987 Ph.D. graduate from Virginia Tech, majoring in chemistry with an emphasis on structure-property relationships and the analysis of polymeric materials. Starting with Albany International Research Company in 1980, Rancourt gained experience with the thermal analysis and failure analysis of a diverse range of polymers. At Virginia Tech he synthesized and characterized thermally stable electrically conductive polymers and analyzed the chemical and physical properties of energetic polymer compositions. Rancourt holds eight United States patents and has published more than 60 technical papers. In 1987, Rancourt founded Polymer Solutions Incorporated (PSI). PSI is a company that provides the world with premier technical solutions for molecular systems. Serving as technical director through 2007 and CEO thereafter, he has been involved in more than 6,000 analytical projects primarily for industrial clients. Medical and pharmaceutical companies comprise the largest portion of PSI's client base.

Steve Saunders is director of supply chain
for the mother and child care business within Philips Healthcare. He has a broad business background working in multinational companies and has held positions in field service, factory marketing, finance, logistics and distribution with Hewlett-Packard, Agilent Technologies, and Philips. He has a Bachelor of Science in business adminstration from the University at Buffalo and an MBA from the Amos Tuck School at Dartmouth College.