Final Program - Omtec

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Final ProgramAddresses, Educational Sessions/WorkshopsI will address these specific points:• y The price paid for an offshore purchase is not its cost.It is only one of many elements that comprise thecost of an item being purchased.• y Traditional accounting methods obscure therelationships between costs incurred to supportoffshore purchases and the items being purchased.This leads to inappropriate offshoring decisions andundermines a company’s profitability.• y A well-designed, robust cost model can providemanagement with the accurate and relevant costinformation required to make economically soundoffshoring decisions.Attendees will receive these tools to put to immediate use:• y An understanding of how the “price” of a purchaseditem does not equal its “cost” — especially when theitem is manufactured by an offshore supplier.• y A checklist of costs that must be considered if acompany is to understand the true cost of offshorepurchases.• y An outline for creating a valid and robust costmodel that will enable an organization to measurecosts related to offshoring and link them to themanufactured items being purchased.BIO: During his 25 years as a consultant, Doug Hicks haschampioned the development of practical, down-to-earth costmanagement solutions for small and mid-sized organizations.In that time he has helped nearly 200 organizations of all typesand sizes transform their history-oriented accounting data intocustomized, value-enhancing decision support informationthat provides accurate and relevant intelligence needed tothrive and grow in a competitive world. He has shared hisexperience through dozens of seminars conducted throughoutthe U.S. and in dozens of trade and professional periodicals(including Management Accounting, Cost Management,Manufacturing Engineering and Journal of Accountancy) and twobooks, including I May Be Wrong, But I Doubt It: How AccountingInformation Undermines Profitability.Doug is a 1970 graduate of the University of Michigan— Dearborn. In 1997, he was awarded the University’s“Professional Growth and Scholarship Award” for his role asa leader in advancing cost management concepts, and in 1998he was selected as the Institute of Management Accountants’“Instructor of the Year.” He is a member of the Instituteof Management Accountants, Institute of ManagementConsultants and the Michigan Association of CPAs.Workshop: FDA 510(k) 101Floyd G. Larson, MS, MBAPresident, PaxMed International, LLCThursday, June 172:00 p.m. – 3:30 p.m.While there is uncertainty about the future of the 510(k) processfor marketing clearance of medical devices, this has for the past30 years been the dominant pathway by which new medicaldevices have reached the market in the U.S. The 510(k) processhas changed over the years, and may change further, but wedo not expect that it will be abandoned by FDA. Therefore,anyone who works in the field of medical devices, whetherentrepreneur, investor, manager, engineer or regulatoryprofessional, should be familiar with how the process worksand how he or she can contribute to a successful outcome.I will address these specific points:• y History of the 510(k) process, how it has changedfrom its early days and how it fits into FDA’s overallapproval processes• y Strategies for submission and the types of 510(k)s• y The role of FDA guidance documents andinternational standards in facilitating the 510(k)process• y The place of bench testing, in vitro testing, animaltesting and clinical studies in the 510(k) processAttendees will receive these tools to put to immediate use:• y How to determine whether a 510(k), anothersubmission, or even no submission is required• y Examples of classification and guidelines forselection of predicate devices• y Structure of a 510(k) and logistics of submitting it toFDA• y How and when to respond to an FDA request foradditional information• y What to do about a Not Substantially Equivalent(NSE) letterBIO: Floyd G. Larson is a leader in biomaterials technologyand regulatory issues, with extensive experience in productdevelopment, regulatory strategy, marketing clearance andthe translation of ideas to commercial reality. His educationalbackground in chemistry, materials science and businessmanagement prepared him for a career that has includedapplied research, management of R&D, and, as Vice President,Scientific Affairs for a manufacturer of implantable medicaldevices, overall responsibility for R&D, Engineering, ClinicalResearch and New Business Development.Page 182010
Final ProgramAddresses, Educational Sessions/WorkshopsAs the President of PaxMed International, Floyd leads a teamof industry professionals serving medical device manufacturerclients in directing and implementing market-oriented research,product development, regulatory strategy, manufacturingimplementation and quality system development. He hasserved as the Industry Representative to the Dental ProductsPanel of the FDA Medical Devices Advisory Committee.He currently coordinates programs on calcium phosphatesand other ceramics for the American Society for Testing andMaterials (ASTM) Committee F4 on Medical Devices, andserves as a U.S. delegate to ISO committees on medical devices.Floyd is the convenor of an ISO Working Group responsiblefor developing medical device testing standards. He is alsothe chair of a subcommittee of the U.S.-Accredited StandardsCommittee (recommending and developing U.S. NationalStandards) and of a U.S. Sub-TAG to an ISO committee onmedical device standards. Floyd is a member of the AmericanCeramic Society, Society for Biomaterials, ASM Internationaland the Academy of Osseointegration. He recently was namedone of 100 Notable People in the Medical Device Industry byMedical Device & Diagnostic Industry magazine.Workshop: Partnering and Outsourcing forWin-Win ScenariosWayne MackeyPrincipal, Product Development Consulting, Inc.Wednesday, June 169:30 a.m. – 12:00 p.m.High performance companies have little patience withmeaningless partnering platitudes. If you and your company areready to get serious about taking the steps to build and executea core/non-core business strategy, make partner communicationwork effectively every day and extend your creative reach farbeyond your company’s borders, this practical partneringworkshop is what you have been looking for.I will address these specific points:• y When to partner or outsource, and when not topartner or outsource and why• y What makes a partnership or outsourcing activity“win-win”• y How to set up, execute and maintain an effectiveAM-HalfPageOMTECProgramHoriz5-23-10_OdtHalfPageAd.qxd 5/24/10 4:30 PM Page partnership 1 or outsourcing activityISO 9001 and ISO 13485 CertifiedA WORLD OF MANUFACTURING EXPERTISE IN EVERY PART.Visit us at OMTEC – Booth Number 400DRILLS • TAPS •DRIVERS •SCREWS • PLATESTotal engineered solutions for any orthopedic application.Talk to us about becoming your single source forprecision-grade surgical instruments and implantsthat fit right and work together.Michigan • Massachusetts • California877 633 8080www.autocam-medical.com2010Page 19
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Final Program - Omtec

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