Facet Technologies - Innovation in Medical Device Manufacturing

QAD MIDWEST USER GROUP EE Implementation On Time And On Budget Spring Conference 2014, Itasca, IL

EE IMPLEMENTATION ON TIME AND ON BUDGET Speaker: John Graham Strategic Information Group

WHO IS FACET TECHNOLOGIES Facet Technologies is an FDA registered, ISO 13485:2003 certified engineering and manufacturing company striving to be the partner of choice for the design, development and manufacture of today's medical device marketplace - Facet's specialty is in development of new, innovative, hand-held medical devices that are designed to offer precision and intuitive performance in the hands of the patient and/or healthcare professional. - Facet has proven achievement through its close partnerships with major OEM's for the design and distribution of diabetes products and safety devices to the marketplace. - Some of Facet's partners include Abbott Laboratories, LifeScan (a Johnson & Johnson Company), Roche Diagnostics, and contract manufacturers such as Flextronics and Sanmina-SCI. Our partnerships also include various small and start-up companies who are leveraging Facet's expertise in the medical device marketplace for new product development and manufacturing to drive exciting new technologies to market quickly.

WHO IS BOBBY YEOMANS Bobby Yeomans is the Manufacturing Technology Director for Facet Technologies. He brings 25 years of experience working in manufacturing environments. He has worked with QAD for 16 years starting with versions 7.4H and is currently supporting a multi-site 2013 EE environment. He has used QAD in the Medical, Food & Beverage, Automotive, and Industrial Manufacturing vertical markets. Bobby has served on the BOD of the SEUG since 1999 and currently serves as Treasurer. Bobby holds a MBA degree from Gardner-Webb University and lives in Carrollton, Georgia.

EE IMPLEMENTATION ON TIME AND ON BUDGET It can be done It takes pre-planning, planning, and more planning It takes a cross functional team representing the entire organization It takes dedication and follow through It takes management support It helps to have a good consulting firm that has been through it before to help guide you through a quick start implementation

EE IMPLEMENTATION ON TIME AND ON BUDGET IT CAN BE DONE To all you doubters out there, it can be done Facet choose to use SIG and their quick start methodology for the conversion from BPCS to QAD 2013 EE in January 2013 I was hired on 01Apr13 to lead the conversion/implementation and support future expansion plans Contracts and schedules was established in the April/May timeframe First on-site session occurred in May13 Full FDA validation occurred in October 2013 We went live on 01Nov13 That s 184 days, or 26 weeks and 2 days

EE IMPLEMENTATION ON TIME AND ON BUDGET IT TAKES PRE-PLANNING, PLANNING, AND PLANNING Planning is extremely important It was great to have a pre-established step by step guide to follow and a SIG project manager and team to work with We were able to use the guide and plan milestone dates You have to stay on top of your plan Adjust where needed Compress where you can But don t get complacent You have to drive, not coast

EE IMPLEMENTATION ON TIME AND ON BUDGET IT TAKES A CROSS FUNCTIONAL TEAM OF THE ENTIRE ORGANIZATION Facet had a 15 members on it s team Represented every area of responsibility I was the project leader/manager for Facet We took a train the trainer approach These 15 Received the training Made design decisions Tested during conference room pilots Trained the people in their areas of responsibility Was onsite when we went live You will find strong, moderate, and weak members Your eyes will get opened

EE IMPLEMENTATION ON TIME AND ON BUDGET IT TAKES DEDICATION AND FOLLOW THROUGH Don t lose sight of the go live date It will approach faster than you think Team members may have to do their regular job and work on the implementation team But you can t let them miss milestones You may not be liked for a while Participation during conference room pilots is very important We did three pilots (1stscripted, 2ndsemi-scripted, 3rdmirror testing) Remembering to think of every possible business scenario and test it Don t worry you will miss something

EE IMPLEMENTATION ON TIME AND ON BUDGET IT TAKES MANAGEMENT SUPPORT Management must be on board and provide support You need to provide management a project update I would say monthly at a minimum They are providing your team members and need to know what is expected of them and where your at There will be some design decisions you will need to inform them of IE: Process changes, Costing changes, Scheduling, etc. Challenge all business practices That s the way we ve always done it is not an acceptable reason Re-engineer the process and company

EE IMPLEMENTATION ON TIME AND ON BUDGET IT TAKES A GOOD CONSULTING FIRM THAT HAS BEEN THROUGH IT BEFORE TO HELP GUIDE YOU THROUGH A QUICK START IMPLEMENTATION An implementation is a large but manageable project You need a step by step proven guide to follow It helped to have experienced consultants to guide us through implementation/design decision in an efficient fashion to support the quick start Your employees know their process, but the software is new to them Use best practices as much as possible The SIG consultants brought us best practice knowledge and experience We did not have time to poll the audience or check what other industries do

EE IMPLEMENTATION ON TIME AND ON BUDGET Any questions?