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Learn how Boston Scientific leverages Windchill Product Analytics to streamline operations, comply with regulations, and drive innovation in the medical device industry.
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Windchill Product Analytics Focus On Customer Business Environment • Attendee Roles • Katie Usher, Program Director, Corporate Engineering • Katie Crawford, Component Engineer, Supplier Engineering • Michael Betschart, Business Systems Analyst, Information Systems • Company: Boston Scientific, • RMC Program: Regulated Materials Compliance including • Software/process improvements and a focus on key upcoming and future regulations • Company. • Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices > 30 years • Approximately 24,000 employees and revenues of $7.6 billion in 2011. • Advancing the practice of less-invasive medicine providing patient’s alternatives to surgery • Broad and deep portfolio of innovative products and technologies across a wide range of specialties. • Interventional Cardiology, Cardiac Rhythm Management, Peripheral Interventions, Endoscopy, Urology, Women’s Health, Electrophysiology, Imaging
Windchill Product Analytics Focus On Customer Business Environment • Identify your number of parts, BOMs, and products* • WPA Implementation not yet completed (February-March 2013) • ~25,000 Parts • ~15,000 BOMs & Finished Goods • ~750 Product Families • How many unique suppliers does your company have? • ~1000 suppliers • What are your key business drivers for the system? • Currently finalizing implementation to roll-out 400 user seats over the next in March • Developed BSC Custom Supplier Request form • Inputs and elements from IPC 1752 • Including key medical device regulations / standards • Combining Full Material Disclosure along with Yes/No Declarations • Also similar to legacy request form used for past 6 years at BSC • Who uses WPA in your organization? • Supplier Quality, Supplier Engineering, R&D, Regulatory, Biocompatibility/Toxicology • What value do they receive from the tool? TBD
Windchill Product Analytics Focus On Data Acquisition • Describe your company’s data acquisition strategy. • Currently using manual PDF form. Internal data collection methods currently being used. • Homegrown PDM solution in-place for certain businesses. • Do you perceive value using third party providers? • Interested, particularly for electronic products • Concerned about availability and quality of data • What other data providers have you evaluated but not selected? • General evaluation of various • Which providers have proven successful for your company? • N/A • How and where do you store most of your environmental data? • Windchill PDM, Product Level & Homegrown PDM Solution
Windchill Product Analytics Focus On Environmental Trends • Describe your most pressing environmental concerns. • RoHS, REACH, Conflict Minerals, Customer Requests, Packaging, California Prop 65 • Do you use the data in WPA to solve these concerns? • TBD (Planning) • What regulations, barriers, or trends are you following? • Medical Device Directive • Nanomaterials • BPA/Phthalates • CMRs / Endocrine Disruptors • What specifications, modules, or “first of a kind” solutions are important to your company? • i.e. Rare Earth Minerals, Trade Compliance, Recycling • Configured Specifications • Device Level Tracking