Science in the Age of Experience

 May 15-18, 2017 • Chicago, IL

 

 

Medical Device Track

Science in the Age of Experience offers the most comprehensive "science experience" for Medical Device manufacturers. The Dassault Systèmes 3DEXPERIENCE Platform empowers not just new 3D innovative models, but collaboration between disciplines, the ability to share data and insights, and the production of better science and patient experiences in less time.

Come and join us at McCormick Place Convention Center in Chicago, Il to gain a better understanding of how Dassault Systèmes solutions for Medical Device Manufacturers are changing the future with science.

Time

Brand

Track Title

Description

Presenters

10:45 - 11:15 am

DELMIA

Digitally Transform Medical Device Manufacturing Operations

Do you want to improve visibility, efficiency and transform your global manufacturing operations? Now more than ever medical device manufacturers require new business strategies to address global regulatory and quality initiatives while improving performance and reducing costs. While many companies rely on paper-based communication and procedures to operate their global manufacturing operations, business line managers are seeing multiple opportunities for reducing compliance risk and improving operating performance. Attend this session to learn how the Made to Cure for Medical Device industry solution experience enables medical device companies to take control of quality manufacturing across your global operations, drive digital transformation, enable smart & connected manufacturing continuity across disciplines and functions and global interconnected production chains all while reducing the risk of non-compliance and improving operational performance.

Tom Muth, Andrew Robbie

11:15 - 11:45 am

ENOVIA / CATIA

Systems Engineering for Effective Multi-Disciplinary Collaboration

Mecial devices are complex machines because they comprise a diversity of systems that govern their efficiency, power and performance. Enabling each expert stakeholder to contribute to the global design effort is as delicate as it is difficult for Medical Device companies whose teams do not share the same tools, locale or methods. They are challenged to provide solutions that streamline multi-disciplinary collaboration so that the system as a whole functions like a well-tuned orchestra.

Learn how system architects have access to tools to define functional and logical system architecture as a multi-disciplinary system starting from system requirements. Where they are able to perform system engineering that accounts not only the main requirements, but incorporates what functions the system will deliver, and what architecture will satisfy them. Learn how to simulate machine behavior and ensure resource, functional, logical and physical traceability for consistent management of product architecture throughout the device development lifecycle all with the Smart & Synchronized industry solution experience.

Stan Piper, Sanjay Khurana

11:45 - 12:15 pm

ENOVIA / SOLIDWORKS

Unleash Your SOLIDWORKS Data

Viewing the DMR throughout the product lifecycle is critical to improve collaboration and achieve compliance with confidence. Turn your SOLIDWORKS® designers into all-stars by enabling the rest of the enterprise to leverage their incredible work. Collaborate with online design reviews. Share designs through connected engineering bills of material. Inform contributors whenever you make changes. Tackle requirements management, program management, sourcing, materials compliancy, product quality, and regulatory compliancy all connected together in the same platform. Learn how to expedite audits, inspections, and other compliance inquiries with a single integrated platform approach with SOLIDWORKS Powered By
3DEXPERIENCE.

Stan Piper, Pierre Oriol

1:45 - 2:15 pm

ENOVIA

Leveraging the
3DEXPERIENCE platform to Accelerate The Delivery of Innovative Medical Devices

High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions for medical device companies. But increasing regulatory scrutiny is putting medical device manufacturers under the gun on total quality and safety.

This session will showcase how companies eliminate scattered processes and data and to “embed” regulations as an asset, optimizing quality and compliance and reducing cost and time to market, leveraging License to Cure for Medican Device, and the 3DEXPERIENCE® platform. In addition, this session will explore how you can create a virtual environment for gathering customer needs and creating requirements that can be managed in the fully-visible, traceable and collaborative environment to ensure product safety and automate regulatory overhead.

Stan Piper, Pierre Oriol

2:15 - 2:45 pm

ENOVIA

Embedding Regulatroy Requirements for Competitive Advantage

Gaining the right product approvals and certificates for major markets is fundamental to both succeed and to ensure safety and effectiveness of every medical device. Properly defined and prepared submission reports help assure that the submission contains the appropriate defined information requested by the various regulatory bodies for the specific product classification. For example, the collection of products and key UDI attributes from a company’s systems can be automatically bulked to refine and reuse data for UDI submission and approvals.

This session will showcase License to Cure for Medical Device, a 3DEXPERIENCE® platform solution that breaks the silo barriers within a company to create a more unified approach to taking a product to market, therefore significantly decreasing time to market. A solution that allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing and controlling the management of highly-regulated business processes for worldwide submissions and approvals.

Stan Piper, Pierre Oriol

2:45 - 3:15 pm

ENOVIA

Going Green: Materials Compliance and the
3DEXPERIENCE platform

Medical Device companies operate more globally to deliver their product more efficiently and at the best quality level. Conforming to regional environmental compliance directives such as RoHS, REACH, Packaging, Prop 65, and WEEE is now mandatory, but connecting the whole ecosystem is an even bigger challenge.

This session will explain how to improve the data collection process by providing your suppliers with an on-line dashboard to view material declaration requests, an ability to create a compliance declaration using a simple web form editor, or to upload completed material declarations in another industry-standard data collection formats. You will also learn how to enhance supplier reporting responsiveness and provide management full visibility of all product compliance data.

Mike Zepp

4:15 - 4:45 pm

SIMULIA

In-Silico Human Modeling & Simulation for Enhanced Device Performance

The product development process and innovation cycle for medical devices has been different, characterized by development of an effective and safe device; with less regard for optimal performance, lowest cost etc. The testing and validation process led by medical device manufacturers is traditionally validated through animal studies and subsequently human clinical trials depending upon the product type, application and use. However, there is a move to do more testing virtually through the use of computational modeling and simulation. Moreover, the simulation of the human environment the devices would interact with is considerably
more difficult than that of metal, plastic or ceramic components and ensures on-budget delivery. You can transform requirements into the architecture of a device and functional specifications early in the development cycle, virtually eliminating late stage design conflicts.

This session will explain how to leverage The Living Heart and Single Source for Speed to help validate and test medical device technologies within a realistic, electro-mechanical human heart model. The Living Heart Model also has applications pre-surgical patient engagement reviewing with the patient the condition of their heart and the surgical therapeutic intervention that will take place. Additional applications include selecting the optimal size implant (stent) for the patient, pre-surgical planning, education and other applications.

Stan Piper, Mahesh Kailasam

4:45 - 5:15 pm

ENOVIA

Design for Quality & Regulatory Compliance: DHF, DMR & Document Control

Project and program management is particularly helpful for providing structure and focus throughout the various design phases. In addition, gaining early visibility of the product capabilities to the entire organization helps ensure regulatory and marketing teams support when preparing regulatory for FDA approval for commercialization and post-market surveillance activities.

This session will showcase advanced project management capabilities for medical device companies to institutionalize best practices in executing new product introduction projects all with License to Cure for Medical Device, and the 3DEXPERIENCE® platform. You will learn how to effectively coordinate project activities and deliverables to ensure completion of design control deliverables and automatic population of the resulting Design History File (DHF), leverage templates to ensure compliance with SOP (standard operation procedures), and access advanced visual tracking and reports for maximum management visibility and control. In addition, you will learn how to improve cross functional design and manufacturing collaboration by sharing views of a common engineering and planning activities, and how to quickly approve complex changes and evaluate improvements to make more informed design decisions and easily find updated Device Master Record (DMR) information to achieve proactive quality and regulatory compliance.

Stan Piper, Pierre Oriol, Arieh Halpern