Digitally transforming the medical device lifecycle

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1 Digitally transforming the medical device lifecycle Siemens PLM Software Product lifecycle management (PLM) is the only mission-critical business initiative capable of helping medical device companies bring higher value therapies more quickly to market while meeting today s global regulatory requirements. Siemens PLM Software ushers in a new era by providing the medical device industry s first integrated end-to-end PLM solution that moves beyond the capabilities of individual applications to meet the needs of multiple lifecycle phases, take-to-market programs and disciplines.

2 Industry challenges Large, medium sized and small medical device companies are under enormous pressure to continually enhance product safety and effectiveness while containing their operational costs as well as the costs of regulatory non-compliance. The following business challenges have emerged as medical device companies try to balance these seemingly contradictory goals within a changing regulatory environment. Increasing the rate of effective innovation. Medical device companies need to improve their rate of effective innovation while working in a compliancesensitive framework. Accelerating time-to-patient care. Medical device companies need to speed their time-tomarket, as well as accelerate the time it takes to put safe and effective products in the hands of real-world health care practitioners. Improving affordability and value. Medical device companies need to understand how each phase in a device s lifecycle directly affects patient recovery, long-term medical costs, and ability of the device itself to provide patients with what they want at an affordable price. Managing the cost of litigation. To handle adverse events and respond to government inquiries, medical device companies need to document and reconstruct all aspects of a device s design history on demand. Companies can minimize the cost of litigation by making compliance management a natural part of their daily activities. Managing the cost of regulatory compliance. Companies need to systematically and repeatedly meet requirements established by the U.S. Code of Federal Regulations (CFR), including 21 CFR Part 11, Electronic Records and Electronic Signatures and 21 CFR Part 820 Quality System (QS) Regulations as well as ISO 1385 specifications. To meet these challenges, Siemens PLM Software provides an integrated end-to-end PLM solution for the medical device industry that extends its knowledge management, process management and collaboration capabilities. There is growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, more affordable and safe medical products for patients.this is because the current medical product development path is becoming increasingly challenging, inefficient and costly.we need superior product development science to address these challenges to ensure that basic discoveries turn into new and better medical treatments. From the FDA whitepaper Innovation Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products

3 Business imperatives for the medical device industry Today s most forward-thinking medical device companies are building Global Innovation Networks that are driven by PLM technology to continuously improve their products and processes and organize their value chains so that innovation can flourish. Global Innovation Networks enable companies to approach compliance as a strategic initiative rather than as just a reporting activity thereby building regulatory compliance directly into all phases of the product lifecycle. These networks empower producers to meet the following business imperatives. Increasing the yield of innovation. Innovation can make or break a medical device company. Better products, technology advances and streamlined development/manufacturing processes illustrate how innovation can deliver business value in different ways. Compressing time-to-market. Medical device companies are driven by the need for speed. Global Innovation Networks enable companies to analyze their processes, designs and/or suppliers to determine whether they work effectively in speeding products to market. Meeting business and regulatory requirements. Meeting compliance mandates is not an option for medical device companies it is an imperative. Guarding the health and safety of consumers and complying with regulations set by the FDA and other national regulatory agencies are time consuming, complex and extremely costly activities unless they are implemented as part of a comprehensive strategy. Optimizing resources. Global competition is shrinking the window of opportunity for companies to recoup their intellectual property investments. Global Innovation Networks enable companies to optimize their resources to achieve cost and quality targets essential for time-sensitive opportunities. Maximizing globalization advantages. By building a compliance framework into a PLM-driven Global Innovation Network, medical device companies are able to launch innovative new products through optimized processes that improve the operation of their widely dispersed supply chains. Most importantly, PLM facilitates global collaboration, seamless information sharing and comprehensive understanding of regulatory requirements. 1

4 Initiatives for the medical device industry Industry initiatives Siemens PLM Software delivers solutions that drive innovation in the medical device industry through strategic initiatives that leverage Siemens experience and its customers best practices. Increase the rate of effective innovation. PLM dramatically improves a company s new product success rate by enabling take-to-market teams to deliver more innovative products and implement more effective product development processes. Teams can use PLM to quickly leverage and re-use materials, knowledge, processes and technology from one product initiative to another. By improving agility, PLM enables a company s entire supply chain to rapidly react to competitive pressures and accommodate quickly rising consumer preferences. Accelerate time to patient care. PLM accelerates time-topatient care by permitting everyone in a global supply chain to work from the same design assumptions, patient requirements and compliance regulations, as well as participate in the same automated development processes. PLM-driven process automation increases the throughput and capacity of the extended supply chain, enabling delivery of more products to market. PLM provides total visibility into the status of multiple delivery projects by allowing decision makers to curtail underperforming initiatives early and accelerate their company s most promising programs. Improve affordability and value. PLM improves affordability and value by digitally managing intellectual assets and leveraging this information in systematic and repeatable processes. PLM improves product quality and minimizes development costs by allowing every participant in the medical device lifecycle to share and exchange diverse kinds of knowledge in real-time, engage in brainstorming and automate standards-based compliance processes. Manage the risk of litigation. PLM helps companies manage the risk of litigation by combining integrated collaboration capabilities with item-level security. This functionality enables companies to protect themselves and their suppliers, as well as healthcare providers and patients. By capturing tightly aligned product, package and label information during product design and development, PLM enables development partners to work with highly accurate product data at all times. Manage the costs of regulatory compliance. PLM manages the cost of regulatory compliance by providing medical device companies with a single environment they can use to manage corrective action/preventive action (CAPA) processes, capture and aggregate patient and healthcare provider input from multiple sources, manage these inputs in a globally accessible repository, perform analyses on aggregated inputs and disseminate the results through automated workflows. 2

5 How PLM works in the medical device industry Medical device companies use PLM to create a digital environment that can be used by multiple take-to-market disciplines to perform a variety of design definition, analysis, validation and simulation processes. Every authorized participant in the device lifecycle from engineering to manufacturing, finance, marketing, sales and service operations can use the PLM environment to share and exchange product knowledge. Typical PLM implementation initiatives start by capturing a take-tomarket program s product and marketing requirements and then tracing these requirements to ideas, concepts, design prototypes, parts, product definitions, bills of materials, process models and after-market service definitions. The resulting body of knowledge is made available to every lifecycle participant and every mission-critical application that drives the medical device lifecycle. This comprehensive approach to product and process management enables medical device companies to proactively address strategic issues that influence a product s marketplace success, constrain its lifecycle costs, and treat regulatory compliance as a systematically manageable product requirement. PLM is especially value during product introduction phases of the medical device lifecycle that determine up to 80 percent of a product s development cost. Numerous studies indicate that PLM enables today s global competitors to achieve the following highly prized benefits. Compress the take-to-market cycle Establish first-to-market premiums Catch design flaws before they impact costly manufacturing setups Reduce rework throughout the take-to-market cycle Establish new sources of product and process knowledge 3

6 Innovation across the entire medical device lifecycle FDA approval Verification using digital simulation FDA submittal Requirements management and system engineering Product and manufacturing process design with global collaboration Project planning and execution Portfolio management Customer needs and ideation management 4

7 Plant and manufacturing execution Non-conformance reporting and CAPA Customer complaint handling Product maintenance and service Environmental compliance 5

8 Best practices for medical device companies Siemens PLM Software implements the following best practices into the solutions and processes it delivers for the medical device industry. Managing and reusing intellectual capital PLM provides medical device companies with a strategic approach for managing and reusing their product and process knowledge as intellectual capital. Best practices require companies to capture product and process definitions, product and compliance requirements, brainstorming ideas, initial concepts, informal knowledge, program history, project milestones and tracking data across a medical device s lifecycle. Siemens Teamcenter software provides multi-cad support for the company s PLM environment, thereby enabling product developers from different organizations to work with their authoring tool-of-choice while ensuring that their designs are seamlessly integrated into unified product definitions. Teamcenter provides methodologies and controls that companies use to establish a baseline for each medical device and its lifecycle configurations. As a device evolves across its lifecycle, Teamcenter enables stakeholders to assess a device s product configuration as it was or is at any point in time. Teamcenter s comprehensive traceability enables companies to understand how design changes directly impact a device s regulatory requirements. Creating innovative designs in a controlled environment Teamcenter enables medical device companies to automatically capture a product s design history in a product-focused context instead of the document-centric or CAD-centric context that other IT systems support. Companies use Teamcenter to establish templates with approval processes and workflows that reflect industry best practices. Teamcenter also provides robust electronic record management capabilities for electronic signatures, dynamic watermarking, security protection, and PDF rendering. Teamcenter automatically captures and renders device master records (DMRs) as DMR documents are associated with the medical device. Product teams leverage Teamcenter s extended change management capabilities to track and manage complaints and issues arising from patient usage. These capabilities enable medical device companies to automatically trigger their CAPA processes. Leveraging today s best document management practices Teamcenter enables medical device companies to incorporate Adobe s rich document rights management features into their PLM environment. Companies use this integration to render both Microsoft Office documents and CAD designs into PDFs at the end of an approval cycle. Companies apply digital signatures to appropriate PDFs using encryption techniques that prevent documents from being falsified both inside and outside of their Teamcenter-controlled environment. 6

9 Signatures are automatically captured during document approval processes to address all CFR Part 11 electronic signature requirements. Companies establish automated procedures to stamp or watermark documents that require security certifications, as well as to apply watermark, stamps and digital signatures to design drawings printed in PDF and CGM formats. Capturing complaints, adverse effects and quality events Medical device companies use Teamcenter to capture and respond to a variety of real-world events and conditions, including manufacturing non-conformance, supplier non-conformance and issues rising from audits, complaints and adverse events. When Teamcenter captures a complaint or other issue, it automatically triggers an appropriate workflow to route that concern to reviewers who are responsible for taking further action. Teamcenter attaches appropriate analysis forms to the routed compliant. These forms enable Teamcenter to capture all relevant review information, along with options that can trigger additional workflows for initiating a CAPA process. Using digital product development for package creation Medical device companies use Siemens NX digital product development solutions to develop, design and test new devices on a virtual basis. Product teams employ these tools to rapidly develop new products as well as to evaluate the cost, quality and manufacturability of their device designs before creating costly physical prototypes. Product developers use NX to embed critical product/process knowledge directly into their designs, thereby enabling their company to design better products and reuse its intellectual assets across multiple lifecycle processes. Optimizing good manufacturing practices Medical device companies use Siemens Tecnomatix digital manufacturing software to improve the manufacturing planning process and optimize manufacturing capacity and throughput. As companies introduce new devices into their manufacturing environment, they use Tecnomatix to simulate operating conditions across diverse facilities. This enables companies to make better capacity allocation decisions, reduce capital investment, shorten ramp up times and improve product quality. Just as importantly, Tecnomatix provides rich 3D functionality that manufacturing teams leverage to comprehensively simulate, demonstrate, verify and submit virtual good manufacturing practices before the device is actually produced. This planning approach materially reduces time-to-approval and time-to-volume assembly. 7

10 Siemens PLM Software solutions for the medical device industry Siemens PLM Software brings unique capabilities to the medical device industry that unleash hidden capacity by automating, standardizing, consolidating, integrating and globalizing product data and automated development processes at every stage in the medical device lifecycle. PLM-driven medical device solutions Siemens technology enablers Collaborative concept development Requirements-driven design Systems-based device platforms Electronic records management GMP process automation Digital validation verification Rapid change management Environmental compliance PLM solution capabilities Increases visibility into informal activities occurring across a company s R&D, product design and manufacturing operations during key concept development phases. Enables the company to share information, hold conferences, and visualize design/application data on a highly flexible basis thereby facilitating fast review processes and improved consensus building. Accelerates regulatory compliance by digitally tracing linked requirements that tie customer requests, design specifications and manufacturing inspections together. Enables a company s supply chain to understand the cost and scheduling impacts of modified product requirements at multiple levels. Facilitates systems engineering by enabling a company to codify its informally held intellectual assets and specialized technical knowledge. Leverages rules-based automation capabilities to link flexible parametric modeling constructs to knowledge based tools. Establishes a device master record (DMR), device history file (DHF) and device history record (DHR). Enables a company to leverage these capabilities to reuse its globally accessible master records for product and process definition, thereby simplifying design control compliance and accelerating timeto-manufacture. Facilitates good manufacturing processes (GMP) by increasing the connectivity between CAPA, customer compliant, adverse events and nonconformance processes. Drives GMP initiatives by optimizing the logical progression of problem resolutions to active product/process changes. Streamlines the validation process for simple cases by enabling developers to test product and performance and digitally identify problems before costly physical prototypes are produced. Establishes accurate, concise, comprehensive and fully iterative change processes for the entire device lifecycle. Enables a company to support its product development, revision control and compliance management initiatives in accordance with the industry standard CMII closed loop change model. Maximizes the visibility of compliance information across every lifecycle phase. Enables companies to establish environmental compliance as a critical product requirement, thereby minimizing the risks and costs of noncompliance. 8

11 Your next step in transforming the medical device lifecycle Teamcenter s medical device solution combines compliance management, traceability and reporting capabilities to help manufacturers address the medical device industry s strict quality and regulatory requirements as well as today s demanding time-to-market pressures. Medical device companies are now able to take advantage of an integrated solution for complete end-to-end management of their product lifecycle. Contact your Siemens client representative today to learn more about applying PLM to the most pressing issues that influence your new product introductions and your ability to cost effectively comply with demanding regulatory requirements. Or feel free to visit us at:

12 About Siemens PLM Software Siemens PLM Software, a business unit of the Siemens Industry Automation Division, is a leading global provider of product lifecycle management (PLM) software and services with 5.9 million licensed seats and 56,000 customers worldwide. Headquartered in Plano, Texas, Siemens PLM Software works collaboratively with companies to deliver open solutions that help them turn more ideas into successful products. For more information on Siemens PLM Software products and services, visit Siemens PLM Software Headquarters Granite Park One 5800 Granite Parkway Suite 600 Plano, TX USA Fax Americas Granite Park One 5800 Granite Parkway Suite 600 Plano, TX USA Fax Europe 3 Knoll Road Camberley Surrey GU15 3SY United Kingdom 44 (0) Fax 44 (0) Asia-Pacific Suites , 68/F Central Plaza 18 Harbour Road WanChai Hong Kong Fax Siemens Product Lifecycle Management Software Inc. All rights reserved. Siemens and the Siemens logo are registered trademarks of Siemens AG. Teamcenter, NX, Solid Edge,Tecnomatix, Parasolid, Femap, I-deas, Velocity Series and Geolus are trademarks or registered trademarks of Siemens Product Lifecycle Management Software Inc. or its subsidiaries in the United States and in other countries. All other logos, trademarks, registered trademarks or service marks used herein are the property of their respective holders W 22 3/09

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