Digitally transformingthe medical device lifecycle

Product lifecycle management (PLM) is the only mission-criticalbusiness initiative capable of helping medical device companies bringhigher value therapies more quickly to market while meeting today’sglobal regulatory requirements. Siemens PLM Software ushers in anew era by providing the medical device industry’s first integratedend-to-end PLM solution that moves beyond the capabilities ofindividual applications to meet the needs of multiple lifecyclephases, take-to-market programs and disciplines.

www.siemens.com/plmSiemens PLM Software

Industry challenges

Large,medium sized and smallmedical device companies areunder enormous pressure tocontinually enhance productsafety and effectiveness whilecontaining their operationalcosts – as well as the costs ofregulatory non-compliance.

The following business challengeshave emerged as medical devicecompanies try to balance theseseemingly contradictory goalswithin a changing regulatoryenvironment.

Increasing the rate of effectiveinnovation. Medical devicecompanies need to improvetheir rate of effective innovationwhile working in a compliance-sensitive framework.

Accelerating time-to-patientcare. Medical device companiesneed to speed their time-to-market, as well as accelerate thetime it takes to put safe andeffective products in the handsof real-world health carepractitioners.

Improving affordability andvalue. Medical device companiesneed to understand how eachphase in a device’s lifecycledirectly affects patient recovery,long-term medical costs, andability of the device itself toprovide patients with what theywant at an affordable price.

Managing the cost of litigation.To handle adverse events andrespond to government inquiries,medical device companies needto document and reconstructall aspects of a device’s designhistory on demand. Companiescan minimize the cost oflitigation by making compliancemanagement a natural partof their daily activities.

Managing the cost ofregulatory compliance.Companies need to system-atically and repeatedly meetrequirements establishedby the U.S. Code of FederalRegulations (CFR), including 21CFR Part 11, Electronic Recordsand Electronic Signatures and 21CFR Part 820 Quality System(QS) Regulations—as well asISO 1385 specifications.

To meet these challenges,Siemens PLM Software providesan integrated end-to-endPLM solution for the medicaldevice industry that extendsits knowledge management,process management andcollaboration capabilities.

There is growing concernthat many of the new basicscience discoveries made inrecent years may not quicklyyield more effective,moreaffordable and safe medicalproducts for patients.This isbecause the current medicalproduct development pathis becoming increasinglychallenging, inefficient andcostly.We need superiorproduct development scienceto address these challenges – toensure that basic discoveriesturn into new and bettermedical treatments.

From the FDA whitepaper“Innovation Stagnation: Challengeand Opportunity on the CriticalPath to New Medical Products”

1

Today’s most forward-thinking medical device companies arebuilding Global Innovation Networks that are driven by PLMtechnology to continuously improve their products and processesand organize their value chains so that innovation can flourish.

Global Innovation Networks enable companies to approachcompliance as a strategic initiative rather than as just a reportingactivity – thereby building regulatory compliance directly intoall phases of the product lifecycle. These networks empowerproducers 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/manufacturingprocesses illustrate how innovation can deliver business valuein different ways.

Compressing time-to-market.Medical device companies aredriven by the need for speed. Global Innovation Networks enablecompanies to analyze their processes, designs and/or suppliersto determine whether they work effectively in speeding productsto market.

Meeting business and regulatory requirements.Meetingcompliance mandates is not an option for medical devicecompanies – it is an imperative. Guarding the health and safetyof consumers and complying with regulations set by the FDAand other national regulatory agencies are time consuming,complex and extremely costly activities – unless they areimplemented as part of a comprehensive strategy.

Optimizing resources. Global competition is shrinking the windowof opportunity for companies to recoup their intellectual propertyinvestments. Global Innovation Networks enable companies tooptimize their resources to achieve cost and quality targetsessential for time-sensitive opportunities.

Maximizing globalization advantages. By building a complianceframework into a PLM-driven Global Innovation Network, medicaldevice companies are able to launch innovative new productsthrough optimized processes that improve the operation of theirwidely dispersed supply chains. Most importantly, PLM facilitatesglobal collaboration, seamless information sharing andcomprehensive understanding of regulatory requirements.

Business imperatives for the medical device industry

2

Initiatives for the medical device industry

Industry initiativesSiemens PLM Software delivers solutions that drive innovationin the medical device industry through strategic initiatives thatleverage Siemens’ experience and its customers’ best practices.

Increase the rate of effective innovation. PLM dramaticallyimproves a company’s new product success rate by enablingtake-to-market teams to deliver more innovative products andimplement more effective product development processes. Teamscan 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 supplychain to rapidly react to competitive pressures and accommodatequickly rising consumer preferences.

Accelerate time to patient care. PLM accelerates time-to-patient care by permitting everyone in a global supply chain towork from the same design assumptions, patient requirementsand compliance regulations, as well as participate in the sameautomated development processes. PLM-driven process auto-mation increases the throughput and capacity of the extendedsupply chain, enabling delivery of more products to market. PLMprovides total visibility into the status of multiple delivery projectsby allowing decision makers to curtail underperforming initiativesearly and accelerate their company’s most promising programs.

Improve affordability and value. PLM improves affordabilityand value by digitally managing intellectual assets and leveragingthis information in systematic and repeatable processes. PLMimproves product quality and minimizes development costs byallowing every participant in the medical device lifecycle toshare and exchange diverse kinds of knowledge in real-time,engage in brainstorming and automate standards-basedcompliance processes.

Manage the risk of litigation. PLM helps companies managethe risk of litigation by combining integrated collaborationcapabilities with item-level security. This functionality enablescompanies to protect themselves and their suppliers, as wellas healthcare providers and patients. By capturing tightly alignedproduct, package and label information during product designand development, PLM enables development partners to workwith highly accurate product data at all times.

Manage the costs of regulatory compliance. PLM managesthe cost of regulatory compliance by providing medical devicecompanies with a single environment they can use to managecorrective action/preventive action (CAPA) processes, captureand aggregate patient and healthcare provider input from multiplesources, manage these inputs in a globally accessible repository,perform analyses on aggregated inputs and disseminate theresults through automated workflows.

3

How PLM works in the medical device industryMedical device companies use PLM to create a digitalenvironment that can be used by multiple take-to-marketdisciplines to perform a variety of design definition, analysis,validation and simulation processes. Every authorized participantin the device lifecycle – from engineering to manufacturing,finance, marketing, sales and service operations – can use thePLM environment to share and exchange product knowledge.

Typical PLM implementation initiatives start by capturing a take-to-market program’s product and marketing requirements – and thentracing these requirements to ideas, concepts, design prototypes,parts, product definitions, bills of materials, process models andafter-market service definitions.

The resulting body of knowledge is made available to everylifecycle participant and every mission-critical application thatdrives the medical device lifecycle. This comprehensive approachto product and process management enables medical devicecompanies to proactively address strategic issues that influencea product’s marketplace success, constrain its lifecycle costs,and treat regulatory compliance as a systematically manageableproduct requirement.

PLM is especially value during product introduction phases of themedical device lifecycle that determine up to 80 percent of aproduct’s development cost. Numerous studies indicate that PLMenables today’s global competitors to achieve the following highlyprized 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

4

Innovation across the entire medical device lifecycle

Portfoliomanagement

Project planningand execution

Requirementsmanagement and

system engineering

Product and manufacturingprocess design with global

collaboration

Customer needsand ideationmanagement

Verification usingdigital simulation

FDA submittal

FDA approval

5

Environmentalcompliance

Plant and manufacturingexecution

Non-conformancereporting and

CAPA

Customercomplainthandling

Productmaintenance and

service

6

Best practices for medical device companies

Siemens PLM Software implements the following best practicesinto the solutions and processes it delivers for the medicaldevice industry.

Managing and reusing intellectual capitalPLM provides medical device companies with a strategic approachfor managing and reusing their product and process knowledgeas intellectual capital. Best practices require companies tocapture product and process definitions, product and compliancerequirements, brainstorming ideas, initial concepts, informalknowledge, program history, project milestones and trackingdata across a medical device’s lifecycle.

Siemens’ Teamcenter® software provides multi-CAD supportfor the company’s PLM environment, thereby enabling productdevelopers from different organizations to work with theirauthoring tool-of-choice while ensuring that their designs areseamlessly integrated into unified product definitions.

Teamcenter provides methodologies and controls that companiesuse to establish a baseline for each medical device and its lifecycleconfigurations. As a device evolves across its lifecycle, Teamcenterenables stakeholders to assess a device’s product configuration asit was – or is – at any point in time. Teamcenter’s comprehensivetraceability enables companies to understand how design changesdirectly impact a device’s regulatory requirements.

Creating innovative designs in a controlled environmentTeamcenter enables medical device companies to automaticallycapture a product’s design history in a product-focused contextinstead of the document-centric or CAD-centric context thatother IT systems support. Companies use Teamcenter to establishtemplates with approval processes and workflows that reflectindustry best practices.

Teamcenter also provides robust electronic record managementcapabilities for electronic signatures, dynamic watermarking,security protection, and PDF rendering. Teamcenter automaticallycaptures and renders device master records (DMRs) as DMRdocuments are associated with the medical device.

Product teams leverage Teamcenter’s extended changemanagement capabilities to track and manage complaints andissues arising from patient usage. These capabilities enablemedical device companies to automatically trigger theirCAPA processes.

Leveraging today’s best document management practicesTeamcenter enables medical device companies to incorporateAdobe’s rich document rights management features into theirPLM environment. Companies use this integration to render bothMicrosoft Office documents and CAD designs into PDFs at theend of an approval cycle. Companies apply digital signatures toappropriate PDFs using encryption techniques that prevent

documents from being falsified both inside and outsideof their Teamcenter-controlled environment.

7

Signatures are automatically captured during document approvalprocesses to address all CFR Part 11 electronic signaturerequirements. Companies establish automated procedures tostamp or watermark documents that require security certifications,as well as to apply watermark, stamps and digital signatures todesign drawings printed in PDF and CGM formats.

Capturing complaints, adverse effects and quality eventsMedical device companies use Teamcenter to capture and respondto a variety of real-world events and conditions, includingmanufacturing non-conformance, supplier non-conformance andissues rising from audits, complaints and adverse events. WhenTeamcenter captures a complaint or other issue, it automaticallytriggers an appropriate workflow to route that concern toreviewers who are responsible for taking further action.

Teamcenter attaches appropriate analysis forms to the routedcompliant. These forms enable Teamcenter to capture all relevantreview information, along with options that can trigger additionalworkflows for initiating a CAPA process.

Using digital product development for package creationMedical device companies use Siemens’ NX™ digital productdevelopment solutions to develop, design and test new devices ona virtual basis. Product teams employ these tools to rapidlydevelop new products – as well as to evaluate the cost, quality andmanufacturability of their device designs before creating costlyphysical prototypes. Product developers use NX to embed criticalproduct/process knowledge directly into their designs, therebyenabling their company to design better products and reuse itsintellectual assets across multiple lifecycle processes.

Optimizing good manufacturing practicesMedical device companies use Siemens’ Tecnomatix® digitalmanufacturing software to improve the manufacturing planningprocess and optimize manufacturing capacity and throughput.As companies introduce new devices into their manufacturingenvironment, they use Tecnomatix to simulate operating conditionsacross diverse facilities. This enables companies to make bettercapacity allocation decisions, reduce capital investment, shortenramp up times and improve product quality.

Just as importantly, Tecnomatix provides rich 3D functionality thatmanufacturing teams leverage to comprehensively simulate,demonstrate, verify and submit virtual good manufacturing practicesbefore the device is actually produced. This planning approachmaterially reduces time-to-approval and time-to-volume assembly.

8

Siemens PLM Software solutions for the medical device industry

Siemens PLM Software brings unique capabilities to the medicaldevice industry that unleash hidden capacity by automating,standardizing, consolidating, integrating and globalizing productdata and automated development processes at every stage inthe medical device lifecycle.

Siemenstechnology enablers PLM solution capabilities

Collaborative concept Increases visibility into informal activities occurring across a company’s R&D, product design anddevelopment 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 – therebyfacilitating fast review processes and improved consensus building.

Requirements-driven Accelerates regulatory compliance by digitally tracing linked requirements that tie customer requests,design 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.

Systems-based device Facilitates systems engineering by enabling a company to codify its informally held intellectual assetsplatforms and specialized technical knowledge. Leverages rules-based automation capabilities to link flexible

parametric modeling constructs to knowledge based tools.

Electronic records Establishes a device master record (DMR), device history file (DHF) and device history record (DHR).management 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 time-to-manufacture.

GMP process Facilitates good manufacturing processes (GMP) by increasing the connectivity between CAPA,automation customer compliant, adverse events and nonconformance processes. Drives GMP initiatives by

optimizing the logical progression of problem resolutions to “active” product/process changes.

Digital validation Streamlines the validation process for simple cases by enabling developers to test product andverification performance and digitally identify problems before costly physical prototypes are produced.

Rapid change Establishes accurate, concise, comprehensive and fully iterative change processes for the entire devicemanagement 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.

Environmental Maximizes the visibility of compliance information across every lifecycle phase. Enables companies tocompliance establish environmental compliance as a critical product requirement, thereby minimizing the risks and

costs of noncompliance.

PLM-driven medical device solutions

Your next step in transforming themedical device lifecycleTeamcenter’s medical device solution combines compliancemanagement, traceability and reporting capabilities to helpmanufacturers address the medical device industry’s strictquality and regulatory requirements – as well as today’sdemanding time-to-market pressures.

Medical device companies are now able to take advantageof an integrated solution for complete end-to-end managementof their product lifecycle. Contact your Siemens clientrepresentative today to learn more about applying PLM tothe most pressing issues that influence your new productintroductions and your ability to cost effectively comply withdemanding regulatory requirements. Or feel free to visit us at:

www.siemens.com/plm

Siemens PLM Software

Headquarters

Granite Park One5800 Granite ParkwaySuite 600Plano, TX 75024USA972 987 3000Fax 972 987 3398

www.siemens.com/plm

Europe

3 Knoll RoadCamberleySurrey GU15 3SYUnited Kingdom44 (0) 1276 702000Fax 44 (0) 1276 705150

Asia-Pacific

Suites 6804-8, 68/FCentral Plaza18 Harbour RoadWanChaiHong Kong852 2230 3333Fax 852 2230 3210

Americas

Granite Park One5800 Granite ParkwaySuite 600Plano, TX 75024USA800 498 5351Fax 972 987 3398

Siemens PLM Software, a business unit of the Siemens IndustryAutomation Division, is a leading global provider of productlifecycle management (PLM) software and services with5.9 million licensed seats and 56,000 customers worldwide.Headquartered in Plano, Texas, Siemens PLM Software workscollaboratively with companies to deliver open solutions thathelp them turn more ideas into successful products. For moreinformation on Siemens PLM Software products and services,visit www.siemens.com/plm.

About Siemens PLM Software

© 2009 Siemens Product Lifecycle ManagementSoftware Inc. All rights reserved. Siemens and theSiemens logo are registered trademarks of Siemens AG.Teamcenter, NX, Solid Edge,Tecnomatix, Parasolid,Femap, I-deas, Velocity Series and Geolus aretrademarks or registered trademarks of SiemensProduct Lifecycle Management Software Inc. or itssubsidiaries in the United States and in other countries.All other logos, trademarks, registered trademarksor service marks used herein are the property oftheir respective holders.

1020-W 22 3/09