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<ul><li><p>Warning: Everything You Know About Medical Design Is Wrong </p><p>Achieve PLM product design utopia in Medical Device</p><p>Whitepaper</p><p>arenasolutions.com</p></li><li><p>2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. &amp; Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 1</p><p>arenasolutions.com</p><p>An Industry Defined By High Hurdles and High Margins Developing a medical device has always been a complex process. </p><p>Manufacturers must continue to drive innovation while facing ever-intensifying business challenges, including the onslaught of fierce competition, the difficulty of managing globally dispersed teams, and an increasing need to address quality and risk. On top of this already challenging state of affairs, OEMs must also comply with strict and ever-changing regulatory requirements imposed by governing agencies around the globe. </p><p>So how does a medical device manufacturer navigate this balance beam at high speed?</p><p>Its a tall order because so much is involved in developing a medical device. Medical device manufacturers face complications with component changes when developing a product. They have to meet compliance regulations and face risks more dangerous than other industries. After all, human lives are at stake. And every time a medical device company makes a single change to a product design, the government needs to know and it doesnt matter whether its just a labeling issue or single component change.</p><p>And heres where things get really crazy: the medical device industry has such extended regulatory approval cycles that by the time a part is approved it can be deemed obsolete. Replacing the part means the submission process starts all over again.</p><p>Gasp.</p><p>The medical device industry is defined by a number of high hurdles that stand in the way of an OEMs success. But for those who can overcome these challenges there is the promise of high marginsand vast riches. </p><p>The only way to manage the entire medical device product lifecycle from regulatory compliance, to global monitoring, quality assurance, risk management and part nonconformance is through a holistic approach that brings all of these moving parts together into a single, integrated view. When quality, design control processes, and risk management are embedded as an integral part of the day-to-day product design and development cycle, OEMs can dramatically reduce supply chain oversights, employee missteps and product design errors.</p><p>Misleading reports that extol the virtues of best of breed solutions, so-called linked systems, and even the traditional model of isolated systems claim to be able to deliver the holistic solution described above; however, recent evidence points to the contrary. Medical device executives, whose use of siloed systems has led to product delays, scrap, rework and risk exposure, can attest to the painful truth that everything they had been told about medical design control waswrong. </p><p>According to an Aberdeen Group report, embedding quality and design control processes within a product lifecycle management (PLM) solution can reduce internal and external failure costs by more than 50 percent and the total cost of quality by 8 percent.1 </p><p>GET DEMO</p></li><li><p>2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. &amp; Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 2</p><p>arenasolutions.com</p><p>For medical device companies, the ideal design environment to avoid risk and ensure quality is a three layer stack: the foundation is a modern cloud-based PLM solution with an extensible architecture to support a range of current and future integrations; next is an embedded quality module with corrective and preventive action (CAPA) capabilities; the final layer are next generation design solution integrations, add-ons and even component databases all woven into the PLM-driven design environment. </p><p>In this medical device-focused whitepaper, we look at strategies and modern solutions that when integrated together can improve quality, streamline design control processes, reduce risk, control design and accelerate innovation. As we search for a utopian medical device design environment, we cover the following topics:</p><p> Why PLM?</p><p> Advantages of Integrating Quality with PLM</p><p> Strategies for Managing REACH and RoHS Risks</p><p> How to Reduce Obsolescence and Counterfeit Parts</p><p> Extending Your PLM Solution </p><p> Why PLM?Before we begin to delve into buzzwords, such as holistic solutions, complete quality pictures and enterprise-wide visibility, lets investigate why PLM is the first step in a medical device companys plan to reduce risk and ensure quality in their design processes. </p><p>To start with, PLM was created to allow all product companies not just medical device OEMs to better manage documents to streamline their extended supply chain efficiencies, improve cross-functional collaboration and increase enterprise-wide visibility into the design process. By this very function alone coupled with configurable routing and electronic signatures companies can reduce costly risks and significantly improve compliance processes. </p><p>PLM specifically helps medical device OEMs by empowering them with greater management control over their quality documents. This expansive list of quality-related documents includes bill of material (BOM), change orders, design history files (DHF), device master records (DMR), validation and verification certifications, risk management reports and product records. And lets not forget the need for a well-documented paper trail for 21 CFR Part 11, 21 CFR Part 820 and CAPA. </p><p>PLM offers greater document control for med device companies by consolidating all design information in one centralized system, enabling OEMs to easily share BOMs with globally dispersed suppliers. Because quality-related documents can be complicated (a DMR is an enormous compilation of records containing the procedures and specifications for a finished medical device), a solution like PLM is necessary to avoid misplacing documents and keeping a tight rein on version control. </p><p>GET DEMO</p><p>Collaborative Quality Management Life Cycle</p><p>Collaborativequality</p><p>managementlife cycle</p><p>Requirements denitionand management</p><p>Build and releasemanagement</p><p>ConstructionTesting</p><p>Analysis and design</p><p>Riskmanagement</p><p>Testmanagement</p><p>Defectresolution</p><p>Analytics</p><p>Dynamicplanning</p><p>Coverageanalysis</p></li><li><p>2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. &amp; Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 3</p><p>arenasolutions.com</p><p>When quality processes (CAPAs, supplier corrective action requests (SCARs), corrective action requests (CARs), NCMRs, 8D, etc.) are integrated into the PLM system, supply chain teams have access to the quality product records, enabling them to be proactive rather than re-active in managing quality. And because this information is tracked and visible throughout the organization, auditors can quickly and easily verify compliance.</p><p>Advantages of Integrating Quality with PLMIn todays hyper-competitive medical device market, medical device companies must balance the need to meet increasingly stringent regulations while continuing to innovate quickly and be first to market. To succeed, medical device companies should ensure these quality best practices:</p><p> Processes complement one another: Manufacturing, engineering, quality control and compliance management must all work together to control costs and shorten development cycles and retain a First Mover advantage. </p><p> Compliance becomes part of the culture: Medical device developers must embed compliance into the day-to-day work life of all global teams; otherwise employees will never be able to keep up with, much less meet, the ever changing array of local regulatory requirements.</p><p> Ongoing, global monitoring of risks: Again, organizations need to take a holistic monitoring approach to account for the diversity of risks a medical device OEM faces, including lifecycle, compliance, multi-sourcing and inventory risks. </p><p> Ensure everyone participates: If the quality process is relegated to an isolated team using an isolated system, it is almost a guarantee that the product will face quality issues. Quality processes must be integrated into the day-to-day product record so that everyone, including members of the extended supply chain, can contribute to producing the highest quality product. </p><p>LNS Research recently released the results of a quality management survey that showed medical device executives ranked the ability to better manage operational risk and ensuring compliance as the top two quality management objectives. The roadblocks that executives felt kept them from achieving those goals were effectively measuring quality metrics and disparate quality systems and data sources.</p><p>GET DEMO</p><p>Quality metrics are not eectively measured</p><p>Quality is considered a department not a responsibility</p><p>Disparate quality systems and data sources</p><p>Lack of visibility into supplier quality</p><p>No formal process for continuous improvement</p><p>Engineering lacks feedback on quality</p><p>Top Quality Management Challenges</p><p>Chal</p><p>leng</p><p>es</p><p>Percentage of Respondents Source: LNS Research</p><p>0 10% 20% 30% 40% 50%</p></li><li><p>2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. &amp; Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 4</p><p>arenasolutions.com</p><p>How Arena Helped Swan Medical Take FlightSwan Medicals COO Larry Sampson was frustrated with his companys CAPA processes. Unreliable and unpredictable design controls were keeping him awake at night. We suffered from poor internal understanding of process flow and inability to produce corrective evidence, said Sampson. Simply put: we had improper information in the specified locations. </p><p>Sampson realized he could not depend upon divergent systems to ensure quality. Redundancy and version control issues were creating havoc. With siloed systems, it was hard enough to get the input correct once, let alone twice in exactly the same way, said Sampson. The COO knew a holistic PLM-driven approach to quality control was the key to his medical device companys success. </p><p>Sampson turned to Arena PLM to streamline his companys design processes. According to Sampson, Arena PLMs change management capabilities and document control enabled him to improve processes for creating, reviewing and gaining formal approval for engineering change requests, change orders and change notifications. He also integrated Arena Quality into Arena PLM.</p><p>I use all of Arenas tools together to establish a regulatory compliant standard work flow for predictable outcomes, said Sampson. The quality process integration is great, the ECO management capabilities are awesome. Arena allowed me to establish a complete quality and risk management solution that streamlined processes to ensure quality for better business results.</p><p>In addition to Arena Quality, Sampson also integrated Arena Projects into the design mix to flexibly track CAPA project progress through customizable phases with assignable milestones and tasks. When an auditor comes in, its useful to have quality processes tied directly with project tasks, said Sampson. You can click and show them exactly where youre at in the project and how much time you expect to complete the CAPA and which aspects of the system youre touching upon.</p><p>Fortunately, with a PLM-based quality solution, processes are embedded into enterprise business systems and other external data sources, producing as documented by this research the following business benefits:</p><p> Reduction of the cost of quality by up to 3X2</p><p> A 25 percent increase in operating margin and a 29 percent reduction in failure costs.3</p><p> A reduction of the cost of poor quality (COPQ), which increased earnings 10 to 15%4</p><p>When organizations employ disparate systems to manage quality, risk and other key processes, in large part they fail to perform because there is no effective way to retrieve recorded notes, making prior corrective actions difficult to adjudicate and true up. Quality Digest discovered that up to 80 percent of quality issues are repeat issues for which a corrective action has already been identified but does not persist.5</p><p>Because of existing investments in engineering, many companies are implementing quality management systems (QMS) and associated functionalities, such as CAPA, as an extension of PLM. For engineering-intensive organizations, this helps to incorporate quality processes not only into the design phase, but also into manufacturing, sourcing and business operations. </p><p>Extending CAPA and other QMS functionalities with PLM strengthens the feedback loop, because it enables stakeholders to take advantage of critical information earlier in the value chain. This rapid iterative process in new product introduction (NPI) results in better-formalized first versions.</p><p>With a modern PLM solution, medical device manufacturers can develop a unified information management system for engineering and quality, which creates a single point of entry for all product and quality information irrespective of function. Streamlining independent data sources into a centralized system delivers more accurate product information, improves knowledge sharing, supports better design processes, and provides improved visibility into quality information for all stakeholders. It also eliminates the duplication of data in various disconnected systems. </p><p>The benefit of integrating quality within PLM is clear, but what other tools and strategies can help reduce an increasingly broader array of risks and pains that afflict and ail the medical device industry?</p><p>Strategies for Managing REACH and RoHS RisksWhen introducing a new medical device onto the market, organizations should initiate a number of well-defined risk analysis and evaluation phases. Risk management and the performance of risk assessments are key parts of the design, development and control process, because they help ensure that manufacturers fully understand the product and that that designers have fully considered user requirements, the patient and the operator. </p><p>GET DEMO</p></li><li><p>2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. &amp; Tm. Off.All rights reserved. Other product and company names are the property of their respective holders. 5</p><p>arenasolutions.com</p><p>At a high level, ISO 14971 defines risk as the combination of the probability of occurrence of harm and the severity of that harm. Risk management for medical devices is the systematic application of management policies, procedures and practices, to the tasks of analyzing, evaluating, monitoring and controlling risk. </p><p>The first step in the risk assessment path is to identify the...</p></li></ul>