A Holistic Approach to Product Introduction and Change Processes

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A Holistic Approach to Product Introduction and Change Processes: Reliable Medical Device Innovation in the Face of Regulatory Uncertainty for Dassault Systèmes

Date:

November 2010

Author:

Julie Fraser, Cambashi

© 2010 Cambashi Inc. Federal ID No. 26-2432982. Registered office as above.

A Holistic Approach to New Product Introduction and Change Processes

Contents Executive Summary.............................................................................................. 2 The Certainty of Uncertainty ................................................................................ 3 Total Product Lifecycle vs. Traditional Approaches ......................................... 4 Quality and Compliance Embedded in NPI ........................................................ 5 Quality and Compliance Embedded in Product Change ................................... 8 Preventing Quality and Compliance Problems .................................................. 0 Moving Toward a Holistic Approach ................................................................. 10

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A Holistic Approach to New Product Introduction and Change Processes

Executive Summary Patients live and die by medical device innovations – and so do the companies that make them. While regulations have made dangerous products somewhat rare, focusing on compliance has also tended to leave medical device companies struggling to innovate as rapidly as they would like. At this juncture, the FDA has the 510(k) process under review, and is considering tightening rules around what products are considered predicates or “substantially equivalent” for streamlined approval. This is adding quite a bit of uncertainty for many companies’ product improvement cycles. The leading medical device companies are now working to streamline and standardize internal processes to match the FDA’s vision of total product life cycle (TPLC). TPLC is a multi-disciplinary approach that helps to establish quality and compliance from the earliest conceptual stages of a product or a change to a product. It leverages records from every stage to make good decisions at each stage of a product’s lifecycle: early concept through design, development, production, and use in the market. To support TPLC, most companies use paper, but are finding that challenging. Leading companies use a product lifecycle management (PLM) system as the enterprise system of record for product information for the entire lifecycle. It also provides a system whereby documentation of many types can be stored and analyzed in useful ways. Migrating to a holistic TPLC environment does not require altering the basic stages in new product introduction (NPI) or product change; TPLC streamlines and improves those processes by leveraging knowledge from other stages. Using PLM to support TPLC, companies are finding that quality and compliance are natural outcomes. With information in a single system, many processes not only in product development, but in production, quality, regulatory affairs, and patient or caregiver support are all streamlined. This paper walks through the major phases of both NPI and product change with a brief description of what the holistic approach supported by PLM can provide. Medical device companies that use primarily paper systems of record today will not migrate to this approach all at once, nor must they. A gradual approach of adopting the principles and systems of TPLC can pay off in phases. While the regulatory landscape continues to shift, companies must establish reliable, adaptable, streamlined and repeatable processes internally to cope. In this scenario, the NPI and change processes not only leverage the same information system, they support and feed each other as well as the quality, regulatory, production, and service processes. For most medical device companies that operate in departmental silos, this inter-disciplinary approach is a major change that top executives must sponsor for the disciplines to work together effectively. It is the executives who should care the most – TPLC is intended to reduce cost and complexity while ensuring high quality and regulatory compliance. By making more knowledge accessible to decision-makers throughout the company, TPLC can both speed and improve an array of business processes. Those who move forward can improve their competitive position as well as their regulatory standing – a combination that has not been common until recently in the industry.

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A Holistic Approach to New Product Introduction and Change Processes

The Certainty of Uncertainty Uncertainty is not new in the medical device industry, but has some added dimensions today. One longstanding area of uncertainty is the efficacy and safety of products in early development and trials. In both established and emerging markets, there is currently extra uncertainty in the regulatory landscape as well. With the global expansion many companies have also found new supply chain partners, who can introduce risk if they do not control processes properly. Any company in an industry that rests on frequent new product introductions is guaranteed some uncertainty. The study Total Product Lifecycle Management: Lowering Costs While Increasing Quality showed that most medical device makers have been increasing the rate of new product introductions (NPI). Nine of ten respondents expect the NPI rate to increase over the next few years. (See Figure 1) When the product portfolio is changing constantly, it causes uncertainty in marketing and development – and also throughout the operation in manufacturing, distribution, quality, sales and regulatory affairs.

New Product Introduction Change Rate 100% 80%

60% 40% 20% 0% Decrease

No change

Past 3 years

Increase

Next 3 years

Source: © 2009 Axendia and Cambashi Inc: Total Product Lifecycle Management: Lowering Costs While Increasing Quality

Figure 1: Medical Device companies have been increasing their product introduction rates and that trend accelerates in the future.

Some of the challenge is also with product upgrades or variations. Regulatory agencies often cite companies or deliver Warning Letters when the company makes too many product changes without filing for approval (i.e. additional information to a 510(k) or a PMA supplement). Without appropriate tools and processes in place, companies must walk a fine line in deciding whether to risk slowing down innovation cycles to accommodate what for most is a cumbersome regulatory filing process. Regulations themselves change also. Currently, the U.S. Food and Drug Administration (FDA) is considering tightening rules on when a company may file a 510(k) for “substantially equivalent” products. For many companies, this would present a much longer cycle to actually gain FDA clearance and sell improved products. Each regulatory agency worldwide has somewhat different regulations, makes changes on a fairly regular basis, and every company must keep up with these regulatory changes in every country where they want to sell their products. Another critical factor adding uncertainty for many companies is that they work with partners for ingredients, components, raw materials, production (subcontracting), packaging, and sales. The FDA has made it clear that the final device maker or brand owner is responsible for the compliance of all materials from each of their partners. To continue to innovate, companies must show that their suppliers have adequate quality based on purchasing controls.

Quality Processes that Matter Most Design control Supplier quality

Predicting Quality issues (preventing non-… Risk Management (FTA, FMEA, FMECA, etc…) Quality root cause analysis CAPA management

Complaint management (from external sources) Non-conformance management 0%

Unfortunately, right now many companies’ new product introduction (NPI) and engineering change (EC) processes are unpredictable also. Figure 2 shows that

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20%

40%

60%

Source © 2009 Axendia and Cambashi Inc: Total Product Lifecycle Management: Lowering Costs While Increasing Quality

Figure 2: Design controls are one of the top areas where investment would improve quality outcomes.

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A Holistic Approach to New Product Introduction and Change Processes

the most commonly cited quality process where investment would improve outcomes is design control. Developing all of the required models, analyses, and documentation for products and materials is challenging in any case. However, most medical device companies also conduct time-consuming manual searches to find relevant precedent information, regulatory compliance documentation, and all data related to current products. With all of this guaranteed uncertainty, many companies are looking to reduce the variability of their own processes. Fortunately, the regulatory agencies recognize that need as well.

Total Product Lifecycle vs. Traditional Approaches The FDA has encouraged medical device makers to take a total product lifecycle (TPLC) approach to lower costs and improve quality. TPLC is a holistic approach to managing products. FDA states that the stages of a product’s lifecycle from concept through development, production, use and obsolescence must support and leverage each other. This is an iterative product development and management approach. Companies must apply information learned in one stage for one product to future products that they develop. Lifecycle: TPLC works through a product’s lifecycle, from concept to obsolescence. This also allows companies to make improvements to new products based on experiences with current products. The FDA itself has created a TPLC database that includes pre-market and post-market information on the same device to improve its own ability to understand product issues. Disciplines: TPLC not only spans the entire lifecycle of a device, it also crosses functional boundaries to involve research and engineering, clinical, production, quality, regulatory, and commercial departments. In addition, information from the users of the product, both patients and healthcare providers, must be included in this TPLC view – whether from adverse events and complaints or focus groups or any other direct input. Just as design for manufacturability is a major thrust at many companies, supply chain, quality, and many other factors can be included during initial product design to ensure that the product meets the needs of patients, regulators, and the company for profitability. Proactive Quality: A holistic approach can ensure that quality, and in fact regulatory compliance, are a natural outcome of a sound design process. While every product designer may strive for quality, only with easy access to well managed and clear information, whether that be about other products and post-market events from earlier versions of a product or similar products or many other portions of the quality system record can designers reliably make sound decisions. This is a huge benefit not only to quality and regulatory outcomes, but to costs. This is because it avoids the cost of making a change to Traditional Development TPLC correct quality in later stages such as design, Network-like channels of preclinical, clinical and in the field (including Rigid and limited continuous communication through the feedback channels expensive product recalls and the cost to course of lifecycle remediate compliance problems). In short, TPLC spans the lifecycle and disciplines. The result is that a TPLC approach is proactive, with quality, compliance and thus costs built in from the outset. This is in stark contrast to most development approaches today, as Figure 3 indicates. Most development today is sequential and with so much paper-based record-keeping, being thorough and adaptable is a significant challenge.

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Each department or discipline is involved at a specific point rather than through the course lifecycle

Continuous involvement of all disciplines through the course of lifecycle

Quality information is generated and used in specific points of design and production

Quality considered at the outset and through lifecycle, with quality information permeating the cycle

Compliance validation is introduced at specific points of design and production

Compliance is considered and validated persistently through the course of lifecycle

Figure 3: Most product development and management approaches are not as efficient and reliable as TPLC.

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A Holistic Approach to New Product Introduction and Change Processes

Setting up and sustaining a TPLC effort requires good information flows, and ideally a centralized information repository. The information from throughout the product lifecycle as well as from every discipline should be accessible in a useful, easy to find context for any given product. Systems commonly called product lifecycle management (PLM) provide just this type of repository. The best PLM solutions have easy ways to interface to nearly any source of data from any part of the company or even from suppliers, distributors or other external sources. The following scenarios for holistic NPI and product change assume not only approaching this with a TPLCoriented process, but also that the process is supported by credible PLM software. Both the process and the information capabilities are crucial to achieving the vision these scenarios express – each is necessary but not sufficient without the other.

Quality and Compliance Embedded in NPI The overall cycle of new product development may not change dramatically between traditional methods and this holistic or TPLC approach. However, the streamlining of the end-to-end process and the benefits that result are significant. Figure 4 conceptually illustrates the contrast in connection and time to market between these approaches. Another important difference you will notice is how quality and compliance flow from the NPI process, rather than forming totally separate processes that cannot fully benefit from one another.

Figure 4: 4A shows the traditional approach to new product introduction, but without the links to show nearly every block and data source connecting to every other. These interfaces are where complexity, uncertainty, error, risk, and time to market appear. 4B shows the streamlined TPLC/PLM approach.

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A Holistic Approach to New Product Introduction and Change Processes

Requirements: In either the traditional or holistic approaches, the process begins when market or customer requirements, research or new science or technology generates a need or opportunity for a new product. These market needs will become the marketing claims against which product efficacy will be measured in regulatory review cycles. That means that data to measure efficacy and quality must be defined as early as possible. In the holistic NPI environment, the new product’s requirements and opportunities are added into a context of the requirements and design intent for all of the products in this family, or even in adjacent product families. The PLM system would enable effective search of all of the design and product feedback that might be relevant. It also provides a way to store and leverage requirements data from sales, healthcare providers, and others who are not design-oriented. This same PLM repository can store input from clinical trials and input about products as they are used in the market, to build not only quality and compliance histories, but also requirements for new versions and new products. NPI Project Launch: One of the key aspects of a project launch in this holistic environment is that the project is considered as one in a portfolio of design projects. This helps ensure that appropriate resources are available and assigned to the project. The better PLM systems today provide a complete project management system that goes well beyond timelines and resource allocation, however; it also serves as the repository for both the design history file (DHF) and the device master record (DMR). The breakthrough here is that the regulatory requirements are met in the same system as the project management itself. So in addition to the product information repository, the PLM software provides resource checking and structured workflow to ensure projects are moving forward. PLM also assists in maintaining and achieving regulatory compliance. Conceptual and Systems Engineering: Systems engineering aims to consistently manage the product definition, simulation of behavior, and tests for a device from product definition through project launch. Part of the value comes from clearly understanding the behavior of a product and validating its ability to meet customer requirements during early conceptual engineering. In many complex devices, this involves not only putting the system through modelling and simulation early on, but also exploring alternative concepts and configurations. Holistic, parallel (not sequential) and lifecycle approaches, such as the process shown in Figure 5, are a foundation for success of systems. The iterative and collaborative nature of this process is

So urce: http://www.incose.org/practice/fellowsconsensus.aspx , The Systems Engineering Process from A. T. Bahill and B. Gissing, Re-evaluating systems engineering concepts using systems thinking, IEEE Transaction on Systems, Man and Cybernetics, Part C: Applications and Reviews, 28 (4), 516-527, 1998.

Figure 5: Systems Engineering uses the structured SIMILAR process to ensure that a complex product or project will satisfy needs in a high quality, reliable manner throughout the system's entire life cycle.

just what TPLC specifies. A PLM system can not only document and store the diverse types of information, but automatically provide traceability and linkages among logical definitions, virtual models, and test results across disciplines and throughout the lifecycle. Product Development: A multi-disciplinary approach to integrated or “mechatronics” engineering to evaluate interactions between mechanical, electrical, electronic, and software elements is increasingly critical for achieving quality and regulatory compliance in complex devices. In addition, development may include aesthetic and ergonomic design for patient and caregiver comfort in using products, as well as device and

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drug interactions for combination devices. Naturally, development also includes testing a unit, sub-system and system level that need to come together for verification and validation of product design outcomes. All of these disciplines can come together in the PLM environment to collaborate effectively. Beyond engineering itself, PLM provides an integrated source of information about the product to technical documentation as well as to production, quality and regulatory compliance teams. It also enables these teams to participate in design more effectively. One of the key capabilities that PLM makes easier to handle effectively is risk management. Now that products are so complex, assessing risk is far more challenging for most companies. Hazard analysis and failure modes and effects analysis (FMEA) must be built up starting at the early requirements stages of a product and within product development. With the information structure and workflow of a PLM system, each design step can naturally build up the DHF and DMR. This documentation is an integral output of the process, not a time-consuming post-facto search effort to ensure everything is included. Purchasing Controls: Concurrent with the design engineering process, procurement will be finding and qualifying suppliers for the product. Ideally, suppliers will be involved in optimizing the product design based on their specialty areas and deep understanding of how their particular contributions might impact product design. The collaborative capabilities of PLM software certainly help to allow this in secure ways that protect intellectual property of all parties. Workflows for system engineering and project management can include suppliers to ensure sound materials, parts, and sub-system specifications and high quality, compliant product outcomes from the very outset. The best PLM systems today can also track supplier audits and corrective actions. In some instances, early supplier collaboration can also reduce bid costs. Design Transfer: Ensuring that device design is correctly translated to product specifications for manufacturing is always a challenge, but doing so in an auditably compliant way as regulatory bodies require enforces the need for comprehensive documentation. Design transfer can benefit greatly from the use not only of traditional engineering tools, but of a system that encourages and supports the participation of suppliers, manufacturing engineers and production teams in the design process. PLM’s collaboration tools include not only production process design, but also mechanisms for non-engineers to participate effectively from early in the process. Regulatory Submissions: Throughout each stage of the new product’s design, the company may be required to submit specific documentation to the regulatory authorities before selling the product in their jurisdiction. Naturally, the FDA’s premarket approval (PMA) and 510(k) processes – or equivalent marketing approvals from other regulators – are major filing points. There are many others, which might include investigational device exemptions (IDEs) to run a clinical study – and for some devices, a pre-IDE is wise to ensure that the clinical trial results go through regulatory approval smoothly. Many pieces of information are developed or collected during the product design and development cycle that may also be needed for regulatory submissions and to address inspectional findings. Some examples include risk evaluations that are based on FMEAs, fault tree analysis, preliminary hazard analysis, and so on. The DHF is also built up throughout the cycle. The benefit of PLM is that it can support these processes with a central repository of information about the design process, the product, analyses of it, test results, trial results, as well as post-market information. Design teams working on new products can both leverage this Figure 6: PLM stores not only the original information about current products and build the records design engineering files, but also views of the for new products during the normal course of their work. product at every stage of its lifecycle.

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Service Hand-off: While initial design transfer to the service team is similar to the manufacturing hand-off, a major benefit of the PLM approach is that all versions can be stored and signed off in this single system. As shown in Figure 6, the as-engineered, as-built, as-installed, and as-serviced records are in a single location. Those developing documentation for service technicians have all of the original design information to pull from, as well as this full lifecycle view. Repairs from current products can factor into engineering analyses for new products. In summary, the NPI process is both streamlined and improved with this holistic approach. It can enable cross-functional participation and information access, and thus improve the quality, safety and efficacy of new products. In fact, the documentation generated during these sound design processes can be stored in a central PLM repository from which the company can automate documentation of the DHF and the regulatory submissions.

Quality and Compliance Embedded in Product Change Not every product change is significant enough to require a new product filing such as a PMA or 510(k). However, poor handling of complaints and non-conformance reporting have been major causes of FDA Warning Letters recently. When problems arise for an approved product, the company will need to take effective action and document it. While not all of these issues will result in engineering changes to the product, many will. Product Change Requirement: A product change is often triggered by adverse events as reported to regulators, or complaints received by the firm or non-conformances observed at the company. A holistic approach will capture the drivers of the change and the design change activities as part of the DHF, and the DMR will be updated, as applicable, to ensure those changes are used in production. Investigation and Risk Assessment: Understanding the cause of an issue can be challenging. However, having all data from early concept and hazard analysis data through every design, development, and production phase in a single PLM repository can minimize or even eliminate one of the largest challenges: finding all relevant information on which to base the investigation and assessment. In addition to investigation workflows, sound PLM systems also have built-in analysis tools to assist. PLM can also support the other main objective, preventing the problems from occurring, escalating or reoccurring. Corrective and Preventative Actions: While many companies manage these largely through documentoriented systems, PLM can support moving beyond corrective and into preventative actions. With product requirements and specifications as well as quality, production process, FMEA, and test information in a single source, the CAPA process is stronger and faster. PLM can also set up workflows for opening a CAPA, conducting the investigation, developing corrective and preventive actions, and ensuring those changes are implemented and effective over the long run. Product changes and testing: When a product, supplied part, or production process is the cause of a nonconformance, the PLM ties directly back to the design systems to allow rapid changes. In addition to the 3D models for design and simulation, PLM also is designed to manage the simulation and test data. So as a product change is executed, all of the data to validate the effectiveness of the change is easily available. Regulatory submissions: One of the largest challenges for companies operating globally is often ensuring that each regulatory body in each region gets appropriate submissions. The PLM keeps everything organized by product revision level, so even if different versions are approved for shipment in different regions, the entire set of data behind the submissions is already organized. This is true whether it’s a short process for a substantially equivalent product, or the full approval for major product changes. It also encourages filing for smaller changes, since the time to assemble and format data is streamlined. Adverse event reporting such as eMDRs can also be a significant burden. Deciding when complaints should result in

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A Holistic Approach to New Product Introduction and Change Processes

such reports is part of the risk analysis, and not handling it well often leads to FDA483s (inspectional findings or observations) or Warning Letters. Monitor change and effectivity: While the number of nonconformances, adverse events, and complaints are relatively easy to count, tracing the results back to gauge the effectivity of a change is not always so easy. Analysis tools in PLM can help, and if the Figure 7: Product changes with TPLC and PLM support can streamline the process, whether it is considered to have a precedent or requires a full new submission. 7A hazard analysis is shows the traditional approach; 7B the PLM approach. done well, it can point to specific areas where issues are most likely to occur. Approve and close: Closing out a change process sometimes requires significant documentation. However with PLM, steps throughout the change process occur within the PLM and the system stores and organizes the data for compliance, so that people can find everything they need there. Systematic review and sign off migrates from a “wade through reams of paper” process to an efficient on-line review of key points of interest. Figure 7 shows some of the streamlining effect that this holistic approach with PLM can provide to the product change process. Quality and compliance are a more likely outcome of changes with a TPLC approach.

Preventing Quality and Compliance Problems The pace of progress means that engineering changes will not decrease for most companies – in fact, for 40% of medical device companies they are increasing. That is only a problem if processes are cumbersome, costly or ineffective. Unfortunately, we have seen first hand that at many companies they are. Figure 8 shows that CAPAs, non-conformances and even FDA inspectional observations and internal audit findings are staying the same or increasing for most companies. This is not a

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Changes, costs and quality not decreasing for most device makers

Engineering Changes Product costs CAPAs Non-conformances Audit Findings

0% Increasing

50% Same

100%

Source: © 2009 Axendia and Cambashi Inc: Total Product Lifecycle Management: Lowering Costs While Increasing Quality

Figure 8: For most companies, engineering changes, product costs and quality challenges are constant or increasing. 9

A Holistic Approach to New Product Introduction and Change Processes

sustainable industry model. The goal must be to reduce CAPAs, non-conformances and audit findings to avoid regulatory warnings and citations, and to lower product costs. The main way to achieve all of that is through a proactive approach to quality that begins at conceptual engineering and works through the entire lifecycle, leveraging information from all disciplines. The previous examples for NPI and product change can only begin to describe the streamlined processes and increase in effectiveness available to companies that make these investments. To improve design control, as many companies believe they must, this multi-disciplinary holistic approach will be the most effective path.

Moving Toward a Holistic Approach While company policies, practices, organizational structures, and mindsets must shift for the TPLC approach to work, information systems are at the core. Having a single repository for information about product versions that spans the lifecycle and disciplines is what enables this approach to take root and flourish over the long haul.

PLM system leverage To create a single repository that includes both the early concept where all of the possibilities were in play and analyzed and a consistent version of the truth for approved products, PLM must be a true enterpriselevel system. The team that selects and implements the software must include quality, regulatory, and operations as well as design engineering. Cross-functional teams will be using the PLM system to develop and store, as well as to search for and find, critical information to support their jobs. Leverage the workflow capability in the system to set up processes for new and changing products to be similar, and for all of those processes to include regulatory and quality elements. While people are comfortable working in their silos, regulators no longer want to see those separate streams. Information for regulatory submissions and communication can come from the information in the PLM system today. This helps companies prepare to have data organized and in electronic format so they can automate submissions and link into regulatory portals. With today’s PLM products, companies can submit eMDRs for adverse events. Soon, these systems will handle new product submissions and product changes with information about how these changes relate to initial filings as well. While PLM is clearly designed to foster collaboration not only across disciplines, but also among trading partners. Tools such as social networking, increasingly integrated into PLM, can help ensure the appropriate partners are involved in collaboration for issues such as supplier quality. Figure 2 shows supplier quality as the second most common area of quality that could be improved with further investment after design control. In addition to design collaboration capabilities, PLM generally offers capabilities to select among suppliers based on audits and event or NCR history and then to monitor supplier quality. PLM offers extremely good security by product, project and supplier to ensure that suppliers have appropriate permissions, can share needed data reliably, and can contribute additional value to the design and product change processes. It can support monitoring of supplier quality as well as initial supplier selection based on audits and event history.

Beyond Software In addition to finding and implementing sound PLM, there are a set of other factors that must be in place for this holistic approach to succeed: 

Explore the business benefits to gain support from the entire executive team and the board of directors. Moving to a full TPLC approach is a never-ending process that must not be dependent on a single visionary executive. It needs to be a long-term objective.

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

 





Change mindsets to eventually eliminate turf battles and departmental “us-vs.-them” approaches. We have observed that holistic approaches that foster more work across departmental boundaries can lead to increased respect and understanding between disciplines. Executives must make the heads of each department accountable for designing and implementing new norms and metrics that foster TPLC success and ensure no one tries to protect old fiefdoms. Dedicate resources to the project to get on the right path and continue to make progress. Executives need to devote time to oversight, and a cross-disciplinary core team that goes beyond IT and design will need to spend their time turning a holistic strategy into a plan and executing against it. Develop a multi-year plan with benefit expectations at major milestones. While some core infrastructure may be difficult to justify at any one stage, process improvements should lead to cost, design, production, quality, and regulatory benefits. Look for benefits in time to market, risk to patients, risk to shareholders, improved product innovation, and streamlined regulatory submissions. Create realistic expectations for each stage. The benefits are great, but making such large changes and moving a new system out to so many groups can be very challenging. It is important to have a vision and get people excited, but also realize there will inevitably be bumps in the road to success.

The goal of a holistic approach or TPLC must be coherent and proactive processes that naturally feed each other. Quality and compliance will spring from product development and change processes, and likewise concepts for product improvement will come from every group. Product innovation and operational efficiency will be hallmarks of successful medical device companies, so the innovation process must become more reliable and also maintain regulatory compliance. As uncertainty remains in how regulations will evolve and be interpreted, companies must embrace new partners, gain approval in new markets, and win the loyalty of healthcare providers and patients every day. A holistic approach to product introduction and change processes is the foundation for that ongoing and sustainable success.

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About the Sponsor, Dassault Systemès As a world leader in 3D and Product Lifecycle Management (PLM) solutions, Dassault Systèmes (DS) brings value to more than 115,000 customers in 80 countries. A pioneer in the 3D software market since 1981, DS applications provide a 3D vision of the entire lifecycle of products from conception to maintenance to recycling. The DS portfolio consists of CATIA for designing the virtual product - SolidWorks for 3D mechanical design - DELMIA for virtual production - SIMULIA for virtual testing - ENOVIA for global collaborative lifecycle management, and 3DVIA for online 3D lifelike experiences. The world’s leading medical device, pharmaceutical and patient care companies depend on DS PLM solutions to master their highly regulated product development challenges and accelerate time to market, collaboratively and efficiently. Learn how DS Life Sciences solutions are catalysts for innovation, visit http://www.3ds.com/life-sciences or call 800.382.3342.

CATIA, DELMIA, ENOVIA, SIMULIA, SolidWorks and 3D VIA are registered trademarks of Dassault Systèmes or its subsidiaries in the US and/or other countries.

About Cambashi Cambashi, based in Cambridge UK and Cummaquid MA, USA provides independent research and analysis on the business benefits of using IT in value-adding industries. Cambashi delivers the latest global market data, plus perspectives on the changing state of technology and current business issues in manufacturing, process, distribution, energy, utilities and construction industries. Our consulting analysts partner with each client to solve difficult problems, clarify decisions, articulate value, and craft a unique path to market rewards. www.cambashi.com

A Holistic Approach to Product Introduction and Change Processes Cambashi Paper #U3031. The information in this report is from a wide variety of sources that represent the best information available to Cambashi Inc. This report includes our interpretation of information in the public domain or released by responsible officers in relevant organisations. Some information is from sources we cannot verify. We survey judgement samples, and results are not statistically significant unless so stated. Cambashi Inc cannot guarantee that the report is accurate or complete. Information changes with time. The analysis, opinions and estimates in this report reflect our judgements as of writing but are subject to change without notice. Cambashi Inc shall not be liable for any loss or injury resulting from use of this information. All trademarks are the property of their respective owners. Cambashi Inc may have a consulting relationship with a company being reported on. It is not an offer to sell or a solicitation of an offer to buy any securities. Cambashi Inc, its staff, their families and associates may or may not have a position in or with respect to any securities mentioned herein.

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