A Holistic Approach to Product Introduction and Change ... · Migrating to a holistic TPLC...

Cambashi Inc P.O Box 463 Cummaquid MA02637, USA Tel: +1 508-362-3480 Fax: +1 508-362-4162 www.cambashi.com

© 2010 Cambashi Inc.

Federal ID No. 26-2432982. Registered office as above.

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

A Holistic Approach to New Product Introduction and Change Processes

© 2010 Cambashi Inc. 1

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



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.



0%

20%

40%

60%

80%

100%

Decrease No change Increase

New Product Introduction Change Rate

Past 3 years 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.

0% 20% 40% 60%

Non-conformance management

Complaint management (from external sources)

CAPA management

Quality root cause analysis

Risk Management (FTA, FMEA, FMECA, etc…)

Predicting Quality issues (preventing non-…

Supplier quality

Design control

Quality Processes that Matter Most

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.

The Certainty of Uncertainty

Uncertainty is not new in the medical device industry, but has some added dimensions today. One long-

standing 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.

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.

Unfortunately, right now many companies’

new product introduction (NPI) and

engineering change (EC) processes are

unpredictable also. Figure 2 shows that



Traditional Development TPLC

Rigid and limited continuous feedback channels

Network-like channels of communication through the course of lifecycle

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.

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

correct quality in later stages such as design,

preclinical, clinical and in the field (including

expensive product recalls and the cost to

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.



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.

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 TPLC-

oriented 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.



Source: 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.

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

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

http://www.incose.org/practice/fellowsconsensus.aspx



Figure 6: PLM stores not only the original design engineering files, but also views of the

product at every stage of its lifecycle.

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

information about current products and build the records

for new products during the normal course of their work.



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 document-

oriented 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 non-

conformance, 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



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

shows the traditional approach; 7B the PLM approach.

0% 50% 100%

Audit Findings

Non-conformances

CAPAs

Product costs

Engineering Changes

Changes, costs and quality not decreasing for most device makers

Increasing Same

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.

such reports is part of

the risk analysis, and

not handling it well

often leads to FDA-

483s (inspectional

findings or

observations) or

Warning Letters.

Monitor change and

effectivity: While the

number of non-

conformances,

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

hazard analysis is

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



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 enterprise-

level 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.



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.



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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