Tuesday Nov 19, 2013

Successful Change Control in the Pharmaceutical Industry

Christina Schröder - Principal Consultant, Enterprise PLM Solutions EMEA

The Facts

"The shipped product fully corresponds to the product documentation." 

A matter of course? 

Or do you have doubts? 

The documentation of product-related data in the pharmaceutical industry is generally very extensive. The process gets even more complex if several departments, sites, and potentially external partners are involved. It takes years from the first formulation to the marketing authorization of a drug product. The long time frame makes a consistent and complete documentation even more difficult. Changes are frequent already before the initial submission: new analytical methods, production process adjustments, supplemental data from clinical studies. Once the product is on the market, obviously the changes do not stop. The effects can be disastrous when the numerous and stringent health authority regulations have not been followed accurately. In the worst case, the product cannot be shipped anymore until the problem or inconsistency has been resolved.

Status Quo 

In spite of this situation, cross-functional change control is still handled with Excel sheets and through emails in many companies. Requested, planned, ongoing, and completed changes are not entered and tracked centrally. An excipient is changed in the chemical development, but the technical writer who is currently revising the leaflet text is not aware. Quality managers are frequently forced to approve change requests or documents without having access to all relevant information. The process is not transparent: even if all required persons have provided their signature, the reasons for approving or rejecting are not recorded and cannot be tracked.

Route to Success 

There are many software packages that support change management. It gets a bit more difficult when you have to consider the special requirements of the pharmaceutical industry: sophisticated approval workflows; full audit trail, history, and data security that comply with FDA 21 CFR part 11; representation of complex submission or product launch projects, to name just a few. However, the goal is not reached just with suitable software. Change management within the organization is at least as important as a proper tool. Existing walls between departments must be broken down successively both in terms of electronic data exchange and in people's minds. This cannot be achieved without proactive executive sponsorship. Furthermore, a software implementation for such a purpose is not just an IT project; it should be primarily driven by the business.

Even if the software is flexible enough to represent existing business processes, the introduction of a new central system provides the opportunity to review, simplify and standardize workflows. In many cases, processes were initially designed a long time ago and some workflow steps are done only because of the historic manual and paper-based conditions. Such transformations cannot be achieved over night; a central comprehensive change control platform is the long-term goal which should be approached in manageable phases. Preferably, an area with concrete pains is chosen as a starting point, e.g. because a bottleneck is apparent, regulatory obligations have to be fulfilled, or a legacy system cannot be maintained anymore. A quick success and return on investment is possible and helps to increase the number of supporters within the company. If the introduction is managed properly, significant cost and time savings as well as increased throughput can be realized in a short timeframe. In parallel, a careful analysis is needed which existing systems should be interfaced or replaced.

How Oracle can help Pharmaceutical Companies 

The Agile PLM Solution Suite provides all necessary functionality to address the requirements for change management and other areas in the pharmaceutical industry. Furthermore, you benefit from the experience with other customer projects. On top of that, Oracle has developed a new presales engagement model that comprises an assessment of opportunities for improvement, visualization of potential benefits, and a demonstration of the software tailored to a customer-specific use case. As a result, the client can rapidly validate the fit and is supported by metrics that help to build the business case.

Wednesday Oct 23, 2013

Variant Management– Which Approach fits for my Product?

Jürgen Kunz – Director Product Development – Oracle ORACLE Deutschland B.V. & Co. KG

Introduction

In a difficult economic environment, it is important for companies to understand the customer requirements in detail and to address them in their products. Customer specific products, however, usually cause increased costs. Variant management helps to find the best combination of standard components and custom components which balances customer’s product requirements and product costs.

Depending on the type of product, different approaches to variant management will be applied. For example the automotive product “car” or electronic/high-tech products like a “computer”, with a pre-defined set of options to be combined in the individual configuration (so called “Assembled to Order” products), require a different approach to products in heavy machinery, which are (at least partially) engineered in a customer specific way (so-called “Engineered-to Order” products).

This article discusses different approaches to variant management. Starting with the simple Bill of Material (BOM), this article presents three different approaches to variant management, which are provided by Agile PLM.


Single level BOM and Variant BOM

The single level BOM is the basic form of the BOM. The product structure is defined using assemblies and single parts. A particular product is thus represented by a fixed product structure. As soon as you have to manage product variants, the single level BOM is no longer sufficient. A variant BOM will be needed to manage product variants. The variant BOM is sometimes referred to as 150% BOM, since a variant BOM contains more parts and assemblies than actually needed to assemble the (final) product – just 150% of the parts

You can evolve the variant BOM from the single level BOM by replacing single nodes with a placeholder node. The placeholder in this case represents the possible variants of a part or assembly. Product structure nodes, which are part of any product, are so-called “Must-Have” parts. “Optional” parts can be omitted in the final product. Additional attributes allow limiting the quantity of parts/assemblies which can be assigned at a certain position in the Variant BOM. Figure 1 shows the variant BOM of Agile PLM.


Figure 1 Variant BOM in Agile PLM

During the instantiation of the Variant BOM, the placeholders get replaced by specific variants of the parts and assemblies. The selection of the desired or appropriate variants is either done step by step by the user or by applying pre-defined configuration rules. As a result of the instantiation, an independent BOM will be created (Figure 2).

Figure 2 Instantiated BOM in Agile PLM

This kind of Variant BOM  can be used for „Assembled –To-Order“ type products as well as for „Engineered-to-Order“-type products. In case of “Assembled –To-Order” type products, typically the instantiation is done automatically with pre-defined configuration rules. For „Engineered- to-Order“-type products at least part of the product is selected manually to make use of customized parts/assemblies, that have been engineered according to the specific custom requirements.


Template BOM

The Template BOM is used for „Engineered-to-Order“-type products. It is another type of variant BOM.

The engineer works in a flexible environment which allows him to build the most creative solutions. At the same time the engineer shall be guided to re-use existing solutions and it shall be assured that product variants of the same product family share the same base structure.

The template BOM defines the basic structure of products belonging to the same product family. Let’s take a gearbox as an example. The customer specific configuration of the gearbox is influenced by several parameters (e.g. rpm range, transmitted torque), which are defined in the customer’s requirement document. 

Figure 3 shows part of a Template BOM (yellow) and its relation to the product family hierarchy (blue). 

Figure 3 Template BOM

Every component of the Template BOM has links to the variants that have been engineeried so far for the component (depending on the level in the Template BOM, they are product variants, Assembly Variant or single part variants). This library of solutions, the so-called solution space, can be used by the engineers to build new product variants. In the best case, the engineer selects an existing solution variant, such as the gearbox shown in figure 3. When the existing variants do not fulfill the specific requirements, a new variant will be engineered. This new variant must be compliant with the given Template BOM. If we look at the gearbox in figure 3  it must consist of a transmission housing, a Connecting Plate, a set of Gears and a Planetary transmission – pre-assumed that all components are must have components. The new variant will enhance the solution space and is automatically available for re-use in future variants.

The result of the instantiation of the Template BOM is a stand-alone BOM which represents the customer specific product variant.


Modular BOM

The concept of the modular BOM was invented in the automotive industry. Passenger cars are so-called „Assembled-to-Order“-products. The customer first selects the specific equipment of the car (so-called specifications) – for instance engine, audio equipment, rims, color. Based on this information the required parts will be determined and the customer specific car will be assembled.

Certain combinations of specification are not available for the customer, because they are not feasible from technical perspective (e.g. a convertible with sun roof) or because the combination will not be offered for marketing reasons (e.g. steel rims with a sports line car).

The modular BOM (yellow structure in figure 4) is defined in the context of a specific product family (in the sample it is product family „Speedstar“). It is the same modular BOM for the different types of cars of the product family (e.g. sedan, station wagon). The assembly or single parts of the car (blue nodes in figure 4) are assigned at the leaf level of the modular BOM. The assignment of assembly and parts to the modular BOM is enriched with a configuration rule (purple elements in figure 4). The configuration rule defines the conditions to use a specific assembly or single part. The configuration rule is valid in the context of a type of car (green elements in figure 4). Color specific parts are assigned to the color independent parts via additional configuration rules (grey elements in figure 4).

The configuration rules use Boolean operators to connect the specifications. Additional consistency rules (constraints) may be used to define invalid combinations of specification (so-called exclusions). Furthermore consistency rules may be used to add specifications to the set of specifications. For instance it is important that a car with diesel engine always is build using the high capacity battery. 

Figure 4 Modular BOM

The calculation of the car configuration consists of several steps. First the consistency rules (constraints) are applied. Resulting from that specification might be added automatically. The second step will determine the assemblies and single parts for the complete structure of the modular BOM, by evaluating the configuration rules in the context of the current type of car. The evaluation of the rules for one component in the modular BOM might result in several rules being fulfilled. In this case the most specific rule (typically the longest rule) will win. Thanks to this approach, it is possible to add a specific variant to the modular BOM without the need to change any other configuration rules.  As a result the whole set of configuration rules is easy to maintain. Finally the color specific assemblies respective parts will be determined and the configuration is completed.

Figure 5 Calculated Car Configuration

The result of the car configuration is shown in figure 5. It shows the list of assemblies respective single parts (blue components in figure 5), which are required to build the customer specific car.


Summary

There are different approaches to variant management. Three different approaches have been presented in this article. At the end of the day, it is the type of the product which decides about the best approach. 

For „Assembled to Order“-type products it is very likely that you can define the configuration rules and calculate the product variant automatically. Products of type „Engineered-to-Order“ ,however, need to be engineered. Nevertheless in the majority of cases, part of the product structure can be generated automatically in a similar way to „Assembled to Order“-tape products. 

That said it is important first to analyze the product portfolio, in order to define the best approach to variant management.

Clicky Site Meter

Monday Jun 17, 2013

Enterprise Product Lifecycle Management: Why Pharma Should Engage Now?

Bertrand Godillot - Senior Director, Enterprise PLM Solutions EMEA

Modern Approaches

We have recently seen some traction around new ways of looking at product lifecycle management in the pharmaceutical industry. Traditional approaches focused on revenue optimization for in market products. Modern approaches bring the light on the front end (early to late phase III), cross functional processes which lead to commercialization: from clinical to operations…

The Shifting Focus

There are multiple reasons for this shift, but the most important one is probably the massive structural change in the pharmaceutical companies’ product portfolios: the golden ages of blockbusters are gone! Pharmaceutical executives have been extremely active in the last few years trying to figure their way out of foreseeable challenges in revenue streams and margins: acquisitions, out and in-license, generics business development etc… At the same time, they have embarked into classic cost reduction initiatives, especially outsourcing. On this later point, a number of product related activities have been transferred to partners including late stage development, clinical trials, clinical supplies, regulatory activities, as well as commercial manufacturing.

So far we have seen very little focus into the execution part of the story! Execution performance remains poor, essentially because of a significant lack of coordination between disciplines. This leads to unacceptable delays and compliance issues responsible for missed revenue and increased costs. Both top and bottom lines are affected. While successful modern Product Lifecycle Management initiatives would drive “indecent” benefits to the pharmaceutical industry, very few companies have developed implementation plans…

Lean Techniques 

It is about applying “lean” techniques before moving to commercialization. It is also about developing a progressive IT roadmap to migrate towards a simplified, more integrated landscape. Both of these should be executed concurrently to ensure continuity of compliant business with the “product” at the center.

While early adopters of PLM for pharmaceutical are definitively out there, they are, interestingly enough, not very talkative about their results. The main reason is to be found in the competitive advantage they gain out of their transformation to a “connected” organization: enhanced visibility, consistency and predictability in business process execution, and better compliance.

We are certainly ready to give our views and share our experiences with decision makers in the pharmaceutical industry to help drive this topic in their organizations!


Monday Apr 22, 2013

Next Generation Product MDM for Retailers

Shyam  Lakshman - Director of Product Management, PIM Data Hub

Unique Challenges and Opportunities of Multiple Retail Channels

Retailers around the globe face unique challenges in managing product information.  Competitive pressures are forcing retailers to provide customers with a consistent and integrated buying experience across channels.   Mobile commerce has become increasingly important with the usage of smart phones and tablets in the buying process. Evolving business models such as online marketplaces and store-within-store are redefining the boundaries of traditional retail stores.  These trends also represent an opportunity for retailers to differentiate themselves and provide their customers with a better buying experience while improving their margins and enhancing their online reputations.

Here are some of the common challenges we hear about from retail customers:

  • Volume and volatility of product changes: It is very common for retailers to deal with millions of products SKUs.  Due to seasonality, competitive pressures and customer expectations, products are introduced and retired at very fast pace.   There is an increasing need to capture and manage additional product attribution - from an average of 66 product attributes today to an estimated 250 attributes in future years according to a study conducted by GS1 UK.  All this information needs to be captured in multiple languages to facilitate seamless operations across the globe.
  • Variability of product data: The assortment of products carried by retailers varies widely in scope.   The attribution requirements can vary significantly across merchandising categories and continue to evolve over time.  Defining and capturing the correct product attribution is critical in making assortment and merchandising decisions.  Compliance with regulatory and legal mandates also requires appropriate product attribution to be captured.  The consequences of incomplete or inadequate attribution can result in loss of revenue and business reputation.
  • Multiple sources and formats of product data: The source of product information is often the supplier and tends to be in different formats. The study conducted by GS1 UK has revealed that retailers are working with data that is inconsistent with their suppliers in well over 80% of instances.  With the increasing acceptance of GDSN (Global Data Synchronization Network), larger retailers are looking for product data management solutions which can be easily integrated with it.  If integrated correctly, this could increase the efficiency of data exchange retailers and their suppliers.
  • Data Quality:  Product data is often duplicated, inaccurate and not standardized.  This contributes to process inefficiencies and hinders the ability to correctly classify products and translate product information into different.  This is also a contributing factor to higher product return rates and its related costs.
  • Multiple publication channels: Accurate and consistent product data needs to be made available to multiple channels – point-of-sale systems, merchandising systems, web stores, print catalog publication systems, mobile commerce. According to RSR Research, 40% of retailers have difficulty coordinating with other channels to create a seamless cross channel experience.  They often lack the ability to centrally maintain and distribute content to create a seamless omni-channel experience

Next Generation MDM - Fusion Product Hub

Fusion Product Hub is the next generation product master data management solution built to address these challenges today.  At the core of the solution is the enterprise product model around which we have built various business processes to consolidate, cleanse, govern and share the product record.  We have re-invented the user experience to emphasize task based navigation, easy access to contextual information, embedded business intelligence and collaboration.    It is available for on-premise deployment and on the Oracle Public Cloud.  The solution was built around 3 key themes:

  • Accelerate Business Processes: The new item introduction process was designed to efficiently induct large volumes of new items while validating business rules and policies.   Optimized task based notifications and a dynamically generated user interface are designed to improve accuracy and response times.  Social collaboration is enabled through integration with Webcenter Spaces, helping further streamline the item induction process.   A configurable publication framework is provided to define criteria and content for publishing product data by spoke system.  This enables product data to be managed once and re-used many times.
  • Enforce Data Governance:  Real time and batch data quality checking is enabled through integration with Enterprise Data Quality for Products (EDQP).  This enables customers to de-duplicate, standardize, cleanse and categorize their product data effectively.  A configurable business rules framework enables definition of rules across business entities and analyzes the impact of introducing a new business rule before activating it.  Approval management for item changes can be used to dynamically derive key stakeholders and participants based on product attributes.  Item version management allows customers to maintain a complete audit trail of product data changes and control the timing of their release.
  • Protect Existing Investments: Data, user interface and business process extensibility enables business users to configure the system to address their unique business needs.  A comprehensive set of business web services facilitates easy integration with existing systems.  The user interface has been designed with a modern look and feel making it easy for new users to get started.  

In subsequent blog posts, I will talk about each of these themes in more detail.  In the meantime, we invite you to visit the Oracle Fusion Product Hub Product Overview to learn more about the solution.  Find out how Fusion Product Hub can help retailers meet their unique challenges in managing their product master data.

Thursday Apr 11, 2013

What Is Wrong with the Management of the Product Portfolio?

James Ramsey - Master Principal Consultant

Editor's Note: This article is the first in a series entitled "The Value of Complete Product Lifecycle Portfolio Management"

Introduction

This is the first in a series of articles exploring the benefit of taking a lifecycle approach to managing the product portfolio.  The article discusses the importance of Product Portfolio Management and identifies some common barriers preventing companies achieving the perfect portfolio mix.

For the purposes of this article, consider the Product Portfolio as a representation of a company’s business strategy providing the plan of action of how it will meet its goals, and Product Portfolio Management as the continuous business process of refining and optimizing the product mix.

Importance of Product Portfolio Management

Companies can have the fuzziest “innovation front-ends” and the best idea-to-launch processes, but if they lack formalized decision-making processes around their product portfolios they will be continually disappointed with their return on innovation. 

According to Cooper & Edgett (Product Development Institute Inc), “recent benchmarking studies have identified portfolio management as the weakest area in product innovation management.”  Whilst there is no doubting the importance of generating ideas and being able to execute on them, a company is only going to achieve the desired growth from innovation if it is executing on the right mix of ideas. 


Product Portfolio Management is often disconnected from Product Lifecycle Management (PLM)


The business benefits of PLM systems are well established.  Many of these benefits come from creating a centralized “Product Record” and by executing projects in the development pipeline in the right way, utilizing the right resources.

But profitable innovation is not just about executing efficiently and doing things in the right way, it is also about investing in doing the right things.

Increasingly a widening gap is emerging between a company’s PLM driven execution activities and their innovation strategy.  Most companies still support their strategic product portfolio planning processes with multiple Excel spreadsheets, point software solutions and PowerPoint presentations, all totally disconnected from the PLM product record.


[Read More]

Monday Mar 25, 2013

Private Label Management for Grocery Retailers

Alex van de Velde  - Principal Consultant, Enterprise PLM Solutions EMEA

Broader Solutions 

Managing product information remains important in private label strategy. Today, leading grocery retail companies are increasingly looking for broader solutions that allow them to better manage cross-functional product lifecycle business processes across their global product networks.

Product Lifecycle Management solutions give complex enterprises the comprehensive support they need to implement an integrated private label process.  These solutions provide a single view of products across business processes and geographical regions. By optimizing the global product network, they allow private label retailers to achieve key business objectives such as enhanced product innovation, faster speed to market, shorter time to shelf, lower costs, improved product quality, and regulatory compliance.


Accelerate Time to Shelf

Time to shelf and time to volume determine success and failure in many markets. Product Lifecycle Management helps retailers turn time into a competitive advantage for your company by enabling your teams to collaborate across your extended supply chain to design, source, and build (outsourced) products that are right for the consumers. As a result, you can eliminate information latency, minimize errors,   and accelerate both time to shelf and time to volume.


Minimize Cost

As your product network extends around the world, managing costs can become more complicated and cumbersome. It becomes even more important to streamline and formalize (cost) price management processes by giving  managers the information, tools, and analytical power they need to apply their business insight and skills to (cost) price management and product sourcing activities. Product Lifecycle Management gives private label retailers the ability to manage and improve product margins, release new products at or below target costs, control margin erosion through purchased material repricing, and outsourced (manufacturing) activities without losing control of your product cost. 


Improve Product Quality

As the product network expands outside the four walls of the company, it becomes more difficult to manage the design, formulation and manufacturing details that affect product quality. With private label management, retailers can put into place the processes and product improvements required to improve quality and customer satisfaction. It also allows retailers to design higher-quality products, improve product reliability, shorten complaints resolution times, and ultimately increase customer satisfaction and loyalty.


Ensure Regulatory Compliance

Without a product lifecycle management backbone, managing compliance documentation and processes across a global product network, complying with diverse regulations from various countries, and keeping documents consistent can be a tough challenge. Software solutions allow some retailers to turn regulatory compliance into a competitive edge by tightly controlling the whole process. With these solutions, retailers can establish and manage compliant, efficient, and auditable product lifecycle processes, thereby reducing business risks and ensuring adherence to regulatory requirements.


Drive Innovation

Innovation is the engine of growth for shareholder value. Product Lifecycle Management enables private label retailers to accelerate innovation without compromising creativity or supply chain flexibility. Dispersed product design teams can collaborate in real time to leverage insight, creativity, and core product designs. As a result, retailers can compress cycle times from concept through release  .


Drive Strategic and Operational Decisions

Leading grocery retail companies need solutions that let them leverage embedded decision support and analytics capabilities to drive better strategic and operational decisions about their private label portfolio.  Out-of-the-box decision support allows grocery retailers to make better decisions that improve product quality and enhance customer satisfaction and loyalty.


Summary

Product Lifecycle Management helps retailers to add best-selling products or drop poor-selling ones from the supply chain faster, and it helps in reduction of inventory losses. It also helps increasing product quality by minimizing errors in the design and development process and bringing compliant products to the market. 

Monday Mar 11, 2013

Software Product Lifecycle Management

Marc Charmetant - Principal Consultant, Enterprise PLM Solutions EMEA

Why Software Product Lifecycle Management? 

When talking about Software management, it is often said that it is a high risk scheduling activity. Why? Well,  software management combines several specifics making it difficult:

  • The release plans are at the program level  but  execution is at the feature or at the sprint level.
  • Software is often embedded into hardware and the maturity of the hardware obviously impacts the embedded software.
  • Changes are constant and overlapping. Scope changes, content changes, schedule changes generate unplanned and iterative processes that can overlap one another.

Is Software Management the Same as Source Code Control?

Very often software management is reduced to source code control. Most companies have very good code source code control and test management tools, but this is not enough as software management requires more than source code control and test. 

These tools leave very important questions open such as "Is everyone aware of the scope, content and schedule changes?", "Are the programmers working on the right specifications?", "Are the system test cases in alignment with the programmer’s code and requirements?", and  "It is all about the alignment of product content, schedule and quality."


Managing the Software Product Lifecycle in PLM

We can consider two main cases in the software development lifecycle:

  • Software that is developed independent of hardware
  • Software as an integral part of a hardware

In the two cases, the software is driven by a release date defined by market and customer requirements. Software can be managed in PLM as PLM can support the BOM beyond only the hardware BOM, providing a full information repository for the hardware and software. Enterprise PLM also provides a global security model and supports the following four important processes for software development:

  • Schedule Management
  • Content Management
  • Change Management 
  • Quality Management

Schedule Management

A good PLM system includes a schedule management system  managing the complex schedule of multiple interdependent projects. It will be used to manage the release scoping and execution, the feature /sprint process execution, the build process/test execution, the approval and gate management and last but not least, the customer commitments. It could also manage the alignment with the hardware schedule for the embedded software case


Content Management

Content definition should be done with the use of a source code control system. Source code control is an authoring tool like an ECAD or MCAD system, a highly specialized tool with integration to build tools and automated test systems. 

A PLM tool is a software IP management system providing  enterprise visibility and compatibility to software. It provides software configuration control as well as  software IP tracking and audit.


Change Management

Change management is the core of SPLM. It will allow detailed control of :

  • Specification changes 
  • Schedule changes
  • Test plan changes
  • Scope plan changes
  • Requirements changes
  • Resources changes 

Quality Management

 A PLM system includes a closed loop quality system allowing integrated product testing and issue tracking, with full visibility given to stakeholders of the process. It allows full content revision and version alignment on requirements, test plans, scope and specifications. Driven by deliverables the  formal gate review and approvals will guarantee completeness. Audits can also be managed directly in the PLM tool for customer certifications or regulatory audits. 


In Closing

Combining all the facets of a Software PLM solution is very challenging, however  Enterprise PLM solutions like Oracle Agile PLM can enable full software lifecycle management. Combing advanced program management features, full change management with traceability, closed loop quality processes and advanced content management allowing full control over the Software Product Lifecycle. 

Monday Feb 25, 2013

RoHS II Regulation Challenges Medical Device Manufacturers

Elmar Frühe - Master Principal Consultant, Enterprise PLM Solutions EMEA

A New Challenge

There is a new challenge making Medical Device manufacturer’s worry:  the updated RoHS regulation, now officially known as RoHS 2011/65/EU or just RoHS 2.0. RoHS regulation and the corresponding responsibility to manufacture or buy only compliant components and products is already well accepted by the Electronic and High Tech industry, but still new to the Medical Device markets.

The regulation itself becomeseffective on 2nd January 2014 and includes all Medical Devices (according legislation 93/42/EWG) except active medical implants. In Vitro Diagnostics products will follow in 2016. So the time to act is now!


RoHS II 

So what does the RoHS regulation mean specifically? First of all medical-device products have to be built without (or limited) use of certain hazardous substances like lead, cadmium or mercury. In addition the manufacturer has to prove by an adequate documentation that one is following the RoHS compliance. And last but not least there is a certificate of conformity and a CE-labeling necessary.

Every quality and regulation representative in Medical Device companies is facing a huge additional amount of work or another pile of (paper based) documentation and dossiers ready to be shipped with the product. But couldn't life be easier if software could support the overall process from a compliant design to sufficient documentation? Yes it could and the good news is that the appropriate software is there!


A Best Practice Solution

Medical Device companies using Product Lifecycle Management (PLM) software today are not nervous about the new regulation. Starting in the very early beginning of the product design they already keep an eye on being RoHS compliant while selecting only allowed components. They additionally qualify their manufacturers and suppliers as being a trustful partner providing materials and components without containing any hazardous substances. Of course all the declarations and certificates are stored as an electronic record in the system ready to be reused for any audit or technical documentation. Even new introduced parts undergo an approval process including strong supplier collaboration and collecting all signatures needed for a “Compliance OK” designation!

During the ongoing Product Lifecycle the PLM system helps to manage all the processes and information in a collaborative network. Any requirement, Bill of materials, drawings as well as schematics and layouts are managed within the system. Furthermore, they have a lifecycle status, are linked together and are change and revision controlled within the software tool. In addition, quality related processes are built in a PLM tool to manage a closed loop from a first sample inspection finding to the final corrective action and design change.

So when it comes to an audit or to the necessary RoHS documentation including product descriptions, construction drawings, compliance declarations, process plans and operation procedures, the system already has the information ready to submit or print. Medical Companies already using PLM software dramatically reduce the cost and effort of being compliant and of course mitigate the risk of launching a non-compliant product.


In Summary 

All in all PLM systems help to keep a compliant data set of records within one single source of truth – always ready to be used and managed in a collaborative network – saving time and costs, ensuring high quality and mitigating the risk of non-compliance .

Monday Feb 11, 2013

Building a Better Business Case

Bertrand Godillot - Senior Director, Enterprise PLM Solutions EMEA

Hard Cost Benefits

How would you back up a recommendation to your board to implement a Product Lifecycle Management strategy? Soft benefits only go so far in convincing decision makers yet most executives shrink from providing hard cost benefits to them. Why?  

In most cases they are doing this for the first time and are desperately looking for help! The problem begins when most solution providers position standardized spreadsheets as customer specific benefits calculators. While the usual suspect consulting firms sell their expertise, and six or so months later an RFI process is launched, few initiatives reach this stage with a realistic, approved business case.


The Cash Curve 

Over the years, the "cash curve" has proven to be a successful framework. It helps drive business process discussions with representatives from sales and marketing, development, sourcing, quality, manufacturing engineering and operations. Similarly to some of the lean techniques, it helps visualizing dependencies between disciplines as well as some of the bottlenecks, issues, nightmares... In other words, areas of improvements -primarily from a process perspective, can be identified, shared and acknowledged across disciplines. This is clearly a major first step in the development of a proper business case.


Evaluating Benefits

Evaluating benefits is somewhat industry specific. A pharmaceutical or a medical device company is likely to be very sensitive to compliance and risk mitigation. Consumer packaged goods companies will be very focused on brand protection. Consumer electronics will pay a lot of attention to scrap, rework, and obsolete inventory. A common denominator for all seems to be the ideal balance between growth and margin.

Therefore, a PLM business case should always include three main sections:

Increased Revenue

Cost Reduction

Industry Specific driver: Risk Mitigation, Brand Protection...

Unsurprisingly, there has been a lot of frustration on both sides in the past as very few executives would commit on the revenue dimension: in this just like in a number of other domains, compensation drives behaviour...

In future contributions, articles will drill down in each of the value area of the "cash curve" and share what should be considered as part of a Product Lifecycle Management business case. These will include pragmatic examples to make this as valuable as possible. Hopefully, this will help development and operations representatives in their business case development. 

Wednesday Feb 06, 2013

The Rise of Information and the Risk to Brands

Clinton Chadwick - Principal PLM Consultant – Oracle
 
Information Overload and Brands
 
A world of ever more empowered consumers means brands are simultaneously becoming more important and open to more risk. Consumers are suffering from information overload. A simple consumer question like “what is the best laptop to buy?” or “is grape juice safe for my child to drink” instantly becomes a discussion inexorably linked to brands.


When consumers try and find answers to these questions are swimming in a sea of information.  Brand names are key landmarks in navigating this sea. While the details of what consumer may read on the websites, blogs and social network posts they find will fade, what remains is brands – “Brand X makes great laptops”, “Brand Y juice is safe for my child”.


Furthermore when researching products, brands are an extremely import keywords for internet searches. Without brand names, the amount of results and the ratio of useful information to noise is vanishly small.


 
The Risk to Brands
 
This unprecedented access to information greatly empowers consumers. This includes both positive information about brands and, more importantly, negative.  Consumers are more likely to share their bad experiences than their positive ones so companies have come to expect many more complaints than complements.


Previously, it took a major product problem with significant impacts before the issue would come into the media spotlight. Even then, the coverage was often limited to a particular region or geographic area.


Now, it only takes a few negative consumer experiences to damage a brand. Design or quality problems that would never be large enough to gain traditional media attention are now quickly publicized by unhappy consumers via websites, chat forums and increasingly – social media.


This grassroots publicity begins impacting potential customers immediately.  Consumers now often begin their purchasing process with internet research. These consumers will be impacted by the reports to unhappy customers – even if those customers’ experiences were with vastly different products.


This reality greatly amplifies the negative consequences of even the smallest design or quality problem.

How can this be prevented?


 
Mitigating Brand Risk
 
The risk comes from design and quality problems that produce a sufficient quantity of unhappy consumers that they produce an online record of the product problems for future potential customers to find.


Is it possible to prevent unhappy customers entirely? No, there will always be unhappy customers for a variety of reasons. However, savvy consumers know this already. If they see isolated bad experiences they will naturally filter these out and ignore them. It is only when many consumers confirm the same problem that potential customers sit up and take notice!


Avoiding serious design and quality problems is a matter rigorous and consistent innovation processes that include numerous checks and controls.


The innovation process is a particularly complex one as it involves virtually every part of the enterprise from marketing to R&D to procurement. However, innovation is inherently a creative process in which individuals need freedom and flexibility.


 
Solving the Problem with Product Lifecycle Management (PLM)
 
Combining the rigor and consistency with complexity and flexibility is very challenging to do manually either on paper or with Office type computer applications. Enterprise PLM applications like Oracle Agile PLM enables a consistent, auditable innovation process which still allows for creative freedom for small, mid and large organizations.


Product Lifecycle Management mitigates the problem of brand risk in a few way:

  • Product Data Management. Having a single version of the truth is the best way to make sure that teams are all speaking the same product “language”. Miscommunication due to individuals or teams looking at wrong or outdated product information is source of significant potential errors.
  • Project Management. One of the largest problems with innovation project is skipping steps. It is natural for a busy team to decide to skip a step and sometimes this is an appropriate decision, but often it can open the door to significant risk. Projects with PLM can still be flexible, but when a decision to accelerate a project by skipping steps (this is often a valid course of action) are made there is a record of when, who when and why.
  • Approval Workflows. Making sure the appropriate checks are made is critical and automating the process is a great way to enforce these important steps.
  • Automated Compliance. Compliance takes many forms depending on the industry one is working in. Some PLM solutions include automated compliance determination which can perform automatic checks on your product data to determine if the product is compliance with regulations like RoHS, REACH and even FDA regulations. With complex products, it is conceivable to miss a single non-compliant part or material with potentially disastrous implications. Automating this process is the best way to avoid this risk.
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A cross industry discussion on ways to better manage product data and the entire product lifecycle from idea to end of life with special attention to the unique challenges faced by European companies.

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