From introducing a first-of-its-kind breakfast cereal to rolling out the latest iteration of an already popular kitchen appliance, there’s nothing new about new products. Indeed, a whopping 30,000 new product offerings reach the market in the average year, according to NielsenIQ. And that’s just in the consumer-packaged goods segment. A mere fraction of these product offerings, however, gain traction with the buying public.

A critical component to the success of a product launch is the product commercialization process. Whether you own a startup company and are dipping your toe into the product commercialization process or are a seasoned CEO aiming to streamline your new product introduction or new product development workflows, this article will address your business objectives.

Product commercialization explained

Product commercialization is a branch of product lifecycle management, which involves all the activities that occur over the course of a product’s life, from conceptualization to launch to retirement. Product commercialization occurs during the launch phase of a product’s lifecycle.

To the average consumer, commercialization might seem to refer solely to advertising and marketing – the promotional work that lets buyers know that a product exists, what it does, and where to buy it. Regarding product lifecycle management, however, commercialization can include ideation, research, assessment,  development, prospecting, marketing, and more. In other words, commercialization encompasses all the processes that need to be completed before a product is ready for release. The specific activities relevant to commercialization largely depend on the type of product being brought to the market. What follows are some of the steps commonly involved in successful product commercialization:

1. Perform research: Research helps to identify what, if any, market exists for a given product or innovation.
2. Gather feedback: This stage involves soliciting the opinions and feedback of other stakeholders to determine what a new product should include to resonate with buyers, based on your market research.
3. Obtain a patent: This step entails obtaining the credentials that identify you as the inventor from a governing authority. Patent protection is crucial to your intellectual property.
4. Identify target audience: This is the prospecting stage, where you go out and identify the most likely customers for your new product offering and the best way to reach them, which includes marketing. Audience identification can be incorporated with your overall sales strategy.
5. Monitor sales performance: After product launch, monitoring sales performance can help you with production and determining whether the new product is resonating with your audience.

Product commercialization: the most consequential stage of product lifecycle management

Product commercialization may be the most consequential stage of product lifecycle management. The commercialization process is largely where all the planning takes place. This includes not just marketing the product, but conducting the relevant research and collecting pertinent feedback to determine if there is an appetite or buying interest for a new soft drink, hard candy, plush mattress, or whatever your new product may be.

The reliability of the methods and procedures used during product commercialization can largely determine the end result. And because so many new product launches wind up failing, there is a lot of room for error during this pivotal stage. However, when done carefully and accurately, product commercialization can increase profitability, expand your customer base, improve process innovation, and enhance customer satisfaction through better product development.

The right tool to bring your products to life

There are many critical components to product lifecycle management. Oracle’s Product Lifecycle Management (PLM) applications have them all covered. Oracle Cloud PLM helps bring your product to life, from innovation to collaboration, to commercialization and more. It enables businesses to turn their best ideas into highly profitable product offerings. Cloud PLM makes this possible by helping you connect and manage all the steps and phases that are involved in the innovation pipeline to improve visibility and alignment across new product and service offerings or investments.

The removal of cordoned-off silos helps to support greater collaboration among all the departments taking part in bringing a product to the marketplace, thereby enhancing overall productivity, streamlining communication, reducing errors, and minimizing downtime. In a demand-heavy, consumer-driven economy — where beating the competition truly does matter — more collaboration in getting products ready for launch can be the difference between coming in first with your prospective customers or coming up short.

But beating the competition is all for naught if you get something wrong with the design or concept. Oracle Cloud Product Management guards against this by allowing you to reuse existing items, trace requirements through the design phases, and validate that each new product has been designed to reduce new product introduction risks. This shortens the time to market with a product that achieves business and technical expectations and specifications.

In addition, Oracle Cloud Product Management helps your company more effectively engage with your extended supply chain, providing visibility via collaboration on product design and features, as well as integrating PLM to other imperative enterprise business processes like Quality Management and more.

Oracle’s Product Management Cloud, which encompasses everything from ideation to commercialization, allows you to seamlessly monitor and manage product specifications, component optimization, supply risk, and other key production metrics. It also unifies processes in the production cycle — such as engineering and manufacturing — that might otherwise be disconnected, thereby driving overall efficiency and cost savings.

Regardless of your specific needs and goals, our Product Lifecycle Management team will help you move from ideation to project delivery without compromising quality or missing a beat. Contact us today to learn more.

In a truly global landscape, the medical device supply chain may be the single most complex one for manufacturing entities to navigate. With health care representing one-fifth of the U.S. economy, there is tremendous demand for state-of-the-art technology that can improve health outcomes, whether it’s through early diagnosis, more accurate blood pressure readings, or any number of other health solutions that medical devices have made possible. How quickly and effectively the medical device industry can get these products to market can be life-changing — quite literally.

But the pathway to distributing medical devices is a difficult one due to the costs of production, stiff competition from rival developers, and increasingly strict medical device regulation from oversight bodies. Medical device manufacturers must routinely clear numerous hurdles and regulatory requirements in order to bring their products to market, as well as expand into other geographies.

Product lifecycle management — and, by extension, PLM solutions — can make your journey to the market more of a straight line. Here’s a breakdown of what product life management is all about and how it helps solve medical device manufacturers’ biggest pain points by improving quality management.

First things first

Product lifecycle management is a process that represents the entirety — hence the term “lifecycle” — of a product’s existence. To consumers, a product’s life may seem like it begins when they first purchase the item. But to the manufacturer, the product lifecycle begins much earlier, starting at conceptualization and concluding at retirement, with development, product launch, and servicing and support representing the three phases in between. All product-based industries use some iteration of product lifecycle management, including toy companies, automakers, industrial machinery developers, home appliance manufacturers, and more.

When it comes to the stages of product lifecycle management, both the names and the number tend to vary, depending on the industry and what is being produced. The activities that occur within those phases can also be different. Generally speaking, though, there are at least five. Let’s dive into these stages a little further:

1. Conceptualization: The conceptualization phase is the seminal one. Ideation happens here, as well as requirements guiding the features and functionality of the product.
2. Development: Development is where ideas are put into practice. In this stage, the product is designed and validated, analysis is performed, and prototypes are created. This allows stakeholders to provide feedback on what, if anything, needs to be changed about the product design before moving on to mass production. “Design for X” is also critical in the development process. “X” means manufacturability, quality, compliance, and other governing parameters. Examples of relatively recent regulatory requirements for medical manufacturers include Unique Device Identifier (UDI) and EU MDR.
3. Product launch: Here, feedback on refinements is implemented and the product design goes from prototype to ready for purchase. Stakeholders collaborate with marketing entities to assist with getting the product to the market. The product design goes from prototype to ready for purchase. Additionally, commercial and regulatory requirements now come into play, which if not met, can impair the launch and sale of your products.
4. Servicing and support: Producers may offer supplementary services to end-users on an as-needed basis, such as troubleshooting and support to ensure the product works as intended and is delivering the correct results. And with regulated products, various regulatory agencies have requirements relative to how long product information must be maintained, what acceptable archive processes are, and other factors in the data retention area.
5. Retirement: This is the stage where the product is phased out because it’s reached its endpoint. It no longer works, buying trends have shifted, or improvements in technology have rendered it obsolete.

Product lifecycle management software is a tool that helps manufacturers organize product development so creations find their way to the actual marketplace, not just the marketplace of ideas. With product lifecycle management software in place, manufacturers have more visibility and control over all the phases and stages that a product goes through over the course of its life. Product lifecycle management software makes it easy to track data, share product data with other stakeholders, and make more informed decisions regarding development, marketing, pricing, and compliance across the supply chain, thanks to unifying many disparate processes.

Effective product lifecycle management is essential to medical device companies

Without a plan and the right technology, product lifecycle management is fraught with risks. According to Inc., as many as 95% of products that are newly released wind up being pulled from the market because they don’t sell well. There are also unique challenges facing medical device manufacturers in particular. In addition to financing development, medical device developers must adhere to strict quality control measures and regulatory compliance protocols established by major oversight entities — both in the healthcare industry (such as the American Medical Association) and the federal government (such as the Federal Drug Administration). Because the bar is so high, estimates suggest that only 45% of medical devices wind up being approved, according to a study published in the medical journal BMJ.

Product lifecycle management software helps medical device companies successfully bring their creations to market by supplying them with the added visibility, efficiency, and project delivery capabilities critical to product development.

The medical device lifecycle is a little different
The process of bringing medical devices to market typically takes longer than it does with other products that don’t have as many regulatory structures. This is one reason the medical device lifecycle runs longer than with other products. The phases are similar, though, and include:

1. Concept: In the ideation phase, a medical device is conceptualized, its capabilities are defined, and funding options are explored.
2. Planning: Similar to the general product lifecycle management workflow, the planning component for medical device manufacturers involves creating a prototype of the device – a design based on the needs of health care practitioners or patients – and a strategy to market the device. This stage also ensures that users’ needs align with technical requirements.
3. Design: In the design stage, engineers and manufacturers collaborate to mass-produce the medical device in question. This process is informed by feedback from users, technical documentation, design verification, and initial studies verifying that the device is safe and effective to use.
4. Validation: The validation process for medical device manufacturers is significantly more complex than for many other types of manufacturers. Medical device companies conduct clinical studies to corroborate the soundness of their devices and must comply with extensive regulations and documentation requirements before their products can be marketed to the general public or health care providers.
5. Launch: Once approved by oversight entities, the medical device is marketed and sold to hospitals, clinics, patients, or other intended users. The launch phase may also include training and support if technical know-how is required.
6. Post-market: The post-market phase represents any point after which the device has gone to market and become available for use. During this phase, medical device manufacturers continue to monitor product safety and may conduct additional marketing and customer research initiatives in the hopes of increasing future sales.

PLM software solves medical device manufacturers’ challenges

Because the medical device supply chain includes multiple players in addition to manufacturers and end-users, a lack of transparency across the landscape can present quality issues during every phase of product lifecycle management.

PLM software helps break down walls so there is easier coordination. Oracle Cloud PLM is one such solution that allows for increased visibility and agility. By leveraging Oracle Cloud PLM, every stage of a product’s lifecycle is centralized, from conceptualization to planning, design, validation, and more. Because Oracle Cloud PLM is built on a SaaS model, the solution is automatically updated with the latest features, functions, and best practices that help you manage your current devices and roll out the next big thing.

Whether you’re looking to streamline your product launch, make the regulatory compliance process easier, or improve the quality of your product lifecycle management, Inspirage can help make it all possible. We partner with companies to break down barriers and identify opportunities to drive better performance. Contact us today to learn more about Oracle’s PLM platform and our innovative Medical Device solutions.

Where PLM solutions have come up short in the past

An Aberdeen survey found that organizations often cite challenges related to:

• Disconnected systems, processes, and departments (cited by 49% of companies that launch 10+ products per year).
• Subpar data quality (26%).
• Overly frequent engineering change orders (31%).

The new capabilities and possibilities of PLM

1. Real-time IoT sensor data

2. Digital twins and a digital thread

3. Cloud computing infrastructure

Like other essential business platforms, PLM tools have moved into the cloud. Cloud-based PLM has substantial advantages over legacy systems, including:

• More manageable costs that are billed as operating expenditures.
• Easier system maintenance and upgradeability.
• Scalable resources that can be matched to evolving workloads.
• Security managed primarily by the service provider.

Cloud-based PLM that draws upon the scale and real-time insight available through the IoT is the future. As companies look to gain more value from their PLM solutions and use them in contexts other than just engineering, working with a trusted Oracle partner on the necessary migrations is crucial.

Inspirage is an experienced Oracle partner with a track record of success on PLM, ERP, and supply chain implementations for companies of all types. Learn more about how we can guide your next project by contacting us.

Mass production implies uniformity. A mass-produced product gets made in enormous quantities based on common specifications; its entire production run may even happen in the same facility, on one set of machines. Product customization is the polar opposite of mass production, as it involves bespoke items created in smaller batches, sometimes by hand.

The happy medium: Mass customization

Between these two concepts is the notion of mass customization, which attempts to blend the relatively low costs of mass production with the personalization of product customization. Mass customization isn’t a new concept. Harvard Business Review examined it in-depth in 1997, focusing on different approaches such as collaborating with customers on an individual basis or creating a uniform product that was user-customizable.

But companies have intensified their focus on mass customization over time, in response to evolving customer demands. A 2020 survey from Dassault Systèmes and CITE Research found that younger consumers, in particular, expect personalization of the products they purchase:

• Over 80% of respondents wanted their products to be personalized.
• These consumers are also willing to spend 25% more on such customized items.

What are the rewards and risks of mass customization?

Companies can benefit from increased personalization, as custom products may increase sales, boost brand awareness, and engender customer loyalty. Personalized products – such as shoes tailored to 3-D scans of a person’s feet and vehicles with numerous possible configuration options for wheels, trim, and color – can become important competitive differentiators.

However, delivering these types of made-to-order items at scale is a growing challenge for manufacturers. They need the shortest path possible from the design and assembly of each bill of material (BOM) to releasing the configured product to market.

SolidWorks found that three-fourths of companies felt that customization had at least somewhat increased from 2014 to 2019, and even more expected it to do so from 2019 to 2024. With this rising demand, several hurdles emerge:

• Controlling costs and waste: Mass customization means more SKUs going out the door, which translates to more patterns, configurations, and colors, etc. that can be entered and produced incorrectly. This can lead to additional runs and the money and waste they entail. A unified source of truth for this custom product data may also be missing.
• Meeting customer expectations: The bar is high for customized products. Customers expect their apparel and shoes to fit perfectly, their car to look exactly as they imagined, and the customizations they made to actually be available. A manufacturer should be able to ensure a product is configurable and customer-aligned before producing samples.
• Ensuring system performance: Product lifecycle management (PLM) systems can struggle with the scope and complexity of mass customization. Building a data architecture for millions of configurations can exceed traditional PLM capabilities. Configurator tools can introduce additional issues like incorrect entities in the database.

How PLM solutions must evolve

All isn’t lost for PLM, though. The right modifications and changes in strategy – namely, integrating configuration lifecycle management (CLM) tools and migrating an on-prem PLM implementation to the cloud – can deliver the flexibility necessary to pursue mass customization.

CLM + PLM = CPQ

Integrating CLM with PLM delivers a single source of truth for all custom product data. This combination lets sales teams, for instance, see every functional option for a product (without having to consult an engineer first) and configure, price, and quote (CPQ) it directly for the customer. This setup is also fully scalable as custom product lines expand with new options. Everyone wins: data is easier to access internally within a company, plus more presentable to customers in the form of accurate and detailed customization options.

Cloud PLM

By shifting PLM activities into the cloud, manufacturers can access the latest features of a cloud-based PLM solution while scaling their overall operations. Cloud PLM can enable critical workflows like multi-site BOM management and simplified engineering change orders for made-to-order items.  The cloud provider also takes on tasks like updates and patches, freeing the customer to focus more on its mass customization strategy.

Inspirage is an experienced, expert Oracle partner with a track record of success in PLM implementations. Connect with our team to learn more about how we guide your next project supporting mass customization.

Product lifecycle management (PLM) is at a pivotal juncture. As numerous relatively new digital technologies are gaining popularity, more companies are looking to harness the power of cloud computing, artificial intelligence (AI) and machine learning (ML) to enhance their PLM strategies.

Over the years, these PLM practices and supporting systems have evolved significantly, to the point that they are now integral parts of the business models of many organizations – not just manufacturers. Worth slightly more than $18 billion in 2018, the global PLM solution market is expected to top $26 billion by 2023, according to Quadrant Knowledge Solutions.

This expansion means that new trends and challenges in PLM have wide-reaching implications. Let’s look at some of the major ones to keep an eye on in the 2020s.

1. Digital twins and digital threads turbocharge the product lifecycle

Digital twins are virtual representations of physical systems and processes, displaying all of the attributes and workflows associated with them. Each digital twin provides an easily graspable model of something tangible, which can help in not only understanding how it works currently but how it might evolve over time as well.

Similar to digital twins, digital thread are virtual representations, but in this case of a communication flow related to a digital twin. Digital threads offer traceability of a digital twin back to its specifications. They link together different product, performance and supply chain data, to provide a straightforward yet comprehensive model of a real-world product’s lifecycle.

2. Investment in PLM cloud solutions continues to ramp up

Many companies have opted to move on from their on-premises PLM solutions in favor of cloud-based services. According to the 2021 CIMdata PLM Foresight Poll, all respondents had increased their cloud investments in the wake of the COVID-19 pandemic.

PLM cloud solutions offer distinct advantages over traditional PLM systems:

• Relatively low total cost of ownership.
• Flexibility, with numerous possible integrations.
• Regularly scheduled software updates.
• Superior resource scalability (scale up or down as needed).
• Simplified software licensing.
• Accelerated deployment and modification.
• Out-of-the-box functionality.

The move to cloud-based PLM has coincided with the shift to cloud software across other core business operations, including in enterprise resource planning and customer experience (ERP and CX, respectively).

3. Aging infrastructure highlights the need for fresh investment

A big part of PLM is recognizing when certain products and services are in decline and thus in need of replacement. The winter weather that caused major problems for the Texas state electricity grid is a case in point.

Although there were attempts to pin the widespread outages in Texas on the perceived unreliability of renewable energy sources like wind and solar, the reality was that aging fossil fuel infrastructure was at fault. Natural gas pipelines that had not been winterized froze in the unseasonably cold temperatures, choking off a vital source of fuel.

The ransomware attack on a major refined oil pipeline, Colonial Pipeline, illustrated another liability in critical infrastructure, namely, its vulnerability to cyberattacks. Modernization via expert PLM will be essential in thinking about the way forward.

In 2021, the mean age of a power transformer in the U.S. was 25 years, while transmission lines averaged 30 years, according to The American Prospect. Hundreds of billions of dollars in upgrades will be needed to ensure sustainable infrastructure in the years to come. PLM platforms will ensure detailed planning and proper execution for new additions to the grid.

Inspirage is an experienced Oracle partner with expertise across PLM, ERP, supply chain and more. As your organization thinks about the next steps on its PLM journey, our expert team is here to help. Contact us to learn more about how we can implement the right Oracle solutions for your business requirements.

Are you considering a move to Oracle Cloud PLM?

As with any technology migration or implementation, one of your first considerations is data and how you will preserve and move it to a new platform. The same holds true for a migration to a next-generation PLM tool. Moving from one Enterprise PLM platform to another doesn’t require bringing all item and/or change data (i.e., obsolete parts) over nor should it mean losing access to historical product data necessary for audit and data preservation requirements. The balance comes with optimizing and enriching the legacy data carried over to the new platform, while providing access to data not being migrated.

Accelerate your migration with Inspirage’s Agile PLM Archive Utility

The Inspirage Agile PLM Archive Utility does just this with a highly intuitive user interface that’s similarity to Oracle Agile PLM will make it familiar to users. Its easy to navigate user interface allows for minimal training or other non-value-added activities. While addressing concerns around data transfer and archiving, the tool offers the added benefit of eliminating the need to keep and maintain on-premise infrastructure and maintenance expenses for the Agile PLM Platform (i.e., App Server and Database). These time and money saving features make the Agility Archive Utility application one that you will want to leverage for your cloud migration. One of our customers, a leading provider of innovative technology and services for utilities and cities, leveraged Agile PLM Archive Utility for a faster migration to the cloud. They continue to use the tool to save investment in the ongoing management of their Agile PLM infrastructure and have chosen to disable Agile for their end-users.

Prepare for your migration to a next-generation PLM platform

It is important to note that often obsolete data is mistakenly moved to new systems resulting in inaccurate and flawed results. So too, excess data can impair your PLM platforms performance, impacting usability, reporting and decision making. If your technology roadmap includes migrating to a next-generation PLM platform, Agile PLM Archive Utility lets you expedite implementation timelines, reduce activities and costs and improve systems performance. By preserving and archiving non-essential product data, Inspirage’s powerful Agile PLM Archive Utility helps you establish the criteria for the data being migrated to your new PLM platform while saving your company money on infrastructure and maintenance. To learn more download our data sheet or contact our team to learn more.

The cloud keeps the wheels of innovation moving. Inspirage can help your business decide on the correct cloud migration strategy to fit your specific business needs and keep your company innovating. Companies need a partner who understands their goals and will help you leverage the agility and capabilities necessary to be leaders in today’s changing economy.

Our client, a leading bottled water company, understood the importance and advantage of moving their systems to the cloud and identified the transition to cloud-based applications to be the core of their IT strategy. The client appreciated the integrated business processes, data model and user interface capabilities provided by the Oracle Cloud suite. Taking a phased approach in their cloud journey, our client chose to implement Cloud PLM first with future cloud migrations determined by the success of this project. At the start, our client had concerns about their current process, solution and user complexities. One such example was the large number of workflows that needed to be addressed in the solution design. To help resolve this challenge, and to add both simplicity and flexibility, the Inspirage Approval Matrix was implemented, which improved system user engagement, solution maintenance and scalability.

Generally on-premise systems have complexities that are distinctive to their business operations. This client was no different; their on-premise PLM solution had some unique complexities in use that made the migration complex, including change management of manufacturing operations. Their users, like many other corporations, were in different geographies that utilized different products and product manufacturing capabilities which was driving different participation in the Product Launch and Change Management process. Oracle PLM Cloud equipped our customer with the tools they needed to ensure that they modeled this varying participation in the process, ‘localization,’ while continuing to seek process standardization, ‘globalization.’

By implementing the Inspirage Approval Matrix along with Oracle PLM Cloud, our client was able to realize significant improvement in this area while establishing a framework for ongoing processes. They are now seeing enhanced collaboration and process automation leading to faster new product launches, enhanced visibility to product and artwork changes, reduced user complexity on change routings and approvals, and improved change cycle times.

Our client, a leading bottled water company, identified the transition to cloud-based applications to be the core of their IT strategy.
 

As in any integration, it was important that the Inspirage team considered the balance between global process standardization and localized business needs when executing this cloud migration. Inspirage’s industry and PLM experience allowed us to arm our client with improved practices coupled with Inspirage IP that improved the user experience and reduced the solution complexity and maintenance. Additionally, we leveraged our proprietary PLM Cloud Methodology and IP to enable a smooth transition from on-premise to the cloud. This included data extraction, transformation and migration, as well as solution configuration propagation from non-production to production environments.

Because there were additional process and solution complexities that factored into this migration, Inspirage’s industry and product expertise was vital for the success of this project. The Oracle Cloud Suite shares item master and product data with other modules and integrated business processes. As a result, the implementation of one (i.e. PLM) can influence others (i.e. ERP). Embracing the advantages of cloud products while understanding the intricacies of these relationships was key to forging a foundation suitable for expansion, evolution, and business process harmonization.

Our client is realizing the benefits of PLM as they have shifted their focus and time from customizing the solution to meet their business objectives to optimizing the business processes built into their cloud technology. They are now positioned for growth and expansion by realizing a streamlined automation process which has resulted in expedited production of new goods, clear line of sight to product and design changes, simplification to the approvals and change routings processes and enhanced processing times.

The medical device manufacturing industry is currently facing a period of regulatory reform unlike anything it’s seen before. The European Union is ground zero for the development of new regulations dictating how data produced and stored by medical devices is managed, preserved and disseminated, among other responsibilities.

At the center of this sea change is the EU’s Medical Device Regulation, which went into effect on May 25, 2017. The set of rules and guidelines established a three-year grace period for medical device regulations to make any necessary changes in order to comply with these new data standards. Even with an extension pushing the deadline to May 26, 2021 due to COVID-19, time is quickly running out to bring products and systems in line with MDR. Follow these steps to be adequately prepared once that window closes:

Conduct an internal review (if you haven’t already)

Hopefully at this stage in the game, your organization has already run a comprehensive audit to identify compliance gaps and determine what changes need to be made. If not, don’t worry, you still have some time to get things underway.

An important point to consider is that there is no grandfather clause built into MDR. It applies to both new and legacy products. However, devices lawfully placed on the market pursuant to MDD/AIMDD prior to May 26, 2021 may continue to be made available on the market until May 27, 2025.

Other areas to focus on include creating and preserving accurate documentation for every device, verifying clinical evidence and updating product labels. Medical device manufacturers may find that the costs to comply with these stricter requirements for older devices may not be worth the amount of revenue such devices are expected to generate. In those cases, their analysis may reveal that the better course of action is to retire those legacy medical devices and focus their energy on developing more sophisticated product lines that comply with MDR.

Make internal product data systems compatible with EUDAMED

One of the core requirements facing medical device manufacturers that hope to continue doing business in European markets is submitting a wide variety of device data to the European Database on Medical Devices (EUDAMED). That information includes unique device identification numbers, product data and clinical evidence data. The EUDAMED will function as a centralized repository of information from which various entities, such as Notified Bodies, regulators, healthcare companies and consumers can all access and view medical device data.

Medical device manufacturers will need to update or replace their product data management platforms so they are compatible with EUDAMED’s data standards. At the same time, companies need to be mindful about similar regulations taking shape in other international markets. If they hope to continue selling their wares in those regions as well as the EU, medical device manufacturers need to implement a product data management solution that is both flexible and scalable and can facilitate operations in various markets.

Work with an experienced implementation partner for MDR preparation

Depending on the current state of their existing product management systems, manufacturers could have their work cut for them. Ripping and replacing an entire platform is a major undertaking — although a wholly necessary one, given the stakes at play.

Company leaders shouldn’t feel as if they need to take on such an extensive and complex project on their own. Working with an experienced implementation partner that has successfully carried out numerous similar projects in the past will help clear any obstacles and potential disruptions.

Even though the MDR deadline has been pushed back to 2021, why not get a jumpstart and partner with an organization like Inspirage to streamline and accelerate implementation. Our experience and expertise can deliver guaranteed results in a short project window.

Inspirage’s Product Lifecycle Management solutions expand upon the core functionality of leading product management platforms like Oracle PLM Cloud. While those software suites are typically industry-agnostic, Inspirage’s implementations can be tailored to the specific requirements of medical device manufacturing, giving you a PLM solution that comprehensively addresses your regulatory demands.

MDR’s deadline is still right around the corner, so don’t wait longer to bring your systems into compliance. Contact Inspirage today for more information and assistance.

Walking into a supermarket, bodega or even gas station convenience store in 2020 is a very different experience than it was just a decade ago. Products that were once somewhat obscure, such as plant-based proteins and milks, are now mainstream. Overall, there’s just a much wider range of foods, beverages, vitamins and supplements available to the public.

For manufacturers of these packaged goods, this long-term expansion in product variety has been accompanied by a similar uptick in regulations and compliance requirements from bodies such as the FDA in the U.S. Everything from proper labeling of organic, gluten-free and non-GMO ingredients, to accurate listings of the any allergens present, is now a central challenge for companies in this space.

Consumers have also become much more sophisticated in their tastes and need access to relevant information. They want to know about each product’s nutrition, allergen content and sourcing, and accordingly the Nutrition Facts Label — which the FDA has revised in recent years to provide additional information — is more important than ever, as are regulations like Proposition 65 in California.

However, the industry’s recipe management processes are, in many cases, not up to all of these new operational and regulatory challenges . Deep, continuous and holistic product management throughout their supply chains is essential, but many recipe management paradigms don’t provide such capabilities.

 

What are some of the big challenges in recipe management?

Traditional recipe management has numerous pain points that complicate compliance and consistency:

• Products have to be labeled in compliance with ever-evolving FDA rules (e.g., for the Fact Panel) and other complex regulations like Proposition 65, which is enforced by California’s Office of Environmental Health Hazard Assessment.
• The stakes are high for accurate certifications and allergen listings, such as USDA Organic, vegan, gluten-free, dairy-free, paraben-free, and more.
• Inventory can easily become outdated and inaccurate, making it more difficult to fulfill orders and keep needed items in stock — not to mention ensure up-to-date FDA compliance.
• Important product-related data is siloed in such a way that it’s difficult to get a holistic view of the supply chain at any specific point in time or ensure proper formulation. This also increases risks around data accuracy for regulatory and public safety purposes.
• Making changes at scale is tough. Accordingly, manufacturers can struggle to make sure that all of their products across their entire supply chain are compliant.
• The issue of compliance is compounded by the fact that different laws apply in different jurisdictions. For example, an ingredient acceptable in the U.S. might be banned in the European Union. Likewise, Norway, for instance, regulates many more allergens than the U.S., and so manufacturers have to ensure that they’re addressing these divergent regulatory requirements.
• As product definitions evolve (e.g., with new information about nutrients, vitamins, etc.), old and highly manual processes are ill-suited to implementing updates at scale. The 2016 revisions to the FDA Facts Label is a good case in point for how regulators frequently change their requirements.
• Cybersecurity is also an issue in an old-fashioned recipe management paradigm, as the disparate and aging systems in use can leak information or be mismanaged.
• On that note, managing recipe information in spreadsheets or with predominantly on-prem solutions raises the risk of human error, which can trigger delays and noncompliance.

That sounds like a lot of bad news, but it doesn’t have to be read that way. Modern recipe management solutions open up new possibilities for much more efficient management, translating into easier compliance and more streamlined product evolution as regulations change.

 

How Inspirage Recipe Management makes life easier

Many critical systems of record and business applications have been moved into the cloud in recent years, and recipe management solutions are no exception. In fact, the Inspirage Recipe Management Solution is built on top of the Oracle PLM cloud, with key capabilities for helping manufacturers gather as much data as possible and ensure that that information is always up-to-date. Specific features include:

Automatic calculations

Ingredient definitions and quantities can be easily created and then processed via automatic calculations, which ensure they’re accurate and up-to-date. That helps greatly with overall product compliance and safety.

Change management

What would happen to your product line if you changed the amount of a single ingredient, like a sweetener or preservative? A recipe management solution removes the guesswork that once accompanied such change, instead providing a holistic view of how the portfolio would be affected.

Supply chain visibility

Gaining greater control over your recipes requires knowing what’s going on throughout your supply chain. What regulatory obligations do you currently need to meet? Do you have the right suppliers and partnerships to get compliant ingredients on the timetable you need? Inspirage Recipe Management makes it simpler to answer these questions.

To learn more, check out this product data sheet, or contact our expert team for support.

If you’ve read virtually any marketing collateral about moving to the cloud, you might get the impression that it was as simple as flipping a switch that converts all of your capital expenditures (CAPEX) into more manageable operating expenditures (OPEX), making business-critical IT resources available on-demand.

It’s true that transitioning your supply chain management, logistics and enterprise resource planning operations to the cloud can provide a major upgrade in convenience, but the process can take time. Plus, planning is essential: As we’ve documented in our piece on famous ERP disasters, a lot can go wrong when a pivotal system is upgraded or modified.

With cloud deployments becoming more complex thanks to the rise of hybrid and multi-cloud environments, the stakes are being raised for acing the cloud transition. In this guide, we’ll look at some of the biggest pain points when shifting to the cloud and how you can address them with a combination of the right technologies and processes.

A step-by-step process for taking on the biggest challenges in cloud migration

Most companies already have some presence in the cloud. According to RightScale, the average enterprise uses almost five public and/or private clouds, and 86% of them have a multi-cloud strategy.

Working backward from these numbers, we can already identify one fundamental challenge, namely dealing with the complexity of selecting, setting up and running the right cloud services – among a huge range of options – for your particular requirements. Other major challenges include ensuring adequate security and keeping costs under control after switching from CAPEX to OPEX.

Fortunately, there’s a reliable phased process for identifying navigating these obstacles.

1. Application selection, baselining and roadmapping

Some applications are better suited to the cloud than others. Plus, it’s likely that you won’t be moving everything into the cloud (at least not at once), but instead targeting a select few platforms, such as a transportation management solution.

Usually, the easiest applications are the best candidates to migrate first, although circumstances vary and sometimes a more complex asset such as an ERP system will be your priority. According to a 2017 IDC survey, the top criteria for moving apps to the cloud were security and regulatory compliance (65% of respondents), infrastructure scalability and flexibility (57%) and app performance (56%). With that in mind, some questions to answer at this early stage include:

• How much would it cost to move the app in question?
• What security measures will be in place once the app is migrated?
• What are the app’s current availability and performance levels?
• What other services and programs does it need to be integrated with?
• Which cloud deployment model – public, private or hybrid – is best suited to it?
• Which cloud provider offers the services to meet my requirements?

Sometimes, there’s low-hanging fruit to pick when planning your migration, such as legacy IT infrastructure that was going to be retired or replaced soon anyway and as such is a natural candidate for a cloud upgrade. In other cases, the project will be more complex and require the expertise of an experienced integrator like Inspirage, which can help with projects such as implementing Oracle applications for supply chain management.

2. Migration, KPI verification and acceptance testing

When you move to the cloud, you expect results in the form of demonstrable ROI and improvement across specific key performance indicators (KPIs). Software such as dashboards and data analytics tools can help you track your progress and see what is and isn’t working so that you can continuously improve your implementation.

Whereas the initial migration stage involves paying a lot of attention to application security requirements and performance characteristics, this one entails taking the more concrete steps of actually migrating your apps and evaluating their performance via KPIs. Doing so provides the opportunity to:

• Flag issues with the migration, such as security loopholes or issues with moving databases.
• Compare pre- and post-migration metrics such as transaction time and CPU utilization.
• Performance acceptance testing to determine if all business requirements are being met.

Taking these steps ensures that your migration is on track. An integrator can provide vital guidance along the way, both in helping you select and use the right technical tools and perform any necessary course corrections.

3. Ongoing monitoring and optimization

One of the most appealing aspects of the cloud is being able to worry less about IT infrastructure upkeep, since the cloud service provider (and/or) managed/hosted services provider) takes care of that. However, that doesn’t mean that the cloud deployment should be left completely alone after it’s set up.

You’ll want to continuously monitor it and possibly consult with your partners on how to optimize it for cost and performance. As experts in integrated supply chains and the digital technologies that support them – including cloud tools from vendors like Oracle – Inspirage can help you at this stage and throughout the entire migration process. As Gartner states in their 2019 Critical Capabilities for Oracle Cloud Applications Services, Worldwide: “[Inspirage’s] In2Cloud offering provides an end-to-end solution focused on accelerating Oracle Cloud adoption and focuses efforts and IP to make implementations faster, minimize risk and lower integration costs.”
 
Learn more by visiting our Resource Center or contacting our team directly.

By building a cloud ERP, you can put your organization on the track toward a superior supply chain as well as digital operations that address the Internet of Things, blockchain technology and more. But while the “why” of cloud transformation is obvious, the “how” is less clear. ERP transitions almost inevitably feel overwhelming. Accordingly, it pays to have specific tools in mind before you make the leap.

In this blog, we will examine five transformation ERP solutions from Oracle that will streamline your cloud journey.

1. Design-to-Deploy

This solution helps you maintain a consistent product pipeline. It supports initial product planning, along with the subsequent development and commercialization, thanks to streamlined management of your marketing, sales and manufacturing data. At Inspirage, we leverage our expertise in the PLM Cloud to deliver the best results at the design-to-deploy stage.

2. Plan-to-Produce

Seeking a way to reduce overhead in manufacturing? Look no further. Plan-to-produce helps balance supply and demand and provides insight into your entire supply chain. You can also more easily define your processes and produce the corresponding work orders. Analytics on everything from accounting to customer responsiveness help you make informed decisions about your operations.

3. Order-to-Cash

Order-to-cash is a complex process requiring a comprehensive solution. Oracle Order-to-Cash rises to the challenge with tools for managing all of the key inflection points, including:

• Order change management
• Global supply view
• Pricing and tax information
• Order backlogs
• Fulfillment orchestration

4. Record-to-Report

How is your business performing at any given moment? With record-to-report functionality in your ERP, you can remove any uncertainty around your company’s performance in meeting customer expectations and working with key suppliers. Record-to-report ensures readily available feedback, not only on corporate financials but also on other operations and how they are (or aren’t) aligning with your strategic vision.

5. Procure-to-Pay

Within a procurement cloud, procure-to-pay (P2P) offers a way to automate the source-to-settle process. You can navigate all steps from initial identification of sourcing events, through negotiation and invoicing and finally to payment for any goods received. P2P is also your go-to resource for supplier qualification management and indirect spend management.

As integrated supply chain and Oracle experts, the Inspirage team can help you turn your cloud ERP vision into a reality through these five solutions and others. Learn more by visiting our Resource Center or contacting our team.

Whether your organization uses on-premise, Cloud or hybrid PLM, ERP and/or other enterprise software solutions, not fully integrating your product data from design and development through manufacturing and service is costing you (whether it’s through product inventory, stockouts, customer satisfaction, premium transportation and/or many other issues.) Moreover, your business is continually changing via mergers and acquisitions, new projects and products, new customers and more. You need an automated, error-proof and seamless way to integrate your product record among the systems you use and to be adaptive to tomorrow’s needs. You need to be able to facilitate the accurate flow of information across your enterprise and focus on new product design, launch and manufacturing; while establishing the foundation for adoption of emerging technologies, like IoT, Digital Twin and more.

A Next Generation Integration of PLM to Business Execution Systems will provide flexibility, scalability, and real-time status/reporting on enterprise business transactions

The challenge is that too many companies using Oracle PLM either have sub-optimal integrations between PLM and downstream systems or no integration at all. Those that do, lack the flexibility and scalability to easily modify the integration based on evolving business needs. Oftentimes, in addition to flexibility, the ease of use, maintainability and integration dashboarding/status are significantly lacking. Clients need to readily understand that the integration is functioning as desired in order to react to, fix, and predict errors or jobs not prioritized appropriately.

 
The Inspirage iHub solution is architected for both Cloud and on-premises PLM applications and readily enables seamless integration to multiple downstream systems, such as ERP, MES, CRM, etc. In addition to seamless business and data integration, Inspirage’s iHub solution includes the iHub Integration Portal, where the client can see a complete data audit trail with current and historical transactions, including enhanced transaction and error monitoring and other key automations. This is key as the necessity of the product data being both accurate and shared in real-time is vital. Incorrect or unavailable data can lead to lost of revenue and increased costs.

Use Inspirage’s iHub platform to automate and optimize the management of your PLM integration(s) with intelligent transactions and reporting, on a platform that can evolve with your business needs.

Top 3 Reasons for the Inspirage iHub Solution:

1. Increased data availability and accuracy, with optimized and intelligent flow between systems, PLM and other. 
   Eliminate manual or redundant data entry and reduce data errors with validations, error handling, transaction prioritization, monitoring and more.
2. Return on Integration Investment in six months to a year. 
   Let iHub not only propagate data to your downstream systems, but provide intelligence and validations across the processes, markedly reducing manual involvement.
3. Flexible and scalable to evolve with your business.
   Unlike most PLM integrations, which are ‘black box’ or hard coded, the Inspirage iHub solution is flexible, adaptive and scalable to other enterprise integration needs.

Ready to learn more?

iHub for PLM: Cloud Product Hub to On-Premise EBS

Update on our PLM / EDM Services

In recent years, many organizations have felt growing pressure to accelerate their product lifecycles and bring finished assets to market on or ahead of schedule. The lifecycles of everything from bikes to smartphones have gotten shorter over the years.

The shift is perhaps most obvious in IT equipment, which is often refreshed every three to five years (or sooner) despite having a longer theoretical useful life, according to research from both Forrester and Gartner. Growth in cloud computing has been both a cause and an effect of the overall change: Companies are streamlining their costs and operations by transitioning from on-prem infrastructures to cloud-based services, which in turn allow them to more quickly innovate, develop and commercialize their product lines

However, there are still significant challenges in front of any firm looking to step up the pace of its product-related processes. According to an Oracle ebook, “Three Tenets of Modern Product Lifecycle Management Cloud,” almost two-thirds of companies are ineffective at transforming ideas into products, while half of all development and commercialization resources are wasted.

R13 PLM: What you need to know

Enter the Oracle Product Lifecycle Management Cloud (PLM). This platform supports data-driven product value chains, with numerous features for capturing ideas, controlling the product record and enforcing governance policies. The recent release of R13 PLM introduces some important new capabilities. Let’s look at a few of them.

Easier navigation and management  of the latest versions of Items

In R13 PLM, it is simple and fast to navigate between Projects and Proposals and see all changes therein. Real-time access to both workflows contributes to better collaboration between product owners, since everyone can discern how processes are measuring up against key performance metrics. Both Proposals and Concepts also now support versioning. This feature permits comparison of their risk levels and probabilities of aligning with stated business goals.

An overhauled user interface

The user interface (UI) of a business application is a crucial factor in how productive workers can be while using software. A modern, intuitive UI was a big driver of PLM’s adoption in the first place, since it enabled easy quality checks and data governance, not to mention straightforward identification and remediation of any problems. R13 PLM includes further enhancements, such as optimizations for access to Change Orders, Manufacturer Part Numbers and other tasks, along with management of attachments for Items and Documents.

Updates to Product Hub

There are some notable changes to Product Hub (PH) in R13 PLM, including the removal of products still at the design stage from PH, to lessen confusion in downstream systems. Another new feature is a security upgrade, allowing intellectual property to be secured at the trading partner level or for individual items.

What’s next? Thinking about deployment options

R13 PLM brings a lot to the table. To capitalize on its potential, it’s important to work with a business partner with deep expertise and experience in end-to-end Oracle solutions, as well as ERP and supply chain management (SCM). Contact Inspirage today to learn more about your options for deployment of R13 PLM!

The Product Lifecycle Management (PLM) / Enterprise Data Management (EDM) practice continues to add value and drive customer success, below we have  outlined some key accomplishments, investments, solutions / IP, clients and projects.

First, we continue to invest heavily in PVC Cloud, and now have multiple Live Clients. In addition, we have 13+ Active Projects where there is at least (1) PVC Cloud module in scope. The emerging importance of Enterprise Data Management and Data Quality in enterprise transformative projects also continues to help us align services in Cloud projects, including PVC, ERP and SCM. Our Enterprise Data Readiness Assessment (EDRA) helps clients identify and appreciate the importance of data readiness upfront by enriching data quality and through data normalization and harmonization.

Customer Example – End-to-End Ideation through Commercialization

Our customer, a leading European grocer, is a great example of a fully Oracle Cloud-based solution spanning Innovation Management, Product Development, Product Hub, Product Hub Portal, Project Management, Task Management and Supplier Portal, in the CPG / Retail space.

IM and PPM are now live, with PD and PDH planned for a March 2018 go live. The overall Project/Architecture is below:

• The company sought to replace disparate bespoke systems with a single modern platform to drive growth and eliminate information latency and errors.
• All future Private Label information and processes will be controlled in a single secure location in the Oracle Cloud. Inspirage Consulting PLM for Private Label expertise was crucial to close this deal.

Inspirage Cloud-based Solutions & Intellectual Property

We also have multiple investments in Cloud-based solutions which we are implementing and demonstrating. We are currently implementing GDSN on the Agile PLM and Cloud PDH platforms (with publishing to OneWorldSync) and have multiple enhancements and extensions, ongoing in late November.

We have pre-built integrations between Agile PLM and Cloud Product Hub, and from CPH to Oracle EBS. Additionally, we are working on the second Release of our ‘Compliance on the Cloud Solution’ which will add Roll Up functionality to Release One.

A Snapshot of our Solutions & IP built for PVC Cloud are below:

On-Premise and Saas-based Integrations to Agile PLM and Oracle EBS

Inspirage iHub for Agile to Cloud and Cloud to ERP integrations can be used with our Integration Portal for transaction management and error handling.

iHub

iHub is an omnidirectional application integration platform with complete audit trails that is easy to install, use and modify. iHub can support one to many integrations on the same platform and it doesn’t require a developer to manage. Pre-built iHub integrations support integrating applications quickly both on-premise and in the Cloud. iHub can also be installed on-premise or in the Cloud.

Another key benefit of the Inspirage iHub solution is the Integration Portal, which is a very user friendly means of monitoring the flow of data between systems, error handling and more.

The iHub Integration Portal manages the transactions between various systems, such as PLM and ERP, as well as provides an interface to track and administer the transactions. The Integration Portal dashboard can be embedded in other web-based UIs for ease of administration.

The iHub integration designs are flexible to not require modifications to the source and target systems for data flows to occur; however, some source and target systems are not flexible enough to support the business needs. In these cases, custom code and/or configurations may be deployed to the source or target system to support the integration.

Please contact us for additional information and demonstration requests, and look for pre-recorded videos in the coming days on Agile to Cloud, Cloud to ERP and the Integration Portal.

Agile PLM

We continue to help clients achieve success on the Agile PLM platform as well, and have several worth mentioning below:

• Agile PQM & PGC, with integrations to EBS, MES and their chosen Content Provider
• Agile PC, globally across NA & Asia, with integration to EBS
• “Merge” of global Agile PLM system with Agile PLM system (which includes Inspirage’s UDI and GDSN solutions)
• Global PLM Roadmap/Architecture, and soon-to-start Agile PGC, with integration to their chosen Content Provider

What good is the data you’re collecting throughout your supply chain if you can’t utilize it effectively? It’s a question that continues to plague companies from every industry – and it’s why organizations turn to experts for help with analyzing their historical data.

A successful product development teams uses data from across the enterprise to inform decision-making and improve response times to challenges. However, it’s not enough to simply collect the information and store it on company servers; organizations need to drill down into this data to identify trends and make effective decisions.

Predictive analytics is the name of the game in supply chain data.

 

How do companies use supply chain data?

There are several important uses for the steadily increasing amount of information that companies collect on a daily basis. Here are only some of the ways organizations are utilizing data to improve their operations:

• Enhance transparency: When you can see all of the data throughout the organization, you have greater transparency into your operations – which means that outside actors (like the government or other regulatory bodies) will be able to gauge your level of compliance. This is especially important for organizations within the high tech and medical device industries.
• Reduce risk: Effective risk management is possible through data analysis, as well, according to Computerworld. By analyzing historical information, organizations can assess the likelihood of a problem and its potential impact. Historical analysis, risk mapping and scenario planning are all made possible by data analytics.
• Increase visibility: Supply Chain Dive contributor Edwin Lopez noted that logistics visibility is one of the main use cases for utilizing supply chain data to derive value within operations. Being able to pinpoint problems and to address issues immediately, before they become full-fledged crises, is integral.

Predict to stay ahead

The name of the game is predictive analytics – by using existing information about customer preferences, logistics challenges and supplier pitfalls, organizations can effectively predict what the business landscape looks like at any given moment.

“[Another use of data] is getting some better form of demand and supply synchronization,” supply chain data expert Adam Mussomeli told Lopez. “There is a pretty long history of people building things in the hopes that it’s what the market wants, but it turns out the market does not.”

To this end, product data can help executives know when to adjust product design to meet demand. This is a better alternative than the build-it-and-hope method that Mussomeli alluded to.

When it comes to analyzing your operation’s data and making sure you’re pulling out all the right insights so you can make the best design decisions, it starts with storing the data properly so when you retrieve it for analysis, you have access to the proper channels.

Inspirage can help your company maintain an historical archive so you can manage this access and facilitate better decision-making. Get in touch with the supply chain data experts at Inspirage today for more information about how we can help you make the most of your enterprise information.

Product developers need to have the right data in front of them in order to make the most effective decisions regarding the creation of new products. A host of important activities depends on the accessibility of this key information; therefore, it’s necessary to have access to flexible reporting to facilitate the decision-making process.

No. 1 goal: Transparency and traceability

For product developers to have access to this kind of data, transparency remains the most important aspect of product innovation. Developers need to be able to dive down into the inner workings of their complete supply chain – looking at the data of partners from every part of their operations, including suppliers, logistics providers and end customers – not just for their own purposes, but also in order to be able to answer customer questions, according to SupplyChain247.

“A lack of ability to provide [important] information in the face of safety or environmental violations can create a negative perception of the brand that may require immediate remediation and could take a brand years to recover from, if at all,” said Mike Burnette, director of the Global Supply Chain Institute and a co-author of the study, Creating a Transparent Supply Chain.

Flexible reporting tools facilitate information access throughout the enterprise.

 

Information access depends on information sharing

In a recent study, researchers at the National University of Malaysia (Zahra Lotfi, Muriati Mukhtar, Shahnorbanun Sahran and Ali Taei Zadeh) stressed that organizations have four main questions to answer in order to improve information sharing activities:

1. What information should you share?
2. Who should you share it with?
3. How do you share this information?
4. When should the data be shared?

The answers to these questions will help organizations avoid redundancy, reduce sharing costs and improve responses, thereby improving information sharing operations and helping to facilitate transparency in the long run. For instance, the manufacturing industry has an especially important relationship with data, as it’s so closely tied to economic development, according to the researchers.

“To survive in today’s global economy, manufacturers need to definitely rethink their approach to cooperation and hence should provide ways to share up-to-date information within the enterprises,” wrote Lotfi et al. “However, providing the software and hardware alone is not sufficient. The members should have the willingness to participate in information sharing activities. Nowadays, enterprises do not operate alone; they have now been networked to many other partners.”

Essentially, the point that Lofti et al. are trying to make is that because of the important connection between the manufacturing sector and the global economy, manufacturers need to ensure their methods of sharing information between partners depends on not only the software involved – like enterprise resource planning tools – but also on human interaction and the willingness to build relationships.

Optimize information access

Flexible reporting tools facilitate the access to important information that product developers need for effective decision-making on a daily basis. This is why your organization needs fast, efficient reporting tools like the Inspirage Agile PLM Report Framework. Having the right data on hand is a critical part of making the best decisions possible.

Get in touch with the experts at Inspirage today for more information.

 
It’s clear that the supply chains of today have to be more agile and efficient in order to effectively manage demand and industry trends. To help with that, some are turning to technology and analytics tools. The resulting integration of organizational partners is a product innovation platform that allows enterprises to make better products that conform to the demands of their consumers.

The need to be more efficient and adapt more quickly to changing regulatory environments and consumer desires necessitates a revision of current product innovation strategies. Companies that choose to implement product innovation platforms – which allow large companies to shift supply chain boundaries and derive design input from their suppliers themselves – can create better products faster, therefore taking advantage of everything their supply chains have to offer.

Let’s take a look at how creating new strategies for product innovation is critical:

1. Companies in different industries finding inspiration in one another

Just because two separate industries have next to nothing to do with each other doesn’t mean that they can’t learn by watching each other function. For instance, consumers within the health care industry have begun to research their options more, which is more than likely a lesson learned from their dealings with retailers. In fact, PwC’s Health Research Institute found that 30 percent of American adults called different doctors and asked about pricing in 2015.

As consumers take the lessons learned from dealing with retailers to their interactions with health care providers, so too should those health care companies be taking a leaf out of the retail playbook. They need to innovate quickly and shift with changing consumer expectations – just like consumer product companies. It’s an example of how strategic, forward-thinking innovations can come about by looking at what different industries are doing, especially as challenges continue to exist across multiple industries.

Companies need to implement successful innovation models to keep up with shortening lifecycles.

2. The importance of consumer-led decision-making

Digital transformation is the name of the game for many industries now, and as companies seek to assess challenges relating to their supply chains, they’re turning to technology to help them more accurately and quickly meet the needs of their customer bases. However, according to Business2Community contributor Randall Beard, only around 25 percent of new product concepts address consumer desires – which means that 75 percent of them aren’t taking customer needs into account.

Consumers are becoming more knowledgeable and powerful when it comes to what they want out of the companies they interact with – so enterprises need to be aware of how their customers’ demands impact their operations, and make decisions accordingly.

“2017 will be a year of action for many companies, as they address the realities of a fast-moving customer-led and digital-centric market,” Cliff Condon, chief research and product officer at Forrester, explained in a recent report. “Empowered customers are forcing the hand of virtually every industry. And so the question for most companies and business leaders is not if they will respond to these market dynamics, but when and how. Inaction presents immediate revenue risk – or much worse – a threat to a company’s existence.”

3. Get products to market faster

In the fast-paced modern world, companies should not only make decisions based on what their customers need and pay attention to digital trends that would help them achieve their innovation goals, but they have to put products on the market in record time, as well.

Data Informed contributor David Kung noted that devising a successful innovation model – or product innovation platform – is a key step for companies that want to meet the time constraints of shortening product lifecycles.

“The ability to repeat a successful innovation model – the holy grail of new product development – confers upon enterprise organizations an important additional benefit: lasting competitive advantage,” Kung wrote.

However, more collaboration is necessary between departments within a business and also between supply chain partners. Integrating suppliers and manufacturers with product innovation strategies is clearly the first step.

For more information about product innovation and how to effectively manage lifecycles in order to get the most out of your supply chain – not to mention create products that your customers actually want and get them to market in time to meet that demand – please check out our webinar on the convergence of product lifecycle management and supply chain management below. Then, get in touch with the experts at Inspirage today.

As the global marketplace continues to expand and become more complicated, enterprises in every industry are finding that collecting the most data possible is a critical part of maintaining complex operations. The more information that enterprises have available, the better decisions they’ll be able to make in order to improve processes and increase their viability.

The bottom line is that data is being used by enterprises to support their supply chain operations, and it’s becoming more important every day. By leveraging analytics and effective data management, organizations have the tools at their disposal to drive profits and operate more efficiently even as regulations evolve across the globe.

Big data and digital transformation

One of the biggest advantages of incorporating a data management solution into supply chain operations is that it provides key insights into the inner workings of the supply chain, giving organizations better information upon which to base important decisions. According to Diginomica contributor Phil Wainewright, by bringing more digital tools into the supply chain and using data analytics to derive important insights, logistics organizations can improve their business acumen and create better customer experiences.

“By being able to track items through the supply chain, enterprises can optimize stock levels and transport modes, improve risk management and collaborate more effectively with suppliers to manage costs,” Wainewright wrote.

Being able to more effectively manage costs will mean a better bottom line for organizations down the road.

Supply chain data can help organizations create a better customer experience.

Finding a use for all that data

Data is a crucial resource for organizations to conduct operations in a more efficient, effective manner, and there are different technologies that are being used to help enterprises support their data analytics efforts. For instance, Marine Transport International, Ltd., a U.K.-based freight forwarder, logs and monitors financial transactions and creates real-time digital ledgers of shipping data.

“Ultimately we are simply better enabling and repurposing the existing data flow to provide increased transparency and more efficient data flow within the existing data network which has major benefits for the global shipping industry,” Jody Cleworth, CEO of Toyota, told CIO Journal in an email, The Wall Street Journal reported.

In other words, the shipping industry uses data to enhance transparency and efficiency within its operations.

Data management is critical

As organizations collect more data and utilize it to improve visibility and transparency, it’s crucial for them to have an effective strategy of dealing with it all. Supply & Demand Chain Executive contributor Matt Leigh wrote that high-quality product data is one of the most critical aspects for the supply chain of today. At every step of the product cycle, having the right data is important for different functionalities. For instance, benefits like trailer efficiency, accurate bin sizing and better regulatory compliance can all be gained from effective data management.

To that end, the Enterprise Data Management solutions from Inspirage can make a difference in the effectiveness of your supply chain. For more information about how our EDM solutions can provide your organization with the insights necessary to drive better decision-making and improve operations, check out our Product MDM white paper below and contact the experts at Inspirage today.

One of the biggest challenges for supply chain managers in today’s ever-shrinking global marketplace is product lifecycle management. Every item has a shelf life; some things enjoy longer spans than others. Understanding all of the nuances associated with lifecycle management—lowering cost, creating higher quality products, getting them to market faster—and applying that knowledge to the supply chain is especially critical for products with shorter cycles, and PLM software is quickly becoming the best way to tackle this challenge.

Market data: Why cloud?

More enterprises are turning to cloud-based solutions to help them streamline lifecycle management and mitigate risks. In fact, the PLM marketplace continues to expand at an ever-accelerating rate. According to Transparency Market research, the total value of the global PLM software market is expected to grow at an 8.1 percent compound annual rate from $40.2 billion in 2014 to $75.8 billion in 2022.

TechTarget contributor Beth Stackpole noted that cloud-based PLM solutions may provide a ready answer to some of the challenges of on-premises deployments. PLM spans many different applications and departments, not to mention it requires integration with a wide range of applications. Therefore, a high level of business process transformation is necessary. Cloud-based tools simplify this transformation by facilitating collaboration between departments without requiring huge capital expenditures out of the gate.

Key vertical: Medical devices

The impressive growth of the PLM software market can be attributed to several factors, but none are more important to mention than the challenges faced by both the medical device manufacturing sector. In order to deal with increasingly shorter product lifecycles and integrate supply chain data from across a steadily growing supply chain landscape, operations managers in this specific industry are turning to cloud-based tools.

Medical device manufacturers offer a critical example of how PLM software can be used to improve operations. With the recently imposed traceability requirements for medical devices, manufacturers and distributors within this vertical need to be able to easily manage all the phases of a device’s lifecycle – including design, build, purchase, use and end of life.

All of this requires sufficient management of massive amounts of data. For instance, Medical Device and Diagnostic Industry noted that radio-frequency identification devices can help companies improve their PLM capabilities. RFID solutions generate information used to help track and organize these products, and with PLM software, organizations have the tools at their disposal necessary to stay on top of product lifecycles and, ultimately, maintain compliance with traceability requirements.

In addition, a solution for regulatory compliance is critical in the medical device field. For this reason, Inspirage’s UDI solution can help organizations remain compliant as industry regulations continue to evolve.

Team up with Inspirage for PLM help

Partnering with Inspirage for all of your PLM needs could give your supply chain the boost it needs in this ever-changing competitive global landscape. Knowing you have not only the right cloud-based tools to deal with this situation but also expertise at your disposal can make a difference. PLM tools can help you improve visibility throughout your entire operation and assist you in marrying business needs with the data being generated on a constant basis.

Contact the PLM experts at Inspirage today for more information about how we can help you improve your operations.

The health care supply chain management market is looking at massive expansion in the next few years. According to estimates from MarketsandMarkets, the vertical will be worth a total value of $13.81 billion by 2019, growing at a compound annual rate of 8.3 percent. This means that companies within the health care industry are in search of a way to improve their operations without increasing the costs associated with the business and implement better inventory management practices in hospitals in order to improve the quality of care.

Supply chain managers within the health care space come up against various challenges during their tenure, but none are more important than inventory management. Hospitals need to have the right tools on hand, and pharmacies need to maintain their prescription stock. How does the health care supply chain achieve success and efficiency?

Is your organization ready for the latest UDI deadline?

A lot of chefs in the kitchen

Health care supply chains have a few important unique problems to deal with on a regular basis. RevCycleIntelligence contributor Jacqueline Belliveau noted that one of the biggest challenges for supply chain managers within this vertical is the number of players involved in each step of the operation.

“Health care supply chain management is unique because each stakeholder has their own interests to protect,” Belliveau wrote. “Different stages in the supply chain flow may be focused on their own goal. Providers may want to use a specific product because they were trained with it, whereas hospital executives aim to purchase the most affordable quality items.”

In either of the circumstances Belliveau mentioned, the supply chain has to operate effectively and efficiently. The only constant within the supply chain is change – evolving product lifecycles and consumer demand continue to transform along with the industry, and organizations have to adapt.

Changing regulations

Another important thing supply chain managers have to deal with in the realm of health care is constantly evolving regulations. The unique device identifier mandate, for instance, has an impact on how certain life sciences devices move through the supply chain, with traceability requirements becoming more stringent.

Some medical device manufacturers are finding that they may not meet the UDI requirements in time for the mandate to go into effect. Health Data Management contributor Joseph Goedert reported in early August 2016 that a recent survey predicted only 15 percent of organizations would be ready for the Sept. 24 deadline, which governs the placement of labels on certain Class II and Class III medical devices. Infusion pumps, powered wheelchairs, medical apps, medical imaging systems and surgical needles are all included in this particular deadline.

One answer to the challenges of the health care supply chain is to integrate product lifecycle management with supply chain management solutions. By marrying product innovations with effective management practices and making sure supply chain data is being put to good use, health care organizations can take the stress out of their product lifecycle operations.

For more information about how the integration of SCM and PLM solutions from Oracle can help your health care organization improve supply chain operations and comply with industry regulations, contact the experts at Inspirage today.

Companies within the life sciences sector have to follow a strict set of guidelines for the production, management and distribution of their products. Especially as the regulations for unique device identifiers and traceability standards have evolved over the past few years, biotech companies and medical device manufacturers need to gain critical insights into their supply chains in order to maintain compliance.

The unique product management and supply chain challenges faced by life sciences companies force operations managers to take a step back from their supply chains and make sure they're remaining compliant while simultaneously keeping up with demand. Therefore, there are a few key concepts the health care supply chain has to take into account.

Here are just a couple of those challenges:

Cost control impacted by inefficiencies

As the supply chain becomes more global and regulations evolve, life sciences companies are faced with the need to manage cost more effectively in order to ensure business vitality. The U.S. Department of Health and Human Services found that in 2014, spending on health care in the U.S. increased by 5.3 percent to reach a total of $3 trillion, or around $9,500 per person, according to The New York Times. This staggering amount of money being poured into the health care industry impacts the supply chain in different ways, but the fact remains that costs are rising, which means companies have to figure out how to curb the ever-rising costs of manufacturing and distributing health care products.

According to Inbound Logistics contributor Justine Brown, although health care companies have traditionally had pretty good margins, the evolving landscape of the industry is forcing them to reevaluate how they do business.

"The sector is still burdened by manual processes and a significant amount of re-work," Brown wrote. "Such inefficiencies can result in ordering errors, lack of product on hand to treat patients, clinicians receiving incorrect product, and expired inventory."

These inefficiencies need to be ironed out and the supply chain augmented with logistics solutions, in other words, in order to support these constantly evolving requirements.

Health care spending is on the rise in the U.S. – and it's proving to be a challenge for life sciences organizations.

UDI compliance

Medical device manufacturers have to comply with stringent regulations, as well. For instance, the UDI mandate that took effect in 2015 stipulates that manufacturers of all Class I, II and III devices have to have an identifier in both machine-readable and human-readable formats. The FDA also requires that these identification codes are all submitted to a centralized database. In the long term, it's hoped that these regulations will create a foundation for a secure global distribution chain and allow for more accurate reporting.

In order to remain compliant with these regulations, supply chain managers for life sciences companies need to have complete oversight over their entire operations.

Inspirage has developed a range of industry-focused solutions for these unique supply chain challenges. For instance, our UDI solution was created specifically to help companies in the life sciences industry properly manage their compliance with the recent traceability regulations.

Recently, Inspirage was selected to assist a global medical device company focused on cardiovascular health implement UDI compliance within its operations. By utilizing a phased rollout process and our easy-to-use UDI software, this company was able to become fully compliant with the FDA's traceability mandate – one of the first of its kind to do so.

For more information, be sure to get in touch with the supply chain experts at Inspirage today.

Supply chain and operations managers understand the importance of being able to pinpoint exactly what’s going on within their operations at any given time. Maintaining a high level of visibility throughout the supply chain – from source to consumer – is a crucial part of doing business in today’s increasingly connected world, and it has a bearing on how productive, flexible and profitable enterprises can be.

This is especially true within the high-tech industry. According to TechTarget contributor Margaret Rouse, one of the goals of having high visibility in the supply chain is to make data readily available to all stakeholders. However,  Luis Humberto Erana wrote for Material Handling & Logistics that visibility has traditionally been one of the greatest challenges of the high-tech world. Visibility, Erana said, is one of the ways tech companies differentiate themselves, because they have to figure out how to move products before their shelf life expires.

Product lifecycle management in high tech

One of the biggest challenges facing companies within the high tech industry is product lifecycle management – and lifecycle management depends on maintaining high levels of visibility. In order to know how to move products quickly and change them if necessary, enterprises have to know where their resources come from, how much they’re spending in logistics and any number of other important metrics.

“In the warp-speed business of high tech, simply gaining visibility will not be sufficient in immediate years to come,” Erana wrote. “Companies will need to layer robust intelligence engines into this visibility, to optimize channel inventory on the fly to assure the right amount of inventory for every [stock-keeping unit] and raw material, at every location, at all times, across the extended supply chain.”

Supply chain visibility is important to avoid issues like conflict materials.

Keeping an eye on products

Supply chain visibility in the high-tech supply chain is especially important in the wake of recent changes in regulations concerning product sourcing. In particular, The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 requires all companies to report whether or not they use conflict minerals, or resources that are tied to war-torn areas of the Democratic Republic of the Congo, in their products. Companies that manufacture computers and other devices have been especially affected.

Companies need to figure out whether their products contain 3TG minerals (tin, tungsten or gold – which most electronics contain) and whether or not they are resourced from the area around the Democratic Republic of the Congo. From there, they have to take the proper steps to ensure that their minerals are not coming from conflicted mines.

At Inspirage, we can pair you with supply chain management solutions that give you critical insights into how your supply chain is operating. With solutions like Agile Product Lifecycle Management, we can help you remain compliant with current and evolving regulations affecting the high-tech industry. In addition, Inspirage has developed its own conflict minerals solution geared toward helping enterprises address the requirements set forth by the U.S. Securities and Exchange Commission.

Contact the supply chain experts at Inspirage today for more information.

Maintaining a well-oiled data trail and supply chain is critical in any industry, but it’s especially important in the life sciences sector. Not only does this industry make up a large portion of the global economy, but there are other reasons that traceability and transparency are important for the health field, too; namely that people’s lives are potentially on the line if something goes wrong.

The regulations surrounding this sector are particularly strict, especially given the FDA’s final ruling on unique device identifies from 2013. With growing complexities in the global marketplace and higher demand than ever for more control over and transparency within the product development process, it’s becoming critical for companies to step back and assess their data. Design data, therefore, is a crucial aspect of this industry.

Regulations regarding medical devices and UDIs will continue to evolve as other jurisdictions develop and finalize their unique device identifier legislation.

Regulations regarding medical devices and UDIs continue to evolve.

The news on UDIs

Industry standards involving UDIs have been evolving over the past few years, and will continue to do so for several more. As of Sept. 24, 2015, medical device manufacturers were required to label all medical implantable, life-saving or life-supporting devices with UDIs, as well as register the products in the GUDID (Global Unique Device Identifier Database) in order to facilitate increased transparency in the supply chain. By 2018, compliance will be required of all Class I, II and III devices.

The idea behind requiring all medical businesses to comply with UDI requirements stems from the need for traceability of medical devices. The important thing to note is that with this kind of transparency, companies will be able to better and more swiftly manage product quality issues and potential recalls that could have an impact on patients’ lives. In addition, consumers can access the data about their own medical devices through the GUDID.

Technology in the supply chain

With the stringent regulations surrounding UDIs and the need to have effective practices for implementation, manufacturers should ensure they have the right tools for managing UDI data and processes, as well as maintain clear documentation trails. In this endeavor, technology solutions and data-gathering functionality play an important role.

The more critical the performance of these devices, the more imperative the need for medical device companies to have complete oversight over product development. Innovation management solutions from Inspirage, such as the UDI solution that leverages Oracle Agile Product Lifecycle Management technologies, offer companies within the medical device supply chain the oversight necessary to maintain transparent operations in the wake of changing regulations. Inspirage is the leader in helping medical device companies become UDI compliant because of our deep expertise in the medical device industry and history of rapid and effective UDI implementations across the globe. For more information, contact Inspirage today.

In today’s complex Supply Chain environment enterprises have multiple Product Life Cycle, Product Data Management, ERP, Sales Catalogs, Order Capture and Fulfillment systems that all possess master data information. Due to these multiple systems, the most common challenges organizations face are:

• Fragmented data
• Lack of governance
• Poor data quality
• Non-standard data sharing

At Inspirage, we adopt a unique approach with Enterprise Data Management. We start from the ground up, focusing to establish a strong foundation by first creating a detailed strategy and roadmap to determine what you need and what it will take to have a robust data management solution in place. Our EDM offerings are platform agnostic. We have many different solutions we can implement depending on your need and what tools and systems you have in place. We focus on people, process and technology to set up, implement and oversee an EDM solution that works perfectly for you.

Below are the key best practices to help organizations succeed with product master data management solutions. Business and IT professionals involved in running product MDM programs should use these practices to help build a successful business case for product MDM, create the right data governance, and make the right choices of MDM for product data technologies and architectures.

• Get high-level sponsorship and business buy-in
• Develop a business case
• Understand the different MDM technology capabilities needed, whether you buy or build
• Establish strong data governance
• Identify PIM use cases and plan for evolving requirements
• Ensure that data quality is part of your PIM/MDM implementation

Ready to learn more?

Download Whitepaper (PDF)

Much of the news impacting supply chain operations of late has to do with conflict minerals and other problematic raw goods. Most recently, in February 2016, the U.S. Congress passed a bill that included a ban on imports that were created via forced labor. The bill is to be looked at – and, presumably, signed – by President Obama sometime in late February. At that point, it will be on the shoulders of manufacturers to find ways to eliminate these kinds of products from their supply chains.

This ban includes products like gold mined by children in Africa, clothes woven by abused women in Bangladesh and fish caught by slaves in Southeast Asia, according to Manufacturing.net contributor Martha Mendoza. The ban is part of an effort to decrease the rate of labor abuse across the world — and the exposure these practices are getting seems to be working. For instance, after an exposé conducted by The Associated Press in 2015, more than 2,000 trapped fishermen have been freed from the fishing business in Thailand.

“If signed by President Obama, imports of a Labor Department list of more than 350 goods produced by child or forced labor – cotton from Kazakhstan, wheat from Pakistan, lobsters from Honduras – may now face federal law enforcement,” Mendoza wrote.

This isn’t the first time forced-labor products and conflict minerals have been in the news. For instance, a recent report published by Amnesty International linked cobalt to child labor in the Democratic Republic of the Congo. This is going to have an impact on the high-tech industry because cobalt is used in lithium-ion batteries like the kind found in smartphones and electric cars, according to GreenBiz.

Why are conflict minerals a big deal?

The ban on importing forced-labor products is the latest in a long line of attempts to bring accountability into the supply chain and curb the use of – among other things – conflict minerals within the manufacturing process. What is an undisputedly positive action for humanity could prove difficult to manage for affected companies, however. It will require massive amounts of oversight to first identify where conflict minerals are coming from and then, if necessary, modify the supply chain accordingly.

In 2010, President Obama signed the Dodd-Frank Consumer Protection Act into law, denoting that manufacturers needed to determine whether conflict minerals exist within their supply chains and then publicly report those findings. However, there have been nothing but troubled waters since this law was passed. The reports filed in 2014 with the Securities and Exchange Commission showed a worrying trend: A startlingly low percentage of businesses even knew which country their minerals came from, according to New York Times contributor Denis Mukwege.

The ban on forced-labor products will have far-reaching impacts.

PLM tools can help

As conflict minerals – and, if the ban on forced-labor imports is signed into law by President Obama, over 350 other items created by forced labor around the world – become more of an issue for businesses and their supply chain managers, entire processes may need to undergo change. Managers don’t have to do it alone.

Oracle’s Agile Product Lifecycle Management suite, which includes the Agile Product Governance & Compliance solution, can be a great way for manufacturers to get a better handle on these kinds of issues and make sure they’re remaining compliant with government mandates surrounding conflict minerals. In addition, we at Inspirage offer our own Conflict Minerals Solution that can assist supply chain managers with oversight and control over the entire manufacturing process.

Contact Inspirage today for more information about how our solutions can have an impact on your supply chain.

If there is one thing for certain within the manufacturing and distribution industry, it’s that changes to the manufacturing process are necessary but expensive. In today’s fast-paced market environment, it’s crucial that companies be able to change their engineering processes to accommodate increasing demand or new compliance guidelines – but it’s also important they know how to determine how these kinds of changes will impact their existing inventories.

An engineering change order or enterprise change order, often called an ECO, is what managers can use to track product changes and implement these shifts in design. Determining the cost of even one engineering change can be a challenge, and it’s often time-consuming. In a world where productivity is crucial to bottom lines, inefficient processes when it comes to these changes and their implementation can be detrimental.

The importance of change order insight

It’s crucial to know how to calculate the cost of a change order from a management perspective. Some important questions to ask would be: How will this design change impact my inventory? How much will it cost to completely get rid of one or more of the parts used to create my product and manufacture a new part? Why would an ECO even be necessary?

That last question has a simple answer. A paper from the 2nd Nordic Conference on Product Lifecycle Management noted that changes in product requirements and compliance guidelines necessitate that ECOs be implemented to the fullest effect possible – and that includes measuring exactly how much to put aside in the budget for inventory changes and redistribution.

“There are often multiple ways to implement a requirement change, and it is thus important to identify the most cost-effective option prior to beginning its implementation,” the authors wrote.
Therefore, being able to have the insight required to make budget decisions regarding manufacturing changes is an important part of implementing change orders. Included in an accurate measurement of ECO cost is who is initiating the ECO, which product is being changed, how much it will cost to redesign said product and where this interacts with the inventories associated with these items. Each of these steps comes with a price tag – and it’s integral to have the insight necessary to determine what that expense will be.

When assessing just how much a change order is going to impact inventory, it helps to think in broad terms. Imagine, for example, that your company manufactures medical devices. New compliance standards and regulations are constantly being implemented for the health care industry, and each product change is hopefully accompanied by a change order. When implementing engineering changes, it’s essential to understand how much of your inventory is going to need to be scrapped following one of these modifications. This can help you determine overall cost.

These kinds of inventory calculations are rarely straightforward, and they often require a lot of manual calculation under legacy setups. For instance, let’s say a customer of a major limousine manufacturer wants to switch the kinds of doors it will be getting on its vehicles halfway through a major order. Determining the cost of such a change order is about far more than just much it costs to make the new doors. Other factors that need to be considered include all of the costs and parts that went into the old doors, what can be done with the already manufactured old doors, whether the parts exist to make the new doors, the labor involved, and so on. By trying to calculate all this manually, companies are likely to miss multiple key variables.

Change orders that come from customers typically have to be implemented, but what about potentially unnecessary change orders? Using the same limousine manufacturer, let’s say an internal designer requests to change the color of all doors from black to white while production is ongoing. In this situation, having an accurate idea of what such a change order would cost both now and in the future is key for determining if such an ECO should be followed through on or not.

Cost analysis tools from Inspirage

The Inspirage ECO Cost Analysis Tool offers a way for inventory managers to understand where the charges are coming from associated with their ECOs, and thus have complete oversight as to how much of the budget should be devoted to them.

With the Cost Analysis Tool, in other words, managers can more easily determine exactly how much expense an ECO will incur in terms of how much excess inventory there will be after changes have been made and how much of a certain product will need to be scrapped. This technology solution automates processes, gathers and validates data, and executes analysis of said data so that you know exactly how much future changes will cost your company. It can also be customized to fit the data you want to see and predict the future demand of the products you’re changing.

Get in touch with Inspirage today to learn more about the ECO Cost Analysis Tool and give your business a leg up over your competitors.

The health care supply chain is under increasing pressure from federal organizations to comply with strict regulations governing data collection and the movement of medical devices through the distribution cycle. This year, the U.S. Food and Drug Administration’s mandate concerning the use of unique device identifiers goes into effect.

With the adoption of such an important technology looming on the horizon, it’s imperative that manufacturers and distributors learn about UDIs and how they work within the supply chain to provide improved visibility and better manage product quality issues within the medical industry.

Let’s take a look at UDI labeling and explore the reasons behind the push for adoption.

An overview of unique device identifiers
According to the FDA, UDI labeling consists of assigning alphanumeric codes to all classes of medical devices in order to track them throughout the supply chain. With this kind of tracking, both the FDA and manufacturers themselves will be able to measure the effectiveness of the labeled devices.

Within the medical supply chain, it’s crucial to implement oversight strategies that allow manufacturers and distributors to ensure product quality and address issues as soon as they arise. With UDI labeling, manufacturers will be able to closely monitor where these products go and how they perform when they reach their final destination.

How does the UDI impact the supply chain?
Modern Healthcare contributor Steven Ross Johnson reported that the FDA’s phased rollout of UDIs is beginning to take place within manufacturing companies across the country. In September 2014, medical devices like implanted pacemakers and heart valves were required to include these kinds of labeling.

This year, in late September 2015, the second phase of the mandate was put into place, which states that all implantable, life-supporting or life-sustaining devices must now include the UDI labeling to facilitate supply chain management.

“The FDA has built the [identification] system so that this information will be widely available for anyone who needs it,” Dr. Josh Rising, director of health care programs for the Pew Charitable Trusts, told Johnson. “So now that products are appearing with these new codes, it is kind of incumbent on the health care system to realize a lot of the benefits that are out there for having these new codes.”

How can Inspirage help?
Agility within the supply chain can through responsive manufacturing and logistics processes, McKinsey & Company has noted. This is where UDI data analytics solutions come in.

With the data generated by the management of UDIs, manufacturers and distributors within the medical industry can have more oversight on the important phases of delivery. This ensures that they are better enabled to pinpoint where in the supply chain the devices are and how they are currently being used.

By partnering with Inspirage, companies can be sure they will get the best out of their UDI analytics solutions. With the UDI Foundation Pack, you can learn how to manage the data that comes with UDIs. Contact us today to see how we can help your company comply with the FDA regulations governing unique device identifiers.

Tracking conflict minerals is a difficult challenge for companies to comply with regulations. Our clients that utilize the Oracle Agile Product Governance & Compliance (PG&C) application have a distinct advantage and are able to extend the solution to provide a comprehensive compliance for Conflict Mineral regulations and standards.

What are conflict minerals?
Companies in the manufacturing and distribution industries know that they need to stay away from conflict minerals, which are materials such as  tin, tantalum, tungsten, and gold (known as 3TG)  that contribute to the funding of conflict in Africa or other parts of the world. President Obama signed the Dodd-Frank Consumer Protection Act into law in 2010, which dictates that companies have to determine whether any of the materials used to manufacture their products come from conflict minerals and publicly report their findings.

The Dodd-Frank law has been able to reduce revenue to militias. However, since the law’s inception, companies have had a hard time keeping these conflict minerals out of their supply chains, according to The New York Times. The U.S. Securities and Exchange Commission released some reports detailing companies’ efforts at identifying if any of these materials appeared within their supply chain – but according to NYT contributor Denis Mukwege, only 16 percent of these businesses could even pinpoint which country their minerals are coming from. In other words, most companies remain unaware whether or not they are financing conflict in African countries.

Forbes contributor Mike Scott noted that the consumer electronics industry is most impacted by the federal government’s rules surrounding conflict minerals, with big-name companies appearing on the list. As Browning pointed out, disclosing information like this can bring businesses under scrutiny from parties like human rights activists or consumer rights groups. But what can be done in this situation?

Product Lifecycle Management (PLM) tools can help
The extreme lack of awareness indicated by the SEC reports is a real oversight issue. Your company would want to comply with these regulations, but if you don’t have visibility of every step in your supply chain, how are you supposed to eliminate conflict minerals from your products?

When used as a supply chain management solution, data analytics and acquisition tools can help organizations augment oversight so that they can be sure not to gather these kinds of materials unknowingly. With these kinds of solutions, the management of indirect and direct sales channels can move to a single platform that’s remotely accessible on myriad devices, creating better visibility at all levels of the supply chain.

Leveraging our expertise in Oracle Agile Product Governance & Compliance solution, Inspirage has built an innovative Conflict Minerals Solution, which can assist companies in monitoring conflict minerals within the context of a broader product governance and compliance process. The Inspirage solution helps companies deal with a dynamic environment of constantly changing players to identify non-compliant parts and lead to proactive resolution. To demonstrate whether products are conflict-free, information must be captured and centralized from numerous content providers early in the supply chain. The Inspirage Conflict Mineral Solution can help by performing the following three functions:

This solution has been leveraged by a number of global companies, such as National Instruments, and can be deployed in a matter of weeks for existing Agile customers. There are still many companies that do not have robust PLM systems in place that can help in providing compliance solutions for challenges like Conflict Minerals. These regulatory compliance requirements will only increase over time and perhaps such a need will drive the further adoption of solutions like Oracle Agile Product Governance & Compliance. Agile PG&C provides significant value by itself in providing the platform for regulatory compliance and it does it by adding value managing the product record, supplier information and quality and ultimately improve product quality and speed to market.

Managing the implementation of Innovation in the Cloud

The purpose of this article is to expand the use of “Innovation Management” from the perspective of an organization looking at Oracle Cloud Innovation Management (IM). For the purpose of this paper Innovation will be broken down to three areas:

• Market Offerings – Taking current market offerings to the next level
• Process Improvement – Improve processes around the organization
• New Initiatives – Radical departures from the norm

Market Offerings
This area represents the most common example of innovation, which is taking a current offering and moving it to the next level. Examples would include:

• Upgrading the processor in a PC
• Providing additional hard drive options in PC
• Adding data quality capabilities to a data migration service
• Changing the pedals on a bike to non-slip
• Add fields to Chart of Accounts for new GAP rules.

Oracle Cloud IM can be used to manage the requirements gathered across the customer’s innovation process. Today that process needs to capture information from various sources such as CRM, Employees, Social Media, Marketing, Sales, etc. By leveraging the integration capabilities provided by Oracle Cloud IM an organization can easily capture and manage these change requests.

Process Improvement
TQM, SCM, Six Sigma, Lean Manufacturing, PLM were all new innovate processes and techniques at one point and all of them have some type of continuous feedback loop. Even with these in place there is still a place for process improvement innovation within a customer’s organization. Depending on the industry there are different business models that are used to define the process and the information that needs to be captured. These models are customized to the terminology of the area of business where the proposed changes are being captured. Oracle Cloud IM provides the ability to capture these new process concepts and requirements that are being generated within an organization.

New Initiatives
This is the radical culture and process change within an organization and changes the “norm” from one way of doing business to another. So there is probably a combination of one or more of the following:

• A new value chain is created based on the new business models being implemented
• The new product or service will cause the creation of new markets or radically reshape current markets
• Both the organization and the organization’s customers perceive an increase in the value as a result of the change

Again, depending on the industry there are different business models that are used to capture this type of information. These models are customized to the terminology of the area of business where information is being captured.

Oracle Cloud IM should be the product of choice to capture the new concepts and ideas that are flowing into an organization. As the concepts and ideas are analyzed, defined and ranked new requirements are generated which drive the new product/process definition. Here the power of capturing concepts and ideas and massaging via the features of Oracle Cloud IM reduces the time to market.

Conclusion

For Market Offerings the management of Innovation revolves around an already available product. For example if a new seat option is being added to a current bicycle offering the data around the product is available. While these changes to current market offerings can be disruptive and culture changing to the organization it is not really taking the value proposition to a new level.

In Process Improvement the value is derived from the process execution. So improving the process inherently increases its value.

New initiatives come from concepts like “be the first to embed a performance measurement system within a nanotube bicycle frame.” These initiatives drives a meta-data capture that is much more extensive. Being first means no “product” to start from. There is capturing market requirements, cost models, prototypes, packaging, support, etc. that will need to be defined before released to detailed product design.

The objective in Innovation Management is to capture the meta-data around the idea or concept. As clusters of concepts and ideas come together the Product definition starts to form. At this point additional Oracle Cloud PLM products (Product Development, Product Portfolio Management, etc.) come into play.

Refer to the diagram “PLM Cloud Business Functions.” This is an innovations process that captures core product definition BEFORE going to product development. Oracle Innovation Management configuration is performed to match the process or processes used within the organization.

PLM Cloud Business Functions

Cloud IM is the enabler for the Innovation Management process; it is not the Innovation Management process. Inspirage works with organizations such that the objectives of the innovation process are clearly understood and objectives achieved through implement Cloud Innovation Management.

Managing Product Development in the Cloud

The purpose of this article is to clarify the scope of “Innovation Management” from the perspective of the Product Value Chain Cloud (PVC) solution set. There are four feature sets in the PVC family, including:

• Innovation Management – to align Innovation
• Product Development – to accelerate development
• Product Hub – to synchronize Commercialization
• Embedded Analytics – to gain transformative insight

If you’re not familiar with the Oracle Fusion / Cloud strategy, my colleague at Inspirage, Jay Ramaswamy, has written an excellent piece, What is Oracle Fusion Cloud and Why Does It Matter that I encourage you to review. While many Oracle Fusion Cloud products are the next generation of existing on-premises Oracle Solutions, the Innovation Management application is a brand new solution providing a completely new set of required capabilities.

Ideation to Portfolio Decisions

Traditionally, “innovation management” is defined as management of the process of introducing something new or better and bringing ideas to reality. The primary focus of Oracle Fusion Innovation Management (IM) starts at the very beginning stages of this process, from collating and collaborating on ideas through defining the offerings and making portfolio decisions.

Again, the sweet spot for IM seems to be during this period of innovation management. Typical phases during this period include Ideation, Concept, Feasibility, Definition, etc.

• What ideas and inventions should we invest in? What’s the ROI?
• How should we incorporate these ideas and inventions into our product and/or service offerings?
• What happens if we remove feature A, add feature B or tweak feature C? If we swap product Z with Y in the portfolio? What’s the impact on resources, financials and strategy? What can we afford?
• How do we foster innovation, and how can we get closer to hearing the voice of our customers?

These are questions that companies must be able to answer, effectively and efficiently, in order to be competitive. Examples of innovation management process deliverables include Market Requirements Document, Product Requirements Specification, Portfolio Decisions (e.g. roadmap, metrics, etc.).

By managing the core entities, incl. ideas, concepts, requirements and portfolios, in a single solution set, Oracle Fusion IM streamlines this upfront planning and decisions management process. Having said that, you won’t transform your process overnight by simply having an integrated solution. But this is a tangible and achievable goal, if you have a clear vision and are willing to take the journey one step at a time.

Project Planning and Execution

Fusion IM is not intended to manage this part of the innovation management process. However, it does play critical role in ensuring that the definitions and decisions be aligned with the execution processes, providing end-to-end traceability. Oracle Fusion IM has to be an integral part of driving the following enterprise dimensions:

• Product
• Program, Project Grouping or WBS Element
• Requirement

It goes without saying that consistent data model between Fusion IM and surrounding systems is a key success factor.

Inspirage defines Product Lifecycle Management, PLM, as a set of business capabilities that maximizes the economic value of a company’s products. In this context, the objective of Oracle Fusion IM is to ensure that the right strategy and roadmap be developed, defined and communicated clearly to execution teams to achieve the PLM goals.

Have any of these scenarios happened to you?

• I tried to open an attachment using AutoVue and I get a blank page.
• I need to launch the Java Client, but the JRE required to run it is later than the version required to run my application.
• My security team says that I have to upgrade to the latest secure release of the JRE, but that means it won’t be compatible with my other software.

Java Runtime Environment (JRE) releases are very common as they typically address security concerns as well as introduce new features and functionality. Unfortunately, not all systems are certified and operational with the latest JREs. To help address this issue Oracle released a feature with Java 7 update 40 called “Deployment Rule Set” that will allow installing the latest JRE while still allowing older JREs to run with applications that require them.

In a nutshell, Deployment Rule Sets allow having multiple JREs installed on one machine and a file with rules will specify which JRE to use for a given application. For instance, the rules may indicate that for Agile use JRE 1.7, for EBS use JRE 1.6 and for everything else use 1.8. The solution is fairly simple, but should be handled by a system administrator who can push out the configurations to multiple user computers.

What’s the solution?

Download Whitepaper (PDF)

Please join us for a LIVE Webcast on Thursday, December 5th at 2:00pm CDT where Todd Hein – Life Sciences Industry Product Specialist from Oracle and Mike Lieberman – Director, Solution Architecture from Inspirage will highlight industry trends and best practices. This will also include a technical review of the solutions offered by Inspirage, USDM and Oracle.

Featured Topics:

• The Latest in FDA Rulings
• Lessons Learned from over 20 UDI Customer Engagements
• UDI Readiness Survey Results
• Overview and Demo of the Inspirage and Oracle 3-Step UDI Solution
• Extract, Standardize and Aggregate Legacy Product Attributes
• Manage all Device Identifier Attributes within an FDA Auditable Archive under 21 CFR Part 11 Change Control
• Manage Packaging Hierarchy Dependencies
• Associate Device Identifiers with Device Master Records
• Enable HL7 SPL Submittal to the FDA’s GUDID
• Facilitate Data Flows to the Downstream Supply Chain/Manufacturing System for Consumption onto the UDI Label

Explore more UDI Resources

Countdown to UDI: The Inspirage-Oracle Solution

Join our UDI Expert Roundtable Group

Oracle Agile PLM Now Available for iPad

Inspirage is pleased to have had the opportunity to help Oracle Product Management test the Oracle Agile PLM Mobile application iTunes connectivity, and worked with Oracle to leverage an Inspirage environment of Agile PLM 9.3.2, which was then used for such purposes.

This new mobile enterprise PLM solution helps companies accelerate product innovation and maximize profitability.

To enhance decision making and drive productivity across the entire lifecycle of a product, organizations need applications that can securely provide complete visibility into product lifecycle management processes at any time or from anyplace. Addressing this need and extending its support for complex product lifecycle processes, Oracle has introduced Oracle Product Lifecycle Management (PLM) Mobile for Agile. Part of Oracle’s Agile Product Lifecycle Management, the new mobile application enables users to quickly and easily access PLM data on the Apple iPad and turn it into valuable and actionable insights.

This app is now available for iPad and can be purchased through iTunes store.

For more information

Working with the Oracle Agile team, Inspirage has developed a solution to help companies with UDI Compliance leveraging the Agile solution. Learn more about how Inspirage can help your company meet these requirements.

The FDA is in the final stages of implementing Unique Device Identifier (UDI) which will place requirements on Medical Devices to have a label containing Device Identifier data and Production Identifier data. The UDI data must be submitted to the FDA via their submittal system: all Class 3 devices must be compliant by summer of 2014 and all Class 2 devices must be compliant within two years of that.

Please join us for a LIVE Webcast on Thursday, August 15 @ 1:00pm CT where Todd Hein, Life Sciences Industry Product Specialist from Oracle and Mike Torek, Sr. Practice Director from Inspirage, highlight the benefits of utilizing Oracle applications and the Inspirage designed solution.

Featured Topics:

• Extract, standardize, and aggregate legacy product attributes
• Manage all Device Identifier attributes within an FDA auditable archive under 21 CFR Part 11 change control
• Manage packaging hierarchies dependencies
• Associate Device Identifiers with Device Master Records
• Enable HL7 SPL XML submittal to the FDA
• Facilitate data flows to the downstream Supply Chain/Manufacturing system for consumption onto the UDI label itself.

Who should attend?

Medical Device Professionals with responsibilities in: Quality, Compliance, Regulatory, Analytics, Reporting, IT