Medical Device Link.

Originally Published MX January/February 2002

INFORMATION TECHNOLOGIES

Web-Based Product Change Management

Today’s product change management systems can provide device companies with real-time project visibility, access to data, and coordinated execution of core manufacturing tasks.

Michael Carroll

Web-based product change management (PCM) is the ability to manage and execute simple and complex product changes across distances and under time constraints. If integrated seamlessly with a medical device manufacturer’s other business processes and existing IT infrastructure, product change management can be a useful strategic tool, especially in today’s slow world economy. Web-based coordinated execution of product changes enables device manufacturers to decrease costs and increase revenues by improving accuracy, decreasing waste, reducing redundant processes, speeding changes in production and design, reducing time to market, and ultimately increasing productivity within a narrow time window.

To gain market share and drive revenues, medical device manufacturers have to efficiently roll out first-to-market products one after another. But that is only half the struggle; they must also introduce the right products at the right time and do so within budget. Such demands leave no room for sloppy development efforts, wasted raw materials, strategic errors, or mismanaged projects.

For medical device manufacturers—working as they do in highly pressurized, fast-changing markets—the key to success is coordinated execution of product changes. They need to be able to adapt in real time to changes in business requirements, customer demands, raw material availability, new strategies of competitors, geopolitical shifts, and so on. They need to be able to formulate new supply chains or revise plans for introducing or manufacturing new products. By coordinating actions across the entire value chain, medical device companies can ensure that tasks are completed, records kept, and profits maximized (see Figure 1).

Figure 1. Medtech manufacturers can ensure that tasks are completed and profits are maximized by coordinating actions across the entire value chain. Source: Ingenuus Corp. (Livermore, CA).

Coordinating business processes on a global basis can be very difficult and time-consuming. Challenges are rife and ever-present, and gross inefficiencies are never too far away. Compliance with various regulations makes coordination even more important, especially in the increasingly popular sphere of outsourced services such as document management, manufacturing, and IT services. In the highly competitive and regulated environment of the medical device industry, one of the greatest challenges is coordinating product changes internally and externally.

The answer is to go beyond mere visibility of information by automating the change process throughout every stage of the product life cycle—from concept to new product introduction to ramp to volume production to maintenance—and finally to end of life. The best way to automate change is through electronic change management (ECM) that intelligently and actively drives the entire change process via the Web. An effective ECM system accomplishes automation by leveraging a task-flow engine that expedites change requests, tracks approvals, and helps to push and implement such changes right down to the factory floor.

The Slow Pace of Change

Making a change to a product can be a slow, costly, and complicated process—particularly for global medical device manufacturers with widely dispersed factories, employees, and supply-chain partners. Even with sophisticated computer-aided design (CAD) systems and the Internet, most global device companies still spend an inordinate amount of time and resources on meetings, transportation, couriers, overnight services, faxing, printing, and other document-handling services before they see the design for the approved change, let alone the new product.

Some medical device manufacturers still process change through electronic homegrown systems. Such systems have numerous drawbacks. They are costly to develop, prone to error, expensive to maintain, usually lack real-time integration with other companies’ computer systems, and don’t leverage the speed of the Internet. Consequently, they provide marginal value. Many of these systems are based on basic e-mail or messaging technology, where data are simply sent to a hub or a server for someone else to retrieve. It is not uncommon for these automated systems to be run alongside manual systems because users feel that they cannot rely on them.

A joint study conducted in 2000 by Ernst & Young (New York City) and the National Association of Manufacturers (Washington, DC) showed that fewer than one in four U.S. manufacturers uses electronic technology. Only 8.6% of companies connect electronically with major suppliers, 11% connect the plant floor with the Internet, and 23% share product design specs with suppliers.

Herein lies the problem. The global connectivity made possible by the Internet is rewriting the ways in which device manufacturers make and sell products. More importantly, it is rewriting the way in which businesses expect to make and sell products. Ease of use is being applied not only to technology, but also to business relationships. Old business models, based solely on process or operational efficiency, simply cannot deliver the results needed to compete in a world where the most successful companies leverage the Internet for instant communication and global collaboration. In this new world where time truly is money, medical device manufacturers need a new business model based on competitive efficiency that leverages the Internet, allowing them to move faster than the competition. Consequently, the most successful medical device manufacturers are beginning to adopt intelligent e-business systems as part of their core competency in order to advance their competitive position.

Introducing C-Commerce

The next big trend in global medical device manufacturing will be the ability to collapse time and distance variables in new product introduction, forecasting, planning, and materials delivery—a tough row to hoe. Collapsing these phases of the product life cycle is the key to competitiveness in today’s new economy. Analysts at the Aberdeen Group (Boston), an IT market analysis and positioning services firm, believe that this will be made possible through collaborative product commerce (CPC).

CPC is a category of software and services that uses Internet technology to enable individuals to collaboratively share intellectual data, allowing them to improve the development, manufacture, and management of products throughout the entire life cycle. In short, CPC systems are expected to solve the problem of connecting disparate databases while allowing them to interact.

CPC systems will likely herald the end of the old business model of using manual and ad hoc electronic systems—and companies that continue to rely on these methods will find themselves at risk competitively.

The growing interest in CPC systems underscores a more pervasive trend in global competition: the belief that Internet-enabled technologies are fundamental to improving business processes and competitiveness. A few years ago, medical device manufacturers embraced e-commerce because it promised to deliver efficient transactions at lower cost than existing technology or practices. Today, manufacturers are looking to collaborative commerce (c-commerce), the second generation of e-commerce, which promises to provide considerably more value and power than its predecessor.

C-commerce, the core component of CPC, focuses on new revenue opportunities by allowing medical device companies to bring more innovative products to market faster than the competition. C-commerce is much more than a transaction exchange; it is an intellectual capital exchange that can potentially deliver the much-anticipated virtual enterprise. To reach the next competitive plateau, medical device manufacturers are deploying new collaborative platforms and strategies. Unfortunately, simply providing a collaborative platform is not enough. Device manufacturers must deploy automated business processes that facilitate the exchange of intellectual capital and capture business process logic that can be used to improve existing and future products and processes.

To thrive in the c-economy, medical device manufacturers must be superefficient at sharing information internally as well as with partners, suppliers, and customers in the supply chain. To keep pace, reduce cost, and ultimately increase profitability, device manufacturers must speed product changes while creating an environment that promotes continuous improvement and constant innovation. As the rate and volume of product changes increase, so does the need to streamline change processes.

Collaboration, Communication, Synchronization

Obviously, what device manufacturers need are automated systems that eliminate all the drawbacks of manual systems and homegrown electronic systems. In addition, these systems must be able to automate critical business processes, assist in regulatory compliance, be easy to use, and enable all participants of the supply chain to collaborate, communicate, and synchronize change in real time. Some software vendors are already providing out-of-the-box systems that facilitate collaborative commerce and Web-enabled electronic change management. The benefits that such systems can provide medical device manufacturers are clear: faster new product introduction, faster time to ramp, faster time to volume, faster time to productivity and profit, better quality products, strict adherence to FDA requirements, and more satisfied customers.

The best PCM systems allow medical device companies to control critical knowledge and force action across their organizations and the supply chain. To do so, the system must have a fast implementation process and a positive impact on productivity (see Table I). As products and business processes grow more complex and as competition expands on a global scale, every person within the supply chain must be empowered to create, share, and access the information needed to initiate and accelerate change. Adding more users, processes, tasks, or business rules should be simple and easy to do, and not require programming. Waiting to roll out a bulky, stunted PCM system that requires massive amounts of customization and coding and takes months or years to develop will not meet the requirements of today’s medical device manufacturer.

With this in mind, it becomes clear that not all PCM systems available today are created equal. Very few systems can deliver real-time, Web-based communication, collaboration, and synchronization. Furthermore, only a handful can deliver coordinated execution.

Delivering Change Across the Supply Chain

Coordinated execution enables medical device manufacturers to deliver information in anticipation of future changes and to collaborate securely over the Internet so that they can create smarter business processes, such as ways to instantly inform partners of new product requirements and changes, and ways to monitor whether specific notifications were acted upon. At the same time, device companies need to securely integrate their business processes with those of partners and customers over the Internet. Thanks to multilayered security in software, companies can extend collaborative business processes over the Internet, sharing proprietary information and intellectual property among value chains under need-to-know access control.

Achieving coordinated execution requires business process applications and a technology infrastructure that can support rapid and frequent change without disrupting business operations. At the core of the best PCM systems are some form of life cycle management and workflow technology. Life cycle management provides dynamic management of ad hoc processes, while workflow capabilities lay the groundwork for repeatable processes. When both capabilities are integrated, they maximize collaboration and productivity. Increasingly, PCM systems that enable coordinated execution feature wireless connectivity, mostly using wireless application protocols.

A prerequisite of any PCM system is its ability to integrate new and existing technologies without disrupting business operations, essentially creating a future-proof answer to business and market challenges. Such a system should be able to integrate the best attributes of disparate tools and applications to encompass the entire business-based management of the product development process into a Web-enabled blueprint for success. The best systems enable manufacturers to integrate them with leading CAD, partner relationship management, enterprise resource planning, customer order, visualization, and other core manufacturing applications (see Figure 2).

Figure 2. An effective change management system should allow seamless integration with existing core manufacturing applications. Source: Ingenuus Corp. (Click to enlarge.)

At the same time, such a system must be able to provide consistent and repeatable results in the complex and variable environment that is typical of product development. Ideally, the system will allow device companies to modify and update automated procedures at any time, addressing changing needs without recompiling, rebooting, or ceasing operations.

A superior PCM system allows medical device manufacturers to take control of every manufacturing collaborative commerce need, including all outbound and inbound documents and data, automatically archiving changes to manufacturing flows and providing audit trails compliant with ISO and FDA requirements. It pushes manufacturing change orders through the global supply chain, assigning tasks, scheduling work, alerting constituents of overdue situations, and prioritizing problems on a timely basis. An automated PCM system is also flexible enough to work directly in aiding medical device manufacturers with compliance issues. It replaces faxed electronic signatures with true electronic ones, which can be filed as electronic records that comply with FDA’s 21 CFR Part 11 requirements.

Conclusion

In the highly competitive medical device market—where getting to market faster than other manufacturers is key to survival—companies need every tool at their disposal. For more and more manufacturers, Web-based management of product changes holds a prominent place in their software resources because it allows real-time visibility into countless projects, access to mountains of data, and coordinated execution of tasks and duties on a global basis. If properly integrated with existing technologies and processes, a superior automated PCM system will enable the device company’s entire organization to speak the same language at the same time, so that participants can plan, transact, and implement change together. The results of using this type of system are impressive. Medical device companies can manage change anywhere, anytime; save money in the process; and gain the competitive advantage of producing better products faster and more cost-effectively than their competitors.

Michael Carroll is chairman and CEO of Ingenuus Corp. (Livermore, CA), a provider of software services that allow users to collaborate and share design information.

Illustration by Campbell Lairo/Laughing Stock.

Copyright ©2002 MX