Medical device manufacturers are overburdened with managing a tremendous amount of data, in addition to maintaining the systems with which to utilize that information in order to keep pace with competition. This article examines four areas where a company can streamline its processes to ensure a higher return on investment.
  • Software solutions
  • Electronic vs. paper records
  • Managing content database
  • Optimizing IT systems
By Tim Dombrowski
Identifying where and how peer companies are achieving goals of growth and profitability is always on the mind of executives as just one more piece of information used in planning to meet their own objectives of profitability and growth. Certain trends have emerged in the medical device industry for product development that offer an insight to lessons learned and an avenue to improve planning.

There are four areas that emerge as the top process and business system issues being tackled by leading companies in this industry.
  • Alleviating heavy software customization and pursuing COTS (commercial off the shelf) products
  • Having “transitional” capabilities for moving off paper-based processes
  • Repurposing informational content and automating deliverables
  • Consolidating the IT business application portfolio
These initiatives are pursued with the looming requirement of remaining compliant to federal regulations. Although the productivity payback on accomplishing all of the above is extraordinary, the costs incurred during implementation can challenge the acceptable hurdle rate unless the vision of top line opportunity is considered.
Customization vs. COTS
Everyone is painfully aware of the total cost of ownership equation associated with a highly customized software application. In the not too distant past, the early adopters of software applications, such as PLM, have had to expand the functionality of purchased systems to meet the requirements of their organization. In many cases, there was the desire to implement a new technology that automated most of the existing processes.

The PTC Windchill PDMLink product is a data management tool that allows manufacturers to expertly manage all forms of product data and to control and manage product data from a single digital source (Click here to enlarge)
There’s a fundamental flaw in automating poor or outdated processes with new technology and not having the fortitude to pursue organizational changes to the business. As these implementations have now gone on for years, the opportunity for change has naturally surfaced, either by grassroots acceptance of the technology or by management mandate in the shadow of an inevitable costly revision update to the software application. Regardless of the channel driving the change, the results are the same.

Companies are taking a hard look at the value of deviating from the COTS product and the potential for adopting the business processes the application was designed around. They’re evaluating what processes are a market differentiator or a competitive advantage and what processes are not. Those processes that are not concede the ways of the application’s intent. A problem often arises for implementation teams to find clear documentation of the application’s intent.

The intended-use cases and processes for which software applications were developed are not always clear, yet a few vendors are now publishing the process vision for which their applications are architected, designed, developed, tested, and deployed. These are sometimes referred to as business process guidelines or validated processes.
Transitional Capability
As all companies move from their fully compliant paper-based world to having electronic-based documentation, processes, and systems, the need to mitigate the risk of noncompliance during the transition is critical. This is especially true when the transition for some may be occurring over the next decade.

For this mitigation, the solution is having a continuous mix of paper-based and electronic-based controls with particular capabilities that allow for SOPs to mature, yet remain compliant at all times. This capability is found in only a few different solutions, one of which is the concept of Composite PDF.

The notion of Composite PDF takes advantage of electronic business systems that can control documentation content, signature authorizations, and version change, then assemble records in a proper format so as to retain the document’s compliance in its printed form. With this capability, a company can sustain a compliant paper-electronic mix of processes indefinitely.

In every branch of government and especially the FDA, a preference toward electronic records is emerging. There is no evidence to support preferential treatment for companies that interact with the agency through compliant electronic means, yet the performance results of those companies with the ability to do so might speak for itself.
Content Reuse
The most compelling trend in content management goes far beyond PDF and extends the goal to having a complete representation of your product in XML. The Enterprise Content Management (ECM) of XML opens up unprecedented opportunities for knowledge capture, content repurposing, and dynamic publishing.Managing content with smaller pieces of subject matter, which have associated metadata and linkages, allows for data search results to yield meaningful snippets. This is opposed to a typical data search result that references an entire document and may or may not contain the specific information sought after. Even if the document has the desired data, the challenge then becomes the task of extracting it without losing the context by which it was supported.

The XML data bites that become part of an ECM system are easily repurposed in every type of literature a company might produce. The mechanism for this extraordinary reuse is a type of document template that dynamically assembles itself with all the latest content pieces, thus never being out of date. This function taken to another level tracks and maintains not only the revision and history of the document but the revision and history of every XML component within it as well.

Further implications of managing content at this level extend into an ability to effortlessly publish in any language. The requirement to publish similar content in the specified framework for the different international regulatory agencies is simple as well, whether it is a submission and communication form, product label, or product package.
Consolidating Business Systems
The redundancy of functionality within a company’s various business system applications continues to grow as the IT portfolio remains unreconciled from company mergers and implemented niche software products continue to extend their capabilities into adjacent areas. Software vendors are pursuing more and more ownership of product development stages that occur both earlier and later in the process from which their products were originally deployed and they’re achieving broader footprints through R&D spend and acquisitions.

Through years of M&A, medical device companies can end up with a whole array of similar systems that a centralized IT authority needs to take responsibility for reconciling. The same issue occurs when IT decisions for niche products are made within functional or departmental silos. This too needs to be fixed or runaway IT budgets will persist. Deciding which systems stay as true infrastructure, which are retired, and which will be integrated to while maintaining their niche is as much a business decision as are the decisions for the selection of a new technology.

The advertised scope of business systems like ERP and PLM are broad enough to suggest they may be all you ever need and some companies are pursing infrastructure consolidation to this level. Their thinking being that the ERP and PLM vendors have already made integral the functionality of CRM, QMS, CAPA, SCM, MES, and other systems, so the responsibility lies with the vendor to maintain it. Where the need for further integration to a system you may be unwilling to retire exists, there are no better systems with which to create the interoperability than ERP and PLM.

Fewer vendors to deal with, less integrations to support, and a common architecture for the product development function make this particular trend worth an immediate look.

In so many cases, following the herd and trends lead to, at best, average results which are at par with the competition. The trends discussed here are not necessarily the optional “me too” considerations; these trends tend to be the sorts of initiatives companies think about when they wonder where they went wrong and why their competition may have slipped ahead.

Consider standardizing on fewer business systems with far less customization as that will most likely affect profitability. Consider how information assets can be more effectively exploited for quickening time to market or garnering market share. The double digit growth that will be achieved and maintained will be the question the competition will then be asking.
For additional information on the technologies and products discussed in this article, visit PTC online at

Tim Dombrowski is the vice president of business development at PTC, 140 Kendrick St., Needham, MA 02494. With a BSIE from Cleveland State University and extensive business education, he has 25 years experience in product design and development. Dombrowski has spent the last 13 years at PTC focused on opportunities for applying technology solutions to product development across distinct vertical markets including medical devices. He can be reached at 781-370-5000 or