Web document management may seem new to many medical device companies--it is certainly worth the consideration of all medical device manufacturers--but for those medical device companies that have already implemented web document management software in their own regulated environment and seen the benefits of a healthy ROI, the question arises as to what IT solution will hold the next competitive edge in the race for the biggest slice of the industry's revenue and profits.
A New Competitive Edge
For medical device companies that have already invested in web document management, what is the next step?
Start by asking yourself (or your software vendor) whether your current web document management solution can interface with your PDM solution (e.g. SolidWorks' PDMWorks, Pro/INTRALINK from PTC and Windchill). If you don't currently have a web document management solution, refer to the rest of this article for features that you should consider.
Web Document Management + PDM Solution = More Power
When a web document management solution can interface with a PDM solution the possibilities for better control, better compliance and easier product turnaround may astound even the most believing IT enthusiasts.
CAD File Management
CAD drawings are not likely to be categorized as flexible digital documentation any time soon. CADs seem almost impossible to manage in a generic web document management solution but can easily be managed if your web document management solution interfaces with your PDM solution.
The Hunt for the Right Interface Connector
When searching for the right interface connector, medical device professionals should look for a system that does the following:
Allows users to collaborate and redline on the PDF version of CAD files;
Ensures that all PDF versions of CAD files are automatically stored in the corresponding web document management system;
Automatically edits PDF copies in the web document management system when changes are made to the original CAD file in the PDM solution;
Allows engineers to continue using the native PDM solutions they are familiar with while simultaneously controlling CAD files in conjunction with all other documentation for best compliance results;
Publishes CAD files automatically (to PDFs) and automatically routes and sends these PDFS for approval to pre-approved users;
Automates the routing and approval of the PDFs, while the updating the PDM solution;
Allows for the tracking of CAD creation and modifications and automatically archives the CAD PDF files when appropriate.
Find What's Right for Your Company
The list of features mentioned above is by no means conclusive. Every medical device company has its own agenda and corporate personality. After checking to see if a solution provides the features mentioned above medical device companies should consider features they would find useful to their own company and look for that type of product as well. Some software vendors may even agree to build and customer software requests and/or upgrades.
Conclusion
There are a variety of additional products that may prove to be the "next-in-line" competitive edge products for life science companies. For the pharmaceutical industry a start-to-finish eCTD solution can provide a very significant ROI especially considering the fact that a marketing delay of a year or even 6 months can result in millions of dollars lost.
For medical device companies another product that offers a competitive edge are BOM or Bill of Materials software solutions. Keep in mind however that a BOM solution should provide ERP system integration.
For blood/tissue companies, a sophisticated training/learning management solution might be the next competitive software tool. One thing is sure however...competition and technology are both of the utmost value for any life science company.
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