The medical device market is among the fastest growing manufacturing industries. Along with this rapid growth, however, has come many challenges. For example, because of its highly competitive nature, time-to-market is critical: Being late by only a few weeks can result in millions of dollars in lost sales.

In addition, companies within this segment are required to meet Food and Drug Administration (FDA) regulations required by US law for any medical product. Failure to comply can result in costly recalls or, in extreme cases, company shutdowns. Further, in June 1997, the FDA Regulations changed to align with ISO 9001 regulations for design control. This pushed medical companies to adopt document and process management systems to control design documents during the in-progress phase as well as the released phase, where most of the focus is today. Thus, Medrad Inc. took a significant step when it purchased SofTech’s product lifecycle management (PLM) system, for it not only gained better control over its numerous electronic and hard-copy files, it was also more efficiently able to satisfy ISO 9001 standards and FDA regulations.

Medrad is a leading maker of quality medical devices, including fluid delivery products and magnetic resonance imaging products. While the business has continually been well run, over the years different departments within the company struggled to manage the voluminous amount of data that was stored during the design and development processes.

For example, its document control group used an aging Rbase database designed in the 1980s to store current files, while older versions were stored off site at a cost of several thousand dollars each month. Rbase provided no control over historical files because it didn’t contain the files themselves, only information about them. Further, it offered few data validations and provided no links to files. In order to review old documentation, staff had to request for information to be delivered, which could take up to a day to receive. Once they received material, the desired documents often were not in the requisitioned box because of a manual index method that often resulted in errors. This meant the order process had to be repeated.

At the same time, Medrad’s engineering design and services group, which manages all of the company’s electronic product documentation, including Pro/Engineer® CAD models and mechanical drawings, recognized an opportunity to improve the management of its current and historical files.

At a higher level, Medrad wanted to more efficiently meet the increasingly stringent regulations required by the FDA in order for any medical device to be sold in the US. In addition, it sought to attain more easily ISO 9001 certification to facilitate the sale of medical products in many European countries.

The FDA requires that medical device firms maintain a Device Master Record (DMR), which is the recipe for how the product is to be made. It contains all the product documents specifying the manufacturing processes and specifications. It also requires a Device History Record, which is a record of all the steps actually performed to produce the product.

All documents in the DMR must be under revision control. It is not unusual for the FDA to check to ensure that the right configuration of documents were used on a particular date to build a specific device identified by its unique serial number or lot number. Maintaining all these documents and configurations is very difficult to do manually. For example, in order to prepare a DMR information for even a small product line, Medrad might need to spend six to eight weeks to manually go through and distinguish what documents would be required to build a specific configuration. Then, within a day, it could become outdated because of changed parts or procedures.

ISO 9001 requirements also pose a challenge to medical device manufacturers. ISO 9001 is a quality standard that requires a company to document all of its procedures and prove that it follows them. It includes the management of product documentation and the control of the design procedures.

Given these demands, Medrad determined a product data management system could best address them and formed a five-person team that drew up a list of 30 potential suppliers. That list was quickly whittled down to 15 based upon a required a solution that could accommodate diverse hardware, operating system and database requirements. Then, after participating in demonstrations and more research, the group focused on three potential suppliers. Medrad brought each of the three vendors in for a week and had 16 key users gain hands-on experience with the products. Based on the results of a user survey that followed these sessions, the company selected SofTech’s PLM solution.

According to Paul Kwiecinski, Medrad’s product data management project manager, there were several key reasons for the decision. “We really liked SofTech’s focus on tool integration. For example CMS/Pro is a tight integration between CMS and Pro/Engineer, which allows our engineers to manage the complex configuration of files generated during product design.”

Kwiecinski continued, “We also appreciated the graphical file structure browser, which allows users to see how information is organized. In addition, it was easier to use than competitive products. With SofTech’s solution, Medrad could tailor the custom attributes screen with its own data without any programming. Another data management product required all documents to be stored in its own proprietary format, whereas the SofTech solution could retain information in its native format.”

From an IT standpoint Medrad liked the SofTech solution because it allowed it to define the applications that launch and work with the system. “At the time, we did not have a corporate standard for word processing,” he said. “SofTech’s solution enabled us to select different viewers based on the individual PC desktop — so one person could use Word, another WordPerfect and a third Ami Pro.”

Based on the evaluation, Medrad licensed SofTech’s solution. The implementation process included a pilot program to ensure the company could gain success for fully implementing the products. “The test period revealed that the SofTech solution worked perfectly,” said Kwiecinski. “In fact, during the parallel process, the old system, which required manual intervention, produced erroneous information. The SofTech solution picked up the mistake.”

Today, Medrad has control over a broad array of files, including WordPerfect, Word, Excel, Lotus Pro/Engineer, etc. “Now, our users can go through the SofTech system, look up the document that they want, and obtain it. We estimate that our R&D and mechanical engineers save up to two days a month just searching for information. That’s significant to our organization. We can obtain information directly at the desktop without making special requests. It also gives us a lot better control over the different versions of each of the files. We no longer have new versions in-house and older versions sent off site.”

Moreover, Kwiecinski added, “When a user puts in a change request today, the drawings and documents are directly affected by the change. Today, associations are made from the change request back to the original control documents. This means that when users look at change requests, they are assured of looking at the original document, and vice versa. Now people can see that association; we never had that with our old system.”

In the past, Medrad could not easily view older revisions of documents. “Now,” said Kwiecinski, “we have quick access to all revisions, no matter how many times it has been changed. That has proved to be very beneficial. Today we have an automated audit trail to more quickly and easily meet FDA and ISO 9001 regulations and standards.”

From a regulatory perspective our SofTech solution has also succeeded. “The FDA was impressed with our demonstration of how it would enable us to meet its regulations,” he said.
“ When it saw our system, the FDA said our method would exceed its requirements. They had suggested that we keep a separate Device Master Record for each configuration of our injectors and we have more than 650 different configurations. SofTech’s solution will accomplish this so we will be fully FDA compliant.”

SofTech’s solution has helped Medrad maintain better records in the Device Master Record and Device History Records. The same process that could have taken six to eight weeks can now be handled online in minutes.

“Overall we believe SofTech’s solution will play an important part in helping us get our products to market more quickly,” Kwiecinski said. “This is extremely important in the medical device market. We estimate that CMS will provide our engineers with at least 10% more available time to do their jobs. In conjunction with a number of other programs, this should have a significant impact on reducing our cycle time.”