Automate or Antiquate: The Software Solution
Software Providers Tackle Complex Needs With Streamlined Systems
In a deadline-driven market that relies on speed to get products to market and stay ahead of the competition, a device manufacturer still needs to remain conscious about complying with FDA and ISO regulations, as well as maintain thorough financial records. Careful documentation and risk management are crucial. As a result, many companies are starting to re-evaluate their processes for maintaining records and controlling manufacturing processes to meet both internal and external standards.
In this act of due diligence, many medical device manufacturers are finding that existing systems are outdated. Paper-based systems are time-consuming, requiring personnel to waste precious time searching through volumes of paperwork to locate a single document, and they’re not cost effective in the long run. And simply entering the contents of a paper file into an electronic database doesn’t really address the need for changing processes.
The semiconductor industry faced a similar challenge in the past, when manufacturing relied on manual operations that required plenty of human interaction. Over the previous 20 years, however, the industry has driven productivity by incorporating software technology to automate systems.
“There’s a parallel thing happening in the medical device industry—it’s a similar evolution,” noted Jeff Nestel-Patt, director of marketing for Chelmsford, MA-based Brooks Software.
In a climate of what seems like daily mergers and acquisitions, many newly joined device companies are finding that their systems often don’t mesh well together or they aren’t streamlining processes. Therefore, the larger companies in particular are trying to use software to achieve “globalization and harmonization,” according to Nikki Willett, VP of marketing and regulated compliance products for Pilgrim Software in Tampa, FL.
Indeed, many savvy executives are now finding that a fully automated system can alert them to problems quicker and enable production to operate smoothly. Customers are increasingly turning to software providers for solutions that can streamline, facilitate and simplify operations; help get products out quicker; and help improve outsourcing relationships (see sidebar on page 44).
A Slow Transition
According to Chris Parsons, director of marketing for Charlotte, NC-based Camstar, only 7% of medical device companies are currently using an electronic-based system. However, “Device manufacturers are now seeing manufacturing operations systems as strategic to their business,” he said.
Many software experts told Medical Product Outsourcing that the medical device industry as a whole has been somewhat resistant—until now—to shift operations toward electronic systems, believing the transition would be extremely complex and too expensive to justify the cost involved with such an undertaking. However, paper-based methodology contributes to inefficiency, experts say, and certainly results in higher costs.
“People have a lot of apprehension—putting in another system scares people. You have plenty of excuses not to do it, but clear data prove you should go paperless on the manufacturing floor,” said Joseph Vinhais, VP, regulatory compliance for Brooks Software.
Some companies have tentatively replaced paper systems with simple electronic systems but are overlooking the need to additionally reconfigure managerial approaches to optimize the technology. “They aren’t necessarily looking at how their management should be changed with a new system,” Vinhais said.
Historically, many device companies would implement a software system based on what was available in the market, but they weren’t really considering what they really needed the software to do and how their existing internal processes should be adjusted along with the implementation of a new system. “Someone would find a cool product that was interesting and thought it would meet the company’s needs,” explained Daniel R. Matlis, president of Yardley, PA-based Axendia. “Companies were buying based on what was out there, as opposed to what their own business needs were.”
Many device companies have also tried to implement their own systems (and still do, with mixed results). Minnetronix, a contract manufacturer of software-based medical devices, has found success by implementing various systems developed both in-house and by external vendors. “We’re using a lot of proprietary tools—tools we’ve invented,” reported Lynn Ihlenfeldt, VP of product development for the St. Paul, MN-based company. “It can be difficult to find an off-the-shelf system that does exactly what you want it to do.”
The problem for many internal IT personnel, though, is that they may understand the technical nature of what’s trying to be accomplished but still can’t grasp the business needs. In addition, IT is often inundated with other daily tasks and finds that maintaining a new system can be disruptive and time consuming.
As a company that makes devices embedded with software, Minnetronix has used a combination of in-house and external software technology to automate its operational systems. Photo courtesy of Minnetronix.
• Thorough recordkeeping. This helps to ensure that documents are complete—ie, electronic signatures are in place, correct dates are recorded and all form fields are filled out. You can ensure that fields are properly entered as well—if you have a value between 4 and 5, for example, and someone enters a number outside that range, some systems automatically will reject it, offering more confidence that data are correct.
• Key word, category and other searches. The integration and auto-mation of large volumes of data can be easily searched by numerous parameters and then be used to generate reports on trends or to track operations in real time.
• Discussion threads. Some software, such as offerings from Pilgrim, offers a forum similar to message boards on the Internet that can place everyone’s input on a discussion into one central location. This can eliminate the need to read multiple e-mail responses on a topic and improve overall collaboration across the organization.
• Drag-and-drop menus. Many of today’s features are being simplified for all levels of users through the use of these menus. In addition, Web-based systems that operate on browsers, and dashboards that display information without any mouse clicks, are also popular.
The Software Solution
Before any of these features can be implemented, software consultants and providers are playing a major role in helping the medical device community evaluate business processes and analyze needs.
For instance, Axendia uses a “pyramid” analysis: the top angle relates to the business objective a company is trying to achieve, and the bottom angles equal (1) how the technology will be used to fulfill this need and (2) compliance requirements. “By determining requirements and project strategies [ie, what’s on top], then you can look at the technologies that will help serve the business needs and regulatory requirements,” Matlis said.
Using this methodology, Axendia’s customers start at “base camp,” assessing needs (eg, regulatory requirements, current technology in use, internal experience with new systems). Then they create a strategic map with this information, developing a timeline to implement tactics. At the “trek” stage, a strategy is honed based on the “base camp” findings and pilot programs are developed. Customers reach the “summit” when an actual plan is implemented.
“Instead of using the ‘big bang’ approach, we take a continuously learning approach. We’re not turning an organization upside down, and we can show actual results from pilot programs to build on what wins in the process,” said Matlis.
Leslie Rickey, director of product line marketing for MSC Software in Santa Ana, CA, agrees. “You have to follow a crawl, walk, run approach—that is, start in a phased approach. You can’t just jump in. You need to work with your partner to put phases into place,” she explained.
Software experts say it’s important to work with a technology expert who is also well versed in regulatory requirements for the device industry. They caution that some of the more generalized software providers may not be properly accounting for the specialized needs of medical product manufacturers.
This figure illustrates how today’s software can help streamline operations. Graphic courtesy of Pilgrim Software.
Technological Advances Address Vast Needs
The medical device sector certainly has its share of differentiating needs. Luckily, software developers are developing a wide range of solutions for all these areas. Following is a sampling of what’s being offered today.
Streamlined documentation. Per-haps the top request by medical device companies is to acquire technology that can ensure device history records (or electronic batch records) are thoroughly documented. “A lot of offerings are now trying to offer the capability to support electronic device history records,” noted Daniel Olivier, president of Certified Software Solutions in San Diego, CA. “Automated records are a significant benefit in that you don’t have to process and retain manual paper records.”
Product Manager Susan Lamb, who works at Camstar’s regional office in San Jose, CA, additionally reported that automation helps prevent human error that can lead to an incomplete audit trail or, worse, product quality issues. “Errors can be fixed, but it may be very time consuming and risky. You don’t want rework and product quality assurance to become bottlenecks.”
Today, everything from CAPA documents and design history files to device history records are being stored electronically. Financial recordkeeping is also being scrutinized with the advent of the Sarbanes-Oxley Act—no device company wants to risk going to the way of an Enron scandal. With an automated process, “companies can easily attest to the accuracy of their financial records,” said Tim Lozier, strategic development manager for EtQ in Farmingdale, NY.
Advanced risk management. FDA regulations and other industry guidances and standards (such as ISO 13485 and 14971) are now placing a spotlight on risk management and improved quality processes. “With more scrutiny from the FDA and mass media exposure on regulatory warnings, both OEMs and contract manufacturers are getting more pressure to meet the demand of higher quality and compliant products,” Willett said. “Pilgrim’s solutions not only provide support to improve quality systems to meet regulatory compliance, but also offer the benefit of helping continuous improvement for customers to achieve operational excellence.”
In the past, risk management wasn’t so much a mandate as it was a good manufacturing process. While industries such as automotive have been doing this for years, it’s now becoming just as important to device manufacturers and their outsourcing partners.
Today, software can actually help companies determine risk factors in the manufacturing of a device and calculate the probability of them occurring. EtQ offers software featuring a formula-driven risk table that helps evaluate the level and severity of risk within specific processes. “This software has the ability to automate risk assessment and document it in a digital format so nothing falls between the cracks,” said Lozier. “You can issue a corrective action based on solid, quantitative risk data.”
New European regulations that restrict use of hazardous substances (RoHS) in new commercial products are already affecting medical equipment, which could also lead US manufacturers who distribute overseas to acquire risk-mitigation software during this transition period. According to Ihlenfeldt of Minnetronix, this regulation will directly affect companies whose devices include printed circuit boards, for example, because these are currently built with non-compliant components.
“All of our parts now have to be classified according to their RoHS-compliant status, and our systems have to support that,” she explained, noting that more software developers may try to create technology to help companies achieve compliance with this newer requirement. Her company already improved its internal database management system by adding new features, such as fields that allow users to specify whether parts are compliant with this regulation.
Automated manufacturing. Another major trend software companies see is the use of technology to help automate manufacturing systems. Camstar is one business offering a manufacturing compliance solution that provides real-time data about manufacturing statuses. “Dashboards are important to manufacturers,” Parsons reported. “They see these systems as a key area where they can improve efficiency. Adding visibility into things like their capacity, work in process and yield performance gives them better decision-making abilities.”
Brooks Software also launched its MEDIC suite of products in January. This system tracks a product’s history and all aspects of production. “We’re taking the functionality of many applications and bringing them together and applying them in medical device manufacturing,” Nestel-Patt said.
Product simulation for testing. In the quest to reduce time to market, medical device innovators are relying on newer technology to help reduce physical product testing and learn more about the device’s performance by using CAD-embedded simulation software. MSC Software created its SimDesigner platform to help inventors validate products, understand performance and reduce the testing cycle while minimizing risk.
Designers have traditionally relied on technology that was “too sophisticated for anyone other than PhDs to use,” explained Rickey of MSC Software. Since applications such as MSC’s solution are now being embedded in simpler CAD-based technology, simulation is easier to achieve for people with varying levels of technical knowledge. And managers or suppliers can get access to the data more easily.
Secure systems. As outsourcing proliferates in the medical device industry, intellectual property often circulates among partners. Many OEM executives may fear that electronic-based platforms are placing the company at risk for information reaching the wrong hands. That’s one reason Austin, TX-based Pinion Software developed its products for what’s known as “Technical Rights Management.”
The benefit of such software, said Michael Staley, Pinion’s director of marketing, is that information from a variety of technical and business applications (including CAD, Word, PDFs, etc.) can be readily shared in a protected environment. The user forwarding information can assign certain viewing rights and even limit a reader’s capability to cut and paste or screen-capture sensitive data. In addition, users can control the viewer’s use of printing documents or even go so far as to assign a time limit for viewing (at expiration, the document will erase itself from the screen).
“People understand that if they are outsourcing and sharing valuable information, a risk is there,” Staley said. “Our solutions minimize that risk by controlling how the information is used.”
The Cost of Doing Business
While the benefits of automated technology are clear, the reluctance to convert from a paper-based system often stems from the fear an expensive transition. In reality, the cost can be as little as a few hundred dollars per user to several hundred thousands of dollars for a large system. The payoff is that “if there’s potential efficiencies to be gained on a larger production scale, the quicker you will realize a return on your investment in these tools—and it should also increase confidence with compliance,” said Olivier.
Steve Cagle, VP, marketing and product development for Sparta Systems in Holmdel, NJ, said one medical device client had 12 disconnected systems for managing deviations, investigations, complaints and change controls. After implementing Sparta’s TrackWise software, a global quality and regulatory compliance management system, all these applications were integrated and the company realized a $5.6 million savings. Furthermore the device company “is recognizing an ongoing return on investment of $300,000 per year,” he noted.
Lozier of EtQ has found that today’s new systems could generate an estimated 150% cost savings for companies over a three-year period.
One area that device companies are concerned with is the cost of upgrading systems over time. Since the FDA’s CFR 21 Part 11 deals with validation of systems, manufacturers know the agency places the onus on the software user to validate the system in place—not the software provider. And validation procedures can be expensive.
To reduce the need for upgrades (and consequent revalidation), many software vendors are ensuring that their “off-the-shelf” products are flexible enough to be easily reconfigured by the user—that is, they don't have to rewrite software code to rename fields or change users’ access to data.
In the Pipeline
As familiarity with automated systems takes hold, the logical progression of software technology will be more integration and merging of systems such as those used for quality assurance and CAPA records. “Most companies have a hodgepodge of little stuff,” said Olivier of Certified Software Solutions. “The integration is really incremental in terms of bringing some of these things together. It’s going to be a trend.”
One way this will be achieved is by using what’s called service-oriented architecture—sort of a “one stop” solution that integrates various systems. While software experts say these platforms aren’t fully developed yet, the future will see many efforts at refining this type of technology.
As automation plays a bigger role in the medical device industry’s documentation and manufacturing processes, executives are gaining more confidence in their operations and management. The flow of information is seamless, trends can be evaluated in real time and a variety of risks are reduced—all leading to speed to market, lower costs and peace of mind.