A Prudent Investment


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by Mark Crawford, Contributing Writer
April 25, 2011 

Investing in the right software keeps you on the leading edge of productivity and compliance. 

It’s confusing and costly, but taking the plunge and investing in advanced software solutions could be the smartest capital investment you make this year, with a payback period of six to 12 months after implementation.

In many ways, software is the magic bullet for everything medical device manufacturers (MDMs) or their suppliers find vexing, such as adverse events, slowdowns, communication failures, U.S. Food and Drug Administration (FDA) recalls and validation issues. Across the increasingly complex compliance landscape, software is essential for adhering to worldwide standards, such as ISO 13485, ISO 14791, 21 CFR 820, 21 CFR Part 11 and others. Precious,glorious speed—from reacting quickly to changing market needs to submitting electronic medical device reports (eMDRs) to managing product complexity—is driven by software.

“More MDMs are including software and other leading-edge technologies such as mobile/wireless in their products,” said Nikki Willett, vice president of product marketing and regulatory affairs for Tampa, Fla.-based Pilgrim Software Inc., a provider of enterprise risk, compliance and quality management solutions. “The complexity of many medical devices, combined with the additional complexity of software and mobile/wireless technology, is requiring manufacturers to step up their risk, compliance, quality and validation processes and initiatives—from design through production—to ensure the highest level of product quality and minimal issues and cost through the product value chain.”

What OEMs Want

IT departments increasingly are looking for solutions that operate in a virtual environment, such as the cloud. Software as a Service (SaaS) is becoming more popular in the compliance industry and many vendors are offering SaaS solutions in addition to their “on premises” solutions.

“On-demand, cloud-based or SaaS deployment is the easiest to use, fastest to deploy and most affordable delivery method for supply chain quality applications,” said Karim Lokas, vice president of product strategy and marketing for Camstar Systems Inc., a Charlotte, N.C.-based provider of software solutions that advance product quality in the manufacturing industry. “These also provide manufacturers with unique business benefits that are simply not possible with traditional client/server solutions.”

The SaaS delivery model allows customers to have greater scalability of their quality systems. Instead of just having the software installed at individual sites, multiple sites can be set up to share data and conduct comparative analyses. Medical device manufacturers also can view real-time quality data at their supplier’s sites. The software provides visibility into the shop floor manufacturing operations of suppliers, so that manufacturers have more control over the product they are ordering.

“Other advantages of the on-demand delivery model are rapid deployment (the system can be up and running within days) and the fact that minimal, if any, IT support is required,” said Elizabeth Clor, director of marketing for InfinityQS International Inc., a Chantilly, Va.-based company that provides real-time statistical process control (SPC) software. “Customers who are leveraging this solution are benefitting from the ability to improve quality at a global level, not just at a single site.”

Real-time SPC software uses proven statistical methods to proactively monitor quality while products are on the manufacturing line. SPC data provides predictive analysis that enables manufacturers to perform corrective actions that prevent defects from occurring. This proactive approach to quality management saves medical device manufacturers the time and money of having to scrap product or rework it once it comes off the line.

“New emphasis is being placed on going beyond monitoring for compliance to using sampling strategies that correlate process inputs and outputs in real time,” added Clor. “This way the same data can be used for both compliance and predictive analysis.”

Perhaps the latest trend in improving and streamlining quality lies with how companies prioritize and make decisions on adverse events.

FDA Compliance

As technology progresses, an increasing number of medical devices rely on embedded software as a control component, such as infusion pumps, implantable cardioverter defibrillator devices and ultrasound imaging/therapeutic devices. There also are standalone software solutions for electrocardiogram arrhythmia detection, radiation therapy treatment planning, and PACS (picture archiving and communication systems).

Software is an evolving area of regulation and remains a high priority for the FDA and international regulatory agencies. Medical device software now includes aspects for integration of medical data output from devices with electronic health records, which have been promoted as a cornerstone of planned healthcare reform. The FDA also has released the final rule classifying medical device data systems (MDDS) that transmit, receive, store and display medical device data. This new MDDS regulation will affect many products that were not previously regulated and now need to meet FDA quality system regulation requirements.

“Hospitals and clinics that have incorporated systems and networks with software that manage medical device data are concerned that the FDA may come knocking to conduct an inspection regarding the 21 CFR Part 820 quality system regulation, in case they really would be now classified as a medical device manufacturer due to the MDDS regulation,” said DennisRubenacker, senior partner with Noblitt &Rueland, a medical device consulting and training firm in Irvine, Calif., that specializes in strategic FDA and international regulatory and quality issues. “Also, with the new software technologies for mobile apps that are now becoming readily available for use by the general public on cell phones and tablets, such as diabetes disease management applications, the FDA is concerned whether these mobile software applications are really medical devices. Some might actually require FDA 510(k) or other submissions to be reviewed by FDA prior to marketing.”

Many companies are taking advantage of software to comply with Title 21 of the Code of Federal Regulations, Part 11 (electronic records and signatures). These regulations allow medical device manufacturers to take full advantage of electronic technology while ensuring their implemented systems are aligned with the FDA’s responsibility for protecting public health.

“Of the upmost importance are well-defined security practices around data access, such as password encryption, password uniqueness, maximum password age, minimum password length, account lockout plus other password management functionality,” said Clor. “Other compliance needs include reason for change tracking, data record change history reports and retention of all edited records.”

Supply Chain Management

Globalization and outsourcing have become increasingly prevalent in the medical device market. These trends are forcing the industry to manage more extended, globally dispersed, complex and risky supply chains—a growing concern to industry executives. This was a key finding in a major research study of 112 life-science industry executives conducted by Axendia Inc., titled “Achieving Global Supply Chain Visibility,

Control and Collaboration in Life Sciences: Business Imperative, Regulatory Necessity.”
According to the research:

Fifty percent of executives said raw materials sourced outside of the United States as the greatest vulnerability to thesupply chain;

  • Sixty-one percent viewed contaminated or nonconforming raw materials as the top threat in the next five years;
  • Seventy-eight percent said global sourcing outside of the United States will increase; and
  • Seventy-six percent said their global manufacturing outside of the United States will be increasing.

According to the FDA, the registered device owner is fully responsible for the end quality of its products. MDMs realize the best way to reduce these risks (and boost profits) is by implementing manufacturing and supply chain quality software that connects with product/process design models to enable more agile, less burdensome product quality verification and compliance traceability.

“This awareness is driving more integrated software solutions for product quality planning, execution and closed-loop feedback lean/paperless manufacturing and compliance, such as electronic device history records and electronic certificates of compliance,” said Lokas. “This not only lowers compliance overhead and creates more agility for varied product configurations, but also shortens cycle times and improves product quality. Closed-loop quality management allows for tracking product quality and failure analysis from manufacturing, supply chain and aftermarket and feeding back for design, manufacturing control and supplier controls improvement.”


About four years ago, a division of Medtronic Spinal and Biologics in Warsaw, Ind., was using two separate software packages—one for statistical process control (SPC) and one for acceptance sampling. The company then implemented a single solution from InfinityQS that performed both functions and also easily tracked SPC and acceptance sampling results on a batch-by-batch basis.

“Our results from the implementation at our facility have been overwhelming,” said Patty Steele, project coordinator with Medtronic Inc. “We are now able to track data with the click of a mouse that would have taken several man hours to do previously. The software also saves the validation team time in manipulating the data; they can export the data into third-party analysis software like Minitab without manually re-keying the data. This eliminates data entry errors.”

Regarding return on investment (ROI), there is the obvious cost savings in paying for one system instead of two separate systems, as well as reduced labor costs. “We have found that it takes less time to operate the system from a user level and from the engineering level,” commented Steele. “We have also been able to advance our paperless initiative within our facility, drastically reducing the amount of paper that follows each batch through the system, thus reducing scanning and storage cost after the batch is shipped.”

Parting Thoughts

Somewhat surprisingly, according to Lokas, fewer than 50 percent of device manufacturers have invested in this kind of advanced software. Supply chain complexity is a big cost and risk factor, especially for Tier-1 and Tier-2 companies, yet there is still a lack of awareness.“These companies are starting to accelerate adoption because they cannot continue to operate by human heroics and endeavor, like some smaller companies can,” said Lokas. 

“Tier-3 and Tier-4 companies can still brute-force it. Historically the cost of enterprise software has been quite expensive. Now cloud-based software makes it much more affordable and user-friendly with a very low learning curve. Before making the transition recently, one of our customers employed four to six inspectors to find possible problems; now there are fewer issues and they are solved by one person getting instant notification by exception only.”

The price tag, of course, varies according to a wide range of variables, including the size of the company and whether the advanced software applies to manufacturing, quality, supply chain, etc. A ballpark cost for a cloud solution, for example, might range from $80,000 per year to $250,000 per year or more, depending on the complexity of the operations and scope of solution.

At this level of investment Lokas estimates an ROI of four to 12 months. “This doesn’t include intangibles such as brand protection, market share impact, and reduced cost of recalls,” he said.

Lozier recommended doing thorough due diligence. Look at all the major players and get hands-on with the tools. Ask for on-site workshops, references and details on the overall financial health of the vendor.

“Software is an investment and you want to make sure you test-drive the solution as much as you can,” he said. “Sometimes software ‘shows well’ but then doesn't perform the way it should.Vet the solution as much as you can and find a vendor you can trust.”

Ultimately software implementation is all about people—the right teams need to be in place to ensure success.

Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. 

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