Tamar June09.08.06
Medical Device Companies Harness the Power of On-Demand Quality Solutions
By Tamar June
AssurX, Inc.
With the healthcare industry under growing pressure to curb costs and improve quality, nowhere is that more clearly evident than in the medical device arena.
The impact of failing to maintain product quality—which can result in a costly product recall—is made crystal clear just by taking a glance at some recent history for Boston Scientific Corporation. Amid all of its other recent quality problems, including those stemming from recently acquired Guidant’s defibrillators and pacemakers, in July the company reported that it might have to put off the launch of its new drug-coated stent because of a delay in clearing up thorny issues with federal regulators.
If medical device manufacturers are under pressure for ensuring top-notch quality and safety, they’re most definitely feeling the heat when it comes to cost, too.
Med-tech companies have drawn the very public ire Capitol Hill lawmakers, who talk about a “medical arms race” between hospital systems outbidding each other to get the most innovative technology. In rhetoric reminiscent of the Cold War in the 1980s, when the United States and Soviet Union engaged in a nuclear arms race, leading lawmakers such as Minnesota Senator David Durenberger have launched major investigations to determine the role of medical technology in escalating healthcare costs.
Therefore, perhaps it should not be so surprising to learn that some medical device enterprises have begun embracing a new way of doing business that can save time and money while immediately improving product quality. It’s called OnDemand software, or Software as a Service (SaaS), and if you aren’t already exploring it, you probably should—now.
The Story Behind OnDemand
The cost of poor quality for suppliers and purchased parts impacts every aspect of the business. Shorted and wrong deliveries disrupt product schedules, and often the result is poor quality due to expedited and shifted schedules that lead to late shipments, unhappy customers and potentially cancelled orders. Nonconforming purchased parts increase costs, lengthen cycle times and consume expensive labor hours tying up inspectors, buyers, engineers and managers.
All of these issues can hurt the bottom line and, far worse, hurt or even potentially kill those using your medical devices.
Getting suppliers and purchased part quality under control can improve operations at nearly every level of the company—including purchasing, quality, manufacturing and engineering.
It is critical, therefore, to have a system in place that ties together all of these functional areas. It must automate and help manage supplier qualification and auditing, as well as deal with delivery issues and non-conformances. The system should be able to assign findings, track follow-ups and issue reports. It should consolidate supplier information and calculate supplier scores based on performance—in real time. In addition, it should feature executive dashboards, task status reporting and query tools that are configurable and provide everything needed for ad-hoc queries. Most importantly, it should be configurable to ensure you can modify forms, fields and workflows to match the way you do business both now and in the future, if you need make changes to the system.
“A medical device company’s supplier should have a quality system that provides a closed-loop process for recording and responding to supplier quality issues immediately,” summed up Sal Lucido, vice president of enterprise solutions at AssurX.
Enter OnDemand quality and compliance software solutions.
The OnDemand trend has been in the works for many years in market segments beyond medical devices. For example, in 2003, Business Week named Salesforce.com CEO Mark Benioff one of its top innovators. “Wags in the technology industry used to poke fun at Marc Benioff and his pint-sized startup, Salesforce.com Inc. No more,” the magazine said. “That's because Benioff, more than anyone else, is demonstrating to corporations that buying software delivered as a service over the Web is a viable alternative to software packages that can cost hundreds of thousands of dollars and take months or years to install.”
A Beneficial Tool
Like other industries, many medical device companies already are enjoying the benefits of OnDemand solutions to enhance supplier quality. The software comes ready to use, and it doesn’t require the typical capital expenditure for hardware and software. Following are some of the particular benefits of this software.
Software-as-a-Service comes with everything. There is no need to install software, no hardware or databases to purchase, no complex backup systems to implement and SaaS typically comes with ironclad security features. In addition, new features and upgrades are available immediately. Such full-featured quality solutions formerly were only affordable to large-sized companies but now are available to companies of all sizes. The system is fully functional and validated—including robust audit trails and compliance with 21 CFR Part 11—with no restrictions on the client operating system or version. The same goes for the client browser or browser version.
It allows for immediate implementation of business processes and time to value. Among the best features of OnDemand software is its ability to allow both small- and large-sized businesses to deploy a solution immediately rather than waiting weeks, months or even years to do it in-house. Among the more obvious benefits this offers a company is that overworked IT staff are freed up to work on other mission critical applications. For smaller firms, this is ideal because it allows them to implement electronic systems for their quality processes that would otherwise be too costly and complex to do with traditional software. OnDemand solutions also allow for the flexibility to add or delete users immediately or on an “as needed” basis.
Real-time metrics are a handy feature. OnDemand provides “management dashboards” by monitoring corporate performance for the entire enterprise or by division, function and department. By leveraging the software, a medical device company will see instant performance metrics for trends, cycle times and costing. It also will have drill-down capability in all reports using tabular data and navigation to individual records. This helps to produce management reports on trend elements—including products, problems, cause (reason) codes and costs—by department, function, division and the entire enterprise. It also provides reports that cover cycle time (eg, response, resolution, planning and implementation) or activity cost reports (eg, labor and material costs, among others) that isolate a month, quarter or year.
The software facilitates fast response and global access. This translates into fast performance—on average, sub-second response times—from low bandwidth locations, such as dial-up or overseas, because all that’s needed is a simple Internet connection to access the data.
Perhaps the best feature of OnDemand software is that there is no additional client software to worry about. Any browser on any type of computing device will work—even handhelds or Internet-equipped mobile phones.
Medical device companies harnessing OnDemand software solutions can provide access to business partners and key suppliers via restricted logins and other field- or record-level security options. In the end, all those involved in bringing product to market will achieve a much higher level of quality, reduce errors, increase productivity and the overall bottom line for everyone.