Medical Device Reprocessor Enjoys Clear Visibility with Cloud-based SAP Business One Solution
Control and Lot-Tracking of All Materials Attached to a Device as Part of the Reprocessing Cycle
ReNu Medical, Inc. is an environmentally safe and sustainable medical device reprocessor, delivering the most sustainable, cost-saving, environmentally beneficial “green” reprocessing programs to hospitals and healthcare facilities nationwide, while maintaining the highest quality and safety standards. ReNu Medical’s ecologically friendly processes save nearly 250,000 pounds of non-critical medical devices from U.S. landfills every year. The company’s level of compliance with the FDA is unparalleled, passing a Quality System inspection with absolutely zero deficiencies in their most recent inspection in December 2014.
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It’s Hard to be “Green” in a Sea of Paper
ReNu Medical sets the standard for “green,” utilizing only the most environmentally responsible methods for reprocessing medical devices. However, for many years, one facet of the company’s operations challenged their unwavering commitment to this approach – different business applications were not integrated, causing staff to rely on manual, paper-based output for reporting and FDA compliance. According to Amy Long, one of ReNu Medical’s Directors, “The amount of paper we were using to run our business was inefficient, wasteful and not in sync with our commitment to running a green business.”
ReNu Medical employed a combination of three different disconnected systems – one application for accounting, one for operations and one for customer service and sales. The lack of integration between these three applications made it very challenging to maintain data, generate custom reports and meet its customers’ demands for analytics. “The old system was inefficient in that it was slow in handling the 70 million (and growing) transactions required to operate,” said Long.
Ultimately, these systems did not have the flexibility to keep pace with ReNu Medical’s growth, which led management to initiate a search for a viable replacement. “We wanted a streamlined, more environmentally responsible solution that was in alignment with our core values as a company – one that would support our green business model and create production efficiencies, capture strategic data points and expedite the turnaround time of reprocessed medical devices for our customers,” said Long.
A Match Made in Cloud Heaven – Softengine, ReNu Medical and Hosted SAP Business One Form an Unbeatable Team
One critical requirement of the new solution was that it be “cloud”-based. “With the astronomical number of data points we have to control, the last thing we wanted to worry about was the risk of server crashes or data corruption issues due to any failures of an on-premises solution,” said Long. “We also didn’t want the expense of additional IT personnel to support the system.”
The company’s search led them to SAP Business One and Softengine (www.softengine.com), an SAP Business Partner who possessed the expertise to help design and implement a flexible solution that supported their vision.
A key selling point was Softengine’s experience and comfort level with SAP Business One Hosted. This “cloud”-based solution greatly reduces IT expenses and virtually eliminates the risk of a catastrophic database failure, while providing safety and security through a hosted state-of-the-art datacenter.
The complete SAP Business One Hosted solution for ReNu Medical provided total ERP and accounting capabilities – all combined into one unified platform, plus a number of Softengine SAP Business One extensions, including WMSm Warehouse Management System mobile, Production System and UPS/FedEx/USPS Shipping Integration.
There was tremendous synergy between Softengine personnel and our team,” claimed Long. “Right from the start, I could tell they were united in purpose and fully prepared to see us through a long and complex design and implementation. They gave us a commitment up front that they were willing to take the time to fully understand our unique methodologies and to make well-considered recommendations to help us achieve the greatest possible efficiencies.
There were several critical control points that SAP Business One was entrusted to capture, including:
- Tracking of devices every time they enter (or reenter) the process.
- Tracking the number of reprocessing cycles for each device so that it is removed from the process and discarded after reaching its predetermined lifecycle.
- Control and lot-tracking of all materials attached to a device as part of the reprocessing cycle.
Upgrading from an inefficient (and potentially error-prone) paper-based system to a fully integrated and automated system was essential for streamlining the FDA reporting process. George Biggins, Senior Quality and Regulatory Affairs Specialist at ReNu Medical noted, “Medical device reprocessors are part of an industry regulated by the FDA and, as such, production records are always audited during regular FDA inspections. Thus, it was vitally important that the new SAP Business One system possess all the functionality necessary to achieve these goals.”
A key piece of the new configuration was Softengine’s Warehouse Management System mobile (WMSm) extension, which augmented the core functionality of SAP Business One to help ReNu Medical meet all the production reporting and documentation requirements for the FDA. Specifically, WMSm enabled ReNu Medical to capture new QA data points at each production step, which eliminated the lengthy paper trail generated in the past.
Our process is unique and must strictly adhere to FDA regulations,” said Long. “Softengine’s WMSm extension enabled us to authenticate all the steps required for our unique process and provide complete traceability and documentation.
Another compelling feature of the overall system upgrade was the installation of very large, “smart” TV monitors that displayed up-to-the-minute department and production schedules. These displays have proven to be a very effective sales tool, as clients visiting the facility can see the progress of customer orders on-screen, in real time, as they move through the different production phases of the process.
Green is the Color of Success. Sales are Way Up and Paper is Way Down.
ReNu Medical is riding the crest of a growth wave and the new SAP Business One Hosted solution is growing and adapting right along with them. As a company determined to stay true to its mission as an environmentally responsible enterprise, the virtual elimination of paper once used for documentation has delighted Amy Long and her associates.
With SAP Business One and Softengine’s extensions, we now have further visibility into our entire process from beginning to end,” claimed Long. “We recently completed two consecutive record-breaking months in terms of sales and devices processed. In addition, the ability to access production information on-demand has been incredibly helpful in responding to customers.”
Amy Long is no less effusive in her praise of Softengine’s can-do attitude and perseverance in shepherding the design and implementation to a successful conclusion. “Softengine did everything it took to get the job done, which involved a number of tweaks to the system to meet all production and regulatory requirements. The spirit of collaboration that existed between our two teams was and continues to be an exquisite non-tangible asset that money cannot buy.”