Millions of people suffer from lower back pain (LBP). It’s one of the leading causes of physician visits. According to British Medical Journal “Clinical Evidence”, over 70 percent of people in developed countries will experience low back pain at some time in their lives.
Lumbar spinal fusion surgery is a common surgical treatment for low back pain caused by degenerative disc disease. Often it is effective in reducing pain, but it limits range of motion and may require many months of recovery time. Each year in the US surgeons perform more than one million spine surgeries. The lumbar fusion segment of the spine surgery market is well over USD$1 billion in annual revenue in the US.
A less invasive approach
TranS1, a privately held company headquartered in Wilmington, NC, designs, develops, and sells products that treat degenerative disc disease of the spine’s lower lumbar region. Its new AxiaLIF System is a far less invasive approach to lumbar fusion. According to clinical studies it dramatically reduces patient recovery time in comparison to traditional lumbar fusion procedures. Typically patients are able to walk the same day of the surgery. Many are released from the hospital in as little as 24 hours and, may return to work within as little as 15 days.
Rick Randall, President and CEO of TranS1, says, “We offer surgeons and their patients a ‘two-stitch’ lumbar fusion alternative to the more invasive fusion and disc replacement therapies currently employed.” Since the introduction of AxiaLIF in 2005, surgeons have treated more than 2000 patients around the world with this minimally invasive solution.
As more surgeons are trained in the procedure the rate of adoption is increasing. Today, spine surgeons from 37 states and seven countries are using this novel approach.
Addressing operational pain points
In addition to increasing market share with its AxiaLIF product, TranS1 is on a growth path with other innovative products in the pipeline. The company is developing two mobility platforms: a disc replacement and a prosthetic disc nucleus, both delivered through this minimally invasive approach. In order to expand the company’s national and international reach, Randall and his management team knew it was time to invest in an ERP solution that could help them make needed operational improvements. An immediate priority was to achieve greater precision in inventory management to better understand such things as carrying costs and to facilitate better forecasting.
Additionally the team wanted to ensure U.S. Food and Drug Administration (FDA) validation of a new solution in advance of deployment. The goal was to start out right, reduce regulatory risk, get to work right away, and enable ironclad audit trail capabilities.
Finally, to keep up with lot traceability requirements in their quickly growing business, they wanted to automate lot trace.
Assessing solutions and making the choice
TranS1 assembled a team of representatives from each of the company’s competency centers to determine the requirements for a comprehensive ERP solution. Fundamentally, they wanted a solution to map to their top priorities and, more broadly, to provide an immediate and complete view of all business operations. And it had to match their budget size.
Validation turned out to be one of the fastest qualifiers of the candidates. “We needed a solution with the capability to model the FDA Quality Systems Inspection Technique (QSIT) to help ensure that the business system as implemented would meet the requirements for regulated companies,” says Greg Manson, Director of IT at TranS1. “And not many vendors could demonstrate that.”
From an initial field of 15 contenders, the team narrowed their search to two. Of those two, TranS1 selected FourthShift Edition for SAP Business One.
“We chose FourthShift Edition for SAP Business One for its solid SAP Business One foundation and because its integrated manufacturing modules support our business,” says Manson. “We knew it could help us address our top priorities and support us over the long term. And it stood out as the one that could help us execute the critical validation process.”
“We were pleased with the whole package,” says Manson. “And ultimately, what put FourthShift Edition for SAP Business One on top was the clear commitment to ensure our implementation success. The implementation actually was easy.”
Go live chart notes
“A basic law of technology is that you only get smart results from smart tools when they’re used by smart people,” says Manson, quoting James Owen at InfoWorld. The core team worked with SoftBrands consultants to review and adjust TranS1 business processes. “We built the business rules into the system and the system helped us create our business rules,” says Manson.
For instance, they configured SAP Business One workflow rules along with user profiles for appropriate access. They also defined preferred suppliers and supply schedules, and assigned identities to outside partners such as suppliers, transportation providers, and government agencies. And they focused careful attention to records management and the way data sources are handled to maintain referential integrity and to ensure that business rules are applied properly.
On the inventory front, Manson reports that the new system “dramatically reduced inventory cost.” One area of savings lies in the way field inventory is managed. In the past, field sales reps could ask for any inventory they wanted and it was shipped to them, a generous but costly and inefficient approach. Today each rep has a “stock and bin” that is visible and easily managed. The company replenishes quantity plus one, based on historical data derived from prior sales activity. As an indicator of newfound simplicity, the associated reporting to track and monitor field inventory is down from ten pages to just one page.
Validation was accomplished before cut over to the live system. Cheryl Wagoner, Quality Manager, considers this a must to reduce risk in implementation. “SoftBrands worked with me to customize the scripts we needed to use and the process moved very smoothly,” she says. “Overall I only had to spend about twenty hours to review, rather than spending weeks and weeks to write the scripts myself and then find somebody to review, since I can’t review my own work.”
TranS1 also found it important that the process is “risk-managed.” That is to say, it identifies the critical points at which FourthShift Edition for SAP Business One functions and data records intersect with specific cGMP (current good manufacturing processes) regulatory requirements and focuses documentation and audit/test coverage at those intersections, rather than giving equal attention to each FourthShift Edition for SAP Business One function.
The validation process and the SoftBrands consultants’ support gave TranS1 the peace of mind that its business system is operating as intended.
The third piece, implementing lot trace functionality, moved TranS1 from a manual, paper-based system to a fully automated system. Wagoner says, “In the past, when there were questions, we used to have to dig manually through records, which might take an hour or more if someone was available to dedicate the time. Now it takes just minutes to pull up pertinent information and I can do it at my desk.