A number of market trends are driving the adoption of lean initiatives in the medical device industry:
- Greater FDA oversight of outsourcing coupled with a significant increase in the use of outsourced resources. This is leading to more refined supplier selection processes, as well as tighter quality checks and tracking of incoming data (including documentation) from suppliers.
- New and expanded sales channels. The emergence of these channels demands a more streamlined approach to communications with the sales function, and has driven the need for reduced lead times from quote to order to production.
- The need for streamlined fulfillment. To meet rising customer expectations, agile delivery of products is essential. The quality and traceability of all products shipped must be safeguarded, while also ensuring that products are matched to unique, country-specific requirements.
- New regulations. Medical device manufacturers need to be ready to cope with the uncertain and often changing regulatory environment.
An Aberdeen Group study shows how best-in-class manufacturers are leveraging IT tools and architectures (e.g., business intelligence, master data management, service oriented architecture [SOA], business process management) to support business process improvement. A recent webinar sponsored by Epicor and moderated by the editor-in-chief of Medical Device and Diagnostic Industry (MDDI) featured a detailed case history of a medical device manufacturer successfully leveraging ERP to support its effort to implement leaner processes, underscoring the Aberdeen findings.
Webster, Texas-based IDEV Technologies, Inc. is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery, and cardiology. The company started operation in 2000, had sales of $9 million by 2010, and a sales target of $40 million in 2012. According to Carl Heeder, director of ERP at IDEV, like many companies who grow very fast, IDEV had implemented ERP but failed to leverage its capabilities for value. In 2010, the company made a number of decisions to change that:
- They determined to re-implement their Epicor ERP.
- They decided to employ tailoring to make processes leaner.
- They geared up their system validation capability.
At that time, IDEV’s environment was in need of change. All quality process and many manufacturing ones were paper-based. They had no experience with software validation, in light of 21 CFR Part 11. Because it was essentially a start up, there was a lack of focus on efficient processes, and a clear need to focus on lean techniques.
“By tailoring, we mean using features inherent in the software to add or modify controls, limits, and actions of processes,” says Heeder. “The Epicor core processes remained intact; there were no code changes to delivered processes; we tailored to add functionality before or after standard processes.”
IDEV focused on three process areas to begin implementing lean techniques: purchasing and supplier, sales order, and shipping. “None of these were manufacturing per se; but they were most promising for achieving lean efficiency and quality improvements,” says Heeder.
To see the details of how IDEV improved these processes, look at the webinar. The overall results were impressive, moving the enterprise toward its goal of shifting from manual processes to systems-based processes:
- Eliminated the need for manual review of each PO.
- Achieved better control of time-sensitive inventory.
- Eliminated the need for hard-copy sales order approvals.
Eliminated manual verification for each shipment.
Posted by the Epicor Social Media Team