A medical device manufacturer increases output while maintaining a high level of quality through the use of software that manages enterprise risk and quality.

Neurostim Design and Innovation (NDI) Medical (Cleveland) develops, manufactures and markets implantable neuro-stimulation products including leads and implantable pulse generators (IPG), external devices for patient controllers and clinician programmers. Quality is the standard and other goals revolve around it. The challenge for NDI was how to stay on top and improve timing and cost in a very competitive environment without sacrificing high levels of quality. “When developing new products, how can we accelerate time-to-market while ensuring that our Class III medical devices meet all FDA regulatory and ISO quality system standards?” asks Michael Haessly, director of operations and quality for NDI Medical.

A veteran of quality operations, Haessly knew that the best way to improve timing and cost without sacrificing quality was to eliminate nonvalue-added tasks, wait time and waste. Like most organizations, at NDI the most glaring problem was the manual procedures associated with quality. Without a cohesive enterprise system for quality, various processes such as design document approvals, managing nonconformances and corrective actions were paper- and spreadsheet-based or completely manual.

Wait time was a leading candidate for Haessly’s timing improvements. Document and change approvals were taking far too long. First, manual workflow caused the folder to sit on an individual’s desk awaiting approval until they had time to work on it, or while they were tracking down the information they needed to approve it. This happened multiple times depending on the number of approvals, and delayed other approvers from performing their review and approval of the document.

“A second challenge to the manual process was that it also was possible for the document to get lost in the paper shuffle on an individual’s desk, or when the document could not be found, reissuing the document and resubmitting it for approval restarting the whole process over again,” says Haessly. “This significantly impacted the rate at which we could make design changes, resolve nonconformance issues and issue corrective actions. Although our process was rigorous and assured quality, its manual nature impacted our ability to accelerate the time to market and added unnecessary labor costs.”

Because of the multi-faceted nature of these processes, traditional linear workflow was too simplistic and did not provide access to the wide range of information gathered in the manual process to facilitate sound decision-making. When developing a wish list for its ideal quality management and risk control solution, NDI Medical’s requirements totaled 30 pages, and touched on a wide variety of functions including robust document control, tracking and escalation of tasks, corrective and preventative action processes, auditing, nonconformance management, calibration and supplier management capabilities.

Most importantly, it was essential that these components all be linked providing staff fingertip access to the information needed to assure existing levels of quality. In addition to producing the product effectively, NDI requirements also mandated the ability to meet FDA requirements, ISO 9000 quality management system requirements, ISO 13485 requirements and be 21 CFR Part 11 compliant. Lastly, but just as important, NDI wanted a solution that would not increase IT costs for maintenance and system support.

The Right Solution

After reviewing several options, NDI Medical chose IQS’ (Cleveland) Enterprise Risk and Quality Management software to meet its requirements. “IQS stood out from the other options because it was like a carefully woven web,” says Haessly. “Document management for us wasn’t simply routing the documents, but providing access to all of the information needed to make sound business decisions, at the click of a mouse. In addition, the automated routing of information drastically reduced our approval times. Access to all information required reduced analysis and approval time, and the to-do lists and tracking virtually eliminated the time we use to spend tracking down missing documents, nonconformances and corrective actions.”

With IQS’ built-in flexibility, NDI established a process in which approvals are sent out in parallel to all approvers for independent review and approval, without having to wait for the document to show up on their desk. In addition to tracking approval status, IQS enables the author of the engineering change to manage the change process and work with those who were still pending approval of the document.

“One of the greatest items is that the IQS system maintains a to-do list of activities which highlights actions that an individual needs to address through the system,” says Haessly. “Tied with this list is the ability to send out reminders-both automated and manual-to personnel as well as management that tasks are coming due and need to be addressed before they become overdue to keep the project on track and on time.” Also available in IQS is the ability to delegate tasks when someone is out of the office so that tasks requiring action can be executed during vacations, travel, etc. Finally, with IQS all of the quality data and documents are embedded in the system and delivered electronically, which prevents documents from getting physically misplaced or lost in the process.

“The tracking and escalation capability makes us efficient on several levels,” says Haessly. “Once rules are in place, processes are automatically escalated extending the reach and ability to keep things on track. Managers and staff alike have accountability built into their day, which supports a value-added tie-in with lean initiatives. Let’s be honest, running around trying to manually process documents is a nonvalue activity for any business.”

“Another significant benefit of the IQS system is that our ability to process change orders has dramatically increased,” says Haessly. “A change order for us can be the result of design improvements to increase the yield and/or speed of the manufacturing process, reduce costs, etc. They also can be systematic improvements just to improve the speed and efficiency of internal processes such as reducing the time to market for a new product. Finally, they can be the result of quality issues.”

Prior to IQS, change orders flowed through NDI’s manual system at a rate of 1 every 5.8 days due to the difficulty of processing the change, the amount of paperwork and the need to get handwritten signatures. “Since the implementation of the IQS system, we’re processing two plus change orders per day- an incredible improvement,” says Haessly. “Clearly stated, the rate at which change orders can be implemented has increased from 62 per year to more than 860 per year with the IQS system. This provides NDI with a tremendous competitive advantage in terms of customer satisfaction and quality improvement: the ability to initiate and approve change orders has dramatically impacted our response-time to the needs of our internal-manufacturing process-and external customers, and for quality issues, we’re catching them earlier in the manufacturing process-and in many cases preventing them back in the design cycle before they actually impact production.”

A byproduct of IQS’ high-level of connectivity and traceability is that by using the product on day-to-day basis, NDI ended up with turnkey compliance. Audits and validation became events that took hours, not days and weeks.

“A big advantage of the IQS audit system is that the results of the audit can be entered directly into the audit rather than maintaining paper-based notes throughout the audit process,” says Haessly. “This immediately eliminates the re-entering of audit information, which is a nonvalue-added task. Overall this has cut the time to process the audit results in half. In addition, we’re able to generate immediate observations and findings with the auditor rather than waiting for the closing meeting at the end of the day.”

The next phase of implementation includes converting manual-based systems for calibration requirements and tracking, adding product and component illustrations to IQS for accurate and timely data sharing, managing component cost data, using the IQS Web interface for supplier audits and communication, facilitating customer communication and satisfaction surveys, and project management.

“We take tremendous pride in the quality of our products because of the improved quality of life our products bring to the individuals who need them,” says Geoffrey Thrope, president and CEO of NDI. “Clearly we see IQS as a competitive advantage and a smart investment in the future success of our products and company.”
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  • With the IQS system, NDI Medical has improved manufacturing throughput by increasing change order processing from 62 to 860 annually.

  • The system allows NDI to pinpoint quality issues early in the manufacturing process.

  • The turnkey compliance NDI has gained through the system has reduced audit times from days to hours.