A medical device manufacturer implements management system software to help it fulfill its desire to expand its customer base to the United States.

Birmingham hip resurfacing (BHR) provides an alternative to total hip replacement for patients suffering from abnormalities of the hip, including osteoarthritis, and has found critical acclaim worldwide. Source: Simth&Nephew UK Orthopedics Ltd.

Pioneered by United Kingdom orthopedic surgeons Derek McMinn and Ronan Treacy, hip resurfacing replaces the surfaces of the hip joint, leaving the femoral head substantially preserved. This is a less invasive bone sparing approach to treating arthritis in younger or more active patients. The system uses proven low-wear metal-on-metal bearing surface technology and the broad hip head design offers a high range of motion and excellent stability. More than 80,000 surgeries have been performed since Birmingham hip resurfacing (BHR) was introduced in 1997.

Evolution of a Cutting-Edge Business

Simth&Nephew UK Orthopedics Ltd.’s (S&N, London) metal-on-metal group evolved from the acquisition of Midland Medical Technologies (Birmingham, United Kingdom) in 2004. With an initial staff of 18, two of whom were in manufacturing, the majority of the BHR workforce focused on sales and marketing. The challenge ahead for the organization was to grow its manufacturing capability in line with the projected growth for hip resurfacing. In addition, this would severely test the existing quality management system, which although adequate for small businesses, would not support the 100% growth S&N UK was looking for.

“S&N UK’s metal-on-metal group came about from the acquisition of Midland Medical Technologies,” says Dave Telling, senior manager quality assurance and regulatory compliance, S&N UK Orthopedics Ltd. “The management group realized that significant improvements were needed to take the division forward and the first step was to recruit a quality manager to ensure that the company had all the necessary systems and procedures in place.”

The medical device industry is subject to ISO 13485, which has specific requirements that require an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The standard requires that S&N UK can demonstrate that a quality management system is implemented and maintained.

“ISO 13845 is the recognized quality management standard for medical devices and the existing paper-based system was approved to this standard. However, we realized that to support the forecast growth we needed more control than the manual legacy system afforded,” says Telling.

Finding an automated solution to address S&N UK’s needs required the company to perform a thorough review of the quality management system market, eventually settling on Proquis SBS from Proquis Ltd. (Kent, United Kingdom).

“We looked at a number of software solutions and chose Proquis because it offered modules beyond typical quality management system modules and batch control. This would enable us to book goods in and also see our existing stocks. Proquis would allow us to see our inventory on screen and allocate specific materials to batches. This would give us more accurate control of our processes and underpin quality management,” says Telling.

With Proquis SBS, S&N UK implemented the fault logging, calibration, maintenance and document control modules. The system provided all S&N UK needed in a quality management system that would be accepted in the North American market.

Further Upgrades

The U.S. Food and Drug Administration (FDA) requires that all software is validated and complies to the rigorous Code of Federal Regulations Part 21 (CFR 21) for auditing, system validations, audit trails, electronic signatures and documentation as part of business operations and product development. This would prove an initial obstacle to S&N UK’s venture into the United States.

Following discussions with Proquis experts, S&N UK chose to upgrade its quality management system to Proquis Enterprise to meet FDA requirements. In May 2007 S&N UK rolled out the revised solution, using specific modules that would enable it to tap into the U.S. market. These were issues and actions, equipment control, document control and audit management. “After the system had been successfully validated in accordance with FDA 21 CFR requirements, it was used successfully during recent FDA approval audits,” says Telling.

The Birmingham hip resurfacing (BHR) product is approved by the FDA for use in the United States and is recognized as the leading hip resurfacing product globally. Source: Simth&Nephew UK Orthopedics Ltd.

Putting Proquis Enterprise into Action

“We subdivide issues and actions into issue types,” says Telling. “This module is then used for incoming nonconformance receipts, internal manufacturing nonconformance and internal audit nonconformance. With such tight control we can then apply the measures FDA requires called corrective action preventative action, or CAPA, to address the issues. By capturing all nonconformances, CAPAs can be allocated to specific people and tracked through the system. This means that we now have all staff involved in quality management.”

All calibration is managed by the Proquis equipment control module. Each piece of calibrated equipment has its measurements registered within the system. This can then be used to create and allocate a calibration schedule, with automatic notifications sent directly to the senior inspector.

“The integration between Proquis and Microsoft Outlook has enabled key individuals within the business to be automatically notified of calibration requests,” says Telling. “This automation has allowed the quality engineers to use their time more effectively to study the calibration results instead of chasing equipment. We also can use the system with equipment that needs external calibration. The calibration certificate is scanned into the system and retained in the equipment record.”

The document control module can register and hold all documents but S&N UK has started with only the quality management system documentation. This provides a secure and tamperproof system. “The document control module has provided automation of a key process,” says Telling. “This ensures that documents are approved and released in correct sequence without failure. It also provides management with a clear overview of document status.”

S&N UK has eradicated paper documentation and the system ensures that it has no uncontrolled documents. The document viewer allows read access only so that all staff can see the documents they are interested in via a PC with a web browser. In addition, Proquis allows S&N UK to set system parameters to allow eligible people to comment and amend documents with a full audit trail that show exactly who made changes and when they were made.

Using the audit management module, S&N UK schedules, plans, monitors, records and reports all of its internal audits. “Proquis allows us to not only schedule and plan our audits, we also can update progress of each audit,” says Telling. “Any evidence we pick up during the audit is scanned into the system and held on a specific audit file. Any findings that are classed as nonconformance are linked directly to issues and actions, which then puts in place the necessary follow-up actions. After an audit is complete, we can assign final closure and verification via the system.”

Minimizing Effort, Maximizing Gains

“The overall key benefit of the system is the modular approach it provides for managing a quality system,” says Telling. “This approach encourages all users to methodically execute and record activities, thus providing for a full systematic review.”

As far as system purchase costs are concerned, Proquis Enterprise has now paid for itself and S&N UK is set for repeated successes as it pushes forward its plans for its groundbreaking hip resurfacing system.

“The return on investment on Proquis was achieved in approximately 12 months by minimizing effort and manpower associated with day-to-day quality management. This benefit was further amplified during subsequent notified body audits,” says Telling.
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  • Simth&Nephew UK metal-on-metal group saw a return on investment approximately 12 months after purchasing the Proquis system.

  • Through use of the Proquis system, S&N UK has achieved compliance to ISO 13485 and the FDA’s CFR Part 21.

  • S&N UK now can sell product in the United States thanks in part to the Proquis system.