LPE Medical is the preferred supplier of manufacturing services for orthopaedic reconstructive medical devices. To support the medical device industry LPE Medical has employed the latest quality techniques and current Good Manufacturing Practices to ensure that our customer and regulatory requirements are achieved and maintained. Throughout the continual commitment to quality LPE Medical has previously gained certification to ISO 13485 and ISO 9001.
Earlier this year LPE Medical was subject to a US FDA Inspection, performed against the Quality System Regulations (QSR) for medical devices Title 21 Code of Federal Regulations (CFR) Part 820. The FDA Inspection of the LPE Medical site, in the New Forest, Hampshire, was a fundamental milestone for a Premarket Approval (PMA) application in order to support the objectives of Smith & Nephew Orthopaedics Ltd, Warwick, to allow the sale and distribution of the complete Birmingham Hip Resurfacing (BHR) System within the US marketplace.
In recent years LPE Medical has been working to enhance the Quality Management System and business operations to achieve the highest quality standards and compliance against the latest industry regulations. At the point the FDA inspection was confirmed, LPE Medical developed and implemented a quality plan to finalise critical objectives to guarantee a successful outcome from the four day inspection, therefore ensuring that Smith & Nephew's expectations were delivered. LPE Medical's obligation to Smith & Nephew made certain that every aspect of the organisation would undergo review; collaborative continual improvement exercises were adopted to develop first class standards.
The LPE Medical team, in partnership with Smith & Nephew Orthopaedics Ltd, worked with vendors, independent consultants and industry experts, considerable investment and resources were planned into critical phases of preparation and ongoing controls to support FDA Regulatory requirements.
On the 14th October 2008 the US FDA gave final approval to the Smith & Nephew Orthopaedics Ltd PMA and to LPE Medical Ltd for compliance against 21 CFR 820, thus resulting in final product release of the complete BHR product range within the USA.
Marcus Daniels, Managing Director, commented 'The FDA inspection has generated a wealth of experience for LPE Medical. As a subcontractor to the medical device industry we can now offer a unique service to our customers and provide first hand experience of the latest strategies, quality techniques and manufacturing controls. The FDA inspection approval is a testament to the expertise, hard work and discipline of the LPE Medical team, with particular mention to Steve Brown, QA & Development Manager. Every challenge was welcomed with a proactive approach and the organisation has achieved its ultimate aim. We now look forward to future targets, maintaining objectives and defining new ways to offer an optimum service to our customer base'.
Microfinishing at LPE Medical
LPE Medical has recently added fully automated microfinishing of large diameter femoral heads and acetabular devices to its range of medical device manufacturing capabilities.
The significant investment in the plant was necessary in order to ensure LPE Medical could continue to offer orthopaedic device manufacturers a single source, cost effective supplier partnership for metal-on-metal bearing joints together with the manual metal finishing techniques required for the more complex geometry associated with femoral stem production.
LPE Medical staff have worked together with the machine tool supplier since the purchase of the plant was agreed in order to ensure both the machine tool and the software would meet all the specified requirements for accuracy, precision and current Regulatory requirements for validation purposes.
Since acquiring the plant, the microfinishing process has been continually monitored, measured and developed over a significant period of time in order to determine the optimum operating conditions and preferred process parameters. Consequently this has necessitated the purchase of additional high precision metrology equipment, capable of measuring to less than nine tenths of one micron, in order to measure the devices and determine compliance to the close tolerance requirements as dictated by the customer specification.
The equipment is now in routine production use following the successful in-house process development and validation and subsequent customer regulatory approval and commercial product launch.
As an overview, following the pre-machining of the cobalt chrome femoral head and acetabular device, components are processed through the microfinishing plant to achieve the specified requirements for size, sphericity and surface finish. In-process measurement and gauging is a key asset to this process. Parts are then 100% verified off the machine, secondary processed, laser marked and ultrasonically cleaned prior to packaging and labelling in the LPE Medical class 10,000 clean room before terminal sterilisation and supply to the customer.
The LPE Medical developed microfinishing process is capable of routinely producing parts within a tolerance of less than 4 microns, in a 'free state', within a single process cycle (i.e. off the machine tool), with no further manufacturing process requirements, whilst still maintaining efficient cycle times.
Marcus Daniels, Managing Director, commented “The significant investment and process development required in the acquisition of such processes would further demonstrate LPE Medical's commitment to move forward 'side by side' with customer innovation and to continue to be at the forefront as a provider of reliable, cost effective medical device sub-contract services.”