Nick Gardener
Managing Director, Gliatech Inc
Q: What Products do you sell?
A: Global offer Trauma Implants of Bone Screws/Plates and an extensive range of Kirschner Wires from ISO approved Stainless Steel and Titanium. Global have also helped develop and design various Implants currently being sold worldwide. Global are very proud to manufacture 100% of our product range on-site and never sub-contracting any process.
Q: What are your Accreditations?
A: We are certified ISO 9001:2000 for Quality Compliance, ISO 134585:2003 for Medical and CE registered compliant with Annex II of the Medical device Directive 93/42/EEC. All of our Medical Implants have the security of Insurance Backed guarantee of £5 million and are fully Traceable.<br><div style=”text-align: center”>
Q: Why do you think you have been a success?
A: Global have always listened to all of our customers requests and have dealt directly with Surgeons, nurses and support staff to identify new opportunities and ideas. The personal service we have always offered has been unique and will in the long term be beneficial to the most important customer-the Patient.
Q: What Machinery and Skills do you use?
A: We have a strict policy to invest in the latest technology to constantly improve the manufacturing processes and thus helping to reduce price increase to be passed on to the buyer. Our latest acquisition of £200,000 in two new Sliding Head Lathes has ensured we are continuing to supply our customers demanding needs. The personnel at Global are expected to work in every area of the manufacturing process and we encourage internal and external training to further their professional qualifications., with our financial backing. Every product produced by Global is hand finished and closely inspected throughout every stage of manufacturing.
Q: What are your Current Markets?
A: Global currently have active roles in some of the latest developments within Orthopaedic markets including Spinal Implants and Dentistry. We enjoy good working relationships with various customers who also expect the client confidentiality we constantly maintain.
We also exclusively supply Implants to Veterinary Instrumentation in Sheffield and enjoy their fresh and innovative approach to advancing the needs of animals.
All of our clients expect the finest quality, targeted delivery dates and exceptional value for money which Global are happy to meet.
Q: You have mentioned Accreditation and Compliance – Is this the same for all Manufacturers Products?
A: The marketplace for Trauma/Orthopaedic Implants, like most commodities, is littered with poorly manufactured illegal products from countries that are un-regulated and unqualified to offer an implantable device. Many reputable manufacturers like Global have sought to educate potential clients about the legal pitfalls and health risks involved in purchasing Implants for an unrealistic low cost.
Q: How do you know if the Products are legally Compliant?
A: Global have always encouraged potential clients to check their current suppliers and Distributors to ensure they receive Implants that are fully compliant, compatible and above all safe to use. Manufacturers and suppliers have a moral and Legal obligation to ensure Patient Health is not compromised.
My simple advice would be to ask for a Certificate of Conformity (Known as a CofC) which has a written declaration of Inspection reports, Materials used, Country of origin and ISO specifications applied. The next and probably most important is to contact the Notified Auditing Body of the manufacturer and check that credentials are up to date, and insist upon an insurance backed guarantee.
For example a common occurrence in the Trauma Implant Industry: Incorrect material specification. The stainless steel used in all Orthopaedic Implants must conform to the ISO 5832 material standards. Normal 316L Stainless Steel, even with the manufacturers boast of ‘Finest/Highest quality 316L’ does not necessarily meet the strict chemical compositions or physical properties defined in the ISO specifications.
Q: The future for Global Orthopaedics?
A: Global will continue to help develop new products and offer the best advice to all potential clients to help make their ideas a reality. We will continue to invest in new modern manufacturing principles, this will help reduce costs that would normally be passed onto clients medical budgets. Global will implement the new revised version of the medical device directive 2008 and constantly monitoring all future compliance issues. We have also taken the step to use Distributors to sell Global branded products directly without reducing the exceptional service we are proud of.
