Views:14 Author:Site Editor Publish Time: 2019-01-21 Origin:Site
“From a market surveillance perspective, we have found that Tier 1 and Tier 2 suppliers are under greater pressure than before.” Michael Venturini, President and CEO of DOT Coatings USA, said: “We saw the proof. Demand is getting higher and higher, for OEM companies, they not only need to provide short-term and long-term report materials such as coating performance, mechanical properties, biocompatibility, etc., but also need to submit more in-depth verification data. We expect this The situation will intensify after the entry into force of ISO 13485:2016. As the FDA increasingly focuses on the role of suppliers for OEMs, the entire supply chain tends to be transparent.” The new revised regulations focus on the quality of the entire supply chain and product life cycle. Management System (QMS), as well as equipment availability and post-marketing inspection requirements.
Compared to general medical device coatings, orthopedic implants are more stringent in their coating requirements because the implant surface needs to provide a special environment for postoperative bone growth. In response, Swedish biomaterials company promimic AB designed a HAnano Surface coating with hydroxyapatite as the main material. HAnano Surface has a porous structure and can be applied to the surface of substrates of various high performance implants such as ceramics and polymers. The surface of the HAnano Surface has a similar composition of human bones, and its main component, hydroxyapatite, promotes bone growth. Recently, the company signed a strategic partnership with Danco Anodizing in the United States to invest in the production line of the HAnano Surface product, expand its customer base in the US market, and promote the rapid development of the Asia Pacific market. LCD
Promimic's existing technology includes a hydroxyapatite coating with a bone-like chemistry that attracts bone cells and accelerates fusion. According to Brogren, because the thickness of the coating is only 20 nanometers, the bone can be gradually fused with the surface of the implant, replacing the traditional coating surface. Not only that, but compared to other technologies, Promimic coating technology can effectively reduce the cost while meeting the production of different shapes and material coatings. Currently, the company has submitted its HAnano-coated predicate device certification and confidential file to the FDA. Promimic has also developed a pre-clinical large-scale data combination system to facilitate and support customer registrations.
Kevin Gilbert, Quality Manager from Danco, focused on standards and quality changes that could affect the coatings industry. He believes: "The revision of ISO9001 and ISO13485 mitigates the risks involved in the implementation process, and more importantly, the company needs to focus on the corresponding prevention process. This must be based on a correct analysis of the data rather than a conservative judgment. A large number of The correct data will be KPI (Key Performance Indicator) and PFMEA (Process Failure Mode and Consequence Analysis System). This applies to all aspects of the quality management system and production process. For example, in evaluating the communication between Danco and the customer base, Danco There is a need to communicate with customers about the quality issues that may result in quality problems for the company. This includes ensuring that products are not contaminated during shipment from the accuracy of the purchase order to the packaging of the product."