Continuing to demonstrate its clear leadership in the medical device market, SABIC Innovative Plastics has created a comprehensive healthcare product policy - including over 50 high-tech healthcare materials designed with the intent of supporting OEMs in achieving regulatory compliance for their healthcare and pharmaceutical applications. SABIC Innovative Plastics' healthcare product policy is making huge contributions to faster marketing approval and successful commercialization of a range of medical devices.
SABIC Innovative Plastics' high-value service is designed to ensure the consistency and biocompatibility of the company's healthcare grades so customers have the confidence that the material they choose will help them meet regulations - such as the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMEA). SABIC Innovative Plastics' healthcare policy is another key example of how the company works with customers over the long-term, to help them achieve business success.
"Our medical device customers look to SABIC Innovative Plastics to help them comply with toughening regulations imposed by FDA, European Food Safety Authority (EFSA) and other agencies to enhance patient safety," said Tom O'Brien, product marketing manager, Healthcare, SABIC Innovative Plastics. "Our solution was to proactively develop an industry-leading healthcare product policy to simplify regulatory compliance, both during marketing approval and throughout the device lifecycle. Pre-assessing biocompatibility of our healthcare products helps speed up marketing approval in the regulatory process, while internal controls and change management help assure consistent quality and reliability."
No other resin supplier offers such a broad range of amorphous and crystalline materials for healthcare. Materials included under the SABIC Innovative Plastics' policy have been assessed for biocompatibility, are covered by an FDA Drug or Device Master File, and are subject to formula lock and a stringent change management process.
Healthcare Policy Can Save OEMs Time and Money
SABIC Innovative Plastics' healthcare product policy provides the following:
- Pre-assessment of resin biocompatibility according to ISO 10993 or USP Class VI standards
- Food contact compliance for most healthcare products
- FDA Drug or Device Master File listing, with letter of authorization provided if needed
- Products subject to formula lock and change management process
- Healthcare product nomenclature for easy identification
SABIC Innovative Plastics' formula lock and management of change policy can save significant time and money. These provisions can avoid requalification delays of up to 12 months and, depending on the number of parts, costs in excess of USD $1 million.
Note: SABIC Innovative Plastics does not support applications that remain implanted longer than 29 days.
Adding Value to New Medical Devices
The following are examples of the added value this policy gives to medical device manufacturers.
To create the Breastlight home-use device for self-examinations, the manufacturer, Scotland's PWB Health Ltd, selected Cycoloy* PC/ABS HC resin for the housing components. Cycoloy resin, which is assessed to ISO 10993 standard for biocompatibility, offers excellent impact resistance for durability and high flow for thin-wall molding. It also offers the ability to incorporate special opacifiers without deteriorating mechanical properties. For the lens, Lexan* HP polycarbonate resin was selected for its optical clarity, impact strength and the ability to be ultrasonically welded to the housing. This grade is also assessed for biocompatibility in accordance with the ISO 10993 standard.
Another firm that benefited from SABIC Innovative Plastics' policy is Biorep Technologies, based in Miami, Fla. The company was able to bring a distinctive diabetes treatment to the market quickly and efficiently by selecting resins from the healthcare product portfolio. These included Cycolac* HM resin for a perfusion tray, and Ultem* HU resin for the Ricordi Chamber, used to isolate and purify islets for transplantation in patients whose Type-1 diabetes cannot be controlled with insulin injections.
A hemodialysis blood pump from Renal Solutions, Inc., featuring SABIC Innovative Plastics' advanced hemocompatibility Lexan HPM resins helps prevent buildup of thrombus on the pump's walls that could potentially interfere with the effectiveness of treatments. Renal Solutions worked closely with SABIC Innovative Plastics to identify a material that met the mechanical and physical needs for the blood pump's optimum hemodynamic filling design while offering enhanced blood-contact properties.
SABIC Innovative Plastics' Healthcare Products to be Featured at MD&M West 2010
SABIC Innovative Plastics will showcase several medical device examples that have benefited from its new healthcare product policy in booth 1783 at MD&M West in Anaheim, Calif., on Feb. 9 - 11, 2010. The company will also feature new medical-grade materials for new industry sectors and high-performance application areas within the drug delivery segments.
Among these introductions will be a new series of bio assessed, clear, antistatic LNP* specialty compounds that benefit the efficiency of inhalation devices.