While deregulation of large swathes of industry is a driving force in Washington these days, the opposite is true of the global medical technology sector. Europe’s new Medical Devices Regulation (MDR), the hardline succesor to the new-approach, "soft-touch" Medical Device Directive, and revisions to ISO 10993-18, the international standard related to the chemical characterization of materials, are bringing a wave of regulatory change to the medtech community.
Much of that change affects the way medical materials, notably polymers, are sourced and processed, according to Jacqueline Anim, Principal Material Engineer and Subject Matter Expert at Ethicon (Cincinnati, OH), part of the Johnson & Johnson (JNJ) family of companies. She will be speaking to that and related issues during a session devoted to trends and innovations in new materials for medical devices at the forthcoming co-located PLASTEC and Medical Design & Manufacturing (MD&M) Minneapolis event. She will also participate in a panel discussion on a similar topic during the trade show and conference.
“To meet today’s complex medical device design requirements, such as the EU’s MDR, most OEMs are moving toward the selection of specific materials that enhance the biological safety of devices,” Anim told PlasticsToday. Correspondingly, “resin manufacturers are also investing time and resources in the segregation of materials and replacing those that are on the restricted substance listed with alternatives that meet current new regulations. Materials containing DEHP and heavy metals are one example,” added Anim.
The most recent draft of ISO 10993-18 also will drive innovation in the medical manufacturing sector, according to Anim. The international standard describes a framework for the identification of a material and the identification and quantification of its chemical constituents, according to the ISO website. It is intended for suppliers of materials and manufacturers of medical devices when carrying out a biological safety assessment.
“Section 6 of the latest draft of the ISO 10993-18 in review states the following,” explained Anim: “Medical device manufacturers should preferably obtain qualitative and quantitative compositional information about materials from the supplier of the starting material. Qualitative information about any additional processing additives—for example, mold release agents—should also be obtained from appropriate members of the manufacturing chain, including convertors and component suppliers. In the absence of sufficient supplier information, such information should be obtained by chemical testing (for example, extractables or leachables testing). Sufficient information should be obtained to identify all biological safety hazards arising from the chemical constituents of the material for inclusion in the toxicological risk assessment (see ISO 10993-1). The composition of materials used in medical devices shall either be in accordance with applicable material standards or shall be specified by the medical device manufacturer to the extent possible.”
This will drive the need for transparency as well as vendor information protection and management to a new level, according to Anim.
Given chemical characterization requirements, Anim bemoans the lack of a comprehensive reference list for chemistry identification for liquid chromatography mass spectrometry compared with gas chromatography mass spectrometry. “With the expanded chemical characterization requirements associated with material extractables per ISO 10993-1, ISO 10993-12 and ISO 10993 -17, this could be a growth area for the entire industry,” noted Anim. “Additionally, there aren’t many reputable contract research organizations out there to support medtech development. Very few have repeatable processes and the quality system and setup to support the requirements of medical device testing,” said Anim.
Anim will discuss trends and innovations in new materials for medical devices at PLASTEC/MD&M Minneapolis at 8:30 AM on Oct. 31 in the Technical Solutions conference track (room 211B). She is also part of an expert panel discussing the future of medical materials. The panel discussion will be moderated by Len Czuba on Oct. 31 at 2 PM as part of the Medtech Central track (booth 1347). For a preview, read “The future of medical materials and medtech innovation.”