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PatentGuy1

09/11/19 11:47 AM

#179549 RE: joshuaeyu #179536

I hope they can ISO-10993 certification of LM106c quickly. I imagine that an absolute way to upset your customer, CoNextions Medical, is to allow the customer to go through clinical trials using one material (105) and then at the end of that tell the customer: "That the material is now obsolete. Here is another material (106c), but we don't have all the certifications for that yet. Hopefully we (LQMT) can get the certifications without upsetting your timeline for FDA approval of your 510(k) application."

It seems to me that obsoleting 105 (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150954780) before getting certifications for 106c isn't very good customer service.

jrs5

09/11/19 12:46 PM

#179555 RE: joshuaeyu #179536

The design guide on the website still references 105. And the website still advertises medical use, including implantable devices which has to be 105. Surgical devices which are only in brief contact with the patient is an easier and faster approval process, so hopefully this can be achieved with 106c in short time. But implantables will take a while. So I am not convinced that they have completely dropped 105 yet. They may phase it out over time (as 106c obtains various approvals), this would be the logical way to handle.