Yes, Shayne, that is exactly the "project time" to which I am referring. It will be impossible to come up with a tight estimate, but I still need an estimate to work with, and the only way I know how to get it is to see what experience others have had with the process. Or I could just pull a guess out of the air, which is probably not an uncommon practice, but still, not my preferred approach. :)
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Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 04-20-2014 15:39
From: Shayne Cox Gad
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
Julie
Yes, it is a different question, and harder to answer if you are including the internal components of decision and action (pick a lab, pick a consultant, get prices, authorize - and at the other end, review, revise and accept). However, for the externals (assuming analysis and subsequent risk assessment is required - which while not necessarily the case, has become much more the case in the last two years if your device can be construed to have systemic exposure (ie, almost everything except not breached body surface) for more than 29 days CUMULATIVELY (are multiple devices used sequentially?)
Based on better than 50 of these - analytical time, assuming samples on hand and delivered and the lab not backed up) a month to six weeks. Toxicologist risk assessment time (somewhat dependent on how complex the analytical L&E report is and the toxicology shop not being backed up - one to two weeks for the draft.
Good luck.
Shayne
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Shayne Cox Gad PhD, DABT, ATS
Principal
Gad Consulting Services
Cary NC
United States
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Original Message:
Sent: 04-19-2014 13:32
From: Julie Omohundro
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
I'm afraid I didn't ask my question very clearly, for which I apologize. For people with experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how much PROJECT time it takes to get from:
Time Point A - You have manufactured devices ready for testing
to:
Time Point B - The tox risk assessment of the results of the chemical characterization/quantification of degradation products has been completed.
I am asking for the purposes of project planning. I came to this forum because a regulatory professionals is often a member of a new product development team, one who tends to pay close attention to the biocompatibility validation. The biocompatibility and toxicology experts are typically external to the product development team and are often external to the company. Therefore, regulatory professionals are likely to be in a position to know how long it took a project to get from A to B, where bio/tox experts are not,
As an example, I was planning to give my tox assessment consultant a week to turn around the risk assessment, but that's not project time, that just the consultant's turnaround time. Project time is something quite different. If you have been part of a project team through the design V&V phase, you know what I mean. And if you have, then I would be very grateful to know of your experience with this part of it.
Thanks.
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Julie Omohundro RAC
Durham NC
United States
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Julie Omohundro RAC
Durham NC
United States
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Original Message:
Sent: 04-17-2014 12:09
From: Julie Omohundro
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
If you have experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how long it takes to get from the date on which you devices available for testing to the date you have completed the risk assessment that is based on the results of chemical characterization and quantification of degradation products.
Thanks,
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Julie Omohundro RAC
Durham NC
United States
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