Please check out our sponsors in this holiday season, they help us provide you with the content you've come to know us for.
When we posted this survey, we knew it would probably elicit a strong response on both sides of the table. When change is on the way and the gold standard is being questioned, especially when it concerns the use of animals in testing, it’s bound to be controversial. Animals have been used as one of the primary cruxes of medical device, drug and chemical safety testing for a significant period of time and the methods have been well characterized. Europe was the leader in allowing in-vitro and chemical characterization data to supplant animal data for medical device safety testing but the change is moving throughout the world. FDA is allowing that following an appropriate risk assessment, literature and chemical characterization can replace some animal testing, but this can be hard to actually enact because they want the data collected, if referencing predicate devices/materials, to be almost identical in components, manufacturing, sterilization etc.
Recently, American Preclinical Services has published an in-vitro thrombogenicity method and rumor has it that a validated in-vitro skin irritation testing is being included in the new revision of ISO 10993-10. A tremendous amount of effort and cost has gone into developing these methods and industry has self-funded these endeavors. Furthermore, even though these, and other methods have been developed, they still have not received complete regulatory replacement approval by FDA and other regulatory bodies. If these in-vitro alternative methods receive regulatory approval, the biocompatibility labs must then expend cost to validate the methods before they can move forward to include them in their test offerings. These costs should be shared. If the in-vitro methods are simply an alternative, some biocompatibility labs may need financial incentive to bring in house and validate the methods which can potentially be a very costly process.
continue reading below
Recently, American Preclinical Services has published an in-vitro thrombogenicity method and rumor has it that a validated in-vitro skin irritation testing is being included in the new revision of ISO 10993-10. A tremendous amount of effort and cost has gone into developing these methods and industry has self-funded these endeavors. Furthermore, even though these, and other methods have been developed, they still have not received complete regulatory replacement approval by FDA and other regulatory bodies. If these in-vitro alternative methods receive regulatory approval, the biocompatibility labs must then expend cost to validate the methods before they can move forward to include them in their test offerings. These costs should be shared. If the in-vitro methods are simply an alternative, some biocompatibility labs may need financial incentive to bring in house and validate the methods which can potentially be a very costly process.
continue reading below
Now, on to the results!
The options that we posted in the survey included only direct options to select the willingness to pay at least 2X more for the in-vitro methods. We still received a number of “other” responses where people stated that they felt they should not have to pay more for in-vitro methods which may become alternatives. The actuality is that some of these in-vitro alternative methods are just as expensive, if not more so, to perform. The mix of worldwide respondents was distributed between the “No More,” “2X” and “3X” responses. All of the “3X more” responses were from Europe. 43% of responses were for “No More”, 43% were for “2X more” and 14% were for “3X more.”
It’s probable that analytical and in-vitro techniques will replace at least some animal testing in the future and one of the biggest thing in this regard is to keep increasing the amount of toxicological data available in relation to the results of these alternative and supportive methods. The willingness to pay more for them will increase the support for and help fund the methods worldwide as the push for development, regulatory approval and then individual adoption.
The options that we posted in the survey included only direct options to select the willingness to pay at least 2X more for the in-vitro methods. We still received a number of “other” responses where people stated that they felt they should not have to pay more for in-vitro methods which may become alternatives. The actuality is that some of these in-vitro alternative methods are just as expensive, if not more so, to perform. The mix of worldwide respondents was distributed between the “No More,” “2X” and “3X” responses. All of the “3X more” responses were from Europe. 43% of responses were for “No More”, 43% were for “2X more” and 14% were for “3X more.”
It’s probable that analytical and in-vitro techniques will replace at least some animal testing in the future and one of the biggest thing in this regard is to keep increasing the amount of toxicological data available in relation to the results of these alternative and supportive methods. The willingness to pay more for them will increase the support for and help fund the methods worldwide as the push for development, regulatory approval and then individual adoption.
