510(K) COSTS DISCUSSIONS CAN BE MISLEADING
A discussion of a report on the multimillion dollar costs of 510(k)s is showing up on several websites/blogs. As it stands it can be highly misleading. While some companies may in fact have spent that total dollar amount cited, $24 Million USD, to get a product to the point where it has received a 510(k)clearance, to say 77% is tied to regulatory costs is very misleading. To arrive at those figures, those costs have to include features, documentation, engineering, testing, validation, personnel salaries, et al, activites that may be required under the cGMPs but are really related to product / use safety and quality.
Does any one seriously argue that many bench / functional testing, biocompatibility testing, sterilization, documentation systems, validations (including software), the other basics (including principles of Shewhart, Deming,Juran, et al) required under the cGMP quality management systems and its infrastructure, and yes, some clinical trials, should not be required? I've worked for years (28+) on medical device projects (the last 16 as a consultant), 510(k)s, validations, and unless the above are added to the equation, the figures quoted and attributable to FDA regulatory / clearance costs are completey unrealistic.
I for one would not want a device used on me or my loved ones that had not proved its safety and quality by such testing, and manufactured, labeled, tested / validated, packaged, and sterilized under documented / validated systems. True, some points raised about inefficiences, uncertainties, delays, personnel qualifications, unnecessary or redundant activities,et al, are valid (but nowhere near the dollars implied), and not just on the FDA side, but also on the manufacturer's side, including their submissions. Some companies even report other companies' violations to the FDA to "level the playing field".
The majority of the Stanford Report itself raises legitimate questions, and certainly the conclusions of EU / other 'reputable', regulatory bodies should be strongly considered by the U.S. FDA, 'tho there are dangers (remember the drug thalidomide). However, a key point on costs, page 28, leaves the reader to guess what really contributes to the costs per month due to delays (idle personnel, borrowing costs / interest on loans, lost opportunity costs, or ...). In fact, the last sentence on that page opens up major questions ("liklihood", "self-selected" ... ) that beg answers to really justify the headlines given this study.
Many requirements work to a company's advantage, e.g., design control and fast cycle development, documentation and liability / IP / minimal "reinventing the wheel", reduced recalls (some recent events w/ treated wood pallets and odor- contaminated product for two major pharma companies come to mind). Of course such benefits are only realized IF (a big 'if') companies use them for business reasons, not just to satisfy regulatory / bureacratic procedures.
-- John E. Lincoln, Medical device / cGMP consulting: http://www.jelincoln.com/
A discussion of a report on the multimillion dollar costs of 510(k)s is showing up on several websites/blogs. As it stands it can be highly misleading. While some companies may in fact have spent that total dollar amount cited, $24 Million USD, to get a product to the point where it has received a 510(k)clearance, to say 77% is tied to regulatory costs is very misleading. To arrive at those figures, those costs have to include features, documentation, engineering, testing, validation, personnel salaries, et al, activites that may be required under the cGMPs but are really related to product / use safety and quality.
Does any one seriously argue that many bench / functional testing, biocompatibility testing, sterilization, documentation systems, validations (including software), the other basics (including principles of Shewhart, Deming,Juran, et al) required under the cGMP quality management systems and its infrastructure, and yes, some clinical trials, should not be required? I've worked for years (28+) on medical device projects (the last 16 as a consultant), 510(k)s, validations, and unless the above are added to the equation, the figures quoted and attributable to FDA regulatory / clearance costs are completey unrealistic.
I for one would not want a device used on me or my loved ones that had not proved its safety and quality by such testing, and manufactured, labeled, tested / validated, packaged, and sterilized under documented / validated systems. True, some points raised about inefficiences, uncertainties, delays, personnel qualifications, unnecessary or redundant activities,et al, are valid (but nowhere near the dollars implied), and not just on the FDA side, but also on the manufacturer's side, including their submissions. Some companies even report other companies' violations to the FDA to "level the playing field".
The majority of the Stanford Report itself raises legitimate questions, and certainly the conclusions of EU / other 'reputable', regulatory bodies should be strongly considered by the U.S. FDA, 'tho there are dangers (remember the drug thalidomide). However, a key point on costs, page 28, leaves the reader to guess what really contributes to the costs per month due to delays (idle personnel, borrowing costs / interest on loans, lost opportunity costs, or ...). In fact, the last sentence on that page opens up major questions ("liklihood", "self-selected" ... ) that beg answers to really justify the headlines given this study.
Many requirements work to a company's advantage, e.g., design control and fast cycle development, documentation and liability / IP / minimal "reinventing the wheel", reduced recalls (some recent events w/ treated wood pallets and odor- contaminated product for two major pharma companies come to mind). Of course such benefits are only realized IF (a big 'if') companies use them for business reasons, not just to satisfy regulatory / bureacratic procedures.
-- John E. Lincoln, Medical device / cGMP consulting: http://www.jelincoln.com/
