510(K) COSTS DISCUSSIONS CAN BE MISLEADING
A discussion of a report on the multi-million 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, most basic design, prototyping, testing, and production, et al, activities that may be required under the cGMPs but are really related to normal design / R&D, pre-production and production activities, and 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 completely 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 inefficiencies, 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 ("likelihood", "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 / bureaucratic procedures.
-- John E. Lincoln, Medical device / cGMP consulting: http://www.jelincoln.com/
Note: The FDA-related cost were recently restated in a 2018 article:
"Also, the current cost to clear and approve a medical device in the U.S. is $31 million on average to bring a 510(k) product from concept through clearance, with $24 million spent on FDA-dependent/related aspects."
-- https://www.policymed.com/2011/12/interventional-cardiologist-sees-negative-trend-in-innovation-despite-decreases-in-cvd-mortality.html
I believe my above comments still apply. - JEL
A discussion of a report on the multi-million 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, most basic design, prototyping, testing, and production, et al, activities that may be required under the cGMPs but are really related to normal design / R&D, pre-production and production activities, and 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 completely 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 inefficiencies, 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 ("likelihood", "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 / bureaucratic procedures.
-- John E. Lincoln, Medical device / cGMP consulting: http://www.jelincoln.com/
Note: The FDA-related cost were recently restated in a 2018 article:
"Also, the current cost to clear and approve a medical device in the U.S. is $31 million on average to bring a 510(k) product from concept through clearance, with $24 million spent on FDA-dependent/related aspects."
-- https://www.policymed.com/2011/12/interventional-cardiologist-sees-negative-trend-in-innovation-despite-decreases-in-cvd-mortality.html
I believe my above comments still apply. - JEL
Note: Most 510(k)s do not require clinical trials for FDA clearance. However, PMA's do for FDA approval. Clinical trials can add thousands to millions, and years, to obtaining marketing authority. But for many involving clinicals, it's still hard to justify a $24M price tag. Pharmaceuticals are a totally different issue, but with 510(k)s we're talking devices. - JEL 09/06/2023
