Regulatory Open Forum

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

[tongue in cheek] Well, if I didn't work for the company and presumably have a vested interest in the product getting to the market someday, I'd be tempted to say "you go ahead and do that." Because, after all, if we are talking any of the well established electrical safety tests, it is unlikely that simply retesting over and over will lead a non-conforming device to pass. And wasting company time and lots of money in a losing cause is far more likely to get them fired than me :-)

But, in the real world, much depends on the situation. In a development situation, first I'd explain that their proposed approach is unlikely to be successful. Then let's assess the criteria - were they strictly from the standard or something the company drove (say from essential performance). Do we know the reason it didn't pass? if so, is the fix simple or complex? If not, how hard is it to assess the root cause? Is there something we can do to reduce or clarify said requirement while maintaining safety and effectiveness of the device? Is it largely a labeling issue? All of this matters to get to a solution that makes sense and should be part of a discussion with the engineering team.

Now, if this is for some reason or other on a device that is already on the market, well, that is another kettle of fish and requires a completely different assessment and set of actions.

g-

ps -  a much harder question would be "your engineer says let's just launch this product only in markets that don't require this test" - because it raises other company culture issues, and in many ways requires much more persuasion and explanation than just going back to "a requirement is required" :-)

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

Or, in short, Ginger, the answer is "it depends".

[tongue in cheek] Well, if I didn't work for the company and presumably have a vested interest in the product getting to the market someday, I'd be tempted to say "you go ahead and do that." Because, after all, if we are talking any of the well established electrical safety tests, it is unlikely that simply retesting over and over will lead a non-conforming device to pass. And wasting company time and lots of money in a losing cause is far more likely to get them fired than me :-)

But, in the real world, much depends on the situation. In a development situation, first I'd explain that their proposed approach is unlikely to be successful. Then let's assess the criteria - were they strictly from the standard or something the company drove (say from essential performance). Do we know the reason it didn't pass? if so, is the fix simple or complex? If not, how hard is it to assess the root cause? Is there something we can do to reduce or clarify said requirement while maintaining safety and effectiveness of the device? Is it largely a labeling issue? All of this matters to get to a solution that makes sense and should be part of a discussion with the engineering team.

Now, if this is for some reason or other on a device that is already on the market, well, that is another kettle of fish and requires a completely different assessment and set of actions.

g-

ps -  a much harder question would be "your engineer says let's just launch this product only in markets that don't require this test" - because it raises other company culture issues, and in many ways requires much more persuasion and explanation than just going back to "a requirement is required" :-)

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

Or, in short, Ginger, the answer is "it depends".

[tongue in cheek] Well, if I didn't work for the company and presumably have a vested interest in the product getting to the market someday, I'd be tempted to say "you go ahead and do that." Because, after all, if we are talking any of the well established electrical safety tests, it is unlikely that simply retesting over and over will lead a non-conforming device to pass. And wasting company time and lots of money in a losing cause is far more likely to get them fired than me :-)

But, in the real world, much depends on the situation. In a development situation, first I'd explain that their proposed approach is unlikely to be successful. Then let's assess the criteria - were they strictly from the standard or something the company drove (say from essential performance). Do we know the reason it didn't pass? if so, is the fix simple or complex? If not, how hard is it to assess the root cause? Is there something we can do to reduce or clarify said requirement while maintaining safety and effectiveness of the device? Is it largely a labeling issue? All of this matters to get to a solution that makes sense and should be part of a discussion with the engineering team.

Now, if this is for some reason or other on a device that is already on the market, well, that is another kettle of fish and requires a completely different assessment and set of actions.

g-

ps -  a much harder question would be "your engineer says let's just launch this product only in markets that don't require this test" - because it raises other company culture issues, and in many ways requires much more persuasion and explanation than just going back to "a requirement is required" :-)

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

Ginger,

I don't think the question was vague at all. The key point here is not what was happening with the device, it is the engineer's attitude "Let's just forget this report exists and repeat the test until it meets the spec."  Forget the report exists? Try to test quality into a product? IMHO, anyone who takes that attitude regarding the quality of a device or drug has no business being in this industry. In this scenario the engineer showed a complete disregard for regulatory requirements, quality requirements and doing his/her job as required. Additionally, that kind of attitude - especially spoken out loud - could be adopted by the people who report to this engineer, creating a bigger kettle of fish that smells even worse.

Nope, this is not an "it depends" situation. To paraphrase W. Edwards Deming, "You cannot inspect quality into the product; it is either there or it is not."

Or, in short, Ginger, the answer is "it depends".

[tongue in cheek] Well, if I didn't work for the company and presumably have a vested interest in the product getting to the market someday, I'd be tempted to say "you go ahead and do that." Because, after all, if we are talking any of the well established electrical safety tests, it is unlikely that simply retesting over and over will lead a non-conforming device to pass. And wasting company time and lots of money in a losing cause is far more likely to get them fired than me :-)

But, in the real world, much depends on the situation. In a development situation, first I'd explain that their proposed approach is unlikely to be successful. Then let's assess the criteria - were they strictly from the standard or something the company drove (say from essential performance). Do we know the reason it didn't pass? if so, is the fix simple or complex? If not, how hard is it to assess the root cause? Is there something we can do to reduce or clarify said requirement while maintaining safety and effectiveness of the device? Is it largely a labeling issue? All of this matters to get to a solution that makes sense and should be part of a discussion with the engineering team.

Now, if this is for some reason or other on a device that is already on the market, well, that is another kettle of fish and requires a completely different assessment and set of actions.

g-

ps -  a much harder question would be "your engineer says let's just launch this product only in markets that don't require this test" - because it raises other company culture issues, and in many ways requires much more persuasion and explanation than just going back to "a requirement is required" :-)

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

[tongue in cheek] Well, if I didn't work for the company and presumably have a vested interest in the product getting to the market someday, I'd be tempted to say "you go ahead and do that." Because, after all, if we are talking any of the well established electrical safety tests, it is unlikely that simply retesting over and over will lead a non-conforming device to pass. And wasting company time and lots of money in a losing cause is far more likely to get them fired than me :-)

But, in the real world, much depends on the situation. In a development situation, first I'd explain that their proposed approach is unlikely to be successful. Then let's assess the criteria - were they strictly from the standard or something the company drove (say from essential performance). Do we know the reason it didn't pass? if so, is the fix simple or complex? If not, how hard is it to assess the root cause? Is there something we can do to reduce or clarify said requirement while maintaining safety and effectiveness of the device? Is it largely a labeling issue? All of this matters to get to a solution that makes sense and should be part of a discussion with the engineering team.

Now, if this is for some reason or other on a device that is already on the market, well, that is another kettle of fish and requires a completely different assessment and set of actions.

g-

ps -  a much harder question would be "your engineer says let's just launch this product only in markets that don't require this test" - because it raises other company culture issues, and in many ways requires much more persuasion and explanation than just going back to "a requirement is required" :-)

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?

Hi Nancy,

I believe I would have the head of Quality have a serious CTJ talk with the engineer.

Your medical device is bench tested for electrical safety and the report comes back stating: "Does not meet the acceptance criteria." The engineer says, "Let's just forget this report exists and repeat the test until it meets the spec." What action would you recommend?