Regulatory Open Forum

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

I like to think that RA can shift from being seen as a service provider to a more valuable strategic partner by building trust and credibility within the organization as well as delivering innovative wins. In addition to David's comments, I'd add a couple points:

- Engage with your commercial colleagues to have a thorough understanding of what their end goals are. Oftentimes, RA may be perceived as putting up roadblocks because we are only being presented with part of the overall strategy. If we know where the organization is trying to end up, we can propose different (and perhaps more effective) ways of getting there.

- Look beyond those primary goals and bring back strategic regulatory options. For example, if the company is focusing on launching in country A, RA may suggest accelerating country B due to an anticipated increase in regulatory burden. The advantages gained from the regulatory strategy can then be measured and communicated back to the business.

- Educate your internal stakeholders on high-level regulatory requirements that link to your company's specific pain points. This leads to a reduction in the types of behavior that may result in RA necessarily putting up roadblocks in the first place.

- Be willing to take constructive criticism and change your position when appropriate. Similarly, own your mistakes.

I like to think that RA can shift from being seen as a service provider to a more valuable strategic partner by building trust and credibility within the organization as well as delivering innovative wins. In addition to David's comments, I'd add a couple points:

- Engage with your commercial colleagues to have a thorough understanding of what their end goals are. Oftentimes, RA may be perceived as putting up roadblocks because we are only being presented with part of the overall strategy. If we know where the organization is trying to end up, we can propose different (and perhaps more effective) ways of getting there.

- Look beyond those primary goals and bring back strategic regulatory options. For example, if the company is focusing on launching in country A, RA may suggest accelerating country B due to an anticipated increase in regulatory burden. The advantages gained from the regulatory strategy can then be measured and communicated back to the business.

- Educate your internal stakeholders on high-level regulatory requirements that link to your company's specific pain points. This leads to a reduction in the types of behavior that may result in RA necessarily putting up roadblocks in the first place.

- Be willing to take constructive criticism and change your position when appropriate. Similarly, own your mistakes.

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

I agree with the wisdom shared here, but, as Victor has noted, this topic has been discussed a number of times, typically with the same suggestions, because they are good suggestions.  This time, I'd like to add a few different perspectives.

Whether or not RA is a hurdle depends on how you "do" RA.  If you put yourself in the role of internal regulator, then you *are* a hurdle.  If you take the role of service provider and/or strategic partner, then the hurdle is the regulators, not RA, which helps the company clear it.

There is nothing wrong with being a hurdle.  It doesn't serve a company or its shareholders well to continue to invest resources in a product that isn't going to sell, isn't going to be profitable, and/or is going to have safety and effectiveness issues once it gets on the market.

There are really only two big hurdles in product development.  One is on the marketing side, where the hurdle is that you have to be able to sell enough of the product at a high enough price to generate profits that will warrant the costs of developing and marketing the product.  The other is on the manufacturing side, where you have to be able to develop a manufacturing process that can produce the product in high enough volumes  at a low enough cost to generate profits that warrant the costs of developing and marketing the product. 

Design gets caught in the middle, since it must design a product that manufacturing can manufacture at an attractive cost and that marketing can sell at an attractive price.  And they have to figure out how to V&V it too

In a regulated industry, the added need for regulatory registration, clearance, or approval is a lesser hurdle, but it does add to development costs.  This means the product will have to generate more profit to warrant investing in its development.  This creates a higher bar for everyone involved, which is why more highly regulated industries tend to pay higher salaries than less regulated industries...to attract people who can clear that bar.

Often, when RA is being painted as "the" hurdle, it means someone else is falling short and looking to re-direct blame.  As noted elsewhere, the best you can do is try to find regulatory solutions that help reduce development costs.  But, in the end, it's a hurdle, and they have to be able to clear it, like all the other hurdles.  So...just tell 'em to man up and jump. lol.

Other important questions that never seem to get asked are what problems result when RA is seen as "the" hurdle, and how can those problems be addressed in situations where you aren't likely to change perceptions of RA any time soon?

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Hi Julie.

This is one of the great debates of our time - what happens when you are seen as *the* hurdle.  I have seen/been in situations where people selectively choose when to bring RA into the discussions as late as possible in the process to ensure that RA has the greatest possible difficulty in dealing with any regulatory or safety issue that might arise.  This allows the individuals to say that "they told regulatory and regulatory said they couldn't do it" and thereby place/re-direct/misdirect the blame for any failings of the process or failure to obtain approval or whatever.  The biggest problem is that this continues to sow discontent and animosity between the groups and that isn't healthy for the business as a whole.  The only true way I have ever seen this issue eliminated or at least mitigated is to actually remove the "ring-leaders" (usually the managers) of both groups which again isn't really healthy to the company, its culture or its bottom line because then you need consultants at usually much higher hourly rates to step in until everyone who is brought in as replacements are able to get up-to-speed and diffuse the situation.

I agree with the wisdom shared here, but, as Victor has noted, this topic has been discussed a number of times, typically with the same suggestions, because they are good suggestions.  This time, I'd like to add a few different perspectives.

Whether or not RA is a hurdle depends on how you "do" RA.  If you put yourself in the role of internal regulator, then you *are* a hurdle.  If you take the role of service provider and/or strategic partner, then the hurdle is the regulators, not RA, which helps the company clear it.

There is nothing wrong with being a hurdle.  It doesn't serve a company or its shareholders well to continue to invest resources in a product that isn't going to sell, isn't going to be profitable, and/or is going to have safety and effectiveness issues once it gets on the market.

There are really only two big hurdles in product development.  One is on the marketing side, where the hurdle is that you have to be able to sell enough of the product at a high enough price to generate profits that will warrant the costs of developing and marketing the product.  The other is on the manufacturing side, where you have to be able to develop a manufacturing process that can produce the product in high enough volumes  at a low enough cost to generate profits that warrant the costs of developing and marketing the product. 

Design gets caught in the middle, since it must design a product that manufacturing can manufacture at an attractive cost and that marketing can sell at an attractive price.  And they have to figure out how to V&V it too

In a regulated industry, the added need for regulatory registration, clearance, or approval is a lesser hurdle, but it does add to development costs.  This means the product will have to generate more profit to warrant investing in its development.  This creates a higher bar for everyone involved, which is why more highly regulated industries tend to pay higher salaries than less regulated industries...to attract people who can clear that bar.

Often, when RA is being painted as "the" hurdle, it means someone else is falling short and looking to re-direct blame.  As noted elsewhere, the best you can do is try to find regulatory solutions that help reduce development costs.  But, in the end, it's a hurdle, and they have to be able to clear it, like all the other hurdles.  So...just tell 'em to man up and jump. lol.

Other important questions that never seem to get asked are what problems result when RA is seen as "the" hurdle, and how can those problems be addressed in situations where you aren't likely to change perceptions of RA any time soon?

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Yes, that's my experience.  You have two different situations...

Executive sees RA as "the" hurdle. This happens mostly in VC-funded start-ups, which mostly come to an unhappy end.

Individual departments or teams see RA as "the" hurdle.  The consequences are as you describe.

Sometimes you can overcome this, because often people who genuinely want to do good product development were previously trained in this mindset, perhaps at a VC-funded start-up, perhaps by a former manager, perhaps by an unfortunate experience with a "police mentality" RA department. If you can patiently contribute value to their efforts...over time, they will get it.

But other times it's a conscious or unconscious effort at CYA and/or to deflect blame, and sometimes it's simple stubbornness on the part of someone who is not well-suited for a team environment.

When it's a departmental manager, then the ideal solution isn't to flat-out fire them and bring in a consultant, but for executive management to bide its time until a suitable replacement is available internally.  If it's a team member, ideally you wait until their project(s) wrap up.  Often the ideal scenario will not present itself, and then it's a choice between suffering the consequences in the short- or long-term, and business functions mostly in the short-term.

Yes, that's my experience.  You have two different situations...

Executive sees RA as "the" hurdle. This happens mostly in VC-funded start-ups, which mostly come to an unhappy end.

Individual departments or teams see RA as "the" hurdle.  The consequences are as you describe.

Sometimes you can overcome this, because often people who genuinely want to do good product development were previously trained in this mindset, perhaps at a VC-funded start-up, perhaps by a former manager, perhaps by an unfortunate experience with a "police mentality" RA department. If you can patiently contribute value to their efforts...over time, they will get it.

But other times it's a conscious or unconscious effort at CYA and/or to deflect blame, and sometimes it's simple stubbornness on the part of someone who is not well-suited for a team environment.

When it's a departmental manager, then the ideal solution isn't to flat-out fire them and bring in a consultant, but for executive management to bide its time until a suitable replacement is available internally.  If it's a team member, ideally you wait until their project(s) wrap up.  Often the ideal scenario will not present itself, and then it's a choice between suffering the consequences in the short- or long-term, and business functions mostly in the short-term.

Yes, that's my experience.  You have two different situations...

Executive sees RA as "the" hurdle. This happens mostly in VC-funded start-ups, which mostly come to an unhappy end.

Individual departments or teams see RA as "the" hurdle.  The consequences are as you describe.

Sometimes you can overcome this, because often people who genuinely want to do good product development were previously trained in this mindset, perhaps at a VC-funded start-up, perhaps by a former manager, perhaps by an unfortunate experience with a "police mentality" RA department. If you can patiently contribute value to their efforts...over time, they will get it.

But other times it's a conscious or unconscious effort at CYA and/or to deflect blame, and sometimes it's simple stubbornness on the part of someone who is not well-suited for a team environment.

When it's a departmental manager, then the ideal solution isn't to flat-out fire them and bring in a consultant, but for executive management to bide its time until a suitable replacement is available internally.  If it's a team member, ideally you wait until their project(s) wrap up.  Often the ideal scenario will not present itself, and then it's a choice between suffering the consequences in the short- or long-term, and business functions mostly in the short-term.

Hi Julie.

This is one of the great debates of our time - what happens when you are seen as *the* hurdle.  I have seen/been in situations where people selectively choose when to bring RA into the discussions as late as possible in the process to ensure that RA has the greatest possible difficulty in dealing with any regulatory or safety issue that might arise.  This allows the individuals to say that "they told regulatory and regulatory said they couldn't do it" and thereby place/re-direct/misdirect the blame for any failings of the process or failure to obtain approval or whatever.  The biggest problem is that this continues to sow discontent and animosity between the groups and that isn't healthy for the business as a whole.  The only true way I have ever seen this issue eliminated or at least mitigated is to actually remove the "ring-leaders" (usually the managers) of both groups which again isn't really healthy to the company, its culture or its bottom line because then you need consultants at usually much higher hourly rates to step in until everyone who is brought in as replacements are able to get up-to-speed and diffuse the situation.

I agree with the wisdom shared here, but, as Victor has noted, this topic has been discussed a number of times, typically with the same suggestions, because they are good suggestions.  This time, I'd like to add a few different perspectives.

Whether or not RA is a hurdle depends on how you "do" RA.  If you put yourself in the role of internal regulator, then you *are* a hurdle.  If you take the role of service provider and/or strategic partner, then the hurdle is the regulators, not RA, which helps the company clear it.

There is nothing wrong with being a hurdle.  It doesn't serve a company or its shareholders well to continue to invest resources in a product that isn't going to sell, isn't going to be profitable, and/or is going to have safety and effectiveness issues once it gets on the market.

There are really only two big hurdles in product development.  One is on the marketing side, where the hurdle is that you have to be able to sell enough of the product at a high enough price to generate profits that will warrant the costs of developing and marketing the product.  The other is on the manufacturing side, where you have to be able to develop a manufacturing process that can produce the product in high enough volumes  at a low enough cost to generate profits that warrant the costs of developing and marketing the product. 

Design gets caught in the middle, since it must design a product that manufacturing can manufacture at an attractive cost and that marketing can sell at an attractive price.  And they have to figure out how to V&V it too

In a regulated industry, the added need for regulatory registration, clearance, or approval is a lesser hurdle, but it does add to development costs.  This means the product will have to generate more profit to warrant investing in its development.  This creates a higher bar for everyone involved, which is why more highly regulated industries tend to pay higher salaries than less regulated industries...to attract people who can clear that bar.

Often, when RA is being painted as "the" hurdle, it means someone else is falling short and looking to re-direct blame.  As noted elsewhere, the best you can do is try to find regulatory solutions that help reduce development costs.  But, in the end, it's a hurdle, and they have to be able to clear it, like all the other hurdles.  So...just tell 'em to man up and jump. lol.

Other important questions that never seem to get asked are what problems result when RA is seen as "the" hurdle, and how can those problems be addressed in situations where you aren't likely to change perceptions of RA any time soon?

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Julie is 100% correct in that there are very different situations that lead to this "RA is a barrier" mentality. They can come at many levels (from executive to engineer level) and from either side of the equation. There are unreasonable execs/engineers and there are RA folks who really LIKE being a barrier - I once interviewed someone whose answer to "what do you like best about RA" was "well, I really like telling people no." [and no I did not hire them]

Most commonly though, this only becomes a huge problem when the attitude starts at the executive level. And yes, I have worked in a company where the CEO once said "regulatory is the sphincter of the company - it keeps anything from getting out." And this was at a place that did not have an overly conservative RA group. I have also worked for CEOs that truly understand the value that RA brings to the team, and have been very involved in forums to understand RA and help drive policy.

By the way, the same holds true in Quality. I have worked with CEOs who pretty much viewed quality as just a cost center and whose only concern was whether costs could be cut. I have also worked for CEOs who understood the QSR and other quality requirements almost as well as I did, and were totally supportive of doing things the "right way" and understanding that investing in quality was really investing in customer satisfaction. Similarly, I have run into quality folks who are truly business focused and bring their skills to that, and I have run into ones that simply like to throw up hurdles. There are all kinds on both sides.

Happily, I have reached the point in my career where I simply choose not to work for individuals who don't "get" the value QA/RA/compliance brings to the organization. I also only take roles where I get enough control over hiring my team to ensure that the approach is NOT "the department of NO" - yes, we say no when needed, but we also collaborate to find ways to meet the needs of the business as a routine part of the job. I realize others don't have this luxury. However, I do tend to believe that RA/QA folks should ALWAYS know where there line is. That is "at what point is what you are being asked to do so off-base that you will quit rather than do it." David's example about falsifying documents is a great one - you should think ahead of time if you are willing to go on this "slippery slope" or just get yourself out. I have seen too many otherwise good people get sucked into these situations because they didn't think about it ahead of time and then kept "giving up" one more thing.Obviously, if the problem is a lower level individual, there may be potential to go "up the chain" to solve the problem. But in the end, the top executive get to make the calls for their company. Our job is to make clear the risks to them. If you can't "go along" with their calls, it really is time to leave. Valuable, ethical RA folks are in demand and new opportunities will arise.

I am interested in hearing from our consultant folks if they take any kind of similar approach? Do you ever "screen" or "drop" clients because they don't want to do things the right way?

g-

Yes, that's my experience.  You have two different situations...

Executive sees RA as "the" hurdle. This happens mostly in VC-funded start-ups, which mostly come to an unhappy end.

Individual departments or teams see RA as "the" hurdle.  The consequences are as you describe.

Sometimes you can overcome this, because often people who genuinely want to do good product development were previously trained in this mindset, perhaps at a VC-funded start-up, perhaps by a former manager, perhaps by an unfortunate experience with a "police mentality" RA department. If you can patiently contribute value to their efforts...over time, they will get it.

But other times it's a conscious or unconscious effort at CYA and/or to deflect blame, and sometimes it's simple stubbornness on the part of someone who is not well-suited for a team environment.

When it's a departmental manager, then the ideal solution isn't to flat-out fire them and bring in a consultant, but for executive management to bide its time until a suitable replacement is available internally.  If it's a team member, ideally you wait until their project(s) wrap up.  Often the ideal scenario will not present itself, and then it's a choice between suffering the consequences in the short- or long-term, and business functions mostly in the short-term.

Hi Julie.

This is one of the great debates of our time - what happens when you are seen as *the* hurdle.  I have seen/been in situations where people selectively choose when to bring RA into the discussions as late as possible in the process to ensure that RA has the greatest possible difficulty in dealing with any regulatory or safety issue that might arise.  This allows the individuals to say that "they told regulatory and regulatory said they couldn't do it" and thereby place/re-direct/misdirect the blame for any failings of the process or failure to obtain approval or whatever.  The biggest problem is that this continues to sow discontent and animosity between the groups and that isn't healthy for the business as a whole.  The only true way I have ever seen this issue eliminated or at least mitigated is to actually remove the "ring-leaders" (usually the managers) of both groups which again isn't really healthy to the company, its culture or its bottom line because then you need consultants at usually much higher hourly rates to step in until everyone who is brought in as replacements are able to get up-to-speed and diffuse the situation.

I agree with the wisdom shared here, but, as Victor has noted, this topic has been discussed a number of times, typically with the same suggestions, because they are good suggestions.  This time, I'd like to add a few different perspectives.

Whether or not RA is a hurdle depends on how you "do" RA.  If you put yourself in the role of internal regulator, then you *are* a hurdle.  If you take the role of service provider and/or strategic partner, then the hurdle is the regulators, not RA, which helps the company clear it.

There is nothing wrong with being a hurdle.  It doesn't serve a company or its shareholders well to continue to invest resources in a product that isn't going to sell, isn't going to be profitable, and/or is going to have safety and effectiveness issues once it gets on the market.

There are really only two big hurdles in product development.  One is on the marketing side, where the hurdle is that you have to be able to sell enough of the product at a high enough price to generate profits that will warrant the costs of developing and marketing the product.  The other is on the manufacturing side, where you have to be able to develop a manufacturing process that can produce the product in high enough volumes  at a low enough cost to generate profits that warrant the costs of developing and marketing the product. 

Design gets caught in the middle, since it must design a product that manufacturing can manufacture at an attractive cost and that marketing can sell at an attractive price.  And they have to figure out how to V&V it too

In a regulated industry, the added need for regulatory registration, clearance, or approval is a lesser hurdle, but it does add to development costs.  This means the product will have to generate more profit to warrant investing in its development.  This creates a higher bar for everyone involved, which is why more highly regulated industries tend to pay higher salaries than less regulated industries...to attract people who can clear that bar.

Often, when RA is being painted as "the" hurdle, it means someone else is falling short and looking to re-direct blame.  As noted elsewhere, the best you can do is try to find regulatory solutions that help reduce development costs.  But, in the end, it's a hurdle, and they have to be able to clear it, like all the other hurdles.  So...just tell 'em to man up and jump. lol.

Other important questions that never seem to get asked are what problems result when RA is seen as "the" hurdle, and how can those problems be addressed in situations where you aren't likely to change perceptions of RA any time soon?

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Hi All,

In my humble opinion, it all down to the company culture & ethics you work in.

I am fortunate enough to work in "Risk-Taker" and "Maximum Compliance" type of company and learned tremendous valuable experience through them.

"Risk-taker" company are highly driven by products sale figures, and "RA" definately a hurdle for the company. Often, you will getting feedbacks from Marketing & Sale team like " We been selling this device for over 10 years, never we heard / come across this requirements! Come on guys, this is a huge order!" Most often, products safety compliance will be done at the very minimum just enough satisfy registration purpose.

While for "Maximum Compliance", this type of company take good care of their branding by market safe and quality device. RA served as a business partner / in-house consultant where we provide valuable view and insight to the innovation team along product development. Project team valued the participation of RA in the team, which then promised a sucessful product launch to the company.

It still down to the company culture.

Regards,

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Winson, can you provide examples of some regulatory requirements that a company might not have heard after years of marketing a device?  And any thoughts about how the requirements got overlooked for so long?

Hi All,

In my humble opinion, it all down to the company culture & ethics you work in.

I am fortunate enough to work in "Risk-Taker" and "Maximum Compliance" type of company and learned tremendous valuable experience through them.

"Risk-taker" company are highly driven by products sale figures, and "RA" definately a hurdle for the company. Often, you will getting feedbacks from Marketing & Sale team like " We been selling this device for over 10 years, never we heard / come across this requirements! Come on guys, this is a huge order!" Most often, products safety compliance will be done at the very minimum just enough satisfy registration purpose.

While for "Maximum Compliance", this type of company take good care of their branding by market safe and quality device. RA served as a business partner / in-house consultant where we provide valuable view and insight to the innovation team along product development. Project team valued the participation of RA in the team, which then promised a sucessful product launch to the company.

It still down to the company culture.

Regards,

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

Winson, can you provide examples of some regulatory requirements that a company might not have heard after years of marketing a device?  And any thoughts about how the requirements got overlooked for so long?

Hi All,

In my humble opinion, it all down to the company culture & ethics you work in.

I am fortunate enough to work in "Risk-Taker" and "Maximum Compliance" type of company and learned tremendous valuable experience through them.

"Risk-taker" company are highly driven by products sale figures, and "RA" definately a hurdle for the company. Often, you will getting feedbacks from Marketing & Sale team like " We been selling this device for over 10 years, never we heard / come across this requirements! Come on guys, this is a huge order!" Most often, products safety compliance will be done at the very minimum just enough satisfy registration purpose.

While for "Maximum Compliance", this type of company take good care of their branding by market safe and quality device. RA served as a business partner / in-house consultant where we provide valuable view and insight to the innovation team along product development. Project team valued the participation of RA in the team, which then promised a sucessful product launch to the company.

It still down to the company culture.

Regards,

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation? 

One that I have run into at least 3 times now......

21CFR1000, 1010, 1020, 1040

Small companies often think solely of the medical device regulations, and not the radiation emitting product regulations even if they apply to their products. Similarly, US state requirements specific to things like electronic equipment or lasers. A company can have had a product for many years and not be compliant with these.

Additionally, in the international realm, I have had many discussions in the past that went roughly

"we need to comply with this requirement in [country]"

"that isn't a requirement"

"yes, it is, says right here"

"oh, well, our distributor holds the registration and he doesn't think we need to do it"

The trick is to not be in a situations where you are relying on distributors of varying regulatory skill to make your regulatory decisions for you.

g-

Winson, can you provide examples of some regulatory requirements that a company might not have heard after years of marketing a device?  And any thoughts about how the requirements got overlooked for so long?

Hi All,

In my humble opinion, it all down to the company culture & ethics you work in.

I am fortunate enough to work in "Risk-Taker" and "Maximum Compliance" type of company and learned tremendous valuable experience through them.

"Risk-taker" company are highly driven by products sale figures, and "RA" definately a hurdle for the company. Often, you will getting feedbacks from Marketing & Sale team like " We been selling this device for over 10 years, never we heard / come across this requirements! Come on guys, this is a huge order!" Most often, products safety compliance will be done at the very minimum just enough satisfy registration purpose.

While for "Maximum Compliance", this type of company take good care of their branding by market safe and quality device. RA served as a business partner / in-house consultant where we provide valuable view and insight to the innovation team along product development. Project team valued the participation of RA in the team, which then promised a sucessful product launch to the company.

It still down to the company culture.

Regards,

As RA professionals, what have been some of your most successful ways for convincing people within the development/management team that we are not the hurdle to innovation?