Ah, my old friend, Gary, hello!

How would your quality department answer, "What precisely are you afraid of?"

In my view, FDA is not in the business of making things hard for medical device companies. They don't have the resources to scour every marketing effort from every medical device company. Having said that, each medical device company needs to behave in a responsible manner.

So, I'd start with FDA's site: "How to Market Your Device" http://ow.ly/uIy3T

Then, using the same controls you have for brochures and your current website, make it easy for prospects and customers to find and access your content. It really is as simple as that.

• Today: We have a brochure.
• Tomorrow: We have a brochure in digital form that can be downloaded.
• Next week: We have a brochure in digital form that can be downloaded after the visitor gives us his/her email address.
• Next month: We email that person to see if we can help them.

I don't see an FDA violation here. Do they?

Michelle Bonn A Great story that is rather common.

One way to help the quality department move from the place of fear into the place of opportunity; assure the quality department that the marketing department has a crystal clear understanding of the products intended use and mode of action. Assure QA that marketing will stay within the boundaries of how the products are and can be used. The FDA is most concerned that your products use (function) precisely match the marketing & labeling material. Assure the quality department that the marketing claims will fit within the boundaries of the product function and intended use (treatments, cures etc.) listed in the 510k clearance (if you have one) and you will be on the right track to FDA labeling compliance.

FYI: the FDA defines labeling to include items such as instructions for use (IFU) and any marketing material such as brochures, web copy and sales literature.

Perfect, Michelle: "Assure the quality department that the marketing claims will fit within the boundaries of the product function and intended use (treatments, cures etc.) listed in the 510k clearance (if you have one) and you will be on the right track to FDA labeling compliance."

Karen Eason I have to mimic Joe's sentiments. You need to understand what they are afraid of. Having a clear understanding of concerns, should be a great step forward in developing a solid plan. It may be as simple as promising the head of Quality with the copy before going live with it. Try not to make things more complicated for yourself unless necessary. Sometimes all it takes is inclusion to bridge the gap.

The fear is that Sales and Marketing will overstate and/or over promise beyond the scope of the program.
The way to calm everyone is "inclusion" as stated above by Joe. Make sure marketing knows what the product or service is before starting the program. Then bring engineering, manufacturing and Quality into the picture to see how it is being presented to the world. Insure they have a voice in the process.
Work as a team not adversaries.

Very recognizable. I think it is pretty simple though. Marketing is not all about making promises. It's about a lot more than that. It's connecting with customers, possible new customers etcetera. Hence, it is something very positive for the company. Quality is cautious, but that also comes with their idea and perception of marketing itself. Have a dialogue with them, let them know your intentions (could be customer service as well) and make them part of the team. And if you want to make a promise, let them decide what that promise should be.

I have learned that most of the scepsis comes from not fully understand / oversee what marketing is. A short presentation or sharing best practices can get their minds open. If you then cooperate you will also provide them with great customer feedback on tons of stuff.

Good luck!

Sofia Epshtein Elbrus Hi Gary,
Is it possible your Quality ppl are concerned about 21 CFR Part 11?

Best,
Sofy

Karen Eason Sofia, electronic records? I'm a bit lost. Would you mind explaining further?

Sofia Epshtein Elbrus Karen, in addition to the above points I've witnessed a fear to not be able to control and properly trace the information distributed digitally.

Karen Eason Thanks Sofia! Appreciate it!

William (Bill) Jackson Education for all parties including S/M as to off label promotion, plus include RA/QA early on in the process with S/M and R/D to improve perceptions and communication.

It has been my experience in the past the communication issue was between S/M and R/D, design control for what it is worth has improved that and a good RA/QA person can often bridge the gap between S/M and R/D.

We are ALL part of the same TEAM, that is my MO!

Good discussion!!!!

Gary Price Thank you to everyone for your comments! I have an uphill battle, but will persevere.

Ian Nemerov Gary, the earlier comments are excellent. I'd add a few questions/suggestions.

How does the content for the digital information differ from the content for the assumedly compliant and approved non-digital information?

Does the digital information enable a company employee or customer to modify the content in such a way that it could possibly make off-label claims or create any other non-compliance?

If the content is modifiable, are there measures that could prevent such off-label modification or mitigate its impact, such as preventing employees from making the modifications and giving customers a conspicuous reminder of the on-label claims and taking other actions that are like those described in FDA's draft guidance on off-label communication?

Finally, if desired by your compliance team, are there any surveillance techniques that could be implemented to verify that use meets agreed-upon requirements?

P.S.: if there is an underlying issue driving the quality department's concern, e.g., a fear about something that doesn't fall neatly within a factual discussion about on or off-label communication, you may be able to win big points if you demonstrate how you will be the champion of ensuring compliant usage of the digital materials.

Karen Eason Well said Ian!

As others mentioned, consider putting an approval process in place, so that regulatory and legal concerns are reviewed when creating promotional programs. Of course, do not promote off-label use or state bold claims you cannot support. It's not just a regulatory issue...also legal issues (FTC).

Consider less product-focused messaging and more 'issues' messaging. What problem are you trying to solve for your audience? Build content around what they care about, and then how you can help them. Get them to want your content enough to provide their data so you can begin to nurture that relationship - is it a hot lead (call me now) or just warm (interested in more info. from you). Product information is also needed, but content marketing around key issues is important. It also allows you to optimize your site for search with those hot key terms your customer is searching on...

Also mentioned by other post - determine the risk and make decisions to accept it or not. Some risks are low and worth taking.

L&R is a constant dance in a regulated marketing environment...dance on! :)

Carl Goosen Did you know that the doctors are tied to prescribe and treat solely to the FDA's mandate?
IO have frquently refused prescribed medication and procedures sice I am not bound by them.
Please remember that the FDA has to consult with "experts" to give their opinion. Just as Louis Pasteur, I feel that the doctors are not always right. Remember that it took 1,000 years to stop blood-letting. The first president of the USA died after he was bled 12 pints overnight!
As an inventor, The FDA has to consult with and consider the 'Existing" practices so that a new idea is met with much scepticism.
Carl Goosen

I too had those same issues when started our SM efforts in 2008-09. And still have worry warts even today. Finding champions in the C-suite and regulatory really helped us. We also had multidisiplianary team from regs, compliance, legal, and marketing who worked together to sort out the issues and find workable solutions

Robert Christensen Don't let the FDA push you around. Enlist your Congressman or the Press if the process appears to be delaying you or seems corrupted.

Read my book, FDA You Were WRONG!
Can be found on Amazon

Hi Gary,

I agree with everyone that you need to have an informal conversation with your quality department to find out their concerns. But more important, does your regulatory person or department have the same feeling or are they on board with your ideas? If your regulatory person is not on board, then you may need to have an informal conversation with this person to find out their concerns. Perhaps their concerns is why the quality dept feels the same way.

If you don't have a regulatory person, then contacting your local FDA office may be the way to go to find out who you can talk to in supporting your position. The FDA has a group within the FDA to answer questions that companies may have and they are open to dialog. I recently spoke with someone in a local FDA office and they told me about this subgroup.

I also agree with the group about putting processes in place and getting everyone on the same page and in the loop with everything.

Good luck.

I agree with what Ian and Kelly have both said. Process controls are important.

Quality and Regulatory should be very experienced with risk analysis and risk mitigation tools and processes, i.e. HRA, HHE, etc. Could you frame a meeting discussion with them where the "product" is your marketing material and the objective is to identify all risks, hazards and concerns wherein a review team scores each identified item on a pre-mitigated basis and then again on a post-mitigated basis?

This could at least get them into a mode of being part of the solution instead of part of the problem. And you'd be using tools and processes they're familiar with.

But maybe the first question should be "Do they generally support the idea?" If they do, but are fearful, maybe there's hope, and they just need training, tools, etc.

As a Quality Professional of 40 years I think you are all being far too kind with the "very conservative" QA staff involved. It seems to me that they have completely lost the Quality plot.
The company is in business to make a profit.
It makes a profit by selling products.
Regulatory compliance is nothing more than a necessary tool that permits you to sell products so that you can make a profit. (Although it also stops you killing your customers!).
If you don't sell any products (the Sales & Marketing part) then there will be no profit and the QA staff will all be redundant along with everybody else.
So if you really want to make the point you could argue that QA works for Sales & Marketing!
It is my sad experience that QA people who have only ever worked in the regulatory environment have never learned that the true objective of Quality Management is to make customers happy and to make the business more efficient, effective and profitable.

John Strupat Good one Gary! In smaller medical device companies RA has every reason to be afraid, VERY afraid of what troubles S&M can get them into with the FDA. The more experienced will recall the thrill of discovery that brochures and price sheets had been handed out at trade shows for products that were only prototypes. Was the darn FDA ever testy about this kind of "pre-market testing". Who knew?

Great to think that digital media might be exempt from those wet towels in RA as well, since the claims and pictures are all just virtual anyway, right? Since even our comments here might be stored forever for instant retrieval, you can be sure that someone will be looking closely at anything you might create for your digital marketing. The FDA and other regulators may not apply resources to monitor your efforts, but you can be totally confident that your competitors and customers will. Cool how easy it easy to copy an entire webpage for storage and then email it to interested parties.

Put RA in charge of "publishing" your digital marketing content and gain everyone's confidence and cooperation.

William (Bill) Jackson Yes Trefor's comments are appropriate and yes the company is in business to make a profit by selling products and yes compliance is a tool but the role of good quality/regulatory professionals is to educate sales/marketing and to keep companies from being under consent decrees and deferred prosecution agreements.

Bill J

I emphatically disagree with your conclusion, John, about putting RA in charge of publishing.

First, agree on the rules.
Then, let marketing do its job.

In my experience, the universe of professionals equally adroit (and passionate) about regulatory and marketing is frightfully small. In truth, I personally don't know a single person with those characteristics.

I agree with Bill Jackson. It's all good having regulatory educate marketing and sales.

This just occurred to me: We can all relate to quality/regulatory not trusting marketing.

Can you imagine if marketing didn't trust quality/regulatory?

I mean, why is one group assumed to be competent while the other incompetent?

Do we have a team of professionals or not?

William (Bill) Jackson It is all about communication and understanding each departments roles, my experience for over 30 years is you need an excellent QA/RA person/department who understands S/M and can speak the language plus explain the concerns (FDA) of the QA/RA department that does not happen overnight.

You should have sign off of all marketing communication especially if you have recently received a 483, warning letter, as you do not want it to escalate to the next level, not fun at all !!!

Joe as far as agreeing on the rules, the rules to me mean having QA/RA along with S/M and upper management sign off then all can share in the success and/or the pain.

Bill J

John Strupat Hi Joe. If I could explain my terms a bit, I recognize S&M as the creative force with a job to do to convince customers and find new customers, so they should be developing modern strategies that are effective in doing that.
As Bill just commented, RA has the role of reviewing everything that the company produces that represents the company, including marketing literature and product labelling.
Perhaps I should have picked a different term than "publishing" as it carries the old printed media connotation. It does fit the process of approving a company document and issuing a purchase order to have it printed and shipped.
Not a good fit with today's reality of creation of a virtual document that can be uploaded for the world to see in just a few keystrokes. Modification is just as fast and easy.

Whatever you call this should still be a role for RA.
RA should still be the gatekeeper for all information about the company and it's products.
If there is no mutual respect and confidence between RA and S&M, then Management has formal decisions to make and announce to all...you know, for the official records.

Carl Goosen I wish this group existed many years ago when I stupidly got 510K's on two products in the wrong order instead of establishing marketability first. I even had the patents too!
I have not been able to get interest from any manufacturer. Needless to say the 510K's expired many years ago!
Carl Goosen

George Johnson I've been doing advertising and marketing for Medical device companies for almost 30 years and have encountered both very conservative (almost paralyzingly so) and very liberal clients. It's really a tough situation you find yourself in, and any one piece of advice would be totally inadequate. Please contact me thru LinkedIn and I'll be happy to share any words of wisdom I may have.

Sofia Epshtein Elbrus After being on both sides I can say that w/o a cooperation and professional respect between the departments it will not work as it should. Same as it is critical for the QA&RA to see out of the box and understand the financial implications of the proposed activities, it is critical for the S&M to understand that QA&RA is not only about digging into some papers and looking for a way to make their lives hard. Both departments are doing their critical parts in the company success. Only when there is a true team work and an understanding that there is a mutual goal for all involved rather than an attempt to prove who's the better professional, the company will blossom. And this is, clearly, the senior management job to make it happen and prevent all internal politics inside the company. Regulations must understand marketing same as marketing must understand regulations, as these two departments functioning one w/o the others' professional knowledge it a straight way to a dead end.

William (Bill) Jackson Sofia, Totally agree with your comments, it is all about TEAM not I not QA/RA or S/M but TEAM!!!

Don't fight them, join them. Trust issues between Marketing and RA is a very common problem. Assure the RA people that they will vet all product claims and that you will run everything through Document Control.

Keep it simple.

Marie Suetsugu Apologies for joining/asking belatedly, and I confess I am one of the quality/regulatory people...but could you please enlighten me:

Aren't there specific requirements for electronic labeling, e.g.

'Upon enactment, distributors of prescription devices who intend those devices to be used within the confines of a health care facility may provide labeling for those devices solely in electronic form, so long as they afford users the opportunity to request the labeling in paper form and promptly provide such labeling to requestors without additional cost.'
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109200.htm

Here, 'without additional cost' means that we would need to provide a toll free number, I've been told...

Please let me know if you have the above discussion because you provide your labeling also in paper form, etc.
If there's no need to worry about such specific requirements we too would like to provide our labeling solely in electronic form, but if a toll free number is required then we simply can't afford it.

Thank you for your help,
Marie

Marie, you are asking a question different than Gary's.

If I understand what you've shared, FDA says you can label in electronic form as long as there is a way a user can contact your company and get a paper form.

You may want to start a new question for the Medical Devices Group and someone more knowledgeable than I on the subject may advise you.

Thanks.

Hello Gary,
All great comments and advice. My thought is to construct a simple matrix describing what your product is designed to do and is approved to do. Then gather a team from quality, sales and marketing to not only approve of marketing documents but perhaps also be part of the development of the message. That will help allow the team (departments) decide to approve potentially much easier and faster. Plus everyone/ department may gain a greater sense of ownership in the success.
All the best, Mark

Richard Oberreiter Gary,
This is really simple. Ask the Quality people how long they would like to stay employed, considering that the competition (there must be some) is doing marketing. Then get them to tell you what the rules are, after all they are the regulatory experts. That makes sure they are part of the process. Make sure you steer the process to the result you want.

Lastly, make sure senior management is behind the effort - usually this fixes most obstacles.

Good luck.
Richard

George Johnson You have big problems that are not going to be solved unless some one there takes charge. Regulatory and quality have no business in marketing or advertising other than policing you from making unsubstantiated or off-labeling claims.

Marie Suetsugu Dear Joe,
Thank you for your response, and sorry if I commented inappropriately. In fact I originally got confused having read your comment
'• Today: We have a brochure.
• Tomorrow: We have a brochure in digital form that can be downloaded.
[...]'

Of course you were talking about a brochure and not an IFU, but I was/am confused because none of you seems to me to talk about the different requirements for paper and electronic labeling above...

I'm not courageous enough (!) to start a new discussion, given especially that there is already a similar discussion in the Medical Devices: QA / RA subgroup http://www.linkedin.com/groupItem?view=&gid=2070960&item=5854835911228928001&type=member
which, perhaps unsurprisingly, operates on the safe side. I guess I'll have to stick to my possibly rather literal reading of the regulations then.....

Donna J. Bandal, MBA Gary, Gary, Gary. It seems absurd that your QA Department is living in fear of the FDA. The only way to truly overcome that is to educate this Department. The mere fact that you are using words like "fear" and "conservative" to describe this area speaks for itself. Coming from pharma, diagnostics AND devices, and having worked collaboratively with many attorneys, Medical Affairs, Regulatory and QA Departments, I can tell you that as long as you can substantiate with literature support, clinicals, and/or studies and you stay within label and intended use, you should be fine in alleviating this so called "fear." The vehicle in which you choose to communicate to your audience is not the issue at hand...it is the message on which you need to be concerned. Whether print or digital...it doesn't matter. It is the message. Basically, you cannot say the product is better than any others unless you can very specifically demonstrate and support that; you cannot make comparatives without substantiation; you cannot say anything outside of the indications or intended use (emphasizing and driving this key message point home!). It's pretty simple. Using words like "best" in your messaging and content are not advisable and difficult to prove across all claims. Astute Marketers know this, as does L, M, R, QA (Legal, Medical, Regulatory and QA) collectively. Some other notes...if you need to use disclaimers and/or list out stipulations for use of your device, then be explicit. It is always better to state these items vs. make inferences. Make these types of information readily available to the audience. Always imagine that you/the company might be audited, so keep it all transparent. Use footnotes, citations, references to note where your information is coming from and how it is supported, and your message will be a good, well-supported one. Remember to balance out from a visual or from a voice perspective, the Marketing message with the L, M, R, QA must-haves. Editors and proofreaders in healthcare know the rules and regulations re: type-size, content balance, formatting, etc. Everyone wants to mitigate risk. Think collaboration, but as a Marketer, you should lead the way.

Ginger Cantor Sure Richard O. Go ahead and intimidate quality and regulatory to get your way regardless of the regulations because your competition is cutting corners..... really? Sounds like that is what you are advocating to me. It's your right as a business owner no doubt. I especially love working in an atmosphere of fear and intimidation. But on the flip side -can you deal with the fallout of a ticked off regulatory function? Hmmmm whistleblower comes to mind. Go ahead and ask Glaxo-Smith Kline or GE how those large Consent Decrees helped their bottom lines.

Richard Oberreiter I'm glad to see that my comments have added some spice to this thread. In a regulated environment it is critical to know the rules and play by the spirit and letter of the law. At the same time, being so conservative that a company can't do marketing will only lead to one thing - falling sales which lead to lay offs which is bad for everyone. All departments, particularly in an ISO certified firm need to work together. Senior leadership needs to set the tone and direction and remove obstacles that prevent top performance. Its all easy to say and very hard to do.

Lastly, and maybe its me, but I've never found that making money was "easy stuff".

Sofia Epshtein Elbrus Wow, this thread is a long living one. I'm kind a surprised to keep reading these marketing vs. RA comments - even the FDA is working pretty hard in order to stay aligned with the industry and technology, addressing most controversial issues. So it's just about getting together, communicating desires and concerns, making sure that the regulatory requirements are well understood by all parties (even if it means communicating with the regulator) and developing a plan accordingly, verifying it is within the regulatory limits. These regulations were not written so we will all suffer, they actually do make sense. Once all sides are interested in finding a solution and making it work - it will work, as easy as that. After all, it's business, nothing personal, right?

Cheers,
Sofy

Julie Chisholm This has been enlightening in the device world. Luckily companies are structured to have marketing reporting to the CEO and quality/ regulatory to the President. Between the two they can decide ultimately if "removing obstacles, aka Regulatory is a benefit or a risk. I'm glad I worked many years for a company where the President had also been the head of Regulatory and Quality at one phase in his life. It's a tough job, but Regulatory/ Quality truly is in place to protect a company from themselves because the natural knee jerk reaction is to get rid of what isn't making money until you get dinged. Then a company is more than happy to hire expensive Quality consultants. Everybody else in the organization is disciplined and working with Quality. In fact in my company, I'm busy day in and day out answering questions and "consulting" as we're in process improvement mode and everyone is excited to have their processes functional and easy to use. The only group that has issues is marketing as they don't want to seem to play with anyone else and this thread has confirmed my suspicions.

Marie Suetsugu Which is very sad...
But perhaps that's why the person in charge of post-market surveillance isn't allowed to be engaged in marketing too (or is it just in Japan?). Perhaps that's how things are.

I'm still awaiting someone's help (here or elsewhere) though, please!
Am I somehow 'blocking [our] marketing for fear of FDA' as the title of a branch discussion of this one unfortunately suggests, should I rather be letting them go ahead, or am I on the right track telling (or having to tell) them not to provide info electronically (whether or not it is the same info as the paper one) until we've met the specific (risk management and other) requirements for that purpose?
Once again I'm sorry if I am deviating, but to me it seems quite relevant...
Thank you.

Sofia Epshtein Elbrus Marie, IMO, you clearly shouldn't do anything that contradicts with the regulatory requirements. We are all aware of the price the company may pay for that. What we usually do in such cases is investing many hours in analyzing the exact gaps between the marketing goals to the regulatory requirements and trying to find the golden path, while marketing is fully engaged in this process. Sometimes you find out that by investing in, say, something seemingly unrelated as warehouse reorganization or optimization of the signing process you have freed the resources required to comply with the desired requirement. Obviously, in some cases the marketing desires just cannot be fulfilled (easy example is stating a claim that cannot be clearly supported) but, at least, after such process all parties are aligned and understand the pros / cons, so nobody thinks that the other side is just having some non-rational fears.

Marie Suetsugu Aw, thank you Sofia!
But...my question was more of an elementary one, it was rather that: Is my interpretation of e-labeling requirements wrong?

I've been advised to start a new discussion on this subject, which I'm going to do now...

Sofia Epshtein Elbrus Oh, my apology, I thought it was a more general question rather then a specific one.

Hi Gary,
Many companies struggle with this issue. I've also worked in the class II space for many years and I'm familiar with the challenges you're facing. Making the decision about how to market in light of the FDA regulations can be difficult because of the need to align so many stakeholders. The obvious path of least resistance is to not market at all. However, as the industry has evolved, marketing has become a necessary component of every manufacturers strategy. I'd be happy to have a conversation about strategies I've seen/used in the past to get the program started.

Julie Chisholm I find this entire thread quite disturbing which is not a popular comment on a public forum like LinkedIn. I'm entirely busy, but was drawn to comment on this one specifically because it was a source of a major nonconformity (and the only one) with our last ISO (renewal audit so very complete) was specifically with marketing. I came from pharma where marketing and pharma was so integrated and streamlined that it shocked me when I made the transition back to devices. I went from a very open streamlined environment to a very "this is our department". The original poster has it right, get in this century. The worst job that I have is to say "no" because although that may be a delay in cash flow, ultimately my company will remain in business.

It has to be cooperative, because your Regulatory/ Quality department understands the risks of your independence. All information, website, twitter, etc. must be approved by Regulatory and via change control. This is timely, but it's a requirement.

I came from an environment where this was seamless for a reason. Other companies were under consent decrees for marketing claims they could not substantiate via their marketing application. It's why commercials for a drug are so long -- the regulatory claims surpass marketing claims.

Devices are catching up and even Notified Bodies (medical devices) are requiring that every addition/ change to a website be approved by Regulatory. The big problems in my opinion are with Marketing believing they are independent from the process. They also ultimately report to the CEO vs. the President. You will also stay employed because the Quality/ Regulatory people are protecting the company from themselves. Making money is easy stuff, but read what is going on on fda.gov.

It's cooperative. And like I said, I find this entirely disturbing.

Scott Spinka I have read these discussion segments with great interest. I am a 30+ year Class III medical device developer/marketer/executive/entrepreneur. I have successfully launched and marketed scores of different products for many different companies Through the years, I have seen a broad spectrum of approaches to regulatory/business integration. All of these have the intercourse of reaching all departments inside your company.

Every successful company must continuously strive to build/upgrade/manage its strategic customer relationships (understanding the customer needs and profitably providing for those needs). This is an ever changing platform; wherein, one needs to continuously re-assess product definition/enhancement/use/liability/regulatory compliance/other.

I have read here some saying that the FDA is in business to help; truthfully, I have not shared that experience. They are the necessary "evil" (if you will); so, we must find ways to stay on top of product claims/proof/compliance/etc. and satisfy their demands.

Through the years I have found selected expertise that has helped me, e.g., xFDA.com; but in all cases, when there is disagreement about regulatory positions, I recommend testing convictions. If a legal or regulatory consult suggests a certain approach, push them to show the strength of their position. Do not just take for granted that they are right. If their conviction remains strong, you will see where you must moderate.

These inter-workings, as I said previously, "intercourse", are critical components to successful medical device businesses.

If I can help any of you in any way, I will be happy to speak with you (919) 923-9522. Feel free to call me. You can also E-mail me at scottspinka@caremericainc.com .

Donna J. Bandal, MBA Final note: There isn't any one Department who rules the roost. Some of the commentary appears disturbing over which area is leading the way. Just remember, Sales & Marketing are the revenue generators and ultimately provide the paychecks, L, M, R, & QA, help mitigate the risk. Everyone has to ultimately, be on the same page and work towards the success of the company.