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I have spent a lot of time taking help desk and technical support calls. I often wonder how much of my time is spent actually solving problems over the phone as opposed to dealing with all the other things that don't relate or hin

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

der the troubleshooting process. I decided to make a simple little guide that everybody should follow when calling a support line or their help desk for their technical related problems.

1. Stop complaining and let me solve yo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ur issue

Us people that take support calls, we are problem solvers. We want to solve your problem and get you off the phone. Ok, so your issue has been happening for a while, and you've been dealing with other people i

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

my department, I understand that. Can we please get to solving what you called for please? If I can just do that, there will be no reason to complain. I can understand some level of venting, but when it goes on forever it hind

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ers our ability and desire to help you.

2. Follow our direction and do nothing else

Call, describe your problem and then let us take over. It's now time for us to direct you now. Click only where we tell you to click an

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

type only when and where we tell you to type. Forget about the screens you were on before or other areas where there was a problem. Bouncing around and doing your own thing will only result in a longer call.

3. Don't say t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

hat you are a tech

If you are a computer tech yourself and you feel you are going to win points with the tech you are calling by saying "I'm a tech.", forget about it. Understand that 9 out of 10 people that claim they are

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

"techs" aren't able to follow the simple direction they are provided. If you truly are a tech, you won't need to tell me, because I will know just by the way you follow direction. I also know you want to solve the issue now by

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

trying your own things in the middle of what I'm trying to tell you, but please see #2. People that say they are technicians are the #1 violators of rule #2.

4. Have the error message written down

If there was an error

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

message, please be sure you can recite it to the tech when you call. That way we can search for it in our knowledgebase or on the internet and come up with a quick solution. If you don't have the exact error message VERBATIM

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

/b>, it helps us very little. Don't just make up an error message that sounds similar to what you read.

5. Be in front of the computer when you call

It amazes me how many people call and think that a problem can be tro

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ubleshooted while they are on their morning drive miles away from their computer. This should be a no brainer, but I guess people feel they are somehow saving time instead of wasting mine.

6. I can't help you in getting comp

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ensation

If you want money back because your computer problems are making you suffer, I can't do anything about it. Seriously! I have no "pull" in that direction, nor do I care to. Take all that up with your salesman or ou

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

billing department. We are problem solvers. We solve the technical issue you are having and that is our only function.

7. No, we don't know it all

Some people expect all of the answers to their problems right now. They

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

get frustrated when they don't get them right away. Please understand that things need to be researched and that may take time.We also may give information that is not true from time to time. Again, we don't know it all and we

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

are human and may slip up from time to time. It doesn't mean we are stupid or have less knowledge than somebody else.

8. Before calling support, please try restarting your computer

I hate asking people to restart their comp

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

uter, but sometimes I have to. Sometimes I don't even remember to ask until an hour into the call because this should be tried by the user before they even call. Computers malfunction and sometimes just need to be restarted. If

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

that does the trick, then move on. By doing so you avoid wasting our time and your own.

9.Be sure you are calling the right people

Check to make sure the product you are using is supported by the people you are calli

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

g. If you bought a Dell computer loaded Adobe software on it, Dell is not going to help you with it. They know nothing about it. Call Adobe.

Most tech's really want to help you out, although there are a few that have a bit of

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

attitude. In that case, ask for a manager, or just hang up and call again to get somebody else. In most cases though, you can simply follow these guidelines and you will be ensured your problem gets solved as quick as possible

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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