Useful Advices - Business

This is a situation we’ve all run into at one time or another, be it at work, the mall, or any virtually any other setting: We have a hard time

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

understanding someone because of their accent. While they may be speaking perfectly fluent English, it can be really difficult to understand s

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

Examples of combination products may in

meone with a thick accent. While it may only cost you an extra pair of socks at the mall, or make you return your dinner because you got the wr

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

ng dish, at the office the cost of such a misunderstanding can be much greater. The problem is some people don’t want to ask for clarification

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

rom someone if they can’t understand them, because they think it’s rude. This leaves them in a self-made catch-22 situation: If they don’t ask

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

Combination pro

then whatever they are working on with that person probably won’t be done right, but if they do ask they feel they’re going to offend them.

Th

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

solution to this can be simple: Just ask. It’s been my experience that if you really are having a hard time understanding someone because of

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

heir accent, it’s much better to ask for clarification then to just interpret the best you can. Why? Because it’s better that you ask and the

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

ork gets done right than if you don’t’ ask and the work ends up wrong. Now, you don’t need to be rude about it and say “What the hell are you s

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

ying???”, but a polite “Excuse me, could you go over that last part again?” or something to that effect will do the trick. Will some people get

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

offended? Probably, but as long as you’re not asking every three seconds for them to repeat themselves, 99% of the time they should be ok with

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

Following aspects would a

it. This leads us into another situation: What do you do if you constantly can’t understand someone?

I haven’t run into this situation too ma

dd to the challenges in developing combination products:

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

y times, as I’ve found that when you work with someone for a while, you generally learn to interpret their accent better. However, one way to m

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

tigate this problem is to have everything in writing. Through email, meeting minutes, letters, whatever you can get your hands on, try and get

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

heir thoughts in writing. It should be much easier to read what they are trying to say instead of trying to guess at it. Once again, don’t jus

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

say “I can’t understand anything your saying” and throw a notepad at them. Instead, try something like “Could you send me an email with that?”

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

Professional from academic institutions, pharmaceutical industries, health care indust

It’s not unusual to request an email even if you can understand someone, as you may want to pass it on to other people or look at it later, so

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

this shouldn’t be a problem. Email is a widely used tool nowadays anyway, so people are pretty used to sending much of their communication thro

.

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

gh it.

At the end of the day, your decision will come down to this: Do you want to risk making a mistake on what you’re working on because you

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

Companies that provide selfless information through particip

feel uncomfortable asking for clarification? Only you can make that decision, just make sure you given it sufficient thought before you make it

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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