Useful Advices - Business

As business professionals, we spend lots of our time interacting with all sorts of people – clients, sup

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

pliers, consultants etc. Our interactions can be in person, on the telephone, by email or even these day

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

Examples of combination products may in

, by sms.

If you do some reading on the subject, you’ll quickly find the predominant school of thought

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

is that all communication must be “professional”, and that if it’s not, you risk damaging your reputatio

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

or credibility.

Part of communicating professionally it seems, is keeping our language and sentence st

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

Combination pro

ructure formal, using important sounding words and not letting anyone in on the big secret - that we are

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

actually real people.

For example, saying: “Please le us know at your earliest convenience if this appo

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

intment is suitable”, rather than: “If this doesn’t work for you, just give me a call and we’ll work out

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

another time”.

The first is cold, bland, and sounds like a business with no soul. The second sounds war

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

m, friendly and actually feels like the sender wants a personal relationship with you.

At the risk of f

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

ying in the face of conventional wisdom, I believe our status as small business operators gives us a hug

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

Following aspects would a

advantage over bigger businesses. We can take the opportunity to let our real selves shine through in o

dd to the challenges in developing combination products:

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

ur communications, and in the process we can differentiate ourselves from our competitors. There are a f

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

w of the big guys that do warm communication well. If you are a Virgin customer, you’ll know that they e

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

xcel at friendly and fun communications.

The reality is that people really notice and appreciate the di

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

ference between the two. I can’t count the number of times that clients have mentioned how much they app

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

Professional from academic institutions, pharmaceutical industries, health care indust

reciate my relaxed style and sense of humor.

So take a look at the messages you are sending out. Do the

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

need to be rewritten in plain conversational English? Are the icicles dripping off the pages of your em

.

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

ails and letters, or is the hearth warm and inviting?

After all –who wants to sound big, bland and corp

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

Companies that provide selfless information through particip

rate like everybody else? Leave that to those who think it’s important (although why they do escapes me)

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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