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Patricia runs a small graphic design company. She employs several designers, illustrators and copy writers. Her office is a beehive

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

of creative activity and often deadlines can mean a hectic atmosphere.

This is a typical right-brain office and when you have so

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

Examples of combination products may in

any creative employees, there can be friction between team members. Her employees are highly talented. Sometimes these creative peo

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

ple lose track of time and deadlines. Pat, on the other hand, has a business to run and cannot afford to be late with the end produ

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

t. Her clients wouldn’t stand for that.

But I am surprised she never loses her temper with either her employees or clients both of

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

Combination pro

whom can try her patience. I asked her once what her secret was. Pat seems unfazed by all this but I know she must secretly froth

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

at the mouth. Here’s what she told me.

“Marilyn, it is hard to be the boss of creatively charged twenty somethings and if I don’t

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

anage it well, I would be close to losing my temper every hour of every day. I find it better to hold my tongue than let go of a va

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

luable employee. I have spent hours training them, refining their skills, and that is too much of an investment to lose. I wait til

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

my anger has passed and then speak calmly to them. Most of the time I am able to get the point across and avert a crisis.” Patrici

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

said.

I employ the same strategy myself. Our conversation re-affirmed my belief in not making a decision or delivering criticism

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

Following aspects would a

when angry. Anger can spoil a good thing – it is a moment of weakness for a business owner and repeated bursts of anger with employ

dd to the challenges in developing combination products:

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

es can destroy a good team.

Sometimes your clients or employees will make you angry. The trick is in not dealing with them right a

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

way. Take some time to compose yourself, rehearse your case, and then present it to the other party in a calm voice. Invariably, yo

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

will come out the winner.

A good strategy is to let the phone call go to voice mail if you think the caller will be telling you b

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

d news or you have just handled a stressful situation and are still upset. Always invest in caller ID!

If you are talking to an em

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

Professional from academic institutions, pharmaceutical industries, health care indust

ployee or client and the conversation is going badly, take a break and think about the situation. Hardly any problem cannot wait a

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

ew hours for a solution. Always leave yourself time to think. It is better to be seen as “not decisive” than make a decision you wi

.

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

ll regret.

Use this strategy when you anticipate bad news or even when you have to deliver a bad news. It is better to wait and th

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

Companies that provide selfless information through particip

nk about a problem with clarity in your mind before responding. You can never take your words back or undo an action taken in anger

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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How to avoid difficult words. Choose words suitable to your readers reading ability

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