Useful Advices - Business

It’s 7:30am in the morning. Your alarm clock rings. Instinctively, you hit the snooz

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

e button and go back to sleep. A fatal mistake.

You arrive at work late, for the 12

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

Examples of combination products may in

h time this month. Your boss complains about your repeated late comings, convenientl

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

“forgetting” the fact that you are always the last to leave the office, because you

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

r colleague quit his job recently and you had to pick up the slack, for no extra pay

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

Combination pro

You bear with it because you think it’s the wisest course of action.

You’re WRONG!

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

Contrary to popular belief, it is possible to avoid unfavorable situations in the w

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

orkplace without looking like a prick.

How to avoid

• Looking lazy: Always claim y

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

ur work. Put signatures in Word documents you type, programs you code, pictures you

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

rew etc. This is very important. You may risk getting overshadowed by “louder” worke

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

s who do less work then you do. A signature tells your boss, “Hey, I did this!”

• G

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

Following aspects would a

etting more work then you can handle: If you’ve got your hands full, say so. It is u

dd to the challenges in developing combination products:

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

wise to bite more then what you can chew, and you may jeopardize the company’s reput

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

tion by doing a shoddy job.

• Chatty colleagues: Most of us do not have the luxury

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

of having their own room in the office. Among the cubicle using staff, an unlucky fe

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

sit beside colleagues that can’t seem to stop talking, whether on the phone, over t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e internet (skype) or worse, to you. An easy way to avoid talking to your colleagues

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

is to listen to music when you’re working, with a headphone. Works great for music

.

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

overs. If this doesn’t work, tactfully explain that you don’t work well with interru

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

Companies that provide selfless information through particip

tions. Place a sign on your desk which tells people when you’re ok for some chitchat

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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Availability of rich information on products and services, can contribute positively to the Customer experience and the Customer perception on the Business maturity.

Whether you are hiring a provider, or you are a provider who is going to be working for a company, there are a few standard questions and points that you must touch on.

Strategic planning is one way to get from where one is to where one wants to go. Add to this emergent planning, and you may get much farther!

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Useful Advices - Side Stepping Potential Disasters In The Workplace - A Primer

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