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I often ask clients to tell me about the management and leadership practices they use. Recently, I a

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

sked one client how he organizes priorities and plans his work.

He stated that he comes in each 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

and hits the ground running; he's constantly putting out fires, answering questions, solving problems

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

, etc. Sound familiar? My first question for him was "How's that working for you?"

It was obvious t

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

o me that it wasn't. This pattern was not allowing him to focus on the true priorities of his job or

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

Combination pro

to be proactive, yet he just laughed when I asked the question. He laughed because that simple questi

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

on made a light bulb go off for him.

You see, one of his goals for coaching was to improve his strat

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

gic planning and thinking. Now he could see that he was his own worst enemy to success with this goal

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

.

His day-to-day practices didn't leave room to thinking or planning strategy, and so he was sabotag

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

ing himself instead of improving.

This coaching interaction didn't give him the answers; it did caus

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

e some internal questioning and a gain in self-awareness, which is the first step towards personal an

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

Following aspects would a

d professional change.

So many of us walk through life repeating ineffective patterns and behaviors.

dd to the challenges in developing combination products:

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

Sometimes just having someone ask, "How's that working for you?" can wake you up to more conscious l

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

iving. This client reports that he now often asks himself this question, especially as he reviews his

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

own management and leadership practices in relation to his objectives and goals. He credits this one

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

question as the catalyst for many changes at home and work.

What practice or pattern is impeding YOU

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

Professional from academic institutions, pharmaceutical industries, health care indust

R success? What will it take to wake you up to that?

What about the people working around you? Do yo

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

u see someone stuck in a pattern of behavior that goes against what they're trying to achieve? You do

.

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

n't have to be a professional coach to ask them, "How's that working for you?"

That one simple quest

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

Companies that provide selfless information through particip

ion opens your consciousness to these ineffective patterns – and that's the first step towards change

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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