Cases - Business

I am not interested in a theory of management. I am interested in the practice of management. I am interested in having ma

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

nagers fulfill their purpose. And their purpose is that the jobs get done more and more effectively with them there than wi

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

Examples of combination products may in

thout them there.

That needs to begin with an honest look at how we are as managers.

The Distinction ‘Most-Manager’

There

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 a class of management….equivalent, say, to 2nd and 1st lieutenants. They have no real management authority. They often

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

cannot even make recommendations.

They may have supervisors report to them (or even very low level managers). They have b

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

Combination pro

etween 8 and 40 people directly and indirectly below them. They may have their own administrative assistant, though usually

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

the administrative assistant is shared.

This is the critical one: They are almost always promoted from the ranks. If not

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

, that is their genealogy. They receive no management training… Or, if they do, it has virtually nothing to do with their j

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

obs. I say this is so for most managers…and so I class this class of management ‘most-management’.

Most-managers don’t have

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

MBA’s, don’t know anything about business; have read virtually nothing of management.

Promotions are all of the battlefiel

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

d variety…They learn by imitation of those who learn by imitation of those who…This field promotion strategy perpetuates all

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

Following aspects would a

that doesn’t work.

Most-managers are powerless. They are never even told the limits or scope of their accountability and

dd to the challenges in developing combination products:

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

authority. There is no break-in; there is no planning period. And the scope of their authority is nearly non-existent (who

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

trusts a 2nd lieutenant? (if they're lucky, their sargeants run everything)). They have little or no administrative respon

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

sibility or support. They can request to purchase equipment and to hire personnel, but are then told yes or no. They may g

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

et to say who to hire (unless the salary will be too large); they do get to review their people and recommend salary action

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

Professional from academic institutions, pharmaceutical industries, health care indust

(but can’t begin to guarantee it). They can recommend dismissals and are usually backed up – but must discuss it first.

T

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

hey may get to prepare a budget – but it’s an exercise (and they don’t get to work against it anyhow).

They often have no i

.

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

dea of the purpose of their job, certainly not the real purpose – and are focused on short-term objectives. They may get to

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

Companies that provide selfless information through particip

participate in planning cycles, but have little ability to do more than continue what exists.

Waht's your experience been?

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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