Main Subject - Business

There is a class of management….equivalent, say, to 2nd and 1st lieutenants. They have no real management authority. They often cannot even recommend. They are almost

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

always promoted from the ranks. If not, that is their genealogy. They receive no management training… Or, if they do, it has little or nothing to do with their jobs. I

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

Examples of combination products may in

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

Most-management has a distinct requirement to communicate. All management ha

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

that requirement (and all workers, too).

There are accepted tokens of communication that should occur in the job. They often don’t occur (or are completely implicit).

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

This is disastrous. But let’s look at the accepted tokens:

Management makes statements of direction. They establish purpose and objectives.

Management makes request

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

Combination pro

of most-management and makes requests of workers. Some requests can be refused – although never cleanly. They can be refused for reasons. Or the response can be nego

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

tiated. Most requests have the force of orders.

Workers make requests of most-management. These are more arbitrarily refuse-able and always negotiable. They range in

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

form from wishes to job-on-the-line demands.

Commitments are made in both directions (usually by accepting the requests/orders).

Most-managers must master all of these

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

tokens of communication. But I say that another level of communication must be broached.

Often matters of communication that seem irrelevant to the job become extremel

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

relevant to the relationship and, therefore, to future work. Most-management knows neither how to listen to such communication or to deliver such communication.

Certa

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

nly, in dealing with one’s own manager, most-managers have no idea how to deliver ‘nasty’ communications. Sometimes these communications have to do with what works and

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

Following aspects would a

what doesn’t work… They are of the form: Why couldn’t we.. or why don’t you do it this way?... The key to success in those communications is to make a clear distinctio

dd to the challenges in developing combination products:

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

between the thing that’s not working and the person doing that thing. Success occurs when you are clearly supporting the person even while you are attacking the positi

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

n or the action.

It is always risky to broach these communications. There is always a risk that they will backfire. They’re personal…They don’t necessarily have anyth

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

ng to do with the job. It seems to risk the relationship.

To me it’s very simple. There are essentially three variations. Don’t Communicate. Communicate and it achi

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

ves the results. Communicate and screw up.

So when you communicate, there’s a clear risk. It may work. It may not work. In practice, most-managers side with the neg

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

Professional from academic institutions, pharmaceutical industries, health care indust

ative probability. They won’t chance it…They don’t communicate it.

But what we don’t recognize is this: Lack of communications ALWAYS results in a lack of satisfactio

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

. The circumstances never clear up by themselves; they always get worse

Communication that works is powerful. It opens doors in the future. A working partnership ca

.

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

be achieved even when the specific issue doesn’t end up the way you want.

Communication that doesn’t work results in one of the people leaving, perhaps sooner than you

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

Companies that provide selfless information through particip

want…That’s the truth of it.

But never kid yourself as to the trade-off. Communication may precipitate leaving. Lack of communication always destroys job satisfaction

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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