Advice You - Business

Power is an integral aspect of all negotiations. Those who have it flaunt it. Those who don't, crave it. But is power all it is bu

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

ilt up to be? Yes, it is!

Everyone possesses some form of power. It is not a unique or rare commodity. It exists within each of u

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

Examples of combination products may in

s. The ability to reach in and drawing upon it in time of crisis is another matter.

People who wind up hospitalized after an oper

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

ation or accident become astutely aware of their helplessness as they lie waiting for the next onslaught of medical staff to probe

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

press, check, inject, administer and otherwise subjugate the patient with minimal, if any, feedback on what is happening. Powerle

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

Combination pro

ss to question, much less manage, what is happening to them, many patients become distraught at the helplessness of their situatio

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

n. This leads to depression and diminished interest in the outcome. Not a healthy attitude for the patient.

Power is an interesti

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

ng commodity. It can be blatant or subdued. In a negotiation, power is both fact and illusion. Factual power has to do with money,

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

options and time. The more you have of these three items, the more negotiating strength you have. Illusionary power, on the other

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

hand, is often based in how the other person "sees" or perceives you. Your image is based in part on the reality of the situation

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

and the assumptions the others make about you. You can fuel those assumptions by the way you act, your dress, and your mannerisms.

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

Following aspects would a

Power is a state of mind; both yours and those around you.

Power does have one salient trait. Having power, being empowered, giv

dd to the challenges in developing combination products:

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

s one a sense of purpose, of control. The patient noted above is much more likely to heal quickly if they are empowered by the hos

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

pital staff and attending physicians with some knowledge of what is happening and what will be happening next. Even better, if the

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

y can be given some control of their destiny through participating in the decisions being made on their behalf they are likely to

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

become involved in the healing process rather than remain detached, albeit ambivalent.

Every doctor knows that it a patient's att

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

Professional from academic institutions, pharmaceutical industries, health care indust

tude can make a huge difference in the recovery process. Giving them choices, options and, ergo, power, gives them a vested intere

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

st in improving.

When negotiating consider how you can bestow elements of power on the other side by inclusive tactics. No matter

.

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

how much power you have, you will need the other person to eventually agree to your proposal. The entire negotiating dance is a p

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

Companies that provide selfless information through particip

relude to getting to 'yes'. Inclusive strategies that empower the other side in the process goes a long way to achieving an accord

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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Advice You - Power is an Essential in Negotiations

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