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A series of articles exploring the seven critical areas that can indicate a partnership is in trouble.

The 5th C: Control Issues

When control is in the picture it is a lose/lose proposition.

First, it is an illusion that anyone can control a person or

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

a situation. The need to control is born of fear, lack of trust and insecurity. A person who feels it is necessary to control is robbed of a sense of well being. In business, control or the attempt to control can occur in many venues.

The attempt to cont

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

Examples of combination products may in

ol can go on at the top between partners or anywhere else in the organization where two or more people work together. It may be between a group of managers, or between a CEO and direct report. It can be a manager and the team for whom he or she is respons

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

ble. It might be an owner CEO and stock holders, or a member of the board of directors. Family members such as siblings often attempt to control each other, or a father hands the business to his son, but won't let go of the reins.

When someone attempts 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

control, they expend enormous mental and emotional energy to hold things within boundaries. Controlling behavior is constrictive and confining. It takes its toll on one's ability to function in a healthy, stress free and creative manner.

In business whe

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

Combination pro

re the desirable goals are growth, expansion and creativity, this constricting behavior imposes the loss of these elements and seriously affects the bottom line. Here are some ways in which this loss is manifested:

7 WAYS CONTROLLING BEHAVIOR EFFECTS THE

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

BOTTOM LINE

Unhappy, controlled employees do not work to capacity.
Unhappiness breeds stress, illness and costs in sick leave and lack of productivity.
Increased turnover is costly. Often businesses do not calculate the enormous costs

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

around turnover such as costs for advertising, loss of the revenue until a new person is hired, trained and moved up to the level of the prior person, as well as a compensation package. There are higher taxes for Workman's Compensation when a business has

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

employees leaving.

Loss of clients who liked that person may leave.

Projects that were left unfinished may never get completed.

Demoralization of employees left behind.

Overall lower level functioning when top managers and CEO's stifle

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

the atmosphere by controlling behavior

An example of controlling behavior is Lance, who was promoted to manager of a department in the bank where his expert financial skills earned him recognition. However, no one thought about or realized his pe

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

ple skills were not developed. He had never had any training in how to be a manager. Now faced with his new challenge his previous level of self confidence diminished to zero. But since he didn't want anyone to know it, he remained hidden a lot in his off

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

Following aspects would a

ce, didn't interact in a personal way with his team members, and micro-managed them by requiring them to get his ok on everything they did, even ordering paper clips. The result was a demoralized, low functioning team made up of disgruntled members who fe

dd to the challenges in developing combination products:

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

t devalued and lacked motivation to be creative and productive. This type of control, as in all controlling behavior, besides debilitating to the individuals involved, negatively affects the bottom line of the business.

It is more cost effective not to p

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

lace people in positions requiring skills and talents beyond their present level. A more positive solution would be to offer the candidate for promotion the opportunity for personal development through coaching.

When partnerships are made up of family me

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

bers it is even more pronounced. For example, older siblings may boss younger ones. They may diminish, victimize, browbeat, threaten or protect. Younger ones may be defiant or fall victim.

Obviously, not only their relationship but the business and all o

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

those involved in it will pay the price.

How To Stop Controlling Behavior

Having a coach on board helps the controlled person let his feelings be known in a non-threatening manner and also helps the controller grow from these revelations.

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

Professional from academic institutions, pharmaceutical industries, health care indust
>Learn to build trust with the client(s) through coaching.
Encourage productivity and creativity by showing how to value and appreciate each other.
Learn how to delegate without fear of loss of stature
Encourage input and creative ideas and

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

the permission to do them

Show a top executive that if his team members out perform him it reflects well on him. It may also secure his positioning for promotion because his department will be left in good hands thanks to her good management skills.

.

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

Address the structure of the partnership or team to ascertain if it is in alignment with the vision and goals they set for the business and is in sync with their values.

Coaching can be beneficial for anyone in an organization who exhibits co

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

Companies that provide selfless information through particip

trolling behavior. The first step to getting the behavior under control is self-awareness and that can be accelerated with the help of a coach. Then, as awareness is developed, previously negative situations can be turned around to be win/win for everyone

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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