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At one time or another, organizations develop an over-abundance of "negative energy" or attitudes. Sometimes they can be linked to organizational trauma, like down-sizing, budget restrai

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

nts or workload increases, but sometimes they evolve over time with no apparent triggering event. The negative organization is characterized by increased complaining, a focus on reasons

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

Examples of combination products may in

why things can't be done, and what seems to be a lack of hope that things will get better. It feels like the organization in stuck in treacle. And, it's contagious. Negativism can af

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

fect even the most positive employees.

What can you do? Based on an article by Arthur Beck and Ellis Hillmar, professors in organization development at University of Richmond, we sugges

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

t the following:

Model Positive Behaviour

It is obvious that if management is walking negative and talking in a negative way, staff will follow. Don't do it. More than that, tak

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

Combination pro

e a positive approach with staff by showing confidence in their abilities. Expect a lot, support staff, hold them accountable, confront them and be clear and honest. Set standards for

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

your own work and relations with employees, and work towards meeting them to set an example of positive behaviour.

Acknowledge Negativity

You can't ignore negativity and expect i

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

to go away. If you do not acknowledge it, then staff will feel that you are out of touch, and will not be confident in your abilities. Acknowledge the frustration negative feelings, a

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

nd do not try to convince the person or people that they shouldn't have their negative feelings. However, when acknowledging employees' negative feelings, try asking for suggestions rega

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

rding what to do about them.

Look For And Identify The Positives In All Situations

Sometimes we forget to find positives. When an employee makes an impractical solution, we are

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

quick to dismiss the idea. We should be identifying the effort while gently discussing the idea. Look for small victories, and talk about them. Turning a negative organization into a p

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

Following aspects would a

ositive one is a result of thousands of little actions.

Give Positive Recognition Often

Pretty straight-forward. Provide positive recognition as soon as you find out about good p

dd to the challenges in developing combination products:

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

erformance. Do not couple positive strokes with suggestions for improvement. Separate them. Combining them devalues the recognition for many people.

Refrain From Collusion On Negat

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

ivity

It is easy to get caught in the general complaining and bitching, particularly in informal discussions. When faced with negative conversations, consider changing the subject,

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

comment on the negative content ("Let's talk about something more pleasant"), or ask what can be done about the situation (move from negative to positive slant).

A Few More Quick Tips

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

:

Hold a strategic planning session to focus on a positive future (but make sure it is well facilitated).

Encourage staff to find creative ways to make the work environment more enj

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

Professional from academic institutions, pharmaceutical industries, health care indust

oyable.

Encourage staff to be involved in decision-making and delegate where possible.

Introduce a "work-smart" program to dehassle the workplace. Conclusion

It is not uncommon for or

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

ganizations to go through periods of negativity. Managers play important roles in determining if that negativity will increase, or whether the trough is relatively short. Above all, rem

.

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

ember that it is the little things that you do, day in and day out, that make the difference.

(c) 2005, Robert Bacal, Bacal & Associates. You are welcome to "reprint" this article online

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

Companies that provide selfless information through particip

as long as it remains complete and unaltered (including the "about the author" info at the end) all links are made live, and this copyright notice and indication of authorship are included

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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