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It is common for people to want to be considered indispensable in their jobs. After all, the competiti

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

on is out there, the younger generation is more numerous and demanding. The challenge is to be constan

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

Examples of combination products may in

tly building your value to your organization because of personal integrity, humility, and creativity.

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

Look at the more common picture. Managers who feel they are indispensable often behave in ways that a

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

e contrary to their organization’s success. Their goals, decisions, actions, and personality styles se

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

Combination pro

em to communicate that no one can manage the roles and responsibilities of their department better 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

n they can. They feel that without them, their organization or department would fail miserably. This 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

often the height of an out-of-control ego, arrogance, ignorance, and/or any combination of these fact

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

ors. It can also be caused by poor self-image or insecurity.

This style of management can often be se

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

en in a “my way or the highway’” corporate culture. The negative impact of a manager with this outlook

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

isn’t a pretty picture. To believe you are indispensable is totally naive. If this “lone giant” attitu

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

Following aspects would a

de is a part of your psyche, I recommend you consider the following:

1.How was your departm

dd to the challenges in developing combination products:

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

ent or organization able to function before you arrived?
2.When you take a week off for vacation,

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

does everything fall apart at the seams?
3.Are you cultivating employees to take on additional r

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

les or responsibilities that are part of your job function?
4.Do you tend to delegate only fluff

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

to your employees?

On the other hand, smart managers and leaders who truly make themsel

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

Professional from academic institutions, pharmaceutical industries, health care indust

ves indispensable will constantly build their value by staying on top of their game and enlarging the

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

ision of their own future. To do this, they will:

1.Offer their employees adequate training

.

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

.
2.Hire strong candidates so the employee will contribute to the good of the department and comp

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

Companies that provide selfless information through particip

any.
3.Delegate tasks or assignments to help the employee grow in skills and responsibilities.

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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