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If I was a fly on the wall what would I hear your employees say? Would it something like this? “They won't allow me to make even the s

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

implest decisions.” “The red tape here makes it very difficult for me to do my job.” “Management has to sign off on everything; they do

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

Examples of combination products may in

't trust me."

A big time waster for managers is micro-managing - paying extreme attention to small details and not giving people the a

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

thority to do their job. If it is such a time waster why do so many managers get hooked into micro-managing? Here are some reasons.

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

b>Top down mirroring. The CEO or President micro-manages his or her direct staff. The staff then unconsciously adopts the same ma

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

Combination pro

agement style with their direct reports. The practice spreads, or ‘mirrors’ itself, and becomes part of the culture.

Fear. In

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

today's difficult economy, managers live in perpetual fear that their department better produce or else. This fear drives them to micro

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

-manage, rather than trust their employees to make the appropriate decisions.

A wrong belief. Many managers think success is

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

ased on amassing as much power as possible. They therefore do not allow their employees to make decisions by themselves because that wo

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

ld be giving up their own power. However, the more management allows employees to make decisions, the more powerful the entire organiza

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

ion will be.

Here’s what can be done to influence managers to focus their time, energy and resources on the important tasks of managin

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

Following aspects would a

g – getting work down by and through others.

Start at the top. Hire an executive coach to help the CEO learn to tru

dd to the challenges in developing combination products:

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

t and delegate to subordinates. Managers will then likely follow suit with their own direct reports.

Ask employees.

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

se focus groups and individual interviews to learn from employees what decision-making authority they feel they need to do their jobs w

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

ell. Then communicate this information to their supervisors.

Put yourself in their shoes. It is very easy for manage

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

s to lose perspective about what decisions their employees really need to make by themselves. Managers should ask themselves, what deci

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

Professional from academic institutions, pharmaceutical industries, health care indust

ions would I need to make if I were doing that job?

Train managers. Delegating and trusting employees are all skills

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

that can be taught. During the training, those few managers that ARE doing a good job of delegating should be asked to share their bes

.

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

practices and successes with others.

Many managers often know in their heart of hearts that they are micro managing. Yet

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

Companies that provide selfless information through particip

they find it difficult to change old habits. Great leaders are consummate learners and are willing to take risks and try new approaches

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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One of the reasons that so many people are unhappy at work is lack of good careers advice or being influenced by well-meaning family and teachers. If you are looking for a new career, here are some tips to help you find one which you will enjoy.

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