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You’ve just lost a key employee. Everything seemed to be OK with him, yet he is quitting. Why? You recently added a new employee benefit at great

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

expense to the company, but employees are complaining. Why? For the third straight month productivity has declined even though better systems an

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

Examples of combination products may in

d processes were just implemented. Why?

It seems that the more you try to improve things for your company and employees, the more problems are c

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

eated. What are your employees thinking?

How can you find out what your employees are thinking, and frankly, why should you care? Well, when tur

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

nover increases, productivity decreases, and employees generally seem unhappy, you need to find out why...and fast! And your employees probably h

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

Combination pro

ave the answers. So how do you find out what they are thinking? Frankly, the easiest way is simply to ask them.

Employees are a great source of

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

nformation. They are often the closest to your production, services, and customers. They often see problems before you do, hear about issues earl

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

ier, and have ideas that can improve overall company performance. Yet in to many situations, employees will never bring the information to you un

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

less you ask for it. So how do you ask for it?

There are a number of effective ways. Tom Peters made famous the acronym MBWA (Management By Walk

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

ng Around). By being visible and LISTENING to what your employees are saying, you will learn so much. But you must do it consistently, care about

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

what they are saying, be open to them, avoid being defensive, follow-up where appropriate, and do what you promise. The key to getting people to

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

Following aspects would a

talk to you is trust...and trust doesn’t just happen, it is earned.

Other methods to open up communications include attitude surveys, where emp

dd to the challenges in developing combination products:

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

oyees respond anonymously to a questionnaire. Attitude surveys, in fact, are probably one of the best tools managers have for taking a barometer

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

reading of what is happening in the workplace at any given point. Listening sessions are round table discussions between a group of employees and

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

a key manager. In these sessions employees are free to discuss any item they choose and the manager’s role is to listen and respond...not to def

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

nd. Finally a fourth tool is a focus group, where a manager will assemble a group a employees to discuss a particular issue.

There are many othe

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

Professional from academic institutions, pharmaceutical industries, health care indust

r tools to open up communications and to find out what your employees are thinking. The key is to find a method that you and your employees are c

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

omfortable with using and then to integrate this methodology into your normal everyday business process. If it is regular and genuine, and if emp

.

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

oyees trust you, then communication will flow.

When managers truly know what their employees are thinking, then dramatic things occur. Besides i

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

Companies that provide selfless information through particip

mproved understanding, companies often experience greater employee retention, productivity, morale and communications. That’s why you should care

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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