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If you want to find out what’s going on in your company just listen carefully what kind of nicknames are used by your employees for the managers. It will tell you

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 lot about the state of your company and whether your out look is promising.

Often the interesting jobs are personally done by the boss while the more boring tas

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

Examples of combination products may in

s are delegated. Once the job is done and the result is great the merit of course goes directly to the boss, if not others will be hold responsible.

Employees tel

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

ing their bosses their opinion are often labeled as “troublemakers”. Those getting sick are often label as “lazy” or having personal problems. Never ever it is the

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

environment at work or the disastrous leadership skills of the managers (If you ask the employees exactly those issues are mentioned as the main causes for their s

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

Combination pro

ckness or discontent).

If you look at those companies (especially large corporations) being in deep trouble and you analyze what led to such a catastrophe it almo

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

t always boils down to terrible decision making by the upper management. And yet the employees are paying the bill by being laid off or outsourced or at least suff

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

ring severe pay-cuts.

All kinds of reasons are told by management: It was the bad performance of the market, or the general development of the economy, or mistake

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

made by the employees, or the taxes, or, or, or…but it was never the management. Hello? Who is in command of this ship? Who is determining the course to take? Who

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

is supposed to lead the company by leading the employees?

Management and employees, they just can’t team up and work together for the better of all involved it se

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

ms, and their mindsets are worlds apart. In the end both are sitting in the same trap making each others lives miserable.

Interesting enough most managers and sel

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

Following aspects would a

-proclaimed leaders don’t realize that nothing goes without their employees. They are the ones carrying out the strategies; they are the ones bridging the gap betw

dd to the challenges in developing combination products:

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

en the ivory tower and the customers. They are providing advice to the customer, manufacturing the products and in the end being the face of the company determinin

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

the image. And all they get back is that they are just a “cost-factor”.

Leaders and managers should just walk around and watch closely what’s going on n the offi

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

es and hallways. They will notice that as soon as they appear the small talk stops, laughter is gone and so is motivation. Those talking at the phone quickly finis

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

their conversation, others surfing the internet immediately open working document, because they don’t want to be in any problem or even be fired.

Is this a healt

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

Professional from academic institutions, pharmaceutical industries, health care indust

y climate for success and prosperity for the company? I don’t think so.

As a side note: In those companies where employees are encouraged to participate and have

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

n opinion, where nobody is checking by the minute the breaks taken and nobody criticizes employees for some private small talk, success is achieved must faster and

.

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

at a lower cost. It’s called the power of mutual trust. Why the Human Resources departments are called “Human Resources”? Because your employees are a resource,

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

Companies that provide selfless information through particip

our employees are your capital of the future! Now, how do you treat your capital?

…to be continued…

Walter H. Groth
Institute for Life and Career Transitio

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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Business has never been better. Word of mouth finally seems to be spreading, every seat in the restaurant is full, you've even hired extra staff. So, what now?

Researcher, Nancy Adler conducted a monumental study in the mid 1980’s to address myths about women and international business. Her study investigated if commonly held myths about women in international business were true including: women are not interested in International business, women were not willing to travel overseas for a variety of reasons namely family responsibilities and women would not be viewed as credible in overseas business due to the local perception of women.

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