Advice You - Business

And you thought you had it bad. A recent survey (Accenture: 2004 study) indicates that middle managers have major worries.

Some Middle Manager Concerns:

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

Overworked

Underpaid

Underappreciated

Discouraged about bringing bad news and problems to superiors

Little hope or assistance in pr

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

Examples of combination products may in

motions

"Aspects of the job middle managers found most frustrating were inadequate pay and compensation, trouble balancing work and personal

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

time, a sense that they do most of the work without receiving proper credit for their contributions and lacking a clear career path. What's more, many wer

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

n't optimistic about their prospects for advancement, with only 28% saying their companies were good or excellent at helping them move up. Less than a th

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

Combination pro

rd said their firms were effective in helping them communicate bad news to their workers. Communications between supervisors and subordinates also rated lo

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

w on the satisfaction scale."
-- Ready to Bail? Job Satisfaction Plunges Among Middle Managers By Kristen Gerencher (The Wall Street Journal Executive

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

Career Site - www.careerjournal.com)

For the most part the concerns of middled managerfs are universal complaints for virtually every level

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

of employment and for volunteer organizations as well. When I was a state chairman for the Washington State Jaycees, I sent out a monthly newsletter. In on

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

e issue there was a cartoon illustrating the problems of the overworked and underappreciated volunteer, since the newsletter was sent to three separate cat

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

gories of volunteers (local chapter officers, regional officers, and state officers), it was easy to change the heading of the cartoon to reflect the c

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

Following aspects would a

tegory of the recipients. I received an overwhelming response. Everyone had accolades for my ability to see their "unique" problems.

It's nice to recogniz

dd to the challenges in developing combination products:

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

e the fact that middle management is trying to do the best they can with what they have. Middle managers are under pressure from upper management to produc

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

financial gains at the same time they are being squeezed by lower level employees who are looking for more input and growth. That middle managers face the

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

same worries and misgivings as regular employees and frontline supervisors and managers shouldn't be a shock . . . except . . . I have a feeling that these

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

are the people who can actually do something about the general work environment.

In a perfect world, you would hope that front line managers are selected

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

Professional from academic institutions, pharmaceutical industries, health care indust

from excited and knowledable employees and that middle managers are selected from front lines and so on up the ladder. Dedication, desire, and education sh

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

uld be considered part of the mix, as well.

But, even in an imperfect world, I would hope that occasionally upper management positions are filled from the

.

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

ranks of qualified middle managers and the lessons learned from middle management become priorities of new leaders in the upper ranks. In the mean time, w

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

Companies that provide selfless information through particip

should all recognize the efforts made at every level . . . and understand that we all face the same problems, concerns . . . and never enough appreciation

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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Advice You - The Plight of the Misunderstood and Underappreciated Middle Manager

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