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“Every failure is a blessing in disguise, providing it teaches some needed lesson one could not have learned without it. Most so-called Failures are only temporary defeats.”

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

- Napoleon Hill

Does downsizing really hurt an organization or is it ‘hype?’ Federal leaders need to carefully consider their response. Was it just another fad in corpora

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

Examples of combination products may in

te America? Let’s review. In the quest for profit in the 90s, many businesses lost focus on the importance of socio-technical systems. Katsioloudes, a management guru, stated that

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

as profitability of mechanization increases, technology is amplified while workers are often devalued. Pfeffer, author of The Human Equation, argued that an organization’s

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

success is directly related to its implementation, and this capacity comes from the workers.

However, most workers no longer trust management in any organizational structure. Ac

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

Combination pro

cording to a USA Today poll, nearly half of those interviewed said that corporations can be trusted only a little or not at all when it involves looking out for the best interest o

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

f employees. Therefore, organizational structure will ultimately fail without proper strategy.

For federal workers, this current environment has caused them to demand more than th

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

e current organizational status quo. The 21st century presents a brave, new world of personnel challenges, such as virtual organizations, outsourcing, and the financial constraints

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

of declining budgets in many federal agencies.

Some of the cultural changes include acceptance of downsizing as a part of work life, the traditional family decline, competitive n

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

ature of a global business structure, and advancement of communication technologies to build person-to-person relationships. Some of these factors have impacted the workers’ attitu

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

des about their jobs and the quality of life. In the 1990s, many government agencies followed the cue of the private sector by implementing downsizing or re-engineering in an effor

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

Following aspects would a

t to correct any organizational inefficiencies or miscues.

Government executives felt that downsizing survivors would grumble about the downsizing efforts but would eventually “ge

dd to the challenges in developing combination products:

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

t over it.” These executives assumed that employees would just be happy to be employed. These leaders were wrong, however. In a study conducted by the American Management Associat

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

ion of over 1,000 companies in the 1990s, surviving employees were found with lower morale, fearing they would be downsized next; survivors were also twice as likely than stable em

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

ployees to take sick leave and five times as likely to suffer back and muscle pains. Government executives now have a leaner workforce, but at what cost?

Caudron, a management exp

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

ert, maintains that management has lost credibility and trust of workers. She further cited that the primary reason trust has degenerated was not because of the loss of job securit

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

Professional from academic institutions, pharmaceutical industries, health care indust

y, but was due to managers mishandling the workforce changes by treating employees inconsistently, thereby losing credibility in the process. Clearly, any initiatives without worke

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

r buy-in will eventually fail. Therefore, effective leaders in the federal system should consider if downsizing is worth the effort.

References:

Caudron, S. (1996). Rebui

.

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

lding Employee Trust. Training & Development, 18-21.

Hackman, M. & Johnson, C. (2000). Leadership: A communication perspective. Long Grove, IL: Waveland Press. Katsioloudes, M. (

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

Companies that provide selfless information through particip

1996). Socio-technical analysis. Human Systems Management, 15(4), 235. Pfeffer, J. (1998). The human equation. Boston, MA: Harvard Business School Press.

© 2007 by Daryl D. Gree

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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