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If you remember the sonic boom of the early “faster-than-the-speed-of-sound” flights, then you may not be taken totally off-guard by the boom created across America during the “f

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

aster-than-you-can-say-hippie” employee shortages and knowledge loss expected to occur during the exodus of the baby boomers from the workforce. The start of what may be the largest demograp

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

Examples of combination products may in

ic change to hit the American workforce began last year.

The first of the Baby Boomer generation turned 60 years old, and every seven seconds for the next eighteen years another baby boomer will

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

turn 60. With approximately 83 million workers set to retire in the next decade, many employment experts warn that there may not be enough younger American workers to replace those who will retire

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

and that even the massive productivity gains made in the past decade may not be enough to make up for the lost labor, talent, and knowledge base. In fact, by 2010, more than 25 percent of the U.S.

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

Combination pro

working population will be at or near retirement age. The generation just behind them, the GenXers, with less than 54 million people, is 35 percent smaller.

Every industry will be impacted. For

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

xample, manufacturing already faces shortages of skilled workers in many sectors. This shortage will only intensify as the boomer generation of welders, tool and die makers, mechanics, and electri

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

cians begins retiring. The “2005 Skills Gap Report – A Survey of the American Manufacturing Workforce,” conducted by The National Association of Manufactures (NAM), Deloitte, and

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

The Manufacturing Institute, states: “The picture that emerges is both more complex and more disturbing than in the past, because it exposes a broadening gap between the availability of skil

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

led workers and the employee performance requirements of modern manufacturing.”

As companies compete to attract the best of the GenXers, manufacturing must overcome the “assembly line

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

stereotype image” that the younger generations find so negative that there is a decreasing number of young people pursuing manufacturing careers. One positive action being taken is the campa

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

Following aspects would a

ign developed by the National Association of Manufacturers (NAM) and The Manufacturing Institute, its research and education affiliate, to recruit young people by putting a more glamorous face on

dd to the challenges in developing combination products:

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

he industry. If you’re having, or anticipating, labor shortages, you might want to check out any campaigns being undertaken by associations in your industry.

The biggest problem facing ever

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

yone, however, is not the loss of warm bodies, but the loss of institutional knowledge. Peter Drucker, a renowned management thinker, calls the coming knowledge loss, “a hemorrhaging of work

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

lace knowledge and knowledge-based experience at a time when such knowledge and experience is increasingly important to the American economy and to the organizations that comprise it.”

Why

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

the uproar? Well, how much does your company value experience? Do you look for new employees with five years or ten years experience? Then consider these numbers, the Society of Petroleum Engineer

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

Professional from academic institutions, pharmaceutical industries, health care indust

estimates that the industry will lose 44 percent of its petroleum engineers between 2000 and 2010, a loss of 231,000 years of cumulative experience. That’s a lot of experience and knowledge

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

from just one sector, and we can expect similar losses in every industry. Almost every expert agrees that now is the time to plan.

Some innovative companies have already begun programs to replac

.

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

the talent and knowledge lost by the baby boomer exodus by identifying and documenting the knowledge and experience held by boomers before they exit the workplace. U.S. companies with a goal of b

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

Companies that provide selfless information through particip

uilding a post-boomer high-performance workforce may need to take a “long-term investment” view of the value of job-specific training, employee development, and knowledge documentation

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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