Main Subject - Business

In most industrialized nations, the average age a student graduates from high school is 18 years old and the average retirement age is 65 years old – a difference of 47 years. On average, most peop

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

le work 40 to 50 years of their lives. It is well established that during these 40 to 50 years of employment workers undergo at least three distinct phases in their career development:

1. The “Br

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

Examples of combination products may in

ng It On” Stage

2. The “Realistic” Stage

3. The “Reinvention” Stage

The Bring It On Stage ranges from the mid-20’s to the early-to-mid-30’s. It is during this first stage of career development

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

that workers are determined to make their mark in the world or work. It is also the time when they have the most energy and the strongest drive to achieve their goals. Most people in this stage bel

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

eve strongly that they can make what they want happen – possibilities and success seem unlimited.

The Realistic Stage ranges from the early-30’s to mid-40’s. It is in this stage that specific valu

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

Combination pro

s and career realities begin to emerge. At this point of their career development, many people feel the values clash between choosing priorities in their work lives and their home lives. Having be

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

n in the workforce for 10 to 15 years, they are discovering that they might not be able to do it all after all. They may feel that they are not necessarily the ones in total control of their own ca

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

reer destinies. The passion they felt in the Bring It On Stage has been tempered by workplace realities and truths such as lack of leadership support on their ideas, a more than likely mediocre wor

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

environment, and the reframing of their earlier passions and goals.

The Reinvention Stage occurs from the mid-40’s to retirement. This is when people are well on their way to totally redefining a

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

d reconciling their work and outside-of-work lives. They have learned from and have mastered many of the challenges they faced in the previous two stages and this is the time many choose to focus o

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

creating a legacy of specific contributions they want to be remembered for in their careers, their families and their communities.

This progression through the three stages of career development i

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

Following aspects would a

natural and normal for most workers. Following are some ideas that employees, managers, and leaders of organizations can use to increase effectiveness, productivity, and satisfaction in the workpl

dd to the challenges in developing combination products:

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

ce:

-- Realize that in today’s and tomorrow’s workplaces, these stages of career development are normal, natural, and will occur

-- Understand that your organization, work group or team is made up

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

of a combination of people who reside within each of the three various stages of career development

-- Recognize that an individual’s work-related and personal values, beliefs, and behaviors are in

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

large part shaped in relation to which career development stage he or she is currently in

-- Be aware and prepared that conflict is likely to occur among people who reside in different stages of c

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

reer development. For example, an employee in her or his mid-20’s may not understand or agree with the leadership approach or direction given by a manager in his or her early-50’s

-- Whenever poss

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

Professional from academic institutions, pharmaceutical industries, health care indust

ble, try to find ways to match people’s values, beliefs, and behaviors to tasks and projects. For example, consider assigning people in the Bring It On Stage to tasks or projects that require a lot

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

of energy; assigning people in the Realistic Stage to value-added initiatives where they can feel engaged and a part of something bigger; and Reinvention Stage people to legacy projects, such as a m

.

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

ntoring program, company history initiatives, or leadership development programs.

Understanding that career development stages are natural, normal, and will occur can go a long way to keeping emplo

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

Companies that provide selfless information through particip

ees motivated. In addition, knowledge of the three stages can help managers and leaders prevent and resolve conflicts that may occur due to career development differences in values and perspectives

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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The environment of any workplace is highly dependent on the type of manager and his/her management style. This article describes some of these management approaches.

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