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According to the U.S. Census Bureau, there are more than 10 million self-employed workers in the United States and

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

that number is increasing - for good reason. Being your own boss means not worrying you'll be laid off or fired.

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

Examples of combination products may in

It allows you to create your own work schedule. It holds out the promise of great financial reward. It frees you

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

rom having to attend mind-numbing staff meetings. In short, self-employment lets you call the shots.

Being your o

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

wn boss is not, however, without significant challenges. Potential concerns include, but are not limited to:

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

Combination pro

Lack of financial security or predictability

Isolation from peers or co-workers

Lack of

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

clarity about job demands and expectations.

Related social and emotional challenges include:

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

i>Tolerating financial uncertainty

Finding the right balance between business and leisure

Obta

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

ining much-needed support and encouragement from friends, family and peers

Combating those feelings of l

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

neliness and isolation that can lead to depression and anxiety.

The following can help maximize your

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

chances for success and satisfaction:

Look to your support network for encouragement, constructive feed

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

Following aspects would a

back and companionship.

Have a financial backup plan.

Have a well-thought-out, written busines

dd to the challenges in developing combination products:

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

plan. The more planning you do with respect to short- and long-term goals and tasks, financial expectations and d

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

aily work routines, the less vulnerable you are to stress, anxiety and depression.

Implement your plans.

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

Be flexible where needed. Successful self-employment requires openness to learning, growing and adapting to changi

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

ng needs and conditions.

Make it a priority to strike a healthy work/life balance. Regularly set aside t

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

Professional from academic institutions, pharmaceutical industries, health care indust

me for social activities, your family and yourself. Each day should leave some room for non-work related activitie

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

Don't ignore the basics! Sit down to a healthy breakfast and lunch. Get dressed for work every mornin

.

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

. Don't lounge around in your pajamas, as that can easily detract from viewing yourself as a vibrant, productive,

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

Companies that provide selfless information through particip

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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Everyone wants to get rich. Who wouldn't? One can dream about it, work hard for it, or try to find an easy way out to becoming the next millionaire. Of course, trying to find an easy way out won't be so easy afterall...

Several success stories have emanated from the lean manufacturing initiatives. Although some organizations were not able to sustain the success after a few years, many others kept building on the initial success through continual improvements in processes. Discussed below are the keys to lean manufacturing success that were common for most of the success stories:

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