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I can’t even tell you the number of times I’ve talked with skilled professionals who can’t figure out why their career has stalled. “I don’t understand,” they say. “I’m working so hard!”

Perhaps the answer is that

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

they’re working too hard. It’s a common problem for generalists: those professionals who offer a wide range of services in an effort to meet every conceivable need the buying public might have.

Being a generalis

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

Examples of combination products may in

t is very demanding. You need to be prepared for whatever problems your customers bring through the door, whether it’s an everyday problem or a once-in-a-lifetime scenario. This requires a huge skill set, not to mention a ne

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

arly overwhelming need to keep up to date with all the developments in every corner of your field. I get exhausted just thinking about it, actually.

Let’s look at an example.
Rina is a financial advisor. She’

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

s a smart cookie, bright and hardworking. She takes a great deal of pride in providing her clients with the ultimate in customer service. Today, on her agenda, there are three appointments.

The first appointment i

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

Combination pro

s a couple with two small children. They’ve started saving for their children’s college education, but aren’t sure they’re getting the maximum return on their investment. They want Rina to help them build the fund faster.

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

r>
The second appointment is a local businessman. He wants to sell two of his smaller businesses and use the proceeds to buy a third, larger outfit. That is, of course, if Rina thinks it’s a good idea -- and if the ta

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

x bite on the proceeds of the sale won’t be too painful.

The third appointment is with an older woman, well past retirement age. She has a mentally disabled son, and it’s very important to her that she leaves a la

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

sting legacy that will provide him with a lifetime of income.

It’s clear that each of these clients comes to Rina seeking something different. They each require unique assistance. They all expect Rina to provide t

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

horough, complete, and correct information that pertains to their individual situation.

It would seem impossible -- yet many advisors attempt to handle such a disparate caseload, in an attempt to be all things to

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

all people. This trend is not unique to financial advisors. It’s endemic among service professionals, who seem to think that some business is better than none at all.

Let’s go back to Rina for a minute. What does

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

Following aspects would a

she have to do to prepare for her day? She’ll have to make sure she’s up to date on college planning and the latest in financial aid packages. At the same time, it’d be a good idea to read over the most current tax law regar

dd to the challenges in developing combination products:

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

ding the disposal of small businesses. Meanwhile, she doesn’t even know where to start when it comes to fund administration for the care of a disabled adult-- some research is definitely in order. It’s going to be a long day

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

for Rina.

Let’s imagine something else for Rina. Let’s pretend she’s decided to become a Nichepreneur, specializing in estate planning.

Right off the bat, Rina’s life gets easier. Her clients know what

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

her specialty is, and they come to her with questions that pertain to that specialty. They don’t ask her how to set up a college fund or how to finance their next business acquisition. Rina’s schedule opens up -- she doesn’

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

t need to study these topics. Instead, she can concentrate on the estate planning area, going more in-depth and gaining a deeper understanding of the topic than she ever had as a generalist.

This makes Rina more e

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

Professional from academic institutions, pharmaceutical industries, health care indust

fficient. When someone comes to her with an estate planning question, she doesn't have to 'reacquaint' herself with the field, nor do some hurried research to bring herself up to speed on the latest trends in estate planning

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

. She's ready. This means she'll be able to provide her clients with better, more accurate service, and far faster than her generalist peers.

At the same time, because Rina is a Nichepreneur, she can demand higher

.

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

prices for her services. Customers know specialists cost more, and expect to pay more for Rina’s skills than they would for a generalist’s. This results in greater profitability for Rina.

Life has become easier.

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

Companies that provide selfless information through particip

Rina’s work day is now more efficient and focused, and she’s making more money than ever before. Being a Nichepreneur combines the best of both worlds: greater profitability and easier, enjoyable work. Who could ask for more

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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You prepared for the interview and were sure that you aced it, but yet no job offer arrives. What happened? Is it you, or could it be the employer?

In the past couple of years, an increasing number of State Agencies and financial firms have been re-addressing cost cutting solutions by sending customer service jobs to rural areas of the United States, where labor costs can be dramatically lower and where skilled labor forces are available.

My flight from Miami to Los Angeles the other day was something special. Although the 757 was filled to the gills with passengers, which is a circumstance that makes most flight attendants especially prickly, ours did their best to smile throughout the entire trip and to actually thank customers for their business. Apart from hearing the customary phrase, “Thank you for flying with us,” during the initial announcement, and when leaving the plane, I’ve never heard this reinforcing phrase or anything like it being uttered DURING the trip. One of the flight attendants said, to more than one passenger, “It is nice having you aboard!” When was the last time YOU heard that line? I scanned my memory banks, and I don’t think I’ve heard it uttered once, during a couple of decades of flying quite regularly, says Dr. Gary S. Goodman, top speaker, and frequent expert guest on radio and TV, worldwide.

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