Useful Advices - Business

I was thinking this morning about rockets, the “space race” and Customer Service Management. (I dated myself with the “space race”, didn’t I. But it really happened.) I know that the two subjects see

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

m completely unrelated. Not even in the same Encyclopedia volume.

And I submit for your consideration that driving a rocket in the space race and good Customer Service Management are exactly the same.

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

Examples of combination products may in

Let me explain why.

Your business is your rocket ship. In this ship is everything you need to survive when venturing into the hostile environment that is space. (And business) In it you will find life

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

support systems, food and water, power, data bases, computer systems and communications.

Pretty cool, huh. You were driving a rocket ship the whole time and you just thought you were at work.

There i

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 one other element to consider in space flight and business. It’s the people flying your rocket ship. So, I’d like to tell a little story about the space race, monkeys and astronauts.

As the space r

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

Combination pro

ce was starting, it became apparent that eventually someone was going to have to strap in, flip the switch and ride a burst of hot flame into orbit. Not wanting to risk human life, the idea was floated

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

to teach a monkey to ride in the rocket, thereby getting the data necessary to facilitate safe human flight. (Can you imagine the conversation around that conference table? “We’ve just spent a gazillio

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

n dollars on these rockets and we need someone to test fly them.” From the back of the room a voice of reason shouts out “We can get a monkey to do it!”)

So the call went out, find a monkey to go to s

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

ace. Now we have continents full of monkeys, however, it’s doubtful any of them had seen a rocket much less flown one or even had any idea they were going to learn how to fly. They are monkeys after al

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

. As the search started, it became apparent that we would need to set a few standards in place. We had to find acceptable monkeys.We had to train them. They had to be able to complete some simple tas

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

s, pull a few levers, push a few buttons and survive the trip back to earth.

After all of the experiments were over, and we had all of the data, we went out and found the best pilots and asked them if

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

Following aspects would a

they wanted to become astronauts. We had a very stringent selection process that filtered out those that would not make it in the harsh environment of space. We instituted a long intensive training pr

dd to the challenges in developing combination products:

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

gram to make sure that the astronauts could fly rocket ships and respond appropriately in case of an emergency. We then edified the position to attract even more talented pilots who wished to become as

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

ronauts. (Who didn't want to be an astronaut growing up)

We didn’t recruit or train any more monkeys. We found that we had all that we needed.

Nice story. What does that have to do with Customer Serv

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

ice Management?

Well, I have a few questions to answer your question, Customer Service Professional.

Did the monkey actually “fly” the rocket or just ride around in it and complete a few tasks?

In y

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

ur business, are your people flying your rocket, or just riding around pulling a few levers and pushing a few buttons?

Are you searching the continent for monkeys or astronauts?

You might have a poin

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

Professional from academic institutions, pharmaceutical industries, health care indust

there Leonard. Now that we know the questions, what can we do about it? Take a look at the list of seven strategies for your space race.

1. Key people in key positions need to be fully trained in th

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

e operation of your rocket ship.

2. Astronauts make better pilots than monkeys. Hire the right people.

3. Pulling levers and pushing buttons does not make a monkey a pilot. If they are a monkey, give

.

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

them monkey duties. If they are a pilot, let them fly the ship.

4. You can train a monkey to only do so much. Then you need an astronaut.

5. Astronauts need to have a destination to fly to.

6. If yo

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

Companies that provide selfless information through particip

keep flying the ship, no one else learns to be a pilot. They become monkeys.

7. Everyone likes monkeys until there is a crisis.

For the new year is your course set? Do you have astronauts or monkeys

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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Our mental perspective is much like our eyesight. Without new glasses to help us see the world in new ways, we can gradually lose our focus, take things for granted or just assume we know how things are, even if they are blurry. We can always benefit from a fresh perspective…

Every employer or manager is looking for the same thing. If you can demonstrate that you have this much sought after ability you'll rarely experience unemployment and if you do it will be short lived.

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Useful Advices - The space race, Customer Service and monkeys flying rocket ships. 7 strategies for the New Year.

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