Advice Pool - Business

I'm always fascinated by the people who lift huge weights, particularly in competitions like the Olympic Games. There are events for men and women and they get up on stage to lift a bar with huge we

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

ights attached. I often wonder what sort of things they're saying to themselves as they pace up and down, rubbing their hands with resin powder and taking huge breaths.

What if they were saying - "

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

Examples of combination products may in

hat looks really heavy - it's heavier than anything I've lifted before. I'll probably drop it, make a real fool of myself and even injure myself to boot….!"

Do you know what's going to happen if th

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

y say all this stuff to themselves? Their subconscious will say - "Okay, you say you're going to drop it. Then, that's what I'll arrange - and I'll try to make sure you injure yourself at the same

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

ime."

Of course, that isn't what happens. This weight lifter, who's trained for years to do precisely this thing, is screaming at himself internally - "You're going to lift that bar and push it rig

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

Combination pro

ht through the ceiling! You're going to break the world record! You're going to win this competition and everyone in the world will see you doing it!"

In the day-to-day tasks that we face in our lif

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

, we should be no different from these sportsmen and women. Think negative thoughts and that's what your subconscious will focus upon.

If you think illness, you'll become ill. If you think gloom a

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

d doom - that's what you'll get. But if you think health, happiness and success - you're already there.

"Most people are as happy as they make up their minds to be" - Abraham Lincoln.

I read this

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

uote some years ago and I know some people have a problem with it. We all face difficult situations in our lives and some people more than others. However, I've made up my mind to be as happy as I

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

can and I recommend you do the same.

Focus on the positive things in your life - the things you can do - not the things you can't. Think about what you've achieved in the past - not what you haven'

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

. Look at where you're going - not where you've been

There's a story about a young man who was really into positive thinking. His workmates used to make a fool of him and of course, he was challeng

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

Following aspects would a

d by their taunts. He told them one day that positive self-talk was so powerful that if he told himself he could fly through the air, he'd be able to fly.

"Prove it" they cried. So off he went, up

dd to the challenges in developing combination products:

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

o the 20th floor of the building they worked in. He jumped off and was heard to cry as he went past a 10th floor window - "Well, it's all going great so far."

That sort of thinking isn't what this

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

article is about. I sometimes get tired of hearing people say - "Think positive." What I'm suggesting is that - in all the things we face in life, we focus on the positive aspects.

Say for example

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

a customer complains to you about some aspect of your product or service. It's so easy to think - "We've messed up, we're going to lose this customer's business, this is a disaster!"

It's far bette

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

to think - "Okay, we've made a mistake, what can we learn from this so that we don't do it again and make our service even better."

Ironically, it's often the case that if you solve a customer's p

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

Professional from academic institutions, pharmaceutical industries, health care indust

oblem, apologise and recover well, the customer will forgive you and become even more loyal.

Here's another example of what I mean: Say you were to discover a small lump in some part of your body -

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

or a mark on your skin. Positive thinking might cause us to say - "It's nothing, I'll leave it and it'll go away by itself."

Negative thinking, on the other hand, would have us say - "Oh no! I've

.

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

ot cancer, I'm going to be in pain and misery and I might die."

Focussing on the positive allows us to say - "I must get this looked at immediately, whatever it is. They have marvellous ways of rem

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

Companies that provide selfless information through particip

ving and curing these things nowadays."

There will always be challenges to face with customers and the people who work with you. Focussing on the positive will make them so much easier to deal with

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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