Main Subject - Business

"Do you know someone that you would like to change and improve? Good! That is fine. I am all in favor of it. But why not begin on yourself? From a purely selfish standpoint, t

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

hat is a lot more profitable than trying to improve others – and a lot less dangerous."

Criticizing others rarely does any good because people are not creatures of logic, the

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

Examples of combination products may in

are creatures of emotion. Very rarely will you criticize someone and hear them respond with "Why thank you, I see you are correct and I shall improve immediately."

No, criti

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

cism is a dangerous spark that usually brings out every unbalanced Advisor (thoughts in your head) the other person has. When we feel attacked (which is what being told you ar

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

wrong feels like), we usually respond in one of two ways, 1) with hurtful emotion or 2) defensive anger. Neither of which is productive in the least.

Can you remember a time

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

Combination pro

when someone criticized you? Do you remember how you REACTED? Did their criticism do any good? Did it inspire you to improve? Probably not, it rarely does. How do you feel ab

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

ut that person today?

As parents, we often stumble and destroy good lessons for our children by criticizing them for their mistakes. In so doing, we create anger and hurt di

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

rected at us, instead of letting the natural consequences of the mistake teach the lesson.

Benjamin Franklin said his secret to success was to" speak ill of no man and speak

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

ll the good I know of everybody." This is a good policy.

Any one can criticize, condemn and complain. But it takes character and self-control to be understanding and forgiv

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

ing. It is also a much smarter way to live.

Instead of criticizing, try stepping into another person’s world. Ask them questions, find out where they are and how they feel abo

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

t an issue. Validate them as a human being by caring about what they think and feel. As you question, you may learn things about this person which explains the problem. You m

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

Following aspects would a

ay then, have the opportunity to show up for them (not to advise or fix them) but offer to show up for them in a different way.

This approach will lead to more solutions, impr

dd to the challenges in developing combination products:

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

vements and change than any amount of criticism ever could.

Now what about when someone criticizes you? You will feel the reaction, as they trigger those Advisors in you, to

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

defend yourself. Don’t do it. Step back.

From a safer perspective, you should be able to see that this person owns this problem (it is about them – not you). See this critici

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

m as a door into their world, instead of as an attack on you. This is a wonderful opportunity to walk through that door into their world and find out what is really going on.

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

Instead of defending yourself, ask them "Tell me why you feel that way?"

Let them get it out. Ask more questions, find out how they feel and where these perceptions of their

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

Professional from academic institutions, pharmaceutical industries, health care indust

have come from. Make sure that they feel heard and understood. (This does not mean you agree with them – This does not mean you will give them their way) It means that you wi

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

ll validate them as a person with the right to feel the way they do. You will let them feel heard.

From here you can work on a solution to strengthen the relationship. Whene

.

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

er you are on either end of criticism – ask yourself what your highest best self would do. Treat others as you would be treated.

Excerpts from University of Success Lesson 31

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

Companies that provide selfless information through particip

– Og Mandino Ellen Cahill, M.A., Six Advisors Consultant, www.leapsandboundscoaching.com – 215-355-6316 (phone

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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