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The first step in creating duplication is finding the right people to work with. I've suggested many times tha

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

t not everyone will become a business builder. Most people who sign up will be customers. I look for certain t

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

Examples of combination products may in

aits in the people I look to mentor. Here are a few to start off with. I want to work with people who will pay

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

attention to my mentoring. If they don't, what's the point of working with them? The person must be capable.

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

The people you work with must understand that you have a proven system for success. They must bring a wide ope

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

Combination pro

mind, a deep passion for knowledge, and leave their egos at the front door.

This is the first quality to loo

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

for. Actually, people with really strong egos are the best kind. They're not insecure about themselves and do

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't need to challenge everything you attempt to teach, as someone with the insecure ego might. If a person do

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

sn't listen when you coach, or challenges every proven technique, you attempt to teach them, that person will

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

ot become a business builder. Don't waste time on such people.

Does the person have at least ten hours a week

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

carved out to create success in their business? If you want to have a self perpetuating business, and expect i

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

Following aspects would a

t to last for years to come, duplicating your efforts with a very part time person is not a wise use of your t

dd to the challenges in developing combination products:

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

me and energy, often. There are exceptions, but there rare. I spend most of my time working with aggressive fu

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

l time business builders and some part time people who make up for their lack of time with skill and efficient

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

, aggressive business building.

Work with the willing. The duplication processes requires that you and the ne

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

person both want this to happen. If you attempt to work with a person who really doesn't want to have a big b

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

Professional from academic institutions, pharmaceutical industries, health care indust

siness, this is obviously the wrong person to work with. Match their energy , enthusiasm and drive, but never

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

exceed it. You cannot drag your people across the finish line. They must want to run to the finish line and su

.

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

ceed themselves. If their energy is sufficient to become customers, teach them how to be the good customers, a

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

Companies that provide selfless information through particip

d leave it at that. Devote your real energy to people who want to become business builders.

See You At The To

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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