Advice You - Business

While I encourage you to follow your parent’s direction and always use “please” and “thank you” as they are greatly appreciated by

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

all, these are not the words I reference in the title of today’s post. The words that I’ll share with you in the text that follow

; 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 not used nearly often enough and when used correctly can make a dramatic difference in raising your productivity to new heigh

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

s.

Let’s start with the word that will help you clear the decks to focus on highest and best use activities. The word is “no”… Mo

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

t achievement oriented professionals want to take on the world and as such have a propensity to bite-off more than they can chew.

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

Combination pro

eing over committed will suck the life out of those who possess even the greatest amounts of energy.

Saying ”no” doesn’t come eas

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

y to many as it is counter intuitive to wanting to help others succeed. The fact is that by saying “no” more often you’ll help oth

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

rs develop their skill sets faster by not being overly dependant upon your expertise. It is critical to remember that by solving o

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

her’s problems or fixing their mistakes you are neither being productive or a good leader. When someone asks you to bail them out

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

ou should tell them that you would be happy to support them by coaching them through the issue, but that they’ll have to resolve i

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

on their own accord. This is leading by mentoring and educating not by being a doormat.

By learning to say “no” to things that d

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

Following aspects would a

o not constitute highest and best use activities you will find that you have much more time to focus on priorities and you’ll noti

dd to the challenges in developing combination products:

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

e an immediate boost in productivity. Additionally with appropriate use of the word ”no” you will start to build some bench streng

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

h by training people to resolve conflict and problem solve on their own.

My other favorite word is “why”… No other word can cut t

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

rough ambiguity, force justification of positioning, control a conversation, surface flawed logic or stimulate refined thinking li

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

e the proper use of ”why.” The skillful application of “why’ can also serve to test the depth and breadth of someone’s commitment

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

Professional from academic institutions, pharmaceutical industries, health care indust

or subject matter expertise.

My favorite use of ”why” kills two birds with one stone…it allows me to gain an insight into how peo

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

le think by having them step through their thought process while at the same time using the exercise as a teaching tool. By contin

.

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

ing to drill down on a subject with the appropriate use of “why” I have watched individuals take what was little more than a raw c

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

Companies that provide selfless information through particip

ncept and within a matter of minutes refine it into a well fleshed-out plan.

Use these two words and watch your productivity soar

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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Advice You - Two Words That Can Change Your Life

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