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People change their entire lives but argue every time someone else wants to make us change. Think about it? Look back on your life and all progress comes from change. We talk about it, think about it, complain about it; then we dig our heels in when change

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

is what makes the world go round. And it drives businesses crazy. So what do we do about this thing called change that everyone on earth whines about?

The first step to changing your business or life is to accept, I mean really accept, that all progress in

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

Examples of combination products may in

life comes from change but not all change is progress. What does that mean? It means that you have to look around and realize that every major breakthrough in life, such as medicine or science, has come with a break ‘with’ the past. Think about it. New med

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

icines or vaccines, men on the moon, no one thought those things were possible so they had to let go of old thinking to create something new. They had to break ‘with’ the past to enjoy a new and changed future and so do you and your business.

Okay that tak

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

es care of all progress comes from change but what about not all change is progress? We only have to look to Washington and our illustrious Congress to realize that when they make a change ninety-nine out of a hundred times it sure isn’t progress. The Bozo’

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

Combination pro

s we elected as leaders make laws every day that are change but not progress.

The second step is to say I am responsible. If I am going to change my life or my business it is up to me, no one else. It is not the fault of your father or mother or your boss

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

that you are the way you are. Just take responsibility, accept no excuses and understand that if you are to change, it is up to you and no one else. For goodness sakes I saw a Marine Corp martial arts instructor on TV the other night with no hands … you can

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

do what you desire if you will.

The third thing is to begin by answering two questions. The first is what problem am I trying to solve? That means what are you trying to change? Don’t say I want to look better, feel better or change our department. Be spe

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

cific. The second question to answer is what will success look like when I solve this problem? Again, be specific and don’t just fill up a sheet of paper wishing something will change.

I once counseled with the VP of an $8 billion company who asked if I co

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

uld help. I said, what’s the problem? He spent two and a half days telling me he fundamentally wanted to change the way he delivered their products. I finally said, “If I figure out how to deliver your cement on helicopters it would fundamentally change the

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

way you deliver but so what?” He slammed his fist down and said, “If I don’t take $2 dollars a ton out of our delivery cost I’ll be fired!” You see cost was the problem, the $2 was specific and that’s what I am talking about. Once you get this far you’re

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

Following aspects would a

ready for a change.

Start by looking in the mirror and being honest about where you or your organization is today. I mean brutally honest. You have answered where you’re going and what success will look like when you get there, now you need to have a stop

dd to the challenges in developing combination products:

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

kidding yourself day about where you are right now. Only then can you know how far you have to go to reach your change goal. This is what I call removing all of the BS. It’s not right or wrong, it just ‘is’.

By establishing where you are today you know how

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

big the gap is that you have to bridge. Once you know the gap then you decide if you are willing to pay the price it will take to make the journey of change across the gap between where you want to go and where you are today. It is important to know if you

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

will make the commitment before you make the leap of change. Otherwise you get discouraged and feel worse and if you’re trying to change an organization your people will spin wildly into the funnel of cynacism. Don’t let that happen to you.

After you know

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

where you’re going and that you’re willing to pay the price to get there, sit down and make a plan. Your plan needs to be a realistic stretch. You need to stretch yourself and your people without forecasting heroism. Heroes just happen; you don’t build the

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

Professional from academic institutions, pharmaceutical industries, health care indust

m in to a plan. Your plan must be doable or you’ll quit before you get started. You must be honest again, will you have the daily discipline to take the steps necessary to complete the journey from where you really are today to where you want to go. It’s no

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

t rocket science, you can do it by knowing you will either suffer the pain of discipline or the pain of regret.

The journey of change is as normal as the seasons we love to experience each spring and fall, but it’s easier ‘not to change’. Why? I don’t know

.

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

. It doesn’t matter. It only matters that you know it is possible to change at any stage of the game. The steps above are simple; you don’t need therapy or a life coach or one of the big consulting houses. You need to want to change and follow these simple

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

Companies that provide selfless information through particip

steps. And when you fail, dust yourself off, get up and get back in the game and keep making your way across the gap between what problem you are trying to solve and what your success will look like one honest, disciplined, sometimes painful step at a time.

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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