Advice You - Business

When attempting to manage change in an organization you have to first understand that there is no such thing as organizational change – there is only people change. Organiza

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

tions are simply groups of people working under a certain structure that enables them to accomplish the work at hand. It’s important that you get that as most people don’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

Now that we have that out of the way, let’s turn to the question of ‘why’ people change. Understanding the ‘why’ is the first step in the challenge of engaging people in 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.

organization in the change efforts. If you miss this one, you’ll miss lots more and your efforts will never get off the ground.

There are two reasons and two reasons only

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

that people change. One is inspiration, the other is desperation. People are inspired to be different or they are forced through some form of desperation. Think about it … p

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

Combination pro

eople change primarily around events like marriage, birth, death or a health crisis. Let me explain.

Several years back I was an alcoholic. I started drinking when I was fo

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

rteen years old. Growing up in a small town in Ohio, seventy-five people, and we had one saloon. If you could get your head over the bar, you could get served. My friends an

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 I used to gather up soda bottles for two cents each and cash in a quarter’s worth and buy a quart of Carling Black Label. That was my start.

Fast forward a little over a

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

decade, I’m late twenties, married with one child and still drinking out of a fire hose. My time in Nam as a Marine sniper didn’t help matters and after six years of marriag

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

my wife had had all the fun she could take. Long story short, one day my wife punched me in the mouth and said, “Me, or drinking … make a choice!”

Well she changed my life

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

and in that moment of desperation I made a choice … I changed. But I tried for years to change out of my own inspiration and each time I failed. For me, I couldn’t make tha

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

Following aspects would a

t dramatic change until my life was on the edge of the cliff and while it was difficult and very hard to do … I made it, purely out of desperation. While my change was perso

dd to the challenges in developing combination products:

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

al, it is the same. Almost all ‘organizational change’ is also made out of desperation.

Think about IBM when they had to bring Lou Gerstner in to fix it. They put off the c

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

hanges for years until they were near death as a corporation then brought Gerstner in out of desperation. Gerstner was talented and came with a mandate and his changes could

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

be said to be out of inspiration. So what drove the changes was desperation, the changes were out of inspiration.

People in the organization, in IBM’s case, were first for

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

ed to change out of desperation from the lack of leadership before Gerstner. After he took charge and introduced the changes necessary to save the business, the people were

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

Professional from academic institutions, pharmaceutical industries, health care indust

now being changed as a result of his inspiration. That’s how it works. Change from inspiration happens twenty percent of the time and the other eighty percent comes from des

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

peration.

I just returned from working with a large organization that decided to move a headquarters to Europe to save a couple hundred million on taxes. For the people her

.

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

in this country, many with over twenty years with the company, one person’s inspiration was their desperation. While it doesn’t change the pain involved with changing, it d

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

Companies that provide selfless information through particip

oes help to understand the ‘why’ of changing.

When you’re managing change, always understand the two reasons people change … one is inspiration and the other is desperation

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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