Advice You - Business

"Ed, I used to love this place. We were all firefighters when we needed to be, and that's good. But right now it’s full of arsonists

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

."

Change leaders don’t get it. They confuse enthusiasm for progress. Oftentimes their best people are arsonists and they don’t eve

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

Examples of combination products may in

n know it. They allow their organizations to be so hooked on the old ways of firefighting, where they get their jolly's being the fi

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

re chief and putting out fires that they can't let it go. They don’t have the guts to instill process discipline, discipline that is

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

needed to drive change.

When we were brought in to Compaq in the mid-nineties to change the logistics landscape, I met with one of

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

Combination pro

our VP's, a lady I liked a lot, who was leaving. She told me how exciting it was in the beginning of the company. Everyone had to pi

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

tch in and make things happen.

"Why are you leaving then?” I asked.

She dejectedly said, "Because now that we have to change and m

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

ve to the next level, where we need process and discipline like you guys are bringing, we have more arsonists than firefighters. We

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

have people setting fires everywhere just to slow you down.

Every organization needs firefighters, people who step up in a crisis a

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

nd make it happen. But when you live by the match you die by the match. When you thrive on the thrill of the chase you'll soon need

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

fix like the junkie on the corner. The excitement, the thrill in itself becomes the adrenaline that drives you.

I know first hand.

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

Following aspects would a

As a Marine sniper in Vietnam for two consecutive years I was an adrenaline junkie. When I came home it took me five years to wean

dd to the challenges in developing combination products:

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

myself from the high I experienced. I took up flying, rock climbing, racing, you name it but nothing satisfied me until I 'got it'.

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

That's how some people become in organizations.

So what do they do? They do a little like I did; they try doing things to feed thei

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

need for an ego boost. They begin to create problems to feed their fix. They may not even know it, I didn’t for quite awhile. But b

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

efore long if they don’t change, they become like a crack head. Soon your project is heading for a titanic sized crash on the beache

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

Professional from academic institutions, pharmaceutical industries, health care indust

s of change.

As the change leader you must not let arsonists prevail. You must teach and preach process and step in like a forensic

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

cop at the first sign of a fire. Make sure you're not dealing with a serial arsonist if you want project victory.

If you want your

.

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

change to be the talk of your organizational town - you'll make sure you have the right number of firefighters and all the arsonists

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

Companies that provide selfless information through particip

go to jail. It's your choice. Your organizational project will have freedom or anarchy and as the leader, it’s up to you!

Ed Kugle

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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