Advice You - Business

I spend a bit of time on airplanes. So, I was surprised by what I observed on a regional jet. Yes, it was holiday travel. Yes, the flight

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

was overbooked. Yes, infrequent and tired travelers were creating challenges for the only stewardess. Still, she saw the small boy, no m

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

Examples of combination products may in

ore than eight, seated in the exit row next to his grandfather. She chose to ignore him, wishing and hoping her safety message stating a

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

erson must be over fifteen to sit in the exit row would fix it. Maybe she didn't want the hassle of trying to reseat passengers on an alr

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

eady late flight. Maybe she was tired, too. Who knows?

What I do know is that despite the safety implications of her decision, she chose

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

Combination pro

the path of least resistance that day. And she's not alone. Many people take that path at work. They choose the easier way rather than

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

oing what needs to be done. But, the path of least resistance leads away from winning at working.

You'll be on that path if you turn a b

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

lind eye to something you know needs solving but you don't want to address it or "rock the boat;" or you let a mistake pass your desk for

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

someone else to catch and fix because it's too complicated or time-consuming; or you ignore a difficult person or a recurring problem be

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

ause you don't want to create unpleasantness or deal with conflict; or you pass off a poor performer to another department rather than fa

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

ce the difficult conversation; or you resolve the customer complaint without calling out or solving the bigger issues behind it.

In my t

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

Following aspects would a

hinking, that's the adult equivalent of my son, as a child, pretending he never noticed the toilet paper roll needed replacing. He'd leav

dd to the challenges in developing combination products:

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

a sheet or two on the cardboard tube so he didn't have to be the one to do anything about it. Of course no one in the house was fooled.

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

No one at work is either.

In twenty years of management, I've learned that the difference between doing the right thing and the easy thi

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

ng significantly differentiates people's performance. We can debate what the right thing to do is at any given time. Sometimes, it might

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 choosing the more difficult, challenging, time-consuming path or the one that comes with more risk. But like my son and that stewardess

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

Professional from academic institutions, pharmaceutical industries, health care indust

, I think most of us know what the right thing is most of the time, and we know when we've chosen the easier way.

In Lee Ann Womack's co

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

untry hit, "I Hope You Dance," there's a great line that applies as much to work as it does to life: "I hope you'll never fear those moun

.

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

ains in the distance; Never settle for the path of least resistance." You see, if you want to be winning at working, you can't fear the m

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

Companies that provide selfless information through particip

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 - The Path of Least Resistance

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