Advice You - Business

If you are like me you may have been stuck on how we were ever going to take back the lead in business from those countries that are producing tech-savvy engineers now creatin

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

g companies that seem to be taking over every industry. This change has caused me a lot of concern; I couldn’t see how we were ever going to become number one again.

I finall

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

Examples of combination products may in

realized what was happening and now I am no longer worried.

The advantage those other guys have and the problem we have to over come are really one and the same; like opposi

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

te sides of the same coin.

Those fast-rising countries are starting out with nothing in place. There are very few successful business, very few experienced executives and man

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

gers, hardly any proven systems, techniques or practices in place, and scores of eager workers willing to apply whatever works best. These businesses are working on a blank sh

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

Combination pro

eet of white paper; they are applying new ways of handling data, digesting information, analyzing problems and designing solutions. They have no past to replace, no investment

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

in old systems to consider salvaging, no employees who are fighting change and no management stuck on yesterday’s fast-fading success.

We have all of the old stuff to get aro

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

und, over, through, or under. We have to prove every change as better and by how much (what’s the annualized ROI?) We have thousands of experienced employees, managers and exe

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

utives sitting in place convinced that the old way is best.

Not only do these characteristics frustrate the older companies in their quest to join the new millennium, they al

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

so keep the young folks coming up from really getting their bite at the apple.

That’s why entrepreneurship is such a hot item today. These young people - having found no room

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

at the inn - have gone to work in the stable. And once they set up shop, they bring in every new piece of relatable technology they can find and put all those pieces to work o

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

Following aspects would a

n the projects of their choice.

These up and comers don’t care about ROI, or risk analysis, or source and use of funds spreadsheets; they care about doing things that haven’t

dd to the challenges in developing combination products:

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

been done before. They care about succeeding at what they want to do.

The battles our in-place businesses have faced and are facing are difficult. During the last ten or so y

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

ears many executives, managers, and employees had to unlearn things in order to give the new things a chance to show what can be done. Some did, others didn’t and they are no

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

onger employed. These battles are not over, but they are getting easier.

Each day more newcomers enter the business world with great dreams, lots of hope and no history to ov

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

ercome. Each day more old timers, either by choice or directive, move on to their next place in life. Each day the newcomers show the old horses still interested and willing t

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

Professional from academic institutions, pharmaceutical industries, health care indust

learn how to do things differently.

Each day more companies turn the technology corner; improve productivity and get back on the road to reclaiming our place as the number o

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

ne economic engine of the world.

What does this mean to you?

If you are a business owner or a manager, update your skills - constantly. Motivate those who work with you and

.

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

or you to do the same. To quote Dr. Collin’s from his book “Good to Great”, get the wrong people off the bus, get the right ones on the bus and in the right seats - then let t

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

Companies that provide selfless information through particip

he bus pick the best road for your business to travel.

Yes, I feel better about us than I have in a long time.

The author can be reached at www.businessstrategyartconsoli.co

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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Do you fear competition or is it just a fact of life? Your answer dictates what your future actions will be.

When airlines believe that they can not only inconvenience you, waste your time, subject you to spurious rules and regulations, ignore your involuntary bodily functions, and physically abuse you, all with impunity, you just have to say, flying sucks.

Your career might be going great guns - or it might not. You may be 27 or 47; you might be at the top of the tree or you might be just a couple of years into your career. Male or female, pfahh, it doesn't matter a single jot! You don't feel right - you just don't feel right...

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