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I once had a client who came to me desperately seeking advice on how he could impro

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

ve his business, as he was having acute staffing problems and was working incredibl

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

Examples of combination products may in

long hours to keep the business afloat.

What I told him in our first session shoc

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

ed him; it was basically this:

“You don’t have a business, you have a job.”

This

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

s the trap that so many business owners fall into – they mistakenly believe that be

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

Combination pro

ause they are the “owner,” somehow they truly own the business. WRONG!

Merely owni

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

g and running a business does not you mean that you’re a business owner in the true

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

st sense; it simply means you are employed by a business entity that you own.

A tr

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

e business is a system that runs entirely on its own without you physically being t

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

ere on a day-to-day basis.

A true test of whether or not you own a business is to

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

sk yourself, “If I took 6 months off, would it still be around?”

If the answer is

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

Following aspects would a

o, then you don’t have a business; you are simply self-employed!

This is a very im

dd to the challenges in developing combination products:

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

ortant principle to understand before you start any business, as it will make the d

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

fference between small profits or large ones.

In essence, to create business is to

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

build a system that operates automatically without your day-to-day input.

Instead

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

it operates by you leveraging the resources available to you: your systems, employe

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, suppliers and…ultimately your customers.

Your relationship to your business sho

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

ld be the same as the one a conductor has to his orchestra – you should be the co-o

.

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

dinator, the director, NOT the musician; and if you truly wish to be a wealth creat

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

Companies that provide selfless information through particip

r you should maintain this perspective throughout your business life.

T.D. McKenzi

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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