Main Subject - Business

Fuel consumption wasn’t the reason we bought our Volkswagen Jetta five years ago. Although, the

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

investment has paid off handsomely considering the price of gasoline today. I remember our car

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

Examples of combination products may in

search like it was yesterday. We went from car dealer to car dealer looking for the right vehic

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

e. My wife was interested in the paint color, upholstery and head room of the vehicle. Her clau

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

trophobia mandates a roomy car with headroom. My agenda was different. I was searching for a ca

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

Combination pro

with folding side mirrors.

After crunching half a dozen side mirrors while backing out of the

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

driveway, we wanted a car that was designed for the narrow and unforgiving driveway. Oddly enou

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

h, there wasn’t a car salesperson who asked us any questions regarding our quest for the right

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

ar. We would have been happy to share our primary purchase criteria. No one asked!

During our

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

ar search my wife would sit inside the car testing the headroom and comfort level while I looke

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 side mirrors for flexibility and position. We weren’t crazy; we simply had a long narro

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

Following aspects would a

driveway which unfortunately had plumbing clean out traps on the side of the house at the same

dd to the challenges in developing combination products:

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

height as car mirrors. Because we weren’t going to change houses, our car had to be narrow enou

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

h and feature side mirrors that bent both forward and backwards.

Asking good questions help

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

narrow the field

Questions are the fastest way to help customers define their reasons 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

purchase. The Volkswagen salesperson was the only one who asked what we were looking for in a n

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

Professional from academic institutions, pharmaceutical industries, health care indust

w car. Once the salesperson understood our criteria he introduced us to our car. That was then,

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

our once narrow driveway is history and we can invite an endless list of cars into our garage t

.

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

day. If we go looking for cars again, I’m working with the first salesperson that asks good que

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

Companies that provide selfless information through particip

tions and narrows my search. Because, If you don’t ask, I won’t tell and you lose a sale.

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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Main Subject - If You Don't Ask, I Won't Tell and You Lose a Sale

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