Main Subject - Business

Recently, a woman called to ask about replacing a magnetic sign she had purchased fr

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

om another company. Her original sign had actually blown off the side of her 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

had visions of the sign flailing around in the wind and striking some poor motorist

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

behind her or worse yet, some fellow on a motorcycle. I inquired as to whether she

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

ad tried to get her money back. But it seems the company refused to refund her mone

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

Combination pro

y and worse yet, claimed it was her fault. Appallingly, they accused her of placing

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

the sign on a dirty car surface.

Although surfaces should always be cleaned before

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

any type of sinage is placed on them, rarely should a magnetic sign “blow” off, if e

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

er. The sign company that sold her the original magnetic probably made two glaring

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

errors. 1) They used an inexpensive magnetic material not meant for vehicles, espec

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

ally moving ones. The sign business is intensely competitive and some disreputable

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

Following aspects would a

ompanies turn to cheap material for an edge. 2) They cut corners and I mean literal

dd to the challenges in developing combination products:

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

ly! They cut square corners instead of rounded corners. Rounded corners prevent th

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

wind from “catching” an edge.

In fairness to the company, maybe they didn’t know a

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

ny better. There are tricks of the trade that can come only with experience. But t

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

at does not help the woman that lost her sign. And even though these companies don’

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

Professional from academic institutions, pharmaceutical industries, health care indust

t last long because they loose repeat business, it agitates me to see a customer hav

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

a bad experience buying a sign.

So if you are off to buy a magnetic sign, concentr

.

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

ate on getting the right material. Make sure you ask for 30 mil thickness with roun

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

Companies that provide selfless information through particip

ed corners. And don’t let them charge you for the rounding. It should be a standard

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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When knowledge is based on truth it is powerful! When it is critical knowledge, its presence can drive our success, while its absence may contribute to our failure. I will attempt to convey in this ...

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Main Subject - Magnetic Signs: Where Do They Work Best?

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